Incidence, outcomes, and cost of foot ulcers in patients with diabetes

OBJECTIVE: To determine the incidence of foot ulcers in a large cohort of patients with diabetes, the risk of developing serious complications after diagnosis, and the attributable cost of care compared with that in patients without foot ulcers. RESEARCH DESIGN AND METHODS: Retrospective cohort study of patients with diabetes in a large staff-model health maintenance organization from 1993 to 1995. Patients with diabetes were identified by algorithm using administrative, laboratory, and pharmacy records. The data were used to calculate incidence of foot ulcers, risk of osteomyelitis, amputation, and death after diagnosis of foot ulcer, and attributable costs in foot ulcer patients compared with patients without foot ulcers. RESULTS: Among 8,905 patients identified with type 1 or type 2 diabetes, 514 developed a foot ulcer over 3 years of observation (cumulative incidence 5.8%). On or after the time of diagnosis, 77 (15%) patients developed osteomyelitis and 80 (15.6%) required amputation. Survival at 3 years was 72% for the foot ulcer patients versus 87% for a group of age- and sex-matched diabetic patients without foot ulcers (P < 0.001). The attributable cost for a 40- to 65-year-old male with a new foot ulcer was $27,987 for the 2 years after diagnosis. CONCLUSIONS: The incidence of foot ulcers in this cohort of patients with diabetes was nearly 2.0% per year. For those who developed ulcers, morbidity, mortality, and excess care costs were substantial compared with those for patients without foot ulcers. The results appear to support the value of foot-ulcer prevention programs for patients with diabetes.     

Direct health care costs of diabetic patients in Spain

OBJECTIVE: The goal of this study was to estimate the health care resources spent by type 1 and type 2 diabetic patients in Spain during the year 2002. RESEARCH DESIGN AND METHODS: This is a cost-of-illness study focusing on direct health care costs estimated from primary and secondary sources of information. A prevalence of diabetes ranging from 5 to 6% of the adult population was determined. Total cost is composed of six items: insulin and oral hypoglycemic agents, other drugs, disposable and consumable goods (glucose test strips, needles, and syringes), hospitalization, primary care visits, and visits to endocrinologists and dialysis. RESULTS: The estimated direct cost of diabetes in 2002 ranges from 2.4 to 2.67 billion euro. Hospital costs were the most (933 million euro), followed by noninsulin, nonhypoglycemic agent drugs (777-932 million euro). Much lower are the costs of insulin and oral hypoglycemic agents (311 million euro), primary care visits (181-272 million euro), specialized visits (127-145 million euro), and disposable elements (70-81 million euro). Expenditures for all drugs and consumable goods ranged between 1.16 and 1.3 billion euro, representing 48-49% of total cost, which is 15% higher than hospital costs. CONCLUSIONS: The direct health care costs of diabetic patients are high (6.3-7.4% of total National Health System expenditure). Their average annual cost is 1,290-1,476 euro. For individuals without diabetes, the average annual cost is 865 euro.     

Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care

OBJECTIVE: To determine the incidence of foot ulceration and lower limb amputation in type 2 diabetic patients in primary health care. RESEARCH DESIGN AND METHODS: Data on type 2 diabetes were collected by the Nijmegen Monitoring Project between 1993 and 1998 as part of a study of chronic diseases. The records of all patients recorded as having diabetic foot problems and those who died, moved to a nursing home, or were under specialist care were included. The annual incidence of foot ulceration was defined as the number of type 2 diabetic patients per patient-year who developed a new foot ulcer. Incidence of lower limb amputation was similarly defined. Additional information was collected on treatment of foot ulcers. RESULTS: The study population of type 2 diabetic patients increased from 511 patient-years in 1993 to 665 in 1998. The annual incidence of foot ulceration varied between 1.2 and 3.0% (mean 2.1) per year; 25% of the patients had recurrent episodes. The annual incidence of lower limb amputation varied between 0.5 and 0.8% (mean 0.6). Ten of the 15 amputees died, and 12 of 52 (23%) patients with ulceration had a subsequent amputation or a previous history of amputation. In 35 of the 73 (48%) episodes of ulceration, only the family physician provided treatment. Patients with foot problems were older and had more cardiovascular disease, retinopathy, and absent peripheral pulses. CONCLUSIONS: The incidence of foot ulceration and lower limb amputation in type 2 diabetes is low; nevertheless, recurrence rates of ulceration and risk of amputation are high, with high mortality.     

Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology

OBJECTIVE: Foot ulcers and their complications are an important cause of morbidity and mortality in diabetes. The present study aims to examine the long-term outcome in terms of amputations and mortality in patients with new-onset diabetic foot ulcers in subgroups stratified by etiology. RESEARCH DESIGN AND METHODS: Patients presenting with new ulcers (duration <1 month) to a dedicated diabetic foot clinic between 1994 and 1998 were studied. Outcomes were determined until March 2000 (or death) from podiatry, hospital, and district registers. Baseline clinical examination was done to classify ulcers as neuropathic, ischemic, or neuroischemic. Five-year amputation and mortality rates were derived from Kaplan-Meier survival analysis curves. RESULTS: Of the 185 patients studied, 41% had peripheral vascular disease (PVD) and 61% had neuropathy; 45%, 16%, and 24% of patients had neuropathic, ischemic, and neuroischemic ulcers, respectively. The mean follow-up period was 34 months (range 1-65) including survivors and patients who died during the study period. Five-year amputation rates were higher for ischemic (29%) and neuroischemic (25%) than neuropathic (11%) ulcers. Five-year mortality was 45%, 18%, and 55% for neuropathic, neuroischemic, and ischemic ulcers, respectively. Mortality was higher in ischemic ulcers than neuropathic ulcers. On multivariate regression analysis, only increasing age predicted shorter survival time. CONCLUSIONS: All types of diabetic foot ulcers are associated with high morbidity and mortality. The increased mortality appears to be independent of factors increasing ulcer risk-that is, neuropathy and PVD-in patients with established foot ulcers.     

Multidisciplinary management of the diabetic foot ulcer

Diabetic foot ulcers are likely to occur in up to 25% of people with diabetes mellitus at some time in their life (Boulton et al, 2005). Without adequate management, there is a high risk of infection, gangrene, amputation and death. Over 50% of major amputations in the UK happen to people with diabetes, and within three years of amputation, 50% of patients will die. Diabetic foot ulcers need specific management, and some of the principles of moist wound healing do not apply. Diabetic patients with foot ulcers benefit from accurate and prompt assessment, diagnosis, treatment, and long-term follow-up in order to conserve the foot (Jeffcoate et al, 2006). Their management cannot be undertaken by one health care professional working in isolation, but should involve a multidisciplinary team to ensure that these complex wounds are treated appropriately. In this first of two articles, wound healing in the diabetic foot and the principles of assessment of the diabetic foot ulcer are discussed.     

A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers

OBJECTIVE: The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers. RESEARCH DESIGN AND METHODS: In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at 相似文献   

Assessment and treatment of diabetic foot ulcer

BACKGROUND AND OBJECTIVES: Foot ulcers are one of the main complications in diabetes mellitus, with a 15% lifetime risk in all diabetic patients. The rate of lower extremity amputation among diabetic patients is 17-40 times higher than in non-diabetics. A critical triad of neuropathy, minor foot trauma and foot deformity was found in > 63% of diabetic foot ulcers (DFU). Peripheral vascular disease (PVD) has been identified in 30% of foot ulcers. We present a comprehensive assessment and the treatment of DFUs. We also want to notify physicians not to ignore foot assessment and examinations in patients with diabetes. METHODS: We conducted this study on DFU on the basis of: pathogenesis and risk factors, assessment and physical examination, paraclinic assessment, treatment, cost and mortality and prevention. RESULTS AND FINDINGS: Approximately 20% of hospital admissions among diabetic patients are the result of foot problems. Diabetic foot assessment should include dermatological, vascular, neurological and musculoskeletal systems. There are three basic treatments for management of DFU: (i) debridement; (ii) antibiotics and (iii) revascularization. The cost to treat one simple ulcer is $5000 to $8000. CONCLUSION: Awareness of physicians about foot problems in diabetic patients, clinical examination and paraclinical assessment, regular foot examination, patient education, simple hygienic practices and provision of appropriate footwear combined with prompt treatment of minor injuries can decrease ulcer occurrence by 50%.     

