One of our readers recently sent the blog the following comment:

“Anything new to add to comments in book about laser treatment of fungal nails?  In my area there are ads for DPMs offering this $1000 per treatment!  My question is; does it work?”

Up to this point I have been tacitly avoiding this topic waiting for all of the chips to fall into place.  I guess it is time to, at least give my initial thoughts.  I will start by disclosing that I was a member of the original Patholase/PinPointe Advisory Board although I am currently not working with that company and I am a current Advisory Board member for Nomir. Being under a non-disclosure agreement with both I must therefore be very careful to only give background information that is in the public domain and give only MY OPINION based on the information in the public domain so as not to let slip any confidential information that I may have picked up along the way.  This is another reason I have not written about this topic.     

Although there may be more than two commercial products to mention, I will limit my discussion to the two best known, the PinPointe Laser from Patholase and the Noveon Laser from Nomir.  These are totally different devices that use different forms of laser energy. As I write this NEITHER is FDA approved specifically for the treatment of onychomycosis although both have a device clearance for general podiatric and dermatologic use.  Interestingly, if you actually look for the specifics of that general definition, onychomycosis is not included.

To this point each company has taken very different marketing approaches.  PinPointe, despite not having the FDA approval, has been aggressively marketing the device to podiatrists based on their general usage clearance.  Up to this point, their publically available data supporting the use of the device for onychomycosis has been limited to a small number of patients originally treated pre-marketing and by early adapters of the device.  This data is not from a prospective, IRB approved, randomized controlled trial. To their credit, a quick search on www.clinicaltrials.gov under the term “onychomycosis” does reveal that they are currently engaged in such a clinical trial.  They also continue to collect retrospective data from current users.  To the best of my knowledge they have published no studies based on their clinical data or their technology. 

Nomir has taken the path of performing an initial three IRB approved, prospective clinical trials and has submitted their pivotal trial to the FDA in an attempt to receive an onychomycosis indication.  Their technology, using a dual wavelength (870 & 930 nm) near infrared (IR) laser light to cause photoinactivation of  both fungus and bacteria, including T. rubrum and MRSA, at physiologic temperatures, has been shown to be successful in vitro and in vivo, and was recently published by its developer Dr. Eric Bornstein http://www.nomirmedical.com/products/publications.htm in the Nov/Dec 2009 issue of Photochemistry and Photobiology.  They have also submitted the preliminary results of their pivotal clinical data for the treatment of onychomycosis which has been accepted for publication in a peer reviewed, indexed journal.  Although they have signed up podiatrists to be trained on the device, it has not yet been made commercially available. 

Enough background…to answer the question that initiated this discourse, I guess I would have to say that, yes, given the data I have seen, these two laser therapies do, in fact, show positive results in the treatment of onychomycosis.  Will they work in every patient with nail fungus?  Of course not!  Even oral terbinafine only had a 38% total cure rate in its clinical trials.  Which brings up another question…do they work even as well as the oral agents?  Frankly, no one can say at this point without seeing the results of the same type of well designed, controlled trials that those drugs went through.  I will say this much for certain, there is no risk of systemic toxicity with the lasers as there is with the oral drugs, no matter how rare.  Is the treatment worth $1000?  That is something that only an individual patient can answer.  I hear through the proverbial grapevine that there has been no shortage of folks willing to pay that or similar amounts for the treatment.  Heck, there are scores of physicians specializing in cosmetic treatments, some without rigidly controlled and studied FDA approved data, that have done quite well promoting their services.

Until more information is available on which definitive statements can be made, I would have to advise each of my readers to use their own moral and ethical compass in determining what is appropriate for their patients and their practice.   I would really appreciate any comments you may have if you are currently using a laser on either your own patient experience or if you have seen patients treated by other docs and their satisfaction level.

To any of my readers planning on attending the NY Clinical Conference this coming weekend, I will be in the exhibit hall at the DataTrace booth on Saturday January 30th.  I will be there to discuss this blog, sign copies of the 3rd Edition (not that it will increase the value of it…heck, it may diminish it!) and just generally hang out and meet anyone interested in discussing lower extremity infectious diseases.  Please come by and say “Hi”.

