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closeClinical algorithm
Posted by TomBoyles on 21 Sep 2016 at 13:28 GMT
I very much agree with your agenda and that accelerating uptake of ART in SSA is an important area. I am a little concerned about the implication that many people should be able to start on the same day. I'd like to see some flexibility in the system so those who need a bit of time to reflect are given that opportunity and same day is more of an 'opt-in' process for those who are ready.
My main points however relate to your clinical algorithm which i think is cumbersome and not very realistic. The main clinical issues are trying to exclude TB and cryptococcal disease. This can be done fairly easily with a cryptococcal rapid antigen test, a symptom screen and a point of care CRP (these machines are easy to use and have many other uses in the clinic, particularly related to the reducing unnecessary antibiotic prescriptions). Those who are '+ve' on any of these 3 require further assessment.
You say TB Rx < 14 days and an exclusion but this is not the case. The important trials randomized people to TB Rx 'within 14 days' not 'wait 14 days'. I see this mistake all the time in clinical practice.
You also say 'concomitant medication' is an exclusion but very many chronic medications have no drug-drug interactions with ART and are no reason at all to delay therapy.
I'd be happy to give detailed input on the proposed algorithm if you would like.
Regards
Tom Boyles
UCT
RE: Clinical algorithm
sydneyrosen replied to TomBoyles on 27 Sep 2016 at 19:15 GMT
Dr. Boyle, we thank you for taking the time to comment on our article, and we are very pleased to see the journal’s comments space used to foster discussion. You raise some interesting concerns about the simplified algorithm we propose for determining whether a patient can start ART immediately or whether treatment should be delayed, even briefly, pending additional care or services.
Let us start by agreeing with you that the timing of dispensing drugs should certainly be flexible. Under the algorithm, dispensing is intended to be based on the patient’s responses to the readiness assessment. Any patient who indicates hesitation about immediate initiation should be “delayed,” which in this case might be a referral for additional counseling, help with disclosure, or just time to think about it, as you suggest.
Your other concern about the algorithm requiring too many procedures and offering too many reasons for delay is the main reason that we recommend evaluating it in real-world studies. Our intent with the algorithm is to “screen in” (identify) the subset of patients who have absolutely no indications that they cannot walk out with their initial supply of tablets on the same day. For these patients, the algorithm should be easy to apply. At the same time, the algorithm is intended to “screen out” those in whom therapy should probably be delayed. The “delay” called for may be for several days or weeks to treat a co-infection, or for no more than the few minutes for a additional attention from a clinician or counselor. For example, a patient taking concomitant medications may become confused as to whether ARVs should be added to her or his daily schedule, or should replace other medications. An additional brief interaction with a clinic counselor may be enough to allay concern such that the patient can still take home a supply of ARVs that day. Similarly, it will be up to the clinic to decide how soon to start ART in a patient with TB. National guidelines in many countries currently suggest 14 days, which is the reason for our criterion.
The additional screening tests you suggest may be feasible in some settings, and we imagine that the algorithm proposed here will be modified by others to take advantage of the resources available. For now, our experience indicates that these tests are not widely available at point of care.
If successful, the algorithm will screen out anyone who really should not start immediately, while screening in patients who should, and thus minimizing pre-initiation loss to follow up and treatment costs for both clinics and patients. We hypothesize that patients who can start immediately will comprise a large majority of HIV-positive patients who walk in the door, but that is a question for further research. We are looking forward to evaluating the algorithm’s effectiveness and costs, and we hope that others will find opportunities to apply and evaluate it as well.
In the meantime, we thank you again for your detailed input on the proposed algorithm and look forward to additional comments from readers.