The Experts below are selected from a list of 2187 Experts worldwide ranked by ideXlab platform
Dubravko Manestar - One of the best experts on this subject based on the ideXlab platform.
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the effects of disclosure of sequential rhinomanometry scores on post Septoplasty subjective scores of nasal obstruction a randomised controlled trial
Clinical Otolaryngology, 2012Co-Authors: Dubravko Manestar, Marko Velepic, Tamara Braut, Goran Malvic, Milodar Kujundžic, Matanic D Lender, Radan StarcevicAbstract:Clin. Otolaryngol. 2012, 37, 176–180 Objective: We sought to evaluate the effects of awareness of rhinomanometric results on subjective sensation of nasal breathing in patients after Septoplasty. Design: Prospective randomised study. Setting: Clinical Hospital Rijeka. Participants: A study of 60 patients (45 M, 15 F) who underwent Septoplasty was performed at the ENT Clinic, Clinical Hospital Rijeka. The patients were randomised into two groups; group A was shown their rhinomanometry scores at 3 months postoperatively, while group B remained unaware of their rhinomanometry results. Main outcome measure: The assumption is that in the same settings patients aware of their rhinomanometric results have better performances of their Nasal Obstruction Symptom Evaluation (NOSE) scale and thereby a better quality of life (QOL) after Septoplasty. Results: The differences in rhinomanometric results and NOSE scale prior and after Septoplasty were statistically significant (P < 0.001), all patients achieving better results after the operation. There was no statistically significant difference in resistance (F = 0.004; P = 0.948) and improvement of rhinomanometry results in postoperative measurements (F = 0.110; P = 0.896) between groups A and B. The symptoms measured by the NOSE scale were the same in both groups preoperatively and 1 month after Septoplasty (F = 2.906; P = 0.094). Three months postoperatively in group A, the NOSE scale score was lower (M = 11.67; sd = 12.34) than in group B (M = 27.50; sd = 18.04). Conclusions: The results suggest that disclosing information to patients about their post-Septoplasty rhinomanometry results may improve subjective nasal breathing, and thus improve their QOL.
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the effects of disclosure of sequential rhinomanometry scores on post Septoplasty subjective scores of nasal obstruction a randomised controlled trial
Clinical Otolaryngology, 2012Co-Authors: Dubravko Manestar, Marko Velepic, Tamara Braut, Goran Malvic, Milodar Kujundžic, Matanic D Lender, Radan StarcevicAbstract:Clin. Otolaryngol. 2012, 37, 176–180 Objective: We sought to evaluate the effects of awareness of rhinomanometric results on subjective sensation of nasal breathing in patients after Septoplasty. Design: Prospective randomised study. Setting: Clinical Hospital Rijeka. Participants: A study of 60 patients (45 M, 15 F) who underwent Septoplasty was performed at the ENT Clinic, Clinical Hospital Rijeka. The patients were randomised into two groups; group A was shown their rhinomanometry scores at 3 months postoperatively, while group B remained unaware of their rhinomanometry results. Main outcome measure: The assumption is that in the same settings patients aware of their rhinomanometric results have better performances of their Nasal Obstruction Symptom Evaluation (NOSE) scale and thereby a better quality of life (QOL) after Septoplasty. Results: The differences in rhinomanometric results and NOSE scale prior and after Septoplasty were statistically significant (P < 0.001), all patients achieving better results after the operation. There was no statistically significant difference in resistance (F = 0.004; P = 0.948) and improvement of rhinomanometry results in postoperative measurements (F = 0.110; P = 0.896) between groups A and B. The symptoms measured by the NOSE scale were the same in both groups preoperatively and 1 month after Septoplasty (F = 2.906; P = 0.094). Three months postoperatively in group A, the NOSE scale score was lower (M = 11.67; sd = 12.34) than in group B (M = 27.50; sd = 18.04). Conclusions: The results suggest that disclosing information to patients about their post-Septoplasty rhinomanometry results may improve subjective nasal breathing, and thus improve their QOL.
Maroeska M Rovers - One of the best experts on this subject based on the ideXlab platform.
