scholarly journals Determining the Patient Acceptable Symptomatic State for Patients Undergoing Arthroscopic Partial Meniscectomy in the Knee

2020 ◽  
Vol 48 (4) ◽  
pp. 847-852 ◽  
Author(s):  
Tim Dwyer ◽  
Thomas Zochowski ◽  
Darrell Ogilvie-Harris ◽  
John Theodoropoulos ◽  
Daniel Whelan ◽  
...  

Background: Arthroscopic partial meniscectomy is one of the most common procedures in orthopaedic surgery. The patient acceptable symptomatic state (PASS), which defines a level of symptoms above which patients consider themselves well, remains to be well-defined in this population. Purpose: Using an anchor-based approach, our goal was to determine the 1-year PASS for the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC) Subjective Knee Form, the Western Ontario Meniscal Evaluation Tool (WOMET), and the Marx Activity Scale (MAS) in patients who were treated with partial knee meniscectomy. Study Design: Case series; Level of evidence, 4. Methods: A consecutive series of patients with knee meniscal tears and a Kellgren-Lawrence grade of 0 to 2 treated with arthroscopic partial meniscectomy were eligible. The KOOS (0-100), IKDC (0-100), WOMET (0-100), and MAS (0-16) were administered at baseline and 12 months postoperatively. An external anchor question at 1 year postoperatively was used to determine PASS values. A receiver operating characteristic curve (ROC) analysis was used to determine the PASS value at which patients considered their status to be satisfactory. Results: The study included 110 patients (mean ± SD age, 53.8 ± 12.0 years), 57.3% were male, and the follow-up rate was 82%. In total, 70% of patients had an Outerbridge arthroscopic grade of 2 or lower. Based on ROC analysis, the 1-year postoperative PASS values (sensitivity, specificity) were 64.3 (47.8, 100.0) for KOOS Symptoms, 81.6 (71.6, 100.0) for KOOS Pain, 82.4 (82.1, 86.4) for KOOS Function in Daily Living, 71.0 (62.7, 81.8) for KOOS Function in Sport and Recreation, 51.0 (83.6, 95.5) for KOOS Knee-Related Quality of Life, 56.2 (82.1, 100.0) for IKDC, 58.5 (79.1, 100.0) for WOMET, and 7.0 (44.8, 68.2) for MAS. Baseline scores did not affect the PASS threshold across the different instruments. However, patients with higher baseline scores were more likely to achieve the PASS for the KOOS Symptoms (odds ratio [OR], 2.808; P = .047), IKDC (OR, 4.735; P = .006), and WOMET (OR, 2.985; P = .036). Age, sex, and cartilage status were not significantly related to the odds of achieving the PASS for any of the patient-reported outcome measures. Conclusion: These findings allow researchers and clinicians to determine whether partial meniscectomy is meaningful to patients at the individual level and will be helpful for responder analysis in future trials related to the treatment of meniscal abnormality.

2020 ◽  
Vol 49 (1) ◽  
pp. 193-199
Author(s):  
Jaskarndip Chahal ◽  
Drew A. Lansdown ◽  
Annabelle Davey ◽  
Aileen M. Davis ◽  
Brian J. Cole

