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Background: Correction of post-traumatic orbital defects remains a challenge for the maxillofacial surgeon. We examined the added value of combined intraoperative (IO) navigation and IO cone beam computed tomography (CBCT)., Materials and Methods: A retrospective cohort study was performed in all consecutive patients requiring unilateral post-traumatic orbital surgery between January 2012 and December 2018. Patients were divided into 3 groups: IO navigation (NAV), IO-CBCT (CBCT), and IO navigation with IO-CBCT (NAV-CBCT). A detailed description of our workflow is provided. Volumetric comparison of the operated orbit to the contralateral orbit was made with Brainlab., Results: Of the 81 cases, 22 patients were included (12 males/10 females) with a mean age of 51 years. Three patients were assigned to NAV, 6 to CBCT, and 13 to NAV-CBCT. The reconstructed orbital volume did not significantly differ from the contralateral orbital volume within the 3 groups. The mean difference between the contralateral and the operated orbit was 3.05 cm 3 , 3.72 cm 3 , and 1.47 cm 3 for NAV, CBCT, and NAV-CBCT, respectively, where only NAV-CBCT showed a significant smaller volumetric difference in comparison to CBCT alone. Gender or age did not correlate with difference in orbital volume. Normal function and aesthetics was seen at 6 weeks postoperative in 0 of 3, 6of 6, and 6 of 13 patients of the NAV, CBCT, and NAV-CBCT, respectively., Conclusion: Orbital defects can be treated effectively using IO navigation. Although our data could not demonstrate a significant added value of IO-CBCT in cases where IO navigation was used based on volumetric difference alone, the combination of IO-CBCT and IO navigation seems to give the best results considering both volumetric difference and postoperative function and aesthetics. Confirmation in a prospective, randomized trial with a larger sample size is required., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

In the case of pandemic crisis situations, a crucial lack of protective material such as protective face masks for healthcare professionals can occur. A proof of concept (PoC) and prototype are presented, demonstrating a reusable custom-made three-dimensionally (3D) printed face mask based on materials and techniques (3D imaging and 3D printing) with global availability. The individualized 3D protective face mask consists of two 3D-printed reusable polyamide composite components (a face mask and a filter membrane support) and two disposable components (a head fixation band and a filter membrane). Computer-aided design (CAD) was used to produce the reusable components of the 3D face mask based on individual facial scans, which were acquired using a new-generation smartphone with two cameras and a face scanning application. 3D modelling can easily be done by CAD designers worldwide with free download software. The disposable non-woven melt-blown filter membrane is globally available from industrial manufacturers producing FFP2/3 protective masks for painting, construction, agriculture, and the textile industry. Easily available Velcro fasteners were used as a disposable head fixation band. A cleaning and disinfection protocol is proposed. Leakage and virological testing of the reusable components of the 3D face mask, following one or several disinfection cycles, has not yet been performed and is essential prior to its use in real-life situations. This PoC should allow the reader to consider making and/or virologically testing the described custom-made 3D-printed face masks worldwide. The surface tessellation language (STL) format of the original virtual templates of the two reusable components described in this paper can be downloaded free of charge using the hyperlink (Supplementary Material online)., (Copyright © 2020. Published by Elsevier Ltd.)

Objectives: We aimed to determine the proportion of "fit" versus "vulnerable" older patients with cancer included in phase II and III oncology registration trials, as compared to the proportions in a real life oncology setting., Methods: Trial and patient characteristics of older (≥70years) patients treated at the OECI-designated clinical cancer centre in Kortrijk and included in a phase II or III oncology registration trial were collected retrospectively. These patients were matched individually with randomly-selected patients from the general oncology setting, based on gender, age, tumour type, tumour stage, and treatment intent. Patients' fitness, based on routine Geriatric-8 (G8) screening, was retrieved from prospectively constructed databases., Results: Between November 2012 and October 2018, 218 older patients with cancer were included in a phase II or III oncology registration trial. Of those, 41 cases with a mean age of 76.0years were included in the analyses. A Fisher's Exact Test revealed a statistical significant difference between cases and matched controls, with a higher proportion of "fit" patients included in phase II or III oncology registration trials compared to the proportion in the matched control group (respectively 70.7% and 41.5%, p<.010)., Discussion: We provide evidence for the hypothesis that older patients included in phase II or III oncology trials are significantly fitter than the real life oncology population. Some form of geriatric evaluation should be integrated in future cancer clinical trials to enable stratification according to this parameter and allow subgroup analysis. This will broaden the application and interpretation of trial results., Competing Interests: Declaration of Competing Interest The authors have no conflict of interest to declare., (Copyright © 2018. Published by Elsevier Ltd.)

