Characteristics of the 56 excluded studies

Linda Sharples; Matthew Glover; Abigail Clutterbuck-James; Maxine Bennett; Jake Jordan; Rebecca Chadwick; Marcus Pittman; Clare East; Malcolm Cameron; Mike Davies; Nick Oscroft; Ian Smith; Mary Morrell; Julia Fox-Rushby; Timothy Quinnell

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Sharples L, Glover M, Clutterbuck-James A, et al. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure. Southampton (UK): NIHR Journals Library; 2014 Oct. (Health Technology Assessment, No. 18.67.)

Cover of Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure

Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

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Appendix 16Characteristics of the 56 excluded studies

Author	Appropriate intervention^a	Relevant comparator^b	Appropriate study design^c	Appropriate patient group^d	Appropriate outcome measures^e	List applicable outcome measures^f	Duplicate data/study^g	Data extraction possible^h	Specific reason(s) for exclusion
Aarab (2011)³⁵⁰	Yes	Yes	Yes	Yes	Yes	AHI, EDS	Yes	Yes	Follow-up study data to Aarab (2011)⁶⁸ (respiration, included)
Almeida (2013)³⁵¹	Yes	Yes	No	No	Yes	AHI, ESS score, SAQLI	No	Yes	Non-RCT, recruited patients on CPAP
Ayers (2013)³⁵²	Yes	Yes	Yes	No	Yes	AHI, ESS	No	Yes	Recruited patients on CPAP withdrawal vs. continuation study
Barbé (2010)³³¹	Yes	Yes	Yes	Yes	Yes	ESS score, BP	Yes	Yes	Partial results from Barbé (2012)⁸⁹ (included)
Berlowitz (2013)³⁵³	No	No	No	No	No	None	Yes	No	Non-RCT – commentary on Kushida (2012)²⁵ (included)
Bishop (2010)³⁵⁴	Yes	No	Yes	Yes	Yes	RDI, ESS score, SAQLI	No	No	MAD vs. MAD
Blau (2012)³⁵⁵	Yes	No	Yes	Yes	Yes	AHI, ESS score	No	Yes	CPAP vs. auto bilevel pressure relief-positive airway pressure study
Buchner (2007)³⁵⁶	Yes	Yes	No	Yes	Yes	AHI	No	Yes	Non-RCT
Craig (2010)³⁵⁷	Yes	Yes	Yes	Yes	Yes	ESS score	Yes	Yes	Preliminary results from Craig (2012)⁹⁵ (included)
Cross (2008)³⁵⁸	Yes	Yes	Yes	Yes	No	BP	No	Yes	AHI and ESS score not measured after treatment
Dal-Fabbro (2009)³⁵⁹	Yes	Yes	Yes	Yes	Yes	Respiratory sleep parameters; ESS score, SF-36	No	No	AHI and ESS score values not reported after treatment
Deane (2009)³³⁵	Yes	No	Yes	Yes	Yes	AHI, ESS score	No	Yes	MAD vs. TSD. Treatment period 1 week only
Deleanu (2012)³⁶⁰	Yes	No	No	No	Yes	ESS score	No	Yes	Non-RCT, studied CPAP pressures in hypertension vs. resistant hypertension patients
Doff (2010)³⁶¹	Yes	Yes	Yes	Yes	No	None	Yes	No	Long-term follow-up of Hoekema (2008)⁸¹ (included) but no ESS score/AHI reported
Doff (2012)³⁶²	Yes	Yes	Yes	Yes	No	None	Yes	No	Long-term follow-up of Hoekema (2008)⁸¹ (included) but no ESS score/AHI reported
Doff (2013)³⁶³	Yes	Yes	Yes	Yes	No	None	Yes	No	Long-term follow-up of Hoekema (2008)⁸¹ (included) but no ESS score/AHI reported
Drager (2010)	Yes	?	?	?	?	?	Yes?	No	Suspected duplicate study of Drager (2011)³⁶⁴ (excluded). Unable to find
Drager (2011)³⁶⁴	Yes	Yes	Yes	Yes	Yes	AHI, ESS score, BP	No	No	AHI and ESS score values not reported after control treatment
Fleury (2010)³⁶⁵	No	No	No	No	No	None	No	No	Non-RCT
Garbuio (2009)³⁶⁶	Yes	Yes	Yes	Yes	Yes	PSG parameters, EDS	No	No	Abstract only with no information to extract
Gauthier (2009)³⁶⁷	Yes	No	Yes	Yes	Yes	RDI, ESS score, FOSQ	No	Yes	MAD vs. MAD
Gauthier (2010)³⁶⁸	Yes	No	Yes	Yes	Yes	RDI, ESS score, FOSQ	Yes	No	MAD vs. MAD. Abstract of Gauthier (2011)³⁷⁰ (excluded)
Gauthier (2010)³⁶⁹	Yes	No	Yes	Yes	Yes	RDI, ESS score, FOSQ	Yes	No	MAD vs. MAD. Abstract of Gauthier (2011)³⁷⁰ (excluded)
Gauthier (2011)³⁷⁰	Yes	No	Yes	Yes	Yes	RDI, ESS score, FOSQ, BP	Yes	Yes	MAD vs. MAD. Long-term follow-up of Gauthier (2009)³⁶⁷ (excluded)
