How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods.

BACKGROUND: The aim of this systematic review is to describe the different types of anchors and statistical methods used in estimating the Minimal Clinically Important Difference (MCID) for Health-Related Quality of Life (HRQoL) instruments. METHODS: PubMed and Google scholar were searched for English and French language studies published from 2010 to 2018 using selected keywords. We included original articles (reviews, meta-analysis, commentaries and research letters were not considered) that described anchors and statistical methods used to estimate the MCID in HRQoL instruments. RESULTS: Forty-seven papers satisfied the inclusion criteria. The MCID was estimated for 6 generic and 18 disease-specific instruments. Most studies in our review used anchor-based methods (n = 41), either alone or in combination with distribution-based methods. The most common applied anchors were non-clinical, from the viewpoint of patients. Different statistical methods for anchor-based methods were applied and the Change Difference (CD) was the most used one. Most distributional methods included 0.2 standard deviations (SD), 0.3 SD, 0.5 SD and 1 standard error of measurement (SEM). MCID values were very variable depending on methods applied, and also on clinical context of the study. CONCLUSION: Multiple anchors and methods were applied in the included studies, which lead to different estimations of MCID. Using several methods enables to assess the robustness of the results. This corresponds to a sensitivity analysis of the methods. Close collaboration between statisticians and clinicians is recommended to integrate an agreement regarding the appropriate method to determine MCID for a specific context.

Factors associated with Health-Related Quality of Life in Kidney Transplant Recipients in France.

BACKGROUND: Health-Related Quality of Life (HRQoL) assessment after kidney transplantation has become an important tool in evaluating outcomes. This study aims to identify the associated factors with HRQoL among a representative sample size of Kidney Transplant Recipients (KTR) at the time of their inclusion in the study. METHODS: Data of this cross-sectional design is retrieved from a longitudinal study conducted in five French kidney transplant centers in 2011, and included KTR aged 18 years with a functioning graft for at least 1 year. Measures include demographic, psycho-social and clinical characteristics. To evaluate HRQoL, the Short Form-36 Health Survey (SF-36) and a HRQoL instrument for KTR (ReTransQol) were administered. Multivariate linear regression models were performed. RESULTS: A total of 1424 patients were included, with 61.4% males, and a mean age of 55.7 years (±13.1). Demographic and clinical characteristics were associated with low HRQoL scores for both questionnaires. New variables were found in our study: perceived poor social support and being treated by antidepressants were associated with low scores of Quality of Life (QoL), while internet access was associated with high QoL scores. CONCLUSION: The originality of our study's findings was that psycho-social variables, particularly KTR treated by antidepressants and having felt unmet needs for any social support, have a negative effect on their QoL. It may be useful to organize a psychological support specifically adapted for patients after kidney transplantation.

Internet and social network users' profiles in Renal Transplant Recipients in France.

BACKGROUND: The use of the Internet for searching and sharing health information and for health care interactions may have a great potential for Renal Transplant Recipients (RTR). This study aims to determine the characteristics associated with Internet and social network use in a representative sample of RTR at the time of their inclusion in the study. METHODS: Data of this cross-sectional design is retrieved from a longitudinal study conducted in five French kidney transplant centers in 2011, and included Renal Transplant Recipients aged 18 years with a functioning graft for at least 1 year. Measures include demographic characteristics (age, gender, level of education, employment status, living arrangement, having children, invalidity and monthly incomes in the household), psycho-social characteristics measured by the perceived social support questionnaire, and medical characteristics (previous dialysis treatment, duration since transplantation, graft rejection episodes, chronic graft dysfunction, health status and comorbidities: neoplasia for the current transplant, hypertension, diabetes mellitus, smoking status, BMI > 30 kg/m2 and Charlson Comorbidity Index (CCI)). Polytomous linear regression analysis was performed to describe the Internet and social network users' profiles, using lack of Internet access as the comparison category. RESULTS: Among the 1416 RTR participating in the study, 20.1% had no Internet access in the household, 29.4% connected to social networks and 50.5% were not connected to social networks. Patients who connected the most to the Internet and social networks were younger, male, without children, employed, with high monthly incomes in the household, without hypertension and having felt a need for an informative or an esteem support. CONCLUSION: In our study, the majority of RTR were actively using Internet and social networks. Renal transplant units should develop flexible and Web-based sources related to transplant information, which will allow a rapid adaptation to changes in prevalent practice, improve the health of the patients and reflect their preferences.

Indole 3-acetic acid, indoxyl sulfate and paracresyl-sulfate do not influence anemia parameters in hemodialysis patients.

