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Bariatric and metabolic surgery during and after the COVID-19 pandemic: DSS recommendations for management of surgical candidates and postoperative patients and prioritisation of access to surgery.
Rubino, F, Cohen, RV, Mingrone, G, le Roux, CW, Mechanick, JI, Arterburn, DE, Vidal, J, Alberti, G, Amiel, SA, Batterham, RL, et al
The lancet. Diabetes & endocrinology. 2020;8(7):640-648
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Plain language summary
Bariatric surgery has been proven for weight loss in people with severe obesity. However, during the covid-19 pandemic, surgery has been postponed for many individuals. Under normal conditions, patients who are awaiting bariatric surgery are prioritised based on weight, however this does not necessarily reflect severity of their condition. This review paper aimed to develop new criteria in order to help prioritise individuals who are awaiting bariatric surgery. The authors began by reviewing the reasons for delaying bariatric surgery and the need for beds, the risks of covid-19 transmission during the procedure and the severe covid-19 complications that individuals with obesity can experience were discussed. A recommendation was made that all patients having bariatric surgery be tested for Covid-19. Solutions were proposed for those awaiting surgery such as diets, exercise, optimal blood sugar control and the potential use of weight loss medications. Prioritisation of surgery should focus on clinical need; it should be accessible and minimise harm from delays. Individuals with obesity and type 2 diabetes should be prioritised based on those who have an increased risk of death, determined by whether the individual; has poor blood sugar control despite maximal use of medications to control it, uses insulin, has previous heart disease, has liver disease or if they have other risk factors. It was concluded that weight alone is inadequate to prioritise candidates for bariatric surgery. Disease severity should be at the centre of decisions, especially when access to surgery is reduced, as is during the Covid -19 pandemic. This paper could be used by healthcare professionals to understand how to prioritise their obese and type 2 diabetic patients who are awaiting bariatric surgery.
Abstract
The coronavirus disease 2019 pandemic is wreaking havoc on society, especially health-care systems, including disrupting bariatric and metabolic surgery. The current limitations on accessibility to non-urgent care undermine postoperative monitoring of patients who have undergone such operations. Furthermore, like most elective surgery, new bariatric and metabolic procedures are being postponed worldwide during the pandemic. When the outbreak abates, a backlog of people seeking these operations will exist. Hence, surgical candidates face prolonged delays of beneficial treatment. Because of the progressive nature of obesity and diabetes, delaying surgery increases risks for morbidity and mortality, thus requiring strategies to mitigate harm. The risk of harm, however, varies among patients, depending on the type and severity of their comorbidities. A triaging strategy is therefore needed. The traditional weight-centric patient-selection criteria do not favour cases based on actual clinical needs. In this Personal View, experts from the Diabetes Surgery Summit consensus conference series provide guidance for the management of patients while surgery is delayed and for postoperative surveillance. We also offer a strategy to prioritise bariatric and metabolic surgery candidates on the basis of the diseases that are most likely to be ameliorated postoperatively. Although our system will be particularly germane in the immediate future, it also provides a framework for long-term clinically meaningful prioritisation.
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Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
Laharie, D, Bourreille, A, Branche, J, Allez, M, Bouhnik, Y, Filippi, J, Zerbib, F, Savoye, G, Vuitton, L, Moreau, J, et al
Gut. 2018;67(2):237-243
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Intravenous steroids are the first-line therapy for ulcerative colitis (UC) patients who are hospitalised during a severe UC flare-up. In the 40% of patients who don’t respond to steroids, the drugs ciclosporin and infliximab have been found to be efficient in preventing surgery to remove part or all of the colon, but there is a lack of data on the long-term outcomes of using these medications in UC patients. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab. Between 2007 and 2010, 115 patients with UC that did not respond to steroids were randomised to receive ciclosporin or infliximab in association with azathioprine. Patients were followed to January 2015 or death. After a median follow-up of 5.4 years, colectomy-free survival rates at 1 and 5 years were, respectively, 70.9% and 61.5% in patients who received ciclosporin and 69.1% and 65.1% in those who received infliximab. Long-term colectomy-free survival was independent from initial treatment. However, a higher proportion of patients initially treated with ciclosporin needed a new treatment compared with those who received infliximab first. The researchers concluded that these results further confirm a similar efficacy and good safety profiles of both drugs.
Abstract
OBJECTIVE Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab. DESIGN Between 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test. RESULTS After a median follow-up of 5.4 years, colectomy-free survival rates (95% CI) at 1 and 5 years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment. CONCLUSIONS In this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other. TRIAL REGISTRATION NUMBER EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.
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Comparison of the construct validity and reproducibility of four different types of patient-reported outcome measures (PROMs) in patients with rheumatoid arthritis.
Renskers, L, van Uden, RJJC, Huis, AMP, Rongen, SAA, Teerenstra, S, van Riel, PLCM
Clinical rheumatology. 2018;37(12):3191-3199
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Plain language summary
Rheumatoid arthritis is an inflammatory autoimmune disease characterised by chronic joint inflammation, which leads to pain, stiffness, function loss, and fatigue. During outpatient visits, patient-reported outcome measures (PROMs) are taking a more central place because they directly apply to the patients’ personal perception and can identify key concerns that need to be addressed. The objective of this study was to measure and compare construct validity of four scale types of PROMs within four different domains. The study is a prospective longitudinal study which recruited adult patients with rheumatoid arthritis. Two-hundred eleven patients were included for the construct validity assessment and one hundred fifty-three patients for the reproducibility assessment. Results showed that within the construct validity assessment, the differences between the four scale types were small and appeared not different. On the other hand, the assessment on reproducibility of the scales was moderate to high. The exception was for the domain of general well-being, as correlations both for construct validity as well as for reproducibility were lower compared to the other domains. Authors conclude that the numerical rating scale is the preferred PROM scale for patients with rheumatoid arthritis.
Abstract
Patient-reported outcome measures (PROMs) are increasingly used in the assessment of patients with rheumatoid arthritis (RA). The aim of this study was to assess the construct validity and reproducibility of four types of PROMs (numerical rating scale (NRS), visual analogue scale (VAS), verbal rating scale (VRS), and Likert scale). In addition, patients' preference for one of these PROMs was measured. Patients with stable RA and no change in pain medication or steroid medication (n = 211) were asked to complete a questionnaire directly following, and 5 days after their outpatient visit. The questionnaire measured the validity of the PROMs in four domains (pain, fatigue, experienced disease activity, and general well-being). To assess construct validity, Pearson correlation coefficients were calculated using the Disease Activity Score-3. To assess reproducibility, intraclass correlation coefficients (ICCs) were calculated. Correlation coefficients between the different PROMs within each domain were compared. There were no differences regarding construct validity between the different PROM scale types. Regarding reproducibility, VAS and NRS scored better in the domains pain and experienced disease activity. Patients chose NRS as preferred measurement method, with the VAS in second place. The four scale types of PROMs appeared to be equally valid to assess pain, fatigue, experienced disease activity, and general well-being. VAS and NRS appeared to be more reliable for measuring pain and experienced disease activity. The patients favoured NRS. In combination with other practical advantages of NRS over VAS, we do advise the NRS as the preferred scale type for PROMs.