Distribution of preoperative and postoperative astigmatism in a large population of patients undergoing cataract surgery in the UK.

PURPOSE: To assess the prevalence and severity of preoperative and postoperative astigmatism in patients with cataract in the UK. SETTING: Data from 8 UK National Health Service ophthalmology clinics using MediSoft electronic medical records (EMRs). DESIGN: Retrospective cohort study. METHODS: Eyes from patients aged ≥65 years undergoing cataract surgery were analysed. For all eyes, preoperative (corneal) astigmatism was evaluated using the most recent keratometry measure within 2 years prior to surgery. For eyes receiving standard monofocal intraocular lens (IOLs), postoperative refractive astigmatism was evaluated using the most recent refraction measure within 2-12 months postsurgery. A power vector analysis compared changes in the astigmatic 2-dimensional vector (J0, J45) before and after surgery, for the subgroup of eyes with both preoperative and postoperative astigmatism measurements. Visual acuity was also assessed preoperatively and postoperatively. RESULTS: Eligible eyes included in the analysis were 110 468. Of these, 78% (n=85 650) had preoperative (corneal) astigmatism ≥0.5 dioptres (D), 42% (n=46 003) ≥1.0 D, 21% (n=22 899) ≥1.5 D and 11% (n=11 651) ≥2.0 D. After surgery, the refraction cylinder was available for 39 744 (36%) eyes receiving standard monofocal IOLs, of which 90% (n=35 907) had postoperative astigmatism ≥0.5 D and 58% (n=22 886) ≥1.0 D. Visual acuity tended to worsen postoperatively with increased astigmatism (ρ=-0.44, P<0.01). CONCLUSIONS: There is a significant burden of preoperative astigmatism in the UK cataract population. The available refraction data indicate that this burden is not reduced after surgery with implantation of standard monofocal IOLs. Measures should be taken to improve visual outcomes of patients with astigmatic cataract by simultaneously correcting astigmatism during cataract surgery.

Global prevalence and economic and humanistic burden of astigmatism in cataract patients: a systematic literature review.

PURPOSE: To systematically review the published evidence on the prevalence and economic and humanistic burden of astigmatism in cataract patients. MATERIALS AND METHODS: For this systematic literature review, the Medline, PubMed, Embase, and Cochrane databases were searched from 1996 to September 2015 for available scientific literature that met the inclusion criteria. Studies published in the English language reporting prevalence and humanistic and economic burden in patients diagnosed with cataract and astigmatism were included. RESULTS: Of 3,649 papers reviewed, 31 studies from 32 publications met the inclusion criteria of this review. Preexisting astigmatism ≥1 D was present in up to 47% of cataract eyes. The cost burden of residual uncorrected astigmatism after cataract surgery was driven by the cost of spectacles, which was estimated to range from $2,151 to $3,440 in the US and $1,786 to $4,629 in Europe over a lifetime. In cataract patients, both preexisting and postoperative residual astigmatism were associated with poor vision-related patient satisfaction and quality of life, as well as higher spectacle burden. Astigmatism correction during cataract surgery appears to improve visual outcomes and results in overall lifetime cost savings compared to astigmatism correction with postoperative vision correction. CONCLUSION: There is a high prevalence of preexisting astigmatism in cataract patients. Although published data are limited, both preoperative astigmatism and postoperative residual astigmatism affect visual function and vision-related quality of life, resulting in increased humanistic burden. Suboptimal correction of astigmatism during cataract surgery drives the continuous need for vision correction with spectacles in the postoperative period. Patients must bear the out-of-pocket expenses, since payers often do not reimburse the cost of spectacles. Greater access to astigmatism correction during cataract surgery could improve visual outcomes and quality of life in patients. More research is required to gain a better understanding of the disease burden of astigmatism in cataract patients.

Economic and Humanistic Burden of Dry Eye Disease in Europe, North America, and Asia: A Systematic Literature Review.

