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Contains fulltext : 300031.pdf (Publisher’s version ) (Open Access), 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., 01 november 2023

The aim of this paper was to evaluate the results of an integrated treatment delivered remotely to laryngectomized patients with voice prosthesis. Eighteen laryngectomized patients were treated remotely in groups co-led by a speech therapist and a psychologist ("Online Group"). The results were compared with those of 17 patients ("In-Person Group") previously studied. The two groups obtained comparable results on all parameters of the INFVo perceptual rating scale, in the DEP, ANX, PHO and HOS areas of the Symptom Check List-90-Revised questionnaire, and in the areas investigated by the WHOQOL-B questionnaire. The "In-Person Group" obtained statistically better results on the Italian Self-Evaluation of Communication Experiences after Laryngeal Cancer questionnaire. Although the in-person treatment favored the acceptance of the new voice and the development of conversational skills, telerehabilitation guaranteed an adequate level of assistance in terms of voice acquisition, prevention of anxiety and depression, and recovery of a good QoL.

Clival chordomas are rare but aggressive skull base tumors that pose significant treatment challenges and portend dismal prognosis. The aim of this study was to highlight the advantages and limitations of available treatments, to furnish prognostic indicators, and to shed light on novel therapeutic strategies. We conducted a retrospective study of clival chordomas that were surgically treated at our institution from 2003 to 2022; for comparison purposes, we provided a systematic review of published surgical series and, finally, we reviewed the most recent advancements in molecular research. A total of 42 patients underwent 85 surgeries; median follow-up was 15.8 years, overall survival rate was 49.9% at 10 years; meanwhile, progression-free survival was 26.6% at 10 years. A significantly improved survival was observed in younger patients (<50 years), in tumors with Ki67 ≤ 5% and when adjuvant radiotherapy was performed. To conclude, clival chordomas are aggressive tumors in which surgery and radiotherapy play a fundamental role while molecular targeted drugs still have an ancillary position. Recognizing risk factors for recurrence and performing a molecular characterization of more aggressive lesions may be the key to future effective treatment.

Endoscopic transsphenoidal surgery is a novel surgical technique requiring specific training. Different models and simulators have been recently suggested for it, but no systematic review is available. To provide a systematic and critical literature review and up-to-date description of the training models or simulators dedicated to endoscopic transsphenoidal surgery. A search was performed on PubMed and Scopus databases for articles published until February 2023; Google was also searched to document commercially available. For each model, the following features were recorded: training performed, tumor/arachnoid reproduction, assessment and validation, and cost. Of the 1199 retrieved articles, 101 were included in the final analysis. The described models can be subdivided into 5 major categories: (1) enhanced cadaveric heads; (2) animal models; (3) training artificial solutions, with increasing complexity (from “box-trainers” to multi-material, ct-based models); (4) training simulators, based on virtual or augmented reality; (5) Pre-operative planning models and simulators. Each available training model has specific advantages and limitations. Costs are high for cadaver-based solutions and vary significantly for the other solutions. Cheaper solutions seem useful only for the first stages of training. Most models do not provide a simulation of the sellar tumor, and a realistic simulation of the suprasellar arachnoid. Most artificial models do not provide a realistic and cost-efficient simulation of the most delicate and relatively common phase of surgery, i.e., tumor removal with arachnoid preservation; current research should optimize this to train future neurosurgical generations efficiently and safely.

