Toward the Implementation of a Value Framework for Diagnostic Technologies: Operationalization, Piloting, and Validation in Latin America.

OBJECTIVES: In 2020, a group of 30 stakeholders from Latin America established 15 criteria for a diagnostic technologies value framework (D-VF) to help assess and inform decisions on diagnostic technologies. This article aims to present the operationalization, piloting, and initial validation of the framework for its implementation. METHODS: This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) operationalization of the D-VF through a literature search for conceptual definitions and assessment tools, (2) piloting of the D-VF through a rapid health technology assessment document applying the methodology of the framework, and (3) a face validation process conducted through a virtual workshop, where usefulness and implementation aspects of the framework were assessed. RESULTS: The operationalization of the framework was conducted, and a methodological user guide was published. The D-VF criteria were applied in a health technology assessment document on human papilloma virus testing in cervical cancer screening. Also, an open-access training program was developed. Stakeholders agreed on the usefulness of the D-VF for assessment and decision-making stages of diagnostic technologies. However, they highlighted the need to improve technical capacities and the potential for added complexity when applying a D-VF with many criteria. The absence of an established value framework for diagnostic technologies in Latin America and the potential for strengthening technical capacities made the project valuable to those involved. CONCLUSIONS: The diagnostic technologies value framework was shown to be fit for implementation in real-life decision-making settings after the operationalization, piloting, and initial validation phases. Further experiences are important to support its implementation.

A Systematic Review of Value Criteria for Next-Generation Sequencing/Comprehensive Genomic Profiling to Inform Value Framework Development.

OBJECTIVES: To comprehensively identify and map an exhaustive list of value criteria for the assessment of next-generation sequencing/comprehensive genomic profiling (NGS/CGP), to be used as an aid in decision making. METHODS: We conducted a systematic review to identify existing value frameworks (VFs) applicable to any type of healthcare technology. VFs and criteria were mapped to a previously published Latin American (LA) VF to harmonize definitions and identify additional criteria and or subcriteria. Based on this analysis, we extracted a comprehensive, evidence-based list of criteria and subcriteria to be considered in the design of a NGS/CGP VF. RESULTS: A total of 42 additional VFs were compared with the LA VF, 88% were developed in high-income countries, 30% targeted genomic testing, and 16% specifically targeted oncology. A total of 242 criteria and subcriteria were extracted; 227 (94%) were fully/partially included in the LA VF; and 15 (6%) were new. Clinical benefit and economic aspects were the most common criteria. VFs oriented to genomic testing showed significant overlap with other VFs. Considering all criteria and subcriteria, a total of 18 criteria and 36 individual subcriteria were identified. CONCLUSIONS: Our study provides an evidence-based set of criteria and subcriteria for healthcare decision making useful for NGS/CGP as well as other health technologies. The resulting list can be beneficial to inform decision making and will serve as a foundation to co-create a multistakeholder NGS/CGP VF that is aligned with the needs and values of health systems and could help to improve patient access to high-value technologies.

Deliberative processes in decision making informed by health technology assessment in Latin America.

OBJECTIVE: The objective of Health Technology Assessment International's 6th Latin America Policy Form, held in 2021, was to explore the implementation of deliberative processes in the framework of health technology assessment (HTA) and how agencies in the region could involve stakeholders in this process. METHODS: This paper is based on a preparatory survey, a background document, and the deliberative work of participants at the virtual Forum conducted in 2021. There were ninety-one participants in the open session and fifty-two in the closed sessions, representing twelve countries and diverse areas of the health sector. RESULTS: While there are mechanisms in most countries in Latin America to consider stakeholder involvement to some degree, it remains reduced or limited to a consultative role, making true participative involvement rare. There are significant barriers and structural and contextual limitations that have impeded or slowed progress toward deliberative processes. Relatively low levels of institutionalization and knowledge about HTA, as well as the lack of trust among stakeholders are important challenges. This situation has impacted health systems by diminishing the legitimacy of decisions and the very structures and processes of HTA. CONCLUSION: The Forum's broad group of participants identified barriers, facilitators, and recommendations to improve the use of deliberative processes in Latin America to foster improved fairness and reasonableness in HTA and decision making.

Evidence-Informed Update of Argentina's Health Benefit Package: Application of a Rapid Review Methodology.

OBJECTIVES: Argentina has a fragmented healthcare system with social security covering almost two thirds of the population. Its benefit package-called compulsory medical program (PMO; by its Spanish acronym Programa Médico Obligatorio)-has not been formally and widely updated since 2005. However, laws, clinical practice guidelines (CPGs), and a high-cost technology reimbursement fund complement it. Our objective was to comprehensively review such a PMO and propose an update considering the corresponding complementary sources. METHODS: We followed four steps: (i) identification of health technologies from the current PMO and complementary sources, (ii) prioritization, (iii) assessment through rapid health technology assessment (HTA), and (iv) appraisal and recommendations. We evaluated three value domains: quality of evidence, net benefit, and economics, which were summarized in a five-category recommendation traffic-light scale ranging from a strong recommendation in favor of inclusion to a strong recommendation for exclusion. RESULTS: Eight hundred fifty technologies were identified; 164 of those, considered as high priority, were assessed through rapid HTAs. Those technologies mentioned in laws and CPGs were mostly outpatient essential medicines, whereas those from the reimbursement system were mostly high-cost drugs; of these 101 technologies, 50 percent were recommended to be kept in the PMO. The other 63 (identified by the Superintendence of Health Services, technology producers, and patients) were mostly medical procedures and high-cost drugs; only 25 percent of those resulted in a favorable recommendation. CONCLUSIONS: A methodology based on four clearly identified steps was used to carry out a comprehensive review of an outdated and fragmented benefit package. The use of rapid HTAs and a traffic-light recommendation framework facilitated the deliberative evidence-based update.