Background: In patients undergoing cartilage restoration of the knee, limited information is available regarding clinically important difference (CID) and Patient Acceptable Symptomatic State (PASS) estimates for commonly used patient-reported outcome measures (PROMs). Purpose: The objective of this study was to determine the CID and PASS in the population with knee cartilage restoration for the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee Subjective Knee Form (IKDC) score, and the Lysholm score. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: Between 2012 and 2017, patients who underwent a cartilage restoration procedure were prospectively enrolled. Patients completed the KOOS, IKDC, and Lysholm, all of which were scored from 0 to 100, and completed relevant anchor questions at baseline and 1 year postoperatively. Receiver operating characteristic curve analyses were conducted to determine CID and PASS cutoff points. Multivariable regression analyses were performed to determine the effect of age, sex, and baseline score on likelihood of achieving CID and PASS. Results: Of the 113 patients enrolled, 53 (47%) were male, and the mean age was 36 years. The CID values for the PROMs were 10.7 for KOOS Symptoms, 8.3 for KOOS Pain, 8.8 for KOOS Activities of Daily Living (ADL), 30.0 for KOOS Sports and Recreation, 18.8 for KOOS Quality of Life (QOL), 9.2 for IKDC, and 13.0 for Lysholm. The PASS values were 71.5 for KOOS Symptoms, 72.2 for KOOS Pain, 86.8 for KOOS ADL, 43.8 for KOOS Sports and Recreation, 50.0 for KOOS QOL, 62.1 for IKDC, and 70.0 for Lysholm. Patients with higher baseline scores were more likely to achieve PASS for the IKDC (odds ratio, 2.28; P = .03). Baseline score did not have an effect on the likelihood of achieving CID. Younger age was an independent predictor of achieving PASS and CID across all outcomes ( P < .05), but sex did not have such an effect. Conclusion: This study determined CID and PASS values for the KOOS, IKDC, and Lysholm scores among patients treated with knee cartilage restoration. Younger age was a positive prognostic variable, and higher baseline scores implied achieving PASS for the IKDC. The information in this study can be used in designing randomized controlled trials, counseling individual patients as to anticipated outcomes, and conducting responder analyses when evaluating new cartilage technology from a regulatory perspective.


2017 ◽  
Vol 5 (3_suppl3) ◽  
pp. 2325967117S0012
Author(s):  
Thomas Zochowski ◽  
Tim Dwyer ◽  
Darrell Ogilvie-Harris ◽  
John S. Theodoropoulos ◽  
Daniel B. Whelan ◽  
...  

Objectives: Arthroscopic partial meniscectomy is one of the most commonly performed procedures in orthopaedic surgery. However, information on the threshold at which patients consider themselves to be well for patient reported outcome measures (PROMs) after this surgery remains limited. Our goal was to determine the patient acceptable symptomatic state (PASS) for the Knee Injury and Osteoarthritic Outcome Score (KOOS), the International Knee Documentation Committee (IKDC) Subjective Knee Form, the Western Ontario Meniscal Evaluation Tool (WOMET) and the Marx Activity Scale (MAS) in patients with knee meniscal pathology who treated with partial knee meniscectomy. Methods: A consecutive series of patients with knee meniscal pathology treated with arthroscopic partial meniscectomy plus or minus intra-articular debridement were eligible. Other inclusion criteria were: a Kellegren-Lawrence Grade of 0-2, and ligamentous integrity. The KOOS (0-100, 5 subscales), IKDC (0-100), WOMET (0-100) and MAS (0-16) were administered at baseline and 12 months postoperatively. An external anchor question at 1 year postoperatively was utilized to determine PASS values: “Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?” A receiver operator curve analysis was used to determine the PASS value at which patients considered their status to be satisfactory. Results: There were 115 patients (mean ± SD age, 53.8 ± 12.0 years), and 57.3% were male. Based on a receiver operator curve analysis, the PASS values - at which patients considered their status to be satisfactory - at 1 year after surgery were 43 (KOOS-symptoms subscale), 83 (KOOS-pain subscale), 84 (KOOS-functions of daily living subscale), 75 (KOOS-function, sport and recreational activity subscale), 56 (KOOS-quality of life subscale), 56 (IKDC), 61 (WOMET), 7 (MAS). The PASS threshold was not affected by baseline scores across the different instruments and there was no relationship between baseline score and likelihood of achieving the PASS. Age and sex were not significantly related to the odds of achieving the PASS for any of the PROMs. Conclusion: This is the first study to determine PASS in four commonly used knee-related PROMs in patients undergoing arthroscopic partial meniscectomy. The findings can allow researchers and clinicians to determine if partial meniscectomy is meaningful to patients and will be helpful for responder analysis in future trials related to knee arthroscopy and the treatment of meniscal pathology.


2021 ◽  
Vol 9 (8) ◽  
pp. 232596712110269
Author(s):  
Liang Zhou ◽  
Shawn M. Gee ◽  
Philip L. Wilson ◽  
Sharon Huang ◽  
K. John Wagner ◽  
...  

