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Maroeska M Rovers - One of the best experts on this subject based on the ideXlab platform.

  • septoplasty versus non surgical management for nasal obstruction in adults with a Deviated Septum economic evaluation alongside a randomized controlled trial
    BMC Medicine, 2020
    Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M Rovers
    Abstract:

    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.

  • 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, 2019
    Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van Heerbeek
    Abstract:

    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).

  • septoplasty versus non surgical management for nasal obstruction due to a Deviated nasal Septum in adults a modelling study of cost effectiveness
    Clinical Otolaryngology, 2019
    Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M Rovers
    Abstract:

    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.

Neil S Norton - One of the best experts on this subject based on the ideXlab platform.

  • the prevalence of concha bullosa and nasal septal deviation and their relationship to maxillary sinusitis by volumetric tomography
    International Journal of Dentistry, 2010
    Co-Authors: Kyle D Smith, Paul C Edwards, Tarnjit S Saini, Neil S Norton
    Abstract:

    The objective of this study was to determine the prevalence of concha bullosa and nasal septal deviation and their potential relationships to maxillary sinusitis. 883 CT scans taken at Creighton University School of Dentistry from 2005 to 2008 were retrospectively reviewed for the presence of concha bullosa, nasal septal deviation, and maxillary sinusitis. 67.5% of patients exhibited pneumatization of at least one concha, 19.4% of patients had a Deviated Septum, and 50.0% had mucosal thickening consistent with maxillary sinusitis. 49.3% of patients who had concha bullosa also had evidence of maxillary sinusitis. Only 19.5% of patients with concha bullosa also had nasal septal deviation, whereas 19.7% of patients with sinusitis also presented with nasal septal deviation. Although concha bullosa is a common occurrence in the nasal cavity, there did not appear to be a statistically significant relationship between the presence of concha bullosa or nasal septal deviation and maxillary sinusitis.

Machteld M H T Van Egmond - One of the best experts on this subject based on the ideXlab platform.

  • septoplasty versus non surgical management for nasal obstruction in adults with a Deviated Septum economic evaluation alongside a randomized controlled trial
    BMC Medicine, 2020
    Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M Rovers
    Abstract:

    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.

  • 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, 2019
    Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van Heerbeek
    Abstract:

    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).

  • septoplasty versus non surgical management for nasal obstruction due to a Deviated nasal Septum in adults a modelling study of cost effectiveness
    Clinical Otolaryngology, 2019
    Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M Rovers
    Abstract:

    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.

Niels Van Heerbeek - One of the best experts on this subject based on the ideXlab platform.

  • septoplasty versus non surgical management for nasal obstruction in adults with a Deviated Septum economic evaluation alongside a randomized controlled trial
    BMC Medicine, 2020
    Co-Authors: Machteld M H T Van Egmond, Gerjon Hannink, Niels Van Heerbeek, Janneke P C Grutters, Maroeska M Rovers
    Abstract:

    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.

  • 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, 2019
    Co-Authors: Machteld M H T Van Egmond, Maroeska M Rovers, Gerjon Hannink, Carine Tm Hendriks, Niels Van Heerbeek
    Abstract:

    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).

  • septoplasty versus non surgical management for nasal obstruction due to a Deviated nasal Septum in adults a modelling study of cost effectiveness
    Clinical Otolaryngology, 2019
    Co-Authors: Machteld M H T Van Egmond, Niels Van Heerbeek, Jan J Rongen, Carien J T Hedeman, Maroeska M Rovers
    Abstract:

    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.

Kyle D Smith - One of the best experts on this subject based on the ideXlab platform.

  • the prevalence of concha bullosa and nasal septal deviation and their relationship to maxillary sinusitis by volumetric tomography
    International Journal of Dentistry, 2010
    Co-Authors: Kyle D Smith, Paul C Edwards, Tarnjit S Saini, Neil S Norton
    Abstract:

    The objective of this study was to determine the prevalence of concha bullosa and nasal septal deviation and their potential relationships to maxillary sinusitis. 883 CT scans taken at Creighton University School of Dentistry from 2005 to 2008 were retrospectively reviewed for the presence of concha bullosa, nasal septal deviation, and maxillary sinusitis. 67.5% of patients exhibited pneumatization of at least one concha, 19.4% of patients had a Deviated Septum, and 50.0% had mucosal thickening consistent with maxillary sinusitis. 49.3% of patients who had concha bullosa also had evidence of maxillary sinusitis. Only 19.5% of patients with concha bullosa also had nasal septal deviation, whereas 19.7% of patients with sinusitis also presented with nasal septal deviation. Although concha bullosa is a common occurrence in the nasal cavity, there did not appear to be a statistically significant relationship between the presence of concha bullosa or nasal septal deviation and maxillary sinusitis.