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1.
J Orthop Trauma ; 36(Suppl 1): S1-S7, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34924512

RESUMO

SUMMARY: Physical and psychological impairment resulting from traumatic injuries is often significant and affects employment and functional independence. Extremity trauma has been shown to negatively affect long-term self-reported physical function, the ability to work, and participation in recreational activities and contributes to increased rates of anxiety and/or depression. High pain levels early in the recovery process and psychosocial factors play a prominent role in recovery after traumatic lower extremity injury. Cognitive-behavioral therapy pain programs have been shown to mitigate these effects. However, patient access issues related to financial and transportation constraints and the competing demands of treatment focused on the physical sequelae of traumatic injury limit patient participation in this treatment modality. This article describes a telephone-delivered cognitive-behavioral-based physical therapy (CBPT-Trauma) program and design of a multicenter trial to determine its effectiveness after lower extremity trauma. Three hundred twenty-five patients from 7 Level 1 trauma centers were randomized to CBPT-Trauma or an education program after hospital discharge. The primary hypothesis is that compared with patients who receive an education program, patients who receive the CBPT-Trauma program will have improved physical function, pain, and physical and mental health at 12 months after hospital discharge.

2.
J Orthop Trauma ; 36(Suppl 1): S8-S13, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34924513

RESUMO

SUMMARY: In current clinical practice, weight-bearing is typically restricted for up to 12 weeks after definitive fixation of lower extremity periarticular fractures. However, muscle atrophy resulting from restricting weight-bearing has a deleterious effect on bone healing and overall limb function. Antigravity treadmill therapy may improve recovery by allowing patients to safely load the limb during therapy, thereby reducing the negative consequences of prolonged non-weight-bearing while avoiding complications associated with premature return to full weight-bearing. This article describes a multicenter randomized controlled trial comparing outcomes after a 10-week antigravity treadmill therapy program versus standard of care in adult patients with periarticular fractures of the knee and distal tibia. The primary hypothesis is that, compared with patients receiving standard of care, patients receiving antigravity treadmill therapy will report better function 6 months after definitive treatment.

4.
Phys Ther ; 2021 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-34935980

RESUMO

OBJECTIVE: The purpose of this study was to examine associations between level of kinesiophobia and improvement in physical function during recovery from lower extremity injury. METHODS: There were 430 adults (mean [SD]: age = 27.3 [6.4] years; sex = 70.5% men; body mass index = 27.6 [5.2] kg/m2) included in analyses. Using PROMIS, physical function was evaluated in parallel with treatment from a physical therapist at the initial visit and every 3 weeks until final visit or up to 6 months. A Tampa Scale of Kinesiophobia (TSK-17) score of >41 indicated elevated TSK. Four TSK groups were identified: (1) TSK score improved from >41 at initial visit to <41 by final visit (TSK_I), (2) TSK score was <41 at initial and final visits (TSK-), (3) TSK score was >41 at initial and final visits (TSK+), and (4) TSK score worsened from <41 at initial visit to ≥41 by final visit (TSK_W). Linear mixed effects models were used to examine differences between groups in improved physical function over time, with adjustment for depression and self-efficacy. RESULTS: Groups with elevated kinesiophobia at the final visit had smaller positive improvements in physical function (mean change [95%CI]: TSK+ = 7.1 [4.8-9.4]; TSK_W: 6.0 [2.6-9.4]) compared with groups without elevated kinesiophobia at the final visit (TSK_I = 9.8 [6.4-13.3]; TSK- = 9.7 [8.1 to 11.3]) by 12-weeks. CONCLUSIONS: Elevated kinesiophobia that persists or develops over the course of care is associated with less improvement in physical function within military and civilian cohorts. IMPACT: The findings of this prospective longitudinal study support the need to assess for elevated kinesiophobia throughout the course of care because of its association with decreased improvement in physical function. LAY SUMMARY: To help improve your physical function, your physical therapist can monitor the interaction between fear of movement and your clinical outcomes over the course of treatment.

