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1.
Am J Sports Med ; 52(6): 1464-1471, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38590171

RESUMO

BACKGROUND: Given the variability across populations and settings, defining the MCID and the PASS for the Rowe and ASOSS scores and patients undergoing primary and revision Latarjet it is essential to have accurate benchmarks relevant to these groups when interpreting clinical results. PURPOSE: To determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for the visual analog scale (VAS) for pain during sports, Athletic Shoulder Outcome Scoring System (ASOSS), and Rowe scores after primary and revision Latarjet procedures for treatment of shoulder instability. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 3. METHODS: Between January 2018 and January 2020, a retrospective review of 149 patients undergoing primary Latarjet (n = 82) and revision Latarjet (n = 67) to treat shoulder instability was performed in a single institution. Patient-reported outcome measures were collected preoperatively and 1 year postoperatively. The delta was defined as the change between the pre- and postoperative scores. Distribution-based and anchored-based approaches were used to estimate the MCID and the PASS, respectively. The optimal cutoff point and the percentage of patients achieving those thresholds were also calculated. RESULTS: The distribution-based MCIDs after primary Latarjet were 1.1, 7.5, and 9.6 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the MCID thresholds were 93.9%, 98.7%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds after primary Latarjet were ≤1, ≥90, and ≥85 for the VAS, Rowe, and ASOSS scores, respectively. The percentages of patients who achieved PASS thresholds were 82.9%, 89%, and 86.5% for the VAS, Rowe, and ASOSS scores, respectively. The distribution-based MCIDs after revision Latarjet were 0.6, 6.2, and 3.4 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved MCID thresholds were 89.3%, 100%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds were ≤3, ≥87, and ≥86 after revision Latarjet for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the PASS thresholds were 88%, 88%, and 91% for the VAS, Rowe, and ASOSS, respectively. CONCLUSION: This study identified useful values for the MCID and PASS thresholds in VAS, Rowe, and ASOSS scores after primary and revision Latarjet procedures for treating shoulder instability. Most patients achieved MCID and PASS benchmarks, indicating successful primary and revision Latarjet procedure outcomes. These metrics can serve as valuable parameters when analyzing parameters in future studies and have the potential to enhance patient care by optimizing treatment strategies and surgical decision making.


Assuntos
Instabilidade Articular , Diferença Mínima Clinicamente Importante , Medidas de Resultados Relatados pelo Paciente , Humanos , Estudos Retrospectivos , Masculino , Feminino , Adulto , Instabilidade Articular/cirurgia , Reoperação/estatística & dados numéricos , Adulto Jovem , Adolescente , Articulação do Ombro/cirurgia , Articulação do Ombro/fisiopatologia , Medição da Dor , Relevância Clínica
2.
Orphanet J Rare Dis ; 19(1): 154, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38605392

RESUMO

BACKGROUND: The minimal clinically important difference (MCID) is the smallest change in outcome that physicians or patients would consider meaningful and is relevant when evaluating disease progression or the efficacy of interventions. Studies of patients with late-onset Pompe disease (LOPD) have used the 6-min walk distance (6MWD) as an endpoint to assess motor function. However, an MCID for 6MWD (% predicted and meters) has yet to be established in LOPD. The objective of the study was to derive 6MWD MCID (% predicted and meters) with different analysis methods and for subgroups of different disease severity for LOPD. METHODS: Data from the PROPEL trial were used to calculate 6MWD MCID in the overall PROPEL population and subgroups of baseline severity as assessed by walking distance and body mass index (BMI), using anchor- and distribution-based approaches. RESULTS: The 6MWD MCIDs varied widely, depending on the method and subgroup, ranging from 2.27%-8.11% predicted for the overall LOPD population (23.7 m-57.2 m). For patients with baseline 6MWD < 150 m, MCIDs ranged from -0.74%-3.37% (-2.1 m-11.3 m). MCIDs increased with distance walked at baseline until a plateau was reached. For BMI subgroups, the MCIDs were generally lowest in obese patients. CONCLUSION: Our analysis shows that MCID depends on the chosen method and disease severity. The findings suggest that applying a single MCID to all patients can be misleading; consequently, a range of possible MCIDs should be considered. This may also be highly relevant for other neuromuscular diseases. This study provides a range of 6MWD MCIDs for LOPD, with lower MCIDs for more severe patients.


Assuntos
Doença de Depósito de Glicogênio Tipo II , Humanos , Progressão da Doença , Diferença Mínima Clinicamente Importante , Caminhada , Ensaios Clínicos como Assunto
3.
Alzheimers Dement ; 20(5): 3352-3363, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38561021