Two studies published in the January 7, 2010 issue of the New England Journal of Medicine have received a tremendous amount of play in the popular press.  One paper out of Baylor in Houston looked at comparing chlorhexidine + alcohol vs. povidone iodine as a preoperative surgical prep.  In a total of 849 subjects in the ITT analysis they found that the surgical site infection rate was significantly lower with the chlorhexidine + alcohol than it was with the old “standby” povidone iodine (9.5% v. 16.1% P=0.004) Here is a link to that abstract http://content.nejm.org/cgi/content/short/362/1/18.

The second study, out of the Netherlands, explored the issue of decolonization in nasal carriers of S. aureus.  http://content.nejm.org/cgi/content/short/362/1/9.  A total of 6771 patients were screened on admission using PCR for rapid identification of the Staph.  1270 swabs were positive, 808 underwent a surgical procedure.  The patients were all treated with mupirocin nasal ointment and chlorhexidine soap vs. a placebo.  The rate of S. aureus infection was 3.4% in the treated group vs. 7.7% in the placebo group.    Interestingly, ALL were methicillin susceptible (MSSA) so the study may, or may not be able to be extrapolated to MRSA carriage.

Hospital acquired infections, particularly surgical site infections cause a tremendous amount of morbidity and mortality not to mention costing billions of dollars to treat.  The monetary situation is complicated by CMS guidelines that may not pay a hospital for treatment of any nosocomial infection.  Therefore, new and improved techniques for minimizing these infections are being studied.  Some of what is done today for infection prevention in the surgical suite has not changed much in decades i.e. the use of the povidone iodine prep.  I remember doing those back when I was a surgical resident in the early 1980s!  Chlorhexidine is by no means a new product.  In fact, it may be older than povidone iodine.  A quick PubMed search finds papers going back to the 1960s.  More recently, the combination of chlorhexidine with alcohol has shown to be a better antiseptic with longer activity than chlorhexidine alone.  This is true not only for prepping the patient but also as a hand prep for the physician.  This recent study just shows us that as new high level evidence becomes available, we may have to change some very ingrained thoughts and practices.

As for the nasal carriage paper, I find that interesting and not unexpected.  What needs to be looked at is carriage of MRSA and surgical site infections.  There are some papers out there and I do discuss them in the book.  This is a more involved topic for another post. 

Telavancin (Vibativ – Theravance/Astellas) is a novel lipoglycopeptide, related to vancomycin, that has been recently approved by the FDA for the treatment of complicated skin and skin structure infections (cSSSI) caused by MRSA.  Telavancin now joins the ranks of vancomycin, linezolid, daptomycin and tigecycline as being the only 5 antibiotics with this approval.  An excellent review of this drug was published by Saravolatz, Stein and Johnson in the December 15, 2009 issue of Clinical Infectious Diseases.  Here is a link to the Abstract: http://www.journals.uchicago.edu/doi/abs/10.1086/648438 .  I highly recommend anyone interested in this drug to search out this complete article and familiarize yourself with it.

Without going into too much detail (which may infringe on copyright?), I would like to point out a few important take home messages that I got out of this paper and from my review of other literature on the subject. First some of the positives:

1.  The usual dose is 10mg/kg q24h.  Thus, we have the ease of a once daily dosing

2.  The drug is consistently bactericidal against most S. aureus.   Various reviews have shown that this probably has little impact in the treatment of cSSSI and may be more important in blood stream infections for which this drug is not approved.

3.  It is effective against MSSA, MRSA, VISA and hVISA.  It is also effective against daptomycin and linezolid resistant strains.  It does not have activity against the most common strains of VRE.

4.  Unlike vancomycin, there is no call to monitor serum trough levels

5.  In two pivotal cSSSI clinical trials it was found to be “non inferior” (FDA speak) to vancomycin. 63% of the S. aureus strains were MRSA making it the largest number of MRSA patients in a cSSSI study to date.

Now some downsides:

 1.  It is primarily excreted through the kidneys so significant dosage modification must be made in cases of renal insufficiency. The recommendations are the full 10 mg/kg q24h if the creatinine clearance is >50 mL/min, 7.5 mg/kg if 30-50 and 10 mg/kg q48h if the clearance is <30.

2.  Chronic, infected diabetic foot ulcerations were specifically excluded from the two pivotal trials!  I don’t see this drug receiving the coveted “…including diabetic foot infections” approval anytime soon.