5.
BMC Musculoskelet Disord ; 22(1): 883, 2021 Oct 18.
Artigo em Inglês | MEDLINE | ID: mdl-34663295

RESUMO

BACKGROUND: The purpose of this study was to investigate the longitudinal postoperative relationship between physical activity, psychosocial factors, and physical function in patients undergoing lumbar spine surgery. METHODS: We enrolled 248 participants undergoing surgery for a degenerative lumbar spine condition. Physical activity was measured using a triaxial accelerometer (Actigraph GT3X) at 6-weeks (6wk), 6-months (6M), 12-months (12M) and 24-months (24M) following spine surgery. Physical function (computerized adaptive test domain version of Patient-Reported Outcomes Measurement Information System) and psychosocial factors (pain self-efficacy, depression and fear of movement) were assessed at preoperative visit and 6wk, 6M, 12M and 24M after surgery. Structural equation modeling (SEM) techniques were utilized to analyze data, and results are represented as standardized regression weights (SRW). Overall SRW were computed across five imputed datasets to account for missing data. The mediation effect of each psychosocial factor on the effect of physical activity on physical function were computed [(SRW for effect of activity on psychosocial factor X SRW for effect of psychosocial factor on function) ÷ SRW for effect of activity on function]. Each SEM model was tested for model fit by assessing established fit indexes. RESULTS: The overall effect of steps per day on physical function (SRW ranged from 0.08 to 0.19, p<0.05) was stronger compared to the overall effect of physical function on steps per day (SRW ranged from non-existent to 0.14, p<0.01 to 0.3). The effect of steps per day on physical function and function on steps per day remained consistent after accounting for psychosocial factors in each of the mediation models. Depression and fear of movement at 6M mediated 3.4% and 5.4% of the effect of steps per day at 6wk on physical function at 12M, respectively. Pain self-efficacy was not a statistically significant mediator. CONCLUSIONS: The findings of this study suggest that the relationship between physical activity and physical function is stronger than the relationship of function to activity. However, future research is needed to examine whether promoting physical activity during the early postoperative period may result in improvement of long-term physical function. Since depression and fear of movement had a very small mediating effect, additional work is needed to investigate other potential mediating factors such as pain catastrophizing, resilience and exercise self-efficacy.


Assuntos
Catastrofização , Exercício Físico , Medo , Humanos , Procedimentos Neurocirúrgicos , Dor
6.
Contemp Clin Trials ; 111: 106602, 2021 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-34688915

RESUMO

BACKGROUND: Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. METHODS: The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DISCUSSION: The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. TRIAL REGISTRATION NUMBER: NCT03083886.

7.
Implement Sci Commun ; 2(1): 102, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526133

RESUMO

BACKGROUND: Psychosocial factors are pivotal in recovery after acute orthopedic traumatic injuries. Addressing psychosocial factors is an important opportunity for preventing persistent pain and disability. We aim to identify barriers and facilitators to the implementation of psychosocial care within outpatient orthopedic trauma settings using the Consolidated Framework for Implementation Research (CFIR) and Proctor's taxonomy of implementation outcomes, and to provide implementation strategies derived from qualitative data and supplemented by the Expert Recommendations for Implementing Change. METHODS: We conducted live video qualitative focus groups, exit interviews and individual interviews with stakeholders within 3 geographically diverse level 1 trauma settings (N = 79; 20 attendings, 28 residents, 10 nurses, 13 medical assistants, 5 physical therapists/social workers, and 3 fellows) at 3 trauma centers in Texas, Kentucky, and Massachusetts. We used directed and conventional content analyses to derive information on barriers, facilitators, and implementation strategies within 26 CFIR constructs nested within 3 relevant Proctor outcomes of acceptability, appropriateness, and feasibility. RESULTS: Stakeholders noted that implementing psychosocial care within their practice can be acceptable, appropriate, and feasible. Many perceived integrated psychosocial care as crucial for preventing persistent pain and reducing provider burden, noting they lack the time and specialized training to address patients' psychosocial needs. Providers suggested strategies for integrating psychosocial care within orthopedic settings, including obtaining buy-in from leadership, providing concise and data-driven education to providers, bypassing stigma, and flexibly adapting to fast-paced clinics. CONCLUSIONS: Results provide a blueprint for successful implementation of psychosocial care in orthopedic trauma settings, with important implications for prevention of persistent pain and disability.

