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  • 1
    In: Aesthetic Surgery Journal, Oxford University Press (OUP), Vol. 43, No. 1 ( 2023-01-09), p. 40-48
    Abstract: With evolving breast cancer survival and patient preferences, it is essential that reconstructive surgeons worldwide continue searching for the best reconstruction technique for patients. Autologous fat transfer (AFT) is a relatively new technique for total breast reconstruction that has already proven to be effective and safe with all advantages of autologous tissue. However, little is known about the aesthetic results and satisfaction concerning donor sites. Objectives The aim of this study was to measure donor site satisfaction following AFT for total breast reconstruction in breast cancer patients. Methods Between May and August of 2021, participants of the BREAST− trial who were at least 24 months after their final reconstruction surgery were invited to complete an additional survey concerning donor sites. The BODY-Q was utilized for data collection. Results of AFT patients were compared with a control group of implant-based reconstruction patients who did not have a donor site. Results A total of 51 patients (20 control, 31 intervention) completed the questionnaire. Satisfaction with body did not statistically differ between the groups. The most frequent complaint was contour irregularities (31 reports, 60.8%), with the least favorable donor site being thighs (23 reports, 53.5%) in the AFT group. Conclusions Satisfaction with body did not differ between breast cancer patients receiving AFT or implant-based reconstruction, meaning that large-volume liposuction does not aesthetically affect the utilized donor sites. Nevertheless, reconstructive surgeons should be aware of possible donor site complications, especially contour irregularities at the thighs, and discuss this with their patients.
    Type of Medium: Online Resource
    ISSN: 1090-820X , 1527-330X
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2048788-5
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  • 2
    In: Aesthetic Plastic Surgery, Springer Science and Business Media LLC, Vol. 47, No. 2 ( 2023-04), p. 593-604
    Abstract: Autologous fat transfer (AFT) seems to be a new minimal invasive method for total breast reconstruction, yet how patients, surgeons, and laymen evaluate cosmesis is lacking. The aim of this study was to evaluate the aesthetic outcome of AFT (intervention group) for total breast reconstruction post-mastectomy, as compared to implant-based reconstruction (IBR) (control group). Methods A random and blinded 3D photographic aesthetic outcome study was performed on a selection of 50 patients, scored by three panels: plastic surgeons, breast cancer patients, and laymen. Secondary outcomes included agreement within groups and possible patient characteristics influencing scoring. Results Breast cancer patients and plastic surgeons did not differ in the aesthetic scores between the treatment groups. In contrast, the laymen group scored AFT patients lower than IBR patients (− 1.04, p   〈  0.001). Remarkably, mean given scores were low for all groups and overall agreement within groups was poor (ICC  〈  0.50). Higher scores were given when subjects underwent a bilateral reconstruction and if a mamilla was present. Conclusion Evaluation of aesthetic outcomes varies greatly. Hence, aesthetic outcome remains a very personal measure and this emphasizes the importance of thorough patient counseling including information on achievable aesthetic results before starting a reconstructive procedure. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
    Type of Medium: Online Resource
    ISSN: 0364-216X , 1432-5241
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1462126-5
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  • 3
    In: JAMA Surgery, American Medical Association (AMA), Vol. 158, No. 5 ( 2023-05-01), p. 456-
    Abstract: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P  = .002), physical well-being: chest (difference; 7.6; P  = .007), and satisfaction with outcome (difference, 7.6; P  = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration ClinicalTrials.gov Identifier: NCT02339779
    Type of Medium: Online Resource
    ISSN: 2168-6254
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
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  • 4
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 12, No. 1 ( 2022-08-25)
    Abstract: Patients with SARS-CoV-2 infection present with different lung compliance and progression of disease differs. Measures of lung mechanics in SARS-CoV-2 patients may unravel different pathophysiologic mechanisms during mechanical ventilation. The objective of this prospective observational study is to describe whether Electrical Impedance Tomography (EIT) guided positive end-expiratory pressure (PEEP) levels unravel changes in EIT-derived parameters over time and whether the changes differ between survivors and non-survivors. Serial EIT-measurements of alveolar overdistension, collapse, and compliance change in ventilated SARS-CoV-2 patients were analysed. In 80 out of 94 patients, we took 283 EIT measurements (93 from day 1–3 after intubation, 66 from day 4–6, and 124 from day 7 and beyond). Fifty-one patients (64%) survived the ICU. At admission mean PaO 2 /FiO 2 -ratio was 184.3 (SD 61.4) vs. 151.3 (SD 54.4) mmHg, ( p  = 0.017) and PEEP was 11.8 (SD 2.8) cmH 2 O vs. 11.3 (SD 3.4) cmH 2 O, ( p  = 0.475), for ICU survivors and non-survivors. At day 1–3, compliance was ~ 55 mL/cmH 2 O vs. ~ 45 mL/cmH 2 O in survivors vs. non-survivors. The intersection of overdistension and collapse curves appeared similar at a PEEP of ~ 12–13 cmH 2 O. At day 4–6 compliance changed to ~ 50 mL/cmH 2 O vs. ~ 38 mL/cmH 2 O. At day 7 and beyond, compliance was ~ 38 mL/cmH 2 O with the intersection at a PEEP of ~ 9 cmH 2 O vs. ~ 25 mL/cmH 2 O with overdistension intersecting at collapse curves at a PEEP of ~ 7 cmH 2 O. Surviving SARS-CoV-2 patients show more favourable EIT-derived parameters and a higher compliance compared to non-survivors over time. This knowledge is valuable for discovering the different groups.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2615211-3