Identification and selection of health technologies for assessment by agencies in support of reimbursement decisions in Latin America.

OBJECTIVE: There is no health system that has the resources to evaluate all technologies. The presence of a clear process to prioritize health technologies for assessment by health technology assessment (HTA) agencies is a good practice principle recognized at the international level. The objective of Health Technology Assessment International's 2020 Latin American Policy Forum (LatamPF) was to explore how to improve the way HTA agencies in Latin America identify and prioritize technologies for assessment. METHODS: This paper is based on a background document, a survey, and the deliberations of the members of the LatamPF (forty-six participants from eleven countries) using a design thinking methodology. RESULTS: Participants agreed that a lack of clear prioritization mechanisms results in HTA processes and decisions that are perceived to be of low transparency and overly exposed to political or interest group pressures. The LatamPF identified barriers and recommended actions to improve HTA prioritization mechanisms in Latin America. The criteria identified as the most important to be taken into consideration by HTA agencies in the region when prioritizing a technology for assessment were: the burden of illness, the potential clinical benefit, the alignment with national health priorities, the potential impact on equity, a lack of treatment alternatives for patients, and the potential economic impact. CONCLUSIONS: Forum participants agreed that the establishment of transparent prioritization processes is a key element for all health systems. Improvements in these processes will strengthen HTA and provide greater legitimacy to decision making.

[Mecanismos de identificación y priorización de las tecnologías sanitarias a ser evaluadas por las Agencias de ETESA para decisiones de cobertura en Latino America].

OBJETIVO: Ningún sistema de salud cuenta con los recursos necesarios para evaluar todas las tecnologías. Contar con un proceso claro para priorizar qué tecnologías serán evaluadas por las agencias de evaluación de tecnologías sanitarias (ETESA) constituye un principio de buena práctica reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino América (LatamPF) 2020 de Health Technology Assessment International fue explorar cómo puede mejorarse la forma en que las agencias de ETESA de Latino América identifican y priorizan las tecnologías a ser evaluadas. MÉTODOS: Este manuscrito está basado en un documento base, una encuesta, y en el trabajo deliberativo realizado por los miembros (cuarenta y seis participantes, once países) que participaron del LatamPF, a través de la metodología design-thinking. RESULTADOS: Los participantes coincidieron en que la falta de mecanismos claros de priorización trae como consecuencia una falta de legitimidad de las decisiones y procesos de ETESA, que son percibidos como poco transparentes y demasiado expuestos a presiones políticas o de grupos de interés. También se identificaron barreras y acciones para mejorar los mecanismos de priorización de ETESA en América Latina. Los criterios identificados como más importantes para ser tenidos en cuenta por las agencias de ETESA de la región al momento de priorizar una tecnología para ser evaluada fueron la carga de enfermedad, el potencial beneficio clínico, la alineación con prioridades de salud nacionales, el potencial impacto en la equidad, ausencia de otras alternativas para los pacientes, y el potencial impacto económico. CONCLUSIONES: Los participantes del Foro coincidieron en que el establecimiento de procesos transparentes de priorización es un elemento clave para todos los sistemas de salud. Las mejoras en este proceso fortalecerán la ETESA en Latino América y darán mayor legitimidad a sus decisiones.

A Value Framework for the Assessment of Diagnostic Technologies: A Proposal Based on a Targeted Systematic Review and a Multistakeholder Deliberative Process in Latin America.

OBJECTIVES: there are very few value frameworks (VFs) to assess health technologies that are focused on diagnostic tests; they usually do not reflect a multistakeholder process; and they are all developed in high-income countries. Our project performed a targeted systematic review, with the objective of proposing an evidence-based, up-to-date VF informed by a multinational multistakeholder group working in the health technology assessment (HTA) space. METHODS: (1) A targeted systematic review, with the aim to identify existing VFs and their dimensions; and (2) generation a VF proposal through a mixed-methods, qualitative-quantitative approach. RESULTS: From 73 citations identified, 20 met our inclusion criteria and served to provide the initial list of dimensions for our VF. An initial list of criteria and subcriteria for a preliminary VF was proposed. After a full-day deliberative face-to-face meeting with 30 relevant stakeholders from seven Latin American countries and the United Kingdom, the final VF was defined, consisting of 15 criteria: five "essential or core," six highly relevant, three moderately relevant, and one of low relevance. Barriers and facilitators of value assessment of diagnostic technologies were also discussed. CONCLUSIONS: We propose a VF oriented to diagnostic technologies based on a targeted systematic review and a participatory process with key HTA stakeholders. It is the first to be produced in a lower and middle income setting but can also be potentially useful in other contexts aimed to assist decision-making processes with these particularly complex health technologies.

