Automatic electrode scalar location assessment after cochlear implantation using a novel imaging software.

As of today, image-based assessment of cochlear implant electrode array location is not part of the clinical routine. Low resolution and contrast of computer tomography (CT) imaging, as well as electrode array artefacts, prevent visibility of intracochlear structures and result in low accuracy in determining location of the electrode array. Further, trauma assessment based on clinical-CT images requires a uniform image-based trauma scaling. Goal of this study was to evaluate the accuracy of a novel imaging software to detect electrode scalar location. Six cadaveric temporal bones were implanted with Advanced Bionics SlimJ and Mid-Scala electrode arrays. Clinical-CT scans were taken pre- and postoperatively. In addition, micro-CTs were taken post-operatively for validation. The electrode scalar location rating done by the software was compared to the rating of two experienced otosurgeons and the micro-CT images. A 3-step electrode scalar location grading scale (0 = electrode in scala tympani, 1 = interaction of electrode with basilar membrane/osseous spiral lamina, 2 = translocation of electrode into scala vestibuli) was introduced for the assessment. The software showed a high sensitivity of 100% and a specificity of 98.7% for rating the electrode location. The correlation between rating methods was strong (kappa > 0.890). The software gives a fast and reliable method of evaluating electrode scalar location for cone beam CT scans. The introduced electrode location grading scale was adapted for assessing clinical CT images.

[Preclinical models to establish innovative therapy strategies : Ex­vivo assessment of head and neck tumor chemo- and immune responses]. / Präklinische Modelle zur Etablierung innovativer Therapiestrategien : Ex­vivo­Testung der Chemo­ und Immunresponse von Kopf­Hals­Tumoren.

The pharmacological treatment of head and neck squamous cell carcinoma (HNSCC) is currently experiencing an expansion of the spectrum of targeting therapies. It can be expected that use of immune modulators, e.g., checkpoint-inhibitors, and their combination with chemotherapy will lead to a plethora of therapeutic options in the near future, from which the best one for the individual patient can be selected. HNSCCs are heterogeneous in their biology, and responses to chemotherapy are nonuniform and often only observable in subgroups. It would be valuable to know the chance of success of a particular treatment in advance. Evidence-based selection of the best individual treatment is difficult, since predictive biomarkers which are assessable prior to the treatment decision and reliably indicate the suitability of particular therapeutics are lacking. Pretherapeutic predictive ex-vivo chemoresponse testing of HNSCC biopsy specimens could enable identification of responders and allow a more suitable therapy regimen to be chosen for potential non-responders, without exposing them to likely ineffective therapy attempts. However, early ex-vivo assays failed regarding reliable prediction of therapeutic success, even with tolerable doses of pharmaceuticals and, in particular, their combinations. Predictive testing was hence deemed improper for the clinic. Improved methodology has now led to a reappraisal of predictive testing and its additional use in analysis of antitumor immune responses ex vivo. Here we describe recent advances and new results from ex-vivo chemoresponse testing of HNSCC and highlight their ability to facilitate establishment of innovative therapy strategies.

Psychological distress and need for psycho-oncological support in spouses of total laryngectomised cancer patients-results for the first 3 years after surgery.

PURPOSE: A total laryngectomy (TLE) leads to a variety of functional restrictions, which reduce the quality of life of cancer patients as well as their spouses. However, to date, there is little research focusing on the psychological distress of spouses of total laryngectomised cancer patients. The current study assesses psychological distress, need for psycho-oncological treatment and use of professional psychological care among spouses of total laryngectomised cancer patients. METHODS: A prospective multi-centre cohort study was conducted. Participants were interviewed in person 1, 2 and 3 years subsequent to their spouses' TLE with standardised questionnaires (HADS, Hornheide Screening) and self-designed items. RESULTS: One year after their partners' TLE, 154 spouses were interviewed. Over half of spouses (57 %) reported a high level of psychological distress and 33 % reported restlessness. Majority of spouses (21 %) reported wanting to learn relaxation methods and eight (5 %) had received psychological treatment in the past. Sixty-two spouses took part in the complete study. Over all three time points, psychological distress, the need for psycho-oncological support and the use of professional support among spouses remained stable. The need for additional professional counselling was low. CONCLUSIONS: In view of the stability of psychological distress among half of the spouses within 3 years after TLE and their refusal of professional support, there is a need for the development and evaluation of new treatment strategies to help spouses cope with psychological distress. Our results indicated the most common additional professional need was learning relaxation methods, which may be used as a starting point for the investigation of new coping strategies in future studies.