3.  Although the overall safety looked comparable to vancomycin there were higher rates of some significant adverse events including altered taste, nausea and vomiting along with an increase in renal events.  On the other hand, vancomycin had higher rates of infusion reactions

4.  The drug has received a black box warning for fetal risk.

So what is the bottom line?  I agree with the authors of this review that we need new novel antibiotics to combat MRSA especially given all of the increasing reports of vancomycin MIC creep and treatment failures.  Many of the drugs that looked promising earlier in their development have either been slowed considerably (ceftobiprole) or stopped totally (oritavancin, iclaprim) so the once fertile pipeline is looking a bit thin.  Telavancin gives us one more drug to add to that relatively short list of alternatives to vanco especially with organisms that have developed resistance (although extremely rare) to those other antibiotics.  At this early point in its history, I am somewhat concerned about its lack of diabetic foot infection data and its increase in adverse events compared to vanco.  The black box may also impact some potential patients.  Given that we have other vanco alternatives with years of clinical experience, including diabetic foot data, and well known safety profiles I may feel more comfortable seeing more clinical data and published AE experiences before jumping in with both feet.

Some interesting news just came out yesterday.  It looks like J&J’s new anti-MRSA cephalosporin, ceftobiprole has been, once again, turned back by the FDA. See the story here:

http://money.cnn.com/news/newsfeeds/articles/marketwire/0572888.htm

Many of us had pretty high hopes for this antibiotic as it was to be the first cephalosporin active against MRSA.  Although it is IV only, the idea of having a new MRSA agent that was in a class of drugs well liked and trusted by most, was appealing.  It is also broad spectrum against a wide range of other Gram positive and Gram negative organisms. J&J even performed a clinical trial specifically looking at diabetic foot infections with promising results thus hoping to become only the 4^th antibiotic (after linezolid, ertapenem and piperacillin/tazobactam) with that specific FDA indication.  The drug was initially submitted for approval way back in 2007.  The FDA sent an Approvable Letter questioning conduct at some of the study sites.  The action taken yesterday by the Agency now seems to totally question the viability of the two pivotal trials.  This may mean that entirely new studies would have to be completed thus delaying this drug for years more.  It will be interesting to continue to watch this.

In the meantime, all is not lost for anti-MRSA cephalosporins.  The drug most thought would be the late-comer to this party, ceftaroline, seems to be moving ahead.  I will keep you all informed as I hear anything new.

I wish all of my readers a healthy, happy and prosperous, New Year

On Barry Block’s daily PM News (www.podiatrym.com) the other day a colleague presented a case of a neuropathic patient with no wounds presenting with what he felt was osteomyelitis of the 2^nd and 3^rd metatarsals.  Although I did not feel that the case was actually osteomyelitis, a feeling I expressed in a response to that site, I was intrigued by the comment of the original poster that; after giving the patient 8 week of oral ciprofloxacin (another potential misjudgement I discussed in my response), “I just think it is interesting to see how this bone infection responded to very little care.” This comment had me reflecting on what we consider as “Standard of Care” for the treatment of osteomyelitis.

In the 3^rd Edition of the Handbook I review the evidence that shows that perhaps we should rethink this “Standard”.  The entire concept of 4-6 weeks of IV antibiotics as being some magical bullet that will treat osteomyelitis is based on 30-40 year old animal studies.  There is really no human evidence to support that this is the optimum therapy.  In fact, much of the recent data that has been presented, particularly out of Europe, suggests that ORAL antibiotics alone with either NO surgery or just “conservative” debridement of infected bone may be just as effective therapy.  The literature supporting this approach is actually quite a bit more hefty that that supporting the old traditional “standard”.  I explore this question in detail in a lecture I frequently present entitled (thanks to David Armstrong for the catchy title) Antibiotics for Osteomyelitis: Boneheaded or brilliant? One of these presentations can be viewed for free at the website for the always stimulating Diabetic Foot Global Conference (to be held this coming year in Hollywood, CA March 18-20, 2010): http://www.dfcon.com/presentations2009/sat_joseph.html

In no way do I mean to say that surgery is unnecessary.  In fact, if ablative surgery can be performed, it is curative without the use of any antibiotic therapy.  But, sometimes, patients either do not want, or can’t undergo a surgical procedure.  In those cases I am relieved to see that we do have data to support the non surgical treatment of these cases with oral antibiotics alone.  Of course, this approach is not perfect and there are still unanswered questions.  Probably the greatest is the question of duration of therapy.  Do we only need the orals for 4-6 weeks or longer?  One study, referenced in the lecture, by John Embil incorporated 41 weeks +/- 31 weeks of therapy!  This needs to be addressed.  The other literature I would direct you to review is the consensus statement put out by the International Working Group on the Diabetic Foot (IWGDF) http://iwgdf.org  whose recent systematic reviews of the diagnosis and treatment of diabetic foot osteomyelitis should be reviewed by everyone treating this condition. 