Dry eye disease (DED) is a chronic and progressive multifactorial disorder of the tears and ocular surface, which results in symptoms of discomfort and visual disturbance. The aim of this systematic literature review was to evaluate the burden of DED and its components from an economic and health-related quality of life (HRQoL) perspective, and to compare the evidence across France, Germany, Italy, Spain, UK, USA, Japan, and China. PubMed, Embase, and six other resources were searched for literature published from January 1998 to July 2013. Of 76 titles/abstracts reviewed on the economic burden of DED and 263 on the HRQoL burden, 12 and 20 articles, respectively, were included in the review. The available literature suggests that DED has a substantial economic burden, with indirect costs making up the largest proportion of the overall cost due to a substantial loss of work productivity. In addition, DED has a substantial negative impact on physical, and potentially psychological, function and HRQoL across the countries examined. A number of studies also indicated that HRQoL burden increases with the severity of disease. Additional data are needed, particularly in Asia, in order to gain a better understanding of the burden of DED and help inform future health care resource utilization.

Associations between signs and symptoms of dry eye disease: a systematic review.

PURPOSE: The accurate diagnosis and classification of dry eye disease (DED) is challenging owing to wide variations in symptoms and lack of a single reliable clinical assessment. In addition, changes and severity of clinical signs often do not correspond to patient-reported symptoms. To better understand the inconsistencies observed between signs and symptoms, we conducted a systematic literature review to evaluate published studies reporting associations between patient-reported symptoms and clinical signs of DED. METHODS: PubMed and Embase were searched for English-language articles on the association between clinical signs and symptoms of DED up to February 2014 (no lower limit was set). RESULTS: Thirty-four articles were identified that assessed associations between signs and symptoms, among which 33 unique studies were reported. These included 175 individual sign-symptom association analyses. Statistical significance was reported for associations between sign and symptom measures in 21 of 33 (64%) studies, but for only 42 of 175 (24%) individual analyses. Of 175 individual analyses, 148 reported correlation coefficients, of which the majority (129/148; 87%) were between -0.4 and 0.4, indicating low-to-moderate correlation. Of all individual analyses that demonstrated a statistically significant association, one-half (56%) of reported correlation coefficients were in this range. No clear trends were observed in relation to the strength of associations relative to study size, statistical methods, or study region, although results from three studies did suggest that disease severity may be a factor. CONCLUSION: Associations between DED signs and symptoms are low and inconsistent, which may have implications for monitoring the response to treatment, both in the clinic and in clinical trials. Further studies to increase understanding of the etiopathogenesis of DED and to identify the most reliable and relevant measures of disease are needed to enhance clinical assessment of DED and the measurement of response to therapeutic interventions.

Managing oral phosphate binder medication expenditures within the Medicare bundled end-stage renal disease prospective payment system: economic implications for large U.S. dialysis organizations.

BACKGROUND: From January 2016, payment for oral-only renal medications (including phosphate binders and cinacalcet) was expected to be included in the new Medicare bundled end-stage renal disease (ESRD) prospective payment system (PPS). The implementation of the ESRD PPS has generated concern within the nephrology community because of the potential for inadequate funding and the impact on patient quality of care. OBJECTIVE: To estimate the potential economic impact of the new Medicare bundled ESRD PPS reimbursement from the perspective of a large dialysis organization in the United States. METHODS: We developed an interactive budget impact model to evaluate the potential economic implications of Medicare payment changes to large dialysis organizations treating patients with ESRD who are receiving phosphate binders. In this analysis, we focused on the budget impact of the intended 2016 integration of oral renal drugs, specifically oral phosphate binders, into the PPS. We also utilized the model to explore the budgetary impact of a variety of potential shifts in phosphate binder market shares under the bundled PPS from 2013 to 2016. RESULTS: The base model predicts that phosphate binder costs will increase to $34.48 per dialysis session in 2016, with estimated U.S. total costs for phosphate binders of over $682 million. Based on these estimates, a projected Medicare PPS $33.44 reimbursement rate for coverage of all oral-only renal medications (i.e., phosphate binders and cinacalcet) would be insufficient to cover these costs. A potential renal drugs and services budget shortfall for large dialysis organizations of almost $346 million was projected. CONCLUSIONS: Our findings suggest that large dialysis organizations will be challenged to manage phosphate binder expenditures within the planned Medicare bundled rate structure. As a result, large dialysis organizations may have to make treatment choices in light of potential inadequate funding, which could have important implications for the quality of care for patients with ESRD.

Real-world dose-relativity, tablet burden, and cost comparison of conversion between sevelamer hydrochloride/carbonate and lanthanum carbonate monotherapies.

