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Background: During the COVID-19 pandemic, health authorities recommended less interpersonal physical contact. Our hypothesis was that hospital doctors greet new patients with a handshake less frequently after the pandemic than before. Material and method: In January 2024, we undertook a pragmatic cross-sectional survey of a sample of doctors from three different clinics at a large Norwegian hospital. The doctors were asked to report their handshaking habits before and after the pandemic. Results: A total of 152 hospital doctors took part in the study. Before the pandemic, 143 of these doctors (94 %) greeted outpatients with a handshake, while 115 (76 %) greeted hospitalised patients with a handshake. After the pandemic, these figures had fallen to 35 (23 %) and 33 (22 %) respectively. A total of 139 doctors (86 %) reported that they had changed their greeting habits. Of these, 95 (73 %) had changed their greeting habits for reasons of infection control. Interpretation: After the pandemic, hospital doctors are less inclined to greet patients with a handshake than before the pandemic.
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COVID-19 , Pandemias , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Estudios Transversales , Noruega/epidemiología , Hábitos , SARS-CoV-2 , Masculino , Femenino , Cuerpo Médico de Hospitales/estadística & datos numéricos , Cuerpo Médico de Hospitales/psicología , Encuestas y Cuestionarios , Control de Infecciones , Médicos/psicología , AdultoRESUMEN
BACKGROUND: There is limited evidence regarding predictors of functional trajectories after hip fracture. We aimed to identify groups with different trajectories of functional recovery the first year after hip fracture, and to determine predictors for belonging to such groups. METHODS: This longitudinal study combined data from two large randomized controlled trials including patients with hip fracture. Participants were assessed at baseline, four and 12 months. We used the Nottingham Extended Activities of Daily Living (NEADL) as a measure of instrumental ADL (iADL) and Barthel Index for personal ADL (pADL). A growth mixture model was estimated to identify groups of patients following distinct trajectories of functioning. Baseline characteristics potentially predicting group-belonging were assessed by multiple nominal regression. RESULTS: Among 726 participants (mean age 83.0; 74.7% women), we identified four groups of patients following distinct ADL trajectories. None of the groups regained their pre-fracture ADL. For one of the groups identified in both ADL outcomes, a steep decline in function was shown the first four months after surgery, and none of the groups showed functional recovery between four and 12 months after surgery. CONCLUSIONS: No groups regained their pre-fracture ADL. Some of the patients with relatively high pre-fracture function, had a steep ADL decline. For this group there is a potential for recovery, but more knowledge and research is needed in this group. These findings could be useful in uncovering groups of patients with different functioning after a hip fracture, and aid in discharge planning.
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Actividades Cotidianas , Fracturas de Cadera , Humanos , Femenino , Anciano de 80 o más Años , Masculino , Estudios Longitudinales , Recuperación de la Función , Fracturas de Cadera/cirugía , Alta del Paciente , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. METHODS/DESIGN: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. DISCUSSION: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. TRIAL REGISTRATION: ISRCTN12051706.
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Fragilidad , Enfermedad de Parkinson , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Monitoreo Fisiológico , Estudios Observacionales como Asunto , Modalidades de FisioterapiaRESUMEN
BACKGROUND: The incidence of hip fractures are expected to increase in the following years. Hip fracture patients have in addition to their fracture often complex medical problems, which constitute a substantial burden on society and health care systems. It is thus important to optimize the treatment of these patients to reduce negative outcomes. The aim of this study was to assess the effect of comprehensive orthogeriatric care (CGC) on basic and instrumental activities of daily living (B-ADL and I-ADL). METHODS: This study is based on two randomized controlled trials; the Oslo Orthogeriatric Trial and the Trondheim Hip Fracture Trial. The two studies were planned in concert, and data were pooled and analyzed using linear mixed models. I-ADL function was assessed by the Nottingham Extended ADL Scale (NEADL) and B-ADL by the Barthel ADL (BADL) at four and twelve months after surgery. RESULTS: Seven hundred twenty-six patients were included in the combined database, of which 365 patients received OC and 361 patients received CGC. For the primary endpoint, I-ADL at four months was better in the CGC group, with a between-group difference of 3.56 points (95 % CI 0.93 to 6.20, p = 0.008). The between-group difference at 12 months was 4.28 points (95 % CI 1.57 to 7.00, p = 0.002). For B-ADL, between-group difference scores were only statistically significant at 12 months. When excluding the patients living at a nursing home at admission, both I-ADL and B-ADL function was significantly better in the CGC group compared to the OC group at all time points. CONCLUSIONS: Merged data of two randomized controlled trials showed that admitting hip fracture patients to an orthogeriatric care unit directly from the emergency department had a positive effect on ADL up to twelve months after surgery.
