Autoreporte de la calidad de vida en niños y adolescentes colombianos: Estudio FUPRECOL

RESUMEN Introducción: El EQ-5D-Y proxy es un cuestionario genérico, de fácil comprensión y aplicación, que evalúa distintas dimensiones de la salud percibida. El objetivo del siguiente estudio fue describir por autoreporte la calidad de vida relacionada con la salud (CVRS) en una población escolar de Bogotá, Colombia, pertenecientes al estudio FUPRECOL. Métodos: Estudio descriptivo y transversal, realizado en 3.245 niños y 3.354 adolescentes, entre 9 y 17.9 años de edad, de 24 instituciones educativas oficiales de Bogotá, Colombia. Se aplicó de manera auto-administrada la versión validada al castellano por Olivares et al. (2009) del instrumento de CVRS infantil EQ-5D-Y proxy. Se analizaron los datos por medidas de tendencia central y se realizó una comparación de los observados en Colombia con estudios internacionales. Resultados: De la población evaluada, el 58,3% (n=3.848), fueron mujeres. En general, se observa puntuaciones elevadas en la CVRS en niños y adolescentes de ambos sexos. Al comparar por género, las dimensiones del EQ-5D-Y proxy “sentirse triste/preocupado o infeliz” y “tener dolor/malestar”, presentaron la mayor frecuencia de repuesta en el grupo de las mujeres. Al comparar los resultados de este estudio, por grupos de edad, con trabajos internacionales de niños y adolescentes, se observa que las puntuaciones del EQ-5D-Y proxy fueron superiores a los reportados en Suráfrica, Alemania e Italia. Conclusión: Se presentan valores de la CVRS según edad y sexo que podrán ser usados en la evaluación de la salud percibida en el ámbito escolar. Se hace necesario evaluar las propiedades psicométricas del EQ-5D-Y proxy en población Colombiana.

Calidad de vida en una muestra de esquizofrénicos.

1.-Realizar una descripción sociodemográfica, clínica y diagnóstica de la muestra de pacientes; 2.-Valorar la calidad de vida de los pacientes con esquizofrenia utilizando dos instrumentos distintos: uno específico, el LqoLP, y otro genérico, el EuroQol-5D, comparando el comportamiento de ambos; 3.-Analizar las correlaciones que se dan entre las distintas medidas de calidad de vida; 4.-Crear un perfil de calidad de vida objetiva de los pacientes de la muestra, a partir de los instrumentos de calidad de vida utilizados para el estudio; 5.-Mostrar el perfil de la calidad de vida de estos pacientes por medio del LqoLP, valorando cómo es ésta, y cuáles son las variables que más influyen y predicen la misma. 103 pacientes esquizofrénicos/as pertenecientes al Sector de Salud IB de Navarra (Centro de Salud Mental de Burlada) , elegidos mediante el muestreo aleatorio. Los datos sociodemográficos, clínicos, DAS, GAF y PANSS los recoge siempre el mismo evaluador (psiquiatra), con amplia experiencia clínica. Una vez recogidos estos datos, el mismo evaluador pasa las escalas de calidad de vida (EQ-5D y LQOLP) de manera consecutiva. La duración total media de toda la pasación es de dos horas. Variables independientes : sociodemográficas (sexo, edad, estado civil, nivel educativo, nivel profesional, situación laboral, nivel económico, tipo de convivencia y zona residencia ) y variables clínicas (años de evolución de la enfermedad, subtipo sindrómico, subtipo evolutivo, existencia de recaídas psicóticas durante el año, número de hospitalizaciones durante el año, clasificación Prudo & Blum, GAF, DAS y PANSS). Variables dependientes: variables de calidad de vida relacionada con la salud (evaluadas con Euroqol-5D) y variables de la escala específica de calidad de vida (LQOLOP). 1.-El Cuestionariode Evaluación de Costes en Esquizofrenia (CECE), diseñado con el fin de obtener datos relevantes para el análisis de costes de esta enfermedad; 2.-Dissability Assesment Schedule (Evaluación de Discapacidad)-DAS: sirve para valorar discapacidades en relación a las tareas y a las funciones que se espera que se realice el individuo en su específica situación cultural; 3.-Global Assesment of Functioning Scale (Escala para la Evaluación Global del Funcionamiento ).GAF: escala de evaluación simple para evaluación del funcionamiento global de un paciente en un periodo de tiempo específico en un 'continuum' de salud-enfermedad psicológica o psiquiátrica; 4.-Escala del Síndroma Positivo y Negativo en la Esquizofrenia (PANSS): escala semiestructurada de evaluación clínica, para mejorar los problemas de validez de otras escalas; 5.-EUROQOL-5D: escala genérica de evaluación de la Calidad de Vida.

