Reviews on Recent Clinical Trials - Volume 17, Issue 3, 2022

Perianal fistulizing Crohn’s disease (PFCD) is a disabling complication of Crohn’s disease (CD) that can significantly impact the patients’ quality of life (QoL) and often requires multidisciplinary care. Clinical trials assessing the efficacy of medical and surgical interventions for fistulas usually evaluate outcomes such as the closure of fistula tracts or radiologic healing. However, these traditional outcome assessments fail to capture the impact of the disease from patients’ perspectives. In this context, regulatory authorities have increasingly encouraged the inclusion of validated patient-reported outcomes (PRO) that assess disease activity and reveal how a patient functions and feels. This recent trend toward patient-centered care aims to ensure that improvements in efficacy outcomes are accompanied by meaningful benefits to patients. The aim of this review is to discuss currently available PRO measures (PROMS) for the assessment of PFCD to provide physicians with appropriate tools aiming to optimize patient care and disseminate the use of these instruments in clinical practice.

Background: Anxiety and depression are the most common psychological disorders found in Inflammatory Bowel Disease (IBD) patients. Accurate measuring of these disorders should be proposed for prompt management. Patient-reported outcome measurements (PROMs) allow patients to self-report their psychological symptoms. Objective: The objective of this study is to highlight the presence of PROMs measuring anxiety and depression in IBD setting, evaluating the most used psychometric tools. Methods: We reviewed the literature from 2010 up to September 2021. Articles on adult IBD patients assessing depression and anxiety by PROMs in English language were included. Results: Thirty-six studies, including 11 psychometric tools were found. Hospital Anxiety and Depression Scale (21 studies), Beck Depression Inventory II (5 studies), Spielberg State-Trait Anxiety Inventory (3 studies), Patient-Reported Outcomes Measurement Information System (3 studies), Symptom Checklist-90 (2 studies), Euro Quality of Life (2 studies) mostly used psychometric tools for anxiety and depression in IBD settings. Conclusion: Our review analyzed psychometric tools used for PROMs evaluating anxiety and depression in IBD setting. No chronological differences have emerged, all have been used in the last ten years, highlighting lack of specificity. The strong association between IBD and mood disorders suggests that clinicians should consider the evaluation of depression and anxiety as integral parts of IBD clinical care. It is essential to identify tools enabling these items to be detected better. A global view of IBD patients, accounting not only for physical but also for psychical symptoms with an early and feasible assessment of unrecognized psychiatric disorders, can have a strong impact on their management strategy.

Background: Psoriasis is a chronic relapsing immune-mediated disease leading to a strong impact on patient’s quality of life. The treatment of psoriasis has undergone a revolution with the advent of biological therapies. Currently, Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are in use to assess the overall severity of pathology. A new self-administered questionnaire, the Psoriasis Symptoms and Signs Diary (PSSD), assesses the severity of six psoriasis symptoms (itch, skin tightness, burning, stinging, and pain,) and five signs (dryness, cracking, scaling, shedding/flaking, redness, and bleeding). Objective: To evaluate and compare the efficacy of biologic therapies through PSSD in patients with moderate to severe psoriasis. Methods: The PSSD questionnaire was administered to all the patients at the beginning and after 6 months of biologic therapy (anti-TNFalpha, anti-IL17, anti-IL23, anti-IL12/23 and phhosphodiesterase-4 Inhibitors). Results: The study population included 417 adult patients with moderate to severe psoriasis in treatment with biologic drugs. All the drugs contributed to a significant improvement in mean total PSSD at t 24; anti-IL17 and anti-IL23 led to a significantly greater reduction at t 24 mean PSSD when compared to other therapies. Conclusion: The PSSD, is a new validated instrument useful for capturing psoriasis patient’s quality of life and evaluating treatment efficacy. In our study, this score has been useful to put in evidence significant differences between biological drugs.

Background: Although mood disorders have been well characterized by immunemediated inflammatory diseases, physical function and satisfaction with social roles have not yet been defined as independent domains. Objective: The study aims to assess satisfaction with social roles and physical function alterations in a population with immune-mediated inflammatory diseases and identify associated characteristics. Methods: Physical function and social role satisfaction were evaluated through the Patientreported Outcomes Measurement System. Besides comparison between groups, univariate and multivariable logistic regression analyses were performed to identify independent predictors. Results: Two hundred sixty-five patients with immune-mediated inflammatory diseases and 206 controls were recruited. Compared to controls, patients with inflammatory bowel diseases had impaired physical function (p<0.001), while patients with inflammatory arthritis reported impairment in both domains (p<0.001, each). In the univariate logistic regression, gender, high school educational level, physical activity, and occupation were positively associated with physical function and social role satisfaction (p<0.001; p=0.001; p<0.001; p=0.001 and p<0.001; p=0.012; p=0.008; p=0.004, respectively). Active disease and steroids were inversely associated with physical function and social roles satisfaction (p=0.033; p=0.022 and p=0.002; p=0.038, respectively). Further associations were found between age and physical function (p=0.002) and biological treatment and ESR with social roles satisfaction (p<0.001; p=0.043; respectively). In the multivariable regression, gender was found to be associated with physical function (p<0.001) and social roles satisfaction (p=0.003). Negatively associated factors were biological treatment for satisfaction with social roles (p<0.001) and steroids for physical function (p=0.021), and social roles satisfaction (p=0.018). Conclusion: Immune-mediated inflammatory diseases determine alterations in physical function and social life satisfaction. Gender and treatment are independently associated factors. Patientreported outcomes should be considered in clinical management to define patients’ real needs.