8.
J Neurosurg ; : 1-10, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34359037

RESUMO

OBJECTIVE: Neurosurgeons generate an enormous amount of data daily. Within these data lie rigorous, valid, and reproducible evidence. Such evidence can facilitate healthcare reform and improve quality of care. To measure the quality of care provided objectively, evaluating the safety and efficacy of clinical activities should occur in real time. Registries must be constructed and collected data analyzed with the precision akin to that of randomized clinical trials to accomplish this goal. METHODS: The Quality Outcomes Database (QOD) Tumor Registry was launched in February 2019 with 8 sites in its initial 1-year pilot phase. The Tumor Registry was proposed by the AANS/CNS Tumor Section and approved by the QOD Scientific Committee in the fall of 2018. The initial pilot phase aimed to assess the feasibility of collecting outcomes data from 8 academic practices across the United States; these outcomes included length of stay, discharge disposition, and inpatient complications. RESULTS: As of November 2019, 923 eligible patients have been entered, with the following subsets: intracranial metastasis (17.3%, n = 160), high-grade glioma (18.5%, n = 171), low-grade glioma (6%, n = 55), meningioma (20%, n = 184), pituitary tumor (14.3%, n = 132), and other intracranial tumor (24%, n = 221). CONCLUSIONS: The authors have demonstrated here, as a pilot study, the feasibility of documenting demographic, clinical, operative, and patient-reported outcome characteristics longitudinally for 6 common intracranial tumor types.

9.
Phys Ther ; 101(11)2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34403485

RESUMO

OBJECTIVE: Disability is common after lower extremity fracture (LEF). Although psychosocial factors have been associated with patient-reported outcomes after LEF, they have not been associated with objective measures of function. Aberrant gait patterns are important markers of function, but are poorly defined after LEF. The primary purpose of this study was to explore whether pain catastrophizing and fear of movement 6 weeks after surgery were associated with injured limb loading outcomes and 6-minute walk test (6MWT) distance 12 months after femur or tibia fracture. The secondary purpose was to determine if limb loading characteristics differed between injured and uninjured limbs. METHODS: At 6 weeks after LEF, patients completed validated measures of pain catastrophizing, fear of movement, and depression. At 12 months, patients completed a 6MWT while wearing instrumented insoles that recorded the limb loading outcomes of stance time, impulse, and loading rate. Bivariate correlations assessed how patient and psychosocial characteristics at 6 weeks were associated with injured limb loading outcomes and 6MWT distance. Multivariable regression analyses were performed to determine if psychosocial variables were associated with each outcome after controlling for depression and patient demographic and clinical characteristics. Finally, paired t tests compared limb loading outcomes between limbs. RESULTS: Forty-seven participants completed the 6MWT at 12 months (65%), and 38 completed the 6MWT with the instrumented insoles. Fear of movement carried a poor relationship (r = 0.11-0.32) and pain catastrophizing a moderate relationship (r = 0.46-0.54) with 12-month outcomes. The regression results indicated that pain catastrophizing continued to be associated with all outcomes. Finally, the injured limb had significantly lower limb loading outcomes than the uninjured limb at 12 months (Cohen d = 0.54-0.69). CONCLUSION: Pain catastrophizing early after LEF was associated with impaired limb loading and 6MWT distance at 12 months. IMPACT: Impaired limb loading persists 12 months after LEF. Further research is needed to determine whether rehabilitative efforts focused on pain catastrophizing can restore limb loading after LEF.