Objectives: A comprehensive geriatric assessment (CGA) is the key treatment approach to guide decisions in older patients with cancer. In this paper, the added value of an assessment of the patient's hand grip strength to predict survival in patients with an abnormal G8-questionnaire (G8) score is investigated., Materials and Methods: Patients were screened by the G8, followed by a CGA in case of an abnormal screening (≤14.0). Hand grip strength was assessed by use of the JAMAR® hydraulic hand dynamometer. Cut-offs were applied according to the Fried frailty criteria. The survival rate was calculated twelve months after the CGA date., Results: We retrospectively reviewed data of 2071 patients who were treated at the Kortrijk Geriatric Oncology Clinic (General Hospital Groeninge, Belgium) between November 2012 and December 2016. Of those, 944 patients with a mean age of 79.6 years were included in the analyses. 64.2% of patients presented an abnormal hand grip strength score. A log rank test revealed a statistical significant result between patients when accounting for the hand grip strength score (p < .01). When added to a Cox regression model, a significant result was found (p < .01). However, this added only 0.4% to the explained variance of the model., Discussion: While a statistically significant result was detected, when adding the hand grip strength score to a regression model for survival, our data indicate that such assessment may clinically be less relevant when included in an already extensive test battery and may therefore provide only limited information in terms of patient survival., (Copyright © 2019. Published by Elsevier Ltd.)

Objectives: Cognitive complaints, of objective or subjective nature, may negatively impact cancer patients' quality of life (QoL). Further, the early detection of cognitive alterations may lead to an improved QoL. However, the content of such screening is yet unclear. This paper presents long-term QoL data of cancer patients treated with curative intent and its relation with objective and subjective cognitive complaints, and patient-reported outcome measures (PROMs)., Methods: QoL data, measured by the EORTC QLQ C-30, were obtained at baseline, 6 (T1), 12 (T2), and 24 months (T3) after treatment start, and compared between patients with and without objective and subjective cognitive complaints. The predictive value of PROMs was also examined., Results: QoL data at baseline was collected in 125 patients. Response rates at T1, T2, and T3 were 84.7%, 81.5%, and 83.1%, respectively. Eighty-nine patients returned their QoL questionnaires at all times. Baseline subjective cognitive complaints had a stronger association with worse scores on patients' overall QoL and QoL subscale scores than objective cognitive complaints. An exploratory analysis into the value of PROMs in predicting long-term QoL at T3 revealed a significant effect for the Hospital Anxiety and Depression Scale-Depression and FACIT Fatigue scale., Conclusions: Self-perceived cognitive alterations are negatively associated with patients' overall QoL. As these troubles may already be present at baseline, oncology nurses should screen for the early signs of subjective cognitive complaints by use of PROMs, in order to refer the patient to proper intervention programs which may lead to an improved long-term QoL and faster reintegration into society.

Purpose: To evaluate the feasibility and efficacy of a novel concept of early loaded (ie, within 2 weeks) implant-supported fixed dental prostheses (ISFDP) for patients who underwent mandibular reconstruction., Materials and Methods: All patients requiring mandibular reconstruction between July 2013 and March 2016 at AZ Sint-Jan Brugge-Oostende AV were screened for dental rehabilitation according to the proposed concept. Of 17 patients, 10 were eligible for inclusion. Clinical and radiologic assessments of implant integration and prosthetic survival were performed at 6, 12, 24, and 36 months. Patient satisfaction was assessed prior to and after prosthetic rehabilitation using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 and Head & Neck 35, as well as a visual analog scale., Results: Ten patients received mandibular reconstructive surgery for an oral cavity tumor (n = 6), osteoradionecrosis (n = 3), or medication-related osteonecrosis of the jaw (n = 1). Implants were placed within an average of 6 (2 to 21) months postsurgery in a one-stage procedure. Prosthetic rehabilitation was achieved within 2 weeks in 8 of the 10 patients. Two patients received their ISFDP delayed due to postoperative complications. Implant integration and prosthetic outcome at a maximum of 36 months of follow-up were successful in 7 of the 10 patients. At that time, two patients had passed away, while one patient had the ISFPD removed because of graft necrosis after radiotherapy. Patient satisfaction was high, with significant improvement after dental rehabilitation in comparison to mandibular reconstruction alone., Conclusion: The present concept offers a feasible and fast prosthetic rehabilitation that improves patient quality of life.

