Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey.

Introduction: Patient adherence is a major challenge for the successful management of any chronic disease, and ulcerative colitis (UC) is no exception. Patient adherence is closely related to patient preference of medication and formulation used. Aim: The aim of this study was to investigate patient and physician perspectives around UC treatment preference. Methods: This study was conducted in France, Germany, Spain, and the UK. Physicians and UK inflammatory bowel disease (IBD) nurses answered an online questionnaire. In addition, adult mild-to-moderate UC patients, treated with oral mesalazine, were invited to answer a 30-min online survey which included a conjoint exercise. Results: 400 patients, 160 physicians, and 20 IBD nurses participated in the survey. 68% of patients were taking tablets and 32% granules. Physicians stated that from their perspective patients are more adherent to tablets than granules (76% vs. 24%), patients tended to have better relief of symptoms with tablets (69% vs. 31%), and patients found tablets to be the most convenient formulation (61% vs. 39%). From the patients' perspective, when questioned which formulation they prefer, 58% answered tablets, 37% granules, and 5% none of these. When patients were asked about some negative attributes of tablets, the highest agreement was for "I would like to take fewer each day" (6.1/10) and "I wish I could take fewer at a time" (5.4/10). Conclusions: The majority of UC patients in this survey prefer the tablet formulation. A high strength tablet overcoming the high pill burden could be a good solution to address patient expectations.

Monocyte migration profiles define disease severity in acute COVID-19 and unique features of long COVID.

BACKGROUND: COVID-19 is associated with a dysregulated immune response but it is unclear how immune dysfunction contributes to the chronic morbidity persisting in many COVID-19 patients during convalescence (long COVID). METHODS: We assessed phenotypical and functional changes of monocytes in COVID-19 patients during hospitalisation and up to 9 months of convalescence following COVID-19, respiratory syncytial virus or influenza A. Patients with progressive fibrosing interstitial lung disease were included as a positive control for severe, ongoing lung injury. RESULTS: Monocyte alterations in acute COVID-19 patients included aberrant expression of leukocyte migration molecules, continuing into convalescence (n=142) and corresponding with specific symptoms of long COVID. Long COVID patients with unresolved lung injury, indicated by sustained shortness of breath and abnormal chest radiology, were defined by high monocyte expression of C-X-C motif chemokine receptor 6 (CXCR6) (p<0.0001) and adhesion molecule P-selectin glycoprotein ligand 1 (p<0.01), alongside preferential migration of monocytes towards the CXCR6 ligand C-X-C motif chemokine ligand 16 (CXCL16) (p<0.05), which is abundantly expressed in the lung. Monocyte CXCR6 and lung CXCL16 were heightened in patients with progressive fibrosing interstitial lung disease (p<0.001), confirming a role for the CXCR6-CXCL16 axis in ongoing lung injury. Conversely, monocytes from long COVID patients with ongoing fatigue exhibited a sustained reduction of the prostaglandin-generating enzyme cyclooxygenase 2 (p<0.01) and CXCR2 expression (p<0.05). These monocyte changes were not present in respiratory syncytial virus or influenza A convalescence. CONCLUSIONS: Our data define unique monocyte signatures that define subgroups of long COVID patients, indicating a key role for monocyte migration in COVID-19 pathophysiology. Targeting these pathways may provide novel therapeutic opportunities in COVID-19 patients with persistent morbidity.

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol.

INTRODUCTION: Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE-Myelopathy aims to test the disease-modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM. METHODS AND ANALYSIS: RECEDE-Myelopathy is a multicentre, double-blind, randomised, placebo-controlled trial. Participants will be randomised to receive either 60-100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8-14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care. STUDY DESIGN: Clinical trial protocol V.2.2 October 2020. ETHICS AND DISSEMINATION: Ethical approval has been obtained from HRA-Wales.The results will be presented at an international and national scientific conferences and in a peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN Number: ISRCTN16682024.

Systematic review of the impact of cannabinoids on neurobehavioral outcomes in preclinical models of traumatic and nontraumatic spinal cord injury.

