Rapid Responses to:

CLINICAL REVIEW:
Anthony D Woolf and Kristina Åkesson
Preventing fractures in elderly people
BMJ 2003; 327: 89-95 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] HIP PROTECTORS
Arthur Leibovitz   (10 July 2003)
[Read Rapid Response] Coeliac disease should not be overlooked as a cause of osteoporosis
Sharif Hossain   (13 July 2003)
[Read Rapid Response] Bone densitometry measurement at hip has better predictive value
Jamal Hossain   (13 July 2003)
[Read Rapid Response] What about the team approach?
Douglas G MacMahon   (14 July 2003)
[Read Rapid Response] The value of case-finding in Primary Care
Michael R Harvey, Brown Pam   (21 July 2003)
[Read Rapid Response] FALLSAFE
Stephen A Taylor, Brian Hudson retired engineer   (23 July 2003)
[Read Rapid Response] Retrospective analysis: prospective guide
Soneet Aggarwal, Dr. SS Sangwan, Dr. Vikas Yadav,Dr.Ashish Devgan,Dr. Zile Singh,   (13 August 2003)
[Read Rapid Response] How to find patients with osteoporosis from GP records.
Simon de Lusignan, Nigel Hague, and Tom Chan   (2 September 2003)
[Read Rapid Response] ECONOMIC APPROPRIATENESS OF THE EXPENDITURE FOR ALENDRONATE: COST-EFFECTIVENESS ANALYSIS OF NATIONAL PRESCRIPTION DATA IN ITALY
Andrea Messori, Benedetta Santarlasci, Sabrina Trippoli, and Monica Vaiani   (12 November 2003)

HIP PROTECTORS 10 July 2003
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Arthur Leibovitz,
Chief of LTC Ward ans R&D
Shmuel Harofe Hospital Israel

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Re: HIP PROTECTORS

Excellent article . However the simple , low cost, and immediately effective HIP PROTECTORS are not emphasized enough. This device is underused , mainly because it is not known enough among patients and doctors as well. And why - if efficient in nursing homes - should we doubt its efficiency in the community ? Hip protectors should be recommended and used for primary as well for secondary prevention of hip fractures and knowledge of this alternative should be disseminated.

Competing interests:   None declared

Coeliac disease should not be overlooked as a cause of osteoporosis 13 July 2003
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Sharif Hossain,
House Surgeon, Department of Surgery, Princess Royal University Hospital, Orpington, Kent
BR6 8DN

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Re: Coeliac disease should not be overlooked as a cause of osteoporosis

Sir,

It is a timely review for fracture prevention in the elderly (1). The authors states malabsorption syndrome is a contributory factor for osteoporosis. Coeliac disease has been overlooked . It is common,affects upto 20% patients older than 60 years of age, can cause osteoporosis and fracture. This condition as common 1 in 200 to 300 in Europe and North America. It is important to note that in coeliac disease, diarrhoeal symptoms may be absent in adult patients 2 in about 50% cases and iron deficiency anaemia is the most common presentation and other laboratory abnormalities may co-exist (2).

Dr S Hossain House Surgeon Department of Surgery Princess Royal University Hospital Orpington Kent BR6 8ND

References: 1.Woolf A D and Akesson K. Preventing fractures in elderly people. BMJ 2003; 327: 89-95 2. Farrell R J and Kelly C P. Current concepts: Celiac Sprue. New England Journal of Medicine 2002; 346(3): 180-88.

Competing interests:   None declared

Bone densitometry measurement at hip has better predictive value 13 July 2003
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Jamal Hossain,
Consultant Physician,Deaprtment of Elderly care, William Harvey Hospital, Ashford, Kent
TN24 OLZ

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Re: Bone densitometry measurement at hip has better predictive value

Sir, Congratulations for this excellent review (1). Although the measurement bone densitometry is useful to assess the risk of future fractures, but caution should be exercised. Bone densitometry measurement in spine in the elderly may cause difficulty in interpretation due to presence of degenerative changes and may show bone mass artifactually elevated. Measurement of bone densitometry at hip has the highest predictive value for hip fracture (2).

Dr J Hossain Consultant Physician Department of Elderly care William Harvey Hospital Ashford Kent TN24 OLZ

References: 1.Woolf A D and Akesson K. Preventing fractures in elderly people. BMJ 2003; 327: 89-94

2. Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet 2002;339:1929-35.

