Development of a Patient-Centered Functional Outcomes Questionnaire in Head and Neck Cancer.

Importance: Incorporation of patient perspectives, or patient-reported outcomes, in functional outcome measures has been gaining prominence in the literature on reconstructive surgery. Objective: To create and validate an instrument for measuring the main functional areas of concern for patients with head and neck cancer. Design, Setting, and Participants: This 4-phase mixed-methods qualitative study was conducted from July 1, 2013, to June 30, 2016, in a quaternary head and neck oncology center in Edmonton, Alberta, Canada. Patients were recruited from 3 Head and Neck Research Network sites: University of Alberta (Edmonton, Canada), Mount Sinai Health Network (New York, New York), and University of Turku Hospital (Turku, Finland). The inclusion criteria included 18 years of age or older, diagnosis of squamous cell carcinoma involving the subsites of the head and neck (ie, oral cavity, oropharynx, hypopharynx, and larynx), and at least 1 year since treatment completion. Those patients who were undergoing additional active treatment or with evidence of disease recurrence were excluded. Data were analyzed from July 1, 2013, to June 30, 2016. Main Outcomes and Measures: The primary outcome measures were the clinical correlation of the Edmonton-33 instrument scores with swallowing, speech, dry mouth, and chewing assessment outcomes. Results: In total, 10 patients with head and neck cancer (mean age, 59.6 years; 6 men [60%]) were included in phase 1 of the study, 5 patients (mean age, 55.2 years) were included in phase 2, 10 patients were included in phase 3, and 25 patients with head and neck cancer (mean age, 62.6 years; 14 men [56%]) participated in the phase 4 validation. The Edmonton-33 instrument scores correlated strongly with the swallowing scores of the MD Anderson Dysphagia Inventory (r = 0.77; 95% CI, 0.49-1.0), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) (r = -0.73; 95% CI, -1.0 to -0.44), and the modified barium swallow test (r = -0.60; 95% CI, -0.94 to -0.25). The instrument scores were also strongly correlated with the Speech Handicap Index scores (r = -0.64; 95% CI, -0.97 to -0.31), word intelligibility scores (r = 0.61; 95% CI, 0.27-0.95), and sentence intelligibility scores (r = 0.55; 95% CI, 0.19-0.91). A moderate to strong correlation was observed between the Edmonton-33 instrument and the EORTC QLQ-H&N35 scores in the dry mouth (r = -0.54; 95% CI, -0.91 to -0.18) and chewing (r = -0.45; 95% CI, -0.84 to -0.06) domains. The factor loading values for the domains of swallowing, speech, dry mouth, and chewing were all greater than 0.3. The mean factor loading values for the items related to swallowing were 0.71 (95% CI, 0.62-0.80) and for the items related to speech were 0.76 (95% CI, 0.72-0.80). The mean factor loading values for the items related to dry mouth were 0.71 (95% CI, 0.59-0.83) and for those related to chewing were 0.77 (95% CI, 0.69-0.85). Conclusions and Relevance: The Edmonton-33 appears to be a validated instrument that will allow patients with head and neck cancer to assess and report their own functional outcomes. It could serve as a single comprehensive measure for functional outcomes.

Group 2 ITI Consensus Report: Prosthodontics and implant dentistry.

OBJECTIVES: Working Group 2 was convened to address topics relevant to prosthodontics and dental implants. Systematic reviews were developed according to focused questions addressing (a) the number of implants required to support fixed full-arch restorations, (b) the influence of intentionally tilted implants compared to axial positioned implants when supporting fixed dental prostheses (FDPs), (c) implant placement and loading protocols, (d) zirconia dental implants, (e) zirconia and metal ceramic implant supported single crowns and (f) zirconia and metal ceramic implant supported FDPs. MATERIALS AND METHODS: Group 2 considered and discussed information gathered in six systematic reviews. Group participants discussed statements developed by the authors and developed consensus. The group developed and found consensus for clinical recommendations based on both the statements and the experience of the group. The consensus statements and clinical recommendations were presented to the plenary (gathering of all conference attendees) and discussed. Final versions were developed after consensus was reached. RESULTS: A total of 27 consensus statements were developed from the systematic reviews. Additionally, the group developed 24 clinical recommendations based on the combined expertise of the participants and the developed consensus statements. CONCLUSIONS: The literature supports the use of various implant numbers to support full-arch fixed prostheses. The use of intentionally tilted dental implants is indicated when appropriate conditions exist. Implant placement and loading protocols should be considered together when planning and treating patients. One-piece zirconia dental implants can be recommended when appropriate clinical conditions exist although two-piece zirconia implants should be used with caution as a result of insufficient data. Clinical performance of zirconia and metal ceramic single implant supported crowns is similar and each demonstrates significant, though different, complications. Zirconia ceramic FDPs are less reliable than metal ceramic. Implant supported monolithic zirconia prostheses may be a future option with more supporting evidence.