To me, this is one of the most fascinating and important areas that we need to explore in the future.

Osteomyelitis of the 1st MTP Joint

Dr. Todd Divan, a podiatric physician from Potomac, IL, sent me an excellent question via personal email.  On the belief that if one person asks a question, many others may be thinking the same thing, I reprint the question and answer here with Dr. Divan’s kind permission.

Dr. Joseph,

I listened to the lecture you have on PRESENT podiatry for the “Diabetic Foot Infections” involving the IDSA classification system.  This was excellent.  I will also be checking into a slide show share lecture you have placed available online for the “Current Emerging Antibiotics for MRSA”.

I agree that expressing the “tough love” passion with the patient is important.  Some of these patients just don’t get it that they are really suffering increased susceptibility to losing a leg or even a life.

I would like to know any journal readings you would highly recommend regarding this topic.  I have a few thoughts to share.  For example, do we as podiatrist need to worry about Proteus, Serratia, Klebsiella, E. coli, or Citrobacter in the diabetic foot infections?  You mentioned a study which gave the impression we don’t have to worry too much about treating Pseudomonas aeruginosa because there is a fairly high cure rate with the Pseudomonas when treated with a 1st gen cephalosporin (an interesting thought).  However, I think the point should be emphasized to avoid applying this concept across the board on Gram neg infections, with the thinking that they will heal secondarily alongside of therapy focused on Gram pos infections.  My thinking is based a great deal on the fact that once we have taken a culture and the presence of a certain bug is documented in the chart, if we don’t treat because of this concept, then an infection turn bad (and sometimes fast).  I am worried this type of complication could lead us into a higher risk case and expose the practitioner to increased legal liabilities.  Shouldn’t I have to follow the tendency of the infectionist in my area, since working on a multidisciplinary basis is important.   I did pick up on your point that using aztreonam or the like (depending on the culture report) could provide good combination therapy to get coverage for the Gram neg infections.

Thank you for your contributions.  Much appreciated.

Todd Divan, DPM

MY RESPONSE

Todd,

Thank you for the kind words and the thoughtful questions.  I have attached a copy of the Infectious Diseases Society of American Diabetic Foot Guidelines where we go into the concept of gram positive organisms in more detail.  This paper was published in 2004 and we have a new manuscript in the works, hopefully for publication summer of 2010.  The primary importance of gram positive infections does not change with the new document.

When you read the guidelines you will see that we stress the primacy of aerobic gram positive cocci as the major causative organism.  This is particularly true in mild and many moderate infections.  We do say that as the infection becomes more severe, if there is the presence of necrotic tissue, or of the patient has been exposed to previous courses of antibiotics, then gram negative aerobes and anaerobic organisms become more prevalent.  Even if you culture these organisms, the evidence is not clear that you have to treat them.  Tony Berendt, Ben Lipsky and I refer to this as the “head of the snake” philosophy.  In other words, Staph and Strep make up the “head of the snake” and the other bugs you list below make up the body.  If you “cut off the head” i.e. use antibiotic therapy directed at the Staph and Strep, then the “body” dies.  Again, this is primarily true of the mild and moderate levels.  We are NOT advocating only using gram positive coverage for the more severe infections.

Even with this concept, and it is just that, a concept, even though it is based in excellent data, I tend to start empirically with broad spectrum coverage (perhaps partly for the legal exposure reason you mention below).  In the case with our hospital I even need to use MRSA coverage.  Almost all patients are begun on Zosyn + Vanco.  Certainly Invanz can be substituted for the Zosyn and Zyvox for the Vanco depending on your local formulary.  Please note I do NOT use the Zosyn for Pseudomonal coverage.  I am still of the FIRM believe that no evidence supports needing to cover Pseudo empirically in just about any diabetic foot infection.  In fact, I don’t remember the last time I even grew that bug from a DFI.

