Counting the Cost of Cellular and/or Tissue Based Products in Diabetic Foot Ulcers: Is There a Justifiable Price Limit Per Square cm?

OBJECTIVE: To identify how cellular and/or tissue-based products (CTPs) relate to value in terms of cost per quality-adjusted life years in wound care with comparisons to treatments in other medical fields. APPROACH: This is a cross-sectional study, cost-effectiveness analysis. Payment limits for each CTP were obtained via HCPCS Q codes and formulated as cost inputs into a cost-utility model published for treatment of Wagner 1 diabetic foot ulcers using dHACA versus standard of care. Additional changes to cap number of CTP applications and adjust for recent inflation were made. The literature was searched for other cost-utility models in other medical fields as comparisons. RESULTS: When the payment limit was ≤$140 per square cm interventions were dominant (less costly, better outcomes) compared to standard of care. When the limit exceeded $430 per square cm the cost-effectiveness threshold of $100,000/QALY was exceeded. Newer Q codes are generally much more expensive and likely to not be cost-effective in comparison to the results for many other chronic diseases considered to be more serious than chronic wounds. INNOVATION: This study presents decision-makers with tools by which they can determine as to whether a given CTP is likely to be cost-effective for patients. CONCLUSION: Over a third of all CTPs will very likely result in non-cost-effective interventions. This number is likely to be higher when wounds are larger or used in other wound types where they are less efficacious. The recent trend in much higher costs for CTPs is worrisome.

Risk factors of age-related macular degeneration in Argentina.

PURPOSES: To assess the risk factors of age-related macular degeneration in Argentina using a case-control study. METHODS: Surveys were used for subjects' antioxidant intake, age/gender, race, body mass index, hypertension, diabetes (and type of treatment), smoking, sunlight exposure, red meat consumption, fish consumption, presence of age-related macular degeneration and family history of age-related macular degeneration. Main effects models for logistic regression and ordinal logistic regression were used to analyze the results. RESULTS: There were 175 cases and 175 controls with a mean age of 75.4 years and 75.5 years, respectively, of whom 236 (67.4%) were female. Of the cases with age-related macular degeneration, 159 (45.4%) had age-related macular degeneration in their left eyes, 154 (44.0%) in their right eyes, and 138 (39.4%) in both eyes. Of the cases with age-related macular degeneration in their left eyes, 47.8% had the dry type, 40.3% had the wet type, and the type was unknown for 11.9%. The comparable figures for right eyes were: 51.9%, 34.4%, and 13.7%, respectively. The main effects model was dominated by higher sunlight exposure (OR [odds ratio]: 3.3) and a family history of age-related macular degeneration (OR: 4.3). Other factors included hypertension (OR: 2.1), smoking (OR: 2.2), and being of the Mestizo race, which lowered the risk of age-related macular degeneration (OR: 0.40). Red meat/fish consumption, body mass index, and iris color did not have an effect. Higher age was associated with progression to more severe age-related macular degeneration. CONCLUSION: Sunlight exposure, family history of age-related macular degeneration, and an older age were the significant risk factors. There may be other variables, as the risk was not explained very well by the existing factors. A larger sample may produce different and better results.

Visual acuity and refraction by age for children of three different ethnic groups in Paraguay.

PURPOSE: To characterize refractive errors in Paraguayan children aged 5-16 years and investigate effect of age, gender, and ethnicity. METHODS: The study was conducted at 3 schools that catered to Mennonite, indigenous, and mixed race children. Children were examined for presenting visual acuity, autorefraction with and without cycloplegia, and retinoscopy. Data were analyzed for myopia and hyperopia (SE ≤-1 D or -0.5 D and ≥2 D or ≥3 D) and astigmatism (cylinder ≥1 D). Spherical equivalent (SE) values were calculated from right eye cycloplegic autorefraction data and analyzed using general linear modelling. RESULTS: There were 190, 118, and 168 children of Mennonite, indigenous and mixed race ethnicity, respectively. SE values between right/left eyes were nonsignificant. Mean visual acuity (VA) without correction was better for Mennonites compared to indigenous or mixed race children (right eyes: 0.031, 0.090, and 0.102 logMAR units, respectively; P<0.000001). There were 2 cases of myopia in the Mennonite group (1.2%) and 2 cases in the mixed race group (1.4%) (SE ≤-0.5 D). The prevalence of hyperopia (SE ≥2 D) was 40.6%, 34.2%, and 46.3% for Mennonite, indigenous and mixed race children. Corresponding astigmatism rates were 3.2%, 9.5%, and 12.7%. Females were slightly more hyperopic than males, and the 9-11 years age group was the most hyperopic. Mennonite and mixed race children were more hyperopic than indigenous children. CONCLUSIONS: Paraguayan children were remarkably hyperopic and relatively free of myopia. Differences with regard to gender, age, and ethnicity were small.