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Actividades Cotidianas , Fracturas de Cadera , Servicio de Urgencia en Hospital , Fracturas de Cadera/diagnóstico , Fracturas de Cadera/epidemiología , Fracturas de Cadera/terapia , Hospitalización , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
AIMS: Few studies have investigated potential consequences of strained surgical resources. The aim of this cohort study was to assess whether a high proportion of concurrent acute surgical admissions, tying up hospital surgical capacity, may lead to delayed surgery and affect mortality for hip fracture patients. METHODS: This study investigated time to surgery and 60-day post-admission death of patients 70 years and older admitted for acute hip fracture surgery in Norway between 2008 and 2016. The proportion of hospital capacity being occupied by newly admitted surgical patients was used as the exposure. Hip fracture patients admitted during periods of high proportion of recent admissions were compared with hip fracture patients admitted at the same hospital during the same month, on similar weekdays, and times of the day with fewer admissions. RESULTS: Among 60,072 patients, mean age was 84.6 years (SD 6.8), 78% were females, and median time to surgery was 20 hours (IQR 11 to 29). Overall, 14% (8,464) were dead 60 days after admission. A high (75th percentile) proportion of recent surgical admission compared to a low (25th percentile) proportion resulted in 20% longer time to surgery (95% confidence interval (CI) 16 to 25) and 20% higher 60-day mortality (hazard ratio 1.2, 95% CI 1.1 to 1.4). CONCLUSION: A high volume of recently admitted acute surgical patients, indicating probable competition for surgical resources, was associated with delayed surgery and increased 60-day mortality. Cite this article: Bone Joint J 2021;103-B(2):264-270.
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Fijación de Fractura/estadística & datos numéricos , Recursos en Salud/provisión & distribución , Fracturas de Cadera/cirugía , Hospitalización/estadística & datos numéricos , Tiempo de Tratamiento/estadística & datos numéricos , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Fracturas de Cadera/mortalidad , Humanos , Masculino , Noruega/epidemiología , Resultado del TratamientoRESUMEN
PURPOSE: A reduction in the length of hospital stay may threaten patient safety. This study aimed to estimate the effect of organizational pressure to discharge on 60-day mortality among hip fracture patients. PATIENTS AND METHODS: In this cohort study, hip fracture patients were analyzed as if they were enrolled in a sequence of trials for discharge. A hospital's discharge tendency was defined as the proportion of patients with other acute conditions who were discharged on a given day. Because the hospital's tendency to discharge would affect hip fracture patients in an essentially random manner, this exposure could be regarded as analogous to being randomized to treatment in a clinical trial. The study population consisted of 59,971 Norwegian patients with hip fractures, hospitalized between 2008 and 2016, aged 70 years and older. To calculate the hospital discharge tendency for a given day, we used data from all 5,013,773 other acute hospitalizations in the study period. RESULTS: The probability of discharge among hip fracture patients increased by 5.5 percentage points (95% confidence interval (CI)=5.3-5.7) per 10 percentage points increase in hospital discharges of patients with other acute conditions. The increased risk of death that could be attributed to a discharge from organizational causes was estimated to 3.7 percentage points (95% CI=1.4-6.0). The results remained stable under different time adjustments, follow-up periods, and age cut-offs. CONCLUSION: This study showed that discharges from organizational causes may increase the risk of death among hip fracture patients.