Background: Descending necrotizing mediastinitis (DNM) is a severe, life-threatening complication of oropharyngeal infections with cervical necrotizing fasciitis. In this study, we aimed to identify any possible factors that correlate with favorable outcomes. Methods: We retrospectively analyzed our series of 18 patients who underwent surgical treatment for DNM from a cervical abscess. Gender, age, symptoms, etiopathogenesis, comorbidities, time to surgery from diagnosis, degree of diffusion, identified microorganisms, surgical procedure, days in the intensive care unit, need for tracheostomy, complications, and surgical outcomes were reviewed. Results: The main type of surgery was thoracotomy + cervicotomy in eight cases (50.0%), followed by cervicotomy +VATS in four (22.2%). Seven patients (38.9%) had two or more surgeries; a bilateral operation was necessary for four patients. Evaluating the risk factors associated with post-operative complications, age ≥ 60 years (p:0.031), cervicotomy alone as surgical approach (p = 0.040), and the bilateral approach (p = 0.048) resulted in significance in terms of the univariate analysis; age ≥ 60 years (p = 0.04) and cervical approach (p = 0.05) maintained their significance in terms of the multivariate analysis. Conclusions: The low mortality of our series emphasizes the importance of an extensive and immediate surgical drainage of both the neck and the mediastinum. Mediastinal drainage from cervicotomy seems to be a risk factor for post-operative complications. Minimally invasive surgery on the chest cavity, such as with Uniportal-VATS, could be a good approach above all in elderly patients and all those cases where bilateral access is required.

(1) Background: Periorificial face cancer (PFC), defined as both squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) arising around the eyelids, the nose vestibule and the lips, has very high incidence rates worldwide. The aim of our retrospective analysis, focusing on local control (LC) and patients’ degree of satisfaction with the cosmetic outcome, is to present the results of a single institutional series of patients affected by PFC and treated by interventional radiotherapy (brachytherapy–IRT). (2) Methods: We retrospectively evaluated patients affected by PFC who were treated at our Interventional Oncology Center (IOC) with interstitial IRT from 2012 to 2021 with doses and volumes specific for each subsite considered. (3) Results: We report the results of 40 patients affected by PFC and treated by HDR interstitial IRT. The median follow-up was 24 months. The actuarial 3-year LC was 94%. Regarding patients’ satisfaction, we found that 93% of patients were satisfied and only 7% of patients were not completely satisfied with the final cosmetic result. (4) Conclusions: Interstitial HDR IRT could be an effective therapeutic option providing adequate disease control and preventing potentially disfiguring surgical approaches. More numerous and standardized studies are warranted to confirm the available evidence.

The role of elective neck dissection during salvage surgery in patients with a clinically negative neck (cN0) is still discussed. The main objective of this work was to estimate the prevalence and predictive factors of occult neck nodes metastasis; we therefore aimed to evaluate the survival rate and the main oncologic outcomes of cN0 patients who underwent salvage total laryngectomy and elective bilateral neck dissection. In this retrospective observational study, we enrolled 80 cN0 patients affected by recurrent laryngeal cancer and who underwent salvage total laryngectomy and bilateral selective elective neck dissection. Several parameters were collected in order to find prognostic factors; finally, postoperative complications were reviewed and survival analysis was performed. Occult lymph node metastases were reported in 18 out of 80 patients (22.5%). Significant statistical correlation between lymphovascular invasion (p = 0.007), perineural invasion (p = 0.025) and occult nodal metastasis was found. Other variables (glottic subsite of recurrence, clinical T, pathological T, previous chemotherapy) were not significantly predictive of occult nodal metastasis. The 5-year OS, DSS, and RFS were 50.4%, 64.7%, and 63.4%, respectively. In conclusion, our single-institution data on a large cohort of patients, suggest performing routinely elective selective bilateral neck dissection during salvage total laryngectomy in cN0 patients due to the biological attitude of the tumor to spread to cervical nodes, considering an acceptable complications rate.

Autologous tissue-assisted regenerative procedures have been considered effective to close different types of fistula, including the leakage around tracheoesophageal puncture. The aim of this study was to retrospectively review 10 years of lipotransfer for persistent periprosthetic leakage in laryngectomized patients with voice prosthesis. Clinical records of patients who experienced periprosthetic leakage from December 2009 to December 2019 were reviewed. Patients receiving fat grafting were included. The leakage around the prosthesis was assessed with a methylene blue test. Twenty patients experiencing tracheoesophageal fistula enlargement were treated with fat grafting. At the one-month follow-up, all patients were considered improved with no leakage observed. At six months, a single injection was sufficient to solve 75% of cases (n 15), whereas 25% (n 5) required a second procedure. The overall success rate was 80% (n 16). Results remained stable for a follow-up of 5.54 ± 3.97 years. Fat grafting performed around the voice prosthesis, thanks to its volumetric and regenerative properties, is a valid and lasting option to solve persistent periprosthetic leakage.

