Dysphagia After Total Laryngectomy: An Exploratory Study and Clinical Phase II Rehabilitation Trial with the Novel Swallowing Exercise Aid (SEA 2.0).

The aims of this exploratory study and clinical phase II trial were to assess the specific nature and extent of dysphagia in laryngectomized patients with self-reported dysphagia, and its rehabilitation potential using the novel Swallowing Exercise Aid (SEA 2.0). Twenty laryngectomized patients participated in a six-week exercise program with the SEA 2.0. Exercises consisted of Chin Tuck Against Resistance (CTAR), Jaw Opening Against Resistance (JOAR), and Effortful Swallow Against Resistance, conducted three times per day. Swallowing was assessed at baseline (T0), six (T1) and 14 (T2) weeks, consisting of patient-reported outcomes, BMI, videofluoroscopy, swallowing capacity, and muscle strength measurements. Dysphagia significantly impacts quality of life, with impaired swallowing speed and bolus propulsion as main reported issues. Subjective dysphagia parameters, swallowing capacity, and pharyngeal residue clearance were reduced, but BMI was normal. Muscle and tongue strength were within normal ranges. All participants managed to use the SEA 2.0. Adherence was 95%. At T1, subjective swallowing parameters (MDADI and EAT-10) showed clinically relevant improvements. Objectively, CTAR and JOAR strength increased with 27.4 and 20.1 Newton, respectively. Also, swallowing capacity (from 2.4 g/s to 3.8 g/s) and pharyngeal residue clearance improved. At T2, results were slightly lower than at T1, but still better than at baseline. Dysphagia in laryngectomized patients affects quality of life, but swallowing can be improved with a six-week rehabilitation program using the novel SEA 2.0. Adherence was excellent and several subjective and objective swallowing parameters improved.

Overcoming data scarcity in radiomics/radiogenomics using synthetic radiomic features.

PURPOSE: To evaluate the potential of synthetic radiomic data generation in addressing data scarcity in radiomics/radiogenomics models. METHODS: This study was conducted on a retrospectively collected cohort of 386 colorectal cancer patients (n = 2570 lesions) for whom matched contrast-enhanced CT images and gene TP53 mutational status were available. The full cohort data was divided into a training cohort (n = 2055 lesions) and an independent and fixed test set (n = 515 lesions). Differently sized training sets were subsampled from the training cohort to measure the impact of sample size on model performance and assess the added value of synthetic radiomic augmentation at different sizes. Five different tabular synthetic data generation models were used to generate synthetic radiomic data based on "real-world" radiomics data extracted from this cohort. The quality and reproducibility of the generated synthetic radiomic data were assessed. Synthetic radiomics were then combined with "real-world" radiomic training data to evaluate their impact on the predictive model's performance. RESULTS: A prediction model was generated using only "real-world" radiomic data, revealing the impact of data scarcity in this particular data set through a lack of predictive performance at low training sample numbers (n = 200, 400, 1000 lesions with average AUC = 0.52, 0.53, and 0.56 respectively, compared to 0.64 when using 2055 training lesions). Synthetic tabular data generation models created reproducible synthetic radiomic data with properties highly similar to "real-world" data (for n = 1000 lesions, average Chi-square = 0.932, average basic statistical correlation = 0.844). The integration of synthetic radiomic data consistently enhanced the performance of predictive models trained with small sample size sets (AUC enhanced by 9.6%, 11.3%, and 16.7% for models trained on n_samples = 200, 400, and 1000 lesions, respectively). In contrast, synthetic data generated from randomised/noisy radiomic data failed to enhance predictive performance underlining the requirement of true signal data to do so. CONCLUSION: Synthetic radiomic data, when combined with real radiomics, could enhance the performance of predictive models. Tabular synthetic data generation might help to overcome limitations in medical AI stemming from data scarcity.

Decisional Conflict and Decision Regret in Head and Neck Oncology: A Systematic Review and Meta-Analysis.