Competing interests:   None declared

What about the team approach? 14 July 2003
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Douglas G MacMahon,
Consultant Physician (Geriatric Medicine)
Royal Cornwall Hospitals NHS Trust

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Re: What about the team approach?

Sir, May I add my congratulations for this excellent review (1). My only criticism is that it is a very circumscribed medical approach. To really make an impact on this huge and growing epidemic, there is a large evidence base about the value of a multidisciplinary approach(2,3). I would assert the importance of a strategy that ensures the medical profession acts in tandem with therapists, nurses, dieticians, pharmacists, and colleagues in health education. Further, to really impact on the issue, we have tried an approach that attracts the attention of older persons themselves, their family or friends, and/or members of their community. This has included a leaflet (entitled 'Checkmate') that aims to warn those at risk, and those in contact with them, of the dangers of falling and a simple check list(4). It has been widely distributed to all those who have regular contact with elderly persons. We have targeted other groups according to their perceived risk, and the strategy appears on our web-site(4). It is too great a problem for one profession to take exclusive rights!

References:

1. Woolf A D and Akesson K. Preventing fractures in elderly people. BMJ 2003; 327: 89-94

2. Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7.

3. Close J, Ellis M, Hooper R, Glucksman E, Jackson S, Swift C. Prevention of falls in the elderly trial (PROFET): a randomised controlled trial. Lancet 1999;353: 93-7.

4. www.fallsprevention.co.uk/

Competing interests:   Member of local multidisciplinary falls prevention group

The value of case-finding in Primary Care 21 July 2003
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Michael R Harvey,
GP & Chaie NOS Scientific Advisory Group Primary Care Forum
Cuckfield Medical Practice. RH17 5BQ,
Brown Pam

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Re: The value of case-finding in Primary Care

We would like to congratulate Woolf and Akesson on an excellent review of the identification and management of Osteoporosis in people over 65. It is very readable and a concise guide for those at the practical end of osteoporosis and falls management – primary care.

It highlights the true value of the “over 75” annual check in identifying fallers and those at risk of falling, helping to establish a base for the falls register. However it lacks in the details of the practical issues involved in case-finding in primary care. We agree that the approach should be either opportunistic or proactive, but would refer readers to the National Osteoporosis Society’s Primary care strategy for osteoporosis and falls, that is available for downloading from the NOS website – www.NOS.org.uk – and that has been distributed to all PCOs in the country.

A review of data relating to osteoporosis in Primary Care by the Kent, Surrey and Sussex research network highlights the variable recording of identifiable risk factors for either osteoporosis or falls unless there is a specific interest within the practice. The NOS has produced a set of osteoporosis related READ codes for use in general practice, also available for downloading from the website, and is completing a similar set of falls related codes, encompassing all the risk factors discussed by Woolf and Akesson.

Finally in their discussion of monitoring response to treatment, it should be emphasised that peripheral densitometry is not currently suitable for this purpose, only densitometry of the lumbar spine and hip. However we strongly endorse the view that the burden of osteoporosis in the elderly can be reduced now, given a pro-active approach by practices and their PCOs.

Competing interests:   MH has received support from Shire and MSD, PB has received support from Shire, MSD and P & G

FALLSAFE 23 July 2003
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Stephen A Taylor,
GP retired
25 Boscobel Rd. Walsall WS1 2PL,
Brian Hudson retired engineer

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Re: FALLSAFE

Dear Sir, Ref. Clinical review 12th July 03

Preventing fractures in elderly people

I read with interest Professor Woolf’s review of what is being done and what should be done to prevent fractures in elderly people.

An engineer colleague and myself are developing an inflatable “Jacket”. Within this jacket are balloons, which protect the hips, the chest, the back, the face and the back of the head. On evidence that a fall is inevitable, they inflate in less than 0.2 seconds. The balloons draw air into other spaces in the jacket as they inflate.

We have a working prototype of the jacket (which is proof of the concept) and a lot of data from the sensor. If it were to come to the market and be used, it might complete the armamentarium against fractures in those liable to fall.

We are calling it FALLSAFE

Dr Stephen Taylor
retired GP
DSAWTaylor@aol.com

Brian Hudson
retired engineer.

Anthony D Woolf, Kristina Akesson Preventing fractures in elderly people BMJ 2003; 327; 89; 94 12th July.