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Septoplasty versus non surgical management for nasal obstruction in adults with a deviated septum economic evaluation alongside a randomized controlled trial
BMC Medicine, 2020Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M RoversAbstract:For years, the benefits of Septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that Septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of Septoplasty remains unknown. We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) Septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. A total of 203 adults were randomly assigned to Septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between Septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI − 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI − 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. Depending on the selected perspective, cost-effectiveness threshold, and time horizon, Septoplasty has the potential to be cost-effective. Despite considerable uncertainty, Septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, Septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.
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Septoplasty with or without concurrent turbinate surgery versus non surgical management for nasal obstruction in adults with a deviated septum a pragmatic randomised controlled trial
The Lancet, 2019Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Summary Background Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of Septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of Septoplasty for nasal obstruction in adults with a deviated septum. Methods We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have Septoplasty done were randomly allocated (1:1) to receive either Septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age ( Findings Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either Septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to Septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5–12·1], favouring Septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. Interpretation Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. Funding The Netherlands Organisation for Health Research and Development (ZonMw).
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Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults a modelling study of cost effectiveness
Clinical Otolaryngology, 2019Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M RoversAbstract:Objective The objective of this study was to demonstrate how decision-analytic modelling can help to determine circumstances under which surgery may become cost-effective, using Septoplasty as an example. Design We developed a decision-analytic model comparing Septoplasty to non-surgical management for nasal obstruction in adults with a deviated septum. Based on the estimated cost difference between both treatments, we calculated the minimal (a) gain in quality-adjusted life-years, or (b) reduction in productivity losses needed for Septoplasty to be cost-effective. Input was derived from literature and publicly available data sources. The time horizon of our model was one year, and the willingness-to-pay per quality-adjusted life-year was €20 000, in accordance with current guidelines. Results The cost difference between Septoplasty and non-surgical management for nasal obstruction due to a deviated nasal septum was €2227 per patient from a healthcare perspective (including direct healthcare costs) and €3288 per patient from an extended perspective (additionally including travel expenses and productivity losses due to poor health). In comparison with non-surgical management, Septoplasty needed to gain 0.11 to 0.16 QALYs or save 13 sick days for nasal obstruction. The longer Septoplasty's effect lasts, the more time it will have to compensate its extra costs. Conclusion This study shows that the known cost difference between treatments can be used as the starting point to determine beneficial effects needed for cost-effectiveness of surgical interventions. The effect required by Septoplasty from a healthcare perspective seems potentially achievable, meaning that it would be useful to perform an RCT assessing the actual benefits of Septoplasty.
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Septoplasty for nasal obstruction due to a deviated nasal septum in adults a systematic review
Rhinology, 2018Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, A H J Tillema, Niels Van HeerbeekAbstract:Background The status of current evidence for the effectiveness of Septoplasty is unclear. This systematic review evaluates the effectiveness of a) Septoplasty (with or without concurrent turbinate surgery) versus non-surgical management, and b) Septoplasty with concurrent turbinate surgery versus Septoplasty alone, for nasal obstruction due to a deviated nasal septum in adults. Methodology Eligible for inclusion were randomised controlled trials and non-randomised designs comparing treatment strategies. Risk of bias was assessed using Cochrane's tool. Standardised mean differences and risk differences with 95% confidence intervals were calculated. Substantial heterogeneity between included studies did not allow meta-analyses. Results No studies were found comparing Septoplasty (with or without concurrent turbinate surgery) to non-surgical management, but 11 articles were included to compare Septoplasty with concurrent turbinate surgery to Septoplasty alone. Five studies described both subjective and objective outcomes; six studies reported one or the other. Risk of bias was overall high. Although outcomes generally improved after treatment, eight out of nine studies on subjective measures and five out of seven studies on objective measures found no additional benefit of turbinate surgery. Conclusions Despite the routine application of Septoplasty in clinical practice, the current body of evidence does not support firm conclusions on its effectiveness.
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effectiveness of Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults study protocol for a randomized controlled trial
Trials, 2015Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform Septoplasty is nasal obstruction. However, the effectiveness of Septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not Septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of Septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for Septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either Septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of Septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for Septoplasty. Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.
Niels Van Heerbeek - One of the best experts on this subject based on the ideXlab platform.