10.
Artigo em Inglês | MEDLINE | ID: mdl-34425087

RESUMO

OBJECTIVE: To examine the effect of severe lower extremity trauma on meeting Physical Activity Guidelines for Americans (PAGA) 18 months after injury and perform an exploratory analysis to identify demographic, clinical, and psychosocial factors associated with meeting PAGA. DESIGN: Secondary analysis of observational cohort study. SETTING: A total of 34 United States trauma centers PARTICIPANTS: A total of 328 adults with severe distal tibia, ankle and mid- to hindfoot injuries treated with limb reconstruction (N=328). INTERVENTIONS: None. MAIN OUTCOME MEASURES: The Paffenbarger Physical Activity Questionnaire was used to assess physical activity levels 18 months after injury. Meeting PAGA was defined as combined moderate- and vigorous-intensity activity ≥150 minutes per week or vigorous-intensity activity ≥75 minutes per week. RESULTS: Fewer patients engaged in moderate- or vigorous-intensity activity after injury compared with before injury (moderate: 44% vs 66%, P<.001; vigorous: 18% vs 29%; P<.001). Patients spent 404±565 minutes per week in combined moderate- to vigorous-intensity activity before injury compared with 224±453 minutes postinjury (difference: 180min per week; 95% confidence interval [CI], 103-256). The adjusted odds of meeting PAGA were lower for patients with depression (adjusted odds ratio [AOR], 0.45; 95% CI, 0.28-0.73), women (AOR, 0.59; 95% CI, 0.35-1.00), and Black or Hispanic patients (AOR, 0.49; 95% CI, 0.28-0.85). Patients meeting PAGA prior to injury were more likely to meet PAGA after injury (odds ratio, 2.0; 95% CI, 1.20-3.31). CONCLUSIONS: Patients spend significantly less time in moderate- to vigorous-intensity physical activity after injury. Patients with depression are less likely to meet PAGA. Although the causal relationship is unclear, results highlight the importance of screening for depression.

11.
Arch Phys Med Rehabil ; 102(10): 1873-1879, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34175276

RESUMO

OBJECTIVE: To investigate whether early postoperative walking is associated with "best outcome" and no opioid use at 1 year after lumbar spine surgery and establish a threshold for steps/day to inform clinical practice. DESIGN: Secondary analysis from randomized controlled trial. SETTING: Two academic medical centers in the United States. PARTICIPANTS: We enrolled 248 participants undergoing surgery for a degenerative lumbar spine condition (N=248). A total of 212 participants (mean age, 62.8±11.4y, 53.3% female) had valid walking data at baseline. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Disability (Oswestry Disability Index), back and leg pain (Brief Pain Inventory), and opioid use (yes vs no) were assessed at baseline and 1 year after surgery. "Best outcome" was defined as Oswestry Disability Index ≤20, back pain ≤2, and leg pain ≤2. Steps/day (walking) was assessed with an accelerometer worn for at least 3 days and 10 h/d at 6 weeks after spine surgery, which was considered as study baseline. Separate multivariable logistic regression analyses were conducted to determine the association between steps/day at 6 weeks and "best outcome" and no opioid use at 1-year. Receiver operating characteristic curves identified a steps/day threshold for achieving outcomes. RESULTS: Each additional 1000 steps/d at 6 weeks after spine surgery was associated with 41% higher odds of achieving "best outcome" (95% confidence interval [CI], 1.15-1.74) and 38% higher odds of no opioid use (95% CI, 1.09-1.76) at 1 year. Walking ≥3500 steps/d was associated with 3.75 times the odds (95% CI, 1.56-9.02) of achieving "best outcome" and 2.37 times the odds (95% CI, 1.07-5.24) of not using opioids. CONCLUSIONS: Walking early after surgery may optimize patient-reported outcomes after lumbar spine surgery. A 3500 steps/d threshold may serve as an initial recommendation during early postoperative counseling.


Assuntos
Analgésicos Opioides/uso terapêutico , Avaliação da Deficiência , Vértebras Lombares/cirurgia , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/reabilitação , Doenças da Coluna Vertebral/reabilitação , Doenças da Coluna Vertebral/cirurgia , Caminhada/estatística & dados numéricos , Acelerometria , Idoso , Feminino , Humanos , Laminectomia/métodos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Medidas de Resultados Relatados pelo Paciente , Período Pós-Operatório , Estudos Prospectivos
12.
Phys Ther Sport ; 50: 217-225, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34116406