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OBJECTIVE: To perform a systematic review to assess the current scientific evidence concerning the effect of EIR for trauma patients with or without an associated traumatic brain injury. DATA SOURCE: We performed a systematic search of several electronic (Ovid MEDLINE, Embase, Cochrane Library Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health, and SveMed+) and 2 clinical trial registers (clinicaltrials.gov and International Clinical Trials Registry Platform). In addition, we handsearched reference lists from relevant studies. DATA EXTRACTION: Two review authors independently identified studies that were eligible for inclusion. The primary outcome measures were functional-related outcomes and return to work. The secondary outcome measures were length of stay in hospital, number of days on respirator, complication rate, physical and mental health measures, quality of life, and socioeconomic costs. DATA SYNTHESIS: Four studies with a total number of 409 subjects, all with traumatic brain-associated injuries, were included in this review. The included trials varied considerably in study design, inclusion and exclusion criteria, and had small numbers of participants. All studies were judged to have at least 1 high risk of bias. We found the quality of evidence, for both our primary and secondary outcomes, low. CONCLUSIONS: No studies that matched our inclusion criteria for EIR for trauma patients without traumatic brain injuries could be found. For traumatic brain injuries, there are a limited number of studies demonstrating that EIR has a positive effect on functional outcomes and socioeconomic costs. This review highlights the need for further research in trauma care regarding early phase interdisciplinary rehabilitation.
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Background and purpose - There are numerous studies on the weekend effect for hip fracture patients, with conflicting results. We analyzed time of admission and discharge, and the association with mortality and length of hospital stay in more detail. Patients and methods - We used data from 61,211 surgically treated hip fractures in 55,211 patients, admitted to Norwegian hospitals 2008-2014. All patients were aged 50 years or older. Data were analyzed with Cox and Poisson regression. Results - Mortality within 30 days did not differ substantially by day of admission, although admissions on Sundays and holidays had a slightly increased mortality. The hazard ratios were 1.1 (95% confidence interval [CI] 0.97-1.2) for Sundays, and 1.2 (CI 0.98-1.4) for holidays, relative to Mondays. For patients admitted between 6:00 am and 7:00 am the hazard ratio was 1.4 (CI 1.1-1.8) relative to patients admitted between 2:00 pm and 3:00 pm. Discharges during weekends and holidays were associated with a substantial higher mortality than weekday discharges. Patients admitted from Friday to Sunday generally stayed in hospital for a shorter time than patients admitted during other days. Interpretation - Our results indicate that the discussion on weekday versus weekend admission effects might have distracted attention from other important factors, such as time of day of admission, and day of discharge from hospital treatment.
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Fracturas de Cadera/mortalidad , Admisión del Paciente/estadística & datos numéricos , Anciano de 80 o más Años , Femenino , Vacaciones y Feriados/estadística & datos numéricos , Mortalidad Hospitalaria , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Noruega/epidemiología , Análisis de Regresión , Factores de TiempoRESUMEN
BACKGROUND CONTEXT: Lumbar total disc replacement (TDR) is a treatment option for selected patients with chronic low back pain (LBP) that is non-responsive to conservative treatment. The long-term results of disc replacement compared with multidisciplinary rehabilitation (MDR) have not been reported previously. PURPOSE: We aimed to assess the long-term relative efficacy of lumbar TDR compared with MDR. DESIGN: We undertook a multicenter randomized controlled trial at five university hospitals in Norway. PATIENT SAMPLE: The sample consisted of 173 patients aged 25-55 years with chronic LBP and localized degenerative changes in the lumbar intervertebral discs. OUTCOME MEASURES: The primary outcome was self-reported physical function (Oswestry Disability Index [ODI]) at 8-year follow-up in the intention-to-treat population. Secondary outcomes included self-reported LBP (visual analogue scale [VAS]), quality of life (EuroQol [EQ-5D]), emotional distress (Hopkins Symptom Checklist [HSCL-25]), occupational status, patient satisfaction, drug use, complications, and additional back surgery. METHODS: Patients were randomly assigned to lumbar TDR or MDR. Self-reported outcome measures were collected 8 years after treatment. The study was powered to detect a difference of 10 ODI points between the groups. The study has not been funded by the industry. RESULTS: A total of 605 patients were screened for eligibility, of whom 173 were randomly assigned treatment. Seventy-seven patients (90%) randomized to surgery and 74 patients (85%) randomized to rehabilitation responded at 8-year follow-up. Mean improvement in the ODI was 20.0 points (95% confidence interval [CI] 16.4-23.6, p≤.0001) in the surgery group and 14.4 points (95% CI 10.7-18.1, p≤.0001) in