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Septoplasty versus non surgical management for nasal obstruction in adults with a deviated septum economic evaluation alongside a randomized controlled trial
BMC Medicine, 2020Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M RoversAbstract:For years, the benefits of Septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that Septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of Septoplasty remains unknown. We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) Septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. A total of 203 adults were randomly assigned to Septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between Septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI − 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI − 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. Depending on the selected perspective, cost-effectiveness threshold, and time horizon, Septoplasty has the potential to be cost-effective. Despite considerable uncertainty, Septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, Septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.
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Septoplasty with or without concurrent turbinate surgery versus non surgical management for nasal obstruction in adults with a deviated septum a pragmatic randomised controlled trial
The Lancet, 2019Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Summary Background Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of Septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of Septoplasty for nasal obstruction in adults with a deviated septum. Methods We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have Septoplasty done were randomly allocated (1:1) to receive either Septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age ( Findings Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either Septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to Septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5–12·1], favouring Septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. Interpretation Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. Funding The Netherlands Organisation for Health Research and Development (ZonMw).
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Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults a modelling study of cost effectiveness
Clinical Otolaryngology, 2019Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M RoversAbstract:Objective The objective of this study was to demonstrate how decision-analytic modelling can help to determine circumstances under which surgery may become cost-effective, using Septoplasty as an example. Design We developed a decision-analytic model comparing Septoplasty to non-surgical management for nasal obstruction in adults with a deviated septum. Based on the estimated cost difference between both treatments, we calculated the minimal (a) gain in quality-adjusted life-years, or (b) reduction in productivity losses needed for Septoplasty to be cost-effective. Input was derived from literature and publicly available data sources. The time horizon of our model was one year, and the willingness-to-pay per quality-adjusted life-year was €20 000, in accordance with current guidelines. Results The cost difference between Septoplasty and non-surgical management for nasal obstruction due to a deviated nasal septum was €2227 per patient from a healthcare perspective (including direct healthcare costs) and €3288 per patient from an extended perspective (additionally including travel expenses and productivity losses due to poor health). In comparison with non-surgical management, Septoplasty needed to gain 0.11 to 0.16 QALYs or save 13 sick days for nasal obstruction. The longer Septoplasty's effect lasts, the more time it will have to compensate its extra costs. Conclusion This study shows that the known cost difference between treatments can be used as the starting point to determine beneficial effects needed for cost-effectiveness of surgical interventions. The effect required by Septoplasty from a healthcare perspective seems potentially achievable, meaning that it would be useful to perform an RCT assessing the actual benefits of Septoplasty.
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Septoplasty for nasal obstruction due to a deviated nasal septum in adults a systematic review
Rhinology, 2018Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, A H J Tillema, Niels Van HeerbeekAbstract:Background The status of current evidence for the effectiveness of Septoplasty is unclear. This systematic review evaluates the effectiveness of a) Septoplasty (with or without concurrent turbinate surgery) versus non-surgical management, and b) Septoplasty with concurrent turbinate surgery versus Septoplasty alone, for nasal obstruction due to a deviated nasal septum in adults. Methodology Eligible for inclusion were randomised controlled trials and non-randomised designs comparing treatment strategies. Risk of bias was assessed using Cochrane's tool. Standardised mean differences and risk differences with 95% confidence intervals were calculated. Substantial heterogeneity between included studies did not allow meta-analyses. Results No studies were found comparing Septoplasty (with or without concurrent turbinate surgery) to non-surgical management, but 11 articles were included to compare Septoplasty with concurrent turbinate surgery to Septoplasty alone. Five studies described both subjective and objective outcomes; six studies reported one or the other. Risk of bias was overall high. Although outcomes generally improved after treatment, eight out of nine studies on subjective measures and five out of seven studies on objective measures found no additional benefit of turbinate surgery. Conclusions Despite the routine application of Septoplasty in clinical practice, the current body of evidence does not support firm conclusions on its effectiveness.
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effectiveness of Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults study protocol for a randomized controlled trial
Trials, 2015Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform Septoplasty is nasal obstruction. However, the effectiveness of Septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not Septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of Septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for Septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either Septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of Septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for Septoplasty. Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.