Importance: Head and neck cancer (HNC) often requires treatment with a major impact on quality of life. Treatment decision-making is often challenging, as it involves balancing survival against the preservation of quality of life and choosing among treatments with comparable outcomes but variation in morbidity and adverse events; consequently, the potential for decisional conflict (DC) and decision regret (DR) is high. Objectives: To summarize the literature on DC and DR in HNC, to give an overview of its prevalence and extent, and to advise on clinical practice and future research. Data Sources: Embase, Web of Science, MEDLINE, and PsycINFO were searched up to February 24, 2023, including all years of publication. Study Selection: Eligible studies addressed DC and/or DR as primary or secondary outcomes with any instrument in HNC, except cutaneous tumors. Two mutually blinded researchers conducted screening and inclusion with support of an artificial intelligence assistant and conducted risk of bias (ROB) assessment. Data Extraction and Synthesis: The Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines were followed for data extraction. ROB assessments were done using Critical Appraisal Skills Programme (qualitative) and CLARITY (quantitative). Meta-analysis with a random-effects model was used to obtain pooled prevalence estimates for DC and DR when at least 4 sufficiently clinically homogeneous studies were available. Main Outcomes and Measures: Prevalence of DC (qualitative, Decisional Conflict Scale, SURE questionnaire) and DR (qualitative, study-specific questionnaires, Decision Regret Scale, Shame and Stigma Scale). Results: Overall, 28 studies were included, with 16 included in meta-analyses for DR prevalence. The pooled prevalence of clinically relevant DR above the cutoff score for validated questionnaires (11 studies; 2053 participants) was 71% (95% CI, 58%-82%; I2 = 94%), while for study-specific questionnaires (5 studies; 674 participants) it was 11% (95% CI, 5%-22%; I2 = 92%). Only 4 studies investigated DC, showing a prevalence of 22.6% to 47.5% above cutoff values. Derived overarching themes found in qualitative studies were preparation, shared decision-making roles, information, time pressure, stress of diagnosis, and consequences. Conclusions and Relevance: Although limited data on DC and DR were available, the studies performed indicated that DC and DR are highly prevalent issues in HNC. Results suggest that study-specific questionnaires underestimated DR. The findings underscore the rationale to improve counseling and shared decision-making for this patient population.

Organization of head and neck cancer rehabilitation care: a national survey among healthcare professionals in Dutch head and neck cancer centers.

PURPOSE: Head and neck cancer (HNC) treatment often leads to physical and psychosocial impairments. Rehabilitation can overcome these limitations and improve quality of life. The aim of this study is to obtain an overview of rehabilitation care for HNC, and to investigate factors influencing rehabilitation provision, in Dutch HNC centers, and to some extent compare it to other countries. METHODS: An online survey, covering five themes: organizational structure; rehabilitation interventions; financing; barriers and facilitators; satisfaction and future improvements, among HNC healthcare- and financial professionals of Dutch HNC centers. RESULTS: Most centers (86%) applied some type of rehabilitation care, with variations in organizational structure. A speech language therapist, physiotherapist and dietitian were available in all centers, but other rehabilitation healthcare professionals in less than 60%. Facilitators for providing rehabilitation services included availability of a contact person, and positive attitude, motivation, and expertise of healthcare professionals. Barriers were lack of reimbursement, and patient related barriers including comorbidity, travel (time), low health literacy, limited financial capacity, and poor motivation. CONCLUSION: Although all HNC centers included offer rehabilitation services, there is substantial practice variation, both nationally and internationally. Factors influencing rehabilitation are related to the motivation and expertise of the treatment team, but also to reimbursement aspects and patient related factors. More research is needed to investigate the extent to which practice variation impacts individual patient outcomes and how to integrate HNC rehabilitation into routine clinical pathways.

Lymphedema and Trismus after Head and Neck Cancer, and the Impact on Body Image and Quality of Life.

BACKGROUND: To assess the prevalence of chronic lymphedema and trismus in patients > 6 months after head and neck cancer (HNC) treatment, and to explore how the severity of these conditions correlates with body image and quality of life. METHODS: The cross-sectional sample included 59 patients, treated for HNC between six months to three years ago. Physical measurements were performed to assess the presence of external lymphedema and trismus (<36 mm). Furthermore, participants completed two questionnaires regarding body image (BIS) and quality of life (UW-QoL V4). RESULTS: Lymphedema prevalence was 94.1% (95% CI 0.86-0.98), with a median severity score of 9 (range 0-24). Trismus prevalence in this sample was 1.2%. The median BIS score was 2, indicating a positive body image. The UW-QoL score showed a good QOL with a median of 100. Only the domain of saliva and overall related health had a lower median of 70 and 60, respectively. There was no correlation between lymphedema and body image (r = 0.08, p = 0.544). Patients with higher lymphedema scores reported poorer speech with a moderate correlation (r = -0.39, p = 0.003). CONCLUSION: Lymphedema is a highly prevalent, but moderately severe late side-effect of HNC with a limited impact on quality of life domains except for speech, in our cohort.