Regards

Warren

IDSA Moderate DFI

One of the ideas behind creating this blog was to be able to keep readers apprised of any new, interesting papers published in the infectious diseases and microbiology literature I follow on a regular basis. For background I will tell you that my 3 top journals include:

Clinical Infectious Diseases (CID) – put out by the Infectious Diseases Society of America www.idsociety.org and my favorite clinical ID journal.

Journal of Infectious Diseases (JID) – also an IDSA journal.  Mostly HIV and intense basic research but does occasionally publish in interesting review or bacteriology manuscript.

Antimicrobial Agents and Chemotherapy (AAC)  - this journal, published by the American Society for Microbiology asm.org is the best source for new antibiotic research and clinical microbiology

I periodically also receive manuscript files sent to me by a network of ID friends and colleagues. 

Although I try to review each as they are received I admit that, occasionally, they get lost in a pile on my desk. Because of prior commitments, I admit that this is what has happened over the past 3 months and I have been remiss in my reviewing of these back issues.  So, to bring folks up to speed, here are a few papers of relatively recent vintage that I find interesting.

 Thomas Lodise, et. al. Relationship between initial vancomycin concentration – Time profile and nephrotoxicity among hospitalized patients.  CID, August 15, 2009.  Tom Lodise’s pharmacology group from Albany has been doing some terrific work looking at nephrotoxicity of vancomycin given recent recommendations to increase trough levels to between 15-20mg/L.  Just last year in AAC they published their findings that bumping vanco doses to 4 grams/day (sometimes necessary to achieve these higher peaks) was associated with a significantly higher rate of nephrotoxicity.  In this study they concluded that “The results indicate that a vancomycin exposure – toxicity response relationship exists.  The vancomycin trough value is the pharmacodynamic index that best describes this association.”  I have blogged about this vancomycin dosing issue in the past.  Maybe I am being selective about what I read and share but I still have issues with this concept of bumping vanco trough levels especially given the total lack of data in diabetic foot infections where the patients may already have compromised kidneys. 

 Micheal Ryback, et. al. Vancomycin Therapeutic Guidelines: A summary of consensus recommendations from the IDSA, the American Society of Health System Pharmacists and the Society of Infectious Diseases Pharmacists.  CID, August 1, 2009.  Perhaps I should have listed this article before the one above since this summarizes the guidelines that promote this new dosing regimen and the concept of achieving an AUC/MIC ratio of >400 by using weight based dosing and bumping troughs.  Considering the attention given to these new guidelines my readership should become very familiar with them.  The full, original document can be accessed at http://www.ashp.org/DocLibrary/BestPractices/TPSVanco.aspx

 Shveta Rani Singh, et. al. In vitro 24-hour time-kill studies of vancomycin and linezolid in combination versus methicillin resistant Staphylococcus aureus.  AAC Oct. 2009.  This title is a perfect example of what one can expect reading AAC.  Once you get past the wordy titles there is some great information.  I found this interesting because, apparently, there are clinicians trying all different antibiotic combinations to fight MRSA. The authors found that there was no synergy at all, and, in fact, frank antagonism occurred in 3 out of 5 strains when linezolid was added to vancomycin.  The bottom line…try other combinations if you must, just not this one.

 Stan Deresinski. Vancomycin in combination with other antibiotics for the treatment of serious MRSA infections.  CID Oct 1, 2009.  Stan Deresinski out of Stanford University has become a bit of a “go to guy” when it comes to MRSA and the ID community.  I urge all of my readers to find his 2005 CID review paper  Methicillin-Resistant Staphylococcus aureus: An Evolutionary, Epidemiologic,and Therapeutic Odyssey which remains one of the most easily digestible treatises on the topic.  In this more recent review he scans the literature to find support of the commonly employed practice of combining vancomycin with a second antibiotic usually rifampin or gentamicin and finds to supportive evidence for these combinations but known potential toxicities.   

 Jose L. Del Pozo, et al. The electricidal effect is active in an experimental model of Staphylococcus epidermidis chronic foreign body osteomyelitis.  AAC Oct. 2009. This interesting rabbit study compared low amperage (200 µA) electrical current to IV doxycycline treatment to no treatment for foreign body osteomyelitis in the rabbit tibia.  As expected, both treatment groups were significantly better than the no treatment group.  Interestingly, the electrical current group was significantly more efficacious than the doxycycline group.  They feel that this might be related to the activity of the current against the bacterial biofilms.  This entire area of bioflims as determining factors in the treatment of chronic infections is fascinating and bears watching. 