Health-related quality of life in Huntington’s Disease patients: a comparison of proxy assessment and patient self-rating using the disease-specific Huntington’s Disease health-related quality of life questionnaire (HDQoL)

Huntington’s disease (HD) is a fatal, neurodegenerative disease for which there is no known cure. Proxy evaluation is relevant for HD as its manifestation might limit the ability of persons to report their health-related quality of life (HrQoL). This study explored patient–proxy ratings of HrQoL of persons at different stages of HD, and examined factors that may affect proxy ratings. A total of 105 patient–proxy pairs completed the Huntington’s disease health-related quality of life questionnaire (HDQoL) and other established HrQoL measures (EQ-5D and SF-12v2). Proxy–patient agreement was assessed in terms of absolute level (mean ratings) and intraclass correlation. Proxies’ ratings were at a similar level to patients’ self-ratings on an overall Summary Score and on most of the six Specific Scales of the HDQoL. On the Specific Hopes and Worries Scale, proxies on average rated HrQoL as better than patients’ self-ratings, while on both the Specific Cognitive Scale and Specific Physical and Functional Scale proxies tended to rate HrQoL more poorly than patients themselves. The patient’s disease stage and mental wellbeing (SF-12 Mental Component scale) were the two factors that primarily affected proxy assessment. Proxy scores were strongly correlated with patients’ self-ratings of HrQoL, on the Summary Scale and all Specific Scales. The patient–proxy correlation was lower for patients at moderate stages of HD compared to patients at early and advanced stages. The proxy report version of the HDQoL is a useful complementary tool to self-assessment, and a promising alternative when individual patients with advanced HD are unable to self-report.

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Background: Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years.

Design: A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months.

Discussion: The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.

Trial registration: Australian Clinical Trial Register # [ACTRN012605000079640]

The impact of age at onset of bipolar I disorder on functioning and clinical presentation

Objectives: Recent studies have proposed the existence of three distinct subgroups of bipolar 1 disorder based on age at onset (AAO). The present study aims to investigate potential clinical and functional differences between these subgroups in an Australian sample.

Methods: Participants (n = 239) were enrolled in the Bipolar Comprehensive Outcomes Study (BCOS), a 2-year longitudinal, observational, cross-sectional study. Assessment measures included the Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HAMD21), Clinical Global Impressions Scale (CGI-BP), SF-36, SLICE/Life Scale, and the EuroQol (EQ-5D). Participants were also asked about their age at the first major affective episode.

Results: Three AAO groups were compared: early (AAO < 20, mean = 15.5 ± 2.72; 44.4% of the participants); intermediate (AAO 20–39, mean = 26.1 ± 4.8; 48.14% of the participants) and late (AAO > 40, mean = 50.6 ± 9.04; 7.4% of the participants). Higher rates of depression, suicidal ideation and binge drinking were reported by the early AAO group. This group also reported poorer quality of life in a number of areas. The early AAO group had a predominant depressive initial polarity and the intermediate group had a manic predominance.

Conclusion: Early AAO is associated with an adverse outcome.

Not all roads lead to Rome - a review of quality of life measurement in diabetes

Aims Quality of life (QoL) is recognized widely as an important health outcome in diabetes, where the burden of selfmanagement places great demands on the individual. However, the concept of QoL remains ambiguous and poorly defined. The aim of our review is to clarify the measurement of QoL in terms of conceptualization, terminology and psychometric properties, to review the instruments that have been used most frequently to assess QoL in diabetes research and make recommendations for how to select measures appropriately.

Methods A systematic literature search was conducted to identify the ten measures most frequently used to assess QoL in diabetes research (including clinical trials) from 1995 to March 2008.

Results Six thousand and eight-five abstracts were identified and screened for instrument names. Of the ten instruments most frequently used to assess ‘QoL’, only three actually do so [i.e. the generic World Health Organization Quality of Life (WHOQOL) and the diabetes-specific Diabetes Quality of Life (DQOL) and Audit of Diabetes-Dependent Quality of Life (ADDQoL)]. Seven instruments more accurately measure health status [Short-Form 36 (SF-36), EuroQoL 5-Dimension (EQ-5D)], treatment satisfaction [Diabetes Treatment Satisfaction Questionnaire (DTSQ)] and psychological well-being [Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS), Well-Being Questionnaire (W-BQ), Problem Areas in Diabetes (PAID)].

Conclusions No single measure can suit every purpose or application but, when measures are selected inappropriately and data misinterpreted, any conclusions drawn are fundamentally flawed. If we value QoL as a therapeutic goal, we must ensure that the instruments we use are both valid and reliable. QoL assessment has the proven potential to identify ways in which treatments can be tailored to reduce the burden of diabetes. With careful consideration, appropriate measures can be selected and truly robust assessments undertaken successfully.