Ghazal (2009)¹⁹⁴	Yes	No	Yes	Yes	Yes	AHI, ESS score, SF-36	No	Yes	MAD vs. MAD
Hall (2012)³⁷¹	Yes	Yes	Yes	No	No	BP	No	No	BP only reported in patients with OSA and heart failure – abstract only
Heeley (2012)³⁷²	Yes	Yes	Yes	No	Yes	ESS score	No	No	Preliminary trial report. Patients with OSA and prior stroke/CVD – abstract only
Hoekema (2008)³⁷³	Yes	Yes	Yes	Yes	Yes	AHI, ESS score	Yes	Yes	Patient subset of Hoekema (2008)⁸¹ (included)
Hoyos (2011)³⁷⁴	Yes	Yes	Yes	Yes	Yes	AHI, ESS score	Yes	No	Abstract of Hoyos (2012)¹⁰⁷ (included)
Hoyos (2012)³⁷⁵	Yes	Yes	Yes	Yes	Yes	AHI	Yes	No	Abstract of Hoyos (2012)¹⁰⁷ (included)
Kohler (2009)³⁷⁶	Yes	Yes	Yes	Yes	Yes	ESS score	Yes	No	Duplicate data from Siccoli (2008)¹⁸ (included)
Kohler (2011)³⁷⁷	Yes	Yes	Yes	No	Yes	AHI, ESS score, BP	Yes	Yes	Recruited patients on CPAP – withdrawal vs. continuation study. Link with Rossi (2012)³⁸⁹ (excluded)
McEwen (2012)³⁷⁸	Yes	Yes	Yes	Yes	Yes	AHI, ESS score	Yes	Yes	Patient subset of Philips (2011)¹¹⁸ (included) and repeat of Phillips (2012)³⁸² (excluded) AHI data
Mello-Fujita (2012)³⁷⁹	Yes	Yes	Yes	Yes	Yes	ESS score, BP	Unclear	No	Abstract only – insufficient data to extract. Possible link with Rizzi (2010)³⁸⁸ (excluded)
Oliveira (2012)³⁸⁰	Yes	Yes	Yes	Yes	No	BP	No	No	AHI only measured at baseline and on CPAP titration night, not following a treatment period
Permut (2010)³⁸¹	Yes	No	Yes	Yes	Yes	AHI	No	Yes	Positional device vs. CPAP for one night only
Phillips (2012)³⁸²	Yes	Yes	Yes	Yes	Yes	AHI, ESS score	Yes	Yes	Patient subset of Philips (2011)¹¹⁸ (AJRRCM, included)
Phillips (2011)³⁸³	Yes	Yes	Yes	Yes	Yes	AHI, ESS score, FOSQ, SF-36; BP	Yes	Yes	Abstract of Phillips (2013)⁵² (included)
Phillips (2011)³⁸⁴	Yes	Yes	Yes	Yes	Yes	AHI, ESS score, FOSQ, SF-36, BP	Yes	Yes	Abstract of Phillips (2013)⁵² (included)
Portier (2010)³⁸⁵	Yes	Yes	Yes	Yes	Yes	AHI, ESS score, quality of sleep	No	No	Abstract only – insufficient data to extract
Prilipko (2012)³⁸⁶	Yes	Yes	Yes	Yes	No	None	No	No	AHI and ESS score measured at baseline only
Prudon (2012)³⁸⁷	Yes	Yes	Yes	Yes	No	None	Yes	No	Abstract only. Used samples from West (2007)¹³⁰ (included)
Rizzi (2010)³⁸⁸	Yes	Yes	Yes	Yes	No	BP	Unclear	Yes	Abstract only – no ESS score/AHI outcomes. Possible link with Mello-Fujita (2012)³⁷⁹ (excluded)
Rossi (2012)³⁸⁹	Yes	Yes	Yes	No	Yes	AHI, ESS score	Yes	Yes	Recruited patients on CPAP – withdrawal vs. continuation study. Sleep data from Kohler (2011)³⁷⁷ (excluded)
Sari (2011)³⁹⁰	Yes	No	Unclear	Yes	Yes	AHI, ESS score	No	Yes	MAD vs. MAD
Seehra (2013)³⁹¹	Yes	No	No	No	No	None	No	No	Non-RCT – technical note
Sivam (2012)³⁹²	Yes	Yes	Yes	Yes	Yes	AHI, ESS score	Yes	Yes	Patient subset from Philips (2011)¹¹⁸ (included)
Sutherland (2011)³⁹³	Yes	No	Yes	No	No	None	No	No	Compared optimal CPAP pressures in MAD responders vs. MAD non-responders
Sutherland (2012)³⁹⁴	Yes	Yes	Yes	Yes	No	None	No	No	Abstract only – no ESS score/AHI outcomes
Takaesu (2012)³⁹⁵	Yes	Yes	Yes	No	Yes	AHI, BP	No	Yes	Patients with panic disorder and OSA
Toukh (2012)³⁹⁶	Yes	Yes	Yes	No	Yes	AHI	No	Yes	Patients had used CPAP prior to study
Trzepizur (2009)³⁹⁷	Yes	Yes	Yes	Yes	Yes	AHI, ESS score, BP	Yes	Yes	Substudy of Gagnadoux (2009)²⁴ (included)
Turnbull (2012)³⁹⁸	Yes	Yes	Yes	Yes	No	None	Yes	No	Follow-up on vascular events and accidents from Craig (2012)⁹⁵ (included)
Vicini (2010)³⁹⁹	Yes	No	Yes	Yes	Yes	AHI, ESS score	No	Yes	APAP vs. surgery
von Känel (2013)⁴⁰⁰	Yes	Yes	Yes	Yes	Yes	AHI	No	No	Insufficient data to extract
West (2009)⁴⁰¹	Yes	Yes	Yes	Yes	Yes	ESS score	Yes	Yes	Duplicate data from West (2007)¹³⁰ (included)

