August 2014 Phoenix Pulmonary Journal Club: The Use of Macrolide Antibiotics in Chronic Respiratory Disease

This month's journal club reviewed  the role of macrolide antibiotics in chronic respiratory disease. Macrolide usage was suggested from observational studies in Japan in diffuse panbroncholitis, a disorder associated with chronic respiratory infection, usually Pseudomonas aeruginosa (1). Clinical improvement was noted despite doses of antibiotics well below the minimal inhibitory concentration (MIC) of the antibiotic. This  suggested the antibiotic was likely working by an anti-inflammatory effect. These observations were extended to cystic fibrosis (CF) where prophylactic macrolide therapy in CF patients infected with Pseudomonas has become standard therapy (2). More recently, low dose macrolide therapy has been applied to non-CF lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis and asthma.

Time did not permit a review of all studies so a representative sample was discussed. In patients with COPD, the four randomized, placebo-controlled trials reviewed all suggested that chronic therapy with macrolide antibiotics reduced COPD exacerbations (3-5). This beneficial effect was confirmed by 2 recent meta-analysis (6,7). Similarly,  three recent randomized trials in bronchiectasis demonstrated a reduction in exacerbations (8-10). In asthma the data is not as clear. A recent trial did not demonstrate an overall reduction in asthma exacerbations or lower respiratory tract infections (11). However, in the patients with non-eosinophilic, predominantly neutrophilic, asthma there was a reduction.  An excellent review of the use of macrolides in acute and chronic asthma was recently published. (12). The article includes a review of the anti-inflammatory and immunomodulatory properties of the macrolides.

The respiratory disorders where macrolides have been shown to have clinic benefit such as diffuse panbroncholitis, cystic fibrosis, COPD, bronchiectasis and non-eosinophilic asthma are all diseases associated an influx of neutrophils into the airways. The beneficial clinic effects of macrolides are consistent with their effect in reducing neutrophil chemotactic factors such as interleukin (IL)-8 (13). However, macrolides have also been reported to have adverse clinical effects such as QT prolongation in patients with heart disease, impaired hearing and development of bacterial resistance (4,6,14). Whether all COPD patients should be treated with macrolides is controversial but most in the audience used these in patients with frequent exacerbations. It was also pointed out that other antibiotics such as the tetracyclines also have anti-inflammatory effects and have been shown to be efficacious in some respiratory diseases (15). Whether the tetracyclines are equally or more effective than the macrolides with fewer serious side effects is unknown.

Richard A. Robbins, MD¹

Allen R. Thomas, MD²

Manoj Mathew, MD³

¹Phoenix Pulmonary and Critical Care Research Foundation, ²Phoenix VA Medical Center, ³Banner Good Samaritan Medical Center.