Radan Starcevic - One of the best experts on this subject based on the ideXlab platform.
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the effects of disclosure of sequential rhinomanometry scores on post Septoplasty subjective scores of nasal obstruction a randomised controlled trial
Clinical Otolaryngology, 2012Co-Authors: Dubravko Manestar, Marko Velepic, Tamara Braut, Goran Malvic, Milodar Kujundžic, Matanic D Lender, Radan StarcevicAbstract:Clin. Otolaryngol. 2012, 37, 176–180 Objective: We sought to evaluate the effects of awareness of rhinomanometric results on subjective sensation of nasal breathing in patients after Septoplasty. Design: Prospective randomised study. Setting: Clinical Hospital Rijeka. Participants: A study of 60 patients (45 M, 15 F) who underwent Septoplasty was performed at the ENT Clinic, Clinical Hospital Rijeka. The patients were randomised into two groups; group A was shown their rhinomanometry scores at 3 months postoperatively, while group B remained unaware of their rhinomanometry results. Main outcome measure: The assumption is that in the same settings patients aware of their rhinomanometric results have better performances of their Nasal Obstruction Symptom Evaluation (NOSE) scale and thereby a better quality of life (QOL) after Septoplasty. Results: The differences in rhinomanometric results and NOSE scale prior and after Septoplasty were statistically significant (P < 0.001), all patients achieving better results after the operation. There was no statistically significant difference in resistance (F = 0.004; P = 0.948) and improvement of rhinomanometry results in postoperative measurements (F = 0.110; P = 0.896) between groups A and B. The symptoms measured by the NOSE scale were the same in both groups preoperatively and 1 month after Septoplasty (F = 2.906; P = 0.094). Three months postoperatively in group A, the NOSE scale score was lower (M = 11.67; sd = 12.34) than in group B (M = 27.50; sd = 18.04). Conclusions: The results suggest that disclosing information to patients about their post-Septoplasty rhinomanometry results may improve subjective nasal breathing, and thus improve their QOL.
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the effects of disclosure of sequential rhinomanometry scores on post Septoplasty subjective scores of nasal obstruction a randomised controlled trial
Clinical Otolaryngology, 2012Co-Authors: Dubravko Manestar, Marko Velepic, Tamara Braut, Goran Malvic, Milodar Kujundžic, Matanic D Lender, Radan StarcevicAbstract:Clin. Otolaryngol. 2012, 37, 176–180 Objective: We sought to evaluate the effects of awareness of rhinomanometric results on subjective sensation of nasal breathing in patients after Septoplasty. Design: Prospective randomised study. Setting: Clinical Hospital Rijeka. Participants: A study of 60 patients (45 M, 15 F) who underwent Septoplasty was performed at the ENT Clinic, Clinical Hospital Rijeka. The patients were randomised into two groups; group A was shown their rhinomanometry scores at 3 months postoperatively, while group B remained unaware of their rhinomanometry results. Main outcome measure: The assumption is that in the same settings patients aware of their rhinomanometric results have better performances of their Nasal Obstruction Symptom Evaluation (NOSE) scale and thereby a better quality of life (QOL) after Septoplasty. Results: The differences in rhinomanometric results and NOSE scale prior and after Septoplasty were statistically significant (P < 0.001), all patients achieving better results after the operation. There was no statistically significant difference in resistance (F = 0.004; P = 0.948) and improvement of rhinomanometry results in postoperative measurements (F = 0.110; P = 0.896) between groups A and B. The symptoms measured by the NOSE scale were the same in both groups preoperatively and 1 month after Septoplasty (F = 2.906; P = 0.094). Three months postoperatively in group A, the NOSE scale score was lower (M = 11.67; sd = 12.34) than in group B (M = 27.50; sd = 18.04). Conclusions: The results suggest that disclosing information to patients about their post-Septoplasty rhinomanometry results may improve subjective nasal breathing, and thus improve their QOL.
Machteld M H T Van Egmond - One of the best experts on this subject based on the ideXlab platform.
