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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The indication of chronic non-invasive mechanical ventilation &#40;NIV&#41; in patients with chronic obstructive pulmonary disease &#40;COPD&#41; has been controversial for the past 30 years&#46; Despite the lack of support from high quality controlled studies&#44; the number of prescriptions for NIV in patients with COPD was growing progressively&#46; A consensus based on experts criteria appeared in 1999<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">1</span></a> with an essentially regulatory purpose of the prescriptions&#46; Few years later&#44; the Eurovent study demonstrated how heterogeneous the prescription of NIV in COPD in different European countries was&#46; While in Italy or Austria&#44; the prescription percentage of chronic NIV in COPD reached 50&#37;&#44; in others remained around 10&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Twenty years after the publication of the regulatory consensus&#44; the number of prescriptions in COPD has continued to grow exponentially&#46; The main reasons given by the clinicians for its use have been recurrent exacerbations or the impossibility of NIV withdrawal after a severe exacerbation&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> On the other hand&#44; the evidence&#44; although still far from solid&#44; has increased considerably after the publication of some &#40;few&#41; high quality &#40;but complex&#41;&#44; controlled studies&#46; The complexity of such studies to be performed can be summarized as follows&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0015" class="elsevierStylePara elsevierViewall">The primary main of the studies&#44; that not always had been focussed to either exacerbation or hospitalizations</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0020" class="elsevierStylePara elsevierViewall">The duration of follow-up&#58; it is not uncommon to find studies with a duration greater than five years&#44; including recruitment and follow-up period&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5</span></a> Otherwise&#44; a long duration is completely necessary if you look at mortality&#46; Under these conditions&#44; the economic burden can be really high&#46; Some recent studies&#44; however&#44; used composite endpoints &#40;mortality or time until the next exacerbation&#41; that have significantly shortened the follow-up period&#46;<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">6&#44;7</span></a></p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Inclusion criteria&#58; traditionally&#44; hypercapnia in the stability phase was the main inclusion criterion&#44; since it was considered a marker of severity and short or medium-term mortality after the hypoxemia has been corrected&#46; But the PaCO<span class="elsevierStyleInf">2</span> threshold for initiating NIV has also been a matter of controversy&#46; Studies including patients with PaCO<span class="elsevierStyleInf">2</span> values farther from normal have shown greater differences between the arms of the study &#40;NIV vs conventional therapy&#41;&#46; Thus&#44; in a situation of stability&#44; it seems reasonable to recommend a threshold value around 50<span class="elsevierStyleHsp" style=""></span>mm Hg to consider NIV therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a> It is also especially important to rule out other factors that may contribute to the development of hypercapnia&#44; such as the coexistence of apnea&#8211;hypopnea syndrome &#40;overlap syndrome&#41;&#46; More recent controlled studies used a different approach&#44; including patients with persisting hypercapnia after an exacerbation that needed NIV in the acute phase&#46; Similarly to severe hypercapnia in the stable phase&#44; this phenotype identifies a particularly fragile population with a reduced ventilatory reserve&#46; The fact of having received and tolerated NIV in the acute phase can even reduce the difficulties in the shift to the chronic use&#46; However&#44; a key point of this design is the appropriateness of the time frame to define the persistence of post-exacerbation hypercapnia&#46; The experience of the Rescue study<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">6</span></a> showed that if too short periods of time are used &#40;around 48<span class="elsevierStyleHsp" style=""></span>h of NIV withdrawal in the acute phase&#41;&#44; many patients tend to normalize their PaCO<span class="elsevierStyleInf">2</span> spontaneously&#46; For this reason&#44; the use of a time frame between 2 and 4 weeks<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">5&#44;7</span></a> seems more appropriate to exclude patients with spontaneous normalization of PaCO<span class="elsevierStyleInf">2</span>&#44; thus avoiding an over-prescription of NIV after an exacerbation&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0030" class="elsevierStylePara elsevierViewall">The experience of recruiting centers and the procedure of the therapy&#58; Whether stable or post exacerbated