[Epidemiology, resource use and costs of rheumatoid arthritis in Argentina]. / Epidemiología, uso de recursos y costos de la artritis reumatoidea en Argentina.

This review aims to identify information on epidemiological parameters and estimate the cost of moderate to severe rheumatoid arthritis (RA). A search for related literature was carried out in major databases. A consensus of local rheumatology experts was used to find the most realistic parameters, using a modified Delphi method. Direct medical costs were estimated, using information collected from the cost per unit database of the Instituto de Efectividad Clínica y Sanitaria de Argentina. Indirect costs were estimated using the human resources approach. Costs were expressed in US dollars (USD) as of November 2017. The reported prevalence of RA in Argentina was 0.94% (95%CI: 0.86 to 1.02), with an annual incidence rate of 19 per 100,000 people (95%CI: 17 to 20). The annual cost of disease-modifying drugs was 33,936.10 USD per patient. The cost attributed to serious infections was 2,474.6 USD. The cost of bilateral knee replacement per patient was $5,276.8 USD; and the cost for total hip replacement was $9,196.4. Both, the cost of hospitalization days per patient per year, and the indirect costs of RA increased as the disability score increased. This review reports useful information on epidemiological and cost parameters of moderate to severe RA, in the era of biological agents, in order to be useful for conducting economic evaluations regarding health in Argentina.

La presente revisión tiene como objetivo identificar información sobre parámetros epidemiológicos y estimar el costo de la artritis reumatoidea (AR) moderada a severa. Se llevó a cabo una búsqueda de la literatura en las principales bases de datos. Se recurrió a un consenso de expertos locales en reumatología para encontrar los parámetros más realistas, utilizando un método Delphi modificado. Se estimaron los costos médicos directos, utilizando información recopilada en la base de datos de costos unitarios del Instituto de Efectividad Clínica y Sanitaria de Argentina. Los costos indirectos se estimaron a través del enfoque del capital humano. Los costos se expresaron en dólares estadounidenses (USD) a noviembre de 2017. La prevalencia reportada de AR en Argentina fue 0,94% (IC95%: 0,86 a 1,02), con una tasa de incidencia anual de 19 cada 100 000 personas (IC95%: 17 a 20). El costo anual de las drogas modificadoras de la enfermedad fue de USD 33 936,10 por paciente. El costo atribuido a las infecciones serias fue de USD 2474,6. El costo del reemplazo bilateral de rodillas por paciente fue de USD 5276,8, y el del reemplazo total de cadera, de USD 9196,4. El costo por paciente por año de días de hospitalización y los costos indirectos de la AR se acrecentaron al aumentar el puntaje de discapacidad. La revisión reporta información útil acerca de parámetros epidemiológicos y de costos de la AR moderada a severa en la era de los agentes biológicos, con el fin de resultar de utilidad para la conducción de evaluaciones económicas de salud en Argentina.

[Mortality and recurrence of venous thromboembolic disease in adult patients: prospective cohort]. / Mortalidad y recurrencia de la enfermedad tromboembólica venosa en pacientes adultos: cohorte prospectiva.

INTRODUCTION: Venous thromboembolic disease (VTE) is a pathology that increases with age. RESULTS: 446 patients were included, 63% (292) were older than 65 years. Survival was lower in the elderly compared to the young (p 0.007), at 3 months 87% vs. 95% and at one year 73% vs. 87%, respectively. The elderly had a HRc1.71 and HR at 1.68. The overall recurrence was 5% (95% CI 3-8) at one month, 6% (95% CI 4-9) at 3 months, 8% (95% CI). 6-11) at one year and 13% (95% CI 9-18) at two years. No association was found between age and recurrence sub hazard 0.8 (CI 0.34-1.86). Bleeding occurred in 9% (39) of the patients. OBJECTIVE: to compare the survival of the elderly and the young with a first episode of acute and symptomatic VTE. MATERIALS AND METHODS: Prospective cohort of incident VTE cases included in the Institutional Registry of Venous Thromboembolic Disease (NCT01372514) of the Italian Hospital of Buenos Aires between 2012-2014, divided into young groups (17-64 years old) and elderly (65 years old). All the patients were followed annually to assess the time to recurrence (progression or new symptomatic event of VTE) as competitive events in the context of death and major bleeding. Raw (c) and adjusted (a) risks were presented. CONCLUSIONS: The overall mortality in patients with confirmed VTE is higher in the elderly population. There were no differences in relation to the recurrence of VTE, or bleeding, and neither with age.