Functional and quality of life outcomes after partial glossectomy: a multi-institutional longitudinal study of the head and neck research network.

BACKGROUND: While aggressive treatment for oral cancer may optimize survival, decrements in speech and swallowing function and quality of life often result. This exploratory study investigated how patients recover their communicative function, swallowing ability, and quality of life after primary surgery [with or without adjuvant (chemo)radiation therapy] for tongue cancer over the course of the first year post-operation. METHODS: Patients treated for oral cancer at three institutions (University of Alberta Hospital, Mount Sinai Beth Israel Medical Center, and Turku University Hospital) were administered patient-reported outcomes assessing speech [Speech Handicap Index (SHI)], swallowing [(M.D. Anderson Dysphagia Inventory (MDADI)] and quality of life [European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC-H&N35)]. Outcome measures were completed pre-operatively and at 1-, 6-, and 12-months post-operatively. RESULTS: One hundred and seventeen patients undergoing partial glossectomy with reconstruction participated in this study. Results indicated no significant differences in swallowing function (MDADI and EORTC-H&N35 subscales) between baseline and 6 months post-surgery and no significant differences in speech function (SHI subscales) between baseline and 1 year post-surgery. Most quality of life domains (EORTC-H&N35 subscales) returned to baseline levels by 1 year post-operation, while difficulties with dry mouth and sticky saliva persisted. A clear time trend of adjuvant (chemo)radiation therapy negatively affecting dry mouth scores over time was identified in this study, while negative independent effects of chemoradiation on MDADI swallowing, and EORTC-H&N35 swallowing, eating, and opening mouth subscales were found. CONCLUSIONS: Assessment time influenced patient-reported speech, swallowing, and quality of life outcomes, while treatment (by time) effects were found for only swallowing and quality of life outcomes. Results of the present study will help guide clinical care and will be useful for patient counseling on expected short and long-term functional and quality of life outcomes of surgical and adjuvant treatment for oral cavity cancer.

Functional outcomes for clinical evaluation of implant restorations.

The functional outcomes related to treating patients afflicted with tooth loss are an important hallmark in substantiating prosthodontic intervention. The Oral Rehabilitation Outcomes Network (ORONet) conducted two international workshops to develop a core set of outcome measures, including a functional domain. The process followed the general format used in the Outcome Measures in Rheumatology (OMERACT) workshops to develop consensus for clinical outcome measures in arthritis research, which included: developing a comprehensive list of potential outcomes in the literature; submitting them to a filter for validity, clinical discrimination, and feasibility; and ranking those measures meeting all the filter criteria for relative value. The search was conducted to include functional assessments of speech, swallowing, mastication, nutrition, sensation, and motor function as they relate to dental implant therapies. This literature review surveyed 173 papers that produced some result of these descriptors in the functional domain. Of these, 67 papers reported on functional assessments and further defined objective and subjective outcomes. Many of these results were patient-perceived improvements in function, while others were objective assessments based on established methodologies and instruments. Objective evaluations of masticatory function and speech may meet criteria for validity and discriminability for selected interventions, but are generally not feasible for routine use in clinical care settings. The current recommendation is to employ a well-validated survey instrument that covers mastication and speech, such as the Oral Health Impact Profile (OHIP-14, short form), recognizing that patient perceptions of function may differ from objective ability.

Psychologic outcomes in implant prosthodontics.