patients are included&#44; the required sample needs clearly a multicenter approach&#46; The heterogeneity in the experience of recruiting centers requires a strict protocol on how to carry out and control the therapy&#46; In this regard&#44; monitoring of PaCO<span class="elsevierStyleInf">2</span> during adaptation and follow up and adjustment of parameters based on these results should be mandatory&#46; A recent meta-analysis has already suggested that the use of high pressure support values &#40;high intensity ventilation&#41;&#44; with the aim to decrease PaCO<span class="elsevierStyleInf">2</span> significantly &#40;at least 20&#37;&#41; was associated with better outcomes&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">9</span></a> As a consequence&#44; more recent studies used pressure support values much higher than their predecessors&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5&#44;7&#44;10</span></a> Finally&#44; it is also necessary to take into account the growing interest in automatic modes &#40;volume assured pressure support or automatic expiratory pressure modes&#41;&#46; Theoretically these modes are able to adapt to changes in ventilatory pattern or coexistence of upper airway obstructions during the use of therapy&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Assessment of patient centered outcomes&#58; Patient centered outcomes such as dyspnea&#44; health-related quality of life and sleep quality are critically important for the effectiveness of NIV&#46; However&#44; the assessment methods varied widely across studies ending up with heterogenous results&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5&#44;10</span></a> The impact of NIV on sleep is still uncertain as sleep quality has been studied to a lesser extent with different methods which were mostly subjective&#46; Ideally&#44; we need to use validated and specific tools to measure the effect of NIV in these critically important outcomes in COPD patients with chronic respiratory failure&#46;</p></li></ul></p><p id="par0040" class="elsevierStylePara elsevierViewall">The recently published guidelines on Long term Home Non-Invasive Ventilation for Management of COPD by the European Respiratory Society<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a> have tried to cover all these aspects&#46; The content is structured around 4 main PICO questions&#44; suggesting the use of NIV in chronic stable hypercapnic COPD patients and in patients with COPD following a life-threatening episode of acute hypercapnic respiratory failure requiring acute NIV&#44; if hypercapnia persists following the episode&#46; At same time&#44; the target of the procedure should be directed to the normalization or reduction of PaCO<span class="elsevierStyleInf">2</span> values using fixed pressure support mode as a first choice instead of more complex volume-assured modes&#46; Attention has also been given to some questions &#40;narrative&#41; with less evidence in the literature&#46; These questions provide an additional insight into the complexity of the procedure &#40;phenotypic differences such as the presence of comorbidities&#44; heterogeneity in the use of interfaces or even in ventilator models&#41; and&#44; at same time&#44; are focused on important issues for the research in the immediate future&#44; such as the appropriate way of monitoring these patients&#46; Although PaCO<span class="elsevierStyleInf">2</span> monitoring &#40;daytime and overnight continuous by transcutaneous CO<span class="elsevierStyleInf">2</span> sensors&#41; is the recommended way to follow-up patients under NIV&#44; it may lack specificity to determine the ultimate cause of suboptimal ventilation&#46; Therefore&#44; centers with more experience use routinely some advanced monitoring tools&#44; such as polygraphy under NIV or information transfer from the built in software of the ventilators&#46; The influence on outcome of persisting events or asynchronies during ventilation in COPD&#44; classified based on the consensus of experts<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">11&#44;12</span></a> remains to date unclear&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Finally&#44; although the clinicians using the above guidelines may feel uncomfortable about the low level of evidence of the recommendations&#44; we believe that this only emphasizes on the complexity of their implementation in the daily clinical practice&#46; It should be compulsory that their clinical application is accompanied by high levels of technical and clinical skills and continuous medical education&#46; Ultimately&#44; and as experience was the forerunner of the evidence&#44; the clinical application of evidence requires high levels of experience and expertise&#46;</p></span>"
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Editorial
Guidelines for Chronic Non-invasive Ventilation in COPD: From Experience to Evidence
Guías para la ventilación crónica no invasiva en la EPOC: de la experiencia a la evidencia
Manel Lujána,b,
Corresponding author
mlujan@tauli.cat

Corresponding author.