Decisional Conflict in Patients with Advanced Laryngeal Carcinoma: A Multicenter Study.

OBJECTIVES: Decision-making for patients with a locally advanced laryngeal carcinoma (T3 and T4) is challenging due to the treatment choice between organ preservation and laryngectomy, both with different and high impact on function and quality of life (QoL). The complexity of these treatment decisions and their possible consequences might lead to decisional conflict (DC). This study aimed to explore the level of DC in locally advanced laryngeal carcinoma patients facing curative decision-making, and to identify possible associated factors. METHODS: In this multicenter prospective cohort study, participants completed questionnaires on DC, level of shared decision-making (SDM), and a knowledge test directly after counseling and 6 months after treatment. Descriptive statistics and Spearman correlation tests were used to analyze the data. RESULTS: Directly after counseling, almost all participants (44/45; 98%) experienced Clinically Significant DC score (CSDC >25, scale 0-100). On average, patients scored 47% (SD 20%) correct on the knowledge test. Questions related to radiotherapy were answered best (69%, SD 29%), whilst only 35% (SD 29%) of the questions related to laryngectomy were answered correctly. Patients' perceived level of SDM (scale 0-100) was 70 (mean, SD 16.2), and for physicians this was 70 (SD 1.7). CONCLUSION: Most patients with advanced larynx cancer experience high levels of DC. Low knowledge levels regarding treatment aspects indicate a need for better patient counseling. LEVEL OF EVIDENCE: Level IV Laryngoscope, 2024.

Test-Retest Reliability of a Protocol for Assessment of Local Tissue Water in the Head and Neck Area.

Background: Lymphedema measurement is vital to select appropriate treatment and monitor its progress. Quantifying lymphedema in the head and neck area is challenging. The use of tissue dielectric constant (TDC) measurements has shown promising results in other body areas. This study aims to determine the test-retest reliability of a TDC measurement protocol developed for the head and neck area. Methods and Results: A detailed measurement protocol, including eight measurement points per side, was developed. Subsequently, the reliability of the protocol was tested in a sample of healthy participants (n = 50, 28 males). Using the LymphScanner (Delfin, Finland), participants were subjected to two measurement sessions. Each measurement point was measured three times per session. Test-retest reliability for each point was evaluated using intraclass correlation coefficients (ICCs) and standard errors of measurement (SEMs). Using the average of three measurements, reliability was good to excellent for all points (ICCs 0.81-0.95), with small measurement errors (SEMs 1.51-2.86). The reliability of a single measurement was moderate to excellent for all measurement points (ICCs 0.58-0.87), with larger, but still small, measurement errors (SEMs 1.65-3.39). When using single measurements, the lowest ICCs were found for the temporal (left 0.73 and right 0.67) and submandibular (left 0.58 and right 0.77) locations. Conclusion: Measurements with the LymphScanner, taken according to the developed protocol, are reliable in healthy participants. We recommend using the average of three measurements to optimize reliability. The protocol is fit for further testing in patient populations and for determining normal values in a larger scale study with healthy subjects.

Maximal cardiopulmonary exercise testing in laryngectomised patients using different heat and moisture exchangers - feasibility and exercise responses.

OBJECTIVE: After laryngectomy, the breathing resistance of heat and moisture exchangers may limit exercise capacity. Breathing gas analysis during cardiopulmonary exercise testing is not possible using regular masks. This study tested the feasibility of cardiopulmonary exercise testing with a heat and moisture exchanger in situ, using an in-house designed connector. Additionally, we explored the effect of different heat and moisture exchanger resistances on exercise capacity in this group. METHODS: Ten participants underwent two cardiopulmonary exercise tests using their daily life heat and moisture exchanger (0.3 hPa or 0.6 hPa) and one specifically developed for activity (0.15 hPa). Heat and moisture exchanger order was randomised and blinded. RESULTS: All participants completed both tests. No (serious) adverse events occurred. Only four subjects reached a respiratory exchange ratio of more than 1.1 in at least one test. Maximum exercise levels using heat and moisture exchangers with different resistances did not differ. CONCLUSION: Cardiopulmonary exercise testing in laryngectomees with a heat and moisture exchanger is feasible; however, the protocol does not seem appropriate to reach this group's maximal exercise capacity. Lowering heat and moisture exchanger resistance does not increase exercise capacity in this sample.