BACKGROUND: The main reason for anemia in renal failure patients is the insufficient erythropoietin production by the kidneys. Beside erythropoietin deficiency, in vitro studies have incriminated uremic toxins in the pathophysiology of anemia but clinical data are sparse. In order to assess if indole 3-acetic acid (IAA), indoxyl sulfate (IS), and paracresyl sulfate (PCS) -three protein bound uremic toxins- are clinically implicated in end-stage renal disease anemia we studied the correlation between IAA, IS and PCS plasmatic concentrations with hemoglobin and Erythropoietin Stimulating Agents (ESA) use in hemodialysis patients. METHODS: Between June and July 2014, we conducted an observational cross sectional study in two hemodialysis center. Three statistical approaches were conducted. First, we compared patients treated with ESA and those not treated. Second, we performed linear regression models between IAA, IS, and PCS plasma concentrations and hemoglobin, the ESA dose over hemoglobin ratio (ESA/Hemoglobin) or the ESA resistance index (ERI). Third, we used a polytomous logistic regression model to compare groups of patients with no/low/high ESA dose and low/high hemoglobin statuses. RESULTS: Overall, 240 patients were included in the study. Mean age ± SD was 67.6 ± 16.0 years, 55.4% were men and 42.5% had diabetes mellitus. When compared with ESA treated patients, patients with no ESA had higher hemoglobin (mean 11.4 ± 1.1 versus 10.6 ± 1.2 g/dL; p <0.001), higher transferrin saturation (TSAT, 31.1 ± 16.3% versus 23.1 ± 11.5%; p < 0.001), less frequently an IV iron prescription (52.1 versus 65.7%, p = 0.04) and were more frequently treated with hemodiafiltration (53.5 versus 36.7%). In univariate analysis, IAA, IS or PCS plasma concentrations did not differ between the two groups. In the linear model, IAA plasma concentration was not associated with hemoglobin, but was negatively associated with ESA/Hb (p = 0.02; R = 0.18) and with the ERI (p = 0.03; R = 0.17). IS was associated with none of the three anemia parameters. PCS was positively associated with hemoglobin (p = 0.03; R = 0.14), but negatively with ESA/Hb (p = 0.03; R = 0.17) and the ERI (p = 0.02; R = 0.19). In multivariate analysis, the association of IAA concentration with ESA/Hb or ERI was not statistically significant, neither was the association of PCS with ESA/Hb or ERI. Identically, in the subgroup of 76 patients with no inflammation (CRP <5 mg/L) and no iron deficiency (TSAT >20%) linear regression between IAA, IS or PCS and any anemia parameter did not reach significance. In the third model, univariate analysis showed no intergroup significant differences for IAA and IS. Regarding PCS, the Low Hb/High ESA group had lower concentrations. However, when we compared PCS with the other significant characteristics of the five groups to the Low Hb/high ESA (our reference group), the polytomous logistic regression model didn't show any significant difference for PCS. CONCLUSIONS: In our study, using three different statistical models, we were unable to show any correlation between IAA, IS and PCS plasmatic concentrations and any anemia parameter in hemodialysis patients. Indolic uremic toxins and PCS have no or a very low effect on anemia parameters.

"Without Them, I Would Never Have Been Able to Carry on" Levers for the Sustained Employment of Patients with Chronic Inflammatory Arthritis: A French Qualitative Study.

BACKGROUND: Chronic inflammatory arthritis (IA) is known to be involved in declining work outcomes and increased risk of experiencing unemployment. The aim of this study is to qualitatively identify the levers for the employment of patients with IA and AI-like conditions. METHODS: To accomplish this task, a multi-centered, exploratory qualitative design involving one-on-one semi-directed interviews and a focus group was performed among 18 IA French patients to deepen our understanding of what enables patients to maintain employment despite the limiting, chronic, and expanding nature of their symptoms. RESULTS: Analysis revealed five clusters of levers for the employment of chronic IA patients: The first cluster of levers was based on a set of verbatim records mentioning an overall improvement in the management of the disease. The second cluster of levers was based on a set of verbatim records mentioning the perceived added value of one's occupation at a personal, familial, or societal scale. The third cluster of levers was based on a set of verbatim records mentioning the perceived interpersonal supportiveness of the professional sphere. The fourth cluster of levers was based on a set of verbatim records mentioning the micro-, meso-, and macro-characteristics of the working environment. The fifth cluster of levers was based on a set of verbatim records mentioning intrapersonal attributes. CONCLUSIONS: This study deepens and updates the current knowledge on what empowers patients dealing with chronic AI. These results provide valuable insights for stakeholders involved in designing or deploying employment initiatives for patients with AI.

Comorbidity Profiles among Obese-Diabetic End-Stage Renal Disease Patients: Data from REIN Registry of PACA Region of France.

