An interesting debate about vitamin D testing (total 25-OH vitamin D –D3 + D2), I guess we could have similar debates about a number of popular tests – B12, Folate, CRP for example. Here are some observations from out testing experience at Birmingham Heartlands Hospital.
From a laboratory point of view could we argue that the pressure on this analysis has resulted in laboratories “cutting corners” when it comes to the method of analysis http://www.clinchem.org/content/58/3/531.long or are they good enough? (will register a conflict of interest in that we use LC/MSMS here at HEFT)
From a clinical point of We (here at HEFT) recommend a repeat test after treatment to confirm that treatment has been successful. There does appear to a high degree of non-compliance with replacement therapies – although not formally studied. In terms of testing we found in Birmingham that virtually the entire population was deficient as classified by our reference range. This wasn’t related to economic status but to ethnicity and in terms of repeat testing we found this was minimal I.e. Our guidelines weren’t followed anyway!
When it comes to the reference range data, our data certainly suggests that the range is correct in caucasians. I think looking at our data one could argue that it could be lower in asian populations but by around 15 nmol/L (this is based on looking at PTH response and vitamin D concentration – not immune function or any of the other postulated roles of vitamin d) in our experience PTH is significantly elevated from baseline PTH at around 12 ug/L (30 nmol/L) in caucasians and 6 ug/L (15 nmol/L) in asians – this is changes within the reference range for PTH. PTH only appears to become elevated (above reference range) in cases of severe vitamin D deficiency. Its interesting at this point there does appear to be an economic component to vitamin d deficiency which I would theorise may be due to dietary deficiencies other than vitamin D e.g. Calcium)
Finally from our data it does appear we have reached the top of the vitamin D requesting curve, we are now testing around 70K samples per year for a served population of approximately 1 million. In the study looking at vitamin D and economic status around 75% of the tested population have vitamin d concentrations below and on average approx 30-40% of population severely deficient. There are provisos on this data as the population does have a number of potential biases.
Obviously being a shameless self publicist you can get further details in this paper http://acb.sagepub.com/content/50/1/31.long or this one http://www.ncbi.nlm.nih.gov/pubmed/23140614. I should also point out that Berg et al at another laboratory in Birmingham http://www.ncbi.nlm.nih.gov/pubmed/17132277 found more or less the same data in 2006 as we did in 2012 so in six years of testing, on a population basis there appears to have been no improvement in vitamin D status.
Cheers
Craig
[cid:55E07FBB-96DD-4667-A4FA-4C8B01E047EF][cid:36BF9DA8-49A8-4BCF-B4A6-1604DBBD46D7]
From: Joseph WATINE <[log in to unmask]<mailto:[log in to unmask]>>
Reply-To: Joseph WATINE <[log in to unmask]<mailto:[log in to unmask]>>
Date: Thursday, 10 October 2013 07:31
To: "[log in to unmask]<mailto:[log in to unmask]>" <[log in to unmask]<mailto:[log in to unmask]>>
Subject: Re: vitamin D measurements
Rita, Why do the Australian guidelines recommend to monitor serum 25OH-D levels after treatment (apparently just like Lab-Test-Online USA but unlike Lab-Test-Online UK)? There is not any explanation in the guidelines. Many thanks, Joseph
________________________________
Date: Thu, 10 Oct 2013 13:46:33 +1100
From: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: vitamin D measurements
To: [log in to unmask]<mailto:[log in to unmask]>
The most recent AU/NZ guideline on vitD estimates prevalence of inadequate vitD levels as:
“…31% of adults in Australia have inadequate vitamin D status (serum 25-hydroxyvitamin D [25-OHD] level < 50 nmol/L), increasing to more than 50% in women during winter–spring and in people
residing in southern states”
Another report says:
Two publications have attempted to measure the prevalence of vitamin D deficiency in the Australian population. The first study was conducted by the Baker IDI Heart and Diabetes Institute. The population included 11,218 adults aged 25-95 years. The study reported an estimated 31% of adults in Australia have inadequate vitamin D status (serum 25-(OH)D levels < 50 nmol/L) and that 4% of the population had severely deficient levels (serum 25-(OH)D levels < 25 nmol/L). Individuals at greatest risk for deficiency were identified to be women, the elderly, the obese, people doing less than 2.5 hours of physical activity a week, and people of non-European background.(47) The second study, which assessed 24,819 samples taken from a large reference laboratory in NSW between 1st July 2008 and 30th July 2010, reported that up to 58% of Australians are deficient in vitamin D.(48)
47. Daly RM, Gagnon C, Lu ZX, Magliano DJ, Dunstan DW, Sikaris KA, et al. Prevalence of vitamin D deficiency and its determinants in Australian adults aged 25 years and older: a national, population-based study. Clin Endocrinol (Oxf). 2012 Jul;77(1):26-35.