Background: Repetitive microtrauma may contribute to osteochondritis dissecans (OCD) lesions of the femoral condyle. The effect of differential loading between OCD weightbearing (WB) zones has not been studied. Purpose: To determine whether clinical and radiographic variables differ by WB zone in lateral femoral condyle OCD lesions. Study Design: Cohort study; Level of evidence, 3. Methods: We retrospectively reviewed a consecutive series of patients aged <18 years with lateral femoral condyle OCD lesions presenting at a single institution between 2004 and 2018. Patients with OCD lesions outside of the lateral femoral condyle were excluded. Lesions were localized on radiographs using the Cahill and Berg classification, referencing the Blumensaat line and an extension of the posterior femoral cortex. Progeny bone characteristics evaluated at baseline and 24-month follow-up included ossification, distinct borders from parent bone, and displacement. Baseline lesion dimensions were measured on magnetic resonance imaging (MRI) scans. We evaluated posttreatment pain level, return-to-activity rate, and patient-reported outcome measures (PROMs) including the Pediatric International Knee Documentation Committee score, Knee injury and Osteoarthritis Outcome Score, and Pediatric Functional Activity Brief Scale. Results: A total of 62 lateral femoral condyle OCD lesions (mean follow-up, 24.1 months) presented within the study period: 26 WB lesions and 36 nonweightbearing (NWB) lesions. At presentation, no differences between the lesion types were observed in symptom chronicity or symptomatology. NWB lesions were deeper on MRI scans (sagittal depth, 7.11 vs 5.96 mm; P = .046; coronal depth ratio, 0.05 vs 0.01 mm; P = .003), were more likely to develop progeny bone (69.4% vs 44%; P = .047), and demonstrated higher radiographic healing rates (52.8% vs 24%; P = .025) compared with WB lesions. PROMs at follow-up were available for 25 of 62 patients (40.3%), with no statistically significant differences between cohorts at any time. Return to full activity was observed in 72% of WB and 82.1% of NWB lesions ( P = .378). Conclusion: Lateral femoral condyle OCD lesions of the knee in WB and NWB zones presented similarly at initial evaluation; however, NWB lesions demonstrated higher rates of progeny bone formation and radiographic healing at mean 2-year follow-up.


2021 ◽  
Vol 9 (11) ◽  
pp. 232596712110281
Author(s):  
Patrick J. Bevan ◽  
Lutul D. Farrow ◽  
Jared Warren ◽  
Perry O. Hooper ◽  
Elisabeth Kroneberger ◽  
...  

Background: Trochlear dysplasia (TD) is a recognized condition that can become a risk factor for patellofemoral instability. A modified Albee osteotomy procedure using a trapezoidal-shaped wedge to elevate the lateral wall of the trochlea can be used with the goal of preventing further dislocation. However, outcomes studies are lacking, and scores on patient-reported outcome measures (PROMs) are largely unknown. Purpose/Hypothesis: The purpose of this study was to identify PROM scores for the Kujala Anterior Knee Pain Scale (AKPS), International Knee Documentation Committee (IKDC), Activity Rating System (ARS), and 100-point pain visual analog scale (VAS) for patients having undergone the modified Albee osteotomy. The hypothesis was that patients will have acceptable pain and function at mid- to long-term follow-up. Study Design: Case series; Level of evidence, 4. Methods: From 1999 to 2017, a total of 46 consecutive patients (49 knees) underwent a modified Albee procedure by a single surgeon at a single health care system. These 46 patients were contacted and asked to complete the AKPS, IKDC, ARS, and pain VAS. Additional demographic information was obtained via chart review. Frequencies and rates for categorical variables and means and standard deviations for continuous variables of the demographics and PROM scores were calculated. Results: PROM scores were obtained in 28 (30 knees; 61%) of the 46 patients. At minimum follow-up of 82 months, the mean scores were 78.5 ± 18.2 for AKPS, 61.2 ± 11.4 for IKDC, 5.2 ± 5.3 for ARS, and 24.4 ± 28.7 for VAS pain. Notably, only 1 of the 28 patients reported a patellofemoral dislocation since surgery, and this was an isolated incident without further instability. Conclusion: A modified Albee trochlear osteotomy can be a successful adjunctive procedure to prevent recurrent patellar dislocations in patients with mild TD. However, owing to the loss of one-third of patient follow-up scores and the absence of baseline function scores in this study, the procedure deserves further investigation as a way to address a particularly difficult dilemma for a select subset of patients with patellofemoral instability.


