A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study.

PURPOSE: To assess physical examination findings related to maxillofacial trauma to identify patients at risk of midfacial and mandibular fractures and then to construct a clinical decision aid to rule out the presence of midfacial and mandibular fractures in emergency department patients. METHODS: We performed a prospective multicentre cohort study in four hospitals in the Netherlands, including consecutive patients with maxillofacial trauma. Each patient received a standardized physical examination consisting of 15 and 14 findings for midfacial and mandibular traumas, respectively. Consequently, clinical decision aids were constructed with the focus being on ruling out the presence of midfacial and mandibular fractures, and diagnostic accuracy was calculated. RESULTS: A total of 993 consecutive patients were identified of whom 766 and 280 patients were suspected of midfacial and mandibular fractures, respectively. Midfacial fractures were diagnosed in 339 patients (44.3%), whereas mandibular fractures were observed in 66 patients (23.6%). The decision aid for midfacial trauma consisting of peri-orbital hematoma, epistaxis, ocular movement limitation, infra-orbital nerve paresthesia, palpable step-off and tooth mobility or avulsion, produced a sensitivity of 89.7 (86.0-92.5), a specificity of 42.6 (38.0-47.4), and a negative predictive value of 83.9% (78.4-88.2). The decision aid for mandibular trauma consisting of the angular compression test, axial chin pressure test, objective malocclusion, tooth mobility or avulsion and the tongue blade bite test resulted in a sensitivity of 98.5 (91.9-99.7), a specificity of 34.6 (28.5-41.2), and a negative predictive value of 98.7% (92.8-99.8). CONCLUSION: The constructed clinical decision aids for maxillofacial trauma may aid in stratifying patients suspected for midfacial and mandibular fractures to reduce unnecessary diagnostic imaging. CLINICAL TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with the identifier NCT03314480.

Diagnostic accuracy of physical examination findings for midfacial fractures: a systematic review and meta-analysis.

OBJECTIVES: To conduct a systematic review and meta-analysis to assess the diagnostic accuracy of physical examination findings and related clinical decision aids for midfacial fractures in comparison to computed tomography and cone beam computed tomography. MATERIAL AND METHODS: A systematic review was performed by searching the MEDLINE, Cochrane, EMBASE, and CINAHL databases. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Pooled sensitivity, specificity, and diagnostic odds ratios with the corresponding 95% confidence intervals were calculated for each physical examination finding and reported clinical decision aids. RESULTS: After screening 2367 records, 12 studies were included. High risk of patient selection bias was detected in three studies (25%). Additionally, high concerns regarding applicability were found for the patient selection in five studies (41.7%), and for the reference standard in eleven studies (91.7%). Of the total 42 individual physical examination findings, only 31 were suitable for a meta-analysis. High specificity and low sensitivity were found for most findings. The pooled diagnostic odds ratio ranged from 1.07 to 11.38. Clinical decision aids were reported by 8 studies, but none were constructed specifically for midfacial fractures. CONCLUSION: Based on the current available evidence, the absence of physical examination findings can successfully identify patients who do not have a midfacial fracture, but the presence of individual findings does not necessarily mean that the patient has a midfacial fracture. Although various clinical decision aids were presented, none focused on exclusively midfacial fractures. CLINICAL RELEVANCE: The diagnostic accuracy of physical examination findings can be used to diagnose a midfacial fracture so as to reduce unnecessary imaging, health care costs, and exposure to ionizing radiation.

A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study.

PURPOSE: To assess the diagnostic accuracy of physical examination findings and to construct clinical decision aids to discern emergency department patients without and with midfacial and mandibular fractures that require treatment. METHODS: A prospective multicentre cohort study was conducted in four hospitals in the Netherlands. Consecutive maxillofacial trauma patients were included whereupon each patient underwent a standardized physical examination consisting of 15 and 14 findings for midfacial and mandibular trauma, respectively. The primary outcome was the decision whether to treat during the emergency department stay or within 24 h of admission. The diagnostic accuracy was calculated for the individual physical examination findings and ensuing clinical decision aids with the focus being on detecting midfacial and mandibular fractures that require active treatment. RESULTS: A total of 766 midfacial trauma patients were identified of whom 339 (44.3%) had midfacial fractures. Of those, 74 (21.8%) required active treatment. A total of 280 mandibular trauma patients were identified of whom 66 (23.6%) had mandibular fractures. Of those, 37 (56.0%) required active treatment. The decision aid for midfacial trauma consisting of facial depression, epistaxis, ocular movement limitation, palpable step-off, objective malocclusion and tooth mobility or avulsion had a sensitivity of 97.3 (90.7-99.3), a specificity of 38.6 (35.0-42.3), and a negative predictive value of 99.3 (97.3-99.8). The decision aid for mandibular trauma consisting of mouth opening limitation, jaw movement pain, objective malocclusion and tooth mobility or avulsion resulted in a sensitivity of 100.0 (90.6-100.0), a specificity of 39.1 (33.2-45.4), and a negative predictive value of 100.0 (96.1-100.0). CONCLUSION: The clinical decision aids successfully identified midfacial and mandibular trauma patients requiring active fracture treatment and so may be useful in preventing unnecessary radiological procedures in the future. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with the identifier NCT03314480.

