Impact of UK NICE Clinical Guidelines 168 and social deprivation on access to interventional treatment for symptomatic varicose vein and specialist referral for leg ulceration

Abstract

Background

UK National Institute for Health and Care Excellence (NICE) clinical guidelines (CG) 168, published in July 2013, aimed to improve the management of lower limb venous disease by newly recommending interventional treatment for all people affected by symptomatic varicose veins (VV) and specialist vascular referral for all people suffering from a leg ulcer (LU) that had been present for ≥2 weeks. This study aims to determine if CG168 has increased access to vascular services, particularly for the socially deprived, who might be expected to have greater need for such services.

Methods

The study was performed in a highly multi-cultural, socio-economically diverse, mixed urban/suburban population of approximately 1.2 million people living in and around East Birmingham, UK. Index of multiple deprivation quintile (IMD-Q) was used as a measure of social deprivation to compare levels of social deprivation of people undergoing interventions for symptomatic VV or referred with an LU during 18-month periods before and after the publication of CG168. The referring general practitioner practices (GPPs) were also recorded.

Results

There was no change in overall IMD-Q distribution before and after CG168 in terms of VV interventions. However, there was a non-significant increase in proportions of people classified as IMD-Q5 (the most deprived quintile). After CG168, fewer IMD-Q5 people with LU were referred, with a shift in referrals towards those from less socially deprived areas. More GPP referred people with both VV and LU after CG168, and those that referred patients before and after CG168 tended to refer more after CG168.

Conclusions

CG168 has increased VV interventions as well as the number referred with LU. However, this improvement in access to treatment and referral may have disproportionately favoured the more socio-economic privileged. Professional and public education is required to ensure that the beneficial impact of the CG168 recommendations are maximised and that those with the greatest health needs have equal access to evidence-based management of their venous disease.

Keywords

Varicose veins leg ulceration endovenous index of multiple deprivation IMD social

Introduction

The UK National Institute for Health and Care Excellence (NICE) clinical guidelines (CG) 168, published in July 2013, aimed to improve the management of lower limb venous disease by newly recommending interventional treatment for all people affected by symptomatic varicose veins (VV) and specialist vascular referral for all people suffering from a leg ulcer (LU) that had been present for two or more weeks.¹ Although little is known about the effects of social deprivation on the epidemiology of uncomplicated VV, there is considerable evidence of an association between LU, often the most severe manifestation of lower limb venous disease, and social deprivation.²

The aim of this study was to examine the impact of CG168 and social deprivation on access to interventional treatment for symptomatic VV and specialist vascular referral for LU. In particular, we wished to determine whether the publication of CG168 had increased access to care among people from more socially deprived areas, where there might be expected to be greater need for such services.

Methods

The Heart of England NHS Foundation Trust (HEFT) comprises three hospitals and serves a highly multi-cultural, socio-economically diverse, mixed urban and suburban population of approximately 1.2 million people living in and around East Birmingham, UK.

Patients (n = 1236) undergoing surgical or endovenous intervention at the HEFT for symptomatic VV, or referred because of LU, during 18-month periods before (1 January 2012–30 June 2013, group 1) and after (VV: 1 July 2013–31 December 2014; LU: 1 January 2014–30 June 2015) publication of CG168 were compared in terms of clinical severity (CEAP clinical grade),³ index of multiple deprivation quintile (IMD-Q) and the referring general practitioner practice (GPP).

The index of multiple deprivation (IMD) methodology, based on a UK government qualitative study of deprived areas within England,⁴ assigns each postal code an overall deprivation score based upon seven domains: income, employment, health deprivation and disability, education skills and training, barriers to housing and services, crime and living environment. These scores are then divided into quintiles (Q) with Q1 being the least, and Q5 being the most deprived, for further analysis.

Results

VV interventions before and after the publication of CG168

Publication of CG168 was associated with a 65% increase in the number of people (from 253 to 417) undergoing intervention for symptomatic VV at HEFT. This increase was observed in all IMD-Qs and there was no significant change in the IMD-Q distribution overall (Table 1) or, specifically, in those undergoing surgery, endothermal ablation or ultrasound-guided foam sclerotherapy. There was an overall increase in patients undergoing intervention for CEAP clinical grade (C) 2 and 3 disease, but there was no significant association between this increase and the distribution of IMD-Q in the two groups. There was also no significant change in the IMD-Q of people undergoing intervention for CEAP C4 and C5 disease. However, there was a considerable (29%–52%) non-significant increase in the number of IMD-Q5 (most deprived) people undergoing intervention for CEAP C6 disease (Table 2).

Table 1.

VV interventions before and after CG168 by IMD-Q.

	Before CG168		After CG168
IMD-Q	Patients (n)	Percentage	Patients (n)	Percentage	p
1	49	19.4	75	18.0	0.731
2	54	21.3	76	18.2	0.374
3	48	19.0	69	16.5	0.486
4	25	9.9	56	13.4	0.214
5	77	30.4	141	33.8	0.412
Total	253	100	417	100	0.529

CG: clinical guidelines; IMD-Q: index of multiple deprivation quintile; VV: varicose veins.