, Begum Erganc
a Service of Pneumology, Hospital de Sabadell Corporació Parc Taulí, Universitat Autònoma de Barcelona, Sabadell, Spain
b Centro de Investigación Biomédica en Red (CIBERES), Spain
c Department of Pulmonary and Critical Care, Dokuz Eylul University, School of Medicine, Izmir, Turkey
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The indication of chronic non-invasive mechanical ventilation &#40;NIV&#41; in patients with chronic obstructive pulmonary disease &#40;COPD&#41; has been controversial for the past 30 years&#46; Despite the lack of support from high quality controlled studies&#44; the number of prescriptions for NIV in patients with COPD was growing progressively&#46; A consensus based on experts criteria appeared in 1999<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">1</span></a> with an essentially regulatory purpose of the prescriptions&#46; Few years later&#44; the Eurovent study demonstrated how heterogeneous the prescription of NIV in COPD in different European countries was&#46; While in Italy or Austria&#44; the prescription percentage of chronic NIV in COPD reached 50&#37;&#44; in others remained around 10&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Twenty years after the publication of the regulatory consensus&#44; the number of prescriptions in COPD has continued to grow exponentially&#46; The main reasons given by the clinicians for its use have been recurrent exacerbations or the impossibility of NIV withdrawal after a severe exacerbation&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> On the other hand&#44; the evidence&#44; although still far from solid&#44; has increased considerably after the publication of some &#40;few&#41; high quality &#40;but complex&#41;&#44; controlled studies&#46; The complexity of such studies to be performed can be summarized as follows&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0015" class="elsevierStylePara elsevierViewall">The primary main of the studies&#44; that not always had been focussed to either exacerbation or hospitalizations</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0020" class="elsevierStylePara elsevierViewall">The duration of follow-up&#58; it is not uncommon to find studies with a duration greater than five years&#44; including recruitment and follow-up period&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5</span></a> Otherwise&#44; a long duration is completely necessary if you look at mortality&#46; Under these conditions&#44; the economic burden can be really high&#46; Some recent studies&#44; however&#44; used composite endpoints &#40;mortality or time until the next exacerbation&#41; that have significantly shortened the follow-up period&#46;<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">6&#44;7</span></a></p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Inclusion criteria&#58; traditionally&#44; hypercapnia in the stability phase was the main inclusion criterion&#44; since it was considered a marker of severity and short or medium-term mortality after the hypoxemia has been corrected&#46; But the PaCO<span class="elsevierStyleInf">2</span> threshold for initiating NIV has also been a matter of controversy&#46; Studies including patients with PaCO<span class="elsevierStyleInf">2</span> values farther from normal have shown greater differences between the arms of the study &#40;NIV vs conventional therapy&#41;&#46; Thus&#44; in a situation of stability&#44; it seems reasonable to recommend a threshold value around 50<span class="elsevierStyleHsp" style=""></span>mm Hg to consider NIV therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a> It is also especially important to rule out other factors that may contribute to the development of hypercapnia&#44; such as the coexistence of apnea&#8211;hypopnea syndrome &#40;overlap syndrome&#41;&#46; More recent controlled studies used a different approach&#44; including patients with persisting hypercapnia after an exacerbation that needed NIV in the acute phase&#46; Similarly to severe hypercapnia in the stable phase&#44; this phenotype identifies a particularly fragile population with a reduced ventilatory reserve&#46; The fact of having received and tolerated NIV in the acute phase can even reduce the difficulties in the shift to the chronic use&#46; However&#44; a key point of this design is the appropriateness of the time frame to define the persistence of post-exacerbation hypercapnia&#46; The experience of the Rescue study<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">6</span></a> showed that if too short periods of time are used &#40;around 48<span class="elsevierStyleHsp" style=""></span>h of NIV withdrawal in the acute phase&#41;&#44; many patients tend to normalize their PaCO<span class="elsevierStyleInf">2</span> spontaneously&#46; For this reason&#44; the use of a time frame between 2 and 4 weeks<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">5&#44;7</span></a> seems more appropriate to exclude patients with spontaneous normalization of PaCO<span class="elsevierStyleInf">2</span>&#44; thus avoiding an over-prescription of NIV after an