ПОИСК ПО САЙТУ 
поиск по ресурсному центру European doctors ask the question at 2016 Standard of Care meeting
The purpose and structure of clinical HIV guidelines may have to change radically now that universal treatment on diagnosis is the clinical consensus, physicians from the European AIDS Clinical Society (EACS) heard in a meeting on standards of care last month in Brussels. A scene-setting presentation by Kevin de Cock of the US Centers for Disease Control (CDC) has already been summarised in this report.
“We have to get political” was how Manuel Battegay, outgoing president of EACS, summed it up.
He explained that in an era of “test-and-treat”, “getting to zero” and the UNAIDS 90-90-90 target, which seeks to have 72% of everyone with HIV virally undetectable by 2020 and 86% by 2030, HIV treatment has moved from an individualised patient-care model, like cancer treatment, towards a public health model, like vaccination or TB treatment.
This implied that a professional body like EACS had to ally itself to other organisations and issue guidelines in collaboration with normative agencies like the World Health Organization (WHO) and surveillance ones like the European Centre for Disease Control (ECDC).
The focus shifts from care to standard of care
If, as now, there is consensus among globally-followed guidelines about the best course of treatment, then it changes the very nature of what guidelines are for, Battegay said. Clinical consensus means that the focus shifts from care to the standard of care, and to adding public health and quality of life outcomes to clinical ones. As Kevin de Cock pointed out in his presentation, by shifting in this way HIV guidelines would come to more closely resemble those developed from the start with global health in mind.
It also means that guidelines can more easily be used as a standard against which to measure clinical practice. If there was a main theme that emerged at the meeting, it was what part doctors as a profession can play in broadening guidelines to standards, and what data and alliances are needed in order to do this.
It was agreed that a more ‘normative’ set of guidelines, adapted to the continent, are badly needed in Europe. As Antonella d’Arminio Monforte of the University of Milan said, in recapping the previous meeting EACS held on standards of care, in 2014, there has been little positive change in the European HIV epidemic, with continued rises in HIV diagnoses in gay men in the west and HIV threatening to become a generalised heterosexual epidemic in parts of the east, attendant on poor and patchy treatment access.
Dorthe Raben of Rigshospitalet in Denmark, who directs the OptTEST HIV testing project, warned that ‘public health’ guidelines could be a restrictive response by politicians and funders to cost pressures, as well as an expansive response to the need to include factors other than the clinical that influence outcomes. She urged better communication and more joint working between physicians’ organisations like EACS with the ECDC and with national surveillance organisations, with national health ministries, and with WHO Europe.
As OptTEST co-ordinator, Raben also emphasised the importance of including some measure of testing within EACS guidelines as a way of unifying them with the UNAIDS 90-90-90 target and measuring country success over the whole care continuum (the “treatment cascade”).
Better data is crucial
There was a general consensus at the meeting that many national surveillance systems would have to improve to provide enough data for even minimal rating against standards of care. Justyna Kowalska, a Polish doctor, presented the outcomes of an EACS meeting for physicians working in eastern Europe held in February in Warsaw.
She said that many eastern European countries could not even provide reliable figures for the number of people with HIV on treatment, let alone the proportion diagnosed. This was partly because 50% of countries in the region still rely on completely anonymised reports, and partly because care was fragmented; many doctors not tied to major centres did not report on HIV positive people in their care. For this reason some countries like Croatia with small epidemics had centralised their HIV care to just one clinic.
Kowalska added that an additional brake on changing from pure clinical practice guidelines was that in Poland the national guidelines were used as a teaching aid and students examined against them. Finally, especially with generic antiretrovirals already available in some of eastern Europe and soon to arrive in the west, guidelines could not ignore the issues of cost-effectiveness and cost per patient: “Maybe we also need a $90/$90/$90 cascade”, she said, referring to costings for the three main measures of diagnosis, retention in care, and viral suppression.
The availability of multiple generic drugs and fixed-dose combination pills would add another level of complication, Antinori and Møller told the meeting, unless guidelines remained clear about recommended and non-recommended drug regimens. “It could be a big problem when different countries get widely different prices for optimal regimens, or cheaper prices for worse ones.”
Kowalska added that physicians were in an advantageous position to complement and help to modify surveillance data such as that compiled by ECDC. “Physicians are in a unique position to know what’s going on at ground level,” she said, “whether it’s primary care physicians seeing HIV in their patients, or HIV physicians seeing poor retention, treatment shortages, poor adherence and viral suppression in theirs. Because of this EACS could be in a good position to add precision to ECDC’s surveillance figures. It is not possible to discuss continuity of care without physicians.”
What clinicial standards do we need?
Two workshops at the meeting formulated the minimum data needed to establish a set of clinical standards. The first looked at guideline harmonisation across Europe and the minimum standard of data needed, including data on appropriate regimens, monitoring and outcomes such as deaths and viral suppression. Andrea Antinori of Italy and Nina Friis Møller of Denmark said that if EACS’ aim was to be the European HIV guidelines they would have to reform their evidence base, as they do not use the GRADE system for evaluating the strength of evidence, unlike the British HIV Association (BHIVA) guidelines and the Netherlands guidelines.
Meanwhile, at the other end of the scale, a Russian delegate said: “From this year, we will attempt to follow the WHO guidelines” (which in 2015 recommended treatment for all upon diagnosis) “but of course, with 40,000 new HIV cases a year, it’s all about money. Some better-off areas like Moscow manage to go further and follow EACS.”