RESUMO

INTRODUCTION: We conducted a rapid systematic review of minimal clinically important differences (MCIDs) for Alzheimer's disease (AD) trial endpoints. METHODS: Two reviewers searched EMBASE, MEDLINE, and PubMed from inception to June 4, 2023. RESULTS: Ten articles were retrieved. For mild cognitive impairment (MCI), a change of +2 to +3 points on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), +1 points on the Clinical Dementia Rating scale sum of boxes (CDR-SB), -5 points on the integrated Alzheimer's Disease Rating Scale (iADRS), or -1 to -2 points on the Mini-Mental State Examination (MMSE) was considered meaningful. For patients with mild AD, a change of +3 on the ADAS-Cog, +2 points on CDR-SB, -9 points on the iADRS, or -2 points on the MMSE was considered meaningful. For patients with moderate to severe AD, a change of +2 points on the CDR-SB or a change of -1.4 to -3 points on the MMSE was considered meaningful. CONCLUSION: This review identified previously published MCIDs for AD trial endpoints. Input from patients and caregivers will be needed to derive more meaningful endpoints and thresholds. HIGHLIGHTS: This systematic rapid review identified thresholds for minimal clinically important differences (MCIDs) for recently used Alzheimer's disease (AD) trial endpoints: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Clinical Dementia Rating scale sum of boxes (CDR-SB), integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE). MCIDs were higher for more severe stages of AD. Average treatment effects in recent trials of anti-amyloid disease modifying monoclonal antibodies are lower than previously published MCIDs. In future trials of disease modifying treatments for AD, the proportion of participants in each treatment group that experienced a clinically meaningful decline could be reported. More work is needed to incorporate the values and preferences of patients and care partners in deriving MCIDs.


Assuntos
Doença de Alzheimer , Disfunção Cognitiva , Diferença Mínima Clinicamente Importante , Doença de Alzheimer/diagnóstico , Humanos , Disfunção Cognitiva/diagnóstico , Testes de Estado Mental e Demência/estatística & dados numéricos , Testes Neuropsicológicos/estatística & dados numéricos , Ensaios Clínicos como Assunto
4.
Knee Surg Sports Traumatol Arthrosc ; 32(4): 1038-1048, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38477103

RESUMO

PURPOSE: This study aimed to evaluate patient-reported outcome measures (PROMs) and the effects of gender and age on achieving clinically significant outcomes in patients undergoing arthroscopic superior capsular reconstruction (ASCR) with a minimum 2-year follow-up. METHODS: Patients undergoing ASCR for irreparable rotator cuff tear between 2013 and 2020 were reviewed. Preoperative and minimum 2-year postoperative PROMs were collected, including American Shoulder and Elbow Surgeons (ASES), Constant, single assessment numeric evaluation (SANE), and visual analog scale (VAS) scores. Minimal clinically important difference (MCID) and patient-acceptable symptomatic state (PASS) were calculated for each functional score and analyzed according to age and gender. The percentages of patients achieving MCID and PASS were recorded. RESULTS: The study included 83 patients, with a mean follow-up of 3.5 ± 1.4 years. Significant improvements were found in ASES, Constant, SANE, and VAS for all groups based on gender and age. Based on receiver-operating characteristic curves, all scores had acceptable areas under the curve for PASS. Values for PASS and MCID were 81.5 and 10.3 for ASES; 61.5 and 6.2 for Constant; 82.5 and 11.5 for SANE and 1.5 and 1.1 for VAS, respectively. Analysis of achieving MCID and PASS showed no difference between the groups in the majority of outcome measures. However, female patients achieved the SANE thresholds for PASS at significantly higher rates than male patients. Patients ≥65 years old achieved ASES and Constant thresholds for MCID at significantly higher rates than patients ˂65 years old. CONCLUSION: Most patients achieved MCID and PASS at a 2-year follow-up. Patients showed comparable rates of MCID and PASS achievement on most outcome tools based on age and gender. Female patients achieved PASS on SANE at significantly higher rates than male patients and older patients achieved MCID on ASES and Constant at higher rates than young patients. Thus, age is a stronger factor for achieving MCID than gender. LEVEL OF EVIDENCE: Level II.


Assuntos
Diferença Mínima Clinicamente Importante , Lesões do Manguito Rotador , Humanos , Masculino , Feminino , Idoso , Resultado do Tratamento , Ombro , Lesões do Manguito Rotador/cirurgia , Avaliação de Resultados em Cuidados de Saúde , Estudos Retrospectivos , Artroscopia
5.
J Orthop Sports Phys Ther ; 54(5): 1-13, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38457134

RESUMO

OBJECTIVE: To quantify the dose-response relationship between overall and specific exercise modalities and pain, in patients with nonspecific chronic low back pain (LBP). DESIGN: Systematic review with Bayesian network meta-analysis. LITERATURE SEARCH: We searched the Medline, Embase, Web of Science, Cochrane Library, Scopus, and SPORTDiscus databases from inception to June 2023. STUDY SELECTION CRITERIA: We included randomized controlled trials of exercise interventions in adults with nonspecific chronic LBP and at least 1 pain outcome reported at the main trial end point. DATA SYNTHESIS: A random-effects network meta-analysis was conducted. We assessed risk of bias using the Cochrane Risk of Bias Tool 2.0, and used the GRADE approach to judge the certainty of evidence for each outcome. RESULTS: Eighty-two trials were included (n = 5033 participants). We found a nonlinear dose-response relationship between total exercise and pain in patients with nonspecific chronic LBP. The maximum significant response was observed at 920 MET minutes (standardized mean difference = -1.74; 95% credible intervals: -2.43, -1.04). The minimal clinically important difference for achieving meaningful pain improvement was 520 MET minutes per week. The dose to achieve minimal clinically important difference varied by type of exercise; Pilates was the most effective. The certainty of the evidence was very low to moderate for all outcomes. CONCLUSION: The dose-response relationship of different exercise modalities to improve pain in patients with nonspecific chronic LBP had a U-shaped trajectory and low- to moderate-certainty evidence. The clinical effect was most pronounced with Pilates exercise. J Orthop Sports Phys Ther 2024;54(5):1-13. Epub 8 March 2024. doi:10.2519/jospt.2024.12153.