Risk factors of age-related macular degeneration in Argentina / Fatores de risco para degeneração macular relacionada à idade na Argentina

PURPOSES: To assess the risk factors of age-related macular degeneration in Argentina using a case-control study. METHODS: Surveys were used for subjects' antioxidant intake, age/gender, race, body mass index, hypertension, diabetes (and type of treatment), smoking, sunlight exposure, red meat consumption, fish consumption, presence of age-related macular degeneration and family history of age-related macular degeneration. Main effects models for logistic regression and ordinal logistic regression were used to analyze the results. RESULTS: There were 175 cases and 175 controls with a mean age of 75.4 years and 75.5 years, respectively, of whom 236 (67.4%) were female. Of the cases with age-related macular degeneration, 159 (45.4%) had age-related macular degeneration in their left eyes, 154 (44.0%) in their right eyes, and 138 (39.4%) in both eyes. Of the cases with age-related macular degeneration in their left eyes, 47.8% had the dry type, 40.3% had the wet type, and the type was unknown for 11.9%. The comparable figures for right eyes were: 51.9%, 34.4%, and 13.7%, respectively. The main effects model was dominated by higher sunlight exposure (OR [odds ratio]: 3.3) and a family history of age-related macular degeneration (OR: 4.3). Other factors included hypertension (OR: 2.1), smoking (OR: 2.2), and being of the Mestizo race, which lowered the risk of age-related macular degeneration (OR: 0.40). Red meat/fish consumption, body mass index, and iris color did not have an effect. Higher age was associated with progression to more severe age-related macular degeneration. CONCLUSION: Sunlight exposure, family history of age-related macular degeneration, and an older age were the significant risk factors. There may be other variables, as the risk was not explained very well by the existing factors. A larger sample may produce different and better results.

OBJETIVO: Determinar os fatores de risco para degeneração macular relacionada à idade na Argentina utilizando um estudo caso-controle. MÉTODOS: Questionários foram usados para a obtenção de informações dos participantes em relação à ingesta de antioxidantes, idade/sexo, raça, índice de massa corporal, hipertensão, diabetes (e tipo de tratamento), tabagismo, exposição à luz solar, consumo de carne vermelha/peixe, presença de degeneração macular relacionada à idade e história familiar de degeneração macular relacionada à idade. Modelos de efeito principal para regressão logística e regressão logística ordinal foram usados para analisar os resultados. RESULTADOS: Foram recrutados 175 casos e 175 controles com uma média de idade de 75,4 anos e 75,5, respectivamente, dos quais 236 (67,4%) eram mulheres. Cento e cinquenta e nove (45,4%) tinham degeneração macular relacionada à idade em seus olhos esquerdos, 154 (44,0%) em seus olhos direitos, e 138 (39,4%) em ambos os olhos. Entre os casos de degeneração macular relacionada à idade no olho esquerdo, 47,8% apresentavam o tipo seca, 40,3% o tipo úmida, e o tipo era desconhecido em 11,9%. Os achados para os olhos direitos foram: 51,9%, 34,4% e 13,7%, respectivamente. O modelo de efeito principal foi dominado por maior exposição à luz solar (OR [odds ratio]: 3,3) e história familiar de degeneração macular relacionada à idade (OR: 4,3). Outros fatores incluindo hipertensão (OR: 2,1), tabagismo (OR: 2,2), e pertencente à raça mestiça, que diminuiram o risco de degeneração macular relacionada à idade (OR: 0,40). Consumo de carne vermelha e de peixe, índice de massa corporal e coloração da íris não foram fatores de risco. Idade avançada foi associada com progressão para degeneração macular relacionada à idade mais grave. CONCLUSÃO: Exposição à luz solar, história familiar de degeneração macular relacionada à idade, e idade avançada foram os fatores de risco significativos. Podem existir outras variáveis, já que os riscos não foram bem explicados pelos fatores existentes. Um maior tamanho amostral poderia produzir resultados diferentes e melhores.