One fairly radical suggestion was that regular CD4 monitoring could be dropped completely as long as there were regular viral load tests. CD4 counts would only be done on diagnosis, in people not on antiretroviral therapy, in cases of virological failure, and when people were on immunosuppressive (e.g. cancer) chemotherapy.
This step might not be possible in eastern/central Europe. Viral load monitoring is irregular in some countries and in Serbia is not done at all, a situation all delegates agreed needed redressing.
“To conform to guidelines you have to provide access to proper care and diagnostics,” commented Antinori and Møller. “Where does EACS’ responsibility start and end in this? It implies a more political role.”
Mapping shortages and loss to follow-up
From this discussion arose a suggestion that EACS should start a mapping and monitoring project that would enable members to report on drug and diagnostic shortages, issues of retention, prevalence and eligibility for care of migrants, use of generics versus single-tablet regimens, and so on.
Retention in care was the subject of a workshop by itself. One problem is defining what retention in care actually is, and how to measure it, given that stable patients in long term care may only be having two appointments a year and even less frequent monitoring. One draft definition is that the patient has no attendances within a given period that is significantly larger than either the usual monitoring frequency or the treatment refill period. A simpler one suggested at the meeting by Kevin de Cock was that of the proportion of patients failing to appear within a certain number of weeks after a missed appointment. He urged that “test and immediate treat” (i.e. patients walk out of the clinic with their first antiretroviral therapy prescription the day they are diagnosed, to avoid loss of retention) should be adopted in Europe as standard, as it had been in parts of Africa.
If we can identify loss to follow-up (LTFU) patients, can we develop strategies that can usually restore linkage to care and prevent LTFU in future, suitable for summary in a set of guidelines? One issue is how to find LTFU patients. Some studies have found that text messages work best because the one thing highly mobile patients keep is their mobile phone number; in other situations this might be regarded as intrusive or phone numbers are not taken. One course of action is to (discreetly) ask other services about patients: this might include searching for attendances at STI and indeed other clinics; to look for evidence of HIV re-tests, if the country has name-based HIV reporting; to monitor attendances at TB, antenatal and mental health clinics; to make enquiries to see if they are known at local community organisations and centres; and to check for incarcerations with prisons and migrant detention centres.
It was strongly suggested that the next issue of the EACS guidelines include a short section defining retention and suggesting strategies for loss to follow-up.
A third workshop looked specifically at tuberculosis (TB). This is firstly because parts of eastern Europe have the highest levels of multi-drug-resistant (MDR) TB anywhere in the world, secondly because HIV and TB co-infection is itself a driver of TB spread and drug resistance, and thirdly because HIV cases are being missed because of lack of testing in TB patients – and vice versa. Only 50% of people diagnosed with HIV in Europe are tested for TB (partly because of assumptions that TB prevalence in gay men in high-income countries will be very low) and only 65% of TB patients are tested for HIV (in Europe, 5% turn out to have HIV).
A culture of quality
Marco Vitoria from the World Health Organization contributed an in-depth look at what “quality of care” actually meant.
“Why has quality of care not become part of the culture of medicine?” he asked. “We need a culture of quality”. He then partly answered his own question by talking about the complexity of the idea. “Quality” is a multidimensional concept that has to include and synthesise the viewpoints of doctors, patients and healthcare funders. It has to be able to supply measurable benchmarks against which improvements and deteriorations in care can be measured, especially in conditions of expansion, scale-up and task shifting.
And, while it is certainly about “access to high quality commodities and diagnostics”, it is potentially about being able to measure so many other variables. These include laboratory performance; patient tracking and retention; treatment coverage; nutrition and food insufficiency; proportion virally suppressed; transmitted and acquired drug resistance; psychosocial variables ranging from financial situation to mental health; and, last but not least, the proportion of people reporting discrimination of stigma.
Broad conclusions
In general, the meeting concluded that the EACS guidelines should maintain much of their present shape but strengthen their evidence base; but they should also form part of a broader set of standards of care, in collaboration with agencies such as ECDC and WHO, and that interdisciplinary meetings should happen soon to discuss their shape.
Manuel Battegay said that doctors did have a specific part to play in what should be a much broader and more comprehensive set of standards of care. Points to include in any new document were frequency of CD4 monitoring, viral load monitoring as mandatory and of a given minimum frequency, recommendations for testing in settings likely to yield the highest proportion of diagnoses (including hospital admissions), testing all TB patients, a definition and simple guide to retention in care, and, in the new era of antiretroviral-based prevention, uptake of pre-exposure prophylaxis (PrEP) uptake. He suggested a specific agreement be devised to set out EACS and ECDC’s working relationship.
At the same time as a larger set of standards was being formulated, however, it was also emphasised that as a result of the greater consensus between guidelines, there was now an advantage in issuing specific, easy-to-read, perhaps graphically-presented factsheets on specific sections, in a broader variety of languages than currently, that could be used by doctors, patients and patient advocates in a variety of settings. These should be clear on best practice but sensitive enough to adapt to local conditions.
Mike Youle of London’s Royal Free Hospital made the point that especially in the era of comprehensive viral suppression, guideline and standards documents had to be aimed at the whole medical profession “Otherwise you will still get the phenomenon of surgeons who in some countries refuse to operate on people with HIV and midwives who refuse to deliver babies.”
Germany’s Jürgen Rockstroh summed up the meeting by saying: “We are clinicians and up till now have just been clinicians. But now we need to start working with other specialisms and with international organisations.”
By Gus Cairns
Reference
The programme and all presentations from the 2016 EACS Standard of Care meeting can be downloaded from http://www.eacsociety.org/conferences/standard-of-care-meeting/standard-of-care-2016.html