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  • 5
    In: Familial Cancer, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2019-1), p. 137-146
    Type of Medium: Online Resource
    ISSN: 1389-9600 , 1573-7292
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2015448-3
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  • 6
    In: Journal of Genetic Counseling, Wiley, Vol. 28, No. 3 ( 2019-06), p. 533-542
    Abstract: A nationwide pretest–posttest study was conducted in all clinical genetic centres in the Netherlands, to evaluate the effects of an online decision aid to support persons who have a genetic predisposition to cancer and their partners in making an informed decision regarding reproductive options. Main outcomes (decisional conflict, knowledge, realistic expectations, level of deliberation, and decision self‐efficacy) were measured before use (T0), immediately after use (T1), and at 2 weeks (T2) after use of the decision aid. Paired sample t tests were used to compute differences between the first and subsequent measurements. T0–T1 and T0–T2 comparisons indicate a significant reduction in mean decisional conflict scores with stronger effects for participants with high baseline decisional conflict. Furthermore, use of the decision aid resulted in increased knowledge levels and improved realistic expectations. Level of deliberation only increased for participants with lower baseline levels of deliberation. Decision self‐efficacy increased for those with low baseline scores, whereas those with high baseline scores showed a reduction at T2. It can be concluded that use of the decision aid resulted in several positive outcomes indicative of informed decision‐making. The decision aid is an appropriate and highly appreciated tool to be used in addition to reproductive counseling.
    Type of Medium: Online Resource
    ISSN: 1059-7700 , 1573-3599
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2016899-8
    SSG: 12
    SSG: 5,2
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  • 7
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 12, No. 1 ( 2022-01-14)
    Abstract: Although male Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) patients have higher Intensive Care Unit (ICU) admission rates and a worse disease course, a comprehensive analysis of female and male ICU survival and underlying factors such as comorbidities, risk factors, and/or anti-infection/inflammatory therapy administration is currently lacking. Therefore, we investigated the association between sex and ICU survival, adjusting for these and other variables. In this multicenter observational cohort study, all patients with SARS-CoV-2 pneumonia admitted to seven ICUs in one region across Belgium, The Netherlands, and Germany, and requiring vital organ support during the first pandemic wave were included. With a random intercept for a center, mixed-effects logistic regression was used to investigate the association between sex and ICU survival. Models were adjusted for age, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, comorbidities, and anti-infection/inflammatory therapy. Interaction terms were added to investigate effect modifications by sex with country and sex with obesity. A total of 551 patients (29% were females) were included. Mean age was 65.4 ± 11.2 years. Females were more often obese and smoked less frequently than males (p-value 0.001 and 0.042, respectively). APACHE II scores of females and males were comparable. Overall, ICU mortality was 12% lower in females than males (27% vs 39% respectively, p-value  〈  0.01) with an odds ratio (OR) of 0.62 (95%CI 0.39–0.96, p-value 0.032) after adjustment for age and APACHE II score, 0.63 (95%CI 0.40–0.99, p-value 0.044) after additional adjustment for comorbidities, and 0.63 (95%CI 0.39–0.99, p-value 0.047) after adjustment for anti-infection/inflammatory therapy. No effect modifications by sex with country and sex with obesity were found (p-values for interaction  〉  0.23 and 0.84, respectively). ICU survival in female SARS-CoV-2 patients was higher than in male patients, independent of age, disease severity, smoking, obesity, comorbidities, anti-infection/inflammatory therapy, and country. Sex-specific biological mechanisms may play a role, emphasizing the need to address diversity, such as more sex-specific prediction, prognostic, and therapeutic approach strategies.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2615211-3
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  • 8
    In: BJOG: An International Journal of Obstetrics & Gynaecology, Wiley, Vol. 130, No. 12 ( 2023-11), p. 1542-1551
    Abstract: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP‐Q stage ≥2 vaginal vault prolapse (VVP). Design Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. Setting Seven non‐university teaching hospitals and two university hospitals in the Netherlands. Population Patients with symptomatic post‐hysterectomy vaginal vault prolapse, requiring surgical treatment. Methods Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP‐Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. Main outcome measures Primary outcome was disease‐specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri‐operative data, complications and sexual function. Results A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease‐specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P  = 0.887; cohort: P  = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P  = 0.810; cohort: P  = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P  = 0.934; cohort: P  = 0.120; complications RCT: P  = 0.395; cohort: P  = 0.129). Conclusions LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow‐up period of 12 months.