the rehabilitation group. Mean difference between the groups at 8-year follow-up was 6.1 points (95% CI 1.2-11.0, p=.02). Mean difference in favor of surgery on secondary outcomes were 9.9 points on VAS (95% CI 0.6-19.2, p=.04) and 0.16 points on HSCL-25 (95% CI 0.01-0.32, p=.04). There were 18 patients (24%) in the surgery group and 4 patients (6%) in the rehabilitation group who reported full recovery (p=.002). There were no significant differences between the groups in EQ-5D, occupational status, satisfaction with care, or drug use. In the per protocol analysis, the mean difference between groups was 8.1 ODI points (95% CI 2.3-13.9, p=.01) in favor of surgery. Forty-three of 61 patients (70%) in the surgery group and 26 of 52 patients (50%) in the rehabilitation group had a clinically important improvement (15 ODI points or more) from baseline (p=.03). The proportion of patients with a clinically important deterioration (six ODI points or more) was not significantly different between the groups. Twenty-one patients (24%) randomized to rehabilitation had crossed over and had undergone back surgery since inclusion, whereas 12 patients (14%) randomized to surgery had undergone additional back surgery. One serious adverse event after disc replacement is registered (<1%). CONCLUSIONS: Substantial long-term improvement can be expected after both disc replacement and MDR. The difference between groups is statistically significant in favor of surgery, but smaller than the prespecified clinically important difference of 10 ODI points that the study was designed to detect. Future research should aim to improve selection criteria for disc replacement and MDR.
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Terapia Cognitivo-Conductual/métodos , Terapia por Ejercicio/métodos , Degeneración del Disco Intervertebral/terapia , Dolor de la Región Lumbar/terapia , Reeemplazo Total de Disco/métodos , Adulto , Femenino , Estudios de Seguimiento , Humanos , Análisis de Intención de Tratar , Disco Intervertebral/cirugía , Dolor de la Región Lumbar/etiología , Vértebras Lumbares/cirugía , Masculino , Persona de Mediana Edad , Noruega , Dimensión del Dolor , Satisfacción del Paciente , Calidad de Vida , Índice de Severidad de la Enfermedad , Análisis de Supervivencia , Reeemplazo Total de Disco/efectos adversos , Resultado del TratamientoRESUMEN
PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19.
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Artroplastia , Vértebras Cervicales/cirugía , Radiculopatía/cirugía , Fusión Vertebral , Adulto , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Noruega , Tempo Operativo , Dolor/etiología , Dolor/cirugía , Estudios Prospectivos , Reoperación/estadística & datos numéricos , Método Simple CiegoRESUMEN
PURPOSE: Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. METHODS: Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. RESULTS: Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. CONCLUSION: High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.
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Artroplastia/efectos adversos , Vértebras Cervicales/cirugía , Osificación Heterotópica/etiología , Prótesis e Implantes/efectos adversos , Adulto , Artroplastia/métodos , Vértebras Cervicales/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Dolor de Cuello/etiología , Dolor de Cuello/cirugía , Osificación Heterotópica/diagnóstico por imagen , Osificación Heterotópica/cirugía , Diseño de Prótesis , Calidad de Vida , Radiculopatía/complicaciones , Radiculopatía/cirugía , Índice de Severidad de la Enfermedad , Método Simple Ciego , Fusión Vertebral/efectos adversos , Fusión Vertebral/métodos , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
OBJECTIVE: Medication reconciliation is a strategy for reducing medication discrepancies and improving patient safety. Transitions through different levels of care contribute to medication discrepancies caused by lack of communication. In October 2011, St Olav's Hospital initiated a fast-track model for patients with hip fractures, where clinical pharmacists (CPs) are a part of a multidisciplinary team. The purpose of this study was to examine discrepancies discovered in medication lists by CPs at the orthopaedic ward and consider their clinical relevance. METHOD: This prospective study was conducted at an orthopaedic ward at St Olav's Hospital in the period October 2011-August 2012. Medication reconciliation by CPs was done for all patients with a hip fracture using a systematic method. Information was obtained by the CP by interview with the patient and additional sources, for example, medication list from general practitioner and nursing home. An independent expert group consisting of a geriatrician, an orthopaedist and a CP considered level of clinical relevance of the discrepancies found in the collected data. RESULTS: A total of 410 discrepancies were registered for all 317 patients, Discrepancies were found in 159 (50%) patients with an average of 2.6 per patient affected. Of the total amount of discrepancies, the expert group evaluated 68% and 19% as potentially moderate and severe, respectively, if they were unattended during hospitalisation and after discharge. CONCLUSIONS: By using CPs in medication reconciliation at orthopaedic wards, discrepancies that can lead to serious discomfort or clinical deterioration of patients can be avoided.