Table 2.

VV interventions before and after CG168 in patients with open LU (CEAP C6).

	Before CG168		After CG168
IMD-Q	Patients (n)	Percentage	Patients (n)	Percentage	p
1	5	23.8	3	11.1	0.435
2	2	9.5	5	18.5	0.643
3	4	19.0	4	14.8	0.696
4	4	19.0	1	3.7	0.211
5	6	28.6	14	51.9	0.184
Total	21	100	27	100	0.190

CG: clinical guidelines; IMD-Q: index of multiple deprivation quintile; LU: leg ulceration; VV: varicose veins.

LU referrals before and after the publication of CG168

Publication of CG168 was associated with a 112% increase in the number of people (from 181 to 385) referred with LU. Although this increase was observed in all IMD-Qs, there was a significant (χ², p = 0.023) change in the IMD-Q distribution away from the most socially deprived quintiles with the proportion of IMD-Q5 referrals falling from 30% to 20% (χ², p = 0.011) (Table 3). With the exception of functional venous insufficiency, defined as typical venous skin changes and ulceration in the absence of superficial or deep venous reflux on duplex ultrasound, and which was most commonly seen in IMD-Q5 patients in both cohorts, there was no significant relationship between LU aetiology and IMD-Q either before or after the publication of CG168.⁵

Table 3.

LU referrals before and after CG 68 by IMD-Q.

	Before CG168		After CG168
IMD-Q	Patients (n)	Percentage	Patients (n)	Percentage	p
1	37	13.2	94	24.4	0.348
2	43	23.8	84	21.8	0.684
3	20	11.0	74	19.2	0.021
4	26	14.4	55	14.3	0.961
5	55	30.4	78	20.3	0.011
Total	181	100	385	100	0.023

CG: clinical guidelines; IMD-Q: index of multiple deprivation quintile; LU: leg ulceration.

Referring GPP

People undergoing VV intervention before and after the publication of CG168 had been referred from 102 and 122 GPPs, respectively. After CG168, patients came from 44 ‘new’ GPPs who had not referred people prior to the pre-CG168 cohort. By contrast, 22 GPPs who had referred people prior to CG168 did not refer any people afterwards. Of the 78 GPPs represented in both cohorts, 58% referred more people in the post-CG168 cohort, 24% had the same number and 17% had fewer. Following the publication of CG168, the number of GPPs referring people with LU increased from 64 to 102 with 54 ‘new’ GPPs referring people after CG168 and 16 previously referring GPPs not referring any people after CG168. Of the 48 GPPs referring LUs before and after CG168, 48% referred more patients after CG168, 29% referred the same number of patients and 23% referred fewer patients.

Discussion

VV interventions

To our knowledge, there are no published studies examining the relationship between social deprivation and the prevalence and management of uncomplicated VV. Only the Edinburgh vein study looked at deprivation (social class was determined by occupation) and found no relationship.⁶ The present study demonstrates that although the publication of CG168 has led to an increase in the overall number of VV interventions, it has not led to any significant difference in the IMD-Q distribution of the people being treated. Thus, people from the most deprived quintile (IMD-Q5) accounted for approximately 30% of VV interventions before and after CG168. With regard to CEAP clinical grade, publication of CG168 led to no notable change in the IMD-Q distribution except with regard to the C6 disease where there was a decrease in IMD-Q1 and an increase in IMD-Q5. Although this did not attain statistical significance, perhaps due to low numbers, the percentage change was considerable and might possibly suggest that CG168 has improved access to superficial venous intervention in CEAP grade 6 disease (VV with open LU) for the most socially deprived. There was no relationship between IMD-Q and choice of superficial venous treatment with most patients being treated with endovenous, non-surgical techniques in both cohorts and across all IMD-Q.

LU referrals

Although the publication of CG168 was associated with a considerable increase in the overall numbers of people with LU being referred from all IMD-Q, the proportion of people from IMD-Q5 decreased significantly. This suggests that people from socially deprived areas may be less likely to be referred than those from more affluent areas; although, as noted above, once referred, they appear to be just as likely to receive intervention. The reasons for this apparent lack of access to LU referral among the most socially deprived people remain unclear. People from socially deprived areas are more likely to have significant co-morbidity such as diabetes,⁷ atherosclerosis⁸ and higher levels of cigarette smoking⁹ and obesity,⁷ all of which are recognised as risk factors for LU development, poor healing and higher recurrence rates. However, it may be that despite a greater LU burden,¹⁰ people from socially deprived backgrounds are less likely to present to medical services in a timely manner.¹¹ It is also possible that GPPs in more socially deprived areas are relatively underfunded¹² and so are less likely to make specialist referrals for financial reasons. By contrast, more affluent and perhaps better-educated patients may be more health aware and so may be more likely to seek medical advice earlier and then demand specialist referral for their health problems.