Consensus regarding outcomes of the treatment of tooth loss, especially the psychologic outcomes, is needed to guide discovery of best practices and enable a better understanding of patient management for this chronic condition. This paper presents the findings of the ORONet Psychological Working Group for prosthodontics and aims to identify psychologic outcomes with properties deemed critical to meet clinical trial and clinical practice needs for the future. References obtained using a PubMed/Medline search were reviewed for clinical outcomes measures of interest. Clinical outcomes measures were judged relative to the criteria of truth, discrimination, and feasibility. Of the psychologic outcome measures identified in this systematic review, only the OHIP-14 was thought to be suitable for use in general practice and multi-institutional outcome registries and clinical trials. Development of clinically useful psychologic outcomes for future use could benefit from developmental methods and tools outlined in the patient-related outcomes field of clinical care.

Economic outcomes in prosthodontics.

PURPOSE: A systematic literature review was conducted to identify the types of economic measures currently used in implant prosthodontics and determine the degree to which cost of care is considered in the context of any positive outcome of the care provided. MATERIALS AND METHODS: A literature search was conducted using the following set of terms plus some additional hand searching: "dental implants" (Mesh) AND ("cost") OR "maintenance" OR "healthcare policy" OR "access to care" OR "third party" OR "economic") AND (("1995/01/01"[PDat]:'2009/12/31"[PDat]) AND (Humans[Mesh]) AND (English[lang])). RESULTS: After a review of the 466 titles and abstracts identified by the search, 18 articles were accepted for further consideration, as some attempt at economic outcome measures was made. An additional four articles were identified by hand searching. The 22 accepted articles were grouped into four basic categories: (1) measure of costs of treatment (direct, indirect, and maintenance costs), (2) cost-effectiveness mathematical modeling applied to simulate the lifetime paths and cost of treatment, (3) cost-effectiveness analysis/cost minimization, and (4) willingness-to-pay, willingness-to-accept. Attempts at determining the costs of treatment varied widely. When the OMERACT filters were applied to the various measures it was felt that discrimination and/or feasibility was a problem for most of the current economic outcome measures. CONCLUSIONS: Measures of cost-benefit, cost-effectiveness, and cost-utility are currently the gold standard; however, feasibility of such analyses is an issue. Collaboration with health economists to guide future research is highly recommended.

Oral Rehabilitation Outcomes Network-ORONet.

The published literature describing clinical evidence used in treatment decisionmaking for the management of tooth loss continues to be characterized by a lack of consistent outcome measures reflecting not only clinical performance but also a range of patient concerns. Recognizing this problem, an international group of clinicians, educators, and scientists with a focus on prosthodontics formed the Oral Rehabilitation Outcomes Network (ORONet) to promote strategies for improving health based on comprehensive, patient-centered evaluations of comparative effectiveness of therapies for oral rehabilitation. An initial goal of ORONet is to identify outcome measures for prosthodontic therapies that represent multiple domains with patient relevance, are amenable to utilization in both institutional and practice-based environments, and have established validity. Following a model used in rheumatology, the group assessed the prosthodontic literature, with an emphasis on implantbased therapies, for outcomes related to longevity and functional, psychologic, and economic domains. These systematic reviews highlight a need for further development of standardized outcomes that can be integrated across clinical and research environments.

Clinical outcomes measures for assessment of longevity in the dental implant literature: ORONet approach.

The Oral Rehabilitation Outcomes Network (ORONet) Longevity Working Group undertook a search of the literature from 1995 to 2009 on randomized controlled trials related to longevity of osseointegrated implants. Outcomes measures used in these studies were identified and subjected to the OMERACT component criteria of truth, validity, and feasibility. Through this process, it was a challenge to identify clinical outcomes measures that fully met the criteria. An attenuated version of the component criteria was applied, and clinical measures were identified for implant outcomes, prosthetic outcomes, and indices. A recommendation on standardized reporting periods was also presented for future consideration. The endpoint of the evaluation process is to develop consensus on clinical outcomes measures that can be applied across broad populations for osseointegrated implant care. The present ORONet initiative represents a beginning toward continual improvement and consensus development for clinical outcomes measures for osseointegrated implants.