Diagnostic accuracy of physical examination findings for midfacial and mandibular fractures.

OBJECTIVES: To assess the diagnostic accuracy of physical examination findings used to identify patients at risk for midfacial or mandibular fractures. MATERIALS AND METHODS: A five-year retrospective cohort was constructed from all emergency department patients with a midfacial or mandibular trauma. The sensitivity, specificity, pre-test probability, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio data was calculated for 19 and 14 physical examination findings for midfacial and mandibular fractures respectively. Computed Tomography and panoramic radiography were used as index tests. RESULTS: A total of 1484 patients were identified among whom 40.4% midfacial and 33.4% mandibular fractures were diagnosed. Overall, specificity was found to be higher than sensitivity. Regarding midfacial fractures, high specificity was found for raccoon eyes, malar eminence flattening and all the findings that are related to palpation, the nasal, ocular and intra-oral assessment. Malar eminence flattening, external nasal deformity, nasal septum hematoma, change of globe position and palpable step-off had ad high positive predictive value and positive likelihood ratio. Regarding mandibular fractures high specificity was found for mouth opening restriction, auditory canal bleeding, intra-oral assessment related findings, palpable step-off, inferior alveolar nerve paresthesia, the angular compression test and chin axial pressure test. CONCLUSIONS: The diagnostic accuracy of relevant physical examination findings were identified for the prediction of midfacial and mandibular fractures.

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, commonly managed by either continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Long-term follow-up and comparison regarding efficacy of these therapies is scarce. In this study the results of treatment, patient adherence, and satisfaction over a 10-year follow-up of these therapies are reported. METHODS: This is a longitudinal follow-up study taken from a subset of patients initially enrolled in a randomized controlled clinical trial of 103 patients with OSA (51 and 52 patients randomized for MAD and CPAP, respectively). After a 10-year follow-up period, 14 patients using MAD and 17 patients using CPAP could be evaluated for this longitudinal follow-up study. Data were analyzed at baseline, after 3 months and at 1-, 2-, and 10-year follow-up. All 31 patients with OSA underwent polysomnography and self-reported measurements. RESULTS: Polysomnography results showed a favorable outcome of both therapies at 10-year follow-up. At baseline, included patients in both groups did not significantly differ in apnea-hypopnea index (AHI) values. At 10-year follow-up, both the MAD and CPAP groups showed a significant reduction in AHI. At baseline the mean AHI in the MAD group was 31.7 ± 20.6 events/h whereas in the CPAP group it was 49.2 ± 26.1 events/h. At 10-year follow-up the mean AHI in the MAD group was 9.9 ± 10.3 events/h and in the CPAP group it was 3.4 ± 5.4 events/h. Both therapies resulted in a substantial improvement in self-reported neurobehavioral outcomes at 10-year follow-up. CONCLUSIONS: Both CPAP and MAD therapy demonstrate good and stable treatment effects after a 10-year follow-up period. Therefore, when indicated, both therapies are appropriate modalities for the long-term management of OSA. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy; Identifier: NL75; URL: https://www.trialregister.nl/trial/75.

Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study.