GP referral patterns

Encouragingly, the publication of CG168 was associated with an overall increase in the number of GPPs referring people with LU and with the number of people undergoing intervention for symptomatic VV. Furthermore, the majority of practices that referred people before and after CG168 referred more people afterwards. A few GPPs referred fewer or no VV and LU people after CG168; however, these tended to be smaller GPPs who referred one or two patients before the guideline was published. Unfortunately, it is not possible to accurately calculate the IMD-Q distribution for individual practices as their catchment areas are often complex with imprecise boundaries and, hence, the decision to study patients by their individual post-code of residence and not by their registered GPPs. However, it is our impression that the GPPs who referred more patients with VV and LU after CG168 tended to be located in the more affluent regions of the catchment area. This further strengthens the suggestion that the publication of CG168, while improving access to care for lower limb venous disease overall, may have tended to favour those who reside in the less socially deprived IMD-Q.

NICE CG are highly respected in the United Kingdom and overseas. Although the recommendations contained therein are advisory and have no legal authority in terms of the services that individual NHS clinical commissioning groups (CCGs) chose to purchase and prioritise, it would be unwise for CCGs and individual GPPs to ignore or contravene them. Thus in other areas, such as the management of the ‘diabetic foot’, a failure to follow NICE guidelines is usually accepted as a breach of duty in cases of alleged clinical negligence.¹³ There appears to be no reason why this should not be the case in respect of CG168. However, colleagues in primary care often claim, justifiably, that they are overwhelmed by guidelines and that it is simply impossible to be aware of and follow them all, all of the time.

Limitations

Clearly, patients must present to medical services to have diagnosis of VV/LU. This may disproportionately increase numbers of those from less socially deprived IMD-Q as mentioned above, and those from more socially deprived backgrounds are less likely to seek medical attention. Those from more socially privileged background are also more likely to seek private medical attention and thus there may be an under-presenting of patients from IMD-Q1/2 for VV and LU. It is also worth noting that the area served by the HEFT is highly multi-culturally and ethnically diverse and may not be truly representative of the United Kingdom as a whole and that data are based on postal code and not an individual’s true socio-economic standing (e.g. those who are deprived but live in affluent areas).

Future directions

At present, little is known about the incidence of VV or indeed LU related to social deprivation in the general population, as patients are required to present to medical services to obtain a diagnosis, although LU has a higher proportion of socially deprived patients seeking medical attention² and is likely to be more common in these groups. It may be possible for large observational studies (such as the Edinburgh Vein Study) to estimate this from re-analysis of their data. This work is important to ensure that appropriate social demographics are targeted to ensure equality of access to services.

Conclusion

It is very encouraging that, at least in the HEFT catchment area, CG168 has clearly increased numbers of interventional treatments for VV as well as the number of people being referred with LU. However, the current study suggests that this improvement in the care of lower limb venous disease may have disproportionately favoured people from more privileged socio-economic backgrounds. Further professional and public education is required to ensure that the beneficial impact of the CG168 recommendations is maximised, and that those with the greatest health needs have equal access to evidence-based management of their lower limb venous disease.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflict of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

References

National Institute for Health and Care Excellence. Guidelines CG168: varicose veins in the legs: diagnosis and management. NICE, 2013.

Petherick

Cullum

Pickett

. Investigation of the effect of deprivation on the burden and management of venous leg ulcers: a cohort study using the THIN database. PloS One 2013; 8: e58948–e58948.

Eklof

Rutherford

Bergan

et al.

Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40: 1248–1252.

Department for Communities and Local Government. English indices of deprivation 2010. 2011.

Allegra C and Carlizza A. Variants of functional venous disease. Phlebolymphology 2004; 45: 289–292.

Evans

Fowkes

Ruckley

et al.

Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Commun Health 1999; 53: 149–153.

Grundmann

Mielck

Siegel

et al.

Area deprivation and the prevalence of type 2 diabetes and obesity: analysis at the municipality level in Germany. BMC Pub Health 2014; 14: 1264–1264.

Deans

Bezlyak

Ford

et al.

Differences in atherosclerosis according to area level socioeconomic deprivation: cross sectional, population based study. Brit Med J 2009; 339: b4170–b4170.

Health and Social Care Information Centre. Statistics on smoking 2015. 2015. http://www.content.digital.nhs.uk/catalogue/PUB17526/stat-smok-eng-2015-rep.pdf.

10.

Callam

Harper

Dale

et al.

Chronic leg ulceration: socio-economic aspects. Scot Med J 1988; 33: 358–360.

11.

Lane

Mathewson

Sharma

et al.

Social deprivation as a risk factor for late presentation of proliferative diabetic retinopathy. Clin Ophthalmol 2015; 9: 347–352.

12.

Hippisley-Cox

O’Hanlon

Coupland

. Association of deprivation, ethnicity, and sex with quality indicators for diabetes: population based survey of 53,000 patients in primary care. Brit Med J 2004; 329: 1267–1269.

13.

Samanta

Gunn

. Legal considerations of clinical guidelines: will NICE make a difference? J R Soc Med 2003; 96: 133–138.