Objective: To describe a remote approach used with patients with voice prosthesis after laryngectomy during the COVID-19 pandemic and the resulting clinical outcomes in terms of voice prosthesis complications management, oncological monitoring, and psychophysical well-being. Study Design: Prospective cohort study. Setting: Otolaryngology Clinic of the University Polyclinic A. Gemelli, IRCCS Foundation. Subjects and Methods: All patients with voice prosthesis who underwent laryngectomy followed by our institute were offered enrollment. Patients who agreed to participate were interviewed to inquire about the nature of the need and to plan a video call with the appropriate clinician. Before and 1 week after the clinician’s call, patients were tested with the Hospital Anxiety and Depression Scale. Degrees of satisfaction were investigated with a visual analog scale. A comparison between those who accepted and refused telematic support was carried out to identify factors that influence patient interest in teleservice. Results: Video call service allowed us to reach 37 (50.68%) of 73 patients. In 23 (62.16%) of 37 cases, the video call was sufficient to manage the problem. In the remaining 14 cases (37.83%), an outpatient visit was necessary. Participants who refused telematic support had a significantly shorter time interval from the last ear, nose, and throat visit than patients who accepted (57.95 vs 96.14 days, P =.03). Video-called patients showed significantly decreased levels of anxiety and depression (mean Hospital Anxiety and Depression Scale total score pre– vs post–video call: 13.97 vs. 10.23, P <.0001) and reported high levels of satisfaction about the service. Conclusion: Remote approach may be a viable support in the management of patients with voice prosthesis rehabilitation.

Total Laryngectomy seriously affects on patients Quality of Life and on their psychological well-being. The aim of this study was to verify the effects of pre-operative Speech-Language Pathology counselling on laryngectomized patients. Pilot randomized controlled trial. Twenty-seven patients undergoing total laryngectomy and primary tracheoesophageal puncture were randomized as follows: 14/27 subjects were collocated in the Experimental group who received preoperative Speech-Language Pathology counselling and 13/27 in the Control group group that did not receive it. Two interviews and four questionnaires (Psychological Distress Inventory, Impact of Event Scale-Revised, Hospital Anxiety and Depression Scale, Italian-Self-Evaluation of Communication Experiences after Laryngeal Cancer) were administered immediately after surgery (T0), 1- (T1) and 3-months (T2) after hospital discharge in order to asses levels of distress, post-traumatic stress and anxious-depressive symptoms, acquisition and acceptance of the new voice. Student’s t test and chi square test showed that the two groups of patients were equivalent. Experimental group was more satisfied with the information and obtained statistically better (p < 0.05) scores in terms of levels of distress, post-traumatic stress, anxious-depressive symptoms and acceptance of the new voice than the Control group. The Speech-Language Pathology counselling may reduce the anguish, sadness and anticipatory anxiety deriving from the uncertainty of the post-operative course and it might facilitate the process of emotional adaptation, making patients more capable and prepared to face their new condition.

Endoscopic orbital surgery has become a highly evolving multidisciplinary surgical field thanks to development in technical skills of ophthalmologists and otolaryngologists. These advances expanded the clinical application of orbital decompression, with a growing body of literature describing the multidisciplinary management of thyroid eye disease and com-pressive optic neuropathy, since 1990. Although techniques have improved considerably, only few Randomized Control Trials (RCT) provide evidence to support recommendations in clinical practice. This review provides an overview of the current knowledge of orbital decompression to clarify which is the most standardized therapeutic strategy. In the literature, we observed several approaches with contradicting results and the comparison of different surgical techniques was biased by inclusion of patients at different stage of disease (active or inactive), different surgical indications (dysthyroid neuropathy or disfiguring proptosis) and measures of outcomes (such as different system for ocular motility evaluation). The timing of surgical decompression is one of the debated issues. One RCT focusing on Graves’ orbitopathy showed how intravenous corticosteroids achieve better visual recovery than surgical orbital decompression; but in case of absent or poor response to medical therapy the patient should undergo surgery within two weeks. There is slight evidence that the removal of the medial and lateral wall (so-called balanced decompression) with or without fat removal could be the most effective surgical technique, with low com-plication rate, but an increasing number of authors are promoting, for selected cases, a pure endoscopic surgical approach (with removal of medial and infero-medial orbital wall), less invasive than the balanced one; the latter indicated to more severe proptosis or diplopia after endoscopic procedure. Three-wall decompression is chosen for high degrees of proptosis, but complications are more fr