Squamous Cell Carcinoma Antigen in the Follow-up of Patients With Head and Neck Cancer.

OBJECTIVE: to determine if the tumor marker squamous cell carcinoma antigen (SCC-Ag) observed over time may contribute to the early detection of recurrence, metastasis, and second primary tumors in the follow-up of patients with head and neck squamous cell carcinoma (HNSCC). STUDY DESIGN: A retrospective analysis of patients with HNSCC and at least one SCC-Ag measurement was conducted. Hazard ratios (HRs) were used to determine the correlation between SCC-Ag and an event. SETTING: patients with HNSCC, treated in the Antoni van Leeuwenhoek Hospital in The Netherlands between 2010 and 2020 were used for the analysis. METHODS: Data from 789 patients were used on event-free survival (EFS) with time-dependent Cox models. In addition to current (most recent) SCC-Ag (also dichotomized into high and low as done for clinical practice), average SCC-Ag and change between SCC-Ag measurements (delta SCC-Ag) were considered, using restricted cubic splines to explore nonlinear relationships. RESULTS: Dichotomized SCC-Ag values (HR = 3.01, 95% confidence interval [CI]: 2.17-4.18) and the delta SCC-Ag (HR = 1.15, 95% CI: 1.07-1.22) predicted EFS better than models using the cumulative average or current value of SCC-Ag, also after adjusting for tumor site, stage, age, and gender. A strong association was observed when using delta SCC-Ag as a linear predictor in the subgroup of oropharynx patients (HR = 4.88, 95% CI: 2.71-8.79). CONCLUSION: Dichotomized and delta SCC-Ag values can be important markers for EFS, during the follow-up of patients treated for HNSCC. These results were more evident in patients with oropharyngeal cancer.

The development of a decision aid for patients with operable oropharyngeal carcinoma in the Netherlands - A mixed methods study.

OBJECTIVE: The aim of this project is to create an interactive online patient decision aid (PDA) for oropharyngeal cancer (OPSCC) patients, eligible for transoral (robotic) surgery with an ultimate goal to assist both physicians and patients in making treatment choices. MATERIALS AND METHODS: Following the International Patient Decision Aid Standards, a mixed-methods approach was employed. The study involved semi-structured in-depth interviews with patients and physicians, thinking-out-loud sessions, and study-specific questionnaires. Thematic coding and analysis were conducted on verbatim transcriptions of audio-recorded interviews. RESULTS: The PDA drafts were evaluated by twenty OPSCC survivors and twenty multidisciplinary specialists. Significant revisions were made after phase 1 to enhance readability and reduce text, whilst incorporating videos and graphics. Following all phases, both patients and specialists rated the PDA as comprehensible, feasible, and a valuable addition to regular counseling. CONCLUSION: This study showcases the development of a PDA for early stage oropharyngeal cancer patients considering surgery and radiotherapy options. The decision aid emphasizes the disparities in short- and long-term side effects between the two treatments. Patients and physicians found the decision aid to be understandable, user-friendly, and helpful for future patients. The PDA is available on https://beslissamen.nl/.

The Prediction of Biological Features Using Magnetic Resonance Imaging in Head and Neck Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis.

Magnetic resonance imaging (MRI) is an indispensable, routine technique that provides morphological and functional imaging sequences. MRI can potentially capture tumor biology and allow for longitudinal evaluation of head and neck squamous cell carcinoma (HNSCC). This systematic review and meta-analysis evaluates the ability of MRI to predict tumor biology in primary HNSCC. Studies were screened, selected, and assessed for quality using appropriate tools according to the PRISMA criteria. Fifty-eight articles were analyzed, examining the relationship between (functional) MRI parameters and biological features and genetics. Most studies focused on HPV status associations, revealing that HPV-positive tumors consistently exhibited lower ADCmean (SMD: 0.82; p < 0.001) and ADCminimum (SMD: 0.56; p < 0.001) values. On average, lower ADCmean values are associated with high Ki-67 levels, linking this diffusion restriction to high cellularity. Several perfusion parameters of the vascular compartment were significantly associated with HIF-1α. Analysis of other biological factors (VEGF, EGFR, tumor cell count, p53, and MVD) yielded inconclusive results. Larger datasets with homogenous acquisition are required to develop and test radiomic-based prediction models capable of capturing different aspects of the underlying tumor biology. Overall, our study shows that rapid and non-invasive characterization of tumor biology via MRI is feasible and could enhance clinical outcome predictions and personalized patient management for HNSCC.

