Comment
enforcement of compliance, regular wound assessment, and the ability to adjust adjunctive care as needed in an efficient way. Ashby and colleagues have shown that during 1 year of care, two-layer compression hosiery is as effective as are traditional four-layer bandages and is also cheaper. Are the findings of this study sufficient to change practice? Although it was designed as a pragmatic trial, only slightly more than 10% of screened patients were enrolled—a screening percentage similar to that in most randomised controlled trials of venous leg ulcers. The reasons for exclusion included patients with excessive exudate or questionable arterial flow. In the case of excessive exudate, the expectation for patients to clean frequently soiled hosiery would not be practical; and in the case of questionable arterial flow, close observation of patients at risk of tissue necrosis from compression would be warranted. Notably, the discontinuation rate was higher in the hosiery group than in the bandage group, and the reasons for discontinuation were more likely to include discomfort and ulcer deterioration. The study used an intentionto-treat model and nearly 40% of patients enrolled in the hosiery group changed treatment, which we can only presume was to a compression bandage. Thus, although those enrolled and allocated to hosiery were as likely to heal as those assigned to the compression bandage, and at a lower cost, the population might have been more similar to a randomised controlled trial population than a pragmatic effectiveness population, and many patients might have ultimately ended up using a compression bandage.10 However, hosiery was a successful treatment. Patients presumably had increased freedom and felt empowered with regard to dressing changes and fewer medical visits, which translated into both improved quality of life and reduced medical costs. Importantly, once their ulcers had healed, this group
of patients was comfortable wearing hosiery on a regular basis and recurrence (a major problem in the care of patients with venous disease) was reduced. The importance of the study is that hosiery works and should be considered as first-line treatment along with compression bandages. The study might also represent the beginning of a change in clinical approach for selected patients to include discussion about hosiery as the first treatment option, with compression bandages for those who do not respond to this initial treatment. We think this could be a wonderful beginning to more rational care for those with venous leg ulcers. *Robert S Kirsner, David J Margolis Departments of Dermatology and Cutaneous Surgery and Epidemiology and Public Health, University of Miami Leonard M Miller School of Medicine, Miami, FL 33136, USA (RSK); and Departments of Dermatology and Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA (DJM) [email protected] We declare that we have no conflicts of interest. 1
2 3 4 5 6
7 8 9 10
Ashby RL, Gabe R, Ali S, et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet 2013; published online Dec 6. http://dx.doi.org/10.1016/S01406736(13)62368-5. Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg ulcer: incidence and prevalence in the elderly. J Am Acad Dermatol 2002; 46: 381–86. Valencia IC, Falabella A, Kirsner RS, Eaglstein WH. Chronic venous insufficiency and venous leg ulceration. J Am Acad Dermatol 2001; 44: 401–21. González-Consuegra RV, Verdu J. Quality of life in people with venous leg ulcers: an integrative review. J Adv Nurs 2011; 67: 926–44. Purwins S, Herberger K, Debus ES, et al. Cost-of-illness of chronic leg ulcers in Germany. Int Wound J 2010; 7: 97–102. Yim E, Vivas A, Maderal A, Kirsner RS. Neuropathy and ankle mobility abnormalities in patients with chronic venous disease. JAMA Dermatol 2013; published online Nov 6. doi:10.1001/jamadermatol.2013.6723. Meissner MH, Moneta G, Burnand K, et al. The hemodynamics and diagnosis of venous disease. J Vasc Surg 2007; 46 (suppl S): 4S–24S. Herschthal J, Kirsner RS. Current management of venous ulcers: an evidence-based review. Surg Technol Int 2008; 17: 77–83. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database Syst Rev 2009; 1: CD000265. Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials 2006; 1: e9.