References

1. Nagai H, Shishido H, Yoneda R, Yamaguchi E, Tamura A, Kurashima A. Long-term low-dose administration of erythromycin to patients with diffuse panbronchiolitis. Respiration. 1991;58(3-4):145-9. [CrossRef] [PubMed] 
2. Saiman L, Marshall BC, Mayer-Hamblett N, Burns JL, Quittner AL, Cibene DA, Coquillette S, Fieberg AY, Accurso FJ, Campbell PW 3rd; Macrolide Study Group. Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial. JAMA. 2003;290(13):1749-56. [CrossRef] [PubMed]
3. Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008;178(11):1139-47. [CrossRef] [PubMed]
4. Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, Anthonisen NR; COPD Clinical Research Network. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011;365(8):689-98. [CrossRef] [PubMed]
5. Uzun S, Djamin RS, Kluytmans JA, Mulder PG, van't Veer NE, Ermens AA, Pelle AJ, Hoogsteden HC, Aerts JG, van der Eerden MM. Azithromycin maintenance treatment in patients with frequent exacerbations of chronic obstructive pulmonary disease (COLUMBUS): a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2014;2(5):361-8. [CrossRef] [PubMed]
6. Li H, Liu DH, Chen LL, Zhao Q, Yu YZ, Ding JJ, Miao LY, Xiao YL, Cai HR, Zhang DP, Guo YB, Xie CM. Meta-analysis of the adverse effects of long-term azithromycin use in patients with chronic lung diseases. Antimicrob Agents Chemother. 2014;58(1):511-7. [CrossRef] [PubMed]
7. Herath SC, Poole P. Prophylactic antibiotic therapy in chronic obstructive pulmonary disease. JAMA. 2014;311(21):2225-6. [CrossRef] [PubMed]
8. Wong C, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, Milne D, Fergusson W, Tuffery C, Sexton P, Storey L, Ashton T. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):660-7. [CrossRef]  [PubMed]
9. Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013;309(12):1251-9. [CrossRef] [PubMed] 
10. Serisier DJ, Martin ML, McGuckin MA, Lourie R, Chen AC, Brain B, Biga S, Schlebusch S, Dash P, Bowler SD. Effect of long-term, low-dose erythromycin on pulmonary exacerbations among patients with non-cystic fibrosis bronchiectasis: the BLESS randomized controlled trial. JAMA. 2013;309(12):1260-7. [CrossRef] [PubMed]
11. Brusselle GG, Vanderstichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, Verleden G, Demedts IK, Verhamme K, Delporte A, Demeyere B, Claeys G, Boelens J, Padalko E, Verschakelen J, Van Maele G, Deschepper E, Joos GF. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013 Apr;68(4):322-9. [CrossRef] [PubMed] 
12. Wong EH, Porter JD, Edwards MR, Johnston SL. The role of macrolides in asthma: current evidence and future directions.  Lancet Respir Med. 2014 2:657-70. [CrossRef] [PubMed]
13. Abe S, Nakamura H, Inoue S, Takeda H, Saito H, Kato S, Mukaida N, Matsushima K, Tomoike H. Interleukin-8 gene repression by clarithromycin is mediated by the activator protein-1 binding site in human bronchial epithelial cells. Am J Respir Cell Mol Biol. 2000;22(1):51-60. [CrossRef] [PubMed] 
14. Albert RK, Schuller JL; COPD Clinical Research Network. Macrolide antibiotics and the risk of cardiac arrhythmias. Am J Respir Crit Care Med. 2014;189(10):1173-80. [CrossRef] [PubMed] 
15. Rempe S, Hayden JM, Robbins RA, Hoyt JC. Tetracyclines and pulmonary inflammation. Endocr Metab Immune Disord Drug Targets. 2007;7(4):232-6. [CrossRef] [PubMed] 

Reference as: Robbins RA, Thomas AR, Mathew M. August 2014 Phoenix pulmonary journal club: the use of macrolide antibiotics in chronic respiratory disease. Southwest J Pulm Crit Care. 2014;9(2):130-2. doi: http://dx.doi.org/10.13175/swjpcc109-14 PDF

June 2014 Phoenix Pulmonary Journal Club: New Therapies for IPF and EBUS in Sarcoidosis

Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071-82. [CrossRef] [PubMed]

Nintedanib is a tyrosine kinase inhibitor that has been shown to decrease the decline of FVC in phase 2 trials of idiopathic pulmonary fibrosis (IPF). This study was a phase 3 trial in which 2 replicate trials comparing nintedanib 150 mg twice daily to placebo. The trials were randomized double blind placebo controlled performed over 205 sites in 24 countries. Inclusion criteria were an age > 40, FVC > 50% and DLCO 30-79%. Patients were excluded if on prednisone > 15 mg/day or any other treatment for IPF. Patients were followed for 52 weeks and underwent spirometry at weeks 2, 4, 6, 12, 36 and 52. The primary endpoint was decline in FVC and the secondary endpoint was exacerbations of IPF. The results of the 2 trials showed the treatment groups had a 1 year decline in FVC of 114.7 and 113.6 verses 239ml and 207ml in the placebo groups. There was a decrease in acute exacerbations in the Inpulsis 2 group while there was an increase in the time to 1^st exacerbation in the Inpulsis 1 group. The most common side effect was diarrhea, which resulted in treatment cessation in 25 patients. The trial was well done and hit its primary endpoint. A near 50% preservation of FVC at 1 year is impressive and additional longitudinal studies are needed to see if the effects are sustained. A dose adjustment may be needed to help correct the effect of diarrhea and further studies looking at the effect of dose on FVC decline will also be needed.