INTRODUCTION: The proportion of new dialysis patients with comorbidities increased by an average of 5.6% per year in the Provence-Alpes-Côte d'Azur (PACA) region, with major increases in obese, cancer, and diabetic patients. This study aimed to describe comorbidity profiles among obese-diabetic end-stage renal disease (ESRD) patients in the Renal Epidemiology and Information Network (REIN) registry of the PACA region of France on December 31, 2018. METHODS: Data for this retrospective cross-sectional study were retrieved from the REIN registry of the PACA region. Data were analyzed using two models. Firstly, the ESRD patients were divided into two groups and binary logistic regression model used for the analysis of the data. Secondly, ESRD patients were divided into four groups and multinomial logistic regression model used. Univariate analysis was performed for group comparison using x2 and t-tests, while binary logistic and multinomial logistic regression models were used for multivariate analysis to derive ORs and 95% CIs. RESULTS: Among the 4,491 ESRD patients in this study, 623 were obese-diabetic and 3,868 nonobese-nondiabetic and obese only/ diabetic only. Obese-diabetic ESRD patients were younger (<75 years, OR 0.46, p<0.001), smoked less (OR 0.51, p<0.001), were mainly dialyzed at centers (OR 1.29, p=0.014), and less likely to be on the renal transplant waiting list (OR 0.46, p<0.001) compared to the other group. Obese-diabetic ESRD patients also had more comorbidities, including cardiovascular diseases (OR 1.38, p=0.028), coronary insufficiency (OR 1.49, p=0.001) and chronic obstructive pulmonary disease (OR 1.75, p<0.001), but had fewer cases of cancer (OR 0.68, p=0.024) compare to the other group. CONCLUSION: Obese-diabetic patients with ESRD have many specific characteristics. These patients were younger, but had more cardiovascular comorbidities and were less likely to be on the waiting list for transplantation. They should receive special attention and be the subject of prevention and therapeutic education.

Selective reporting of antibiotic susceptibility testing results: a promising antibiotic stewardship tool.

Introduction: Selective reporting of antibiotic susceptibility testing (AST) results is a potentially interesting tool for antibiotic stewardship. It consists of performing AST according to usual practices, but the results are reported to the prescriber only for a few antibiotics (i.e. first-line agents) or not reported at all when colonization is likely.Areas covered: We retrieved 20 studies exploring the impact of selective reporting. Overall, selective reporting is able to influence antibiotic use, both discouraging prescription in case of colonization, and promoting the selection of narrow-spectrum agents. Most studies concerned urine samples. Evidence on the impact on antibiotic resistance is insufficient. Unintended consequences were not observed, but evidence on this topic is scarce. Selective reporting is well implemented in a few countries, and a huge heterogeneity of practices exists.Expert opinion: Evidence shows that selective reporting can help reducing inappropriate and unnecessary antibiotic prescriptions. Uncomplicated urinary tract infections are probably the best initial target, both in hospital and community settings, but other non-severe infections can be a suitable option. The implementation of selective reporting should be promoted by the scientific community, with detailed practical guidelines, and its impact should be further assessed in large interventional studies.

[Daily practices of protein energy wasting management in hemodialysis patients: A French national survey]. / Prise en charge pratique de la dénutrition des patients hémodialysés en France : enquête nationale.

Protein energy wasting (PEW) is frequent among hemodialysis patients. Published international recommendations in this field are sometimes difficult to implement in daily practices. We evaluated daily practices of PEW screening and treatment in French hemodialysis centers using an online computerized questionnaire sent by email (1 answer required per center). Eighty-six centers returned the questionnaire filled by a nephrologist (43%), nurse (14%) or dietician (43%). The mean number of patients per center was 112±64 patients. PEW screening was performed at least once/month in 56% of centers, once/3 months in 36%, and less frequently in 8%. PEW screening frequency and tools were in agreement with recommendations. Regarding treatment, dietitian interviews were proposed in 98% of units. Hundred percent of units prescribed home oral nutrition supplements (ONS), and 90% ONS during hemodialysis. Ninety-seven percent of centers practiced intradialytic parenteral nutrition, 34% enteral nutrition with feeding tube and 41% with gastrostomy. 14% of centers had no dietician or only on call. A dietician was present≤1 day per week in 44% of centers, 1 to 2.5 days per week in 27%, and>2.5 days per week in 15%. After adjustment for the number of patients, private practice units had significantly less time of presence of the dietician than nonprofit associations or public healthcare centers. In all, 36% of centers offered physical activity during hemodialysis sessions - cycling in almost all centers - and only 12.8% proposed physical activity programs apart from dialysis sessions. In summary, in majority of French hemodialysis centers, PEW screening was consistent with recommendations but the dietician time was insufficient to screen for PEW causes and elaborate a treatment program. Only one third of centers perform enteral nutrition, the most recommended artificial nutrition therapy. Nutritional treatment could be improved in hemodialysis centers in France.