Survey of current functional outcomes assessment practices in patients with head and neck cancer: initial project of the head and neck research network.

BACKGROUND: Functional outcomes assessment has become increasingly important in informing treatment decisions in the area of head and neck cancer. However, consistency of assessment methods across studies has been lacking. For the literature to inform clinical decision making, consensus regarding outcomes measurements is necessary. OBJECTIVE: The Head and Neck Research Network (HNRN) was founded in January 2008 to become a conduit for high-quality research in the area of functional outcomes in patients with head and neck defects. The present study surveyed experts in functional outcomes assessment to determine what are considered the most important tools for assessing speech and swallowing and what background patient characteristics are important to capture. DESIGN, PARTICIPANTS, AND MEASURES: Respondents to the online survey included 54 participants with a background in speech-language pathology, with the majority of respondents from the United States, Canada, and the United Kingdom. RESULTS AND CONCLUSIONS: The results from the survey indicated that clinicians consider both subjective and objective measures as important to use when assessing function. More advanced technical tools were often rated as less important; however, it also was noted that clinicians were most often not able to access these tools or were unfamiliar with them.

The use of pedicled temporal musculoperiosteal flap with or without free calvarial bone graft in maxillary reconstructions.

Various techniques have been used to repair maxillary defects. The aim of this study was to evaluate the suitability of pedicled temporal musculoperiosteal flap (PTMF) and free calvarial bone graft for the reconstruction of maxillary defects. In this retrospective series, 34 patients operated on from 1995 to 2006 at Turku University Central Hospital because of defects of maxilla reconstructed using PTMF with or without free calvarial bone graft were evaluated. The diagnosis, the indication for surgery, the location and staging of the tumours, and the type of radiotherapy used were reviewed. The classification of the maxillary defects was performed according to the classification of Brown (Br J Oral Maxillofac Surg 40:183-190, 2002) and the success rates of the reconstructions were evaluated. Of the patients, 32 had been operated on due to a malignant tumour, one due to a benign tumour and one due to posttraumatic palatal defect. Preoperative radiotherapy (n = 14), preoperative chemoradiotherapy (n = 2) or postoperative radiotherapy (n = 11) had been used in the tumour group. As a reconstructive method, PTMF had been used with (n = 21) or without (n = 13) free calvarial bone graft. The use of free calvarial bone graft did not have a significant effect on flap survival. At 1-month follow-up, the flap survival in the 32 patients was 71.9%, whereas 28.1% of the patients suffered from partial flap loss, but there was no total flap loss. At 6-month follow-up, the flap survival in 26 patients was 76.9%, whereas 7.7% of the patients suffered from partial flap loss, and there were four (15.4%) total flap losses. If unilateral alveolar maxillectomy had been performed (Brown classification a), at 1-month follow-up, the flap survival was 82.6%, 17.4% of the patients suffered from partial flap loss, and there was no total flap loss. At 6-month follow-up, the flap survival was 89.5%, while 10.5% of the patients suffered from partial flap loss, and there was no total flap loss. The application of PTMF with or without free calvarial bone graft for reconstruction of limited palatal and maxillary defects appears to be feasible.

Preoperative hyperfractionated accelerated radiotherapy and radical surgery in advanced head and neck cancer: a prospective phase II study.