Competing Interests: none. Self financed

Competing interests:   None declared

Retrospective analysis: prospective guide 13 August 2003
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Soneet Aggarwal,
Registrar Orthopaedics
PGIMS, ROHTAK, INDIA-124001,
Dr. SS Sangwan, Dr. Vikas Yadav,Dr.Ashish Devgan,Dr. Zile Singh,

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Re: Retrospective analysis: prospective guide

Dear Editor, We have done retrospective analyses of all the patients suffering fracture intertrochanteric or intracapsular neck fractures above age of 50 years. The most common cause besides stroke, neuroleptic drugs, imbalance which are related to direct impact on greater trochanter leading to fracture ; indirect torsional stress was also found to be the major cause in Indian males.

On critical analysis for establishing the cause it was found that when they try to wear undergarments they have to stand on one leg strain on weight bearing hip is seven times the normal and centre of gravity is shifted forwards and as soon as they rotate they have the fracture of the osteoporotic neck or the trochanter. This leads to fall.Trauma also occurs due to fall after fracture had occured.This questions the role of hip protectors in such mode of trauma to trochanteric fractures. We recommend that waist belt should be elastic in undergarments as compared from that of string which has to be tied every time.

Secondly aged should wear clothes while sitting on a higher stool; rather than standing on one leg which increases the strain on the affected hip.

Indian or third world countries are more osteoporotic for the same age that of the third world countries. this was well established by our analysis as the mean age of the fracture trochanter was 55 in Indian set up.

Competing interests:   None declared

How to find patients with osteoporosis from GP records. 2 September 2003
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Simon de Lusignan,
Senior Lecturer
Department of Community Health Scineces, St. George's Hospital Medical School, LONDON, SW17 0RE,
Nigel Hague, and Tom Chan

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Re: How to find patients with osteoporosis from GP records.

We wish to add a pragmatic point to the excellent review by Woolf and Akesson [1]. Unfortunately much of what are listed as risk factors for osteoporosis and falls is not widely recorded in General Practice computer records; making it difficult to systematically identify the patients at high risk [2]. GP data relating to risk factors for osteoporotic fracture can be classified into three groups (Table 1):

A) Where recording is likely to be good or a surrogate marker exists – e.g. drugs prescribed for that condition.) Repeat prescribing data is of very high quality in UK General Practice as it saves the doctor time [3].
B) Where recording is patchy,
C) Where recording is absent or problematic.

Whilst it is known that previous fragility fracture, premature menopause, a family history of hip fracture, and the use of oral corticosteroids identify their 10-year risk of hip fracture [4], such scales are difficult to use if the required data is not available.

What is needed is to be able to predict fracture risk from the data held already. The research needed to answer this question should be commissioned as a matter of urgency. This would improve the management of patients with risks of fracture in primary care, while the coding and classification system is “developed” to make it easier for general practitioners to record low impact fractures. Our recommendation is that all adult fractures should qualified as high or low impact, as a matter of routine - just as they are currently classified open or closed.


TABLE 1:  LEVELS OF RECORDING OF RISK FACTORS FOR
OSTEOPOROTIC FRACTURES AND FALLS:

GROUP A:  RECORDING GOOD OR A SURROGATE EXISTS:
1)	BMI (Body Mass Index) <19.  
2)	Treatment with corticosteroids.  
3)	Previous low body weight 
4)	Rheumatoid Arthritis			
5)	Chronic liver disease
6)	Inflammatory bowel disease
7)	Coeliac disease				
8)	Smoking 
9)	Excessive alcohol consumption
(Raised liverenzymes can be found in practices with
automated links to pathology labs.)
10)	Parkinson’s disease
(probably via drugs that are only used to manage Parkinson’s)
11)	Glaucoma
(also through search for drugs used in glaucoma)
12)	Alzheimer’s and drugs for Alzheimer’s disease
13)	Epilepsy and drugs for epilepsy

GROUP B: RECORDING IS PATCHY:
1)	Radiographic evidence of osteoporosis or vertebral deformity or both
(Unlike pathology there is no automatic posting of x-ray results into GP records)
2)	Thoracic kyphosis, with radiographic confirmation of vertebral deformity
3)	Cataracts 
4)	Macular degeneration
5)	Partially sighted, registered blind
6)	Vertibrobaislar insufficiency
7)	Cerebrovascular disease
8)	Transient Ischaemic Attacks