The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study.

BACKGROUND: The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime. OBJECTIVES: This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime. METHODS: Laryngectomized patients previously using a Provox Vega or ActiValve Light were included. Acceptance and voice outcomes were evaluated at two-time points with a 2-week interval. Baseline measurements were taken with the standard VP, followed by placement of the PVHP for the 2-week assessment. RESULTS: Fifteen participants completed the study, with thirteen being initial Vega-users. PVHP acceptance was 87% 2 weeks after placement. Median device lifetime for all VPs was 64 d (range 14-370). In the subgroup without periprosthetic leakage, the median device lifetime was 101 d (range 31-370). Acceptance dropped to 40% after device failure. Voice quality did not differ between PVHP and baseline VP. The most reported adverse event was PVHP valve stickiness (46%). CONCLUSION AND SIGNIFICANCE: Acceptance of the PVHP is largely dependent on device lifetime, decreasing from 87% to 40% after leakage or replacement. Voice quality remains consistent across different VPs. Developing a long-lasting VP remains a challenge.

Improving Hands-Free Speech Rehabilitation in Laryngectomized Patients with a Moldable Adhesive.

OBJECTIVE: This study aims to assess the product performance of a new moldable peristomal adhesive with corresponding heating pad designed to facilitate and improve automatic speaking valve (ASV) fixation for hands-free speech in laryngectomized patients. METHODS: Twenty laryngectomized patients, all regular adhesive users with prior ASV experience, were included. Study-specific questionnaires were used for data collection at baseline and after two weeks of moldable adhesive use. The primary outcome parameters were adhesive lifetime during hands-free speech, use and duration of hands-free speech, and patient preference. Additional outcome parameters were satisfaction, comfort, fit, and usability. RESULTS: The moldable adhesive enabled ASV fixation adequate for hands-free speech in the majority of participants. Overall, the moldable adhesive significantly increased adhesive lifetime and duration of hands-free speech compared to participants' baseline adhesives (p < 0.05), regardless of stoma depth, skin irritation, or regular use of hands-free speech at baseline. The participants who preferred the moldable adhesive (55% of participants) experienced a significant increase in the adhesive lifetime (median of 24 h, range 8-144 h) and improved comfort, fit, and ease of speech. CONCLUSION: The moldable adhesive's lifetime and functional aspects, including the ease of use and custom fit, are encouraging outcomes and enable more laryngectomized patients to use hands-free speech more regularly. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2965-2970, 2023.

A systematic review of validated assessments methods for head and neck lymphedema.

PURPOSE: This systematic review aimed to provide a comprehensive overview of the validity and reliability of existing measurement instruments for quantifying head and neck lymphedema. METHODS: Four databases were searched on January 31st, 2022. The COnsensus-based Standards for selecting health Measurement INstruments (COSMIN) checklists were used for the risk of bias (ROB) assessment. RESULTS: Out of 3362 unique records, eight studies examined the reliability and validity of five measurement instruments of which one patient reported outcome. The Patterson scale for internal lymphedema and the patient reported head and neck external lymphedema and fibrosis (LIDS-H&N) demonstrated validity and reliability. For external lymphedema, none of the instruments had good reliability for all measuring points. CONCLUSION: There is a lack of sufficiently reliable and valid measurement instruments for external head and neck lymphedema. The Patterson scale and the patient reported LIDS-H&N seem reliable for clinical practice and research.

Understanding and predicting the performance of passive heat and moisture exchangers using a numerical model.

BACKGROUND: To improve the understanding of the thermodynamics and performance of small passive hygroscopic Heat and Moisture Exchangers (HMEs), a computer model simulating HME function is required. METHODS: We developed a numerical HME model to calculate the HME's water and heat exchange. The model was tuned and verified with experimental data and validated by applying it to HME design variations. RESULTS: Verification of the model's results to the experimental data shows that the tuned model yields reliable results. The mass of the core, which determines the HME's total heat capacity, is the most important parameter influencing the performance of passive HMEs. CONCLUSIONS: Increasing the HME's diameter is an effective way to improve an HME, as it yields higher performance and lowers breathing resistance. HMEs intended for use in warm or dry climates should contain more and those for use in cold humid climates should contain less hygroscopic salt.

