Corrigendum: Nocebo effects in systemic therapies for adult plaque psoriasis: a systematic review and meta-analysis.

[This corrects the article DOI: 10.3389/fmed.2024.1373520.].

Nocebo effects in systemic therapies for adult plaque psoriasis: A systematic review and meta-analysis.

Introduction: The nocebo effect is defined as adverse outcomes secondary to negative patient expectations rather than the pharmacologic activity of an intervention. Nocebo effects can reduce treatment adherence and/or persistence. Therefore, nocebo effects in psoriasis need to be defined. Methods: A Cochrane systematic review was updated with a search of MEDLINE, Embase, and the CENTRAL Register of Controlled Trials for phase II - IV RCTs comparing systemic therapy versus placebo for patients with moderate-to-severe plaque psoriasis. Estimates were pooled using a random effects model, and heterogeneity was evaluated using the I2 statistic. The primary outcome was the pooled proportion of any adverse event (AE) and corresponding risk difference (RD) in patients randomized to placebo versus systemic therapy. Results: A total of 103 unique trials were identified enrolling 43,189 patients. The overall pooled AE rate in patients randomized to systemic therapy was 57.1% [95% CI: 54.7-59.5%] compared to 49.8% [95% CI: 47.1-52.4%] for placebo [RD 6.7% (95% CI: 4.6-8.9%), p < 0.00001, I2 = 75%]. Both biologic and non-biologic systemic therapy groups had a higher proportion of infectious AEs compared to placebo. No statistically significant RD in serious AEs or AEs leading to discontinuation was identified between systemic therapy and placebo groups. Discussion: Half of patients exposed to inert placebo in clinical trials of systemic psoriasis therapies experienced AEs, which may be explained by nocebo effects. These findings have important implications when counseling patients and designing future studies.

Epidemiology and Healthcare Expenditure for Skin Disease in Emergency Departments in Alberta, Canada.

BACKGROUND: There are limited data on the epidemiology and costs associated with managing dermatologic conditions in emergency departments (EDs). OBJECTIVE: To assess the incidence and mean cost per case of skin diseases in EDs in Alberta. METHODS: Alberta Health Services' Interactive Health Data Application was used to determine the epidemiology and costs associated with nonneoplastic dermatologic diseases in EDs in the province of Alberta, Canada, from 2018 to 2022. Skin conditions were identified using the International Classification of Disease 10th edition diagnostic groupings. RESULTS: Skin disease represented 3.59% of all ED presentations in Alberta in 2022. The total costs associated with managing dermatologic conditions have remained stable over time at approximately 15 million Canadian Dollars (CAD) annually, but the mean cost per case has risen from 188.88 (SD 15.42) in 2018 to 246.25 CAD (SD 27.47) in 2022 (7.59%/year). Infections of skin and subcutaneous tissue were the most expensive diagnostic grouping. The most common dermatologic diagnostic groupings presenting to the ED were infections of skin and subcutaneous tissue [mean age-standardized incidence rate (ASIR) of 143.67 per 100,000 standard population (SD 241.99)], urticaria and erythema [mean ASIR 33.57 per 100,000 standard population (SD 59.13)], and dermatitis and eczema [mean ASIR 18.59 per 100,000 standard population (SD 23.65)]. Cellulitis was both the most common and the costliest individual diagnosis. The majority of patients were triaged as less urgent or nonurgent. CONCLUSIONS: Skin disease represents a substantial public health burden in EDs. Further research into drivers of cost change and areas for cost savings is essential.

Change Management Accompanying Implementation of Decision Support for Prevention of Acute Kidney Injury in Cardiac Catheterization Units: Program Report.