    Type of Medium: Online Resource
    ISSN: 1470-0328 , 1471-0528
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2036469-6
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  • 9
    In: BMJ, BMJ
    Abstract: To review and appraise the validity and usefulness of published and preprint reports of prediction models for prognosis of patients with covid-19, and for detecting people in the general population at increased risk of covid-19 infection or being admitted to hospital or dying with the disease. Design Living systematic review and critical appraisal by the covid-PRECISE (Precise Risk Estimation to optimise covid-19 Care for Infected or Suspected patients in diverse sEttings) group. Data sources PubMed and Embase through Ovid, up to 17 February 2021, supplemented with arXiv, medRxiv, and bioRxiv up to 5 May 2020. Study selection Studies that developed or validated a multivariable covid-19 related prediction model. Data extraction At least two authors independently extracted data using the CHARMS (critical appraisal and data extraction for systematic reviews of prediction modelling studies) checklist; risk of bias was assessed using PROBAST (prediction model risk of bias assessment tool). Results 126 978 titles were screened, and 412 studies describing 731 new prediction models or validations were included. Of these 731, 125 were diagnostic models (including 75 based on medical imaging) and the remaining 606 were prognostic models for either identifying those at risk of covid-19 in the general population (13 models) or predicting diverse outcomes in those individuals with confirmed covid-19 (593 models). Owing to the widespread availability of diagnostic testing capacity after the summer of 2020, this living review has now focused on the prognostic models. Of these, 29 had low risk of bias, 32 had unclear risk of bias, and 545 had high risk of bias. The most common causes for high risk of bias were inadequate sample sizes (n=408, 67%) and inappropriate or incomplete evaluation of model performance (n=338, 56%). 381 models were newly developed, and 225 were external validations of existing models. The reported C indexes varied between 0.77 and 0.93 in development studies with low risk of bias, and between 0.56 and 0.78 in external validations with low risk of bias. The Qcovid models, the PRIEST score, Carr’s model, the ISARIC4C Deterioration model, and the Xie model showed adequate predictive performance in studies at low risk of bias. Details on all reviewed models are publicly available at https://www.covprecise.org/ . Conclusion Prediction models for covid-19 entered the academic literature to support medical decision making at unprecedented speed and in large numbers. Most published prediction model studies were poorly reported and at high risk of bias such that their reported predictive performances are probably optimistic. Models with low risk of bias should be validated before clinical implementation, preferably through collaborative efforts to also allow an investigation of the heterogeneity in their performance across various populations and settings. Methodological guidance, as provided in this paper, should be followed because unreliable predictions could cause more harm than benefit in guiding clinical decisions. Finally, prediction modellers should adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guideline. Systematic review registration Protocol https://osf.io/ehc47/ , registration https://osf.io/wy245 . Readers’ note This article is the final version of a living systematic review that has been updated over the past two years to reflect emerging evidence. This version is update 4 of the original article published on 7 April 2020 ( BMJ 2020;369:m1328). Previous updates can be found as data supplements ( https://www.bmj.com/content/369/bmj.m1328/related#datasupp ). When citing this paper please consider adding the update number and date of access for clarity.
    Type of Medium: Online Resource
    ISSN: 1756-1833
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1479799-9
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  • 10
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 15, No. 2 ( 2023-02), p. 113-119
    Abstract: The relationship between the interventionist’s experience and outcomes of endovascular thrombectomy (EVT) for acute ischemic stroke of the anterior circulation, is unclear. Objective To assess the effect of the interventionist’s level of experience on clinical, imaging, and workflow outcomes. Secondly, to determine which of the three experience definitions is most strongly associated with these outcome measures. Methods We analysed data from 2700 patients, included in the MR CLEAN Registry. We defined interventionist’s experience as the number of procedures performed in the year preceding the intervention (EXPfreq), total number of procedures performed (EXPno), and years of experience (EXPyears). Our outcomes were the baseline-adjusted National Institutes of Health Stroke Scale (NIHSS) score at 24–48 hours post-EVT, recanalization (extended Thrombolysis in Cerebral Infarction (eTICI) score ≥2B), and procedural duration. We used multilevel regression models with interventionists as random intercept. For EXPfreq and EXPno results were expressed per 10 procedures. Results Increased EXPfreq was associated with lower 24–48 hour NIHSS scores (adjusted (a)β:−0.46, 95% CI −0.70 to −0.21). EXPno and EXPyears were not associated with short-term neurological outcomes. Increased EXPfreq and EXPno were both associated with recanalization (aOR=1.20, 95% CI 1.11 to 1.31 and aOR=1.08, 95% CI 1.04 to 1.12, respectively), and increased EXPfreq, EXPno, and EXPyears were all associated with shorter procedure times (aβ:−3.08, 95% CI−4.32 to −1.84; aβ:−1.34, 95% CI−1.84 to −0.85; and aβ:−0.79, 95% CI−1.45 to −0.13, respectively). Conclusions Higher levels of interventionist’s experience are associated with better outcomes after EVT, in particular when experience is defined as the number of patients treated in the preceding year. Every 20 procedures more per year is associated with approximately one NIHSS score point decrease, an increased probability for recanalization (aOR=1.44), and a 6-minute shorter procedure time.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2506028-4
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