GROUP C:  RECORDING ABSENT OR PROBLEMATIC:
1)	Loss of height
(this is difficult as many GPs have recorded height based on the patients verbal statements)
2)	Fracture after low energy trauma
(very hard from GP records –
primary care fracture recording is patchy and
only rarely does it indicate if it was low energy trauma)
3)	Reduced lifetime exposure to oestrogen –
menopause or hysterectomy <45 years
(the date associated with the hysterectomy can sometimes
be the date that the data was entered, and sometimes
the date that the practice changed computer system!)
4)	Maternal hip fracture – there is a code for this (12I4) but it is rarely used. 
5)	Low calcium intake
6)	Physical inactivity
7)	Vit D deficiency – low exposure to sunlight
8)	General deterioration associated with ageing –
poor postural control, reduced walking speed, weak legs, slow reaction times.
9)	Hypoglycaemia
10)	Postural hypotension
11)	Syncope
12)	Hypotensive drugs
13)	Multiple drug therapy

References:

[1] Woolf A D, Akesson K. Preventing fractures in elderly people. BMJ 2003; 327: 89-94

[2] de Lusignan S, Chan T, Wells S, Cooper A, Harvey M, Brew S, Wright M. Can the patients with osteoporosis, who should benefit from the implementation of the National Service Framework for Older People, be identified from General Practice computer records? A pilot study that illustrates the variability of computerised medical records and problems with searching computerised medical records. Accepted for publication: Public Health.

[3] Roland MO, Zander LI, Evans M, Morris R, Savage RA. Evaluation of a computer assisted repeat prescribing programme in a general practice. BMJ 1985;291:456-8.

[4] Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet. 2002 Jun 1;359(9321):1929-36.

Competing interests:   SdeL and NJH are in receipt of an unconditional eductional grant from MSD for the Primary Care Data Quality Programme

ECONOMIC APPROPRIATENESS OF THE EXPENDITURE FOR ALENDRONATE: COST-EFFECTIVENESS ANALYSIS OF NATIONAL PRESCRIPTION DATA IN ITALY 12 November 2003
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Andrea Messori,
Coordinator
Laboratorio SIFO di Farmacoeconomia, Pharmaceutical Service, Careggi Hospital, 50134 Firenze, Italy,
Benedetta Santarlasci, Sabrina Trippoli, and Monica Vaiani

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Re: ECONOMIC APPROPRIATENESS OF THE EXPENDITURE FOR ALENDRONATE: COST-EFFECTIVENESS ANALYSIS OF NATIONAL PRESCRIPTION DATA IN ITALY

ECONOMIC APPROPRIATENESS OF THE EXPENDITURE FOR XXXXX: COST-EFFECTIVENESS ANALYSIS OF NATIONAL PRESCRIPTION DATA IN ITALY

One important pharmacological approach for preventing fractures in women with menopausal osteoporosis is the chronic administration of an oral biphosphonate. Alendronate, given for 5 or more years, is the most widely prescribed agent for this clinical indication. The review of Woolf and Akesson (1) discusses the clinical effectiveness of this agent, but does not address the issue of its cost-effectiveness. In this contribution, we present an analysis where an innovative index for assessing economic appropriateness (2,3) is determined for this treatment and is then compared with those calculated previously for other drug classes. The main advantage of this method lies in its extreme simplicity of application (2,3).

 

Briefly, this innovative method of cost-effectiveness analysis (2,3) interprets the value of national expenditure (EXPEND) for a given drug class (or for single pharmacological agent; in this case alendronate) and, in particular, assigns an index to the treatment(s) under examination wherein the health gain (EHG) theoretically expected from EXPEND (according to current benchmarks of cost effectiveness) is compared with the amount of health presumably gained in the “real” patients (real health gain, or RHG, estimated using epidemiological data and evidence-based information). Because saving one year of life (irrespective of whether the year is unadjusted or adjusted for quality of life) is generally valued around 10,000 Euros (or 10,000 US dollars), spending appropriately an amount of money equal to EXPEND is expected to yield a survival gain (or EHG) of at least EXPEND/10,000 years of life. On the other hand, the value of RHG is calculated from the nation-wide number of patients receiving the treatment (Npatients) multiplied by the average gain in quality-adjusted survival per patient (GAINQALYs). GAINQALYs relies on the availability of an ad-hoc study that has estimated the average gain in quality-adjusted survival for the patients receiving the treatment examined. Comparing the EHG (e.g. 65,400 years of life for the 2002 expenditure for statins in Italy) with the RHG (e.g. 107,114 years of life for statins in Italy) yields the final index, which is favourable when RHG>EHG and unfavourable when RHG

 

In the first semester of 2003, 62 million Euros have been spent on alendronate (personal communication by Bruzzone M and Puca E, Italian Ministry of Health, October 2003). To interpret this finding, our analysis proceeds according to the steps outlined in Table 1.