STUDY DESIGN: Systematic review. OBJECTIVES: To evaluate the impact of cannabinoids on neurobehavioral outcomes in preclinical models of nontraumatic and traumatic spinal cord injury (SCI), with the aim of determining suitability for clinical trials involving SCI patients. METHODS: A systematic search was performed in MEDLINE and Embase databases, following registration with PROPSERO (CRD42019149671). Studies evaluating the impact of cannabinoids (agonists or antagonists) on neurobehavioral outcomes in preclinical models of nontraumatic and traumatic SCI were included. Data extracted from relevant studies, included sample characteristics, injury model, neurobehavioural outcomes assessed and study results. PRISMA guidelines were followed and the SYRCLE checklist was used to assess risk of bias. RESULTS: The search returned 8714 studies, 19 of which met our inclusion criteria. Sample sizes ranged from 23 to 390 animals. WIN 55,212-2 (n = 6) and AM 630 (n = 8) were the most used cannabinoid receptor agonist and antagonist respectively. Acute SCI models included traumatic injury (n = 16), ischaemia/reperfusion injury (n = 2), spinal cord cryoinjury (n = 1) and spinal cord ischaemia (n = 1). Assessment tools used assessed locomotor function, pain and anxiety. Cannabinoid receptor agonists resulted in statistically significant improvement in locomotor function in 9 out of 10 studies and pain outcomes in 6 out of 6 studies. CONCLUSION: Modulation of the endo-cannabinoid system has demonstrated significant improvement in both pain and locomotor function in pre-clinical SCI models; however, the risk of bias is unclear in all studies. These results may help to contextualise future translational clinical trials investigating whether cannabinoids can improve pain and locomotor function in SCI patients.

Patient Preference and Physician Perceptions of Patient Preference for Oral Pharmaceutical Formulations: Results from a Real-Life Survey.

BACKGROUND: Pharmaceutical treatment prescribed according to patient preference for a formulation may have a positive impact on adherence to treatment and consequently on treatment outcomes. AIM: This study aimed at understanding patient preference for pharmaceutical formulations and attributes that trigger patient preference and physician perception of patient preference. METHODS: Between August and September 2017, gastroenterologists and patients with mild to moderate ulcerative colitis from France, Germany, Spain, and the UK participated in an online survey. The investigation was exploratory in nature, and descriptive results are presented. RESULTS: Patient (n = 380) preference appears to be driven by the appearance (format, shape, size, and color - 44%), number of units per administration (39%), and number of administrations per day (17%). Gastroenterologist (n = 159) preference is instead driven by the number of administrations per day (55%), number of units per day (26%), and tablet size (19%). Overall, 254 (67%) patients preferred a tablet formulation, 111 (29%) preferred granules, and 15 (4%) other formulations. According to gastroenterologist perception of patient preference, only 49% of patients prefer tablets, 38% prefer granules, and 13% have no preference. After switching from granules to tablets, 25% patients expressed negative feelings for granules. However, after switching from tablets to granules, 44% of patients still have positive perceptions of tablets. Among patients receiving tablets (n = 255), 18 (7%) perceived their treatment to be not at all effective versus 16 (13%) patients receiving granules (n = 125). A similar proportion of patients in the two groups perceived their treatment as extremely effective (48 vs. 46%, respectively). CONCLUSIONS: Patients generally prefer tablets. Patient and gastroenterologist perception of patient preference for different oral drug formulations is triggered by the same attributes but with inverse importance. To improve adherence, patients should be involved in the choice of the treatment formulation.

Show Us the Data: The Critical Role Health Information Plays in Health System Transformation.

Truly transforming the healthcare delivery and payment system turns on the ability to engage in the interoperable electronic exchange of patient health information across and beyond the care continuum. Achieving transformation requires a legal framework that supports information sharing with appropriate privacy and security protections and a trusted governance structure.

Admit or transfer? The role of insurance in high-transfer-rate medical conditions in the emergency department.

STUDY OBJECTIVE: We study the association of payer status with odds of transfer compared with admission from the emergency department (ED) for multiple diagnoses with a high percentage of transfers. METHODS: This was a retrospective study of adult ED encounters using the Healthcare Cost and Utilization Project 2010 Nationwide Emergency Department Sample. We used the Clinical Classification Software to identify disease categories with 5% or more encounters resulting in transfer (27 categories; 3.7 million encounters based on survey weights). We sorted encounters by condition into 12 groups according to expected medical or surgical specialist needs. We used logistic regression to assess the role of payer status on odds of transfer compared with admission and report adjusted odds ratios (ORs). RESULTS: Among high-transfer conditions in 2010, uninsured patients had double the odds of transfer compared with privately insured patients (OR 2.12; 95% confidence interval [CI] 1.72 to 2.62). Medicaid patients were also more likely to be transferred (OR 1.2; 95% CI 1.04 to 1.38). Uninsured patients had higher odds of transfer in all specialist categories (significant in 9 of 12). The categories with the highest odds of transfer for the uninsured included nephrology (OR 2.44; 95% CI 1.07 to 5.55), psychiatry (OR 2.26; 95% CI 1.65 to 3.25), and hematology-oncology (OR 2.21; 95% CI 1.50 to 3.25); the highest for Medicaid were general surgery (OR 1.61; 95% CI 1.09 to 1.83), hematology-oncology (OR 1.55; 95% CI 1.05 to 2.30), and vascular surgery (OR 1.55; 95% CI 1.02 to 2.28). CONCLUSION: Insurance status appears to play a role in ED disposition (transfer versus admission) for many high-transfer conditions.