Elastic compression stockings—is there any benefit? In The Lancet, Susan Kahn and colleagues1 report the results of a study that will probably stir up a lively discussion on the usefulness of elastic compression stockings for prevention of post-thrombotic syndrome (PTS). The trial findings could have an important effect www.thelancet.com Vol 383 March 8, 2014
on daily practice, leaving doctors empty handed. But would that be justified? PTS is a burdensome constellation of leg complaints that develops in 20–50% of patients after acute deep venous thrombosis.2 So far no treatment options are
Published Online December 6, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)62347-8 See Articles page 880
851
Comment
Life In View/Science Photo Library
available, and prevention of PTS is therefore crucial. Treatment with elastic compression stockings (ECS) is the only option doctors have to both mitigate leg complaints and reduce the post-thrombotic damage associated with acute deep venous thrombosis. The two randomised trials underpinning present guidelines and clinical practice both identified a significant and clinically relevant relative-risk reduction for PTS, of about 50%.3,4 The rationale for use of ECS in prevention of PTS in patients after acute deep venous thrombosis is derived from compression practice in primary venous insufficiency. Graded compressive stockings apply high pressures (30–40 mm Hg), which significantly improve patients’ pain, swelling, activity tolerance, and wellbeing.5 There are several indications of a true effect of elastic compression: reduction of oedema as measured by limb volumetry, haemodynamic effects objectively shown by measuring venous volume, and flow velocity using MRI, duplex ultrasonography, and radioisotopes.6 Elastic compression counteracts the effect of increased intravenous hydrostatic pressure by reducing the venous pressure gradient, and thereby improves the reabsorption of fluids from connective tissue. Furthermore, it has been shown that ECS with a pressure gradient of 30–40 mm Hg can restore venous ejection fraction to the normal range.7 Higher ejection fractions will result in lower venous pressure and increased flow. In the context of PTS, flow is an important component of thrombus resolution and consequent limitation of vein-wall damage, as shown in animals.8 Kahn and colleagues1 aimed to use a placebocontrolled design to confirm the results of previous open-label trials and thereby assess the contribution of the placebo effect to the outcome of previous studies. Therefore active treatment (knee-length stockings with 30–40 mm Hg compression) was compared with placebo treatment (knee-length sham stockings without therapeutic compression), used for 2 years in 806 patients after a first proximal deep venous thrombosis. In terms of the trial’s primary endpoint, diagnosis of PTS by Ginsberg’s criteria at 6 months or later, no treatment effect was identified (adjusted HR 1·13, 95% CI 0·73–1·76). This might have come as a surprise to the investigators, because their sample-size calculation was based on an expected ECS treatment effect of 33% rather than on non-inferiority. 852
What can explain the lack of effectiveness of ECS in this trial? One common but very important reason for lack of effectiveness is lack of compliance with therapy. In this trial compliance after 2 years was suboptimum, with only 55·6% of patients using ECS for 3 or more days a week. The reported compliance in previous effectiveness studies tended to be greater—up to 90%.3,4 However, caution is needed because an actual head-tohead comparison is not possible because of differences in how compliance was measured. Differences in patients’ characteristics could be another reason for lack of effectiveness. Although the investigators state that the study population was comparable with those in previous studies, it is still possible that other patient factors have affected the results. Anticoagulant therapy, although prescribed for roughly the same duration as in previous trials, might have differed in effectiveness. Therapy could have improved over the past 10 years, and also the use of new oral anticoagulants, which were experimentally assessed in some of the study patients, could hypothetically affect the incidence of PTS. Besides Kahn and colleagues’ trial, three additional randomised clinical trials (although far smaller and none placebo-controlled) have addressed the usefulness of ECS for prevention of PTS.9–12 A small trial assessed initial active compression therapy in combination with early ambulation, and identified a significant benefit in mean Villalta scores for patients with initial active treatment for 10 days, even after secondary treatment with ECS for 2 years for both treatment groups.9,10 This finding suggests that the acute phase and possibly ambulation are important factors for successful treatment. Another trial has assessed the late initiation of treatment with ECS, 1 year after deep venous thrombosis, and did not identify a significant benefit;11 the positive finding of this study was that patients who did not have initial treatment with ECS and who did not develop PTS after 1 year are unlikely to do so at a later time. The study11 also suggests that not all patients benefit from treatment with ECS. One trial has assessed variable therapy duration after initial treatment with ECS for 6 months, and no significant benefit was noted after prolonged treatment for 18 months.12 The effect of individualised treatment duration with ECS on PTS incidence was assessed in a management study, and no differences compared with reports of incidence in the literature were identified.3,4,13 www.thelancet.com Vol 383 March 8, 2014
Comment
The main question now is whether the trial by Kahn and colleagues1 has given us a definitive answer on the usefulness of ECS for the prevention of PTS. Although this is the largest and only placebo controlled study so far, some questions remain. What are the individual contributions of the placebo effect, suboptimum compliance, and patient characteristics to the lack of effectiveness? A multicentre randomised trial comparing usual care (ECS for 2 years) with individualised care based on Villalta scores is in progress (ClinicalTrials.gov, NCT01429714). This future study will hopefully give additional information on some open questions: is there any benefit of treatment with ECS, which patients benefit most, and what is the optimum treatment duration?