Assuntos
Teorema de Bayes , Terapia por Exercício , Dor Lombar , Metanálise em Rede , Humanos , Dor Lombar/terapia , Terapia por Exercício/métodos , Dor Crônica/terapia , Adulto , Ensaios Clínicos Controlados Aleatórios como Assunto , Diferença Mínima Clinicamente Importante
6.
Physiotherapy ; 123: 142-150, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38490073

RESUMO

OBJECTIVES: To measure and compare the clinimetric properties of the Chelsea Critical Care Physical Assessment (CPAx) and Physical Function in Intensive Care Test-scored (PFIT-s) for assessment of physical function and activity. DESIGN: Prospective cohort design using crossover-randomisation of the sequence in which participants were assessed with CPAx and PFIT-s. SETTING: Surgical and transplant intensive care units (ICU) in an academic hospital. PARTICIPANTS: Adults who underwent elective open abdominal surgery. Consecutive sampling was used to enrol 69 participants. INTERVENTIONS: Physical function and activity were assessed on ICU days one, three, five and at ICU discharge using the CPAx and PFIT-s in random order. MAIN OUTCOME MEASURES: Responsiveness to change, minimal clinically important difference (MCID), floor and ceiling effect, and convergent validity. RESULTS: CPAx demonstrated a large responsiveness (effect size index (ESI)= 0.83) and PFIT-s moderate responsiveness (ESI=0.73) to change in scores. MCID for CPAx was 2.1 (standard error of measurement (SEM) 1.1) and for PFIT-s 0.6 (SEM=0.3). CPAx had no floor effect and a small ceiling effect (9%, n = 6) at ICU discharge compared to 2% (n = 1) floor and 48% (n = 32) ceiling effects of PFIT-s. Moderate convergent validity was found for both tools at ICU admission (n = 67, r = 0.62, p < 0.001) and discharge (n = 67, r = 0.51, p < 0.001). CONCLUSION: CPAx is most responsive to changes in physical function and activity scores, has no floor and limited ceiling effects and moderate convergent validity, and is recommended for similar cohorts. CONTRIBUTION OF THE PAPER.


Assuntos
Abdome , Unidades de Terapia Intensiva , Humanos , Estudos Prospectivos , Feminino , Masculino , Pessoa de Meia-Idade , Abdome/cirurgia , Idoso , Estudos Cross-Over , Reprodutibilidade dos Testes , Avaliação de Resultados em Cuidados de Saúde , Adulto , Diferença Mínima Clinicamente Importante , Desempenho Físico Funcional , Cuidados Críticos
7.
Eur J Orthop Surg Traumatol ; 34(4): 1749-1755, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38480530

RESUMO

INTRODUCTION: The goal of this research is to identify the factors that negatively impact the achievement of the minimum clinically significant change (MCID) for the American Shoulder and Elbow Surgeons (ASES) score within the realm of various orthopedic shoulder procedures. METHODS: We conducted a comprehensive review of studies published from 2002 to 2023, utilizing OvidMedline and PubMed databases. Our search criteria included terms such as "minimal clinically important difference" or "MCID" along with associated MeSH terms, in addition to "American shoulder and elbow surgeon" or "ASES." We selectively included primary investigations that assessed factors linked to the failure to achieve MCID for the ASES score subsequent to orthopedic shoulder procedures, while excluding papers addressing anatomical, surgical, or injury-related aspects. RESULTS: Our analysis identified 149 full-text articles, leading to the inclusion of 12 studies for detailed analysis. The selected studies investigated outcomes following various orthopedic shoulder procedures, encompassing biceps tenodesis, total shoulder arthroplasty, and rotator cuff repair. Notably, factors, such as gender, body mass index, diabetes, smoking habits, opioid usage, depression, anxiety, workers' compensation, occupational satisfaction, and the preoperative ASES score, were all associated with the inability to attain MCID. CONCLUSION: In summary, numerous factors exert a negative influence on the attainment of MCID following shoulder procedures, and these factors appear to be irrespective of the specific surgical technique employed. Patients presenting with these factors may perceive their surgical outcomes as less successful when compared to those without these factors. Identifying these factors can enable healthcare providers to provide more effective counseling to patients regarding their expected outcomes and rehabilitation course. Furthermore, these findings can aid in the development of a screening tool to better identify these risk factors and optimize them before surgery.