Objective: Periprosthetic leakage represents the most demanding long-term complication in the voice prosthesis rehabilitation. The aim of this article is to discuss the various causes of periprosthetic leakage and to propose a systematic management algorithm. Study Design: Retrospective cohort study. Setting: Otolaryngology clinic of the University Polyclinic A. Gemelli–IRCCS Foundation. Methods: The study included 115 patients with voice prosthesis who were treated from December 2014 to December 2019. All patients who experienced periprosthetic leakage were treated with the same step-by-step therapeutic approach until it was successful. Incidence, management, and success rate of every attempt are analyzed and discussed. Results: Periprosthetic leakage was reported 330 times by 82 patients in 1374 clinic accesses. Radiotherapy, timing of tracheoesophageal puncture, and type of total laryngectomy (primary or salvage) did not influence the incidence of periprosthetic leakage. Salvage total laryngectomy increases the risk of more clinically relevant leakages. Conclusion: By using a systematic algorithm with a step-by-step standardized approach, periprosthetic leakage management could become a less treacherous issue.

The expression of potential stem cell markers in HNSCCs was investigated to assess their potential clinical role. 69 primary, previously untreated oral (OSCC) and oropharyngeal squamous cell carcinomas (OPSCC) were enrolled; personal, clinical and follow-up data were collected. HPV infection and expression of 5 potential stem cell markers (CD44, CD133, Oct-4, Nanog, and Sox-2) were evaluated. HPV+ OPSCC showed lower expression of Nanog. The cytoplasmic expression of Nanog was associated with significantly worse prognosis in OPSCC, but not in OSCC. Sox-2 staining was more intense among OPSCCs. Sox-2 nuclear staining was associated with worse prognosis. Nanog expression was associated with HPV-OPSCC and may have a role as a surrogate diagnostic marker. In general, the expression profile of some stem cell markers in HNSCC seems to vary according to the site of origin and HPV infection. Nanog and Sox-2 may also have prognostic value.

Management of late complications represents the main reason for reluctance in using voice prosthesis rehabilitation. The aim of this paper is to report our experience by describing the one-year management of a large cohort of patients in order to clarify how demanding management is in terms of burden on clinicians. Between June 2017 and June 2018, each access made at the Otolaryngology Clinic of our Institute for issues related to prosthesis by 70 laryngectomised patients rehabilitated by voice prosthesis was registered in a specific database. A review of the data provided information on the incidence, management and outcomes of adverse events encountered during the selected time frame. In addition, a T test was used to evaluate the differences between irradiated and non-irradiated patients and between primary and secondary tracheo-oesophageal-puncture. Leakage through the prosthesis was the most common cause for access (51.86%). The median number of accesses per patient per year was 3.47. The speech therapist autonomously managed 18.1% of accesses. The median number of accesses per patient per year needing a physician was 2.84. The median lifetime of the prosthesis was 4.85 months. Radiotherapy or modality (primary or secondary) of the puncture did not influence the number of accesses per year or the prosthesis lifetime. This retrospective analysis of results highlighted the most frequent issues and the most effective measures to deal with them, which allowed us to define a systematic algorithm to standardise and ease long-term outpatient management.