Let me know what you think of the concept of writing up these reviews, and please suggest other papers you would like to hear my opinion about

Bone exposed through an open ulceration

If I were to ask any reader of this blog the proper technique for harvesting a bone culture I am fairly certain that the common response would be that it must be a) not taken through the ulcer or sinus tract b) taken from a separate clean site c) the patient should be off all antibiotics.  In fact, ever since Mackowiak published his seminal paper in JAMA way back in 1978 showing sinus tract cultures had poor concordance with deep bone cultures; the prevailing wisdom has been that sinus tracts (and thus ulcers) were off limits.  These results were further confirmed by Eric Senneville in 2006 and Khatri in 2001 along with others.  Thanks to these studies, it has become common knowledge that a proper bone culture should never be harvested through a sinus.

The question of whether or not the patient needed to be off of all antibiotic therapy prior to the culture was always less clearly delineated.  It was almost an empirical belief that if a patient was on antibiotics at the time of the culture then the results would be unreliable.  After all, if a culture is reported as showing “no growth” was this because the specimen was poor, the patient never had osteomyelitis in the first place, or the antibiotics had prevented the organism from growing? 

A recent study by Louis Bernard and colleagues out of University Hospital of Geneva Switzerland, and published in the September 6, 2009 issue of the International Journal of Infectious Diseases challenges much of what we currently hold as sacrosanct.  In this non-randomized, prospective trial 141 patient with 154 episodes of osteomyelitis each underwent 4 microbiological samplings.  Sample “A” consisted of 2 consecutive sinus tract cultures with bone contact (“A1” & “A2”) after only local cleansing of the sinus tract with 0.9% saline.  Sample “B” consisted of a surgical bone biopsy through the sinus.  Sample “C” was a surgical biopsy obtained through an uninfected sited, referred to as the “gold standard”.  Their results showed that when both sinus tract cultures “A1 & A2” revealed the same organism the concordance between “A” and gold standard “C” was 96%.  They calculated the sensitivity as 91%, specificity as 86% and accuracy as 90%.  On top of that, they found that the result was not affected depending on whether the patient was on antibiotics prior to the cultures or not. 

In their Discussion the authors go out of their way to state that “in no way should these consecutive deep sinus tract specimens replace bone culture in situations where a biopsy can be readily obtained because bone culture remains the gold standard for the microbiological diagnosis of osteomyelitis”.  There are sometimes, however, when a surgical culture is just not practical and that patient has already been started on antibiotic therapy, as the authors call it “clinical reality”. 

This fascinating work challenges our common thinking about how to harvest microbiological specimens for osteomyelitis diagnosis and treatment.  I urge the readers of this blog to search out this paper and read it.  It is new, innovative, evidenced based works such as this that lead me to wanting to create a blog…so that I could keep those interested readers up to date on current thinking between editions of the book.

Data Trace, the publisher of the Handbook of Lower Extremity Infections, 3^rd Edition, has started a bit of a marketing “blitz” in response to the recent release of the book.  I want to take this opportunity to welcome those of you who have just come across this blog either through the recent direct mailing or the ads in PM News or Podiatry Management Magazine.  The purpose of this site is twofold; to allow me to interact with anyone interested in the treatment of lower extremity infections and to give me an opportunity to update the readership on new developments in infectious diseases as they become available.  I regularly review the ID literature for manuscripts that have a direct bearing on the way we treat the lower extremity and attend ID meetings.  This blog allows me to disseminate that information rapidly which would be impossible if I had to wait for my next book revision.

I envision this site as being interactive.  If you have a question about an interesting case (you can even post pictures), have recently heard a lecture, been detailed by an antibiotic representative or just randomly thought of a question on which you would like my thoughts, ASK AWAY!  I will do my best to answer in a timely manner with the best available evidence to support what I say, not to mention a dose of my opinion/experience.    In the future I hope to start running the occasional poll to capture what others may do in a given situation.  If you have any other ideas for this site, please let me know.  I am open to suggestions on how to make it of value to you.