OBJECTIVES: Patients with obstructive sleep apnea (OSA) are usually treated with either mandibular advancement device (MAD) or continuous positive airway pressure (CPAP) therapy. The objective of this study is to evaluate changes in dental occlusion associated with long-term MAD and CPAP therapy. MATERIALS AND METHODS: Data from 14 OSA patients using MAD and 17 OSA patients using CPAP therapy were evaluated at baseline, 2-year and 10-year follow-up. Changes in dental occlusion were analyzed from dental plaster casts with a digital sliding caliper. RESULTS: At 2-year follow-up, MAD therapy resulted in significant dental changes when compared with baseline values. In MAD therapy, overjet and overbite decreased with 1.1 ± 1.8 mm and 1.1 ± 1.2 mm respectively. With CPAP therapy overjet and overbite decreased significantly with 0.2 ± 0.5 mm and 0.3 ± 0.5 mm, respectively. Both groups also showed significant changes in molar occlusion. After a 10-year follow-up, significant and more pronounced changes were seen in overjet and overbite. In MAD therapy, overjet and overbite decreased with 3.5 ± 1.5 mm and 2.9 ± 1.5 mm respectively when compared with baseline values. In CPAP therapy, overjet and overbite decreased with 0.7 ± 1.5 mm and 0.8 ± 1.4 mm respectively when compared with baseline values. CONCLUSIONS: This study demonstrates that MAD and CPAP therapy result in significant changes in dental occlusion. These changes appear progressive and more pronounced with MAD compared to CPAP therapy. CLINICAL RELEVANCE: Long-term OSA treatment results in significant dental side effects that may progress over time. Informed consent is fundamental before starting MAD treatment and individualized long-term follow-up is of eminent importance.

Usage of positional therapy in adults with obstructive sleep apnea.

STUDY OBJECTIVES: Many positional therapy (PT) strategies are available for treating positional obstructive sleep apnea (OSA). PT is primarily supplied to selected patients as a secondary treatment option when other therapies have failed. To our knowledge this is the largest study to date to assess effectiveness and long-term compliance of PT (both commercial waistband and self-made constructions, mimicking the tennis ball technique) as primary treatment in patients with different positional OSA severities. METHODS: PT was used by 53 patients, of which 40 patients underwent a follow-up polygraphic evaluation under treatment after a median time interval of 12 weeks. Patients were routinely contacted regarding their clinical status and treatment compliance. RESULTS: PT was successful in 27 out of 40 patients (68%). Overall AHI reduced significantly from a median (interquartile range [IQR]) AHI of 14.5 (10.7-19.6) to 5.9 (3.1-8.5), p < 0.001. The commercial waistband and self-made constructions were equally effective (median (IQR) reduction in overall AHI (Δ9.6 (5.5-11.9) and Δ6.8 (3.2-11.3) respectively), p = 0.22). Short-term compliance was good as most patients used PT more than 7 hours/night (mean 7.2 ± SD 1.4) and more than 6 days/ week (mean 6.5 ± SD 1.3). However, after mean 13±5 months, 26 patients (65%) reported they no longer used PT, especially patients with moderate positional OSA (89%). CONCLUSIONS: On the short-term, PT using the tennis ball technique, is an easy method to treat most patients with positional OSA, showing significant reductions in AHI. Unfortunately, long-term compliance is low and close follow-up of patients on PT with regard to their compliance is necessary.

Oral appliance to assist non-invasive ventilation in a patient with amyotrophic lateral sclerosis.

BACKGROUND: From the moment the respiratory muscle groups are affected in amyotrophic lateral sclerosis (ALS), respiratory complications will be the major cause of morbidity and mortality. Untreated respiratory muscle impairment leads to respiratory insufficiency and additionally to difficulties in airway secretion clearance. Non-invasive ventilation (NIV) is the first choice in treating respiratory insufficiency in ALS as it improves sleep-related symptoms, quality of life and life expectancy. Nevertheless, NIV is not always effective, probably due to bulbar dysfunction or anatomical abnormalities. As a result, tracheostomy ventilation (TV) may become necessary. METHODS: In this case report, we present a 60-year-old female with ALS, for whom it was not possible to provide a sufficient tidal volume with NIV. A chin lift was performed while the patient was awake to see if a more anterior jaw position would lead to an increased tidal volume. As this was the case, a mandibular advancement device (MAD) was fabricated. RESULTS: With a combination of a MAD and NIV, the upper airway obstructions were overcome and a good ventilation and adherence to therapy were seen. CONCLUSIONS: When there is the presumption of airway obstructions in combination with an ineffective NIV, we advise to perform a chin lift to assess whether the obstructions can be overcome by a more anterior jaw position. If that is the case, NIV may be combined with MAD to establish effective ventilation and avoid the use of TV.

Maxillomandibular advancement surgery as alternative to continuous positive airway pressure in morbidly severe obstructive sleep apnea: a case report.