RESUMO

OBJECTIVES: To examine associations between preoperative fear-avoidance model (FAM) risk subgroup status and patient expectation of surgical success with postoperative outcomes at 6 and 12 months after anterior cruciate ligament reconstruction (ACLR). DESIGN: Cohort study. SETTING: Academic medical center. PARTICIPANTS: 54 patients (25 females) undergoing unilateral ACLR. MAIN OUTCOME MEASURES: Cluster analysis distinguished FAM risk subgroups based on preoperative fear of movement/reinjury, self-efficacy, and pain catastrophizing. Preoperative expectation for surgical success was assessed with a numeric rating scale. Six and 12-month outcomes included Subjective Patient Outcomes for Return to Sport, Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life, and International Knee Documentation Committee (IKDC) Subjective Knee Form. RESULTS: Thirteen (24%) patients were "moderate-to-high FAM risk." Moderate-to-high FAM risk patients had lower odds of return to sport at 12 months (OR = 0.3, p = .05) and lower KOOS sports/recreation at 6 months (st. beta = -0.27, p = .05), KOOS quality of life at 12 months (st. beta = -0.42, p = .007), and IKDC at 6 (st. beta = -0.29, p = .04) and 12 months (st. beta = -0.47, p = .001). Higher expectation was associated with lower 6-month IKDC (st. beta = -0.36, p = .008) and 12-month KOOS quality of life (st. beta = -0.29, p = .05). CONCLUSIONS: Preoperative FAM risk influences patient-reported outcomes and return to sport at 6 and 12 months.


Assuntos
Lesões do Ligamento Cruzado Anterior/psicologia , Lesões do Ligamento Cruzado Anterior/cirurgia , Reconstrução do Ligamento Cruzado Anterior , Traumatismos em Atletas/psicologia , Traumatismos em Atletas/cirurgia , Aprendizagem da Esquiva , Medo , Adolescente , Adulto , Reconstrução do Ligamento Cruzado Anterior/psicologia , Catastrofização/psicologia , Análise por Conglomerados , Feminino , Humanos , Masculino , Movimento , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Qualidade de Vida , Relesões/psicologia , Volta ao Esporte , Adulto Jovem
13.
Sensors (Basel) ; 21(8)2021 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-33924388

RESUMO

Accelerometers are increasingly being used in biomedical research, but the analysis of accelerometry data is often complicated by both the massive size of the datasets and the collection of unwanted data from the process of delivery to study participants. Current methods for removing delivery data involve arduous manual review of dense datasets. We aimed to develop models for the classification of days in accelerometry data as activity from human wear or the delivery process. These models can be used to automate the cleaning of accelerometry datasets that are adulterated with activity from delivery. We developed statistical and machine learning models for the classification of accelerometry data in a supervised learning context using a large human activity and delivery labeled accelerometry dataset. Model performances were assessed and compared using Monte Carlo cross-validation. We found that a hybrid convolutional recurrent neural network performed best in the classification task with an F1 score of 0.960 but simpler models such as logistic regression and random forest also had excellent performance with F1 scores of 0.951 and 0.957, respectively. The best performing models and related data processing techniques are made publicly available in the R package, Physical Activity.


Assuntos
Acelerometria , Aprendizado de Máquina , Exercício Físico , Humanos , Modelos Logísticos , Redes Neurais de Computação
14.
Injury ; 52(8): 2444-2450, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33814130

RESUMO

BACKGROUND: Patients with lower extremity fracture requiring surgical fixation often have poor long-term pain and disability outcomes. This indicates the need for a risk stratification tool that can inform patient prognosis early in recovery. The purpose of this study was to determine the predictive validity of the STarT-Lower Extremity Screening Tool (STarT-LE) in patients with lower extremity fracture requiring surgical fixation. MATERIALS AND METHODS: One-hundred and twenty-two patients (41.7 ± 14.7 years, 54% male) with lower extremity fracture and no history of chronic pain were enrolled in this prospective cohort study. Patients completed the STarT-LE Screening Tool six-weeks after definitive fixation. Validated measures of chronic pain development, pain interference, and physical function were collected at 12-months. STarT-LE low, medium, and high risk subgroups were compared against each outcome measure with chi-square, one-way analysis of variance, and sensitivity and specificity analyses. Multivariable linear regression analyses determined if STarT-LE risk subgroups at six weeks were associated with each outcome at 12 months when controlling for important baseline demographics. RESULTS: Twelve-month follow-up was completed by 114 patients (93.4%). Increase in STarT-LE risk subgroup at six-weeks was associated with higher frequency of chronic pain (Low: 14.7%, Medium: 48.3%, High: 85.0%), worse pain interference (Low: 48.6 ± 8.88, Medium: 56.33 ± 8.79, High: 61.65 ± 7.74), and worse physical function (Low: 50.77 ± 9.89, Medium: 42.52 ± 6.47, High: 37.44 ± 7.46) at 12-months. The low risk subgroup had high sensitivity (range: 84.9%-93.9%) and the high risk subgroup had high specificity (range: 87.7%-95.2%) for dichotomized 12-month outcomes. The multivariable results showed that medium and high STarT-LE risk categories were associated with chronic pain development (Medium odds ratio: 3.90, 95%CI: 1.11 to 13.66; High odds ratio: 13.14, 95%CI: 2.25 to 76.86), worse pain interference (Medium: ß:4.37, 95%CI: 0.17 to 8.58; High: ß:7.01, 95%CI: 1.21 to 12.81), and worse physical function (Medium: ß:-3.76, 95%CI: -7.41 to -0.11; ß:-7.44, 95%CI:-12.47 to -2.41), respectively, when controlling for important baseline variables. CONCLUSION: The STarT-LE has the potential to identify patients at-risk for poor pain and functional outcomes, and may help inform the post-surgical management of patients with traumatic LE injury.