exacerbation&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0030" class="elsevierStylePara elsevierViewall">The experience of recruiting centers and the procedure of the therapy&#58; Whether stable or post exacerbated patients are included&#44; the required sample needs clearly a multicenter approach&#46; The heterogeneity in the experience of recruiting centers requires a strict protocol on how to carry out and control the therapy&#46; In this regard&#44; monitoring of PaCO<span class="elsevierStyleInf">2</span> during adaptation and follow up and adjustment of parameters based on these results should be mandatory&#46; A recent meta-analysis has already suggested that the use of high pressure support values &#40;high intensity ventilation&#41;&#44; with the aim to decrease PaCO<span class="elsevierStyleInf">2</span> significantly &#40;at least 20&#37;&#41; was associated with better outcomes&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">9</span></a> As a consequence&#44; more recent studies used pressure support values much higher than their predecessors&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5&#44;7&#44;10</span></a> Finally&#44; it is also necessary to take into account the growing interest in automatic modes &#40;volume assured pressure support or automatic expiratory pressure modes&#41;&#46; Theoretically these modes are able to adapt to changes in ventilatory pattern or coexistence of upper airway obstructions during the use of therapy&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Assessment of patient centered outcomes&#58; Patient centered outcomes such as dyspnea&#44; health-related quality of life and sleep quality are critically important for the effectiveness of NIV&#46; However&#44; the assessment methods varied widely across studies ending up with heterogenous results&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#44;5&#44;10</span></a> The impact of NIV on sleep is still uncertain as sleep quality has been studied to a lesser extent with different methods which were mostly subjective&#46; Ideally&#44; we need to use validated and specific tools to measure the effect of NIV in these critically important outcomes in COPD patients with chronic respiratory failure&#46;</p></li></ul></p><p id="par0040" class="elsevierStylePara elsevierViewall">The recently published guidelines on Long term Home Non-Invasive Ventilation for Management of COPD by the European Respiratory Society<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a> have tried to cover all these aspects&#46; The content is structured around 4 main PICO questions&#44; suggesting the use of NIV in chronic stable hypercapnic COPD patients and in patients with COPD following a life-threatening episode of acute hypercapnic respiratory failure requiring acute NIV&#44; if hypercapnia persists following the episode&#46; At same time&#44; the target of the procedure should be directed to the normalization or reduction of PaCO<span class="elsevierStyleInf">2</span> values using fixed pressure support mode as a first choice instead of more complex volume-assured modes&#46; Attention has also been given to some questions &#40;narrative&#41; with less evidence in the literature&#46; These questions provide an additional insight into the complexity of the procedure &#40;phenotypic differences such as the presence of comorbidities&#44; heterogeneity in the use of interfaces or even in ventilator models&#41; and&#44; at same time&#44; are focused on important issues for the research in the immediate future&#44; such as the appropriate way of monitoring these patients&#46; Although PaCO<span class="elsevierStyleInf">2</span> monitoring &#40;daytime and overnight continuous by transcutaneous CO<span class="elsevierStyleInf">2</span> sensors&#41; is the recommended way to follow-up patients under NIV&#44; it may lack specificity to determine the ultimate cause of suboptimal ventilation&#46; Therefore&#44; centers with more experience use routinely some advanced monitoring tools&#44; such as polygraphy under NIV or information transfer from the built in software of the ventilators&#46; The influence on outcome of persisting events or asynchronies during ventilation in COPD&#44; classified based on the consensus of experts<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">11&#44;12</span></a> remains to date unclear&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Finally&#44; although the clinicians using the above guidelines may feel uncomfortable about the low level of evidence of the recommendations&#44; we believe that this only emphasizes on the complexity of their implementation in the daily clinical practice&#46; It should be compulsory that their clinical application is accompanied by high levels of technical and clinical skills and continuous medical education&#46; Ultimately&#44; and as experience was the forerunner of the evidence&#44; the clinical application of evidence requires high levels of experience and expertise&#46;</p></span>"
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Article information
ISSN: 15792129
Original language: English
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