INTRODUCCIÓN: La enfermedad tromboembólica venosa (ETV) es una patología que aumenta con la edad. CONCLUSIONES: La mortalidad global en pacientes con ETV confirmada es mayor en la población anciana. No hubo diferencias en relación a la recurrencia de ETV, ni   el sangrado y tampoco con la edad. OBJETIVO: Comparar la sobrevida de los ancianos y los jóvenes con un primer episodio de ETV aguda y sintomática. MATERIALES Y MÉTODOS: Cohorte prospectiva de casos incidentes de ETV incluidos en el Registro Institucional de Enfermedad Tromboembólica venosa (NCT01372514) del Hospital Italiano de Buenos Aires entre 2012-2014, dividido en grupos jóvenes (17-64 años) y ancianos (≥ 65 años). Todos los pacientes fueron seguidos anualmente para evaluar el tiempo a la recurrencia (progresión o nuevo evento sintomático de ETV) como eventos competitivos en contexto de muerte y sangrado mayor. Se presentaron los riesgos crudos (c) y ajustados. (a). RESULTADOS: Se incluyeron 446 pacientes, el 63% (292) fueron mayores de 65 años. La sobrevida fue menor en los ancianos comparados con los jóvenes (p 0.007), a los 3 meses 87% vs 95% y al año 73% vs 87%, respectivamente. Los ancianos presentaron un HRc1,71 y HR a 1.68. La recurrencia global fue 5% (IC 95% 3-8) al mes, 6% (IC 95% 4-9) a los 3 meses, 8% (IC 95% 6-11) al año y 13% (IC 95% 9-18) a los dos años. No se encontró asociación entre la edad y la recurrencia sub hazard 0.8(IC 0,34-1,86). El sangrado ocurrió en un 9% (39) de los pacientes.

Epidemiología, uso de recursos y costos de la artritis reumatoidea en Argentina / Epidemiology, resource use and costs of rheumatoid arthritis in Argentina

RESUMEN La presente revisión tiene como objetivo identificar información sobre parámetros epidemiológicos y estimar el costo de la artritis reumatoidea (AR) moderada a severa. Se llevó a cabo una búsqueda de la literatura en las principales bases de datos. Se recurrió a un consenso de expertos locales en reumatología para encontrar los parámetros más realistas, utilizando un método Delphi modificado. Se estimaron los costos médicos directos, utilizando información recopilada en la base de datos de costos unitarios del Instituto de Efectividad Clínica y Sanitaria de Argentina. Los costos indirectos se estimaron a través del enfoque del capital humano. Los costos se expresaron en dólares estadounidenses (USD) a noviembre de 2017. La prevalencia reportada de AR en Argentina fue 0,94% (IC95%: 0,86 a 1,02), con una tasa de incidencia anual de 19 cada 100 000 personas (IC95%: 17 a 20). El costo anual de las drogas modificadoras de la enfermedad fue de USD 33 936,10 por paciente. El costo atribuido a las infecciones serias fue de USD 2474,6. El costo del reemplazo bilateral de rodillas por paciente fue de USD 5276,8, y el del reemplazo total de cadera, de USD 9196,4. El costo por paciente por año de días de hospitalización y los costos indirectos de la AR se acrecentaron al aumentar el puntaje de discapacidad. La revisión reporta información útil acerca de parámetros epidemiológicos y de costos de la AR moderada a severa en la era de los agentes biológicos, con el fin de resultar de utilidad para la conducción de evaluaciones económicas de salud en Argentina.

ABSTRACT This review aims to identify information on epidemiological parameters and estimate the cost of moderate to severe rheumatoid arthritis (RA). A search for related literature was carried out in major databases. A consensus of local rheumatology experts was used to find the most realistic parameters, using a modified Delphi method. Direct medical costs were estimated, using information collected from the cost per unit database of the Instituto de Efectividad Clínica y Sanitaria de Argentina. Indirect costs were estimated using the human resources approach. Costs were expressed in US dollars (USD) as of November 2017. The reported prevalence of RA in Argentina was 0.94% (95%CI: 0.86 to 1.02), with an annual incidence rate of 19 per 100,000 people (95%CI: 17 to 20). The annual cost of disease-modifying drugs was 33,936.10 USD per patient. The cost attributed to serious infections was 2,474.6 USD. The cost of bilateral knee replacement per patient was $5,276.8 USD; and the cost for total hip replacement was $9,196.4. Both, the cost of hospitalization days per patient per year, and the indirect costs of RA increased as the disability score increased. This review reports useful information on epidemiological and cost parameters of moderate to severe RA, in the era of biological agents, in order to be useful for conducting economic evaluations regarding health in Argentina.

The link between health technology assessment and decision making for the allocation of health resources in Latin America.

OBJECTIVE: One of the good practice principles for health technology assessment (HTA) is having a clear link between the assessment and decision making. The objective of the 2019 Latin American Policy Forum (LatamPF) of Health Technology Assessment International was to explore different models of connection between HTA and decision making and to discuss the potential applicability of such models in Latin America. METHODS: This paper is based on a background document and the deliberations of the members of the LatamPF (fifty-four participants from twelve countries) where a design-thinking methodology was used. RESULTS: The participants agreed that insufficient links between HTA and decision making undermine the legitimacy of decisions, expose the HTA process to excessive political and judicial influence, and promote the exclusion of some stakeholders from participating in the assessment process and decision making. High priority aspects of the HTA process that could feasibly be improved and which hold the greatest potential to generate positive changes in the health systems in the region were identified. The majority of these aspects were associated with the appropriate institutionalization of HTA, a greater degree of participation by different stakeholders, and improved transparency in the HTA process. CONCLUSIONS: The LatamPF identified barriers and recommended actions to strengthen the link between HTA and decision making. Participants emphasized that there is now a window of opportunity in the region as many societal actors see this as a priority. For this reason, health system stakeholders must take this opportunity to increase efforts toward strengthening the link between HTA and decision making.