Purpose of program: Different models exist to guide successful implementation of electronic health tools into clinical practice. The Contrast Reducing Injury Sustained by Kidneys (Contrast RISK) initiative introduced an electronic decision support tool with physician audit and feedback into all of the cardiac catheterization facilities in Alberta, Canada, with the goal of preventing contrast-associated acute kidney injury (CA-AKI) following coronary angiography and intervention. This report describes the change management approaches used by the initiative and end-user's feedback on these processes. Sources of information and methods: The Canada Health Infoway Change Management model was used to address 6 activities relevant to project implementation: governance and leadership, stakeholder engagement, communications, workflow analysis and integration, training and education, and monitoring and evaluation. Health care providers and invasive cardiologists from all sites completed preimplementation, usability, and postimplementation surveys to assess integration and change success. Key findings: Prior to implementation, 67% of health providers were less than satisfied with processes to determine appropriate contrast dye volumes, 47% were less than satisfied with processes for administering adequate intravenous fluids, and 68% were less than satisfied with processes to ensure follow-up of high-risk patients. 48% of invasive cardiologists were less than satisfied with preprocedural identification of patients at risk of acute kidney injury (AKI). Following implementation, there were significant increases among health providers in the odds of satisfaction with processes for identifying those at high risk of AKI (odds ratio [OR] 3.01, 95% confidence interval [CI] 1.36-6.66, P = .007), quantifying the appropriate level of contrast dye for each patient (OR 6.98, 95% CI 3.06-15.91, P < .001), determining the optimal amount of IV fluid for each patient (OR 1.86, 95% CI 0.88-3.91, P = .102), and following up of kidney function of high risk patients (OR 5.49, 95%CI 2.45-12.30, P < .001). There were also significant increases among physicians in the odds of satisfaction with processes for identifying those at high risk of AKI (OR 19.53, 95% CI 3.21-118.76, P = .001), quantifying the appropriate level of contrast dye for each patient (OR 26.35, 95% CI 4.28-162.27, P < .001), and for following-up kidney function of high-risk patients (OR 7.72, 95% CI 1.62-36.84.30, P = .010). Eighty-nine percent of staff perceived the initiative as being successful in changing clinical practices to reduce the risk of CA-AKI. Physicians uniformly agreed that the system was well-integrated into existing workflows, while 42% of health providers also agreed. Implications: The Canada Health Infoway Change Management model was an effective framework for guiding implementation of an electronic decision support tool and audit and feedback intervention to improve processes for AKI prevention within cardiac catheterization units.

Objectif du program: Il existe différents modèles pour guider la mise en œuvre efficace d'outils électroniques dans la pratique clinique. L'initiative Contrast RISK (Contrast Reducing Injury Sustained by Kidneys) a permis d'introduire un outil électronique d'aide à la décision avec surveillance par le médecin et rétroaction dans tous les établissements de l'Alberta (Canada) pratiquant le cathétérisme cardiaque, dans le but de prévenir les insuffisances rénales aiguës associées aux produits de contraste (IRA-PC) après une coronarographie et une intervention. Le présent rapport décrit les approches de gestion du changement utilisées dans le cadre de l'initiative, ainsi que les commentaires des utilisateurs sur ces processus. Sources de l'information et méthodologie: Le modèle de gestion du changement d'Inforoute Santé du Canada a été employé pour aborder six activités pertinentes pour la mise en œuvre de projets: gouvernance et leadership, engagement des intervenants, communications, analyze du flux de travail et intégration, formation et éducation, surveillance et évaluation. Les prestataires de soins et les cardiologues spécialisés en interventions invasives de tous les sites ont répondu à un sondage avant, pendant et après la mise en œuvre afin d'évaluer le succès de l'intégration et du changement. Principaux résultats: Avant la mise en œuvre, 67% des prestataires de soins étaient insatisfaits des processus pour déterminer les volumes appropriés des produits de contraste, 47% étaient insatisfaits des processus pour administrer l'hydratation intraveineuse et 68% étaient insatisfaits des processus de surveillance des patients présentant un risque élevé. Près de la moitié (48%) des cardiologues spécialisés en interventions invasives étaient insatisfaits du processus d'identification préalable des patients présentant un risque élevé d'IRA. Après la mise en œuvre, on a observé une augmentation significative de la satisfaction des prestataires de soins à l'égard des processus pour identifier les patients présentant un risque élevé d'IRA (rapport de cote [RC]: 3,01; IC 95%: 1,36-6,66; P = .007), quantifier le niveau approprié de produit de contraste pour chaque patient (RC: 6,98; IC 95%: 3,06-15,91; P < .001), déterminer le volume optimal d'hydratation IV pour chaque patient (RC: 1,86, IC 95%: 0,88-3,91; P = .102) et surveiller la fonction rénale chez les patients présentant un risque élevé (RC: 5,49 IC 95%: 2,45-12,30; P < .001). On a également observé une augmentation significative de la satisfaction des médecins à l'égard des processus pour identifier les patients présentant un risque élevé d'IRA (RC: 19,53; IC 95%: 3,21-118,76; P = .001), quantifier le niveau approprié de produit de contraste pour chaque patient (RC: 26,35; IC 95%: 4,28-162,27; P < .001) et surveiller la fonction rénale des patients présentant un risque élevé (RC: 7,72; IC 95%: 1,62-36,84,30; P = .010). Une grande majorité du personnel (89%) était d'avis que l'initiative avait permis de changer les pratiques cliniques visant à réduire le risque d'IRA-PC. L'ensemble des médecins s'entendait pour dire que le système était bien intégré dans les flux de travail existants; 42% des prestataires de soins étaient également de cet avis. Conclusion: Le modèle de gestion du changement d'Inforoute Santé du Canada s'est avéré un cadre efficace pour guider la mise en œuvre d'un outil électronique d'aide à la décision et d'une intervention de surveillance et de rétroaction visant à améliorer les processus de prévention de l'IRA dans les unités de cathétérisme cardiaque.