Background: In cleft palate surgery, there is currently no consensus on the management of patients with Pierre Robin Sequence (PRS). The authors aimed to evaluate the treatment strategy of cleft palate in our centers, with emphasis on patients with PRS, as the authors noted some patients with severe respiratory distress. Moreover, the authors aimed to investigate the prevalence of postoperative respiratory complications, using a modified-Furlow palatoplasty in combination with intravelar veloplasty in both patients with PRS and patients with non-PRS., Methods: The authors retrospectively identified all consecutive patients, both PRS and non-PRS, who underwent palate repair between January 1, 2012 and December 15, 2014 at 2 cooperating cleft centers (Bruges, Belgium; Budapest, Hungary). The treatment modality was uniform and performed by the same 2 surgeons., Results: In 92 consecutive patients, 4 patients experienced respiratory distress after palate repair. The female-to-male ratio was 1:1. The mean age at surgery in these 4 patients was 15 months (range 13-19 months). Fifteen percent (2/13) of patients with PRS experienced respiratory distress in comparison to 3% (2/79) of non-PRS (χ = 4.43; P = 0.035)., Conclusions: This is the first report of postoperative respiratory difficulties, while using a modified-Furlow palatoplasty in combination with intravelar veloplasty. In the present author's experience, the authors suggest to perform a 2-stage closure of the cleft palate in patients with PRS and to do so at a later age, when the palatal tissues and airway structures are more mature. Moreover, patients with PRS should be monitored closely, as they can present with different degrees of respiratory distress after palatoplasty.

Objectives: Research has indicated that cancer-related cognitive impairments (CRCI) may be influenced by psychosocial factors such as distress, worry and fatigue. Therefore, we aimed to validate the distress thermometer (DT) as a screening tool to detect CRCI six months post-treatment-initiation in a group of general cancer patients., Methods: Patients (≥18 years, n = 125) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated at baseline (T0) and six months post-treatment-initiation (T1) for CRCI by a neuropsychological assessment, including patient-reported outcome measures (PROMs). Assessed cognitive domains included premorbid intelligence, attention, processing speed, flexibility, verbal and visual episodic memory and verbal fluency. PROMs entailed distress (DT, cut-off ≥4, range 0-10), anxiety and depression, fatigue (FACIT-fatigue scale) and subjective cognitive complaints., Results: At T0, 60.4% of patients showed a DT score of ≥4, whereas 50% met this criterion at T1. According to the definition of the International Cognition and Cancer Task Force, 25.5% and 28.3% of patients presented with a CRCI at T0 and T1, respectively. When evaluating the DT as a screening tool for CRCI at T1, data showed an inverse relationship between the DT and CRCI. ROC-curve analysis revealed an AUC <0.5. ROC-curve analyses evaluating the DT and FACIT-fatigue scale as screening tools for subjective cognitive complaints showed an AUC ± SE of, respectively, 0.642 ± 0.067 and 0.794 ± 0.057., Conclusions: The DT at T0 cannot be used to screen for objective CRCI at T1, but both the DT and FACIT-fatigue scale at T0 showed potential as screening tools for subjective cognitive complaints at T1.

Introduction: Recent research in the field of cancer-related cognitive impairments (CRCI) has shown CRCI presentation prior to treatment initiation. Some have attributed these problems to worry and fatigue, whereas others have suggested an influence of age, IQ, and other psychosocial and medical factors., Methods: Patients (≥18 years) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated with a baseline neuropsychological assessment including Patient-Reported Outcome Measures (PROMs). PROMs entailed distress, anxiety and depression, fatigue, and cognitive complaints. The neuropsychological assessment comprised several cognitive domains such as premorbid IQ, attention, processing speed, flexibility, verbal and visual episodic memory, and verbal fluency., Results: Cross-sectional data of 125 patients were collected. Patients had a mean age of 60.9 years (range: 30.0-85.0) and comprised primarily females (65.6%). Patients presented with cancer of following sites: breast (44.0%), digestive (28.8%), urological (11.2%), gynecologic (8.0%), hematologic malignancy (4.8%), and lung (3.2%). Patients presented with a premorbid IQ of 105.3 (range: 79.0-124.0). In 29.6% of patients, a CRCI was detected. Binary logistic regression analyses showed that a lower premorbid IQ (β = -.084, P < .01) and a higher level of fatigue (β = -.054, P < .05) predicted baseline CRCI. Premorbid IQ also predicted performance on individual cognitive domains. Some domains were also influenced by age, gender, having a breast cancer diagnosis, and an active treatment for hypertension., Conclusion: Premorbid IQ and fatigue are important predictors of baseline CRCI. Therefore, we advise researchers to implement a short IQ test when conducting clinical trials on CRCI., (Copyright © 2016 John Wiley & Sons, Ltd.)