Surgical site complications of isolated salvage neck dissection post-radiotherapy and post-chemoradiotherapy - A cohort analysis (1997-2017).

INTRODUCTION: This study aims to quantify surgical site complications (SSC) after isolated salvage neck dissection (ND) compared with primary ND. PATIENTS AND METHODS: Between 1997 and 2017 in the Netherlands Cancer Institute - Antoni van Leeuwenhoek, a total of 323 isolated NDs were performed in 308 patients: primary ND (n = 144), post-radiotherapy (RT) ND (n = 53) and post-chemoradiotherapy (CRT) ND (n = 126). Patient, tumor and therapy characteristics were recorded. SSCs were scored according to the Clavien-Dindo Classification (CDC). RESULTS: 101 NDs (31%) were complicated by at least one SSC. In total, 189 different SSCs occurred. Translated to CDC, 45 complications were grade 2, 25 grade 3a and 31 grade 3b. No significant difference in occurrence of SSC (CDC >1) was found between all groups. However, post-CRT, selective (SND) and modified radical ND and radical ND (MRND/RND) (p = 0.005), resection of sternocleidomastoid muscle (SCM) (p = 0.039) and duration of super selective ND surgery (p = 0.048) were significantly associated with more SSC. SCM muscle removal was associated with more surgical site infection (p = 0.045) and necrosis (p = 0.036). From week 10 post-RT/CRT, no difference in complication frequency with primary ND was seen. CONCLUSION: Post-CRT SND, MRND/RND and SCM muscle resection were associated with an increased incidence of SSCs. If oncologically possible, limit the extent of ND and when an MRND is inevitable, preserve the SCM muscle for optimal prevention of SSC. Concerning SSC, optimal timing of salvage ND is minimal 10 weeks after RT/CRT.

External validation of an MR-based radiomic model predictive of locoregional control in oropharyngeal cancer.

OBJECTIVES: To externally validate a pre-treatment MR-based radiomics model predictive of locoregional control in oropharyngeal squamous cell carcinoma (OPSCC) and to assess the impact of differences between datasets on the predictive performance. METHODS: Radiomic features, as defined in our previously published radiomics model, were extracted from the primary tumor volumes of 157 OPSCC patients in a different institute. The developed radiomics model was validated using this cohort. Additionally, parameters influencing performance, such as patient subgroups, MRI acquisition, and post-processing steps on prediction performance will be investigated. For this analysis, matched subgroups (based on human papillomavirus (HPV) status of the tumor, T-stage, and tumor subsite) and a subgroup with only patients with 4-mm slice thickness were studied. Also the influence of harmonization techniques (ComBat harmonization, quantile normalization) and the impact of feature stability across observers and centers were studied. Model performances were assessed by area under the curve (AUC), sensitivity, and specificity. RESULTS: Performance of the published model (AUC/sensitivity/specificity: 0.74/0.75/0.60) drops when applied on the validation cohort (AUC/sensitivity/specificity: 0.64/0.68/0.60). The performance of the full validation cohort improves slightly when the model is validated using a patient group with comparable HPV status of the tumor (AUC/sensitivity/specificity: 0.68/0.74/0.60), using patients acquired with a slice thickness of 4 mm (AUC/sensitivity/specificity: 0.67/0.73/0.57), or when quantile harmonization was performed (AUC/sensitivity/specificity: 0.66/0.69/0.60). CONCLUSION: The previously published model shows its generalizability and can be applied on data acquired from different vendors and protocols. Harmonization techniques and subgroup definition influence performance of predictive radiomics models. KEY POINTS: • Radiomics, a noninvasive quantitative image analysis technique, can support the radiologist by enhancing diagnostic accuracy and/or treatment decision-making. • A previously published model shows its generalizability and could be applied on data acquired from different vendors and protocols.

Does Prophylactic Replacement of Voice Prosthesis Make Sense? A Study to Predict Prosthesis Lifetime.

OBJECTIVE: Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary hospital. METHODS: This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient's history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics. RESULTS: Patients used a median 3.4 voice prostheses per year (range, 0.1-48.1). We found high inter- and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte-Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime. CONCLUSION: Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.