Development and Evaluation of an Audit and Feedback Process for Prevention of Acute Kidney Injury During Coronary Angiography and Intervention.

Background: Contrast-associated acute kidney injury (CA-AKI) is a potentially preventable complication of coronary angiography and intervention. Relatively little research has been done to determine how knowledge on CA-AKI prevention can be translated into clinical practice. Methods: We developed, implemented, and surveyed end-users about the usability, acceptability, and utility of an audit and feedback process for CA-AKI prevention in Alberta, Canada. The audit and feedback reported on amount of radiocontrast dye used, hemodynamic optimization of intravenous fluids, and CA-AKI incidence for each cardiologist practicing coronary angiography or percutaneous coronary intervention, compared with peers at their site and across the province. Reports were developed through an iterative process involving interventional cardiologists throughout the design process and usability testing. Results: Cardiologists participating in usability testing indicated a preference for the visual displays of data and summarizing indicators on the front page, and endorsed the value of peer-to-peer comparisons of performance measures. Of 31 eligible cardiologists from across Alberta, 17 responded to a survey evaluating the audit and feedback process. Fifteen respondents (88.2%) agreed that the data presented in the audit and feedback report were understandable; 17 respondents (100%) agreed or strongly agreed that the presentation of the report helped them better understand their performance compared with that of their peers; and 14 (82.4%) agreed that the audit and feedback process helped them identify ways to reduce the risk of AKI for their patients. Conclusions: Conducting an audit and providing feedback was an understandable and acceptable intervention to help cardiologists identify ways to improve prevention of CA-AKI during coronary angiography or intervention.