[Vocational rehabilitation after total laryngectomy]. / Berufliche Rehabilitation nach Laryngektomie.

BACKGROUND: Aim of this study was to find out how many patients after a total laryngectomy (TLE) return to work successfully and what factors support vocational rehabilitation. PATIENTS AND METHODS: Laryngectomees (n=231) aged up to 60 years completed questionnaires and structured interviews before TLE (t1), before rehabilitation (t2), at the end of rehabilitation (t3), 1 year after TLE (t4), 2 years after TLE (t5), and 3 years after TLE (t6). RESULTS: Prior to TLE, 38% of all respondents were employed, 34% were unemployed, 23% received disability-related and 3% age-related pension retirement. One year after TLE, 13% were employed, 15% 2 years and 14% 3 years after TLE. Unemployed were 10% (t4), 5% (t5), and 7% (t6) of the patients. For 59% of all respondents it was very important to have a job. Predictors of successful vocational rehabilitation were employment prior to TLE, age <50 years, being self-employed or clerical employee, good physical functioning, good speech intelligibility, high motivation to go back to work, and support from colleagues. CONCLUSION: Only few laryngectomees return to work. However, even before TLE only a third of the patients was employed, another third was unemployed. Most of the patients receive pension retirement after TLE. As return to work is important for many patients, patient consultations should consider possibilities to support vocational rehabilitation before offering to apply for retirement.

Co-morbid mental health conditions in cancer patients at working age--prevalence, risk profiles, and care uptake.

OBJECTIVE: This study examined the prevalence of mental health conditions in cancer patients, the role of socioeconomic position in relation to that, and the use of professional mental health care. METHODS: Prospective cohort with measurements at the beginning of inpatient treatment (baseline) and 3, 9, and 15 months after baseline using structured clinical interviews based on DSM-IV, questionnaires, and medical records. RESULTS: At baseline, 149 out of 502 cancer patients (30%) were diagnosed with a mental health condition. Prevalence was associated with unemployment (odds ratio [OR] 2.0), fatigue (OR 1.9), and pain (OR 1.7). Of those with mental health conditions, 9% saw a psychotherapist within 3 months of the diagnosis, 19% after 9 months, and 11% after 15 months. Mental health care use was higher in patients with children ≤18 years (OR 3.3) and somatic co-morbidity (OR 2.6). There was no evidence for an effect of sex on the use of mental health care. CONCLUSION: Few cancer patients with psychiatric disorders receive professional mental health care early enough. If patients are unemployed or if they suffer from fatigue or pain, special attention should be paid because the risk of having a mental health condition is increased in these patients.

[Development of an ICF-based clinical practice guideline for the assessment of function in head and neck cancer]. / Entwicklung eines ICF-basierten Leitfadens für die Beurteilung funktioneller Aspekte bei Kopf-Hals-Tumoren.

BACKGROUND: Functional outcome following head and neck cancer is not regularly assessed in a standardized way in clinical practice. Clinical trials assessing functional outcome apply many different instruments. Therefore, results are not always comparable and have limited clinical implications. Aim of this study was the identification, interdisciplinary evaluation, and recommendation of functional outcome instruments for use in clinical practice and clinical trials in patients with HNC. MATERIAL: Preparatory studies came up with a shortlist of outcome instruments on the basis of previously determined criteria. An interdisciplinary expert group evaluated these instruments and decided on which ones can be recommended for use in 3 application areas: screening, therapy evaluation/planning, and clinical trials. Decision making health professionals included physicians (ENT and maxillofacial surgeons, radiotherapists, oncologists), medical psychologists, speech and language therapists, physiotherapists, and social workers. RESULTS: 98 instruments were presented at the consensus conference. Altogether 21 participants recommended for each of the 3 application areas a basic set of measures for the evaluation of impairment in 6 functional domains: follow-up therapy monitoring, pain, ingestion, voice/speaking, other organic problems, and psychosocial problems. CONCLUSION: A multi-professional expert's pool discussed and adopted recommendations for the use of functional outcome instruments in clinical praxis and/or in research. The re-commended instruments are now available for use in clinical routine.

[QR-Code based patient tracking: a cost-effective option to improve patient safety]. / QR-Code Patienten-Tracking: eine kostengünstige Möglichkeit zur Verbesserung der Patientensicherheit.

BACKGROUND: Hospitals are implementing a risk management system to avoid patient or surgery mix-ups. The trend is to use preoperative checklists. This work deals specifically with a type of patient identification, which is realized by storing patient data on a patient-fixed medium. MATERIAL AND METHODS: In 127 ENT surgeries data relevant for patient identification were encrypted in a 2D-QR-Code. The code, as a separate document coming with the patient chart or as a patient wristband, has been decrypted in the OR and the patient data were presented visible for all persons. The decoding time, the compliance of the patient data, as well as the duration of the patient identification was compared with the traditional patient identification by inspection of the patient chart. RESULTS: A total of 125 QR codes were read. The time for the decrypting of QR-Code was 5.6 s, the time for the screen view for patient identification was 7.9 s, and for a comparison group of 75 operations traditional patient identification was 27.3 s. Overall, there were 6 relevant information errors in the two parts of the experiment. This represents a ratio of 0.6% for 8 relevant classes per each encrypted QR code. CONCLUSION: This work allows a cost effective way to technically support patient identification based on electronic patient data. It was shown that the use in the clinical routine is possible. The disadvantage is a potential misinformation from incorrect or missing information in the HIS, or due to changes of the data after the code was created. The QR-code-based patient tracking is seen as a useful complement to the already widely used identification wristband.

Infrastructure development for human cell therapy translation.

The common conception of a drug is that of a chemical with defined medicinal effect. However, cells used as drugs remain critical to patient care. Cell therapy's origins began with the realization that complex tissues such as blood can retain function when transplanted to the patient. More complex transplantation followed, culminating with the understanding that transplantation of some tissues such as bone marrow may act medicinally. Administration of cells with an intended therapeutic effect is a hallmark of cellular therapy. While cells have been used as drugs for decades, testing a specific therapeutic effect of cells has begun clinical testing relatively recently. Lessons learned during the establishment of blood banking (including the importance of quality control, process control, sterility, and product tracking) are key components in the assurance of the safety and potency of cell therapy preparations. As more academic medical centers and private companies move toward exploiting the full potential of cells as drugs, needs arise for the development of the infrastructure necessary to support these investigations. Careful consideration of the design of the structure used to manufacture is important in terms of the significant capital outlay involved and the facility's role in achieving regulatory compliance. This development perspective describes the regulatory environment surrounding the infrastructure support for cell therapy and practical aspects for design consideration with particular focus on those activities associated with early clinical trials.

[Improved accuracy and precision of the automated shaver (navigated control) in functional endoscopic sinus surgery]. / Verbesserte Umsetzung der Resektionsgrenzen in der Nasennebenhöhlenchirurgie mit dem navigiert-kontrollierten Shaver.

BACKGROUND: The feasibility of a navigate-controlled Shaver for the paranasal sinus surgery was proven in an initial study. Deficits showed up in the conversion of the planed cavity. Goal of this study is (1) the development and evaluation of a FESS demonstrator for the investigations to the surgical accuracy and (2) the evaluation of the resulting surgical accuracy for registration and conversion of the work space with an improved rigidity of the Shaver and a completely revised study design. METHODS: As a demonstrator for the navigate-controlled resection of a volume through the Shaver a two-piece plastic head with an anatomical head and soft tissue model was designed. The investigation of the surgical accuracy takes place with 417 measurements to 4 different fiducial markers on the demonstrator head. The measurements for the deviation of the resulting cavity from the planned volume was realised with a work space by 24 x 24 x 30 mm. The 5 walls of the cavity were seized with 80 measuring points for each level and thus altogether 2000 measured values (5 models x 5 levels x 200 points). RESULTS: The described demonstrator showed itself suitable for the close-to-application attempts to the surgical accuracy. The maximum deviation A (max) indicated position of the Shaver from the reference value amounted to 1,93 mm. The maximum average value of the exceeding of a planned cavity amounts to 1,62 mm. CONCLUSIONS: Based on these results a virtual safety passage of 2.00 mm is sufficient. The study refers the clinical serviceability of the navigate-controlled Shaver in paranasal sinus surgery.

[Accuracy and precision in the evaluation of computer assisted surgical systems. A definition]. / Genauigkeit und Präzision in der Bewertung von chirurgischen Navigations- und Assistenzsystemen. Eine Begriffsbestimmung.

Accuracy represents the outstanding criterion for navigation systems. Surgeons have noticed a great discrepancy between the values from the literature and system specifications on one hand, and intraoperative accuracy on the other. A unitary understanding for the term accuracy does not exist in clinical practice. Furthermore, an incorrect equality for the terms precision and accuracy can be found in the literature. On top of this, clinical accuracy differs from mechanical (technical) accuracy. From a clinical point of view, we had to deal with remarkably many different terms all describing accuracy. This study has the goals of: 1. Defining "accuracy" and related terms, 2. Differentiating between "precision" and "accuracy", 3. Deriving the term "surgical accuracy", 4. Recommending use of the the term "surgical accuracy" for a navigation system. To a great extent, definitions were applied from the International Standardisation Organisation-ISO and the norm from the Deutsches Institut für Normung e.V.-DIN (the German Institute for Standardization). For defining surgical accuracy, the terms reference value, expectation, accuracy and precision are of major interest. Surgical accuracy should indicate the maximum values for the deviation between test results and the reference value (true value) A(max), and additionally indicate precision P(surg). As a basis for measurements, a standardized technical model was used. Coordinates of the model were acquired by CT. To determine statistically and reality relevant results for head surgery, 50 measurements with an accuracy of 50, 75, 100 and 150 mm from the centre of the registration geometry are adequate. In the future, we recommend labeling the system's overall performance with the following specifications: maximum accuracy deviation A(max), precision P and information on the measurement method. This could be displayed on a seal of quality.

Prognostic assessment of sonography and tumor volumetry in advanced cancer of the head and neck by use of doppler ultrasonography.

OBJECTIVE: The objective of this trial was to examine the degree of tumor vascularity in lymph node metastases as depicted by computer-assisted color Doppler sonography and the tumor volumes associated with prognosis in carcinomas of the oropharynx and hypopharynx after primary radiochemotherapy. PATIENTS AND METHODS: In a prospective trial, 25 patients with advanced squamous cell carcinomas of the oropharynx and hypopharynx (stage IV UICC 1997) were treated with radiochemotherapy. The color Doppler findings were quantified with a computer-assisted protocol that quantitatively describes color Doppler images by the relative color pixel density (CPD). As important prognostic cofactor, total tumor volume (TTV) was calculated from CT sections and related to the degree of vascularity. RESULTS: Low CPD in neck metastases showed a correlation with better overall survival. A high-CPD group and a high-TTV group (median survival 10.1 months) were determined and were compared with all other CPD/TTV combinations (median survival 28.4 months); the difference in survival was significant (P = 0.002). CONCLUSION: The results indicate that high tumor vascularity in combination with high TTV indicates a particularly bad prognosis in patients treated with primary radiochemotherapy for head and neck cancer.

[Quality assurance in ENT tumor surgery]. / Qualitätssicherung in der HNO-Tumorchirurgie.

BACKGROUND AND OBJECTIVE: Quality control is of special importance in head and neck oncology since the quality of medical care constitutes a vital parameter for the diseased patient. In contrast to other medical specialties, no quality assurance program for head and neck cancer patients has yet been established in Germany. Therefore, a survey was conducted to assess the quality assurance instruments that are in use today in otorhinolaryngology-head and neck (ORL-HNS) centers. PATIENTS AND METHODS: In a nationwide survey, questionnaires were sent out to 146 German ORL-HNS departments (the return rate was 75%). RESULTS: 56% of all departments apply dedicated quality assurance processes, and 38% have appointed a formal quality assurance officer. Interdisciplinary oncological conferences are held in the vast majority of all departments with the participation of radiation oncologists in 86 (78%), medical oncologists in 84 (76%), diagnostic radiologists in 82 (74%), and pathologists in 73 (66%). Morbidity-mortality conferences are held in seven departments (6%). A standardized follow-up of oncological patients is carried out in 95 units (86%), and 53 departments use computer-assisted data bases to organize their follow-up data (48%). A wide variety of documentation systems is in use throughout the country: 78 units (71%) offer formal follow-up to their oncological patients. CONCLUSIONS: This survey documents a wide-spread interest in quality assurance procedures. Many individual efforts are being undertaken. However, no uniform quality assurance or auditing system is currently in use in Germany nor is a commonly accepted data base available. The ability to offer oncological follow-up within the national social security system is generally considered indispensable for the maintenance of high-quality oncological care in ORL-HNS departments.