The value of EHG is 6,212 years of life. To determine RHG, the cost of alendronate treatment for a semester = is assumed to be 525.6 Euros per patient because each daily dose costs, on average, 1.44 Euros (data from the website of the Italian Ministry of Health). If one accepts that the average treatment duration (4) is 5 years (i.e. 10 semesters) and that the first semester 2003 reflects a steady-state condition, the new users of alendronate are one tenth of the total population receiving these drugs in the first semester 2003 (N=236,371), hence, Nexposed patients is changed to 23,637.

The aim of alendronate treatment is to alleviate disease-related symptoms and to improve the patients’ quality of life. According to the data presented by Johnell et al., starting a new treatment with alendronate in 23,637 Italian patients produces a quality-adjusted survival gain of 0.08 years per patient (with 3% annual discount) or 0.093 years per patient (with no discounting). Hence, RHG = 0.08 years x 23,637 = 1,891 years of quality-adjusted survival gain (with 3% annual discount) or RHG = 0.093 years x 23,637 = 2,198 years of quality-adjusted survival gain (with no discounting).

Comparing the EHG of 6,212 years of life with the RHG of either 1,891 years or 2,198 years shows that spending on alendronate seems to be quite inappropriate for our national health system (at least at the current price level for these agents). This amount of health of about 2,000 years of life (i.e. RHG) has in fact been bought at a three-fold price than the average (as shown by the finding that RHG is one third of EHG). In  our previous studies, this index was favourable for statins (2) and highly unfavourable for coxibs (3).

Some questions on whether this approach to evaluate economic expenditures is acceptable have already been raised, and comments on the weaknesses of this method have been presented as well (2,3). However, despite these limitations, our results show that alendronate has probably been recognised an excessive price in Italy in comparison with the clinical benefit is produces. Hence, its present generalised reimbursement status in patients with postmenopausal osteoporosis might need some form of revision.

 

REFERENCES

 

1. Woolf AD, Akesson K. Preventing fractures in elderly people. BMJ 2003;12;327(7406):89-95.

 

2. Messori A, Santarlasci B, Trippoli S, Vaiani M. Spending on statins. eBMJ http://bmj.com/cgi/eletters/327/7420/933-b#38400, 20 Oct 2003


3.
Messori A, Santarlasci B, Trippoli S, Vaiani M. Economic appropriateness of the expenditure for coxibs: cost-effectiveness analysis of national prescription data in Italy. eBMJ  http://bmj.com/cgi/eletters/327/7420/933-b#39700, 5 Nov 2003

 

4. Johnell O, Jonsson B, Jonsson L, Black D. Cost effectiveness of alendronate (Fosamax) for the treatment of osteoporosis and prevention of fractures. Pharmacoeconomics 2003;21(5):305-14.

 

 

Table 1. Formulas on which our method is based and their application to the alendronate analysis.*

 

        

EXPECTED HEALTH GAIN

(EHG)

REAL HEALTH GAIN

(RHG)

 

-formulas:

EHG (years or QALYs) = EXPEND /10,000

 

Nexposed patients = EXPEND / (COST1DDD x DAYSexpend)

Nbeginners = Nexposed patients / (DAYStreatment  / DAYSexpend)

RHG = N beginners x GAINQALYs

 

-alendronate analysis:

 

EHG = 62,118,205 /10,000 = 6,212 years or QALYs

According to Johnell et al. (4) (QALYs gain with discounting of 3%):

Nexposed patients= 62,118,205 / (1.44 x 182.5) = 236,371

Nbeginners = 236,371 / [(365 x 5) / (365 x 0.5)] =23,637

RHG = 23,637 x 0.08 = 1,891 QALYs

 

According to Johnell et al. (4) (QALYs gain with no discounting):

Nexposed patients =    see above

N beginners =  see above

RHG = 23,637 x 0.093 = 2,198 QALYs

 

 

*ABBREVIATIONS:

-     EXPEND = expenditure in Euros observed over a time interval equal to DAYSexpend (in days) 

-     Nexposed patients = overall number of patients exposed to the treatment over the time interval of  DAYSexpend

-     COST1DDD = cost in Euros of a single DDD

-       Nbeginners  = number of patients who begin the treatment over the time interval of  DAYSexpend

-     DAYStreatment    = duration of the treatment (in days); for example, 5 years of alendronate treatment give DAYStreatment   = 1,825 days

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Competing interests: None declared