Contexte: L'insuffisance rénale aiguë provoquée par un produit de contraste (IRA-PC) est une complication possiblement évitable de la coronarographie et de l'intervention coronarienne. Relativement peu de travaux de recherche ont été menés pour déterminer comment les connaissances sur la prévention de l'IRA-PC peuvent se traduire dans la pratique clinique. Méthodologie: Nous avons élaboré et réalisé un sondage auprès d'utilisateurs finaux sur l'utilisabilité, l'acceptabilité et l'utilité d'un processus de vérification et de rétroaction pour la prévention de l'IRA-PC en Alberta, au Canada. Ce processus visait à rendre compte des données sur la quantité de substances de contraste utilisées, de l'optimisation hémodynamique des liquides intraveineux et de la fréquence de l'IRA-PC pour chaque cardiologue pratiquant des coronarographies ou des interventions coronariennes percutanées, comparativement à leurs confères du même centre et à ceux d'ailleurs dans la province. Les rapports ont été élaborés à l'aide d'un processus itératif auquel ont participé des cardiologues interventionnels tout au long du processus de conception et des tests d'utilisabilité. Résultats: Les cardiologues participant aux tests d'utilisabilité ont indiqué une préférence pour les affichages visuels des données et des indicateurs récapitulatifs sur la première page, et approuvé la valeur des comparaisons des mesures de rendement entre pairs. Sur les 31 cardiologues admissibles de partout en Alberta, 17 ont répondu au sondage évaluant le processus de vérification et de rétroaction. Quinze répondants (88,2 %) ont convenu que les données présentées dans le rapport de vérification et de rétroaction étaient compréhensibles; 17 répondants (100 %) étaient d'accord ou fortement d'accord que la présentation du rapport les avait aidés à mieux comprendre leur rendement comparativement à celui de leurs pairs; et 14 (82,4 %) ont convenu que le processus de vérification et de rétroaction les avait aidés à trouver des façons de réduire le risque d'IRA chez leurs patients. Conclusions: Procéder à une vérification et fournir une rétroaction s'est avérée une intervention compréhensible et acceptable pour aider les cardiologues à trouver des façons d'améliorer la prévention de l'IRA-PC pendant une coronarographie ou une intervention coronaire.

Patient Experience After Risk Stratification and Follow-up for Acute Kidney Injury After Cardiac Catheterization: Patient Survey.

BACKGROUND: Acute kidney injury (AKI) after cardiac catheterization procedures is associated with poor health outcomes. We sought to characterize the experiences of patients after receiving standardized information on their risk of AKI accompanied by instructions for follow-up care after cardiac catheterization. METHODS: We implemented an initiative across 3 cardiac catheterization units in Alberta, Canada to provide standardized assessment, followed by guidance for patients at risk of AKI. This was accompanied by communication to primary care providers to improve continuity of care when patients transition from the hospital to the community. A structured survey from a sample of 100 participants at increased risk of AKI determined their perceptions of information provided and experiences with follow-up steps after the initiative was implemented in each cardiac catheterization unit in Alberta. RESULTS: The mean age of participants was 72.4 (SD 10.4) years, 37% were female, and the mean risk of AKI was 8.8%. Most (63%) participants were able to recall the information provided to them about their risk of kidney injury, 68% recalled the education provided on strategies to reduce risk, and 65% believed their primary care practitioner had received enough information to conduct appropriate follow-up care. Eighty-six percent of patients were satisfied with their transition to the community, and 53% were reassured by the information and follow-up care they received. CONCLUSIONS: These findings suggest that communicating risk information to patients, in combination with education and collaboration for follow-up with primary care providers, is associated with positive patient experiences and satisfaction with care.

CONTEXTE: L'insuffisance rénale aiguë (IRA) après un cathétérisme cardiaque est associée à de mauvais résultats en matière de santé. Nous avons voulu décrire l'expérience des patients après qu'on leur ait transmis de l'information standardisée concernant le risque d'IRA et des directives pour les soins de suivi après un cathétérisme cardiaque. MÉTHODOLOGIE: Nous avons mis en place une initiative dans trois unités de cathétérisme cardiaque en Alberta, au Canada, afin de permettre une évaluation standardisée, puis d'offrir des directives concernant les patients à risque d'IRA. Notre initiative comprenait également des communications aux fournisseurs de soins primaires en vue d'améliorer la continuité des soins prodigués aux patients quittant l'hôpital pour retourner en milieu communautaire. Un sondage structuré mené auprès de 100 participants présentant un risque accru d'IRA a permis de connaître leurs perceptions quant à l'information reçue et à leur expérience à l'égard du suivi après la mise en place de l'initiative dans chacune des unités de cathétérisme cardiaque en Alberta. RÉSULTATS: L'âge moyen des participants était de 72,4 ans (écart type : 10,4), 37 % étaient des femmes, et le risque moyen d'IRA était de 8,8 %. La plupart des participants (63 %) étaient en mesure de se souvenir de l'information qui leur avait été transmise au sujet de leur risque d'insuffisance rénale, 68 % se rappelaient la formation reçue concernant les stratégies pour réduire leur risque, et 65 % estimaient que leur médecin de soins primaires avait recueilli suffisamment d'information pour effectuer un suivi adéquat. Quatre-vingt-six pour cent (86 %) des patients étaient satisfaits de leur transition en milieu communautaire, et 53 % étaient rassurés par l'information reçue et le suivi dont ils faisaient l'objet. CONCLUSIONS: Ces résultats suggèrent que le fait de transmettre aux patients de l'information au sujet des risques, en plus de les éduquer et de leur permettre de collaborer avec leur fournisseur de soins primaires pour le suivi est associé à une expérience positive pour le patient et à la satisfaction à l'égard des soins reçus.