2 3
4
5
6
7 8 9
10
Arina J ten Cate-Hoek Department of Internal Medicine and Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, 6202 AZ Maastricht, Netherlands [email protected]
11
12
I declare that I have no conflicts of interest. 1
Kahn SR, Shapiro S, Wells PS, et al, for the SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet 2013; published online Dec 6. http://dx.doi.org/10.1016/S0140-6736(13)61902-9.
13
Prandoni P, Lensing AWA, Cogo A, et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996; 125: 1–7. Brandjes DPM, Buller HR, Heijboer H, et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet 1997; 349: 759–62. Prandoni P, Lensing AWA, Prins MH, et al. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med 2004; 141: 249–56. Montykie GD, Caprini JA, Arcelus JI, Reyna JJ, Overom E, Mokhtee D. Evaluation of therapeutic compression stockings in the treatment of chronic venous insufficiency. Dermatol Surg 1999; 25: 116–20. Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under auspices of the IUP. Int Angiol 2008; 27: 193–219. Mosti G, Iabichella ML, Partsch H. Compression therapy in mixed ulcers increases venous output and arterial perfusion. J Vasc Surg 2012; 55: 122–28. Cooley BC, Chen CY, Hess R, Schmeling G. Incomplete resolution of deep vein thrombosis under reduced flow conditions. Thromb Res 2013; 131: 55–58. Partsch H, Blättler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg 2000; 32: 861–69. Partsch H, Kaulich M, Mayer W. Immediate mobilisation in acute vein thrombosis reduces post-thrombotic syndrome. Int Angiol 2004; 23: 206–12. Ginsberg JS, Hirsh J, Julian J, et al. Prevention and treatment of postphlebitic syndrome: results of a 3-part study. Arch Intern Med 2001; 161: 2105–09. Aschwanden M, Jeanneret C, Koller MT, Thalhammer C, Bucher HC, Jaeger KA. Effect of prolonged treatment with compression stockings to prevent postthrombotic sequelae: a randomized controlled trial. J Vasc Surg 2008; 47: 1015–21. Ten Cate-Hoek AJ, Ten Cate H, Tordoir J, Hamulyák K, Prins MH. Individually tailored duration of elastic compression therapy in relation to incidence of the postthrombotic syndrome. J Vasc Surg 2010; 52: 132–38.
It is more than 15 years since the intellectual disabilities specialty was mired in controversy when data from California were reported,1,2 which suggested higher rates of mortality among people with intellectual disabilities living in the community compared with those living in institutions. At the time, this finding was regarded as an attack on the movement of people with intellectual disabilities into the community, and there were criticisms of research quality3 and efforts to refute the findings.4 Over time, the findings stood5 and the methods used in studies to refute them were themselves challenged.6 Subsequently, people started asking important questions about the role of communitybased primary care and community hospital care in supporting the lives of people with intellectual disabilities living in the community. In The Lancet, Pauline Heslop and colleagues7 report the results of the Confidential Inquiry into premature deaths of people with intellectual disabilities in the UK. Rather than being a criticism of community placements, www.thelancet.com Vol 383 March 8, 2014
it draws attention to serious questions remaining long after the California study and, in a different national context, about the quality of health care being offered to people with intellectual disabilities in local communities, this time as compared with the general population. The Confidential Inquiry reviewed all deaths of people with intellectual disabilities who had been registered with a general practitioner in southwest England, and who died between June, 2010, and May, 2012. Deaths were described as avoidable, amenable (ie, could have been avoided in principle by medical knowledge and health care available at the time of death), or premature. Contributory factors were grouped into four domains: intrinsic to the individual, within the family and environment, care provision, and service provision. The deaths of a comparator group of people without intellectual disabilities but much the same in age, sex, and cause of death, and registered at the same general practices as those with intellectual disabilities, were also investigated.