2020 ◽  
Vol 8 (8) ◽  
pp. 232596712093627
Author(s):  
Joseph D. Lamplot ◽  
Muhammad Farooq Rai ◽  
William P. Tompkins ◽  
Michael V. Friedman ◽  
Eric J. Schmidt ◽  
...  

Background: While knees with meniscal tears are associated with a heightened risk of developing osteoarthritis (OA), it is difficult to predict which patients are at the greatest risk for OA. Gene signatures in menisci that are resected during arthroscopic partial meniscectomy (APM) may provide insight into the risk of OA progression. Hypothesis: Meniscal gene signatures at the time of APM will predict radiographic OA progression. Study Design: Case series; Level of evidence, 4. Methods: Meniscal fragments were collected from 38 patients without OA during clinically indicated APM of the medial meniscus. The expression of 28 candidate genes with known roles in cartilage homeostasis, OA, extracellular matrix degradation, and obesity was assessed by quantitative real-time polymerase chain reaction. Weightbearing radiographs obtained before surgery and at final follow-up were graded by a musculoskeletal radiologist using the Kellgren-Lawrence classification of OA. The association of meniscal gene expression at baseline with the progression of radiographic OA was determined. Results: Gene expression and baseline and follow-up radiographic data were available from 31 patients (81.6%) at a mean follow-up of 6.2 ± 1.3 years. Patients without OA progression had significantly higher expression of 7 genes: MMP9 (5.1-fold; P = .002), IL8 (2.9-fold; P = .016), CCL3 (3.7-fold; P = .032), CCL3L1 (4.5-fold; P = .008), CXCL6 (6.2-fold; P = .010), LEP (5.2-fold; P = .004), and RETN (46-fold; P = .008). Conclusion: Gene expression in the meniscus at the time of APM may be associated with the risk for progression of OA after surgery. Elevated expression of the aforementioned genes may reflect a chondroprotective response. Stratifying the risk for OA progression after APM could facilitate targeted interventions to delay or prevent the development of OA. Further studies in a larger cohort with an extended follow-up, and inclusion of additional genes, are warranted to better characterize this association.


2021 ◽  
pp. 107110072110044
Author(s):  
Catherine Conlin ◽  
Ryan M. Khan ◽  
Ian Wilson ◽  
Timothy R. Daniels ◽  
Mansur Halai ◽  
...  

Background: Total ankle replacement (TAR) and ankle fusion are effective treatments for end-stage ankle arthritis. Comparative studies elucidate differences in treatment outcomes; however, the literature lacks evidence demonstrating what outcomes are important to patients. The purpose of this study was to investigate patients’ experiences of living with both a TAR and ankle fusion. Methods: This research study used qualitative description. Individuals were selected from a cohort of patients with TAR and/or ankle fusion (n = 1254). Eligible patients were English speaking with a TAR and contralateral ankle fusion, and a minimum of 1 year since their most recent ankle reconstruction. Surgeries were performed by a single experienced surgeon, and semistructured interviews were conducted by a single researcher in a private hospital setting or by telephone. Ankle Osteoarthritis Scale (AOS) scores, radiographs, and ancillary surgical procedures were collected to characterize patients. Themes were derived through qualitative data analysis. Results: Ten adults (8 men, 2 women), ages 59 to 90 years, were included. Average AOS pain and disability scores were similar for both surgeries for most patients. Participants discussed perceptions of each reconstructed ankle. Ankle fusions were considered stable and strong, but also stiff and compromising balance. TARs were considered flexible and more like a “normal ankle,” though patients expressed concerns about their TAR “turning” on uneven ground. Individuals applied this knowledge to facilitate movement, particularly during a first step and transitioning between positions. They described the need for careful foot placement and attention to the environment to avoid potential challenges. Conclusion: This study provides insight into the experiences of individuals living with a TAR and ankle fusion. In this unusual but limited group of patients, we found that each ankle reconstruction was generally perceived to have different characteristics, advantages, and disadvantages. Most participants articulated a preference for their TAR. These findings can help clinicians better counsel patients on expectations after TAR and ankle fusion, and improve patient-reported outcome measures by better capturing meaningful outcomes for patients. Level of Evidence: Level IV, case series.