PURPOSE: Sevelamer hydrochloride/carbonate (SH/C) and lanthanum carbonate (LC) are noncalcium-based phosphate binders used for the management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objectives of this study were to examine the dose-relativity, tablet burden, and cost difference of bidirectional conversion between SH/C and LC monotherapy in a large cohort of real-world patients with ESRD. METHODS: This retrospective cohort study included three 30-day preconversion periods (days -90 to -61, -60 to -31, and -30 to -1) followed by three 30-day postconversion periods (days 1 to 30, 31 to 60, and 61 to 90); day 0 was the index date of conversion. The full analysis population (FAP) comprised two cohorts: SH/C to LC (S-L) converters and LC to SH/C (L-S) converters. The SH/C:LC dose-relativity ratio was assessed in the dose-relativity subset, defined as patients whose serum phosphate levels fell within a caliper range of ± 0.5 mg/dL in the final preconversion (days -30 to -1) and postconversion (days 61 to 90) periods. Tablet burden and phosphate binder costs were assessed in the FAP. Phosphate binder costs were based on average wholesale prices. FINDINGS: The FAP contained a total of 303 patients, comprising the S-L (128 patients) and L-S (175 patients) converter cohorts. The dose-relativity subset contained 159 patients, 72 from the S-L cohort and 87 from the L-S cohort. The overall mean SH/C:LC dose-relativity ratio was 2.27 (95% CI, 2.04 to 2.52). In SH/C dose strata >800 to 2400, >2400 to 4800, >4800 to 7200, and >7200 mg/d, overall mean dose-relativity ratios were 0.79 (95% CI, 0.57 to 1.10), 1.45 (95% CI, 1.20 to 1.75), 2.05 (95% CI, 1.75 to 2.39), and 3.24 (95% CI, 2.89 to 3.66), respectively. The overall mean tablet burden was 6.6 tablets per day lower with LC monotherapy than with SH/C monotherapy (95% CI, -7.1 to -6.0; P < 0.0001). The overall mean binder cost/patient per month was $1080.40 for SH/C compared with $1006.20 for LC, corresponding to a mean binder cost saving for LC of $74.20/patient per month (95% CI, -141.80 to -6.63; P = 0.032). SH/C >7800 mg/d was the inflection point at which conversion to LC resulted in mean cost savings. Patients requiring SH/C >7800 mg/d comprised 50% of the FAP. IMPLICATIONS: Converting patients with ESRD and hyperphosphatemia from SH/C to LC monotherapy offers potential drug cost savings and a significant reduction in the daily tablet burden, without compromising the effective management of serum phosphate levels.

Analysis of serum phosphate control and phosphate binder utilization in incident hemodialysis patients.

The purpose of this study was to conduct a retrospective analysis of serum phosphate level variability in patients new to hemodialysis (HD) and to identify patient characteristics associated with this variability. The medical records of 47,742 incident HD patients attending US outpatient dialysis centers between January 1, 2006 and March 31, 2009 were analyzed. Monthly mean serum phosphate levels determined over a 6-month evaluation period (months 4-9 after HD initiation) were assigned to one of three strata: low (<1.13 mmol/L [<3.5 mg/dL]); target (1.13-1.78 mmol/L [3.5-5.5 mg/dL]); or high (>1.78 mmol/L [>5.5 mg/dL]). Patients were classified into one of six serum phosphate variability groups based on variability among monthly mean phosphate levels over the 6-month evaluation period: consistently target; consistently high; high-to-target; high-to-low; target-to-low; or consistently low. Only 15% of patients (consistently target group) maintained monthly mean serum phosphate levels within the target range throughout the 6-month evaluation period. Age, Charlson comorbidity index, serum phosphate, and intact parathyroid hormone levels prior to HD initiation were strongly associated (P<0.001) with serum phosphate levels after HD initiation. Overall patient-reported phosphate binder usage increased from 35% at baseline to 52% at end of study. The low proportion of patients achieving target phosphate levels and low rates of phosphate binder usage observed during the study suggest that alternative strategies could be developed to control serum phosphate levels. Possible strategies that might be incorporated to help improve the management of hyperphosphatemia in incident HD patients include dietary modification, dialysis optimization, and earlier and sustained use of phosphate binders.

Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease.