48. Boyages S, Bilinski K. Seasonal reduction in vitamin D level persists into spring in NSW Australia: implications for monitoring and replacement therapy. Clin Endocrinol (Oxf). 2012 Oct;77(4):515-23.
Regarding your question why it is being measured so much:
1/ there has been a lot of media coverage about vitD insufficiency in Australia
2/ lack of appropriate info and education of GPs
3/ as well as that of patients who read the media and may demand more testing
4/ there might be some financial drivers too (?)
Regarding the reference range and that it may be wrong – well, I agree, it may well be wrong as we have no real outcome data (apart from bone) that would help in setting the right decision thresholds.
Finally, our College and the National Prescribing Service also advise against vitD testing of asymptomatic healthy people and limits testing to specific indications only.
Their guidance doc-s released this year are found at:
http://www.nps.org.au/publications/health-professional/nps-news/2011/vitamind?gclid=CI7Gz-yei7oCFcLqpAodEmsAwQ
http://www.rcpa.edu.au/static/file/Asset%20library/public%20documents/Policy%20Manual/Position%20Statements/Use%20and%20Interpretation%20of%20Vitamin%20D%20Testing.pdf
Kind regards, Rita
Prof. Andrea Rita Horvath, MD, PhD, EurClinChem, FRCPath, FRCPA
Past President of the European Federation of Clinical Chemistry and Laboratory Medicine
Clinical Director, SEALS North, Department of Clinical Chemistry
Level 4, Campus Centre, Prince of Wales Hospital
Barker Street, Randwick, NSW 2031, Sydney, Australia
Tel: (+612)-9382 9078
Fax: (+612)-9382 9099
Mobile No: (+61)-404 027 843
From: Colley, Michael [mailto:[log in to unmask]]
Sent: Wednesday, 9 October 2013 11:13 PM
To: Rita Horvath; [log in to unmask]<mailto:[log in to unmask]>
Subject: RE: vitamin D measurements
Rita
More to the point, what do the results show? Are Australians VitD deficient as well as little Englanders?
If not, why is it being measured so much? If they are, have we got the reference range wrong?
Michael
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Rita Horvath
Sent: 09 October 2013 00:52
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: vitamin D measurements
Very similar data here in sunny (but very “sunscreened”) Australia too, with (on average) every 7th Australian having had a vit D test in 2012. On average this meant 5.5 AUD spent on vit D testing for every single citizen in Australia in 2012. However, the government is reviewing the reimbursement schedule and the below data come from their review protocol.
(NB: France and the UK have about 3x as much population as Australia, so the figure from France indicates that the situation is still somewhat better in France than in AU – mind you the French may not use as much sunscreen as the Aussies; and the Brits perhaps still do not get enough sunshine, in spite of the global warming trends and increasing hot summers in the UK? :) Time for action indeed!
Table A.2: Number of claims for Vitamin D testing MBS items since 2000/2001
MBS item no
Financial year
02/03
03/04
04/05
05/06
06/07
07/08
08/09
09/10
10/11
11/12
66608
73,330
117,474
171,288
249,933
445,854
847,029
1,492,904
2,219,553
2,982,658
3,481,966
66609
743
13,329
9,442
11,397
15,414
7,203
Total
73,330
117,474
171,288
249,933
446,597
860,358
1,502,346
2,230,950
2,998,072
3,489,169
Source: Department of Human Services Medicare
the number of claims for vitamin D testing is particularly significant for females aged between 24 and 84, showing a marked increase from 2008 to 2012 (green line)compared to 2004-2008 (red line)and 2000 to 2004 (blue line).