2021 ◽  
pp. 107110072110060
Author(s):  
Michael F. Githens ◽  
Malcolm R. DeBaun ◽  
Kimberly A Jacobsen ◽  
Hunter Ross ◽  
Reza Firoozabadi ◽  
...  

Background: Supination-adduction (SAD) type II ankle fractures can have medial tibial plafond and talar body impaction. Factors associated with the development of posttraumatic arthritis can be intrinsic to the injury pattern or mitigated by the surgeon. We hypothesize that plafond malreducton and talar body impaction is associated with early posttraumatic arthrosis. Methods: A retrospective cohort of skeletally mature patients with SAD ankle fractures at 2 level 1 academic trauma centers who underwent operative fixation were identified. Patients with a minimum of 1-year follow-up were included. The presence of articular impaction identified on CT scan was recorded and the quality of reduction on final intraoperative radiographs was assessed. The primary outcome was radiographic ankle arthrosis (Kellgren-Lawrence 3 or 4), and postoperative complications were documented. Results: A total of 175 SAD ankle fractures were identified during a 10-year period; 79 patients with 1-year follow-up met inclusion criteria. The majority of injuries resulted from a high-energy mechanism. Articular impaction was present in 73% of injuries, and 23% of all patients had radiographic arthrosis (Kellgren-Lawrence 3 or 4) at final follow-up. Articular malreduction, defined by either a gap or step >2 mm, was significantly associated with development of arthrosis. Early treatment failure, infection, and nonunion was rare in this series. Conclusion: Malreduction of articular impaction in SAD ankle fractures is associated with early posttraumatic arthrosis. Recognition and anatomic restoration with stable fixation of articular impaction appears to mitigate risk of posttraumatic arthrosis. Investigations correlating postoperative and long-term radiographic findings to patient-reported outcomes after operative treatment of SAD ankle fractures are warranted. Level of Evidence: Level IV, retrospective case series.


2021 ◽  
Vol 9 (1) ◽  
pp. 232596712096792
Author(s):  
James L. Cook ◽  
Kylee Rucinski ◽  
Cory R. Crecelius ◽  
Richard Ma ◽  
James P. Stannard

Background: Return to sport (RTS) after osteochondral allograft (OCA) transplantation for large unipolar femoral condyle defects has been consistent, but many athletes are affected by more severe lesions. Purpose: To examine outcomes for athletes who have undergone large single-surface, multisurface, or bipolar shell OCA transplantation in the knee. Study Design: Case series; Level of evidence, 4. Methods: Data from a prospective OCA transplantation registry were assessed for athletes who underwent knee transplantation for the first time (primary transplant) between June 2015 and March 2018 for injury or overuse-related articular defects. Inclusion criteria were preinjury Tegner level ≥5 and documented type and level of sport (or elite unit active military duty); in addition, patients were required to have a minimum of 1-year follow-up outcomes, including RTS data. Patient characteristics, surgery type, Tegner level, RTS, patient-reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures were assessed and compared for statistically significant differences. Results: There were 37 included athletes (mean age, 34 years; range, 15-69 years; mean body mass index, 26.2 kg/m2; range, 18-35 kg/m2) who underwent large single-surface (n = 17), multisurface (n = 4), or bipolar (n = 16) OCA transplantation. The highest preinjury median Tegner level was 9 (mean, 7.9 ± 1.7; range, 5-10). At the final follow-up, 25 patients (68%) had returned to sport; 17 (68%) returned to the same or higher level of sport compared with the highest preinjury level. The median time to RTS was 16 months (range, 7-26 months). Elite unit military, competitive collegiate, and competitive high school athletes returned at a significantly higher proportion ( P < .046) than did recreational athletes. For all patients, the Tegner level at the final follow-up (median, 6; mean, 6.1 ± 2.7; range, 1-10) was significantly lower than that at the highest preinjury level ( P = .007). PROMs were significantly improved at the final follow-up compared with preoperative levels and reached or exceeded clinically meaningful differences. OCA revisions were performed in 2 patients (5%), and failures requiring total knee arthroplasty occurred in 2 patients (5%), all of whom were recreational athletes. Noncompliance was documented in 4 athletes (11%) and was 15.5 times more likely ( P = .049) to be associated with failure or a need for revision than for compliant patients. Conclusion: Large single-surface, multisurface, or bipolar shell OCA knee transplantations in athletes resulted in two-thirds of these patients returning to sport at 16 to 24 months after transplantation. Combined, the revision and failure rates were 10%; thus, 90% of patients were considered to have successful 2- to 4-year outcomes with significant improvements in pain and function, even when patients did not RTS.