Case studies at Denver Health: 'patient dumping' in the emergency department despite EMTALA, the law that banned it.

The Emergency Medical Treatment and Labor Act was enacted in 1986 to prevent hospitals from turning away patients with emergency medical conditions, often because they were uninsured--a practice commonly known as "patient dumping." Twenty-five years later, Denver Health--a large, urban, safety-net hospital--continues to experience instances in which people with emergency conditions, many of whom are uninsured, end up in the safety-net setting after having been denied care or receiving incomplete care elsewhere. We present five case studies and discuss potential limitations in the oversight and enforcement of the 1986 law. We advocate for a more effective system for reporting and acting on potential violations, as well as clearer standards governing compliance with the law.

Palliative care case management: increasing access to community-based palliative care for Medicaid recipients.

PURPOSE: The purpose of this pilot project was to integrate palliative care principles and practices into the day-to-day operations of a Medicaid managed care provider. This was accomplished through the following five activities: (1) employment of an experienced palliative care nurse and social worker to serve as expert role models and consultants to the case management staff; (2) development of a palliative care training curriculum for case managers; (3) provision and evaluation of the training; (4) identification of appropriate patients, provision of palliative care case management (PCCM), and tracking of outcomes; and (5) development of a resource/reference manual for case managers. PRIMARY PRACTICE SETTING: The project involved a managed care organization providing Medicaid services to patients residing in both urban and rural settings. FINDINGS/CONCLUSIONS: Expert staff was hired and modeled effective PCCM. This, as well as the training program, had significant influence on both the palliative care knowledge and attitudes of existing case managers. Involved patients demonstrated improved symptom management and satisfaction with care. Patient scenarios demonstrated desirable outcomes in healthcare utilization, and timely, appropriate hospice referrals were realized. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Integrating PCCM into the practices of a provider of Medicaid managed care can result in positive patient outcomes, improved utilization of healthcare services, and related savings for the managed care provider. Such a program can increase access to community-based palliative care for Medicaid recipients with life-threatening illnesses. PCCM can address the multiple needs of younger patients with serious illness who are not yet ready to forego curative efforts.

Initial experience of a public sector antiretroviral treatment programme for HIV-infected children and their infected parents.

OBJECTIVE: To describe the initial experience of treating HIV-infected children and their infected parents with antiretroviral therapy. DESIGN: Prospective, cohort study. SETTING: Tertiary, referral hospital. PATIENTS: HIV-infected children and their parents. METHODS: This report focuses on the early response of children to highly active antiretroviral therapy (HAART). Children were followed up at 4-weekly intervals. Monitoring included initial and yearly viral load measurements, baseline and 6-monthly CD4 counts and 4-weekly adherence checks. RESULTS: Between August 2002 and June 2003, 80 children were enrolled in the programme, representing a follow-up period of 23.9 patient-years. Seventy-five children had severe clinical disease, severe immune suppression, or a combination of the two. The response of children who had received HAART for > or = 6 months (N = 17) was assessed. There was no change in mass z-score (p = 0.11) or length z-score (p = 0.37), but a significant increase in CD4 percentage (p < 0.0001) during the first 6 months of therapy. Six-month viral loads were available for 12 children. There was a significant drop in viral load (p = 0.001) and 9 achieved undetectable levels by 6 months. Most children achieved > or = 85% adherence. By June 2002, 67 children (84%) were relatively well, 1 had B-cell lymphoma, 7 (8.8%) had died, 4 (5%) were lost to follow-up and 1 was withdrawn from the programme. Of 57 children who completed 3 months of HAART, 12 were admitted a total of 17 times for infectious complications. There were no severe drug reactions. Three of 7 mothers on HAART received treatment through the programme. CONCLUSION: These initial results suggest that many HIV-infected children in the public sector will benefit from antiretroviral therapy. However, both ambulatory and inpatient facilities are required to manage children on HAART comprehensively.