Assuntos
Dor Crônica , Avaliação da Deficiência , Dor Crônica/etiologia , Feminino , Humanos , Extremidade Inferior , Masculino , Medição da Dor , Estudos Prospectivos
15.
J Neurosurg Spine ; : 1-9, 2021 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-33740766

RESUMO

OBJECTIVE: The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS: Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS: The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS: This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

16.
Spine J ; 21(1): 55-63, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32736036

RESUMO

BACKGROUND CONTEXT: Positive psychosocial factors early after surgery, such as resilience and self-efficacy, may be important characteristics for informing individualized postoperative care. PURPOSE: To examine the association of early postoperative resilience and self-efficacy on 12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity after lumbar spine surgery. STUDY DESIGN/SETTING: Pooled secondary analysis of prospectively collected trial data from two academic medical centers. PATIENT SAMPLE: Two hundred and forty-eight patients who underwent laminectomy with or without fusion for a degenerative lumbar condition. OUTCOME MEASURES: Physical function, pain inference, and social participation (ability to participate in social roles and activities) were measured using the Patient Reported Outcomes Measurement Information System. The Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts were used to measure disability, pain intensity, and physical activity, respectively. METHODS: Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Multivariable linear regression analyses were used to assess the associations between early postoperative psychosocial factors and 12-month outcomes adjusting for age, sex, study site, randomized group, fusion status, fear of movement (Tampa Scale for Kinesiophobia), and outcome score at baseline. This study was funded by Patient-Centered Outcomes Research Institute and Foundation for Physical Therapy Research. There are no conflicts of interest. RESULTS: Resilience at 6 weeks after surgery was associated with 12-month physical function (unstandardized beta=1.85 [95% confidence interval [CI]: 0.29; 3.40]), pain interference (unstandardized beta=-1.80 [95% CI: -3.48; -0.12]), social participation (unstandardized beta=2.69 [95% CI: 0.97; 4.41]), and disability (unstandardized beta=-3.03 [95% CI: -6.04; -0.02]). Self-efficacy was associated with 12-month disability (unstandardized beta=-0.21 [95% CI: -0.37; -0.04]. CONCLUSIONS: Postoperative resilience and pain self-efficacy were associated with improved 12-month patient-reported outcomes after spine surgery. Future work should consider how early postoperative screening for positive psychosocial characteristics can enhance risk stratification and targeted rehabilitation management in patients undergoing spine surgery.


Assuntos
Pessoas com Deficiência , Participação Social , Avaliação da Deficiência , Humanos , Vértebras Lombares/cirurgia , Dor , Resultado do Tratamento
17.
Arch Phys Med Rehabil ; 102(2): 261-269, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33022272