[Vínculo Entre La Evaluación De Tecnologías Sanitarias y La Toma De Decisión Para La Asignación De Recursos Sanitarios en Latino-América].

OBJETIVOS: Un vínculo claro entre la evaluación y la toma de decisión constituye un principio de buena práctica en evaluación de tecnologías sanitarias (ETESA) reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino-América (LatamPF) 2019 de Health Technology Assessment International fue explorar los diferentes modelos que vinculan la ETESA y la toma de decisión y discutir su potencial aplicabilidad en Latino-América. MÉTODOS: Este manuscrito está basado en un documento base y en el trabajo deliberativo realizado por los miembros (54 participantes, 12 países) que asistieron al LatamPF, a través de la metodología design thinking. RESULTADOS: Los participantes coincidieron en que la relación inapropiada entre la ETESA y la toma de decisión atenta hoy contra la legitimidad de las decisiones, expone al proceso de ETESA a una excesiva influencia política y judicial, y condiciona que algunos actores se sientan relegados del proceso de evaluación y toma de decisión. Se identificaron los atributos del proceso de ETESA más prioritarios y factibles de ser mejorados en la región, y con el mayor potencial para generar un cambio positivo en los sistemas de salud. La mayor parte de estos están vinculados con la apropiada institucionalización de la ETESA, ampliar la participación de los diferentes actores y mejorar la transparencia de los procesos de ETESA. CONCLUSIONES: El LatamPF ha identificado barreras y recomendado acciones para reforzar el vínculo entre ETESA y la decisión. A su vez, existe en estos momentos una ventana de oportunidad en la región, ya que el tema es visualizado como una prioridad por gran parte de los actores de la sociedad. Por ello, los diferentes actores de los sistemas sanitarios deberían ahora tomar esta oportunidad para avanzar en el fortalecimiento del vínculo entre ETESA y toma de decisión.

Descompresión ósea metafisaria del radio distal para estadios tempranos de la enfermedad de Kienböck: Seguimiento mínimo de 10 años / Metaphyseal bone decompression of distal radius for early stages of Kienböck's disease. Minimum follow-up of 10 years

Introducción: El objetivo de este estudio es analizar los resultados clínicos y radiológicos a largo plazo de una serie de pacientes con enfermedad de Kienböck en estadios II y IIIA de la clasificación de Lichtman, tratados mediante descompresión metafisaria del radio distal. Materiales y Métodos: Estudio retrospectivo y descriptivo que incluyó a 23 pacientes con enfermedad de Kienböck (estadios II y IIIA de Lichtman) tratados mediante descompresión metafisaria del radio distal con, al menos, 10 años de seguimiento. Al final del seguimiento, se evaluaron el rango de movilidad de la muñeca, la fuerza de puño, mediante la escala de la Clínica Mayo modificada y el dolor, según la escala analógica visual. Se valoró a los pacientes radiográficamente según la clasificación de Lichtman y el índice de altura carpiana. Resultados: El seguimiento promedio fue de 14 años (rango 10-19). Nueve pacientes eran mujeres y catorce, hombres. Quince casos correspondían al estadio IIIA y ocho, al estadio II. Según la escala de la Clínica Mayo, los resultados fueron excelentes en 9 pacientes, buenos en 11 pacientes, moderados en 2 y pobres en uno. El puntaje en la escala analógica visual preoperatoria fue 7 (rango 6-10) y 1,1 (rango 0-6) al final del seguimiento. El arco de flexión/extensión promedio fue del 78% y la fuerza de puño, del 81%. Según la clasificación de Lichtman, hubo progresión en 4 pacientes, mientras que los otros 19 permanecieron en la misma etapa que en el preoperatorio. Conclusión: La descompresión metafisaria del radio distal logró resultados favorables a largo plazo para los estadios II y IIIA de la enfermedad de Kienböck. Nivel de Evidencia: IV

Introduction: The purpose of this study is to analyze the long-term clinical and radiological results of a series of patients with early stages of Kienböck disease treated with radius core decompression. Methods: This retrospective study included 23 patients with Kienböck's disease (Lichtman stage II and IIIA) who underwent distal radius metaphyseal core decompression, and were controlled for at least 10 years. At the last follow-up, wrist range of motion and grip strength using the modified Mayo wrist score and pain using the visual analogue scale were evaluated. Patients were also radiographically evaluated with the Lichtman classification and the modified carpal height ratio. Results: The mean follow-up period was 14 years (range 10-9). Nine patients were women and fourteen were men. Fifteen cases belonged to IIIA stage and 8 to II stage. Based on the modified Mayo wrist score, results were excellent in 9 patients, good in 11 patients, fair in 2 and poor in one patient. Preoperative pain score according to VAS was 7 (range 6-10) and 1.1 (range 0-6) at the final follow-up. Average flexion/extension arc was 78% and the grip strength was 81%. Radiographic disease progression according to Lichtman classification occurred in four wrists, while the remaining 19 patients remained without changes. Conclusion: Radius core decompression achieved long-term favorable results in the early stages of Kienböck disease. Level of Evidence: IV

Patient-Rated Wrist Evaluation: Spanish Version and Evaluation of Its Psychometric Properties in Patients with Acute Distal Radius Fracture.

