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marianna13
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litarch

+{"file": "rc0619_NBK349742/CH5.nxml", "text": "Quantity of Research Available\nThe literature search yielded 542 citations. After screening of abstracts from the literature search and from other sources, 16 potentially relevant studies were selected for full-text review. Seven studies met the inclusion criteria and were included in the review. The PRISMA flowchart in Appendix 1 details the process of the study selection.\nSummary of Study Characteristics\nA detailed summary of the included studies is provided in Appendix 2.\nStudy design\nThe literature search identified two systematic reviews/meta-analysis,12,13 three RCTs,14\u201316 and two cost-effectiveness studies.17,18 The systematic reviews performed literature searches up to September,12 and October 201213 and included 14 and three RCTs, respectively. The RCTs were published in 2013 and 2014, and were not reported in the systematic reviews.\nPopulation\nAll studies included adult patients with moderate to severe OSA.12\u201318 Baseline AHI inclusion criteria varied across studies, ranging from 5 to 30 events per hour.\nInterventions and comparators\nInterventions and comparators were CPAP,12\u201318 oral devices12\u201318 and lifestyle interventions (dietary habits and lifestyle such as posture and exercise).18\nOutcomes\nThe systematic reviews and RCTs reported polysomnographic (including AHI, arousal index, minimum SpO2, rapid eye movement sleep rate),12,14\u201316 neurobehavioral (including ESS score, health-related quality of life [QoL]),12\u201316 cardiovascular (blood pressure),12,14,15 compliance rate,14 treatment usage, preference, side effects, withdrawals,12 weight reduction,13 and BMI.13 The cost studies reported costs, quality-adjusted life years (QALY), incremental cost-effectiveness ratios (ICER), and sensitivity analysis outcomes.17,18 In one cost study, only direct medical costs were considered, with a time horizon of five years.17 In the second cost study, costs comprised the costs of the interventions and the healthcare resources used for strokes, coronary heart diseases, and road traffic accidents, with a patient lifetime horizon.18\nSummary of Critical Appraisal\nIn general, the meta-analyses including in this report is rigorous with limited potential bias due to the inclusion of randomized controlled trials and the independent data extraction process.12,13 The systematic reviews each had a comprehensive literature search and explicit inclusion and exclusion criteria. Both meta-analyses included a small number of studies which may limit the robustness of the findings. Neither meta-analysis analyses took into account difference in oral appliances designs among the included trials, or reported on the likelihood of publication bias. Comparative analyses were not adjusted for the baseline differences in patient characteristics. The included randomized controlled trials were small in size, and short period of follow-up, except one with 2 year follow-up.16 Assessors was blinded to the intervention in one single-blinded RCT,14 while the other two RCTs were open-label in design.15,16 The economic evaluation studies in general provided a good appraisal of the cost-effectiveness of CPAP compared to oral devices and lifestyle changes.17,18 The cost estimates was based on survey data from 1997, and may not be reflective of current costs. Potential differences in costs, treatment effect and adherence of various types of oral devices were not considered, limiting the generalizability of the findings.\nDetails of the strengths and limitations of the included studies are summarized in Appendix 3.\nSummary of Findings\nMain findings of included studies are summarized in detail in Appendix 4.\n1. What is the clinical effectiveness of CPAP compared with oral devices for the treatment of sleep apnea?\nOne systematic review/meta-analysis12 and three RCTs14\u201316 compared the clinical effectiveness of CPAP to oral devices in the treatment of moderate to severe OSA. In general, results from controlled setting of RCTs found that CPAP had better efficacy than oral devices defined as a significant reduction in AHI. This benefit may be offset by patient\u2019s higher compliance to oral devices which may result in similar real life clinical effectiveness.\nThe systematic review, with literature search up to September 2012, included 14 RCTs that compared clinical outcomes of CPAP and oral devices comprising mainly of mandibular advancement device (MAD) in patients with moderate to severe OSA.12 Pooled estimates from meta-analysis showed that CPAP lead to statistically significant better AHI compared to oral devices but other polysomnographic outcomes such as arousal index, minimum SpO2, or rapid eye movement sleep rate had inconsistent findings among trials. Neurobehavioral and cardiovascular outcomes such as ESS score, health-related QoL, cognitive performance, blood pressure were similar between oral appliances (OA) and CPAP (differences not statistically significant). The review did not find statistically significant differences in treatment usage, treatment preference, side effects, and withdrawals between OA and CPAP.