King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2083-92. [CrossRef] [PubMed]

Pirfenidone has been a promising agent in the fight against IPF. Prior studies showed conflicting results on the medications efficacy in preserving lung function, specifically forced vital capacity (FVC). This phase 3 clinical trial was performed over 127 sites within 9 countries. 555 patients with either biopsy proven or radiographically proven IPF were randomized to receive placebo (277 pts) or 2403 mg of pirfenidone (278 pts) daily for 52 weeks. Inclusion criteria were a diagnosis of IPF, FVC > 50%, DLCO > 30%, FEV1 > 80% and a 6 minute walk > 150 meters. The primary outcome was the change in FVC at week 52. Secondary outcomes were 6 minute walk distance, dyspnea, progression free survival and death. The results showed that patients taking pirfenidone had 50% less decline in an FVC of > 10% and > 50% of patients had no loss of lung function. The pirfenidone group also had fewer patients with a loss of 50m or more in their 6 minute walk test. The medication was well tolerated with the main side effects being cough, nausea, headache and diarrhea.

It appears that pirfenidone will be the first drug approved specifically for the treatment of IPF. It has already been approved in Europe and it remains to be seen if the results seen in this trial are sustainable in more long term studies.

von Bartheld MB, Dekkers OM, Szlubowski A, Eberhardt R, Herth FJ, in 't Veen JC, de Jong YP, van der Heijden EH, Tournoy KG, Claussen M, van den Blink B, Shah PL, Zoumot Z, Clementsen P, Porsbjerg C, Mauad T, Bernardi FD, van Zwet EW, Rabe KF, Annema JT. Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial. JAMA. 2013;309(23):2457-64. [CrossRef] [PubMed]

Sarcoidosis is a granulomatous inflammatory condition with multisystem involvement. In 90% of cases the disease involves the lungs, mediastinal and hilar lymph nodes. Definitive diagnosis is obtained by histology obtained through either transbronchial needle aspiration of hilar or mediastinal lymph nodes, transbronchial parenchymal lung biopsy or cervical mediastinoscopy. Transbronchial lung biopsies have shown a sensitivity of 60% with risk of hemorrhage and pneumothorax in up to 6%. Endobronchial (EBUS) or endoscopic esophageal ultrasound (EUS) guided lymph node biopsy have been shown to increase sensitivity to 80% with less than a 1% risk of pneumothorax and hemorrhage. This study compared transbronchial lung biopsy and EUS/BUS in diagnosing sarcoidosis. The study was a randomized control trial done in 14 centers within 6 countries and included 304 patients. 149 patients underwent conventional bronchoscopic evaluation while 155 patients underwent EBUS/EUS evaluation. Bronchoscopic evaluation included bronchoalveolar lavage (BAL) CD4/CD8 ratios, at least 4 transbronchial lung biopsies and 4 endobronchial mucosal biopsy samples. Of note, fluoroscopy was only used in 39% of cases. In the endosonography group, EUS or EBUS was performed . The decision to perform an esophageal or endobronchial procedure was left to investigator. The results showed that EUS or EBUS identified granulomas in 74% of patients compared to 48% in the transbronchial group. It must be pointed out that the greatest yield was seen in with esophageal aspiration of subcarinal lymph nodes and that blind transbronchial needle aspiration of lymph nodes were not performed in the bronchoscopic group. The study had several limitations that deviates from standard practices. In our institution it is rare that a blind transbronchial needle biopsy of an accessible subcarinal node is not performed, in addition, fluoroscopy is routinely used in all parenchymal lung biopsies. Although the study did show that EBUS/EUS is superior to transbronchial lung biopsies and BAL, a study looking at blind transbronchial lymph node biopsies versus EBUS/EUS would have been more valid. However after performing EBUS it will be hard to dispute that direct real time lymph node visualization in conjunction with on-site cytology is now the standard of care in the diagnosis of Sarcoid with lymph node involvement.