Purpose The purpose of this paper is to validate a Spanish version of patient-rated wrist evaluation (PRWE) and evaluate its psychometric attributes in a population of patients with distal radius fracture. Material and Methods A translation and cross-cultural adaptation of the PRWE to Spanish (PRWE-S) was performed according to standardized guidelines. A total of 50 patients with a distal radius fracture were included during the different steps of the study. The reliability of the new instrument was assessed in terms of construct validity with the Quick DASH (Disability of the Arm, Shoulder, and Hand). Internal consistency and test-retest stability were also examined. Results The Spearman's correlation test for analysis of the criterion validity (0.75) indicates a strong positive correlation between the PRWE-S and the Quick DASH. The internal consistency according to Cronbach's α was 0.96, and the intraclass correlation coefficient was moderate (0.46). Conclusion A Spanish version of the PRWE indicated good validity and reliability in distal radius fracture patients. This valuable tool can be used in Spanish-speaking countries to evaluate various aspects as pain and function in patients with injuries of the wrist.

Radius Core Decompression for Kienböck Disease Stage IIIA: Outcomes at 13 Years Follow-Up.

PURPOSE: This study was designed to analyze the long-term clinical and radiological outcomes of a series of patients with Kienböck disease stage IIIA treated with radius core decompression. METHODS: This retrospective study included 15 patients with Kienböck disease (Lichtman stage IIIA) who underwent distal radius metaphyseal core decompression between 1998 and 2005 and who were followed-up for at least 10 years. At the last follow-up, the patients were evaluated for wrist range of motion and grip strength. The overall results were evaluated by the modified Mayo wrist score and visual analog scale pain score. We also compared the radiological changes between the preoperative and the final follow-up in their Lichtman classification and the modified carpal height ratio. RESULTS: The mean follow-up period was 13 years (range, 10-18 years). Based on the modified Mayo wrist score, clinical results were excellent in 6 patients, good in 8 patients, and poor in 1 patient who required a proximal row carpectomy as revision surgery. The mean preoperative pain according to the visual analog scale was 7 (range, 6-10) and was 1.2 (range, 0-6) at the final follow-up. Compared with the opposite side, the average flexion/extension arc was 77% and the grip strength was 80%. All patients, except 1, returned to their original employment. At the final follow-up, 3 patients had decreased modified carpal height ratio, 12 remained unchanged. Radiographic disease progression according to the Lichtman classification to stages IIIB to IV occurred in only 2 wrists. There were no complications related to the core decompression. CONCLUSIONS: In this limited series, the radius core decompression demonstrated favorable long-term results and could be considered as a surgical alternative for stage IIIA of Kienböck disease. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Patología tendinosa en pacientes con placa bloqueada palmar de radio distal: incidencia y resultado clínico del tratamiento / Tendon pathology in patients with distal radius palmar locked plate: incidence and clinical outcome of their treatment

Introducción: El objetivo de este estudio es comunicar la incidencia de complicaciones tendinosas en pacientes con fracturas de radio distal tratados con placa bloqueada palmar y el resultado clínico del tratamiento mediante la sola extracción del implante. Materiales y Métodos: Se realizó una evaluación retrospectiva de 992 pacientes con fracturas de radio distal. Se incluyó a quienes se les extrajo la placa por irritación o rotura tendinosa. La evaluación final de los resultados, una vez extraído el implante, se efectuó con el puntaje DASH y una escala analógica visual de 0 a 10 para dolor en reposo, durante la actividad y para el resultado funcional. Resultados: Treinta y cuatro pacientes tuvieron complicaciones tendinosas: 20 tendinitis de flexores (2%), 13 tendinitis de extensores (1,3%) y una rotura de tendón flexor. Todos fueron tratados sólo con extracción del implante. En la escala analógica visual, los pacientes con tendinitis flexora obtuvieron un puntaje de 1 para dolor en reposo, de 1 para dolor durante la actividad y de 8 para resultado funcional, y un puntaje DASH de 13. La evaluación final promedio de los pacientes con tendinitis extensora fue: dolor en reposo 0, dolor durante la actividad 3, funcional 9 y DASH 15, respectivamente. Conclusiones: La incidencia de complicaciones tendinosas en el tratamiento de las fracturas de radio distal con placas palmares es baja. El tratamiento precoz mediante la sola extracción del implante lleva a la desaparición de los síntomas y evita la rotura tendinosa. Nivel de Evidencia: IV