Background: Evidence-based guidelines concerning the older head and neck cancer (HNCA) patient are lacking. Accurate patient selection for optimal care management is therefore challenging. We examined if geriatric assessment is indicative of long-term health-related quality of life (HRQOL) and overall survival in this unique population., Methods: All HNCA patients, aged ≥65 years, eligible for curative radio(chemo)therapy were evaluated with the Geriatric-8 (G-8) questionnaire and a comprehensive geriatric assessment (CGA). Euroqol-5 dimensions (EQ-5D) and survival were collected until 36 months post treatment start. Repeated measures ANOVA was applied to analyse HRQOL evolution in 'fit' and 'vulnerable' patients, defined by G-8. Kaplan-Meier curves and cox proportional hazard analysis were established for determination of the prognostic value of geriatric assessments. Quality-adjusted survival was calculated in both patient subgroups., Results: One hundred patients were recruited. Seventy-two percent of patients were considered vulnerable according to CGA (≥2 abnormal tests). Fit patients maintained a relatively acceptable long-term HRQOL, whilst vulnerable patients showed significantly lower median health states. The difference remained apparent at 36 months. Vulnerability, as classified by G-8 or CGA, came forward as independent predictor for lower EQ-5D index scores. After consideration of confounders, a significantly lower survival was observed in patients defined vulnerable according to G-8, compared to fit patients. A similar trend was seen based on CGA. Calculation of quality-adjusted survival showed significantly less remaining life months in perfect health in vulnerable patients, compared to fit ones., Conclusions: G-8 is indicative of quality-adjusted survival, and should be considered at time of treatment decisions for the older HNCA patient.

Background: Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact., Methods: Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined., Results: A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes., Conclusion: Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research., (© The Author(s) 2015.)

Background: Therapy-induced mucositis and dysphagia puts head and neck (H&N) cancer patients at increased risk for developing cachexia. Omega-3 fatty acids (n-3 FA) have been suggested to protect against cachexia. We aimed to examine if echium oil, a plant source of n-3 FA, could reduce weight loss in H&N cancer patients undergoing radio(chemo)therapy with curative intent., Methods: In a double-blind trial, patients were randomly assigned to echium oil (intervention (I) group; 7.5 ml bis in die (b.i.d.), 235 mg/ml α-linolenic acid (ALA) + 95 mg/ml stearidonic acid (SDA) + 79 mg/ml γ-linolenic acid (GLA)) or n-3 FA deficient sunflower oil high oleic (control (C) group; 7.5 ml b.i.d.) additional to standard nutritional support during treatment. Differences in percentage weight loss between both groups were analysed according to the intention-to-treat principle. Erythrocyte FA profile, body composition, nutritional status and quality of life were collected., Results: Ninety-one eligible patients were randomised, of whom 83 were evaluable. Dietary supplement adherence was comparable in both groups (median, I: 87%, C: 81%). At week 4, the I group showed significantly increased values of erythrocyte n-3 eicosapentanoic acid (EPA, 14% vs -5%) and n-6 GLA (42% vs -20%) compared to the C group, without a significant change in n-6 arachidonic acid (AA, 2% vs -1%). Intention-to-treat analysis could not reveal a significant reduction in weight loss related to echium oil consumption (median weight loss, I: 8.9%, C: 7.6%). Also, no significant improvement was observed in the other evaluated anthropometric parameters., Conclusions: Echium oil effectively increased erythrocyte EPA and GLA FAs in H&N cancer patients. It failed however to protect against weight loss, or improve nutritional parameters., Trial Registration: ClinicalTrials.gov Identifier NCT01596933.