\nA 2014 randomized, single-blind, cross-over, controlled study on 29 adults with moderate to severe OSA compared polysomnographic, neurobehavioral, and cardiovascular outcomes, and compliance rate between CPAP and MAD.14 Data measured one month after the end of each treatment phase showed statistically significant difference between CPAP and OA in polysomnographic outcomes (AHI, stage 2 sleep %, arousal index, apnea-hypopnea events and minimum SpO2, in favour of CPAP. There were no statistically significant differences in neurobehavioral and cardiovascular outcomes between the two methods. No statistically significant difference between CPAP and MAD in oxidative stress parameters such as lipid peroxidation products, erythrocyte superoxide dismutase activity. MAD led to better compliance than CPAP (differences statistically significant).\nA 2013 randomized, open-label, cross-over, controlled study on 108 adults with moderate to severe OSA compared polysomnographic, neurobehavioral, and cardiovascular outcomes, and compliance rate between CPAP and MAD.15 Data measured after one month at the end of each treatment phase showed a statistically significant difference between CPAP and MAD in polysomnography outcomes (AHI, arousal index, total sleep time, and minimum SpO2), in favour of CPAP. There was no statistically significant difference between the two methods in cardiovascular outcomes and ESS. MAD led to a statistically significant improvement in four general quality-of-life domains and compliance rate compared to CPAP.\nA 2013 randomized, open-label, controlled study on 103 adults with mild to severe OSA compared polysomnographic and neurobehavioral outcomes between CPAP and MAD.16 Data measured after one and two years of treatment showed that, except minimum SpO2 that favored CPAP, data showed similar polysomnographic and neurobehavioral outcomes (ESS, QoL) between CPAP and MAD after 2 years follow-up (differences not statistically significant).\n2. What is the clinical effectiveness of CPAP compared with lifestyle changes for the treatment of sleep apnea?\nA systematic review with literature search up to October 2012 included three RCTs that compared clinical outcomes of CPAP + diet to diet alone in patients with moderate to severe OSA.13 Pooled estimates from meta-analysis showed that CPAP plus diet reduced weight and BMI compared to diet alone (the differences were statistically significant). Neurobehavioral outcomes (ESS, QoL) were similar between the two arms (differences not statistically significant)\n3. What is the cost-effectiveness of CPAP compared with oral devices or lifestyle changes for the treatment of sleep apnea?\nTwo 2009 economic studies calculated costs and cost-effectiveness of CPAP compared to oral devices,17 and CPAP compared to oral devices or lifestyle advice18 in the treatment of adult patients with moderate to severe OSA. In general, the studies suggest that CPAP is more costly than oral devices or lifestyle advice, and oral devices may be a more cost-effective option in patients who are unable to adhere to CPAP.\nIn the study conducted in Canada and the UK,17 CPAP resulted in $1,917 more direct costs than OA, and increased 0.0696 QALY compared to OA (direct medical costs obtained from 2000 report of the National Traffic Safety Administration; estimates using 2004 US $), based on data from RCTs with efficacy defined as the relative reduction of AHI. CPAP was more cost-effective compared to OA (ICER < $50,000/QALY) in most scenarios, except when the gain in utility was assumed to be equal between CPAP and OA. If adherence to OA was at least 80% and adherence to CPAP was only 70%, OA became more cost-effective.\nIn the study conducted in the UK,18 CPAP resulted in an increase of \u00a3504 in medical direct costs compared to dental devices, and \u00a31,161 compared to lifestyle advice (cost estimates using 2005\u20132006 \u00a3). CPAP increased 0.13 QALY compared to dental devices and increased 0.46 QALY compared to lifestyle advice, based on data from RCTs with efficacy defined as the relative reduction of AHI. CPAP was more cost effective compared to dental devices or lifestyle advice (ICER <\u00a320,000/QALY) in all scenarios, except in the mild disease group.\nLimitations\nData were on a population with moderate to severe OSA, and there were no specific data on moderate OSA population, therefore generalizability to particular classifications of OSA is unclear. The small number of trials included in the report, the significant heterogeneity between the included trials for many outcomes, and the difference in length of follow-up periods cautions the interpretation of the results. Difference in designs of oral devices was not taken into consideration in the analyses. The included systematic reviews did not perform funnel plot for pooled estimates to assess the potential publication bias may exaggerate the effectiveness of the intervention. The cost studies did not take into consideration potential differences in costs, treatment effect and adherence of various types of oral appliances.", "pairs": [], "interleaved": []}