Comparative Performance of Prediction Models for Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention.

BACKGROUND: Identifying patients at increased risk of contrast-associated acute kidney injury (CA-AKI) can help target risk mitigation strategies toward these individuals during percutaneous coronary intervention. Illuminating which risk models best stratify risk is an important foundation for such quality improvement efforts. METHODS AND RESULTS: Seven previously published risk prediction models for CA-AKI and 3 models for kidney injury requiring dialysis were validated using 2 definitions for CA-AKI (the Kidney Disease: Improving Global Outcomes definition of ≥0.3 mg/dL within 48 hours or ≥50% increase in serum creatinine from baseline within 7 days and the historical definition of ≥0.5 mg/dL or ≥25% increase in serum creatinine from baseline within 48 hours), and AKI requiring dialysis within 30 days of percutaneous coronary intervention. Model performance was compared based on discrimination, calibration, and categorical net reclassification index before and after model recalibration. Among 7888 patients who underwent percutaneous coronary intervention in Alberta Canada, CA-AKI occurred in 330 patients (4.2%) when CA-AKI was defined using the Kidney Disease: Improving Global Outcomes definition and 571 (7.3%) when using the historical definition. CA-AKI requiring dialysis occurred in 42 (0.6%) patients. When validated using the Kidney Disease: Improving Global Outcomes definition for CA-AKI, the 2 most recently published models for CA-AKI showed better discrimination (C statistics, 0.75-0.76) than older models (C statistics, 0.61-0.68). C statistics of models for kidney injury requiring dialysis ranged from 0.70 to 0.86. The calibration of all models for CA-AKI deviated from ideal, and the proportion of patients classified into different risk categories for CA-AKI differed substantially for the 2 most recent models. Recalibration significantly improved risk stratification of patients into clinical risk categories for some models. CONCLUSIONS: Recent prediction models for CA-AKI show better discrimination compared with older models; however, model recalibration should be examined in external cohorts to improve the accuracy of predictions, particularly if predicted risk strata are used to guide management approaches.

Clinical Decision Support to Reduce Contrast-Induced Kidney Injury During Cardiac Catheterization: Design of a Randomized Stepped-Wedge Trial.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a common and serious complication of invasive cardiac procedures. Quality improvement programs have been associated with a lower incidence of CI-AKI over time, but there is a lack of high-quality evidence on clinical decision support for prevention of CI-AKI and its impact on processes of care and clinical outcomes. METHODS: The Contrast-Reducing Injury Sustained by Kidneys (Contrast RISK) study will implement an evidence-based multifaceted intervention designed to reduce the incidence of CI-AKI, encompassing automated identification of patients at increased risk for CI-AKI, point-of-care information on safe contrast volume targets, personalized recommendations for hemodynamic optimization of intravenous fluids, and follow-up information for patients at risk. Implementation will use cardiologist academic detailing, computerized clinical decision support, and audit and feedback. All 31 physicians practicing in all 3 of Alberta's cardiac catheterization laboratories will participate using a cluster-randomized stepped-wedge design. The order in which they are introduced to this intervention will be randomized within 8 clusters. The primary outcome is CI-AKI incidence, with secondary outcomes of CI-AKI avoidance strategies and downstream adverse major kidney and cardiovascular events. An economic evaluation will accompany the main trial. CONCLUSIONS: The Contrast RISK study leverages information technology systems to identify patient risk combined with evidence-based protocols, audit, and feedback to reduce CI-AKI in cardiac catheterization laboratories across Alberta. If effective, this intervention can be broadly scaled and sustained to improve the safety of cardiac catheterization.