Objective: We aimed to validate the Freund Clock Drawing Test (CDT), with its predefined cutoff score of ≤4, as a screening tool to detect elderly cancer patients in need of a more in-depth cognitive evaluation within a comprehensive geriatric assessment (CGA)., Methods: Patients aged 70 years or older with a histologically confirmed diagnosis of cancer were evaluated with a full CGA, including CDT and Folstein Mini Mental State Examination (MMSE) as gold standard. Validation of the Freund CDT was defined in terms of diagnostic accuracy of the test through receiver operating characteristics (ROC)-analysis. To accept the Freund CDT as a screening tool, we estimated that the area under the ROC curve (AUC) had to differ significantly from 0.70 with an AUC of at least 0.85., Results: Two hundred elderly cancer patients with a mean age of 79.0 years were included. Four patients were excluded from the analyses because of invalid results. Potential cognitive impairment (MMSE ≤23) was observed in 27.0% of patients. Based on of the AUC ± SE, the Freund CDT showed excellent diagnostic performance (0.95 ± 0.17). Furthermore, it provided excellent sensitivity (94.3%) and high specificity (87.4%)., Conclusions: Our results indicate that the Freund CDT can be used as an initial screening tool to detect elderly cancer patients in need of a more in-depth cognitive assessment within CGA, instead of the MMSE., (Copyright © 2014 John Wiley & Sons, Ltd.)

Purpose: Several lines of evidence strongly implicate a dysfunctional endocannabinoid system (ECS) in eating disorders. Using [(18)F]MK-9470 and small animal positron emission tomography (PET), we investigated for the first time cerebral changes in type 1 cannabinoid (CB1) receptor binding in vivo in the activity-based rat model of anorexia (ABA), in comparison to distinct motor- and food-related control conditions and in relation to gender and behavioural variables., Methods: In total, experiments were conducted on 80 Wistar rats (23 male and 57 female). Male rats were assigned to the cross-sectional conditions: ABA (n = 12) and CONTROL (n = 11), whereas female rats were divided between two settings: (1) a cross-sectional design using ABA (n = 13), CONTROL (n = 9), and two extra control conditions for each of the variables manipulated in ABA, i.e. DIET (n = 8) and WHEEL (n = 9), and (2) a longitudinal one using ABA (n = 10) and CONTROL (n = 8) studied at baseline, during the model and upon recovery. The ABA group was subjected to food restriction in the presence of a running wheel, the DIET group to food restriction without wheel, the WHEEL group to a normal diet with wheel and CONTROL animals had a normal diet and no running wheel. Parametric CB1 receptor images of each group were spatially normalized to Paxinos space and analysed voxel-wise., Results: In the ABA model, absolute [(18)F]MK-9470 binding was significantly increased in all cortical and subcortical brain areas as compared to control conditions (male +67 %; female >51%, all p cluster < 6.3×10(-6)) that normalized towards baseline values after weight gain. Additionally, relative [(18)F]MK-9470 binding was increased in the hippocampus, inferior colliculus and entorhinal cortex of female ABA (+4.6%; p cluster < 1.3×10(-6)), whereas no regional differences were observed in male subjects. Again, relative [(18)F]MK-9470 binding values normalized upon weight gain., Conclusion: These data point to a widespread transient disturbance of the endocannabinoid transmission, specifically for CB1 receptors in the ABA model. Our data also suggest (1) gender effects on regional CB1 receptor binding in the hippocampus and (2) add further proof to the validity of the ABA model to mimic aspects of human disease.

Objectives: We aimed to determine an optimal cut-off score for the Clock Drawing Test (CDT), scored by the scale of Freund, for efficient screening for cognitive impairment in elderly (cancer) patients within a Comprehensive Geriatric Assessment (CGA) and to compare the Freund CDT to the Mini-Cog., Materials and Methods: Data of 221 elderly (≥70years) patients, comprising of an OncoGeriatric (OG) and General Geriatric (GG) group, were retrospectively reviewed. All patients were evaluated with both the CDT and Mini Mental State Examination (MMSE) as the gold standard. Receiver Operating Characteristics (ROC) analysis was used to determine diagnostic performance. A pre-established algorithm was applied to retrieve Mini-Cog results through a combination of the CDT and the 3-Word Delayed Recall (3-WDR) test (included within MMSE)., Results: Data of 105 OG and 116 GG patients were evaluated. Potential cognitive impairment (MMSE≤23) was detected in 29.5% and 65.8% of patients, respectively. The CDT showed good diagnostic accuracy in the OG (0.88±0.03) and GG (0.85±0.03) group, based on the area under the ROC curve (AUC±SE). CDT (cut-off≤4) provided good sensitivity (80.7%) and specificity (81.1%) in the OG group and excellent sensitivity (89.6%) and moderate specificity (51.3%) in the GG group. Addition of the 3-WDR test, to form the Mini-Cog, resulted in similar positive and negative predictive values for the OG group and higher negative predictive value for the GG group., Conclusion: These data suggest that the Freund CDT, at the cut-off score of ≤4, is promising for use within a CGA. The Mini-Cog might be preferable in the GG population., (Copyright © 2012 Elsevier Inc. All rights reserved.)