糖尿病足溃疡姑息性治疗的研究进展

糖尿病足溃疡为糖尿病最常见的并发症之一,其发病率高,难以治愈,进行手术和先进的伤口处理方法获益有限。糖尿病足溃疡姑息性治疗着重于创面的气味、疼痛、渗出物、出血和感染管理等,以减少截肢率、截肢的范围,从而提高患者生命质量,减轻医疗经济负担。本文通过综述国内外姑息性治疗在糖尿病足溃疡的相关研究,探讨糖尿病足溃疡局部及全身管理,为糖尿病足溃疡治疗提供新策略、新材料、新理念。【关键词】姑息疗法; 糖尿病足溃疡; 创面管理;     

The health care costs of diabetic peripheral neuropathy in the US

OBJECTIVE: Peripheral neuropathy is common among people with diabetes and can result in foot ulceration and amputation. The aim of this study was to quantify the annual medical costs of peripheral neuropathy and its complications among people with type 1 and type 2 diabetes in the U.S. RESEARCH DESIGN AND METHODS: A cost-of-illness model was used to estimate the numbers of diabetic individuals in the U.S. who have diabetic peripheral neuropathy (DPN) and/or neuropathic foot ulcers (both those with no deep infection and those accompanied by cellulitis or osteomyelitis) at a given point in time, and/or a toe, foot, or leg amputation during a year. Prevalence and incidence rates were estimated from published studies and applied to the general U.S. population. All costs were estimated in 2001 U.S. dollars. In a sensitivity analysis, we varied the rates of complications to assess the robustness of the cost estimates. RESULTS: The annual costs of DPN and its complications in the U.S. were 0.8 billion US dollars (type 1 diabetes), 10.1 billion US dollars (type 2 diabetes), and 10.9 billion US dollars (total). After allowing for uncertainty in the point estimates of complication rates, the range of costs were between 0.3 and 1.0 billion US dollars (type 1 diabetes), 4.3b and 12.7 billion US dollars (type 2 diabetes), and 4.6 and 13.7 billion US dollars (type 1 and type 2 diabetes). CONCLUSIONS: The total annual cost of DPN and its complications in the U.S. was estimated to be between 4.6 and 13.7 billion US dollars. Up to 27% of the direct medical cost of diabetes may be attributed to DPN.     

不同肾脏功能状态对糖尿病足部溃疡疗效及预后的影响

目的探讨肾脏功能对糖尿病足部溃疡疗效及预后的影响。方法采用前瞻性研究的方法，对126例Ⅰ～Ⅴ期糖尿病足部溃疡患者在治疗前检查肾脏功能后，进行全身综合治疗及溃疡局部彻底清创，外敷黄芪提取液加适量短效胰岛素，观测溃疡部位肉芽组织出现时间（GT）、溃疡愈合时间（HT）及溃疡治愈率、截肢率。结果糖尿病肾病从Ⅰ期逐渐过渡到Ⅴ期，相同程度糖尿病足部溃疡患者的GT和HT逐渐延长，其中糖尿病肾病Ⅰ～Ⅲ期相同程度足部溃疡患者GT和HT均显著短于糖尿病肾病Ⅳ期（临床蛋白尿期）和Ⅴ期（终末期肾病）相同程度足部溃疡患者的GT和HT（P〈0．05或P〈0．01）；糖尿病足部溃疡患者的GT和HT与糖尿病肾病病情程度问呈显著正相关（r1=2．344和r2=2．563，P均〈0．05）；糖尿病肾病Ⅰ～Ⅲ期糖尿病足部溃疡患者的截肢率显著少于糖尿病肾病Ⅳ期和Ⅴ期相应程度的足部溃疡患者（P〈0．05），治愈率也显著高于后者（P〈0．05）。结论糖尿病肾病病情的轻重在很大程度上影响了糖尿病足部溃疡的治疗效果及预后，提示对糖尿病足部溃疡患者注重和尽可能改善肾功能状态是非常必要的。     