Science Photo Library
Deaths of people with intellectual disabilities in the UK
Published Online December 11, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)62190-X See Articles page 889 Copyright © McCallion et al. Open Access article distributed under the terms of CC BY-NC-SA
853
enforcement of compliance, regular wound assessment, and the ability to adjust adjunctive care as needed in an efficient way. Ashby and colleagues have shown that during 1 year of care, two-layer compression hosiery is as effective as are traditional four-layer bandages and is also cheaper. Are the findings of this study sufficient to change practice? Although it was designed as a pragmatic trial, only slightly more than 10% of screened patients were enrolled—a screening percentage similar to that in most randomised controlled trials of venous leg ulcers. The reasons for exclusion included patients with excessive exudate or questionable arterial flow. In the case of excessive exudate, the expectation for patients to clean frequently soiled hosiery would not be practical; and in the case of questionable arterial flow, close observation of patients at risk of tissue necrosis from compression would be warranted. Notably, the discontinuation rate was higher in the hosiery group than in the bandage group, and the reasons for discontinuation were more likely to include discomfort and ulcer deterioration. The study used an intentionto-treat model and nearly 40% of patients enrolled in the hosiery group changed treatment, which we can only presume was to a compression bandage. Thus, although those enrolled and allocated to hosiery were as likely to heal as those assigned to the compression bandage, and at a lower cost, the population might have been more similar to a randomised controlled trial population than a pragmatic effectiveness population, and many patients might have ultimately ended up using a compression bandage.10 However, hosiery was a successful treatment. Patients presumably had increased freedom and felt empowered with regard to dressing changes and fewer medical visits, which translated into both improved quality of life and reduced medical costs. Importantly, once their ulcers had healed, this group
of patients was comfortable wearing hosiery on a regular basis and recurrence (a major problem in the care of patients with venous disease) was reduced. The importance of the study is that hosiery works and should be considered as first-line treatment along with compression bandages. The study might also represent the beginning of a change in clinical approach for selected patients to include discussion about hosiery as the first treatment option, with compression bandages for those who do not respond to this initial treatment. We think this could be a wonderful beginning to more rational care for those with venous leg ulcers. *Robert S Kirsner, David J Margolis Departments of Dermatology and Cutaneous Surgery and Epidemiology and Public Health, University of Miami Leonard M Miller School of Medicine, Miami, FL 33136, USA (RSK); and Departments of Dermatology and Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA (DJM) [email protected] We declare that we have no conflicts of interest. 1
2 3 4 5 6
7 8 9 10
Ashby RL, Gabe R, Ali S, et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet 2013; published online Dec 6. http://dx.doi.org/10.1016/S01406736(13)62368-5. Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg ulcer: incidence and prevalence in the elderly. J Am Acad Dermatol 2002; 46: 381–86. Valencia IC, Falabella A, Kirsner RS, Eaglstein WH. Chronic venous insufficiency and venous leg ulceration. J Am Acad Dermatol 2001; 44: 401–21. González-Consuegra RV, Verdu J. Quality of life in people with venous leg ulcers: an integrative review. J Adv Nurs 2011; 67: 926–44. Purwins S, Herberger K, Debus ES, et al. Cost-of-illness of chronic leg ulcers in Germany. Int Wound J 2010; 7: 97–102. Yim E, Vivas A, Maderal A, Kirsner RS. Neuropathy and ankle mobility abnormalities in patients with chronic venous disease. JAMA Dermatol 2013; published online Nov 6. doi:10.1001/jamadermatol.2013.6723. Meissner MH, Moneta G, Burnand K, et al. The hemodynamics and diagnosis of venous disease. J Vasc Surg 2007; 46 (suppl S): 4S–24S. Herschthal J, Kirsner RS. Current management of venous ulcers: an evidence-based review. Surg Technol Int 2008; 17: 77–83. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database Syst Rev 2009; 1: CD000265. Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials 2006; 1: e9.