Figure A.1: Usage of MBS item 66608 by age and gender since 2000
[The graph shows the breakdown by 4 year periods (for 2000 to 2014) and age group for males. For the 2000 to 2004 period the number of claims for Vitamin D testing was low over all age groups. Between 2004 and 2008 the ammount of claims remains low for all age groups with a small increase for age groups from 35 to 44 and 75 to 85 where claims are approximately 90,000. Between 2008 and 2012 the number of claims is significantly higher with the number raising quickly from approximately 75,000 for 5 to 14 year olds to over 60,000 for 55 to 64 year olds at which point the number of claims drops of to approximately 575,000 for 65 to 74 year old, 40,000 for 75 to 84 year olds and finally approximately 100,000 for those over 85 years.][This graph shows the number of MBS claims for vitamin D for women by the age group and date range. Between 2000 and 2004 the number of claims were at their lowest with all age groups having less that 75,000 claims and the majority of claims falling between the age of 35 and 85. Between 2004 and 2008 there were more claims. with 15 to 24 year olds claiming approximately 50,000 tests, 25 to 44 year olds claiming aproximately 125,000. There was a jump in the number for those between 45 to 74 with 45 to 45 year olds claiming over 200,000 tests, 55 to 64 year olds claiming around 220,000 and 65-74 year olds claiming around 200.000. The number of claims drops off here again with 75 to 84 year olds claiming just under 200,000 and those over 85 claiming less than 100,000. Between 2008 and 2012 claims for those under 14 were still low. After this point there is a massive increase in the number of claims with the age group between 15 and 24 claiming almost 400,000, those between 25 and 34 as well as those between 35 and 44 claiming well in excess of 900,000. The number increasing a lot after this too with 45 and 54 claiming up to 1,200,000 and 55 to 64 year olds claiming almost 1,400,000. The number of claims drops a bit here with a steady decrease after the age of 65 to around 300,000 for those over 85.]
Figure A.2 shows that the annual MBS benefits paid for vitamin D testing (item numbers 66608 and 66609) has increased significantly from $2.6 million in 2002 to $126.5 million in 2012. The significant increase in the benefits paid for both item numbers is consistent with the increase in the volume of claims.
Figure A.2: Benefits paid for MBS item number 66608 and 66609 since 2002/2003
[cid:image003.png@01CEC5BD.D1A8BB30]
Source: Department of Human Services Medicare
Kind regards, Rita
Prof. Andrea Rita Horvath, MD, PhD, EurClinChem, FRCPath, FRCPA
Past President of the European Federation of Clinical Chemistry and Laboratory Medicine
Clinical Director, SEALS North, Department of Clinical Chemistry
Level 4, Campus Centre, Prince of Wales Hospital
Barker Street, Randwick, NSW 2031, Sydney, Australia
Tel: (+612)-9382 9078
Fax: (+612)-9382 9099
Mobile No: (+61)-404 027 843
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Joseph WATINE
Sent: Sunday, 6 October 2013 8:05 PM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: vitamin D measurements
In France vitamine D measurement in blood is now the 5th lab test in terms of costs for the "sécurité sociale": it costed almost 100.000.000 Euros in 2111, and the number of requests of vitamin D are increasing exponentially: the costs were below 40.000 Euros in 2009. At such a speed of increase, it would not be surprising that the costs would reach 150.000.000 Euros in 2013 and thus vitamin D would become the 2nd most costly test for the collectivity in France just after blood cell counts which cost 300.000.000 Euros each year (quite stable).
I would be interested to know whether or not such a waste of collective ressources are specific to France or if the same happens elsewhere in the world, particularly in the UK.
Best regards, Joseph, Villefranche-de-Rouergue, France
Dr Joseph Watine, PH, AIHP, PharmD, AAHU, EurClinChem
Laboratoire de Biologie Polyvalente
Centre Hospitalier La Chartreuse
Avenue Caylet
12200 Villefranche-de-Rouergue
France
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