Purpose: The aim of this paper was to evaluate treatment outcomes following interventional radiotherapy (brachytherapy – BT) for nasal vestibule cancer. Material and methods: Considering histological diagnosis and staging, a multidisciplinary tumor board indicated an exclusive interventional radiotherapy for all patients. Plastic tubes were placed mainly with interstitial approach. The total dose was 44 Gy in 14 fractions, 3 Gy/fraction (except for the first and last fractions, 4 Gy), 2 fractions per day (b.i.d.), 5 days a week. Inclusion criteria for this analysis were: patients affected by squamous cell carcinoma with follow-up more than 6 months. Results: 20 patients with primary nasal vestibule cancer were treated with IRT from May 2012 to June 2019. We excluded 4 patients due to follow-up less than 6 months and 2 patients affected by basal cell carcinoma. In total, 14 consecutive previously untreated patients were considered for definitive analysis, median age was 67.5 (range, 51-83) years, median follow-up was 53 (range, 6-84) months. All patients followed the protocol except one, who received a total dose of 42 Gy in 12 fractions, 3 Gy per 6 fractions, and 4 Gy per 6 fractions. Local control at 12, 24, and 36 months was 85.7%. Overall survival at 12 months was 92.3%, at 24 months was 76.9%, and at 36 months was 69.2%. Staging system proposed by Wang was statistically significant on local control (LC), disease-free survival (DFS), disease-specific survival (DSS), and overall survival (OS). Excellent cosmetic results were observed. Conclusions: This study confirms that interventional radiotherapy could be considered as a definitive treatment in nasal vestibule cancer with excellent oncological and cosmetic outcomes.

Background: Interventional radiotherapy (brachytherapy; IRT) reemerged in the last decades as a potentially useful tool in head and neck oncology after a set of clear technical improvements were developed. Methods: Sixty-one high dose ratio (HDR) IRT treatments were recommended and performed on 58 patients. We classified the cases into four relatively homogeneous groups based on the clinical needs that led to the recommended IRT. Also, we separately evaluated primary and recurrent cases. Results: Disease-specific survival was significantly different among the four treatment groups. The group with the best prognosis was the cohort treated locally by exclusive interstitial IRT for resectable midface malignancies (2-year relapse-free survival = 82%, disease-specific survival = 89%). Conclusion: HDR IRT is a valuable tool in well-defined clinical situations and, in particular, in recurrences. In midface malignancies, it could become the preferred primary treatment.

Purpose Functional and aesthetic results after septorhinoplasty (SRP) are often not clearly demonstrated. There is still an open topic in the literature about analysis of aesthetic, functional results and patients’ satisfaction after SRP. The aim of our study is to determine patients’ satisfaction after SRP and concomitant radiofrequency of the inferior turbinate (RF) regarding nose appearance and improvement of symptoms, using patient reported outcome measures (PROMs). Methods ROE questionnaire and the NOSE scale were used for a retrospective evaluation to assess patient’s satisfaction in 369 patients undergoing SRP surgery from 2003 to 2016. Two additional questions were asked to confirm satisfaction following surgery. Results 258 patients completed the questionnaires (71.7%). The global average ROE score was 18.14 (75.6%). The percentage of satisfaction of aesthetic result was 87.3%, in particular 10.5% were very happy, 57% very much satisfied and 19.8% moderately satisfied. The global post-operative average NOSE score was 13.1 with the resolution of nasal obstruction in 72.1% cases and a marked improvement in 9.3%. The results of the two additional questions showed that 81% of patients would undergo the procedure again if required and 72.1% of patients were globally satisfied. Conclusions Our study demonstrates the utility of PROMs in evaluating aesthetic and functional results after SRP and simultaneous RF. In our series, the patients undergoing SRP and RF are generally satisfied by the functional and aesthetic results. This kind of assessments should be the most common post-operative evaluation methods in this surgery.

BackgroundAcquisition and acceptance of the alaryngeal voice, psychological state, and Quality of Life (QoL) of laryngectomized patients.MethodsThirty-two patients who underwent total laryngectomy were included in the study; 17 of them were treated by a psychologist and a speech therapist (experimental group); 15 performed only speech therapy (control group).ResultsThe experimental group showed a significant improvement in all parameters of the INFVo scale, in the score of the Environment subscale and in the total score of the I-SECEL (Self-Evaluation of Communication Experiences after Laryngeal Cancer); in the Depression, Obsession-Compulsion and Paranoia areas of the SCL-90-R (Symptom Check List-90-Revised); and in the Social area (REL) of the WHOQOL-B (World Health Organization Quality of Life Scale-Brief).ConclusionsAn integrated rehabilitative approach to laryngectomized patients improves emotional state and psychosocial aspects and promotes acceptance and use of the new voice and recovery of a better quality of life.