Assuntos
Diferença Mínima Clinicamente Importante , Humanos , Artroplastia do Ombro , Articulação do Ombro/cirurgia , Fatores de Risco
8.
BMC Surg ; 24(1): 59, 2024 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-38365668

RESUMO

OBJECTIVE: To identify the predictors for the achievement of minimal clinically important difference (MCID) in functional status among elderly patients with degenerative lumbar spinal stenosis (DLSS) undergoing lumbar decompression and fusion surgery. METHODS: Patients who underwent lumbar surgery for DLSS and had a minimum of 1-year follow-up were included. The MCID achievement threshold for the Oswestry Disability Index (ODI) was set at 12.8. General patient information and the morphology of lumbar paraspinal muscles were evaluated using comparative analysis to identify influencing factors. Multiple regression models were employed to identify predictors associated with MCID achievement. A receiver operating characteristic (ROC) curve analysis was conducted to determine the optimal cut-off values for predicting functional recovery. RESULTS: A total of 126 patients (46 males, 80 females; mean age 73.0 ± 5.9 years) were included. The overall rate of MCID achievement was 74.6%. Patients who achieved MCID had significantly higher psoas major muscle attenuation (43.55 vs. 39.23, p < 0.001) and preoperative ODI (51.5 vs. 41.6, p < 0.001). Logistic regression showed that elevated psoas major muscle attenuation (p = 0.001) and high preoperative ODI scores (p = 0.001) were independent MCID predictors. The optimal cut-off values for predicting MCID achievement were found to be 40.46 Hounsfield Units for psoas major muscle attenuation and 48.14% for preoperative ODI. CONCLUSION: Preoperative psoas major muscle attenuation and preoperative ODI were reliable predictors of achieving MCID in geriatric patients undergoing lumbar decompression and fusion surgery. These findings offer valuable insights for predicting surgical outcomes and guiding clinical decision-making in elderly patients.


Assuntos
Fusão Vertebral , Estenose Espinal , Masculino , Feminino , Humanos , Idoso , Resultado do Tratamento , Estenose Espinal/cirurgia , Diferença Mínima Clinicamente Importante , Estado Funcional , Descompressão , Vértebras Lombares/cirurgia , Estudos Retrospectivos
9.
Arch Orthop Trauma Surg ; 144(4): 1693-1701, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38386062

RESUMO

INTRODUCTION: The minimal clinically important difference (MCID) is a valuable tool for patient-based outcome analysis, for which limited data is available in the literature, especially after arthroscopic rotator cuff repair (ARCR). Although several studies have reported MCID after ARCR, few have studied the impact of various clinical factors such as Diabetes, pseudoparalysis, type of cuff repair, and retear over MCID. This study attempts to determine the MCID in shoulder functional scores after ARCR and the impact of various factors on MCID. METHODS: 144 patients undergoing ARCR were prospectively evaluated at six and 12 months by ASES and UCLA scores. MCID for American Shoulder and Elbow Surgeons (ASES) and the University of California and Los Angeles (UCLA) scores were calculated using an anchor-based and distribution-based approach. MCID was also calculated for diabetic and non-diabetic patients, smokers vs. non-smokers, presence or absence of pseudoparalysis, type of cuff repair (single row vs. suture bridge), and presence of retears. Uni- and multivariate analysis was performed to identify factors affecting the MCID of both scores. RESULTS: Mean MCID for ASES score was 13.3 and 16.6 using an anchor-based and distribution-based approach, respectively. For the UCLA score, the mean MCID was 10.0 and 12.6 by anchor-based and 12.6 by distribution-based approach, respectively. Patients with higher pre-operative ASES scores demonstrated lower MCID values. No significant difference was observed in MCID scores of diabetic vs. non-diabetic patients, smoker vs. non-smoker, patients with or without pseudoparalysis, and type of cuff repair. The age, gender, and presence of retear did not affect MCID values. CONCLUSION: This study establishes the MCID values of ASES and UCLA scores for rotator cuff repair by anchor and distribution methods. No patient or surgical factors appear to affect the MCID except pre-operative ASES scores. STUDY DESIGN: Prospective cohort, Level II.


Assuntos
Diabetes Mellitus , Lesões do Manguito Rotador , Humanos , Lesões do Manguito Rotador/cirurgia , Ombro , Manguito Rotador/cirurgia , Estudos Prospectivos , Diferença Mínima Clinicamente Importante , Resultado do Tratamento , Artroscopia
10.
J Stroke Cerebrovasc Dis ; 33(4): 107577, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38325034

RESUMO

BACKGROUND: One of the most prevalent symptoms of stroke is fatigue. Fatigue severity scale is the most often used tool for evaluating fatigue in stroke patients, its minimal clinically important difference threshold has not been determined. This study aimed to identify the minimal clinically important difference of fatigue severity scale in stroke patients. METHODS: All study participants were examined using fatigue severity scale and multidimensional fatigue symptom inventory-short form before and after the intervention. The 6-week intervention combined graded activity training and pacing therapy employed to reduce fatigue severity. Participants reported changes in their fatigue severity after the intervention with the global rating of change and visual analog scale. The minimal clinically important difference of the fatigue severity scale calculated using both anchor- and distribution-based methods. RESULTS: A total of 117 stroke patients were included in the study. Using multidimensional fatigue symptom inventory-short form, global rating of change, and visual analog scale as an anchor, the minimal clinically important difference of fatigue severity scale was obtained at 3.5, 4.5, and 4.5, respectively. The minimal clinically important difference for fatigue severity scale varied from 4.28 to 12.90 using the distribution-based method, with SEM = 4.28 displaying the best sensitivity and specificity for use as minimal clinically important difference. CONCLUSIONS: The minimal clinically important difference value for the fatigue severity scale was estimated at 3.5_12.90 using anchor-based and distribution-based methods. The study's results can be utilized to understand the effectiveness of fatigue interventions in stroke patients in clinical and research settings.