: TSD, tongue stabilising device.
a: Does the study look at CPAP/APAP and/or MAD?
b: Does the study have relevant comparators, i.e. placebo/sham treatment/no treatment/MAD (if CPAP intervention)/CPAP (if MAD intervention) and does the intervention and the comparator last ≥ 2 weeks?
c: Is the study a RCT?
d: Does the study include participants with OSAH, 16 years old, who do not specifically relate to a population with brain disease, heart failure, chronic airways disease or psychological disorders, who are not already on treatment with CPAP or MAD?
e: Does the study look at subjective daytime sleepiness (ESS score, AHI or RDI)?
f: Applicable outcome measures include: subjective daytime sleepiness (ESS score), excessive daytime somnolence (EDS), AHI or RDI, SF-36, (EQ-5D-3L), sleep-related QoL (FOSQ, SAQLI, BP)?
g: Have the data been published elsewhere, i.e. duplicated from the same study in another paper or are they from a subgroup of patients in another paper?
h: Are the outcome data suitable for extraction?

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Sharples et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Sharples L, Glover M, Clutterbuck-James A, et al. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure. Southampton (UK): NIHR Journals Library; 2014 Oct. (Health Technology Assessment, No. 18.67.) Appendix 16, Characteristics of the 56 excluded studies.
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Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

Appendix 16Characteristics of the 56 excluded studies

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