Cost-effectiveness of prevention and treatment of the diabetic foot: a Markov analysis

OBJECTIVE: To estimate the lifetime health and economic effects of optimal prevention and treatment of the diabetic foot according to international standards and to determine the cost-effectiveness of these interventions in the Netherlands. RESEARCH DESIGN AND METHODS: A risk-based Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with newly diagnosed type 2 diabetes managed with care according to guidelines for their lifetime. Mean survival time, quality of life, foot complications, and costs were the outcome measures assessed. Current care was the reference comparison. Data from Dutch studies on the epidemiology of diabetic foot disease, health care use, and costs, complemented with information from international studies, were used to feed the model. RESULTS: Compared with current care, guideline-based care resulted in improved life expectancy, gain of quality-adjusted life-years (QALYs), and reduced incidence of foot complications. The lifetime costs of management of the diabetic foot following guideline-based care resulted in a cost per QALY gained of < 25,000 US dollars, even for levels of preventive foot care as low as 10%. The cost-effectiveness varied sharply, depending on the level of foot ulcer reduction attained. CONCLUSIONS: Management of the diabetic foot according to guideline-based care improves survival, reduces diabetic foot complications, and is cost-effective and even cost saving compared with standard care.     

Management of the diabetic foot ulcer: exercising control

The incidence of diabetes is increasing and therefore patients with diabetic foot ulcers will become increasingly common in the community. The NHS model of Health and Social Care (Department of Health (DH), 2005) places a high emphasis on self care and disease management, and, as a long-term condition, diabetes mellitus requires efficient and effective management. The supervision and organization of the care of diabetic patients is multi-factorial and for this reason, a multi-disciplinary approach is essential for effective care, without which patients with diabetic foot ulcers are at high risk of complications. Diabetic wounds present differently to other chronic wounds; unless these are adequately assessed and treated, there may be devastating consequences for the patient--the most serious being major amputation and/or death. In the first article, accurate assessment was discussed; in this second article, the management of diabetic foot ulcers is explored.     

A new wound-based severity score for diabetic foot ulcers: A prospective analysis of 1,000 patients

OBJECTIVE: Several well-accepted classification systems are available for diabetic foot ulcers. However, there are only a few and scientifically not validated severity scores. The aim of this study was to establish a new wound-based clinical scoring system for diabetic foot ulcers suitable for daily clinical practice anticipating chances for healing and risk of amputation. RESEARCH DESIGN AND METHODS: Four clinically defined parameters, namely palpable pedal pulses, probing to bone, ulcer location, and presence of multiple ulcerations, were prospectively assessed in 1,000 consecutive patients. In the next step, a new diabetic ulcer severity score (DUSS) was created from these parameters. Palpable pedal pulses were categorized by the absence (scored as 1) or presence (scored as 0) of pedal pulses, while probing to bone was defined as yes (scored as 1) or no (scored as 0). The site of ulceration was defined as toe (scored as 0) or foot (scored as 1) ulcer. Patients with multiple ulcerations were graded as 1 compared with those with single ulcers (scored as 0). The DUSS was calculated by adding these separate gradings to a theoretical maximum of 4. Wounds were followed-up for 365 days or until healing or amputation if earlier. Probability of healing and risk of amputation were calculated by the Kaplan-Meier method. RESULTS: Uni- and multivariate analyses showed a significantly higher probability of healing for patients with palpable pulses, no probing to bone, toe ulcers, and absence of multiple ulcerations. When patients were divided into subgroups with the same DUSS, we found significantly different probabilities for healing. We showed a decreasing probability of healing for ulcers with a high DUSS, concurrent with increasing amputation rates. An increase in the DUSS by one score point reduced the chance for healing by 35%. Similarly, the higher the ulcer score, the larger the initial wound area, the longer the wound history, and the more likely the need for surgery or hospitalization. CONCLUSIONS: The DUSS categorizes different ulcers into subgroups with specific severity and similar clinical outcome. Using this score, the probabilities for healing, amputation, need for surgery, and hospitalization are predictable with high accuracy. This might be useful for the anticipation of health care costs and for comparison of subgroups of patients in clinical studies.     