Background: Recent literature suggests that the respiratory rate oxygenation (ROX) index may be useful in predicting intubation indication in hypoxemic patients. Objective: In this study, we evaluated the accuracy of the ROX index in predicting intubation, length of stay in the ICU, and mortality in ICU patients with hypoxemic respiratory failure with and without hypercapnia. Methods: A single-centre retrospective cohort study of 290 patients with a preliminary diagnosis of respiratory failure were treated with low-flow oxygen systems. Demographics, medical history, clinical, laboratory, treatment, and prognostic data were obtained from the hospital's electronic records. The ROX index was calculated at the time of ICU admission. Results: Thirty-seven percent of non-hypercapnic and 69% of hypercapnic patients were intubated (p:0.005). In hypercapnic patients, ROX: 6.9 had highest sensitivity (81%) and specificity (65%) values for intubation (p:0.005). In non-hypercapnic patients, ROX: 6.2 had the highest sensitivity (81%) and specificity (40%) values. While 11% of hypercapnic patients and 30% of non-hypercapnic patients died (p:0.05), 22% of hypercapnic patients and 33% of non-hypercapnic patients stayed in the ICU longer than 14 days (p:0.044). The highest sensitivity and specificity values were found for mortality in hypercapnic patients; for ROX value of 5.94 (sensitivity:86%, specificity:61%) and ICU stay longer than 14 days; for ROX value of 7.4 (sensitivity:71%, specificity:68%). Conclusion: Results of our study suggest that the ROX index calculated during ICU admission can help predict intubation indication and length of ICU stay in patients with respiratory failure and hypercapnia may influence the cutoff values.

Background: Highly Active Antiretroviral Therapy (HAART) is composed of several drugs in the antiretroviral class to better treat human immunodeficiency virus type 1 (HIV-1) patients. The estimation of CD4+ T cell counts and HIV-1 viral load in plasma is required to evaluate the treatment success of a specific HAART. Methodology: The study included the effects of NRTIs (nucleoside reverse transcriptase inhibitors) and novel protease inhibitors (HAART) on normal control subjects and HIV-1 positive subjects from SGPGIMS, Lucknow, with different age groups and genders. Furthermore, the study was conducted by the estimation of HIV through ELISA, measurement of absolute CD4+ cell count, and the measurement of viral load through qRT-PCR. Furthermore, NRTIs (Retrovir and Epivir) were administered orally one tablet daily in the morning followed by newly FDA-approved protease inhibitors (fosamprenavir and darunavir) orally in the evening at the same dose. Furthermore, CD4+T cell counts and HIV-1 viral load were investigated and correlated in patients with different genders and age groups. Results: Administration of NRTIs and novel protease inhibitors (HAART) in HIV patients had a significant effect on the CD4+ cell count in various age intervals among males and females. The mean comparison of viral load distribution based on gender in CD4 +ve patients in the case group exhibited a viral load higher in females compared to males, indicating a statistically significant difference between males and females (p<0.05). A notable association between virological and immunological parameters was observed with a reciprocal relationship between viral load and CD4 cell count in CD4 +ve patients, demonstrating multiple correlation coefficients with an R-value of 0.853. Conclusion: The administration of specific HAART (NRTIs and novel protease inhibitors) in HIV patients had a notable improvement in the CD4+ cell count and viral load with significant age and gender disparity.

Background: Tonsillectomy is one of the most common surgical procedures. This study compared the effect of Pregabalin and Clonidine on postoperative pain in adult patients undergoing elective tonsillectomy. Methods: This randomized, double-blind, prospective clinical trial was conducted among 92 patients aged 20 to 50. The clonidine group (C) was given 150 μg of clonidine tablet 90 minutes before surgery, and the pregabalin group (P) was given 300 mg of pregabalin tablet 90 minutes before surgery. The results were analyzed by SPSS 25, and statistical analysis consisted of chisquare, T-test, and χ² tests, and a p-value less than 0.05 was considered significant. Results: The mean pain score and analgesic consumption scores in the pregabalin group were lower than in the clonidine group. According to the t-test, there was a significant difference between the two groups regarding pain score and analgesic consumption (p <0.05). Hemodynamic variation in both groups had no significant differences (p >0.05). Conclusion: The present study showed that pregabalin reduced postoperative pain and analgesic consumption more effectively than clonidine.

Background: Hepatic encephalopathy is defined as a spectrum of neuropsychiatric disorders in patients with liver dysfunction, usually cirrhosis, after exclusion of brain disease. This study reports the role of manganese in brain alterations and clinical manifestations of hepatic encephalopathy. Case presentation: Male patient, 67 years old, suffering from alcoholic liver cirrhosis and two previous episodes of hepatic encephalopathy, developed drowsiness, asterixis, amnesia, disorientation in time and space, and psychomotor retardation. Brain MRI without contrast showed initial signs of cerebral atrophy, a hyperintense signal of globi pallidi and bilateral substantia nigra. The hyperintense signal of globi pallidi is the result of manganese deposition in the brain. Conclusion: The case report presented supports the data reported in the literature, indicating that the increase in plasma manganese levels in subjects with liver dysfunction is correlated with the onset of extrapyramidal symptoms.