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder, characterized by disrupted snoring and repetitive upper airway obstructions. Oral appliance therapy is an effective alternative to continuous positive airway pressure (CPAP) and is especially effective in mild and moderate OSAS cases. Successful oral appliance therapy has been suggested as a predictor for successful maxillomandibular advancement (MMA) surgery in OSAS patients. MMA surgery has gained increasing popularity in this field since this procedure is associated with an enlargement of the entire velo-oro-hypopharyngeal airway. The authors present an unusual case of a CPAP-intolerant morbidly obese female (body mass index (BMI) = 40) with morbidly severe OSAS (apnea-hypopnea index (AHI) = 139, lowest oxyhemoglobin saturation level = 73%), who underwent a successful combination of MMA surgery, a modified genioplasty and cervicomental liposuction after oral appliance therapy. The post-surgical AHI was 6, and the lowest oxyhemoglobin saturation level increased to 86%. The authors suggest that this surgical combination should be seriously considered in obese patients with severe OSAS and CPAP intolerance.

Oral appliance versus continuous positive airway pressure in obstructive sleep apnea syndrome: a 2-year follow-up.

STUDY OBJECTIVES: Oral appliance therapy has emerged as an important alternative to continuous positive airway pressure (CPAP) in treating patients with obstructive sleep apnea syndrome (OSAS). In this study we report about the subjective and objective treatment outcome of oral appliance therapy and CPAP in patients with OSAS. DESIGN: Cohort study of a previously conducted randomized clinical trial. SETTING: University Medical Center, Groningen, The Netherlands. PATIENTS OR PARTICIPANTS: One hundred three patients with OSAS. INTERVENTIONS: CPAP and oral appliance therapy (Thornton Adjustable Positioner type-1, Airway Management, Inc., Dallas, TX, USA). MEASUREMENTS AND RESULTS: Objective (polysomnography) and subjective (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Medical Outcomes Study 36-item Short Form Health Survey [SF-36]) parameters were assessed after 1 and 2 years of treatment. Treatment was considered successful when the apnea-hypopnea index (AHI) was < 5 or showed substantial reduction, defined as reduction in the index of at least 50% from the baseline value to a value of < 20 in a patient without OSAS symptoms while undergoing therapy. Regarding the proportions of successful treatments, no significant difference was found between oral appliance therapy and CPAP in treating mild to severe OSAS in a 2-year follow-up. More patients (not significant) dropped out under oral appliance therapy (47%) compared with CPAP (33%). Both therapies showed substantial improvements in polysomnographic and neurobehavioral outcomes. However, CPAP was more effective in lowering the AHI and showed higher oxyhemoglobin saturation levels compared to oral appliance therapy (P < 0.05). CONCLUSIONS: Oral appliance therapy should be considered as a viable treatment alternative to continuous positive airway pressure (CPAP) in patients with mild to moderate obstructive sleep apnea syndrome (OSAS). In patients with severe OSAS, CPAP remains the treatment of first choice. CLINICAL TRIAL INFORMATION: The original randomized clinical trial, of which this study is a 2-year follow-up, is registered at ISRCTN.org; identifier: ISRCTN18174167; trial name: Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy; URL: http://www.controlled-trials.com/ISRCTN18174167.

Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects.

The objective of this study was to assess variations in the occurrence of temporomandibular disorders (TMDs) and the risk of developing pain and function impairment of the temporomandibular complex in obstructive sleep apnea syndrome (OSAS) patients treated with either an oral appliance (mandibular advancement device) or continuous positive airway pressure (CPAP) in a 2-year follow-up study. In addition, we assessed the relationship between the mean mandibular protrusion and the frequency of wearing the appliance during follow-up with the occurrence of pain and function impairment of the temporomandibular complex. Fifty-one patients were randomized to oral appliance therapy and 52 patients to CPAP therapy. TMDs (diagnosed according to the Axis I Research Diagnostic Criteria for TMD), pain intensity and disability and mandibular function impairment were recorded at baseline, after 2 months, 1 year and 2 years of therapy. Only in the initial period of treatment the occurrence of pain-related TMDs was considerably higher (24%) in the oral appliance group compared to CPAP (6%). Oral appliance therapy furthermore resulted in more temporomandibular pain compared to CPAP (odds ratio 2.33, 95% confidence interval (1.22-4.43)). However, there were no limitations in mandibular function in both groups during the (entire) follow-up period. Although generally not serious and of transient nature, oral appliance therapy results in more pain-related TMDs in the initial period of use compared with CPAP therapy. Oral appliance therapy is associated with increased pain in the temporomandibular complex in the initial period of use. Because of the transient nature, this pain is not a reason to contra-indicate an oral appliance in OSAS patients. Moreover, TMDs and the risk of developing pain and function impairment of the temporomandibular complex appear limited with long-term oral appliance use.