Visual acuity and refraction by age for children of three different ethnic groups in Paraguay / Acuidade visual e refração por idade para crianças de três grupos étnicos diferentes no Paraguai

PURPOSE: To characterize refractive errors in Paraguayan children aged 5-16 years and investigate effect of age, gender, and ethnicity. METHODS:The study was conducted at 3 schools that catered to Mennonite, indigenous, and mixed race children. Children were examined for presenting visual acuity, autorefraction with and without cycloplegia, and retinoscopy. Data were analyzed for myopia and hyperopia (SE ≤-1 D or -0.5 D and ≥2 D or ≥3 D) and astigmatism (cylinder ≥1 D). Spherical equivalent (SE) values were calculated from right eye cycloplegic autorefraction data and analyzed using general linear modelling. RESULTS: There were 190, 118, and 168 children of Mennonite, indigenous and mixed race ethnicity, respectively. SE values between right/left eyes were nonsignificant. Mean visual acuity (VA) without correction was better for Mennonites compared to indigenous or mixed race children (right eyes: 0.031, 0.090, and 0.102 logMAR units, respectively; P<0.000001). There were 2 cases of myopia in the Mennonite group (1.2%) and 2 cases in the mixed race group (1.4%) (SE ≤-0.5 D). The prevalence of hyperopia (SE ≥2 D) was 40.6%, 34.2%, and 46.3% for Mennonite, indigenous and mixed race children. Corresponding astigmatism rates were 3.2%, 9.5%, and 12.7%. Females were slightly more hyperopic than males, and the 9-11 years age group was the most hyperopic. Mennonite and mixed race children were more hyperopic than indigenous children. CONCLUSIONS: Paraguayan children were remarkably hyperopic and relatively free of myopia. Differences with regard to gender, age, and ethnicity were small.

OBJETIVO: Caracterizar os erros de refração em crianças paraguaias com idades entre 5 e 16 anos e investigar efeito da idade, gênero e etnia. MÉTODOS: O estudo foi realizado em três escolas que atendiam crianças de etnia Menonita, indígena e mista. As crianças foram examinadas em relação à acuidade visual, autorrefração com e sem cicloplegia, e retinoscopia. Os dados foram analisados ​​para correção de miopia e hipermetropia (EE ≤-1 D ou -0,5D e ≥ 2D ou ≥3 D) e astigmatismo (cilindro ≥1 D). Valores equivalentes esféricos (EE) foram calculados a partir dos dados de autorrefração cicloplegiada do olho direito e analisados ​​por meio de modelagem linear geral. RESULTADOS: Foram avaliadas 190, 118 e 168 crianças de etnias Menonita, indígena e mista, respectivamente. Diferenças entre os valores de EE de olhos direitos e esquerdos não foram significantes. A acuidade visual (AV) sem correção foi melhor para Menonitas em relação às crianças da etnia indígena ou mista (olho direito: 0,031, 0,090 e 0,102 logMAR, respectivamente; P<0,000001). Houve 2 casos de miopia no grupo Menonita (1,2%) e 2 casos no grupo de etnia mista (1,4%) (SE ≤-0,5 D). A prevalência de hipermetropia (SE ≥2 D) foi de 40,6%, 34,2% e 46,3% para as etnias Menonita, indígena e mista. As taxas correspondentes de astigmatismo foram de 3,2%, 9,5% e 12,7%. As mulheres foram ligeiramente mais hipermétropes do que os homens, e o grupo de 9 a 11 anos de idade foi a mais hipermétrope. Crianças da etnia Menonita e mista se mostraram mais hipermétropes do que as crianças indígenas. CONCLUSÕES: As crianças paraguaias são notavelmente hipermétropes e relativamente livres de miopia. Diferenças com relação ao sexo, idade e etnia são pequenas.

Health Economics Information in Wound Care: The Elephant in the Room.

OBJECTIVE: To describe the role of health economics (HE) in wound care in relation to coverage and reimbursement. APPROACH: Narrative description of key concepts with supporting references. RESULTS: The process of approval or clearance of wound care products within the U.S. regulatory framework often causes lack of high level of evidence regarding clinical outcomes. There is also a paucity of HE information and great reluctance to use such information (when it is available) by insurers and Centers for Medicare and Medicaid, as well as other health-care agencies. Cost-effectiveness (CE) studies are the most common type of HE study in wound care, and the most common outcomes are incremental CE ratios (ICERs). Interpretation of ICERs requires considerable judgment when results are not obvious and is hampered by lack of contemporary and useful benchmarks. While many lessons have been learned in applying CE to coverage and reimbursement decisions in other western countries-including transparency of decision-making and involvement of patients-there is still a major aversion to using CE in the United States Applying CE to basic wound care and advanced therapeutics has the potential to decrease the costs of wound healing considerably. INNOVATION AND CONCLUSIONS: Many CE approaches, including modeling, provide sufficiently detailed information that decision-makers can make informed decisions about wound care products in regard to coverage and reimbursement. The reluctance to use CE information in the United States, however, is likely to contribute heavily to the ever-increasing costs in wound care.