Sustained silver-releasing dressing in the treatment of diabetic foot ulcers

This study investigated the clinical performance and safety of a sustained silver-releasing foam dressing, Contreet Foam, in the treatment of diabetic foot ulcers. Twenty-seven patients with diabetic foot ulcers of grade I or II (Wagner's classification) were followed for six weeks: one week run-in using Biatain dressings, four weeks' treatment with Contreet dressings. Four ulcers healed during the four-week treatment with Contreet 56% in average. Contreet Foam showed good exudate management properties and was considered easy to use. Only two infections occurred showed that all six of the non-study ulcers developed an infection during the study. All ulcers (study ulcers as well as non-study ulcers) were treated according to good practice of diabetic wound care. There were no directions for the treatment of secondary wounds. No device-related adverse events were observed. This study demonstrated that Contreet Foam is safe and easy to use and effectively supports healing and good wound progress of diabetic foot ulcers.     

A cost analysis of diabetic lower-extremity ulcers

OBJECTIVE: Our objectives were to 1) estimate the prevalence of diabetes and diabetic lower-extremity ulcers in the Medicare population, 2) characterize Medicare population-specific costs for lower-extremity ulcer episodes, and 3) evaluate potential cost savings associated with better healing of lower-extremity ulcers. RESEARCH DESIGN AND METHODS: Prevalence and costs of diabetic lower-extremity ulcers were obtained by an analysis of Medicare claims data from 1995 and 1996 Standard Analytic Files (5% sample). RESULTS: Medicare expenditures for lower-extremity ulcer patients were on average 3 times higher than those for Medicare patients in general ($15,309 vs. $5,226). Lower-extremity ulcer-related spending accounted for 24% of total spending for lower-extremity ulcer patients. Most of the ulcer-related costs accrued on the inpatient side (73.7%); proportionately smaller amounts went to physicians and nursing home facilities. To determine the potential effect of better diabetic ulcer management, a model was created that estimated the impact on costs with improved healing rates. Improving the 20-week healing rate from 31 to 40% would save Medicare $189 per episode. CONCLUSIONS: Lower-extremity ulcers cost the Medicare system $1.5 billion in 1995. Any wound care intervention that could prevent even a small percentage of wounds from progressing to the stage at which inpatient care is required may have a favorable cost effect on the Medicare system.     

综合康复治疗对糖尿病足疗效的影响

目的：探讨康复治疗对糖尿病足溃疡的愈合及复发的疗效。方法：108例确诊为糖尿病足溃疡患者分为2组，均按内科常规药物治疗，康复组62例同时康复介入。治疗前后对足溃疡愈合及复发情况进行比较。结果：经过15—20d的治疗，康复组患者足溃疡愈合率高于常规组（P〈0．01），且溃疡平均愈合时间明显缩短（P〈0．01）；溃疡复发率、截肢率与常规组比较均显著降低（P〈0．01）。结论：糖尿病足溃疡患者采用药物及康复介入综合治疗能显著提高疗效，降低残疾率。     

Understanding the multifaceted etiopathogenesis of foot complications in individuals with diabetes

Diabetes mellitus, a chronic disease of metabolism, is characterized by a disordered production or cellular utilization of insulin. Diabetic foot disease, which comprises the spectrum of infection, ulceration, and gangrene, is one of the most severe complications of diabetes and is the most common cause of hospitalization in diabetic patients. The aim of this study is to provide an evidence-based overview of diabetic foot complications. Due to neuropathy, diabetic foot infections can occur in the form of ulcers and minor skin lesions. In patients with diabetic foot ulcers, ischemia and infection are the main causes of non-healing ulcers and amputations. Hyperglycemia compromises the immune system of individuals with diabetes, leading to persistent inflammation and delayed wound healing. In addition, the treatment of diabetic foot infections is challenging due to difficulty in accurate identification of pathogenic microorganisms and the widespread issue of antimicrobial resistance. As a further complicating factor, the warning signs and symptoms of diabetic foot problems can easily be overlooked. Issues associated with diabetic foot complications include peripheral arterial disease and osteomyelitis; accordingly, the risk of these complications in people with diabetes should be assessed annually. Although antimicrobial agents represent the mainstay of treatment for diabetic foot infections, if peripheral arterial disease is present, revascularization should be considered to prevent limb amputation. A multidisciplinary approach to the prevention, diagnosis, and treatment of diabetic patients, including those with foot ulcers, is of the utmost importance to reduce the cost of treatment and avoid major adverse consequences such as amputation.     