Manoj Mathew, MD FCCP MCCM

Reference as: Mathew M. June 2014 Phoenix pulmonary journal club: new therapies for IPF and EBUS for sardoidosis. Southwest J Pulm Crit Care. 2014;8(6):340-2. doi: http://dx.doi.org/10.13175/swjpcc078-14 PDF

March 2014 Phoenix Pulmonary Journal Club: Palliative Care

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. [CrossRef] [PubMed]

The March journal club focused on the role of palliative care in respiratory diseases such as chronic obstructive lung disease (COPD) and lung cancer. Palliative care is specialized care that focuses on life threatening disease and the relief of pain and stress. Although often initiated near the end of life, palliative care should not be  considered as end of life care. This study reviewed the impact of introducing palliative care in conjunction with oncologic care in the treatment of metastatic non-small cell lung cancer versus oncologic care alone. This was a nonblinded, randomized control trial of 151 patients done at the Massachusetts General Hospital.  Seventy-seven patients were randomly assigned to early palliative care + oncologic care (P + O) and 74 patients were assigned to oncologic care only (O). P + O patients were seen by palliative care services within 3 weeks of enrollment and met with services monthly until their death. Primary outcome was quality of life at baseline and at 12 weeks. The results showed that P + O patients had less depressive symptoms (16% P + O vs. 38% O), received less aggressive end of life care (33% P + O vs. 54% O) , and lived 2.7 months longer (11.6 m P + O vs. 8.9 m O). Although this was a small, nonblinded study it showed that palliative care does not need to be exclusive of ongoing oncologic care and that early referral and involvement can help foster goals of therapy and better symptom control.

Carlucci A, Guerrieri A, Nava S. Palliative care in COPD patients: is it only an end-of-life issue? Eur Respir Rev. 2012 Dec 1;21(126):347-54.  [CrossRef] [PubMed]

The role of palliative care in COPD is underutilized and rarely initiated until the end stages of disease. This review on the role of palliative care in COPD emphasizes that COPD is often a more debilitating disease than lung cancer with even higher rates of anxiety and depression. Palliative care should not be considered as transitional or end of life care, but integrated early to improve symptom control and quality of life. The timing as to when to get palliative care services involved in the outpatient COPD population is debatable, as the resources are limited. This paper suggests that looking at parameters that delineate a decreased 5 year survival in COPD, such as THE BODE INDEX, may be useful.  Patients that have a BODE index score of 7 or more would certainly be good candidates and perhaps starting with a score of 5 or more may even be more appropriate. Palliative care should be considered an integrated and complimentary tool in the management of advanced COPD.

Manoj Mathew, MD FCCP MCCM

Reference as: Mathew M. March 2014 Phoenix pulmonary journal club: palliative care. Southwest J Pulm Crit Care. 2014;8(3):194. doi: http://dx.doi.org/10.13175/swjpcc034-14 PDF

February 2014 Phoenix Pulmonary Journal Club: Smoking Cessation

Evins AE, Cather C, Pratt SA, et al.  Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014;311(2):145-54. [CrossRef] [PubMed]