2017 ◽  
Vol 30 (09) ◽  
pp. 925-929 ◽  
Author(s):  
Mariusz Puszkarz ◽  
Lidia Kosmalska ◽  
Martin Wiewiorski ◽  
Boguslaw Sadlik

AbstractThe technique of all-arthroscopic autologous matrix-induced chondrogenesis (AMIC)-aided repair of patellar cartilage lesions using a retraction system and dry arthroscopy has been recently described. We report the first clinical and radiological data at a short-term follow-up. Twelve patients underwent AMIC-aided cartilage repair for a patellar lesion. All steps of the procedure were performed arthroscopically, which include the use of an intra-articularly placed retraction plate for distraction of the patellofemoral joint and evacuation of saline solution for collagen matrix insertion and fixation. Clinical assessment performed before surgery and at a mean follow-up time of 38 months (range: 24–70) included the following scores: Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), and visual analog scale (VAS). Magnetic resonance imaging was performed at the follow-up examination, including the magnetic resonance observation of cartilage repair tissue (MOCART) score. The mean KOOS and IKDC scores increased significantly (p < 0.01) from 50.3 and 37.4 points preoperatively to 90.1 and 79.4 postoperatively. The VAS score decreased from 7.8 to 2.3 points. Mean MOCART score at follow-up was 58.3 points. Cartilage repair of patellar lesions aided by a retraction system in a dry arthroscopy setup is a promising approach. Further studies are needed to evaluate this procedure and compare it to existing matrix implantation techniques. The level of evidence for the study is 4 (case series).


2020 ◽  
Vol 5 (4) ◽  
pp. 247301142096631
Author(s):  
Luke D. Cicchinelli ◽  
Jurij Štalc ◽  
Martinus Richter ◽  
Stuart Miller

Background: A novel biointegrative implant was developed for proximal interphalangeal joint (PIPJ) arthrodesis to treat hammertoe deformity. Composed of continuous reinforcing mineral fibers bound by bioabsorbable polymer matrix, the implant demonstrated quiescent, gradual degradation with complete elimination at 104 weeks in animal models. This prospective trial assessed the implant’s safety, clinical performance, and fusion rate of PIPJ arthrodesis for hammertoe correction. Methods: Twenty-five patients (mean age 63.9±7.5 years) who required PIPJ arthrodesis were enrolled at 3 centers. Outcomes included radiographic joint fusion, adverse events, pain visual analog scale (VAS) score, Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) score, and patient satisfaction. Patients were evaluated 2, 4, 6, 12, and 26 weeks postoperatively. Results: Twenty-two patients (88%) achieved radiographic fusion at 26 weeks. All joints (100%) were considered clinically stable, with no complications or serious adverse events. Pain VAS improved from 5.3±2.5 preoperatively to 0.5±1.4 at 26 weeks postoperatively. FAAM-ADL total scores and level of functioning improved by mean 19.5±19.0 points and 24.4±15.7 percentage points, respectively, from preoperation to 26 weeks postoperation. Improvements in pain VAS and FAAM scores surpassed established minimal clinically important differences. All patients were very satisfied (84%) or satisfied (16%) with the surgery. Patient-reported postoperative results greatly exceeded (72%), exceeded (20%), or matched (8%) expectations. Conclusion: This prospective, multicenter, first-in-human clinical trial of a novel biointegrative fiber-reinforced implant in PIPJ arthrodesis of hammertoe deformity demonstrated a favorable rate of radiographic fusion at 12 and 26 weeks, with no complications and good patient-reported clinical outcomes. Level of Evidence: Level IV, prospective case series.


Sign in / Sign up

Export Citation Format

Share Document