Health-related quality of life and strain in caregivers of Australians with Parkinson’s disease : An observational study

Background: The relationship between health-related quality of life (HRQoL) in people with Parkinson’s disease and their caregivers is little understood and any effects on caregiver strain remain unclear. This paper examines these relationships in an Australian sample.
Methods: Using the generic EuroQol (EQ-5D) and disease-specific Parkinson’s Disease Questionnaire-39 Item (PDQ- 39), HRQoL was evaluated in a sample of 97 people with PD and their caregivers. Caregiver strain was assessed using the Modified Caregiver Strain Index. Associations were evaluated between: (i) caregiver and care-recipient HRQoL; (ii) caregiver HRQoL and caregiver strain, and; (iii) between caregiver strain and care-recipient HRQoL.
Results: No statistically significant relationships were found between caregiver and care-recipient HRQoL, or between caregiver HRQoL and caregiver strain. Although this Australian sample of caregivers experienced relatively good HRQoL and moderately low strain, a significant correlation was found between HRQoL of people with PD and caregiver strain (rho 0.43, p<.001).
Conclusion: Poor HRQoL in people with PD is associated with higher strain in caregivers. Therapy interventions may target problems reported as most troublesome by people with PD, with potential to reduce strain on the caregiver

Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomised controlled trial

Background

Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation.

This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge.

We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08).

Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. 

What's important in defining quality of life for older people? An exploratory study of the views of older South Australians

Background
Cost-effectiveness analyses of interventions for older adults have traditionally focused on health status. There is increasing recognition of the need to develop new instruments to capture quality of life in a broader sense in the face of age-associated increasing frailty and declining health status, particularly in the economic evaluation of aged and social care interventions which may have positive benefits beyond health. 

Reliability, validity, and responsiveness of the Western Ontario and McMaster Universities osteoarthritis index for elderly patients with a femoral neck fracture

Background: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been extensively evaluated in groups of patients with osteoarthritis, yet not in patients with a femoral neck fracture. This study aimed to determine the reliability, construct validity, and responsiveness of the WOMAC compared with the Short Form-12 (SF-12) and the EuroQol 5D (EQ-5D) questionnaires for the assessment of elderly patients with a femoral neck fracture.

Methods: Reliability was tested by assessing the Cronbach alpha. Construct validity was determined with the Pearson correlation coefficient. Change scores were calculated from ten weeks to twelve months of follow-up. Standardized response means and floor and ceiling effects were determined. Analyses were performed to compare the results for patients less than eighty years old with those for patients eighty years of age or older.

Results: The mean WOMAC total score was 89 points before the fracture in the younger patients and increased from 70 points at ten weeks to 81 points at two years postoperatively. In the older age group, these scores were 86, 75, and 78 points. The mean WOMAC pain scores before the fracture and at ten weeks and two years postoperatively were 92, 76, and 87 points, respectively, in the younger age group and 92, 84, and 93 points in the older age group. Function scores were 89, 68, and 79 points for the younger age group and 84, 71, and 73 points for the older age group. The Cronbach alpha for pain, stiffness, function, and the total scale ranged from 0.83 to 0.98 for the younger age group and from 0.79 to 0.97 for the older age group. Construct validity was good, with 82% and 79% of predefined hypotheses confirmed in the younger and older age groups, respectively. Responsiveness was moderate. No floor effects were found. Moderate to large ceiling effects were found for pain and stiffness scales at ten weeks and twelve months in younger patients (18% to 36%) and in the older age group (38% to 53%).

Conclusions: The WOMAC showed good reliability, construct validity, and responsiveness in both age groups of elderly patients with a femoral neck fracture who had been physically and mentally fit before the fracture. The instrument is suitable for use in future clinical studies in these populations.

The health profile of people living with Parkinson's Disease managed in a comprehensive care setting

Background: Globally there are few reports of the impairments, disabilities and medications used in people living with idiopathic Parkinson’s disease. Caregiver characteristics and caregiver burden have seldom been reported. We examined the health status in a large cohort of people living with Parkinson’s disease and their caregivers managed in a comprehensive health care setting.

Methods/Design: A prospective, cross sectional analysis of impairments, disabilities and Parkinson’s disease medication use was conducted in a sample of 100 people with Parkinson’s disease rated I-IV on the modified Hoehn & Yahr scale. Participants were recruited from the Victorian Comprehensive Parkinson Program in Melbourne, Australia. Their caregivers were invited to provide their views on the burden of care, services provided and support received.

Results: The severity of impairments and disabilities was strongly associated with disease duration (mean of 5.5 years). Those with long standing disease or more severe disease also used more Parkinson’s disease medications and participated in fewer social roles than people who were newly diagnosed or mildly affected. The severity of impairments was strongly correlated with limitations in performing activities of daily living. Limitations in performing daily activities were also found to be a significant contributing factor for health-related quality of life (PDQ-39 SI β=0.55, p=0.000; EQ-5D SI β=0.43, p=0.001). People with Parkinson’s disease lived at home with relatives. The average caregiver was a spouse or child providing approximately 3.5 hours of care per day, with the capacity to provide 9.4 hours per day and had provided care for four years. Additional support was high (63%) for 2.5 hours per day.