Introduction: The aim of this paper is to report the incidence of tendon complications in patients with distal radius fractures treated with volar locking plates and the clinical results after plate removal. Methods: A total of 992 patients with distal radial fracture treated with volar locking plates were retrospectively evaluated. Cases with plate removal due to tendon irritation were included in this study. Clinical results were evaluated using DASH score and a visual analogue scale for pain at rest, during activity and functional result. Results: Thirty-four patients had tendon complications: 20 with flexor tendonitis (2%), 13 with extensor tendonitis (1.3%), and a flexor tendon rupture. All cases were treated only with implant removal. Final mean results were: visual analogue scale, 1 for pain at rest, 1 for pain during activity, and 8 for function; DASH score 13 in patients with flexor tendinitis; and 0, 3, 9, respectively, and DASH score 15 for those with extensor tenosinovitis. Conclusions: Tendon complications are infrequent in patients with distal radial fractures treated with volar locking plate. The early removal of the implant improves tendon irritation symptoms and prevents tendon rupture. Level of Evidence: IV

Delayed Repair of Ulnar Artery at the Distal Forearm.

Background:The purpose of this study was to evaluate the rate of patency after delayed repair of the ulnar artery following primary ligation. Methods: Adult patients with primary ligation of the injured ulnar artery at the forearm who had a delayed repair of the artery were included. Postoperative arterial patency was determined by either physical examination or color Doppler ultrasonographic imaging. Postoperative complications and Disabilities of the Arm, Shoulder and Hand score were recorded. Results: Eight consecutive patients during a 3-year period were included. The mean age was 35 years. Four cases were women. The surgery was performed at a mean of 5 days after the injury and ligation. At a mean follow-up of 22 months, 7 patients had a patent artery. One patient suffered a hematoma. Conclusions: A high rate of patency can be obtained after delayed repair of the ulnar artery at the forearm.

Inestabilidad posterolateral cronica de codo. reconstruccion ligamentaria / Chronic posterolateral elbow instability. ligament reconstruction

Introducción: El objetivo de este trabajo es evaluar los resultados de una serie de pacientes con inestabilidad posterolateral crónica de codo, tratados con reconstrucción del ligamento colateral cubital con injerto tendinoso. Materiales y Métodos: Se presentan 10 pacientes, con una edad promedio de 47 años. El tiempo entre la luxación y la cirugía fue de 16 meses. El pivot shift test bajo anestesia fue positivo en todos los casos. Bajo control radioscópico, siete pacientes tenían un estadio 1 de Horii; dos, estadio 3 y uno tenía un estadio 2. En la mayoría de los casos, se utilizó el tendón del palmar menor. El seguimiento promedio fue de 21 meses. Resultados: La flexo-extensión fue de 126-3º. El dolor fue 0 en reposo y 1 en actividad, según la escala analógica visual. El puntaje DASH promedio fue 12 y el de la Clínica Mayo de 95. Ningún paciente reportó sensación de inestabilidad. El pivot shift test con el paciente despierto fue negativo en todos los casos. Conclusiones: La reconstrucción del ligamento lateral del codo con injerto tendinoso en pacientes con inestabilidad posterolateral crónica es eficaz para lograr la estabilidad articular. Los mejores resultados se observaron en pacientes con estadios 1 y 2 de inestabilidad. No hubo casos de inestabilidad residual.

Introduction: The objective of this paper is to evaluate the results of a series of patients with posterolateral elbow instability treated with reconstruction of the ulnar collateral ligament using tendon graft. Methods: We reported 10 patients with a mean age of 47 years. Time from posterolateral dislocation to surgery was 16 months. The pivot shift test under anesthesia was positive in all patients. Seven patients had stage 1 instability according to Horii, one patient with stage 2 and two patients with stage 3 under fluoroscopy. Palmaris minor was the most common tendon used for reconstruction. Follow-up was 21 months. Results: Flexo-extension was 126-3º. Pain according to visual analogue scale was 0 at rest and 1 in activity. DASH score was 12 and Mayo Clinic score was 95. Sensation of instability was not reported by any patient. The pivot shift test in an awake patient was always negative. Conclusions: Ulnar collateral ligament reconstruction with tendon graft in patients with posterolateral elbow instability is useful to restore joint stability. Best results were observed in patients with stage 1 or 2 instability according to Horii. Residual instability was not observed.

Tratamiento funcional de fracturas desplazadas de olécranon en pacientes mayores de 70 años / Functional treatment of displaced olecranon fractures in patients older than 70 years

Objetivo: Reportar los resultados clínicos y radiológicos del tratamiento funcional de fracturas desplazadas de olécranon en pacientes >70 años. Materiales y Métodos: Se evaluaron 28 pacientes >70 años con fracturas desplazadas de olécranon. El tratamiento consistió en la inmovilización inicial con una valva de yeso (promedio 5 días) y, luego, movilización activa según tolerancia. No se indicó rehabilitación kinesiológica. Ningún paciente fue perdido en el seguimiento. El grupo estaba formado por 27 mujeres y un hombre. La edad promedio era de 82 años. Según la clasificación de la Clínica Mayo, 18 fracturas eran de tipo IIA y 10, de tipo IIB. El seguimiento promedio fue de 14 meses. Resultados: La flexo-extensión fue de 142°-15°. La fuerza muscular fue de M5 en 17 pacientes y de M4 en 9. La fuerza de puño fue un 93% del lado contralateral. El dolor según la escala visual analógica fue de 1. La satisfacción con el tratamiento según esta escala fue de 9. Según el puntaje de la Clínica Mayo, 22 pacientes tuvieron resultados excelentes y 6, buenos. El puntaje DASH promedio fue de 15. Veinticuatro pacientes evolucionaron hacia la seudoartrosis. El gap articular final fue, en promedio, de 16 mm. El gap a nivel de la cortical posterior final fue, en promedio de 22 mm. Conclusión: El tratamiento no quirúrgico de las fracturas desplazadas de olécranon en pacientes mayores ofrece un número elevado de buenos resultados funcionales con alto grado de satisfacción. Nivel de evidencia: IV.