Elastic compression stockings—is there any benefit? In The Lancet, Susan Kahn and colleagues1 report the results of a study that will probably stir up a lively discussion on the usefulness of elastic compression stockings for prevention of post-thrombotic syndrome (PTS). The trial findings could have an important effect www.thelancet.com Vol 383 March 8, 2014
on daily practice, leaving doctors empty handed. But would that be justified? PTS is a burdensome constellation of leg complaints that develops in 20–50% of patients after acute deep venous thrombosis.2 So far no treatment options are
Published Online December 6, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)62347-8 See Articles page 880
851
Comment
Life In View/Science Photo Library
available, and prevention of PTS is therefore crucial. Treatment with elastic compression stockings (ECS) is the only option doctors have to both mitigate leg complaints and reduce the post-thrombotic damage associated with acute deep venous thrombosis. The two randomised trials underpinning present guidelines and clinical practice both identified a significant and clinically relevant relative-risk reduction for PTS, of about 50%.3,4 The rationale for use of ECS in prevention of PTS in patients after acute deep venous thrombosis is derived from compression practice in primary venous insufficiency. Graded compressive stockings apply high pressures (30–40 mm Hg), which significantly improve patients’ pain, swelling, activity tolerance, and wellbeing.5 There are several indications of a true effect of elastic compression: reduction of oedema as measured by limb volumetry, haemodynamic effects objectively shown by measuring venous volume, and flow velocity using MRI, duplex ultrasonography, and radioisotopes.6 Elastic compression counteracts the effect of increased intravenous hydrostatic pressure by reducing the venous pressure gradient, and thereby improves the reabsorption of fluids from connective tissue. Furthermore, it has been shown that ECS with a pressure gradient of 30–40 mm Hg can restore venous ejection fraction to the normal range.7 Higher ejection fractions will result in lower venous pressure and increased flow. In the context of PTS, flow is an important component of thrombus resolution and consequent limitation of vein-wall damage, as shown in animals.8 Kahn and colleagues1 aimed to use a placebocontrolled design to confirm the results of previous open-label trials and thereby assess the contribution of the placebo effect to the outcome of previous studies. Therefore active treatment (knee-length stockings with 30–40 mm Hg compression) was compared with placebo treatment (knee-length sham stockings without therapeutic compression), used for 2 years in 806 patients after a first proximal deep venous thrombosis. In terms of the trial’s primary endpoint, diagnosis of PTS by Ginsberg’s criteria at 6 months or later, no treatment effect was identified (adjusted HR 1·13, 95% CI 0·73–1·76). This might have come as a surprise to the investigators, because their sample-size calculation was based on an expected ECS treatment effect of 33% rather than on non-inferiority. 852
What can explain the lack of effectiveness of ECS in this trial? One common but very important reason for lack of effectiveness is lack of compliance with therapy. In this trial compliance after 2 years was suboptimum, with only 55·6% of patients using ECS for 3 or more days a week. The reported compliance in previous effectiveness studies tended to be greater—up to 90%.3,4 However, caution is needed because an actual head-tohead comparison is not possible because of differences in how compliance was measured. Differences in patients’ characteristics could be another reason for lack of effectiveness. Although the investigators state that the study population was comparable with those in previous studies, it is still possible that other patient factors have affected the results. Anticoagulant therapy, although prescribed for roughly the same duration as in previous trials, might have differed in effectiveness. Therapy could have improved over the past 10 years, and also the use of new oral anticoagulants, which were experimentally assessed in some of the study patients, could hypothetically affect the incidence of PTS. Besides Kahn and colleagues’ trial, three additional randomised clinical trials (although far smaller and none placebo-controlled) have addressed the usefulness of ECS for prevention of PTS.9–12 A small trial assessed initial active compression therapy in combination with early ambulation, and identified a significant benefit in mean Villalta scores for patients with initial active treatment for 10 days, even after secondary treatment with ECS for 2 years for both treatment groups.9,10 This finding suggests that the acute phase and possibly ambulation are important factors for successful treatment. Another trial has assessed the late initiation of treatment with ECS, 1 year after deep venous thrombosis, and did not identify a significant benefit;11 the positive finding of this study was that patients who did not have initial treatment with ECS and who did not develop PTS after 1 year are unlikely to do so at a later time. The study11 also suggests that not all patients benefit from treatment with ECS. One trial has assessed variable therapy duration after initial treatment with ECS for 6 months, and no significant benefit was noted after prolonged treatment for 18 months.12 The effect of individualised treatment duration with ECS on PTS incidence was assessed in a management study, and no differences compared with reports of incidence in the literature were identified.3,4,13 www.thelancet.com Vol 383 March 8, 2014
Comment
The main question now is whether the trial by Kahn and colleagues1 has given us a definitive answer on the usefulness of ECS for the prevention of PTS. Although this is the largest and only placebo controlled study so far, some questions remain. What are the individual contributions of the placebo effect, suboptimum compliance, and patient characteristics to the lack of effectiveness? A multicentre randomised trial comparing usual care (ECS for 2 years) with individualised care based on Villalta scores is in progress (ClinicalTrials.gov, NCT01429714). This future study will hopefully give additional information on some open questions: is there any benefit of treatment with ECS, which patients benefit most, and what is the optimum treatment duration?