Benefits of a multidisciplinary approach in the management of recurrent diabetic foot ulceration in Lithuania: a prospective study.

OBJECTIVE: To assess the ability of a multidisciplinary approach to diabetic foot care to reduce the incidence of recurrent ulceration and amputations compared with standard care in a 2-year prospective study. RESEARCH DESIGN AND METHODS: A total of 145 patients with a past history of neuropathic foot ulcers but no evidence of peripheral vascular disease entered the study. Subjects were screened for their neuropathic and vascular status at baseline, and all received identical foot care education. The intervention group (n = 56) was followed by the multidisciplinary team of physicians, nurses, and podiatrists with regular podiatry and reeducation every 3 months and the provision of specialty footwear as required. The standard treatment group was followed in local clinics on a trimonthly basis and received identical screening and education at baseline. RESULTS: There were no significant differences at baseline in age (intervention 59.2+/-13.4, standard treatment 58.5+/-11.5 years), duration of diabetes (14.0+/-7.1 vs. 15.6+/-7.8 years), or neuropathic status (vibration perception threshold [VPT]: 31.1+/-12.1 vs. 33.9+/-11.3 V, neuropathy disability score [NDS]: 8.1+/-1.4 vs. 7.9+/-1.7). All patients had an ankle brachial pressure index (ABPI) of >0.9 and at least one palpable foot pulse. Significantly fewer recurrent ulcers were seen in the intervention group than in the standard treatment group during the 2-year period (30.4 vs. 58.4%, P < 0.001). CONCLUSIONS: This prospective study has demonstrated the effectiveness of a multidisciplinary approach to diabetic foot care together with the provision of specialty footwear in the long-term management of high-risk patients with a history of neuropathic foot ulcers.     

Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures

OBJECTIVE: The purpose of this study was to compare different outcome measures in the audit of management of diabetic foot ulcers RESEARCH DESIGN AND METHODS: Data collected prospectively in a consecutive cohort of patients referred to a specialist multidisciplinary foot care clinic between 1 January 2000 and 31 December 2003 were analyzed. A single index ulcer was selected for each patient and classified according to both the Size (Area and Depth), Sepsis, Arteriopathy, and Denervation [S(AD)SAD] and University of Texas (UT) systems. Ulcer-related outcomes (healing, resolution by ipsilateral amputation or by death, and persisting unhealed) were determined at 6 and 12 months and compared with patient-related outcomes (survival, any amputation, and being free from any ulcer) at 12 months. RESULTS: In 449 patients (63.7% male, mean age 66.7 +/- 13.2 years), 352 (78.4%) ulcers were superficial [S(AD)SAD/UT grade 1] and 134 of these (38.1% of 352) were neither ischemic nor infected. A total of 183 (40.8% of 449) ulcers were clinically infected, and peripheral arterial disease was present in 216 patients (48.1%). Seventeen patients (3.8%) were lost to follow-up and were excluded from analysis. Of the ulcers, 247 (55.0% of 449) and 295 (65.7%) healed without amputation by 6 and 12 months, respectively. Median (range) time to healing was 78 (7-364) days. Of all index ulcers, 5.8 and 8.0% were resolved by amputation, and 6.2 and 10.9% by death by the same time points; 27.8 and 11.6% persisted unhealed. In contrast, patient-related outcomes revealed that of 449 patients only 202 (45.0%) were alive, without amputation, and ulcer free at 12 months. This group had had 272 (1-358) days without any ulcer. A total of 48 (10.7%) patients had undergone some form of amputation, and 75 (16.7%) had died. CONCLUSIONS: These data illustrate the extent to which ulcer-related outcomes may underestimate the true morbidity and mortality associated with diabetic foot disease. It is suggested that when attempts are made to compare the effectiveness of management in different centers, greater emphasis should be placed on patient-related outcome measures.