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Septoplasty versus non surgical management for nasal obstruction in adults with a deviated septum economic evaluation alongside a randomized controlled trial
BMC Medicine, 2020Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M RoversAbstract:For years, the benefits of Septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that Septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of Septoplasty remains unknown. We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) Septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. A total of 203 adults were randomly assigned to Septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between Septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI − 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI − 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. Depending on the selected perspective, cost-effectiveness threshold, and time horizon, Septoplasty has the potential to be cost-effective. Despite considerable uncertainty, Septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, Septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.
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Septoplasty with or without concurrent turbinate surgery versus non surgical management for nasal obstruction in adults with a deviated septum a pragmatic randomised controlled trial
The Lancet, 2019Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Summary Background Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of Septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of Septoplasty for nasal obstruction in adults with a deviated septum. Methods We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have Septoplasty done were randomly allocated (1:1) to receive either Septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age ( Findings Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either Septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to Septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5–12·1], favouring Septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. Interpretation Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. Funding The Netherlands Organisation for Health Research and Development (ZonMw).
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Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults a modelling study of cost effectiveness
Clinical Otolaryngology, 2019Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M RoversAbstract:Objective The objective of this study was to demonstrate how decision-analytic modelling can help to determine circumstances under which surgery may become cost-effective, using Septoplasty as an example. Design We developed a decision-analytic model comparing Septoplasty to non-surgical management for nasal obstruction in adults with a deviated septum. Based on the estimated cost difference between both treatments, we calculated the minimal (a) gain in quality-adjusted life-years, or (b) reduction in productivity losses needed for Septoplasty to be cost-effective. Input was derived from literature and publicly available data sources. The time horizon of our model was one year, and the willingness-to-pay per quality-adjusted life-year was €20 000, in accordance with current guidelines. Results The cost difference between Septoplasty and non-surgical management for nasal obstruction due to a deviated nasal septum was €2227 per patient from a healthcare perspective (including direct healthcare costs) and €3288 per patient from an extended perspective (additionally including travel expenses and productivity losses due to poor health). In comparison with non-surgical management, Septoplasty needed to gain 0.11 to 0.16 QALYs or save 13 sick days for nasal obstruction. The longer Septoplasty's effect lasts, the more time it will have to compensate its extra costs. Conclusion This study shows that the known cost difference between treatments can be used as the starting point to determine beneficial effects needed for cost-effectiveness of surgical interventions. The effect required by Septoplasty from a healthcare perspective seems potentially achievable, meaning that it would be useful to perform an RCT assessing the actual benefits of Septoplasty.
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Septoplasty for nasal obstruction due to a deviated nasal septum in adults a systematic review
Rhinology, 2018Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, A H J Tillema, Niels Van HeerbeekAbstract:Background The status of current evidence for the effectiveness of Septoplasty is unclear. This systematic review evaluates the effectiveness of a) Septoplasty (with or without concurrent turbinate surgery) versus non-surgical management, and b) Septoplasty with concurrent turbinate surgery versus Septoplasty alone, for nasal obstruction due to a deviated nasal septum in adults. Methodology Eligible for inclusion were randomised controlled trials and non-randomised designs comparing treatment strategies. Risk of bias was assessed using Cochrane's tool. Standardised mean differences and risk differences with 95% confidence intervals were calculated. Substantial heterogeneity between included studies did not allow meta-analyses. Results No studies were found comparing Septoplasty (with or without concurrent turbinate surgery) to non-surgical management, but 11 articles were included to compare Septoplasty with concurrent turbinate surgery to Septoplasty alone. Five studies described both subjective and objective outcomes; six studies reported one or the other. Risk of bias was overall high. Although outcomes generally improved after treatment, eight out of nine studies on subjective measures and five out of seven studies on objective measures found no additional benefit of turbinate surgery. Conclusions Despite the routine application of Septoplasty in clinical practice, the current body of evidence does not support firm conclusions on its effectiveness.
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effectiveness of Septoplasty versus non surgical management for nasal obstruction due to a deviated nasal septum in adults study protocol for a randomized controlled trial
Trials, 2015Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Carine Tm Hendriks, Niels Van HeerbeekAbstract:Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform Septoplasty is nasal obstruction. However, the effectiveness of Septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not Septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of Septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for Septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either Septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of Septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for Septoplasty. Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.