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STUDY DESIGN: Prospective randomized controlled multicenter study. OBJECTIVE: To compare the effect of X-Stop with minimally invasive decompression (MID) in patients with neurogenic intermittent claudication due to lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Laminectomy has been the "gold standard," but MID is now widely used. Another minimally invasive surgery option is X-Stop showing good result compared with nonoperative treatment, but showing higher reoperation rate than laminectomy. METHODS: We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either MID or X-Stop. Primary outcome was Zurich Claudication Questionnaire in this intention-to-treat analysis. Secondary outcome was Oswestry Disability Index, EuroQol 5-dimensional questionnaire, numerical rating scale 11 for lower back pain and leg pain, and risk for secondary surgery and complications. RESULTS: No significant differences were found in Zurich Claudication Questionnaire between the groups at any follow-ups. Both groups had a statistical and clinical significant improvement at 6 weeks and throughout the 2-year observation period. The number of patients having secondary surgery due to persistent or recurrent symptoms was significantly higher in the X-Stop group, odds ratio (95% confidence interval) = 6.5 (1.3-31.9). Complication rate was similar and low, but more severe for MID. CONCLUSION: Both MID and X-Stop led to significant symptom improvements. There were no significant clinical differences in effect between the methods at any of the follow-up time points. X-Stop had significant higher risk of secondary surgery. Complication was more severe for MID.
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Descompresión Quirúrgica/métodos , Laminectomía/métodos , Vértebras Lumbares/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Estenosis Espinal/cirugía , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. METHODS: We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. RESULTS: The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. CONCLUSION: The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate. LEVEL OF EVIDENCE: 2.
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Descompresión Quirúrgica/economía , Procedimientos Ortopédicos/economía , Procedimientos Ortopédicos/métodos , Estenosis Espinal/cirugía , Anciano , Anciano de 80 o más Años , Análisis Costo-Beneficio , Descompresión Quirúrgica/métodos , Terminación Anticipada de los Ensayos Clínicos , Femenino , Estudios de Seguimiento , Costos de Hospital , Humanos , Vértebras Lumbares , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/economía , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Procedimientos Ortopédicos/instrumentación , Prótesis e Implantes/economía , Años de Vida Ajustados por Calidad de Vida , ReoperaciónRESUMEN
BACKGROUND: Lumbar spinal stenosis (LSS) is commonly assessed on MRI by measuring dural sac cross-sectional area (DSCA). A new method, morphological grading A-D, has recently been introduced as an alternative method. OBJECTIVE: The aim of this study is to compare these two different methods for assessing LSS on MRI and study their reliability and intercorrelation. METHODS: On pretreatment MRI of 84 patients, two experienced radiologists independently classified level L2/L3, L3/L4 and L4/L5 as no, relative or significant stenosis using both methods. Agreement was analyzed by weighted Kappa. The correlation between the two methods was analysed using Spearman correlation, and visualized in a box plot. RESULTS: The interobserver agreement (95 % CI) was 0.69 (0.61-0.77) and 0.65 (0.56-0.74), respectively. The intraobserver agreements for DSCA were 0.77 (0.60-0.74) and 0.80 (0.66-0.93). On morphological grading A-D it was 0.78 (0.65-0.92) and 0.81 (0.68-0.94). The correlation coefficient between the two methods was 0.85 (p < 0.001). Grades C and D were under the limit value for significant stenosis using the DSCA. CONCLUSIONS: The study shows that the inter- and intraobserver agreements of DSCA and morphological grading A-D were acceptable and their intercorrelation is strong. Both methods may be used in the MRI evaluation of LSS.
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Vértebras Lumbares/patología , Imagen por Resonancia Magnética/métodos , Estenosis Espinal/patología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Estenosis Espinal/clasificaciónRESUMEN
STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR. METHODS: Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio. RESULTS: The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D. CONCLUSION: In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR. LEVEL OF EVIDENCE: 2.