+{"file": "rc0619_NBK349742/CH3.nxml", "text": "In general, results from the controlled setting of RCTs and systematic reviews of RCTs found that CPAP lead to better efficacy than oral devices. This benefit may be offset by patient\u2019s higher compliance to oral devices which may result in similar real-life clinical effectiveness. CPAP may be more costly than oral devices or lifestyle advice, and oral devices may be a more cost-effective option in patients who are unable to adhere to CPAP. The small number of trials included in the report, the significant heterogeneity between the included trials for many outcomes, the difference in length of follow-up periods, and the potential difference in costs, treatment effect and adherence of various types of oral appliances caution the interpretation of the results.", "pairs": [], "interleaved": []}
+{"file": "rc0619_NBK349742/CH2.nxml", "text": "What is the clinical effectiveness of continuous positive airway pressure (CPAP) compared with oral devices for the treatment of sleep apnea?\nWhat is the clinical effectiveness of CPAP compared with lifestyle changes for the treatment of sleep apnea?\nWhat is the cost-effectiveness of CPAP compared with oral devices or lifestyle changes for the treatment of sleep apnea?", "pairs": [], "interleaved": []}
+{"file": "rc0619_NBK349742/CH6.nxml", "text": "In general, limited evidence from a small number of RCTs and systematic reviews of RCTs found that in a controlled setting, CPAP lead to better efficacy than oral devices. This benefit may be offset by patient\u2019s higher compliance to oral devices which may result in similar real life clinical effectiveness between the two methods. CPAP may be more costly than oral devices or lifestyle advice, and oral devices may be a more cost-effective option in patients who are unable to adhere to CPAP.\nMatching therapy to patient\u2019s preferences is important to determine the most appropriate treatment, which in turn will increase the chance of adherence to the treatment. A qualitative survey using focus group sessions found that patients with OSA expressed six expectations for treatment, listed in order of most to least frequently mentioned: improved health, apnea elimination, improved sleep, reduced fatigue, reduced snoring, and bed partner benefits.19 This study showed that patients may weight factors differently from practitioners in regards to the choice for OSA treatment options, and tailored intervention is needed for each individual.", "pairs": [], "interleaved": []}
+{"file": "rc0619_NBK349742/CH1.nxml", "text": "Obstructive sleep apnea (OSA) is a condition in which the repetitive, partial, or complete closure of the upper airway results in repeated, reversible blood oxygen desaturation and sleep fragmentation.1 The prevalence of OSA, defined by an apnea-hypopnea index (AHI) \u2265 5 events/hour, was 9% in women and 24% in men in a random sample of Wisconsin state employees ages 30 to 60 years, and is increased with male gender, obesity, and age.2 When defined as a clinical syndrome (AHI \u2265 5 events/hour combined with significant sleepiness), OSA has a prevalence of 2% in women and 4% in men.2 A Canadian Community Health Survey in 2009 reported a 3% prevalence of OSA in Canadians adults.3 OSA is determined by a number of sleep parameter abnormalities measured by polysomnography such as AHI, arousal index, and minimum oxygen saturation (SpO2).2 OSA is associated with neurobehavioral morbidities reflected by a reduction in the Epworth Sleepiness Score (ESS) and quality of life; increased cardiovascular diseases such as high blood pressure, heart failure; and metabolic morbidities such as oxidative stress.4 OSA is associated with substantial costs to society due to its morbidities, with costs of untreated OSA potentially doubling medical expenses, mainly because of cardiovascular diseases.5 OSA-related motor vehicle collisions in 2000 were estimated at US$15.9 billion in damages and health-related costs.2\nTreatment of OSA includes a wide range of options, such as changes in diet and lifestyle to reduce risk factors for OSA, pharmacotherapy, the use of continuous airway pressure (CPAP) and various oral devices to splint the airway open to facilitate airflow, to upper airway surgical treatment.6,7 In Ontario, patients waited a mean 11.6 months from the time being referred to a sleep clinic to the time of medical therapy initiation, and 16.2 months to surgical therapy initiation.8\nThis Rapid Response report aims to review the clinical and cost-effectiveness of CPAP as compared to oral devices and lifestyle changes in the treatment of OSA.", "pairs": [], "interleaved": []}
+{"file": "rc0619_NBK349742/APP1.nxml", "text": "\n\n", "pairs": [], "interleaved": []}