RESUMO

OBJECTIVES: To determine whether a modified version of the STarT Back Screening Tool in its current structure has adequate properties for use in patients with lower extremity fracture. DESIGN: Single-center, prospective study. SETTING: Level I trauma center. PARTICIPANTS: Patients with lower extremity fracture without a history of chronic pain (N=114), with 93% follow-up. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Six weeks after surgical fixation, individuals completed the Subgroups for Targeted Treatment of Lower Extremity Screening Tool (STarT-LE). A subsample completed the STarT-LE again 1 week later. The following questionnaires were completed at 6 weeks and 6 months: Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia, Brief Pain Inventory pain intensity subscale, and PROMIS Depression and Pain Interference computer adaptive testing modules. Reliability was evaluated using intraclass correlation coefficients (ICC) and Cronbach's alpha (α). Convergent validity evidence was measured concurrently using the Spearman ρ correlation between the 6-week STarT-LE and established questionnaires. Predictive validity evidence was evaluated by area under the curve analysis (AUC) using the 6-week STarT-LE total and psychosocial scores and 6-month criterion physical and psychosocial reference standards. RESULTS: The STarT-LE has good test-retest reliability (ICC, 0.85; 95% confidence interval, 0.78-0.91) and acceptable internal consistency (α=0.74). The convergent validity evidence was fair to moderate (ρ, 0.53-0.68; P<.001) and the predictive validity evidence was acceptable to excellent (AUC, 0.73-0.84). CONCLUSIONS: The STarT-LE has adequate properties for use in patients with lower extremity fracture. Future larger scale studies are needed to validate risk cutoffs.


Assuntos
Fraturas Ósseas/cirurgia , Extremidade Inferior/lesões , Programas de Rastreamento/métodos , Medição da Dor/métodos , Dor Pós-Operatória/diagnóstico , Adolescente , Adulto , Idoso , Catastrofização , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psicometria , Reprodutibilidade dos Testes , Centros de Traumatologia
18.
Spine J ; 21(5): 829-840, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33346156

RESUMO

BACKGROUND CONTEXT: Effective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role. PURPOSE: The purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR - replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration). STUDY DESIGN/SETTING: A retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital. PATIENT SAMPLE: Analysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208. OUTCOME MEASURES: Self-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery. METHODS: The implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success. RESULTS: At 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF. CONCLUSIONS: Here we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure.


Assuntos
Artroplastia de Substituição , Degeneração do Disco Intervertebral , Fusão Vertebral , Espondilolistese , Adulto , Dor nas Costas , Humanos , Degeneração do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Estudos Retrospectivos , Espondilolistese/cirurgia , Resultado do Tratamento
20.
Spine (Phila Pa 1976) ; 46(11): 717-725, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-33337676

RESUMO

STUDY DESIGN: Retrospective analysis of prospectively collected registry data. OBJECTIVE: The aim of this study was to compare the performance of 30% reduction to established absolute point-change values for measures of disability and pain in patients undergoing elective cervical spine surgery. SUMMARY OF BACKGROUND DATA: Recent studies recommend using a proportional change from baseline instead of an absolute point-change value to define minimum clinically important difference (MCID). METHODS: Analyses included 13,179 patients who underwent cervical spine surgery for degenerative disease between April 2013 and February 2018. Participants completed a baseline and 12-month follow-up assessment that included questionnaires to assess disability (Neck Disability Index [NDI]), neck and arm pain (Numeric Rating Scale [NRS-NP/AP], and satisfaction [NASS scale]). Participants were classified as met or not met 30% reduction from baseline in each of the respective measures. The 30% reduction in scores at 12 months was compared to a wide range of established absolute point-change MCID values using receiver-operating characteristic curves, area under the receiver-operating characteristic curve (AUROC), and logistic regression analyses. These analyses were conducted for the entire patient cohort, as well as for subgroups based on baseline severity and surgical approach. RESULTS: Thirty percent reduction in NDI and NRS-NP/AP scores predicted satisfaction with more accuracy than absolute point-change values for the total population and ACDF and posterior fusion procedures (P < 0.05). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 16.8%) and bed-bound disability (ODI 81%-100%: 16.6%) categories. For pain, there was a 1.9% to 11% and 1.6% to 9.6% AUROC difference for no/mild neck and arm pain (NRS 0-4), respectively, in favor of a 30% reduction threshold. CONCLUSION: A 30% reduction from baseline is a valid method for determining MCID in disability and pain for patients undergoing cervical spine surgery.Level of Evidence: 3.


Assuntos
Vértebras Cervicais/cirurgia , Diferença Mínima Clinicamente Importante , Humanos , Doenças da Coluna Vertebral/cirurgia , Resultado do Tratamento
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