Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine.
Waldenström macroglobulinaemia (WM) is an incurable chronic B-cell malignancy, but highly responsive to treatment. Treatments include fixed-duration chemotherapy and continuous oral chemoimmunotherapy. In this expanding field, it is important to have reliable information on the impact of the various therapies on patients' quality of life (QoL). Patient reported outcome measures (PROMs) are increasingly recognised as important to understand patient experience of disease beyond traditional clinical outcome measures. Four QoL questionnaires (EORTC QLQ-C30 [European Organisation for Research and Treatment of Cancer quality of life core questionnaire], BIPQ [Brief Illness Perception Questionnaire], HADS [Hospital Anxiety and Depression Scale], EQ-5D-5L [EuroQoL 5-dimensional descriptive system questionnaire]) are embedded in the UK national WM registry, the Rory Morrison Registry. We reviewed the results from a snapshot of PROMs. As of November 2021, 155 patients completed PROM datawith 98% completion rate across all 58 questions. Complete clinical information was available for 52 patients. The majority of QoL questions (69%) failed to elicit a notable median response. Only four questions elicited statistically significant responses when comparing groups, and these were exclusively found in the EuroQoL-5D-5L and HADS questionnaires. Our data suggest that widely used questionnaires may not be suitable for patients with WM. We advocate the development of WM-specific outcome measures to overcome this.
Background The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high‐ (HICs) and low‐ and middle‐income countries (LMICs). Methods This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7‐day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. Results A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59). Conclusion Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.
Background: The prevalence ofhepatitis C (HCV) infection remains high among transfusion-dependent thalassemic patients. Chronic Hepatitis C, along with iron overload toxicity, eventually leads to liver fibrosis and cirrhosis. The new direct-acting antiviral (DAA)-containing regimens have shown great efficacy in achieving sustained viral response, even in patients with advanced liver disease. The aim of this study was to investigate the impact of HCV treatment with DAA on the hematological profile and management of patients with thalassemia. Methods: Twelve adult patients (5 males, 7 females) with age between 30 and 49 years old (mean: 43±4.5 years) were treated with interferon-free DAA-regimens in accordance to the EASL 2015 guidelines. All patients had previously, either not responded to or relapsed after treatment with interferon. Patients received various regimen schemas, with 10 of them receiving Sofosbuvir-containing regimen. Hepatitis C genotypes were: 1a (n=1), 1b (n=8), 3a (n=1), 4a (n=1) and 4h (n=1). Hematological and biochemical profiles were assessed at -12, -9, -6, -3, -2, -1 months before the treatment initiation, monthly during treatment and at +1, +2, +3, +4 and +6 months after treatment. Patients' transfusion requirements as well as chelation therapy needs were calculated per period. To discriminate the effect on Ferritin levelsof hepatic necrosis and inflammation from iron overload, the ratios Ferritin x (ALT-1) / ALT and Ferritin/ALT were calculated and the values before and after treatment were compared (Eisuke Ozawa et al, 2011, Journal of Gastroenterology and Hepatology, 1326-1332). Paired t-test was used for statistical analysis. Results: All patients responded well and achieved SVR. Patients' Serum Ferritin levels decreased significantly (mean± SD: 776 ± 604 ng/ml before treatment vs 449 ± 385 ng/ml, after treatment, p=0.011) in response to HCV treatment. The decrease in ferritin levels was universal in all patients (mean± SD: 327 ± 372 ng/ml, range=90 -563 ng/ml). Ferritin x (ALT-1)/ ALT ratio decreased also significantly (mean± SD: 768± 599 before treatment vs 426 ± 362, after treatment, p=0.009), whereas Ferritin/ALT ratio generally increased significantly (mean± SD: 8.5 ± 6.1 before treatment vs 23 ± 25, after treatment, p=0.03). Transfusion requirements did not change in between the three observational periods, i.e. before, during and after HCV treatment. Similarly, there were no changes in the usage of chelation therapy. Conclusions: Treatment with DAA-containing regimens shows promising results in controlling chronic hepatis C in thalassemic patients with advanced liver disease, without having an effect in transfusion requirements. The significant drop of serum Ferritin levels in these patients may be due, at least in part, to decreased hepatic inflammation. The kinetics of serum ferritin levels during HCV treatment needs to be evaluated with caution for optimization of chelation therapy. Disclosures No relevant conflicts of interest to declare.
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