Assuntos
Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Fadiga/diagnóstico , Fadiga/etiologia , Fadiga/terapia , Sensibilidade e Especificidade , Diferença Mínima Clinicamente Importante
11.
Br J Oral Maxillofac Surg ; 62(2): 177-183, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38336576

RESUMO

The present study estimated the minimal clinically important difference (MCID) for pain on a visual analogue scale - numerical rating scale (VAS-NRS) and mean bite force (MBF) in patients treated for maxillofacial trauma (MFT). This cohort study included 120 MFT patients treated according to AO principles. Preoperative and four-week postoperative pain on the VAS-NRS, and MBF were measured to calculate MCIDs as indicators of functional rehabilitation. The patient's perspective of the treatment was assessed using a four-item anchor question. The MCID was determined by two anchor-based approaches, namely, the change difference (CD) method and receiver operating characteristic (ROC) curve method. According to the CD method, the MCID for pain was 2.4 and the MBF was 147.9 N. Based on the ROC curve, the MCID for pain was 2.5 (sensitivity 91.7%, specificity 47.2%) and MBF was 159.1 N (sensitivity 71.4%, specificity 61.1%). This study demonstrated a high sensitivity (>70%) for MCID, which implies that pain reduction of 2.4-2.5 points on the VAS-NRS and a gain in MBF of 147.9-159.1N are clinically relevant for patients treated for MFT.


Assuntos
Traumatismos Maxilofaciais , Diferença Mínima Clinicamente Importante , Humanos , Estudos de Coortes , Estudos Prospectivos , Traumatismos Maxilofaciais/cirurgia , Dor Pós-Operatória
12.
Phys Ther ; 104(4)2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38365440

RESUMO

OBJECTIVE: Balance problems are common in patients with stroke, and the Mini-Balance Evaluation Systems Test (Mini-BESTest) is a reliable and valid assessment tool for measuring balance function. Determining the minimal clinically important difference (MCID) is crucial for assessing treatment effectiveness. This study aimed to determine the MCID of the Mini-BESTest in patients with early subacute stroke. METHODS: In this prospective multicenter study, 53 patients with early subacute stroke undergoing rehabilitation in inpatient units were included. The mean age of the patients was 72.6 (SD = 12.2) years. The Mini-BESTest, which consists of 14 items assessing various aspects of balance function, including anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait, was used as the assessment tool. The global rating of change (GRC) scales completed by the participants and physical therapists were used as external anchors to calculate the MCID. The GRC scale measured subjective improvement in balance function, ranging from -3 (very significantly worse) to +3 (very significantly better), with a GRC score of ≥+2 considered as meaningful improvement. Four methods were used to calculate the MCID: mean of participants with GRC of 2, receiver operating characteristic-based method, predictive modeling method, and adjustment of the predictive modeling method based on the rate of improvement. From the MCID values obtained using these methods, a single pooled MCID value was calculated. RESULTS: The MCID values for the Mini-BESTest obtained through the 4 methods ranged from 3.2 to 4.5 points when using the physical therapist's GRC score as the anchor but could not be calculated using the participant's GRC score. The pooled MCID value for the Mini-BESTest was 3.8 (95% CI = 2.9-5.0). CONCLUSIONS: The Mini-BESTest MCID obtained in this study is valuable for identifying improvements in balance function among patients with early subacute stroke. IMPACT: Determination of the MCID is valuable for evaluating treatment effectiveness. The study findings provide clinicians with practical values that can assist in interpreting Mini-BESTest results and assessing treatment effectiveness.


Assuntos
Avaliação da Deficiência , Diferença Mínima Clinicamente Importante , Equilíbrio Postural , Reabilitação do Acidente Vascular Cerebral , Humanos , Equilíbrio Postural/fisiologia , Estudos Prospectivos , Masculino , Feminino , Idoso , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/fisiopatologia , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais
13.
Qual Life Res ; 33(5): 1223-1232, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38319488

RESUMO

PURPOSE: Anchor-based studies are today the most popular approach to determine a minimal important difference value for an outcome variable. However, a variety of construction methods for such values do exist. This constitutes a challenge to the field. In order to distinguish between more or less adequate construction methods, meaningful minimal requirements can be helpful. For example, minimal important difference values should not reflect the intervention(s) the patients are exposed to in the study used for construction, as they should later allow to compare interventions. This requires that they are not sensitive to the distribution of the change score observed. This study aims at investigating to which degree established construction methods fulfil this minimal requirement. METHODS: Six constructions methods were considered, covering very popular and recently suggested methods. The sensitivity of MID values to the distribution of the change score was investigated in a simulation study for these six construction methods. RESULTS: Five out of six construction methods turned out to yield MID values which are sensitive to the distribution of the change score to a degree that questions their usefulness. Insensitivity can be obtained by using construction methods based solely on an estimate of the conditional distribution of the anchor variable given the change score. CONCLUSION: In future the computation of MID values should be based on construction methods avoiding sensitivity to the distribution of the change score.