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Dolor Crónico/terapia , Dolor de la Región Lumbar/terapia , Fusión Vertebral/economía , Reeemplazo Total de Disco/economía , Adulto , Dolor Crónico/economía , Dolor Crónico/rehabilitación , Dolor Crónico/cirugía , Análisis Costo-Beneficio , Femenino , Humanos , Dolor de la Región Lumbar/economía , Dolor de la Región Lumbar/rehabilitación , Dolor de la Región Lumbar/cirugía , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVE: To examine whether combined magnetic resonance imaging (MRI) findings are related to the degree of disability and low back pain (LBP) in candidates for lumbar disc prosthesis surgery. MATERIALS AND METHODS: This cross-sectional study included 170 disc prosthesis candidates (mean age 41 years; 88 women) with chronic non-radicular LBP and localized disc degeneration. Experienced radiologists rated Modic changes and disc findings at L4-S1 on pre-treatment MRIs. An MRI total score (0-10) for findings at L4/L5 plus L5/S1 was calculated for Modic type I and/or II changes, a posterior high intensity zone (HIZ) in the disc, dark/black nucleus pulposus signal, and ≥40 % disc height decrease. We analyzed the relationship of the MRI total score to the Oswestry Disability Index (ODI) (n = 170) and LBP intensity scores (0-100 visual analogue scale, n = 165) using multiple linear regression and adjusting for age, gender, body mass index, smoking, and anxiety/depression. RESULTS: The MRI total score was not related to ODI (regression coefficient 0.12, p = 0.79) or LBP intensity (regression coefficient 0.64, p = 0.37). When individual MRI findings were analyzed, patients with HIZ at L5/S1 had slightly lower ODI scores (4.7 points, p = 0.02). In post hoc analyses, results remained unchanged after adding facet arthropathy to the MRI total score and adjusting also for physical workload and physical leisure-time activity. CONCLUSIONS: The combined MRI findings were not related to the degree of disability or the intensity of LBP. These degenerative MRI findings cannot explain variation in pre-treatment disability and pain in patients with chronic LBP accepted for disc prosthesis surgery.
Asunto(s)
Evaluación de la Discapacidad , Degeneración del Disco Intervertebral/diagnóstico , Degeneración del Disco Intervertebral/cirugía , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/prevención & control , Imagen por Resonancia Magnética/estadística & datos numéricos , Reeemplazo Total de Disco/estadística & datos numéricos , Adulto , Causalidad , Comorbilidad , Estudios Transversales , Femenino , Humanos , Degeneración del Disco Intervertebral/epidemiología , Dolor de la Región Lumbar/epidemiología , Vértebras Lumbares/cirugía , Masculino , Noruega/epidemiología , Dimensión del Dolor/métodos , Dimensión del Dolor/estadística & datos numéricos , Prevalencia , Reproducibilidad de los Resultados , Medición de Riesgo , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad , Reeemplazo Total de Disco/instrumentación , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: A successful outcome after lumbar discectomy indicates a substantial improvement. To use the cutoffs for minimal clinically important difference (MCID) as success criteria has a large potential bias, simply because it is difficult to classify patients who report that they are "moderately improved". We propose that the criteria for success should be defined by those who report that they are "completely recovered" or "much better". METHODS: A cohort of 692 patients were operated for lumbar disc herniation and followed for one year in the Norwegian Registry for Spine Surgery. The global perceived scale of change was used as an external criterion, and success was defined as those who reported that they were "completely recovered" or "much better". Criteria for success for each of (1) the Oswestry disability index (ODI; score range 0-100 where 0 = no disability), (2) the numerical pain scale (NRS; range 0-10 where 0 = no pain) for back and leg pain, and (3) the Euroqol (EQ-5D; -0.6 to 1 where 1 = perfect health) were estimated by defining the optimal cutoff point on receiver operating characteristic curves. RESULTS: The cutoff values for success for the mean change scores were 20 (ODI), 2.5 (NRS back), 3.5 (NRS leg), and 0.30 (EQ-5D). According to the cutoff estimates, the proportions of successful outcomes were 66% for the ODI and 67% for the NRS leg pain scale. INTERPRETATION: The sensitivity/specificity values for the ODI and leg pain were acceptable, whereas they were very low for the EQ-5D. The cutoffs for success can be used as benchmarks when comparing data from different surgical units.