PURPOSE: Sevelamer hydrochloride (SH) and lanthanum carbonate (LC) are calcium-free phosphate binders used in the clinical management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objective of this analysis was to assess the cost-effectiveness of LC monotherapy compared with SH monotherapy in US patients with ESRD in a clinical practice setting. METHODS: This was a post hoc assessment of phosphate binder costs among US patients with ESRD who converted from SH to LC monotherapy in a previously published, 16-week, Phase IV, real-world study. Calculations of drug costs used both average wholesale price (AWP) and wholesale acquisition cost (WAC). FINDINGS: There were 953 patients with available baseline SH dose data; 950 also had a recorded LC dose >0 mg at baseline, and 691 had dose data available for both SH at baseline and LC at week 16 (post hoc analysis population). Baseline demographic characteristics were similar in excluded patients and the post hoc analysis population. Mean (SD) serum phosphate levels were 5.91 (1.66) mg/dL at baseline and 5.93 (1.85) mg/dL after conversion to LC monotherapy for 16 weeks. Mean AWP costs were US$35.72 (16.89) per day at baseline and US$24.69 (8.28) per day at week 16, yielding an overall mean cost change (defined as LC cost - SH cost) of -US$11.03 (16.37) per day in favor of LC. The overall mean WAC cost change was -US$9.17 (13.64) per day. Within baseline SH dose subgroups 2400 to 4800, >4800 to 7200, >7200 to 9600, and >9600 mg/d, the mean AWP cost change ranged from US$2.78 (9.26) per day in favor of SH for the 2400- to 4800-mg/d subgroup to -US$33.15 (12.58) per day in favor of LC for the >9600-mg/d subgroup. Mean WAC cost changes showed a similar trend, ranging from US$2.33 (7.72) per day to -US$27.59 (10.48) per day. Linear regression analyses revealed that the inflection SH doses corresponding to a mean cost change of zero were 4905 mg/d (AWP) and 4908 mg/d (WAC). For the 455 (66%) patients in the post hoc analysis population who had baseline SH doses at least as high (≥ 5600 mg/d) as these point estimates, the mean SH:LC tablet ratio was ≥ 3.7, indicating a mean reduction in the tablet burden after conversion to LC of ≥ 73%. IMPLICATIONS: This real-world assessment of comparative phosphate binder drug costs between SH and LC among US patients with ESRD indicates that average cost savings with LC use increased with increasing SH doses. Conversion to LC from SH ≥ 5600 mg/d reduced drug costs and tablet burden while maintaining serum phosphate levels.

The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease.

INTRODUCTION: Sevelamer hydrochloride (SH) and lanthanum carbonate (LC) are calcium-free phosphate binders used for the management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objective of this analysis was to evaluate the real-world dose-relativity between SH and LC monotherapy in US patients with ESRD. METHODS: This was a post hoc analysis of a 16-week, real-world study (Vemuri et al. in BMC Nephrol 12:49, 2011) of the efficacy of conversion to LC monotherapy from other phosphate binders. The SH:LC dose-relativity ratio, based on the mean daily dose, was calculated in the subset of patients from the Vemuri study who converted from SH to LC monotherapy and had available SH and LC dose data. RESULTS: A total of 950 patients converted from SH to LC monotherapy and had recorded dose data. The post hoc analysis population comprised 691 patients with available dose data for both SH at baseline and LC at week 16. The mean (SD) serum phosphate level at baseline was 5.91 (1.66) mg/dL. After conversion to LC monotherapy for 16 weeks, the mean (SD) serum phosphate level was 5.93 (1.85) mg/dL. The mean (SD) daily baseline SH dose was 7,703 (3,642) mg and the mean (SD) daily LC dose at week 16 was 2,800 (939) mg (9.6 versus 2.8 tablets, respectively; P < 0.0001), resulting in a SH:LC dose-relativity ratio of 2.8. The median individual patient SH:LC dose-relativity ratio was 2.6 (95% CI 2.6-2.8). Across baseline SH dose subgroups (2,400-4,800, >4,800-7,200, >7,200-9,600, and >9,600 mg/day), the mean daily SH dose was 4,051, 7,047, 9,253, and 13,150 mg, respectively. In comparison, the mean daily LC dose was 2,445-3,156 mg. Thus, patients requiring baseline SH doses >7,200 mg/day (41% of the analysis population) had higher SH:LC dose-relativity ratios of 3.1-4.2 (median individual patient ratios 3.1-4.0). CONCLUSION: In this post hoc analysis of real-world dose-relativity, the overall SH:LC dose-relativity ratio was 2.8 (median individual patient ratio 2.6 (95% CI 2.6-2.8). These findings are consistent with the World Health Organization-defined daily dose and previous studies of the relative phosphate binding capacity of the two drugs. Patients requiring SH doses >7,200 mg/day had higher SH:LC dose-relativities of 3.1-4.2 (median individual patient ratios 3.1-4.0). These findings have implications for the tablet burden and cost-effectiveness of SH and LC in the treatment of hyperphosphatemia.