2 3
4
5
6
7 8 9
10
Arina J ten Cate-Hoek Department of Internal Medicine and Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, 6202 AZ Maastricht, Netherlands [email protected]
11
12
I declare that I have no conflicts of interest. 1
Kahn SR, Shapiro S, Wells PS, et al, for the SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet 2013; published online Dec 6. http://dx.doi.org/10.1016/S0140-6736(13)61902-9.
13
Prandoni P, Lensing AWA, Cogo A, et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996; 125: 1–7. Brandjes DPM, Buller HR, Heijboer H, et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet 1997; 349: 759–62. Prandoni P, Lensing AWA, Prins MH, et al. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med 2004; 141: 249–56. Montykie GD, Caprini JA, Arcelus JI, Reyna JJ, Overom E, Mokhtee D. Evaluation of therapeutic compression stockings in the treatment of chronic venous insufficiency. Dermatol Surg 1999; 25: 116–20. Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under auspices of the IUP. Int Angiol 2008; 27: 193–219. Mosti G, Iabichella ML, Partsch H. Compression therapy in mixed ulcers increases venous output and arterial perfusion. J Vasc Surg 2012; 55: 122–28. Cooley BC, Chen CY, Hess R, Schmeling G. Incomplete resolution of deep vein thrombosis under reduced flow conditions. Thromb Res 2013; 131: 55–58. Partsch H, Blättler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg 2000; 32: 861–69. Partsch H, Kaulich M, Mayer W. Immediate mobilisation in acute vein thrombosis reduces post-thrombotic syndrome. Int Angiol 2004; 23: 206–12. Ginsberg JS, Hirsh J, Julian J, et al. Prevention and treatment of postphlebitic syndrome: results of a 3-part study. Arch Intern Med 2001; 161: 2105–09. Aschwanden M, Jeanneret C, Koller MT, Thalhammer C, Bucher HC, Jaeger KA. Effect of prolonged treatment with compression stockings to prevent postthrombotic sequelae: a randomized controlled trial. J Vasc Surg 2008; 47: 1015–21. Ten Cate-Hoek AJ, Ten Cate H, Tordoir J, Hamulyák K, Prins MH. Individually tailored duration of elastic compression therapy in relation to incidence of the postthrombotic syndrome. J Vasc Surg 2010; 52: 132–38.
It is more than 15 years since the intellectual disabilities specialty was mired in controversy when data from California were reported,1,2 which suggested higher rates of mortality among people with intellectual disabilities living in the community compared with those living in institutions. At the time, this finding was regarded as an attack on the movement of people with intellectual disabilities into the community, and there were criticisms of research quality3 and efforts to refute the findings.4 Over time, the findings stood5 and the methods used in studies to refute them were themselves challenged.6 Subsequently, people started asking important questions about the role of communitybased primary care and community hospital care in supporting the lives of people with intellectual disabilities living in the community. In The Lancet, Pauline Heslop and colleagues7 report the results of the Confidential Inquiry into premature deaths of people with intellectual disabilities in the UK. Rather than being a criticism of community placements, www.thelancet.com Vol 383 March 8, 2014
it draws attention to serious questions remaining long after the California study and, in a different national context, about the quality of health care being offered to people with intellectual disabilities in local communities, this time as compared with the general population. The Confidential Inquiry reviewed all deaths of people with intellectual disabilities who had been registered with a general practitioner in southwest England, and who died between June, 2010, and May, 2012. Deaths were described as avoidable, amenable (ie, could have been avoided in principle by medical knowledge and health care available at the time of death), or premature. Contributory factors were grouped into four domains: intrinsic to the individual, within the family and environment, care provision, and service provision. The deaths of a comparator group of people without intellectual disabilities but much the same in age, sex, and cause of death, and registered at the same general practices as those with intellectual disabilities, were also investigated.
Science Photo Library
Deaths of people with intellectual disabilities in the UK
Published Online December 11, 2013 http://dx.doi.org/10.1016/ S0140-6736(13)62190-X See Articles page 889 Copyright © McCallion et al. Open Access article distributed under the terms of CC BY-NC-SA
853