Assuntos
Diferença Mínima Clinicamente Importante , Humanos , Qualidade de Vida , Psicometria , Avaliação de Resultados em Cuidados de Saúde
14.
J Bone Joint Surg Am ; 106(9): 793-800, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38381811

RESUMO

UPDATE: This article was updated on May 1, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. The byline that had read "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†" now reads "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Yuxuan Jin, MS 1 , Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†". BACKGROUND: Literature-reported minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for patient-reported outcome measures demonstrate marked variability. The purpose of this study was to determine the minimal detectable change (MDC), MCID, and PASS thresholds for the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subdomain, Physical Function Short Form (PS), and Joint Replacement (JR) among patients with osteoarthritis (OA) who underwent primary total knee arthroplasty (TKA). METHODS: A prospective cohort of 6,778 patients who underwent primary TKA was analyzed. Overall, 1-year follow-up was completed by 5,316 patients for the KOOS Pain, 5,018 patients for the KOOS PS, and 4,033 patients for the KOOS JR. A total of 5,186 patients had an OA diagnosis; this group had an average age of 67.0 years and was 59.9% female and 80.4% White. Diagnosis-specific MDCs and MCIDs were estimated with use of a distribution-based approach. PASS values were estimated with use of an anchor-based approach, which corresponded to a response to a satisfaction question at 1 year postoperatively. RESULTS: The MCID thresholds for the OA group were 7.9 for the KOOS Pain, 8.0 for the KOOS PS, and 6.7 for the KOOS JR. A high percentage of patients achieved the MCID threshold for each outcome measure (KOOS Pain, 95%; KOOS PS, 88%; and KOOS JR, 94%). The MDC 80% to 95% confidence intervals ranged from 9.1 to 14.0 for the KOOS Pain, 9.2 to 14.1 for the KOOS PS, and 7.7 to 11.8 for the KOOS JR. The PASS thresholds for the OA group were 77.7 for the KOOS Pain (achieved by 73% of patients), 70.3 for the KOOS PS (achieved by 68% of patients), and 70.7 for the KOOS JR (achieved by 70% of patients). CONCLUSIONS: The present study provided useful MCID, MDC, and PASS thresholds for the KOOS Pain, PS, and JR for patients with OA. The diagnosis-specific metrics established herein can serve as benchmarks for clinically meaningful postoperative improvement. Future research and quality assessments should utilize these OA-specific thresholds when evaluating outcomes following TKA. Doing so will enable more accurate determinations of operative success and improvements in patient-centered care. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Artroplastia do Joelho , Diferença Mínima Clinicamente Importante , Medidas de Resultados Relatados pelo Paciente , Humanos , Artroplastia do Joelho/efeitos adversos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Satisfação do Paciente
15.
J Arthroplasty ; 39(6): 1404-1411, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38403079

RESUMO

BACKGROUND: Despite the potential negative impact of preoperative obesity on total hip arthroplasty (THA) outcomes, the association between preoperative and postoperative weight change and outcomes is much less understood. Therefore, this study aimed to determine the impact of preoperative and postoperative weight change and preoperative body mass index (BMI) on health care utilization, satisfaction, and achievement of minimal clinically important difference (MCID) for Hip Disability and Osteoarthritis Outcome Score Physical Function Short-Form (HOOS PS) and HOOS Pain. METHODS: Patients who underwent primary elective unilateral THA between January 2016 and December 2019 were included (N = 2,868). Multivariable logistic regression assessed the association between BMI and preoperative and postoperative weight change on outcomes while controlling for demographic characteristics. RESULTS: There was no association between preoperative weight change and prolonged length of stay (> 3 days), 90-day readmission, nonhome discharge, patient dissatisfaction at 1 year, or achievement of HOOS Pain or HOOS PS MCID. Postoperative weight loss was an independent risk factor for patient dissatisfaction at 1 year but was not associated with achievement of either HOOS Pain or HOOS PS MCID at 1-year postoperative. Preoperative obesity classes I to III were independent risk factors for nonhome discharge. Nevertheless, preoperative obesity class I and class II were associated with an increased probability of reaching HOOS Pain MCID. Preoperative BMI was not associated with an increased risk of patient dissatisfaction. CONCLUSIONS: Preoperative weight change does not appear to influence health care utilization, satisfaction, or achievement of MCID in pain and function following THA. Postoperative weight loss may play a role as a risk factor for dissatisfaction following THA. Additionally, patients who had a higher baseline BMI may be more likely to see improvement in pain following THA. Therefore, when counseling obese patients for THA, surgeons must balance the risk of perioperative complications with the expectation of greater improvements in pain.