Cost-effectiveness of lanthanum carbonate in the treatment of hyperphosphatemia in dialysis patients: a Canadian payer perspective.

BACKGROUND: Hyperphosphatemia is a common and potentially harmful condition in patients with end-stage kidney disease. In Canada, first-line treatment of hyperphosphatemia consists primarily of calcium carbonate (CC). Lanthanum carbonate (LC) and sevelamer hydrochloride (SH) are non-calcium phosphate binders that have been used as second-line therapy in patients intolerant of or not responsive to CC. OBJECTIVES: The primary objective of the present study was to assess the costs and clinical benefits of second-line use of LC after therapy failure with CC in patients receiving dialysis, from a Canadian payer perspective. The secondary objective was to perform an economic comparison between second-line LC therapy and second-line SH therapy, from a Canadian payer perspective. Short-term outcomes were treatment response and cost per additional responder, and long-term outcomes were survival, number of all-cause hospitalizations, and quality of life. METHODS: A cost-effectiveness Markov model was populated with simulated cohorts of 1000 patients receiving incident dialysis, followed life-long. Patients not responsive to CC with a serum phosphate concentration >1.78 mmol/L (>5.5 mg/dL) received a trial regimen with LC. Patients not responsive to LC returned to CC therapy. Patient data from a randomized controlled trial of 800 patients receiving dialysis were used. Extensive (probabilistic) sensitivity analyses were performed. When available, model parameters were based on Canadian data or from a Canadian perspective. All costs are in 2010 Canadian dollars (C$). RESULTS: Results of the model estimated that in patients responsive to second-line LC therapy, survival increased, on average, 0.44 years (95% confidence interval [CI], 0.35-0.54) per patient when compared with continued CC therapy. The mean (range) costs per patient in the first year of treatment with LC was C$2600 (C$2400-C$2800). Over patients' lifetimes, the second-line LC strategy resulted in a gain of 48.8 (37.1-61.3) life-years and 29.3 (21.4-38.1) quality-adjusted life-years (QALYs). The cost-effectiveness of the second-line LC strategy was C$7900 (C$1800-C$14,600) per life-year and C$13,200 (C$3000-C$25,100) per QALY gained. Most sensitivity analyses did not change the cost-effectiveness outcomes; however, including unrelated future costs raised the incremental cost-effectiveness ratio to C$159,500 (95% confidence interval, C$133,300-C$191,600) per QALY gained. Compared with second-line SH therapy, second-line LC therapy had similar effectiveness and was 23% less expensive. CONCLUSIONS: Second-line treatment with LC is cost-effective in the treatment of end-stage kidney disease in patients with hyperphosphatemia, from a Canadian payer perspective. Second-line treatment with LC is less expensive, with similar effectiveness as second-line treatment with SH. The primary limitation of health economic evaluations of phosphate binders is the relative scarcity of clinical data on the association between phosphate concentration and long-term outcome.

Cost-effectiveness of lanthanum carbonate versus sevelamer hydrochloride for the treatment of hyperphosphatemia in patients with end-stage renal disease: a US payer perspective.