Conclusion: The comprehensive care setting of this cohort describes a relatively benign condition despite a wide range of disease duration and severity. This report provides a baseline with which to compare other delivery models.

Association between perception of fault for the crash and function, return to work and health status 1 year after road traffic injury: a registry-based cohort study

Objectives To establish the association between the patient's perception of fault for the crash and 12-month outcomes after non-fatal road traffic injury.Setting Two adult major trauma centres, one regional trauma centre and one metropolitan trauma centre in Victoria, Australia.Participants 2605 adult, orthopaedic trauma patients covered by the state's no-fault third party insurer for road traffic injury, injured between September 2010 and February 2014.Outcome measures EQ-5D-3L, return to work and functional recovery (Glasgow Outcome Scale—Extended score of upper good recovery) at 12 months postinjury.Results After adjusting for key confounders, the adjusted relative risk (ARR) of a functional recovery (0.57, 95% CI 0.46 to 0.69) and return to work (0.92, 95% CI 0.86 to 0.99) were lower for the not at fault compared to the at fault group. The ARR of reporting problems on EQ-5D items was 1.20–1.35 times higher in the not at fault group. Conclusions Patients who were not at fault, or denied being at fault despite a police report of fault, experienced poorer outcomes than the at fault group. Attributing fault to others was associated with poorer outcomes. Interventions to improve coping, or to resolve negative feelings from the crash, could facilitate better outcomes in the future.

Health-related quality of life in people with Parkinson’s disease receiving comprehensive care

Objectives: The aim of the present study was to quantify the baseline variation in health-related quality of life (HRQOL) between individuals with Parkinson’s disease (PD) referred to a comprehensive care program and those attending standard neurological services.

Methods: Participants included individuals with PD receiving conventional care from neurologists in private practice and individuals referred to a comprehensive inter-professional team hospital out-patient service. The Parkinson’s Disease Questionnaire-39 (PDQ-39) and the EuroQoL (EQ-5D-3L) were used to quantify HRQOL.

Results: Participants referred to an inter-professional service were more likely to have poorer indices on PD-specific measures but not for generic HRQOL compared with individuals receiving standard neurological services. After adjusting for age, gender, disease severity and duration, people referred to a comprehensive care program were more likely to have a higher score for the PDQ-39 summary index (PDQ-39 SI; mean ± s.d. 27.2 ± 11.0; 95% confidence interval (CI) 25.5, 28.9) compared with individuals receiving standard neurological services (PDQ-39 SI mean 0.2 ± 12.8; 95% CI 18.0, 22.4).

Conclusions: Compared with those attending standard neurological out-patient clinics, individuals referred to an inter-professional PD program are more likely to have advanced disease and poorer HRQOL. This observation has implications for the way in which people with PD are recruited for future clinical trials, because uneven recruitment from different sources may be a potential source of bias.
What is known about the topic? Given that PD is associated with a complex array of motor and non-motor symptoms, an inter-professional team approach to service provision is argued to be optimal for individuals living with this debilitating condition.
What does this paper add? This paper has shown that individuals referred to an inter-professional service are more likely to have advanced disease and complex care needs. Compared with those referred to neurologist private clinics, those referred to an inter-professional clinic had less functional independence and lower PD-specific HRQOL when first assessed, even after controlling for disease severity.
What are the implications for practitioners? When recruiting for future trials to examine the efficacy of multidisciplinary care programs in people with PD, it is important to take into account whether these individuals have been referred to an inter-professional service. There may be a potential source of bias if participants were recruited predominantly from such services.

A bayesian model for mixed responses and skew laten variable to measure HRQoL in children

The aim of the thesi is to formulate a suitable Item Response Theory (IRT) based model to measure HRQoL (as latent variable) using a mixed responses questionnaire and relaxing the hypothesis of normal distributed latent variable. The new model is a combination of two models already presented in literature, that is, a latent trait model for mixed responses and an IRT model for Skew Normal latent variable. It is developed in a Bayesian framework, a Markov chain Monte Carlo procedure is used to generate samples of the posterior distribution of the parameters of interest. The proposed model is test on a questionnaire composed by 5 discrete items and one continuous to measure HRQoL in children, the EQ-5D-Y questionnaire. A large sample of children collected in the schools was used. In comparison with a model for only discrete responses and a model for mixed responses and normal latent variable, the new model has better performances, in term of deviance information criterion (DIC), chain convergences times and precision of the estimates.

Benchmarking in the SWISSspine registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of "coverage with evidence development". Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study.