Assuntos
Artroplastia de Quadril , Índice de Massa Corporal , Diferença Mínima Clinicamente Importante , Satisfação do Paciente , Redução de Peso , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Osteoartrite do Quadril/cirurgia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Obesidade/complicações , Obesidade/cirurgia , Período Pós-Operatório , Estudos Retrospectivos , Resultado do Tratamento
16.
Am J Sports Med ; 52(1): 174-180, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38164674

RESUMO

BACKGROUND: There is scarce literature on clinically significant values after arthroscopic Bankart repair (ABR). PURPOSE: To determine the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) thresholds at 1 year for the Rowe and Athletic Shoulder Outcome Scoring System (ASOSS) scores after ABR and to determine the effect of patient characteristics on these metrics after ABR. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective review of patients undergoing ABR from a single institution between January 2017 and January 2020 was performed. Patients with at least 1 episode of instability and a minimum follow-up of 12 months were included. The exclusion criteria were as follows: bony defects of >20% on the anteroinferior portion of the glenoid based on a preoperative computed tomography scan; engaging Hill-Sachs lesions at 90° of abduction and 90° of external rotation based on an arthroscopic examination; previous surgery on the same shoulder; multidirectional instability or concomitant repair of full-thickness rotator cuff tears; superior labral anterior to posterior lesions; posterior labral tears; or humeral avulsion of the glenohumeral ligament lesions. Patient-reported outcome measures were collected both preoperatively and 1-year postoperatively. Delta was defined as the change between preoperative and 1-year postoperative scores. Distribution-based (one-half the standard deviation of the difference between pre- and postoperative outcome scores) and anchored-based approaches (response to a satisfaction question at 1 year) were used to estimate the MCID and the PASS, respectively. The optimal cutoff point, where sensitivity and specificity were maximized, and the percentage of patients achieving those thresholds were also calculated. RESULTS: Overall, 190 patients were included. The distribution-based MCID for the Rowe and ASOSS scores were calculated to be 8.2 and 8.7, respectively. The rate of patients who achieved MCID thresholds was 96% for the Rowe and 96% for ASOSS scores. The PASS threshold for the Rowe and ASOSS scores were ≥80 and ≥90, respectively. The rate of patients who achieved PASS scores after ABR were 86% and 83%, respectively. The MCID and PASS values showed great variability based on sex (men: 8.5 and ≥85 for Rowe / 8.9 and ≥90 for ASOSS, respectively, vs women: 6.7 and ≥73 for Rowe / 8.1 and ≥75 for ASOSS), age (≥21: 8.4 and ≥80 / 9.2 and ≥90 vs <21: 7.8 and ≥75 / 7.7 and ≥85), sports participation (sports: 8.8 and ≥85 / 9.5 and ≥90 vs no sports: 8.1 and ≥75 / 8.6 and ≥80), and type of athlete (competitive: 8.4 and ≥85 / 8.9 and ≥87 vs recreational: 7.5 and ≥73 / 8.1 and ≥68). CONCLUSION: This study identified the MCID and PASS thresholds for the Rowe and ASOSS scores at 1 year after ABR. However, these values showed great variability when accounting for different patient characteristics such as sex, age, sports participation, and type of athlete, highlighting the importance of considering individual patient-specific characteristics for optimal treatment decision-making and ensuring treatment success tailored to each patient's unique needs and expectations.


Assuntos
Instabilidade Articular , Luxação do Ombro , Articulação do Ombro , Masculino , Humanos , Feminino , Diferença Mínima Clinicamente Importante , Artroscopia/métodos , Articulação do Ombro/diagnóstico por imagem , Articulação do Ombro/cirurgia , Artroplastia , Estudos Retrospectivos , Resultado do Tratamento , Instabilidade Articular/diagnóstico por imagem , Instabilidade Articular/cirurgia , Instabilidade Articular/complicações , Luxação do Ombro/cirurgia
17.
Am J Sports Med ; 52(1): 207-214, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38164689

RESUMO

BACKGROUND: Posterior glenohumeral instability is an increasingly recognized cause of shoulder pain and dysfunction among young, active populations. Outcomes after posterior stabilization procedures are commonly assessed using patient-reported outcome measures including the Single Assessment Numeric Evaluation (SANE), the Rowe instability score, the American Shoulder and Elbow Surgeons (ASES) score, and the visual analog scale (VAS) for pain. The clinical significance thresholds for these measures after arthroscopic posterior labral repair (aPLR), however, remain undefined. PURPOSE: We aimed to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for the SANE, Rowe score, and ASES score as well as the VAS pain after aPLR. Additionally, we sought to determine preoperative factors predictive of reaching, as well as failing to reach, clinical significance. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: This study was a retrospective analysis of patient-reported outcome scores collected from patients who underwent aPLR between January 2011 and December 2018. To determine the clinically significant threshold that corresponded to achieving a meaningful outcome, the MCID, SCB, and PASS were calculated for the SANE, Rowe score, ASES score, and VAS pain utilizing either an anchor- or distribution-based method. Additionally, univariate and multivariate logistic regression analyses were performed to determine the factors associated with achieving, or not achieving, the MCID, SCB, and PASS. RESULTS: A total of 73 patients with a mean follow-up of 82.55 ± 24.20 months were available for final analysis. MCID, SCB, and PASS values for the VAS pain were 1.10, 6, and 3, respectively; for the ASES score were 7.8, 34, and 80, respectively; for the SANE were 10.15, 33, and 85, respectively; and for the Rowe score were 11.3, 60, and 90, respectively. To meet the MCID, male sex (odds ratio [OR], 1.1639; P = .0293) was found to be a positive predictor for the VAS pain, and a lower preoperative SANE score (OR, 0.9939; P = .0003) was found to be a negative predictor for the SANE. Dominant arm involvement was associated with lower odds of achieving the PASS for the ASES score (OR, 0.7834; P = .0259) and VAS pain (OR, 0.7887; P = .0436). Patients who reported a history of shoulder trauma were more likely to reach the PASS for the SANE (OR, 1.3501; P = .0089), Rowe score (OR, 1.3938; P = .0052), and VAS pain (OR, 1.3507; P = .0104) as well as the SCB for the ASES score (OR, 1.2642; P = .0469) and SANE (OR, 1.2554; P = .0444). A higher preoperative VAS pain score was associated with higher odds of achieving the SCB for both the VAS pain (OR, 1.1653; P = .0110) and Rowe score (OR, 1.1282; P = .0175). Lastly, concomitant biceps tenodesis was associated with greater odds of achieving the SCB for the ASES score (OR, 1.3490; P = .0130) and reaching the PASS for the SANE (OR, 1.3825; P = .0038) and Rowe score (OR, 1.4040; P = .0035). CONCLUSION: To our knowledge, this study is the first to define the MCID, SCB, and PASS for the ASES score, Rowe score, SANE, and VAS pain in patients undergoing aPLR. Furthermore, we found that patients who reported a history of shoulder trauma and those who underwent concomitant biceps tenodesis demonstrated a greater likelihood of achieving clinical significance. Dominant arm involvement was associated with lower odds of achieving clinical significance.