OBJECTIVE: To assess the cost-effectiveness of lanthanum carbonate (LC) versus sevelamer hydrochloride (SH) as a treatment for hyperphosphatemia in end-stage renal disease (ESRD) patients. METHODS: A Markov model was developed to estimate health outcomes; quality-adjusted life years (QALYs) and life-years saved (LYS), as well as associated costs. The model incorporated patient-level data from a randomized head-to-head crossover study that compared the reduction of serum phosphorus using LC and SH for 4 weeks each. The model included patients previously treated with calcium-based binders. Both the intent-to-treat (ITT) population and the cohort of patients who completed treatment in both periods of the study (i.e., completer population) were assessed. The baseline risks of cardiovascular disease (CVD), all-cause mortalities for CVD, and non-CVD patients were derived from a large US renal database. Patient outcomes were modeled for 10 years, and incremental cost-effectiveness ratios (ICERs) were calculated for LC relative to SH. Deterministic and probabilistic sensitivity analyses (PSA) were performed to test the robustness of the base-case model. RESULTS: For the ITT population, the ICERs of LC versus SH were $24,724/QALY and $15,053/LYS, respectively (in US dollars). When the completer population was considered, the ICERs of LC versus SH were $15,285/QALY and $9,337/LYS (Table 2), respectively. The PSA indicated 61.9% and 85.8% probabilities for ITT and completer populations of LC being cost-effective at the $50,000/QALY willingness-to-pay threshold, respectively. CONCLUSION: LC is a cost-effective strategy compared with SH in the treatment of ESRD patients with hyperphosphatemia who were previously treated with calcium-based binders. Sensitivity analyses demonstrated the robustness of the pharmacoeconomic model.

Cost-effectiveness of lanthanum carbonate in the treatment of hyperphosphatemia in chronic kidney disease before and during dialysis.

OBJECTIVES: Hyperphosphatemia is a common and harmful condition in patients with chronic kidney disease (CKD). We determined the cost-effectiveness of the noncalcium-based phosphate binder lanthanum carbonate (LC) as second-line treatment of hyperphosphatemia after therapy failure with calcium-based binders (CB). METHODS: Two CKD populations were modeled: 1) predialysis CKD patients and 2) incident dialysis patients. Patients not responding to CB with a serum phosphate (SP) level >5.5 mg/dl received a trial with LC. Patients not responding to LC (SP >4.6 mg/dl) returned to CB treatment. Patient-level data were obtained from clinical trials in predialysis and dialysis. Time-dependent, life-long Markov models (discounting at 3.5% annually) were developed, using a UK National Health Service perspective. RESULTS: The health gains with second-line LC treatment compared to CB treatment were 44 and 56 quality-adjusted life-years (QALYs) for the predialysis and incident dialysis populations, respectively. Second-line LC was a cost-saving strategy in the predialysis population because of the cost-savings of delayed CKD progression. Second-line LC was cost-effective at £6900 (90% probability interval: £5800-£8300) per QALY gained in the dialysis population. Results were robust to plausible variations in other model parameters; inclusion of future unrelated dialysis costs had a large influence on cost-effectiveness estimates. CONCLUSIONS: Second-line treatment with LC is associated with considerable clinical benefits and good value for money in CKD, irrespective of dialysis status. These results support Kidney Disease Outcomes Quality Initiative guidelines to treat CKD patients with hyperphosphatemia irrespective of dialysis status.

Prediction of healing for postoperative diabetic foot wounds based on early wound area progression.

OBJECTIVE: To evaluate the probability of wound healing based on percentage of wound area reduction (PWAR) at 1 and 4 weeks in individuals with large, chronic, nonischemic diabetic foot wounds following partial foot amputation. METHODS: Data from a 16-week randomized clinical trial (RCT) of 162 patients were analyzed to compare outcomes associated with negative-pressure wound therapy (NPWT) delivered through the V.A.C. Therapy System (Kinetic Concepts, San Antonio, TX) (n = 77) versus standard moist wound therapy (MWT) (n = 85). The 1- and 4-week regression models included 153 and 129 of the RCT patients, respectively. RESULTS: Early changes in PWAR were predictive of final healing at 16 weeks. Specifically, wounds that reached >or=15% PWAR at 1 week or >or=60% PWAR at 4 weeks had a 68 and 77% (respectively) probability of healing vs. a 31 and 30% probability if these wound area reductions were not achieved. Patients receiving NPWT were 2.5 times more likely to achieve both a 15% PWAR at 1 week and a 60% area reduction at 1 month (odds ratios 2.51 and 2.49, respectively) compared with those receiving MWT. CONCLUSION: Results of this study suggest that clinicians can calculate the PWAR of a wound as early as 1 week into treatment to predict the likelihood of healing at 16 weeks. This might also assist in identifying a rationale to reevaluate the wound and change wound therapies.