Mortality following elective abdominal aortic aneurysm repair in women.

BACKGROUND: Previous studies have focused on patient-related risk factors to explain the higher mortality risk in women undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to evaluate whether hospital-related factors influence outcomes following AAA repair in women. METHODS: Patients undergoing elective AAA repair in 61 hospitals in the Netherlands were identified from the Dutch Surgical Aneurysm Audit registry (2013-2018). A mixed-effects logistic regression analysis was conducted to assess the effect of sex on in-hospital and/or 30-day mortality. This analysis accounted for possible correlation of outcomes among patients who were treated in the same hospital, by adding a hospital-specific random effect to the statistical model. The analysis adjusted for patient-related risk factors and hospital volume of open surgical repair (OSR) and endovascular aneurysm repair (EVAR). RESULTS: Some 12 034 patients were included in the analysis. The mortality rate was higher in women than among men: 53 of 1780 (3.0 per cent) versus 152 of 10 254 (1.5 per cent) respectively. Female sex was significantly associated with mortality after correction for patient- and hospital-related factors (odds ratio 1.68, 95 per cent c.i. 1.20 to 2.37). OSR volume was associated with lower mortality (OR 0.91 (0.85 to 0.95) per 10-procedure increase) whereas no such relationship was identified with EVAR volume (OR 1.03 (1.01 to 1.05) per 10-procedure increase). CONCLUSION: Women are at higher risk of death after abdominal aortic aneurysm repair irrespective of patient- and hospital-related factors.

Patient-Reported Outcomes of Yearly Imaging Surveillance in Patients Following Endovascular Aortic Aneurysm Repair.

Little is known about the impact of standardized imaging surveillance on anxiety levels and well-being of patients after endovascular aortic aneurysm repair (EVAR). We hypothesize that patient anxiety levels increase just before receiving the imaging results compared with standard anxiety levels. METHODS: Prospective cohort study from November 2018 to May 2020 including post-EVAR patients visiting the outpatient clinics of 4 Dutch hospitals for imaging follow-up. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used. Patients completed the PROMIS Anxiety v1.0 Short Form (SF) 4a, PROMIS-Global Health Scale v1.2, and PROMIS-Physical Function v1.2 SF8b at 2 time points: prior to the result of the imaging study (T1: pre-visit) and 6-8 months later (T2: reference measurement). Mean T-scores at T1 were compared to T2, and T2 to the general 65+ Dutch population. RESULTS: Altogether 342 invited patients were eligible, 214 completed the first questionnaire, 189 returned 2 completed questionnaires and 128 patients did not participate. Out of 214 respondents, 195 were male (91.1%) and the mean (standard deviation) age was 75.2 (7.0) years. There were no significant differences between T1 and T2 in anxiety levels (0.48; 95% confidence interval[CI] -0.42-1.38), global mental health (0.27; 95% CI -0.79-0.84), global physical health (0.10; 95% CI -0.38-1.18) and physical function (0.53; 95% CI -0.26-1.32). Compared with the 65+ Dutch population, at T2 patients experienced more anxiety (3.8; 95% CI 2.96-5.54), had worse global physical health (-3.2; 95% CI -4.38 - -2.02) and physical function (-2.4; 95% CI -4.00 - -0.80). Global mental health was similar (-1.0; 95% CI -2.21 - 0.21). CONCLUSIONS: Post-EVAR patients do not experience more anxiety just before receiving surveillance imaging results than outside this period, but do suffer from more anxiety and worse physical outcomes than the 65+ Dutch population.

Short-term outcomes of open surgical abdominal aortic aneurysm repair from the Dutch Surgical Aneurysm Audit.

BACKGROUND: The sharp decrease in open surgical repair (OSR) for abdominal aortic aneurysm (AAA) has raised concerns about contemporary postoperative outcomes. The study was designed to analyse the impact of complications on clinical outcomes within 30 days following OSR. METHODS: Patients who underwent OSR for intact AAA registered prospectively between 2016 and 2019 in the Dutch Surgical Aneurysm Audit were included. Complications and outcomes (death, secondary interventions, prolonged hospitalization) were evaluated. The adjusted relative risk (aRr) and 95 per cent confidence intervals were computed using Poisson regression. Subsequently, the population-attributable fraction (PAF) was calculated. The PAF reflects the expected percentage reduction of an outcome if a complication were to be completely prevented. RESULTS: A total of 1657 patients were analysed. Bowel ischaemia and renal complications had the largest impact on death (aRr 12·44 (95 per cent c.i. 7·95 to 19·84) at PAF 20 (95 per cent c.i. 8·4 to 31·5) per cent and aRr 5·07 (95 per cent c.i. 3·18 to 8.07) at PAF 14 (95 per cent c.i. 0·7 to 27·0) per cent, respectively). Arterial occlusion had the greatest impact on secondary interventions (aRr 11·28 (95 per cent c.i. 8·90 to 14·30) at PAF 21 (95 per cent c.i. 14·7 to 28·1) per cent), and pneumonia (aRr 2·52 (95 per cent c.i. 2·04 to 3·10) at PAF 13 (95 per cent c.i. 8·3 to 17·8) per cent) on prolonged hospitalization. Small effects were observed on outcomes for other complications. CONCLUSION: The greatest clinical impact following OSR can be made by focusing on measures to reduce the occurrence of bowel ischaemia, arterial occlusion and pneumonia.