Assuntos
Diferença Mínima Clinicamente Importante , Lesões do Ombro , Humanos , Masculino , Resultado do Tratamento , Estudos Retrospectivos , Estudos de Casos e Controles , Lesões do Ombro/cirurgia , Dor de Ombro , Artroscopia/métodos
18.
Arthroscopy ; 40(2): 214-216, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38296431

RESUMO

The reporting and analysis of patient-reported outcome measures have come a long way. Since the concept of the minimally clinically important difference was first introduced in 1989, threshold scores have grown to include substantial clinical benefit and patient acceptable symptomatic state (PASS). The initial motivation for developing these thresholds was rooted in separating clinical significance from statistical. These thresholds provide insight into the relationship between scores on patient-reported outcome measures (PROM) and patient-reported improvement and satisfaction. It follows that in order to evaluate PROM scores, the best method for deriving the threshold typically uses an anchor-based methodology, i.e., "ask the patient." Specifically, patients are asked how much change they've experienced and whether they consider their current state to be satisfactory. The responses to these questions are compared with the scores on PROMs to find outcome thresholds that best separate patients who reported no improvement from those who reported minimal improvement, substantial improvement, and satisfaction with their current state of health (PASS). The PASS is of particular importance as it speaks to what arguably matters most to patients-a satisfactory state of health. Finally, viewing the PASS from the perspective of variation from study to study rather than as a uniform classifier is needed to make use of the growing number of papers reporting these thresholds. Examining differences in PASS values across papers can provide insight into how well PROM scores reflect patient satisfaction in different settings.


Assuntos
Artroplastia do Joelho , Satisfação do Paciente , Humanos , Medidas de Resultados Relatados pelo Paciente , Diferença Mínima Clinicamente Importante , Resultado do Tratamento
20.
Injury ; 55(4): 111375, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38290908

RESUMO

INTRODUCTION: Understanding minimal clinically important differences (MCID) in patient reported outcome measurement are important in improving patient care. The purpose of this study was to determine the MCID of Patient-Reported Outcome Measurement System (PROMIS) Physical Function (PF) domain for patients who underwent operative fixation of a tibial plateau fracture. METHODS: All patients with tibial plateau fractures that underwent operative fixation at a single level 1 trauma center were identified by Current Procedural Terminology codes. Patients without PROMIS PF scores or an anchor question at two-time points postoperatively were excluded. Anchor-based and distribution-based MCIDs were calculated. RESULTS: The MCID for PROMIS PF scores was 4.85 in the distribution-based method and 3.93 (SD 14.01) in the anchor-based method. There was significantly more improvement in the score from the first postoperative score (<7 weeks) to the second postoperative time (<78 weeks) in the improvement group 10.95 (SD 9.95) compared to the no improvement group 7.02 (SD 9.87) in the anchor-based method (P < 0.001). The percentage of patients achieving MCID at 7 weeks, 3 months, 6 months, and 1 year were 37-42 %, 57-62 %, 80-84 %, and 95-87 %, respectively. DISCUSSION: This study identified MCID values for PROMIS PF scores in the tibial plateau fracture population. Both MCID scores were similar, resulting in a reliable value for future studies and clinical decision-making. An MCID of 3.93 to 4.85 can be used as a clinical and investigative standard for patients with operative tibial plateau fractures.


Assuntos
Fraturas da Tíbia , Fraturas do Planalto Tibial , Humanos , Medidas de Resultados Relatados pelo Paciente , Diferença Mínima Clinicamente Importante , Fraturas da Tíbia/cirurgia , Resultado do Tratamento , Estudos Retrospectivos
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