Laringectomia totale, qualità di vita

OBJECTIVE: The objective of the study was to compare the biofilm growing pattern and its morphological extent on silicone and a teflon-like material using a sonication process and a Scanning Electron Microscope (SEM). DESIGN: A prospective cohort study and a laboratory study. SETTING: Otolaryngology -Head and Neck surgery Department and the Microbiology Institute. PARTICIPANTS: The participants included fifteen laryngectomised patients with phonatory prostheses, which were removed because of device failure, and two different kinds of phonatory prostheses from the laboratory (Provox 2 and ActiValve) that were artificially colonised by Candida albicans. MAIN OUTCOME MEASURES: Tracheo-oesophageal puncture (TEP) is currently considered the gold standard for post-laryngectomy voice rehabilitation. "Leakage" represents the most common cause of substitution and is generated by biofilm colonisation of the prosthesis by mixed mycotic and bacterial agents. New biomaterials have been developed that are deemed to be more resistant to the colonisation of micro-organisms and material deformation. RESULTS: The devices showed colonisation by mixed bacterial flora (Staphylococci 13%, Streptococci 9%, and Haemophilus influenzae 5%) and by yeasts (Candida albicans 12%). Moreover, we observed a different distribution of biofilm layers in Provox ActiValve (22.56%) compared to Provox 2 (56.82%) after experimental colonisation by the previously isolated Candida strain. CONCLUSION: Resident microbiological species from the upper airways unavoidably colonise the polymer surfaces, and no strategies have been effective except for the manipulation of the chemical-physical properties of the device's polymer. Our study confirms that Provox ActiValve, which is made with a fluoroplastic material (teflon-like), is less subject to in vitro colonisation by Candida, and thus showed a higher clinical resistance to biofilm and a longer lifespan. The sonication seems to significantly improve the knowledg

Olfactory neuroblastoma (ONB) is an uncommon neuroendocrine sinonasal cancer associated by many authors to ectopic production of several biologically active substances. We report a case of a 31-year-old male patient who presented with idiopathic syndrome of inappropriate secretion of antidiuretic hormone (SIADH). During diagnostic work-up, a CT scan of the head was performed and an ethmoidal ONB was detected. Endoscopical surgery followed by radiotherapy was carried out. Immediately after surgery natraemia levels normalised. Five years later the patient is disease-free. To our knowledge, 17 cases of SIADH associated to ONB have been published. In nine reports, idiopathic SIADH promptly led to the diagnosis of the sinonasal mass as in our clinical case, however, in many reports, correct diagnosis was accomplished months to years later. In young patients with idiopathic inappropriate antidiuretic hormone secretion, a neuroendocrine malignancy of the sinonasal area must be excluded.

Objectives: The short-term and long-term beneficial effects of HME use by laryngectomees are well described in literature. In this study, we document how laryngectomised patients, who previously did not use an HME, get accustomed to the use of HME and attachments. Participants: Thirty patients, who were at least 3 months post-laryngectomy and previously did not use an HME, were followed for 12 weeks and were asked to complete questionnaires about their experiences with the HME and attachments. Results: Results show that when patients start using an HME, they report some difficulties with breathing resistance during the first 2 weeks of use. However, after 6 weeks, they have become accustomed to the breathing resistance and after 12 weeks over 96% reports that breathing was equal or less strenuous compared with breathing though an open stoma. Only a small proportion of patients experienced problems with increased coughing when starting HME use. Conclusions: This study provides insight in the way laryngectomised patients are experiencing the use of HMEs in the first weeks. These outcomes can contribute to a better knowledge of HME use by healthcare providers and help them to manage patient expectations and improving support to patients in achieving compliant HME use.