Risk Prediction Models for Contrast-Induced Acute Kidney Injury Accompanying Cardiac Catheterization: Systematic Review and Meta-analysis.

BACKGROUND: Identification of patients at risk of contrast-induced acute kidney injury (CI-AKI) is valuable for targeted prevention strategies accompanying cardiac catheterization. METHODS: We searched MedLine and EMBASE for articles that developed or validated a clinical prediction model for CI-AKI or dialysis after angiography or percutaneous coronary intervention. Random effects meta-analysis was used to pool c-statistics of models. Heterogeneity was explored using stratified analyses and meta-regression. RESULTS: We identified 75 articles describing 74 models predicting CI-AKI, 10 predicting CI-AKI and dialysis, and 1 predicting dialysis. Sixty-three developed a new risk model whereas 20 articles reported external validation of previously developed models. Thirty models included sufficient information to obtain individual patient risk estimates; 9 using only preprocedure variables whereas 21 included preprocedural and postprocedure variables. There was heterogeneity in the discrimination of CI-AKI prediction models (median [total range] in c-statistic 0.78 [0.57-0.95]; I2 = 95.8%, Cochran Q-statistic P < 0.001). However, there was no difference in the discrimination of models using only preprocedure variables compared with models that included postprocedural variables (P = 0.868). Models predicting dialysis had good discrimination without heterogeneity (median [total range] c-statistic: 0.88 [0.87-0.89]; I2 = 0.0%, Cochran Q-statistic P = 0.981). Seven prediction models were externally validated; however, 2 of these models showed heterogeneous discriminative performance and 2 others lacked information on calibration in external cohorts. CONCLUSIONS: Three published models were identified that produced generalizable risk estimates for predicting CI-AKI. Further research is needed to evaluate the effect of their implementation in clinical care.

Shoulder muscle endurance: the development of a standardized and reliable protocol.

BACKGROUND: Shoulder muscle fatigue has been proposed as a possible link to explain the association between repetitive arm use and the development of rotator cuff disorders. To our knowledge, no standardized clinical endurance protocol has been developed to evaluate the effects of muscle fatigue on shoulder function. Such a test could improve clinical examination of individuals with shoulder disorders. Therefore, the purpose of this study was to establish a reliable protocol for objective assessment of shoulder muscle endurance. METHODS: An endurance protocol was developed on a stationary dynamometer (Biodex System 3). The endurance protocol was performed in isotonic mode with the resistance set at 50% of each subject's peak torque as measured for shoulder external (ER) and internal rotation (IR). Each subject performed 60 continuous repetitions of IR/ER rotation. The endurance protocol was performed by 36 healthy individuals on two separate occasions at least two days apart. Maximal isometric shoulder strength tests were performed before and after the fatigue protocol to evaluate the effects of the endurance protocol and its reliability. Paired t-tests were used to evaluate the reduction in shoulder strength due to the protocol, while intraclass correlation coefficients (ICC) and minimal detectable change (MDC) were used to evaluate its reliability. RESULTS: Maximal isometric strength was significantly decreased after the endurance protocol (P < 0.001). The total work performed during the last third of the protocol was significantly less than the first third of the protocol (P < 0.05). The test-retest reliability of the post-fatigue strength measures was excellent (ICC >0.84). CONCLUSIONS: Changes in muscular performance observed during and after the muscular endurance protocol suggests that the protocol did result in muscular fatigue. Furthermore, this study established that the resultant effects of fatigue of the proposed isotonic protocol were reproducible over time. The protocol was performed without difficulty by all volunteers and took less than 10 minutes to perform, suggesting that it might be feasible for clinical practice. This protocol could be used to induce local muscular fatigue in order to evaluate the effects of fatigue on shoulder kinematics or to evaluate changes in shoulder muscle endurance following rehabilitation.