It is estimated that > 50% of people with mental illness smoke cigarettes. Pharmacotherapy with varenicline has been shown to reach an abstinence rate of 24% at 12 weeks when compared to placebo at 5%. Once off pharmacotherapy, the maintenance of smoking cessation decreases to 12% at 6 months. This study examined whether a prolonged maintenance course of varenicline over 40 weeks is associated with increased rates of smoking cessation. The study was a randomized double blind placebo-controlled trial done in 10 community centers. 203 patients met inclusion criteria and entered a 12 week smoking cessation program with varenicline and cognitive behavioral therapy (CBT). 87 patients completed the initial smoking cessation to continue onto the maintenance phase. Patients were randomized to receive either 40 weeks of varenicline and CBT or CBT alone. The results showed that at the end of the 52 week study 60% (40 patients) maintained smoking abstinence versus 19% (9 patients) in the placebo group. Side effect profiles were similar in both groups and there were no significant adverse events. The study was well done and showed that varenicline was well tolerated for a prolonged smoking cessation program. The abstinence rate of 60% at 52 weeks is astonishing and needs to be further validated with larger scale trials. The use of varenicline in patients with psychiatric illness has been met with scrutiny due to its black box warning of increased rates of suicidal ideation and depression. It has been debated that these side effects have been related to smoking cessation rather than drug effect. This study, although small, supports that varenicline can be used provided there is close follow up and continued cognitive behavioral therapy. Larger scale studies are still needed to prove long term efficacy as a smoking cessation maintenance therapy.

Volpp KG, Troxel AB, Pauly MV, et al. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009;360(7):699-709. [CrossRef] [PubMed]

It is estimated that it costs a company $3400.00 a year to employ a smoker versus a nonsmoker. The higher cost is attributed to lower productivity, and absenteeism.  This study was a randomized control trial comparing an employer driven smoking cessation utilizing financial incentives to help people quit. The study was performed at a multinational company within the USA. 878 workers were randomized into 2 groups, 442 assigned to control and 436 to the financial incentive group.  Both groups received information on smoking cessation programs but the incentive group was also given a financial incentive at the completion of a smoking cessation program ($100.00), maintenance of smoking cessation for 6 months  ($250.00), and continued maintenance for 1 year ($450.00). Smoking cessation was confirmed by salivary or a urine cotinine test. The results showed that the incentivized group had higher rates of completing the smoking cessation program (20.8% control  vs.  46.3 % treatment ), higher rates of cessation at 6 months (11.8% control vs. 20.9%)  and at 12 months (5% control vs.  14.7% treatment).  The study did show that financial incentives may contribute to smoking cessation, however there are too many variables that may have confounded the results. The study was done at a large multinational company and targeted a select group of more educated and more motivated individuals.

The average price of pack of cigarettes exceeds $5 per day. The average smoker in this study smoked 1 pack per day, The biggest incentive here is the money gained from smoking cessation which is a savings of $1825.00 which is far greater than the financial incentive being offered. The cotinine test is only accurate in detecting a certain level of cotinine acquired from smoking usually within the past 7 days. It is possible that the test may have failed to detect mild, intermittent smokers. A policy such as this is a novel concept and has be instituted but in different forms. Rather than a worker receiving a “BONUS” for not smoking, he/she will be required to pay higher premiums for healthcare insurance, or life insurance. Overall this was an interesting study but not practical to apply on a universal scale.

Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382(9905):1629-37. [CrossRef] [PubMed]