Differences in Comorbidities Between Women and Men Treated with Elective Repair for Abdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis.

OBJECTIVES: Elective abdominal aortic aneurysm (AAA) repair is performed to prevent rupture. For reasons as yet unknown, the 30-day mortality risk after elective AAA repair is higher in women than in men. We hypothesised that this higher risk might be related to differences in comorbidity. METHODS: Systematic review (PROSPERO CRD42019133314) according to PRISMA guidelines. A search in the EMBASE/MEDLINE/CENTRAL databases identified 1870 studies that included patients who underwent elective AAA repair (final search February 17th, 2021). Ultimately, 28 studies were included and all reported comorbidities were categorised into 17 comorbidity groups. Additionally, 15 groups of clearly defined comorbidities were used for sensitivity analysis. For both groups, meta-analyses of each comorbidity were performed to estimate the difference in pooled prevalence between women and men with a random effects model. RESULTS: When analysing data of all reported comorbidities (17 groups), smoking [risk difference (RD) 11%, 95% confidence interval (CI) 4-18], diabetes (RD 3%, 95% CI 2-4), ischaemic heart disease (RD 12%, 95% CI 8-16), arrhythmia (RD 3%, 95% CI 0.4-5), liver disease (RD 0.1%, 95% CI 0.01-0.2), and cancer (RD 3%, 95% CI 2-4)) were less prevalent in women, whereas, hypertension (RD 4%, 95% CI 3-6) and pulmonary disease (RD 4%, 95% CI 3-5) were more prevalent in women. At the time of surgery women were significantly older than men (74.9 years versus 72.4; mean difference 2.4 years (95% CI 2.1-2.7)). In the sensitivity analysis of 15 comorbidity groups, the same comorbidities remained significantly different between women and men, except smoking and arrhythmia. Women had a higher mortality risk than men (RD 1%, 95% CI 1-2). CONCLUSIONS: Although women undergoing elective AAA repair have fewer baseline comorbidities than men, their 30-day mortality risk is higher. In-depth studies on the cause of death in women after elective AAA repair are needed to explain this discrepancy in mortality.

Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent.

Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)-an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a "one size fits all" approach to all clinical biobanks. Rather, differences between clinical biobanks-especially regarding the scientific aims and patient populations-make the case for context-relative norms that determine the appropriate type of consent.

Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials.

BACKGROUND: Standardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision-making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent. METHODS: RCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted. RESULTS: Of 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper. CONCLUSION: Despite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.

ANTECEDENTES: Los métodos para la estandarización en la descripción de los resultados facilitan la comparación entre estudios. La toma de decisiones clínicas debe estar respaldada por los resultados que se obtienen en los ensayos clínicos aleatorizados (randomized clinical trials, RCTs) quirúrgicos sobre los efectos beneficiosos y nocivos de los tratamientos. Es obligado que la descripción de los resultados de los ensayos clínicos sea correcta y completa a fin de estimar la evidencia disponible y poder informar a los pacientes de forma adecuada antes de solicitar el consentimiento informado. MÉTODOS: Se revisaron de forma sistemática los RCTs publicados entre enero de 2005 y enero de 2017 en las 15 revistas principales en los que se comparaba un tratamiento quirúrgico con cualquier otro. Para evaluar las publicaciones, se utilizó la guía de comprobación del CONsolidated Standard of Reporting Trials (CONSORT), haciéndola extensiva también a los efectos nocivos. Se obtuvieron los resultados sobre los efectos beneficiosos y nocivos del tratamiento, sus definiciones y sus medidas de precisión. RESULTADOS: De 1.200 RCTs seleccionados, se incluyeron 88 ensayos. Para comparar las diferencias de los efectos beneficiosos de los resultados, en el 68% de los ensayos se aportó sólo un valor de la P pero no el intervalo de confianza del 95%. Para efectos nocivos, el porcentaje fue del 67%. En sólo 5 de 88 ensayos (6%) se informó del número de pacientes que es necesario tratar (number needed to treat, NNT), y en ningún estudio se precisó el número de pacientes que es necesario para perjudicar (number needed to harm, NNH). En sólo el 61% de los ensayos se informó de los resultados beneficiosos y nocivos de la intervención analizada en el mismo artículo. CONCLUSIÓN: A pesar de la guía CONSORT, la descripción actual de los efectos beneficiosos y nocivos en los ensayos quirúrgicos no permite obtener una clara información del resultado del tratamiento obtenido en los pacientes. Los investigadores, los revisores y los editores de las revistas deben garantizar una descripción adecuada los beneficios y efectos nocivos del tratamiento en los ensayos clínicos.

Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands.

OBJECTIVE/BACKGROUND: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period. METHODS: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. RESULTS: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p < .001]) and INT in 44% (2009: 66%; -22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; +13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; -16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; +19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (€6885 vs. €7300; p = .020). CONCLUSION: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system.

Clinimetric Evaluation of the Vascular Quality of Life Questionnaire in Patients with Lower Limb Ischaemia.

OBJECTIVES: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). METHODS: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. RESULTS: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). CONCLUSIONS: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument.