Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program. METHODS: We conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis of the Consolidated Framework for Implementation Research (CFIR). RESULTS: Transcripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains. CONCLUSIONS: This comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351, registered 8 January 2018, https://clinicaltrials.gov/ct2/show/NCT03393351.

Long-term in vivo observations show biocompatibility and performance of ZX00 magnesium screws surface-modified by plasma-electrolytic oxidation in Göttingen miniature pigs.

Bioabsorbable magnesium implants for orthopedic fixation of bone have recently become available for different fields of indication. While general questions of biocompatibility have been answered, tailoring suitable degradation kinetics for specific applications as well as long-term tissue integration remain the focus of current research. The aim of this study was the evaluation of the long-term degradation behavior and osseointegration of Mg-Ca-Zn (ZX00MEO) based magnesium implants with plasma-electrolytic oxidation (PEO) surface modification (ZX00MEO-PEO) in comparison to non-surface modified implants in vivo and in vitro. Besides a general evaluation of the biological performance of the alloy over a prolonged period, the main hypothesis was that PEO surface modification significantly reduces implant degradation rate and improves tissue interaction. In vitro, the microstructure and surface of the bioabsorbable screws were characterized by SEM/EDS, cytocompatibility and degradation testing facilitating hydrogen gas evolution, carried out following ISO 10993-5/-12 and ASTM F3268-18a/ASTM G1-03 (E1:2017). In vivo, screws were implanted in the frontal bone of Minipigs for 6, 12, and 18 months, following radiological and histomorphometric analysis. A slower and more uniform degradation and improved cytocompatibility could be shown for the ZX00MEO-PEO group in vitro. A significant reduction of degradation rate and enhanced bone formation around the ZX00MEO-PEO screws in vivo was confirmed. Proficient biocompatibility and tissue integration could generally be shown in vivo regardless of surface state. The tested magnesium alloy shows generally beneficial properties as an implant material, while PEO-surface modification further improves the bioabsorption behavior both in vitro and in vivo. STATEMENT OF SIGNIFICANCE: Devices from bioabsorbable Magnesium have recently been introduced to orthopedic applications. However, the vast degradation of Magnesium within the human body still gives limitations. While reliable in-vivo data on most promising surface treatments such as Plasma-electrolytic-Oxidation is generally scarce, long-time results in large animals are to this date completely missing. To overcome this lack of evidence, we studied a Magnesium-Calzium-Zinc-alloy with surface enhancement by PEO for the first time ever over a period of 18 months in a large animal model. In-vitro, surface-modified screws showed significantly improved cytocompatibility and reduction of degradation confirmed by hydrogen gas evolution testing, while in-vivo radiological and histological evaluation generally showed good biocompatibility and bioabsorption as well as significantly enhanced reduction of degradation and faster bone regeneration in the PEO-surface-modified group.

Intraoperative ICG-based fluorescence-angiography in head and neck reconstruction: Predictive value for impaired perfusion of free flaps.

The aim of this study was to prove the hypothesis that intraoperative fluorescence-angiography using indocyanine-green (ICGFA) can be used to predict the occurrence of perfusion-associated complications following microvascular reconstruction. Consecutively perioperative data of patients who received microvascular reconstruction of the head and neck region and underwent ICGFA immediately after anastomosis was established were analyzed. The flow parameters analyzed in the investigation were (1) the baseline (IntMin) and (2) peak intensity (IntMax) of fluorescence, (3) the quotient of the two aforementioned parameters (Fmax/min) as an expression of the relative total increase, (4) the absolute difference in the two parameters (DiffInt) in terms of amplitude, (5) the duration of the intensity increase (TRise) until the peak, and (6) the percent intensity increase per second (Rise/secrel). Within the first 2 weeks postoperatively, every flap complication was documented. Subsequently, statistical analysis of the flap outcome was performed based on the flow parameters obtained intraoperatively. Data of 67 patients (male/female: 41/26) with an average age of 64 years (range 29-84 years) were analyzed. In 10 of these patients, postoperative perfusion-associated complications were observed (arterial/venous/microcirculatory: 4/3/3; p = 0.12). The analysis of the intraoperatively obtained flow parameters showed a significant difference in the ratio of maximum and minimum intensity in arterial pedicle perfusion (Fmax/min) of patients with and without complications (with vs. without complications: 2.3 ± 1.0 vs. 5.0 ± 4.9; p < 0.01) and strong correlation of the mentioned parameter with the occurrence of perfusion-associated complications (odds ratio = 0.27; p = 0.01). The ratio of maximum and minimum intensity (Fmax/min) is a predictor for postoperative venous stasis, arterial hypoperfusion and impaired microcirculation of a microvascular flap. Anastomoses with Fmax/min <2.85 should be revised. However, a high technique sensitivity has to be considered, due to which sufficient hemostasis and reduction of motion artefacts have to be taken into account in order to obtain useable data.

Improved in vivo osseointegration and degradation behavior of PEO surface-modified WE43 magnesium plates and screws after 6 and 12 months.

Magnesium is a highly promising candidate with respect to its future use as a material for resorbable implants. When magnesium degrades, hydrogen gas is released. High doses of gas emergence are reported to impair osseointegration and may therefore lead to fixation failure. The successful delay and reduction of the degradation rate by applying plasma electrolytic oxidation (PEO) as a post processing surface modification method for magnesium alloy has recently been demonstrated. The aim of this study was thus to compare the degradation behavior of a WE43-based plate system with and without respective PEO surface modification and to further investigate osseointegration, as well as the resulting effects on the surrounding bony tissue of both variants in a miniature pig model. WE43 magnesium screws and plates without (WE43) and with PEO surface modification (WE43-PEO) were implanted in long bones of Göttingen Miniature Pigs. At six and twelve months after surgery, micro-CT and histomorphometric analysis was performed. Residual screw volume (SV/TV; WE43: 28.8 ± 21.1%; WE43-PEO: 62.9 ± 31.0%; p = 0.027) and bone implant contact area (BIC; WE43: 18.1 ± 21.7%; WE43-PEO: 51.6 ± 27.7%; p = 0.015) were increased after six months among the PEO-modified implants. Also, surrounding bone density within the cortical bone was not affected by surface modification (BVTV; WE43: 76.7 ± 13.1%; WE43-PEO: 73.1 ± 16.2%; p = 0.732). Intramedullar (BV/TV; WE43: 33.2 ± 16.7%; WE43-PEO 18.4 ± 9.0%; p = 0.047) and subperiosteal (bone area; WE43: 2.6 ± 3.4 mm2; WE43-PEO: 6,9 ± 5.2 mm2; p = 0.049) new bone formation was found for both, surface-modified and non-surface-modified groups. After twelve months, no significant differences of SV/TV and BV/TV were found between the two groups. PEO surface modification of WE43 plate systems improved osseointegration and significantly reduced the degradation rate within the first six months in vivo. Osteoconductive and osteogenic stimulation by WE43 magnesium implants led to overall increased bone growth, when prior PEO surface modification was conducted.

Does a preoperative cone beam CT reduce complication rates in the surgical removal of complex lower third molars? A retrospective study including 486 cases.

BACKROUND: This study was designed to analyse the value of preoperative Cone Beam CTs (CBCT) prior to the surgical removal of complex lower third molars. Furthermore, the aim was to assess injuries to the inferior alveolar nerve (IAN) bundle and postoperative neurological disorders depending on the position of the lower third molar and the inferior alveolar nerve bundle. METHODS: In this retrospective examination preoperative Cone Beam CTs and Orthopantomographs (OPT) of 324 patients were analysed concerning the location of the lower third molars in relation to the mandible and the inferior alveolar nerve bundle. Surgery protocols of all patients who underwent the surgical removal of at least one complex lower third molar were analysed concerning patient data, length of surgery, intraoperative haemorrhage, intraoperative exposure of the inferior alveolar nerve bundle, postoperative swelling and postoperative neurological disorders. The data was then compared to data from international studies. RESULTS: In all 324 patients a permanent neurological damage was not found. Temporary neurological damage was recorded in 13 cases (2.6%). A caudal nerve position with no measurable distance to the root of the lower third molar was associated with the highest risk of a temporal neurological damage. A vestibular touching nerve route also correlated with postoperative sensitivity impairment. If a mesioangulation (Winter) or a Pell and Gregory Type IIIC appears in the OPT, risk of neurological damage is at its highest. CONCLUSIONS: Three-dimensional radiographic imaging, in our patient group, does not significantly affect the risk for complications during the surgical removal of complex lower third molars. Therefore, it should only be utilized for risk assessment, especially in cases of symptom-free lower third molars. A preoperative orthopantomogram still can be accepted as standard for radiographic imaging. An intraoperative exposure of the IAN bundle does not necessarily predict simultaneous neurological damage. Exposure of the IAN bundle is no indication for a discontinuation of the surgery.

Bone Micromorphology and Material Attrition After Sonic, Ultrasonic and Conventional Osteotomies.

BACKGROUND/AIM: Osteotomy as the first step in surgery, provides access to the field and its application could influence the outcome. Nowadays, the conventional burr reduction is being challenged by newer sonic and ultrasonic methods. We investigated the bone structural integrity and metal attrition residues both in bone and the irrigation fluid. MATERIALS AND METHODS: Bovine ribs were cut using three methods. Bone cuts were studied using Environmental Scanning Electron Microscopy (ESEM) for tissue discrepancies and Scanning Electron Microscopy/Energy Dispersion X-Ray Microanalysis (SEM/EDX) for organic and inorganic debris. RESULTS: Better preservation of bone architecture was seen in piezo and sono surgery while metal attrition was not conclusive (p>0.05). Unlike in bone analyses, both bur and ultrasonic osteotomies showed statistically significant higher median inorganic detection per analysis (p=0.021 and p=0.037, respectively). CONCLUSION: Sono and piezo surgery proved to be less invasive while attrition properties were the same.

Parotid sparing and quality of life in long-term survivors of locally advanced head and neck cancer after intensity-modulated radiation therapy.

PURPOSE: Intensity-modulated radiation therapy (IMRT) enables radiation oncologists to optimally spare organs at risk while achieving homogeneous dose distribution in the target volume. Despite great advances in technology, xerostomia is one of the most detrimental long-term side effects after multimodal therapy in patients with locally advanced head and neck cancer (HNC). This prospective observational study examines the effect of parotid sparing on quality of life in long-term survivors. PATIENTS AND METHODS: A total of 138 patients were grouped into unilateral (n = 75) and bilateral (n = 63) parotid sparing IMRT and questioned at 3, 24, and 60-month follow-up using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires. Treatment-related toxicity was scored according to the RTOG/EORTC toxicity criteria. Patients' QoL 24 and 60 months after IMRT was analyzed by ANCOVA using baseline QoL (3 months after IMRT) as a covariate. RESULTS: Patients with bilateral and unilateral parotid-sparing IMRT surviving 60 months experience similar acute and late side effects and similar changes in QoL. Three months after IMRT, physical and emotional function as well as fatigue, nausea and vomiting, pain, dyspnea, and financial problems are below (function scales) or above (symptom scales) the threshold of clinical importance. In both groups, symptom burden (EORTC H&N35) is high independent of parotid sparing 3 months after IMRT and decreases over time in a similar pattern. Pain and financial function remain burdensome throughout. CONCLUSION: Long-term HNC survivors show a similar treatment-related toxicity profile independent of unilateral vs. bilateral parotid-sparing IMRT. Sparing one or both parotids had no effect on global QoL nor on the magnitude of changes in function and symptom scales over the observation period of 60 months. The financial impact of the disease and its detrimental effect on long-term QoL pose an additional risk to unmet needs in this special patient population. These results suggest that long-term survivors need and most likely will benefit from early medical intervention and support within survivorship programs.

Assessing the frequency of deep lingual concavities in 826 posterior mandible sockets.

PURPOSE: To evaluate the frequency of deep lingual concavities in the lower jaw, which can cause surgical complications while inserting dental implants. METHODS: Cross-sections of the mandible alveolar ridge at the edentulous sockets were obtained via cone-beam computed tomography. Measurements were carried out using the freeware 'IC Measure' and based on the basic definitions of a previous study. RESULTS: Most (767/826 = 93%) sockets had concavities of various degrees (30-90°), while 59 (7%) sockets had no concavity. However, the majority of the concavities (71%) were mild, with angles > 60°. The other 220 (26%) sockets had deeper concavities of <60°; among these, 12 (1%) had extremely deep concavities of <40°. CONCLUSIONS: Only a few cases have deep lingual concavities that pose a high risk for lingual plate perforation during dental implantation.

Development of a Deep Learning Algorithm for Periapical Disease Detection in Dental Radiographs.

Periapical radiolucencies, which can be detected on panoramic radiographs, are one of the most common radiographic findings in dentistry and have a differential diagnosis including infections, granuloma, cysts and tumors. In this study, we seek to investigate the ability with which 24 oral and maxillofacial (OMF) surgeons assess the presence of periapical lucencies on panoramic radiographs, and we compare these findings to the performance of a predictive deep learning algorithm that we have developed using a curated data set of 2902 de-identified panoramic radiographs. The mean diagnostic positive predictive value (PPV) of OMF surgeons based on their assessment of panoramic radiographic images was 0.69(± 0.13), indicating that dentists on average falsely diagnose 31% of cases as radiolucencies. However, the mean diagnostic true positive rate (TPR) was 0.51(± 0.14), indicating that on average 49% of all radiolucencies were missed. We demonstrate that the deep learning algorithm achieves a better performance than 14 of 24 OMF surgeons within the cohort, exhibiting an average precision of 0.60(± 0.04), and an F1 score of 0.58(± 0.04) corresponding to a PPV of 0.67(± 0.05) and TPR of 0.51(± 0.05). The algorithm, trained on limited data and evaluated on clinically validated ground truth, has potential to assist OMF surgeons in detecting periapical lucencies on panoramic radiographs.

Prognostic factors for lymphedema in patients with locally advanced head and neck cancer after combined radio(chemo)therapy- results of a longitudinal study.

AIM: Treatment-associated lymphedema is a common side effect after multimodal therapy for locally advanced head and neck cancer (LAHNC). This study aims to evaluate potential prognostic factors for head and neck lymphedema (HNL) and its potential impact on clinical outcome. METHODS: This is a prospective data registry analysis on 280 patients treated for locally advanced head and neck cancer (LAHNC). All patients received surgery and risk-adapted platinum-based adjuvant intensity modulated radio(chemo)therapy (R(C)T, IMRT). Treatment- related toxicity was prospectively registered in a data base in regular intervals (baseline 3 months after R(C)T, every 3 months for 3 years, and every 6 months thereafter) and documented according to RTOG/EORTC toxicity criteria. RESULTS: Predictive for any grade HNL 3 months after R(C)T were age, BMI, number of removed nodes and RT modality. Multivariable logistic regression analysis showed that in the acute toxicity phase (3 months after R(C)T) higher body mass index (BMI), extracapsular spread (ECE), linac-based IMRT, bilateral treatment to the neck (surgery and RT), and the addition of chemotherapy increase the risk for grade 2 HNL. For chronic HNL, higher BMI, linac-based IMRT and ECE were predictive for grade 2 HNL. Higher BMI is associated with better local control rates. Advanced age and ECE had a negative impact on OS. CONCLUSION: HNL is a common acute and late side effect after multimodal therapy for LAHNC. Knowing risk factors for HNL prior to therapy enables caregivers and patients to take measures prior to treatment to prevent or limit the effects of HNL.

Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.

PURPOSE: We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity. PATIENTS AND METHODS: This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery. RESULTS: Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received. CONCLUSIONS: A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.

Analysis of outcome for elderly patients after microvascular flap surgery: a monocentric retrospective cohort study.

OBJECTIVES: Increasingly, aging societies pose a challenge, particularly in the most developed countries. This trend leads to an increasing group of old and very old patients presenting unique requirements and challenges. One of these challenges consists in reassessment and adaption of established treatment strategies for the elderly patients. There is an ongoing discussion taking place among cranio-maxillo-facial surgeons about the appropriate extent of reconstructive flap surgery for old patients. MATERIALS AND METHODS: This monocentric retrospective cohort study investigated 281 reconstructions with microvascular flaps by comparing the risk for a negative outcome, which was defined as revision, flap loss, and patient death, between three subgroups of elderly patients and younger patients. The three subgroups of elderly patients were defined as-1: young old (65-74 years), 2: old (75-84 years), and 3: oldest old (≥ 85 years). The group of the younger patients was defined by age between 50 and 64 years. Data were obtained within a defined period of 42 months. RESULTS: Significant correlations with a negative outcome were found for the variables stay on IMC/ICU, multiple flaps, and radiotherapy prior surgery. Our data showed no significant correlation between age and a higher risk for a negative outcome. CONCLUSION: Defect reconstruction with microvascular flaps in old patients is not related with a higher risk for a negative outcome. CLINICAL RELEVANCE: Independently of age, treatment with microvascular flaps is an option for all operable patients, with an indication for oncologic surgery. For optimal therapy planning, individual patient resources and preferences should be considered instead of chronologic age.

Perioperative Management in Patients With Undergoing Direct Oral Anticoagulant Therapy in Oral Surgery - A Multicentric Questionnaire Survey.

AIM: The purpose of this study was to survey the current opinions of hospitals and medical practices concerning the perioperative management of patients undergoing direct oral anticoagulant therapy (DOAC) and discuss recommendations for the clinical practice. MATERIALS AND METHODS: A questionnaire with 13 topics and multiple ordinal-polytomous subitems was designed and sent to 120 Departments of Oral and Maxillofacial Surgery in Austria, Switzerland and Germany, as well as to 85 oral and maxillofacial/oral surgeons in medical offices in Hamburg, Germany. The data were statistically evaluated by Chi-square, Fisher's exact and Jonckheere-Terpstra tests. RESULTS: The rate of response was 42%. Thirty-seven percent of respondents reported treating over 50 patients per year with undergoing DOAC therapy and only 18% assess a high bleeding risk [33% for vitamin K antagonists (VKA)]. In contrast to that, 62% of respondents would interrupt the DOAC therapy for extraction of one tooth, while 94% would continue VKA therapy. Significantly more clinicians apply suture than those in a medical office. The use of additional hemostatic measures varied between clinic and medical practice. There was a clear request for more detailed guidelines. CONCLUSION: The study shows the current opinion for perioperative management of patients undergoing DOAC therapy. Multi-centric studies under controlled conditions are needed for a safer treatment of anticoagulated patients as therapy strategies differ greatly between institutions and therefore a complication analysis is hardly possible.

Survivin expression in head and neck squamous cell carcinomas is frequent and correlates with clinical parameters and treatment outcomes.

OBJECTIVES: Strong expression of survivin is associated with worse survival in many different tumours, and in cell culture, a correlation between radiation resistance and survivin expression can be seen. The potential of survivin expression as a prognostic/predictive marker or therapeutic target has not been examined in head and neck squamous cell carcinomas (HNSCC) yet. MATERIAL AND METHODS: Retrospective study of 452 tissue samples and clinical data from patients with squamous cell carcinomas of the larynx/hypopharynx (LSCC), oral cavity (OSCC) and oropharynx (OPSCC) treated in the University Medical Centre Hamburg-Eppendorf between 2002 and 2006. The expression patterns were detected by tissue microarray technique and correlated with clinical parameters (sex, age, tumour location, TNM 7th edition, grading, recurrence-free and overall survival). RESULTS: 222 OSCC, 126 OPSCC and 105 LSCC tumours of 118 females and 335 males with a mean follow-up of 41.3 months were examined. Survivin expression correlates with pN, cM, pT and overall survival. CONCLUSION AND CLINICAL RELEVANCE: The potential of survivin as a prognostic/predictive marker is very high. The findings have to be confirmed in a larger cohort of HNSCC esp. in those tumours treated primarily with radio/radiochemotherapy.

Evaluation of long-term functional donor-site morbidity after deep circumflex iliac crest artery bone flap harvest.

PURPOSE: Free flap surgery can be associated with donor-site morbidity. The purpose of this study was to analyze long-term functional outcomes at the donor site after deep circumflex iliac artery (DCIA) bone flap harvesting. METHODS: Fourteen patients (8 men and 6 women, mean age 53.9 years; range 22-87 years) with mandible resection (8 carcinomas, 4 ameloblastomas, 1 osteonecrosis, and 1 myxofibroma) and DCIA flap reconstruction were included in an observational study. Ranges of motion in the hip and lumbar spine, Harris hip score (HHS), jumping mechanography, chair rising, and balance testing were performed on a ground force reaction plate (Leonardo Mechanograph, Novotec Medical GmbH, Germany). The primary outcome was the Esslinger fitness index (EFI, maximum peak power in W/kg normalized to age and gender). RESULTS: Functional assessment was performed preoperatively and 29.0 months postoperatively (range 12-51 months). Mean DCIA flap length was 6.3 cm (range 3.3-10.1 cm). Jaw reconstruction was successful in all cases. HHS (99.2 vs. 97.7 points, P = .004) and all ranges of motion in the lumbar spine and hip joint except for dorsal extension were significantly reduced postoperatively (range -4° to -11.0°). There was no significant difference between pre- and postoperative EFI (77.9% vs. 74.28%, P = .591) and body sway (1.25 cm2 vs. 2.01 cm2 , P = .806). Sensory deficits (n = 5), load dependent pain (n = 3), and limitations of daily activities (n = 3) were subjective complaints. CONCLUSION: Functional donor site morbidity after DCIA harvesting can be expected to be low in the long-term.

Repair of Occipital Bone Defects in Neurofibromatosis Type 1 by Means of CAD/CAM Prefabricated Titanium Plates.

Certain skeletal defects may develop in neurofibromatosis type 1 (NF1), a common tumor-suppressor syndrome, such as cranial lesions confined to the lambdoid suture region. Here, we report on the repair of osseous defects of occipital bone in a NF1 patient with history of skull trauma and tumorous hemorrhage. Computer-aided design and computer-aided manufacturing (CAD/CAM)-assisted devices were applied to safely close the bone defects. The variable phenotype of NF1 in the occipital skull region is discussed and a brief review is presented on NF1-related therapies for tumors and malformations of the occipitoparietal skull region.

Evaluation of Periodontal Space Widening in Patients with Antiresorptive Drug-related Osteonecrosis of the Jaws (ARONJ) on Panoramic Radiographs.

BACKGROUND/AIM: The purpose of this study was to evaluate a potential widening of the periodontal space as an initial measurable imaging criterium on panoramic radiographs in patients with the diagnosis of antiresorptive drug related osteonecrosis of the jaw (ARONJ). PATIENTS AND METHODS: A retrospective analysis of panoramic radiographs of 16 patients (12 females and 4 males; mean age is 70.5 years, standard deviation is 14 years) was performed, over a period of 12 months with the diagnosis of ARONJ. Panoramic radiographs of 16 healthy patients (12 females and 4 males; mean age was 70.6 years, standard deviation was 13.8 years) without diagnosis of ARONJ served as controls. All images were taken with the same device and were evaluated by two experienced maxillofacial surgeons and one dentist. RESULTS: Compared to the control group, a mean widening of the periodontal space of 0.06 mm (confidence interval (CI)=0.05-0.17 mm) was found in the study group. However, this difference was not statistically significant. CONCLUSION: Although a very extensive and sophisticated interindividual comparison was performed to evaluate for slight changes of the periodontal space in patients with antiresorptive drug therapy, our results demonstrate that PDS widening is not a predictive parameter for ARONJ. Therefore, our results indicate that panoramic radiographs are not sufficient enough to allow assessment of stages and disease progress in ARONJ patients regarding to periodontal space widening.

Sensitivity and specificity of sentinel lymph node biopsy in patients with oral squamous cell carcinomas using indocyanine green fluorescence imaging.

PURPOSE: The purpose of this clinical study was to evaluate the sensitivity and specificity of cervical sentinel lymph node biopsy after mapping with indocyanine green fluorescence (ICG) for imaging early-stage oral cancer. PATIENTS AND METHODS: A sentinel lymph node biopsy (SLNB) was performed during a selective neck dissection (SND) in 20 patients with oral squamous cell carcinoma (OSCC, cT1 or cT2, N0 status). The sentinel lymph nodes (SLN) were identified using an infrared video camera after ICG injection. Lymph nodes were examined histologically. The endpoint of this study was to investigate the rate of false-negative results in SLNB. RESULTS: Sentinel lymph nodes could be detected after 8.1 min (range 1-22 min). In eight out of 20 cases, lymph node metastases were found during histopathological evaluation of the neck dissection specimen. In four cases a metastasis could be found in the detected SLN (sensitivity 50%). In the other four cases metastases were found in different lymph nodes. Specificity was 100%, positive predictive value 100%, and negative predictive value 75%. CONCLUSION: In this study, reliability of sentinel lymph node biopsy after ICG imaging could not be verified, as there were false-negative results in 50% of the cases. Therefore, SND can still be recommended as for patients with cT1 or cT2 OSCC, and a N0 neck status.

Impact of different placement depths on the crestal bone level of immediate versus delayed placed platform-switched implants.

PURPOSE: The preservation of peri-implant bone is one requirement for long-term success of dental implants. The purpose of this study was to evaluate the impact of subcrestal placement on the crestal bone level of immediate versus delayed placed implants after loading. MATERIALS AND METHODS: In this retrospective study, data of 159 patients who received 330 implants was analyzed. Implants were placed subcrestally, crestally or supracrestally into fresh sockets or healed sites. Vertical bone level height was assessed radiographically and implants were followed up annually. The influence of patient and implant related risk factors for peri-implant bone loss was evaluated using a linear mixed model. RESULTS: Depth of implant placement was significantly correlated with peri-implant bone loss (P = 0.001, 95% CI). Least effective loss of crestal bone was determined when implants were placed between 1 mm and 1.99 mm subcrestally. Smoking significantly enhanced the risk of peri-implant bone loss (P = 0.04, 95% CI). Immediate implant placement was not positively correlated with peri-implant bone loss (P = 0.51, 95% CI). CONCLUSION: Within the limits of this study, implant placement 1.08 mm subcrestally may be recommendable in order to avoid supracrestal expositions of platform-switched titanium implants over time.

Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. METHODS: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. DISCUSSION: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.