Objective: To report the clinical and radiological outcomes of the functional treatment for displaced olecranon fractures in patients >70 years old. Methods: Twenty-eight patients >70 years old with displaced olecranon fractures were evaluated. The treatment included initial immobilization with a cast (average time 5 days) and then active movement as tolerated. Physiotherapy was not indicated. No patients were lost in the follow-up. The study group included 27 women and a man. Average age was 82 years old. According to the Mayo Clinic Classification, 18 fractures were type IIA and 10 were type IIB. Average followup was 14 months. Results: Flexion-extension was of 142°-15°. Muscular strength of the triceps was M5 in 17 patients and M4 in 9. Grip strength was 93% of the contralateral side. The score in the visual analogue scale for pain was 1. Satisfaction with the treatment according to this scale was 9. According to the Mayo Clinic classification, 22 patients presented excellent results, and 6 good results. Average DASH score was 15. Twenty-four patients evolved to a nonunion. Mean final joint gap was 16 mm. Mean final gap at the posterior cortical level of the olecranon was 22 mm. Conclusion: Functional treatment of displaced olecranon fractures in patients >70 years old is associated with a high degree of goods results and patient satisfaction. Level of evidence. IV.

Artrodesis mediocarpiana: estudio de la evolución clínico-radiológica con tres años de seguimiento mínimo / Midcarpal fusion. Clinical and radiological study on outcomes with a minimum follow-up of three years

Determinar la evolución clínica y radiológica de los pacientes tratados con artrodesis mediocarpiana con un seguimiento mínimo de tres años. Materiales y Métodos: Se estudiaron los pacientes tratados en nuestro Servicio mediante artrodesis mediocarpiana desde mayo de 1998. Entre un total de 27, se incluyeron 11 muñecas que contaban con un seguimiento mínimo de tres años. Ocho pacientes eran hombres y tres, mujeres, con una media de edad de 47 años (rango 16-66) y un seguimiento promedio de 6.7 años (rango 3-15). La técnica utilizada fue artrodesis de 2 o 4 esquinas con resección del escafoides más injerto de radio distal. Se evaluaron el dolor con la Escala Analógica Visual, la movilidad y la fuerza de puño. Se aplicó el cuestionario QuickDASH y se tomaron radiografías de control. Resultados: El dolor mejoró de 5/10 en reposo y 8/10 en actividad antes del procedimiento a 0/10 y 2/10, respectivamente. La movilidad perdida con respecto al lado sano fue del 39% de flexo-extensión, 15% de desviación radial y 31% de desviación cubital. No hubo cambios en la pronosupinación y el QuickDASH posoperatorio fue de 10. La fuerza fue del 92% comparada con el lado contralateral. Radiológicamente cuatro pacientes no tuvieron cambios en la luz articular radiolunar; en los restantes, disminuyó. Dos fueron reoperados por seudoartrosis, con injerto óseo. Conclusiones: La artrodesis mediocarpiana mejora los síntomas y conserva el 61% de la flexo-extensión, el 85% de la desviación radial, el 31% de la cubital y el 92% de la fuerza. Nivel de Evidencia: IV...

To determine the clinical and radiological outcomes of patients treated with midcarpal arthrodesis with a minimum follow-up of three years. Methods: Patients treated in our Service through midcarpal arthrodesis since May 1998 were studied. From a total of 27 patients, 11 wrists with a minimum follow-up of 3 years were included. Eight patients were men and three were women, with a mean age of 47 years (range 16-66) and an average follow-up of 6.7 years (range 3-15). The technique was 2 or 4 corner fusion with scaphoid resection plus distal radius graft. Pain using Visual Analog Scale, mobility, and grip strength were evaluated. QuickDASH scoring and control X-rays were performed. Results: Pain improved from a preoperative value of 5/10 at rest and 8/10 at activity to 0/10 and 2/10 after surgery, respectively. The lost motion with respect to the healthy side was flexo-extension 39%, radial deviation 15%, and ulnar deviation 31%. There were no changes in pronosupination and the postoperative QuickDASH score was 10. Force was 92% compared to the opposite side. Radiologically four patients didn´t show changes in radiolunate joint space; in the remaining, it was narrower. Two patients were reoperated on for nonunion with bone graft. Conclusions: Midcarpal fusion improves symptoms, retaining 61% of flexo-extension, 85% of the radial deviation, 31% of the ulnar deviation and 92% of the force. Level of Evidence: IV...