BACKGROUND AND PURPOSE: To evaluate whether preoperative hyperfractionated accelerated radiotherapy (RT) combined with major radical surgery is feasible and successful in the treatment of advanced primary head and neck cancer. PATIENTS AND METHODS: Ninety four patients with histologically confirmed head and neck squamous cell cancer (HNSCC) in the oral cavity (41/96; 43%), supraglottis (14/96; 15%), glottis (5/96; 5%), oropharynx (16/96; 17%), nasal cavity/paranasal sinuses (8/96; 8%), nasopharynx (3/96; 3%), hypopharynx (7/96; 7%) and two (2%) with unknown primary tumour and large cervical lymph nodes entered into the study. 21/96 patients (22%) had stage II, 17/96 (18%) stage III and 58/96 patients (60%) stage IV disease. The patients received preoperative hyperfractionated RT 1.6 Gy twice a day, 5 days a week to a median tumour dose of 63 Gy with a planned break for 11 days (median) after the median dose of 37 Gy. Then, after a median of 27 days the patients underwent major radical surgery of the primary tumour and metastatic lymph nodes including reconstructions with pedicled or microvascular free flaps when indicated as a part of the scheduled therapy. 12/96 patients had only ipsilateral or bilateral neck dissections. RESULTS: After a median follow-up time of 37.2 mos 77/96 (80.2%) patients had complete locoregional control. All but 2 patients had complete histological remission after surgery. 40/96 pts were alive without disease, two of them after salvage surgery. 32/96 patients had relapsed; 15 had locoregional and 13 distant relapses, 4 patients relapsed both locoregionally and distantly. Fifty patients have died; 29 with locoregional and/or distant relapse, eight patients died of second malignancy, and 19 had intercurrent diseases. Disease-specific and overall survival at 3 years was 67.7 and 51%, respectively. Acute grade three mucosal reactions were common, but transient and tolerable. Late grade 3-4 adverse effects were few. CONCLUSIONS: Preoperative hyperfractionated accelerated RT can be successfully combined with major radical surgery in the treatment of HNSCC. The amount of serious late adverse effects was not increased.

Rehabilitation of patients with congenital unrepaired cleft palate defects using free iliac crest bone grafts and dental implants.

PURPOSE: To rehabilitate the mastication and speech of edentulous congenital cleft lip and palate patients with the use of endosseous implants in conjunction with bone augmentation. MATERIALS AND METHODS: Between 1992 and 1999, 6 partially and 4 completely edentulous adult patients with complex cleft palate defects were treated. Six patients had large, unrepaired defects of the hard and soft palate, whereas the other 4 had residual oronasal fistulas after failed palatoplasty and bone grafting. In 8 patients, free inlay-antral and simultaneous lateral-onlay bone grafts (3 patients) were obtained from the iliac crest, and dental implants were placed secondarily. In the other 2 patients, the implants were placed without grafting in recent extraction sites. Rigid bars with extensions over the defects were used to support obturator prostheses (n = 7), or patients were provided with fixed implant-supported prostheses (n = 3). In all, 50 cylindric, screw-type dental implants were placed and followed up for 1 to 8 years (mean, 5 years). RESULTS: Six implants were regarded as early failures and 1 was lost during the first year of loading; 1 patient lost all 5 implants. The cumulative success rate at 5 years was 85.7%. DISCUSSION AND CONCLUSION: All 9 successfully rehabilitated patients reported a remarkable functional and psychologic improvement after the treatment. The described treatment protocol also seemed to be effective for correcting velopharyngeal insufficiency in patients using an obturator prosthesis.

Cephalometric evaluation of facial types in preschool children without sleep-related breathing disorder.

OBJECTIVE: this study was aimed at characterizing the craniofacial structures, i.e. the facial skeleton, cranial base, dentition, pharyngeal airway space, and the hyoid bone position, in healthy preschool children without sleep-related breathing disorder. MATERIALS AND METHODS: from lateral cephalometric radiographs taken of 92 children for diagnostic purposes, 45 were selected for the present investigation on the basis of head position, and divided according to the classification of Siriwat and Jarabak (Angle Orthod. 55 (1985) 127) into groups representing counter-clockwise (CC), straight downward (SD), and clockwise (C) facial types. RESULTS: the findings showed that, in comparison with the other groups, CC is associated with larger facial taper and posterior facial height, smaller mandibular line angle, ramus position, lower facial height and cranial base angle. By a similar comparison, C is associated with larger mandibular line, gonial angles and convexity, and with a smaller L-1 to mandibular line angle. There were no significant differences in hyoid bone position among the three groups. However, the distance of the lower pharynx was smaller in CC than in C, while the tongue base of CC was noted to be in a posterior position. CONCLUSIONS: thus, the results indicate that there are significant differences in the madibular position and form among the present three groups of children. It is proposed that the objective of vertical facial control ought to be included in the treatment of preschool children with malocclusion and respiratory disorder.