Electronic cigarettes have exploded in availability and popularity over the last 5 years. As a nontobacco nicotine delivery device it offers the desirability of tobacco-based smoking without the odor and additional chemicals. The product has been offered as a mechanism to support smoking cessation by many practitioners but the evidence on whether this is prudent is lacking.  This study as a large randomized control trial comparing nicotine based e-cigarettes to placebo e-cigarettes and to nicotine patches as a smoking cessation tool. The study was performed in New Zealand. A total of 657 patients were randomized and divided into 3 groups, 289 patients into 13 weeks of e-cigarettes with nicotine, 295 patients with nicotine patches, and 73 patients with placebo e-cigarettes. The primary outcome was smoking cessation measured by exhaled carbon monoxide levels at 6 months. The results failed to show a significant difference between the 3 groups. The e-cigarette nicotine group reached cessation in only 7.3% vs. 5.8% in the nicotine patch arm and 4.1% in the placebo e-cigarette arm. The low rates of tobacco cessation were surprising and lower than expected. The authors noted that the study was powered to achieve a 20% quit rate using nicotine e-cigarettes and because it did not reach this level, there was insufficient evidence to state that e-cigarettes were superior. The low quite rate were puzzling as 5-7% quite rates have been standard for behavioral therapy alone. The authors concluded that the nicotine content in the e-cigarettes may have been to low and also that the first generation of e-cigarettes were less pleasurable. The study was well designed and well done but failed to achieve its primary outcome.  E-cigarettes do not have sufficient evidence for us to recommend them as a smoking cessation tool.

Manoj Mathew, MD FCCP MCCM

Associate Editor

Reference as: Mathew M. February 2014 Phoenix pulmonary journal club: smoking cessation. Southwest J Pulm Crit Care. 2014;8(2):136-6. doi: http://dx.doi.org/10.13175/swjpcc025-14 PDF

January 2014 Pulmonary Journal Club: Interventional Guidelines

Feuerstein JD, Akbari M, Gifford AE, Hurley CM, Leffler DA, Sheth SG, Cheifetz AS. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc. 2014;89(1):16-24. [CrossRef] [PubMed] (For editorial comment click here)

A few years ago a colleague and I were discussing the shape of healthcare in the USA.  One of the comments that was made was "that despite the high costs within our system, that at least there was some standardization in the treatment of certain diseases, for example, receiving Aspirin for an acute myocardial infarction".  Guidelines exist to ensure that for certain conditions a standard of care is practiced. When guidelines start to become a measuring stick for what is now considered best practice…..then it our responsibility to ensure that guidelines are rooted on high quality evidence. This paper reviewed the validity of guidelines published and practiced by several of the interventional medical societies including the American Association for Bronchology and Interventional Pulmonology (AABIP), American Society of Diagnostic and Interventional Nephrology (ASDIN), American Society For Gastrointestinal Endoscopy (ASGE) and the Society for Cardiovascular Angiography and Interventions (SCAI).

A total of 153 interventional guidelines were evaluated between November 2012 and January 2013. Each guideline was reviewed to determine the level of evidence and convicts of interest. The large majority of the guidelines reviewed were from the ASGE (67) and SCAI (80). The results showed that out of the 153 guidelines reviewed that only 69 (46%) had a grades of evidence associated with them. The levels of evidence for most guidelines were grade B or C (expert Opinion). Nearly 50% of recommendations were based on expert opinion whereas Only 11% of the recommendations  were validated by Grade A evidence. When looking at conflict of interest only 57 of the guidelines revealed a conflict of interest out of which 52 (91%) revealed that a conflict of interest existed. Most of the guidelines (62%)  failed to report on whether any conflict of interest existed.

Practice guidelines should exist to improve the standard of care wince they have been based on repeated validation and held to the highest level of evidence. We are now to often seeing guidelines set forth based on weak evidence and then tied into best practice measures. It is our duty as clinicians, scientists, and educators, to ensure that practice models are based on the best interest of the patient which can any be met by rigorous and repeated testing and the highest grade of evidence. Setting forth guidelines and recommendations based on expert opinion may be of benefit when no other studies exist but the level of evidence on these practices should be made clear and conflicts of interest be reported. In our haste to standardize healthcare practices we have become lax to include recommendations that are more in the interest of the institutions rather that for the patient.

Manoj Mathew MD FCCP MCCM

Reference as: Mathew M. January 2014 pulmonary journal club: interventional guidelines. Southwest J Pulm Crit Care. 2014;8(1):70. doi: http://dx.doi.org/10.13175/swjpcc007-14 PDF