Arthroscopic Circumferential Acetabular Labral Reconstruction for Irreparable Labra in the Revision Setting: Patient-Reported Outcome Scores and Rate of Achieving the Minimal Clinically Important Difference at a Minimum 2-Year Follow-up

2021 ◽  
pp. 036354652110057
Author(s):  
Benjamin G. Domb ◽  
Cynthia Kyin ◽  
Cammille C. Go ◽  
Jacob Shapira ◽  
Philip J. Rosinsky ◽  
...  

Background: There is a paucity in the literature reporting patient-reported outcome (PRO) scores and the minimal clinically important difference (MCID) after revision hip arthroscopic surgery with circumferential labral reconstruction. Purpose: To report minimum 2-year PRO scores and the rate of achieving the MCID in patients who underwent revision hip arthroscopic surgery with circumferential labral reconstruction in the setting of irreparable labral tears. Study Design: Case series; Level of evidence, 4. Methods: Data were retrospectively reviewed for all patients who underwent revision hip arthroscopic surgery between February 2016 and November 2017. Patients were included if they had undergone circumferential labral reconstruction and had preoperative and postoperative scores for the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score Sport-Specific Subscale (HOS-SSS), International Hip Outcome Tool (iHOT-12), 12-Item Short Form Health Survey physical and mental components (SF-12 P and SF-12 M, respectively), Veterans RAND 12-Item Health Survey physical and mental components (VR-12 P and VR-12 M, respectively), and visual analog scale (VAS) for pain. Exclusion criteria were Tönnis grade >1, Legg-Calve-Perthes disease, slipped capital femoral epiphysis, fractures, hip dysplasia, or revision labral treatment different from circumferential labral reconstruction. The MCID was calculated. Secondary surgical procedures were documented. Results: A total of 26 hips (26 patients; 61.5% female) were included. The mean age and body mass index were 33.2 ± 10.4 years and 25.5 ± 4.9, respectively. Significant improvements were reported for the mHHS (17.0 ± 19.5; P = .0002), NAHS (17.9 ± 16.7; P < .0001), HOS-SSS (21.7 ± 23.1; P = .0005), VAS (–2.2 ± 3.0; P = .006), iHOT-12 (25.8 ± 32.5; P = .0007), SF-12 P (8.5 ± 11.2; P = .001), and VR-12 P (8.9 ± 11.6; P = .001). Rates of meeting the MCID for the mHHS, NAHS, HOS-SSS, iHOT-12, and VAS were 76.9%, 80.0%, 65.0%, 62.5%, and 69.2%, respectively. No case of re-revision arthroscopic surgery was documented, but 1 case of conversion to total hip arthroplasty was documented at 38.6 months. Conclusion: In the setting of revision hip arthroscopic surgery and irreparable labral tears, circumferential labral reconstruction resulted in significant improvements in all PRO and VAS scores at a minimum 2-year follow-up with a high rate of achieving the MCID.

2019 ◽  
Vol 48 (6) ◽  
pp. 1526-1534
Author(s):  
Sarah L. Chen ◽  
David R. Maldonado ◽  
Cammille C. Go ◽  
Cynthia Kyin ◽  
Ajay C. Lall ◽  
...  

Background: There is a plethora of literature on outcomes after hip arthroscopic surgery in the adult population; however, outcomes in the adolescent population have not been as widely reported. Additionally, as adolescents represent a very active population, it is imperative to understand their athletic activity and return to sport after hip arthroscopic surgery. Purpose: To analyze patient-reported outcomes (PROs) after hip arthroscopic surgery in adolescents (aged 10-19 years) and present a return-to-sport analysis in the athletic adolescent subgroup. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed, Embase, and Cochrane databases were searched according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to identify articles that reported PROs after hip arthroscopic surgery in adolescents. The standardized mean difference was calculated to compare the effect size of hip arthroscopic surgery on various PROs. For the athletic subgroup, a return-to-sport summary was also provided. Results: Ten studies, with 618 adolescent hips and a collective study period of December 2004 to February 2015, were included in this systematic review. Across all studies, the mean age was 15.8 years (range, 11.0-19.9 years), and female patients composed approximately 56.7% of the entire cohort. The mean follow-up was 34.5 months (range, 12-120 months). The modified Harris Hip Score (mHHS) was reported in 9 studies, and at latest follow-up, scores were excellent in 4 studies (range, 90-95) and good in the remaining 5 studies (range, 82.1-89.6). All adolescents also showed significant improvement on the Non-Arthritic Hip Score (NAHS), the Hip Outcome Score–Activities of Daily Living (HOS-ADL), the HOS–Sport-Specific Subscale (HOS-SSS), the physical component of the 12-Item Short Form Health Survey (SF-12P), a visual analog scale for pain (VAS), and both versions of the International Hip Outcome Tool (iHOT-12 and iHOT-33) at latest follow-up ( P < .05). Further, mean improvements reported in all studies surpassed reported values of the minimal clinically important difference and patient acceptable symptomatic state for the mHHS, HOS-ADL, HOS-SSS, and iHOT-33. Finally, the collective return-to-sport rate among athletic adolescents was 84.9%. Conclusion: In the setting of labral tears and femoroacetabular impingement, hip arthroscopic surgery can safely be performed in adolescents and leads to significant functional improvement. Furthermore, athletic adolescents return to sport at high levels after hip arthroscopic surgery.


2019 ◽  
Author(s):  
David R. Maldonado ◽  
Mitchell J. Yelton ◽  
Philip J. Rosinsky ◽  
Jacob Shapira ◽  
Mitchell Meghpara ◽  
...  

Abstract Background: Playing tennis is associated with various movements that can lead to labral injuries and may require arthroscopic surgery. While hip arthroscopies have demonstrated good outcomes in athletes, there is limited literature reporting Patient Reported Outcomes (PROs) and return to play in competitive or recreational tennis players after hip arthroscopic surgery. Therefore, the purpose of the present study was to (1) report minimum five-year PROs and return to sport in tennis players who underwent hip arthroscopic surgery and (2) compare outcomes between recreational and competitive tennis players. Methods: Data for patients who underwent hip arthroscopy surgery in the setting of femoroacetabular impingement (FAI) and labral tears between March 2009 and January 2014 and who played tennis at any level within one-year of surgery were retrospectively reviewed. Patients with preoperative and minimum five-year postoperative scores for the following PROs were included: modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score-Sport Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain. Patients with preoperative Tönnis osteoarthritis Grade >1, Workers’ Compensation claims, age > 60 years old, or previous ipsilateral hip surgeries or conditions were excluded. Patient Acceptable Symptomatic State (PASS) and Minimal Clinically Important Difference (MCID) for mHHS and HOS-SSS were calculated. Results: Of 28 patients, 31 hips met all inclusion and exclusion criteria of which 28 (90.3%) had minimum 5-year follow-up (mean: 72.8 ± 13.9 months). There were 3 professional, 3 collegiate, 2 high school, 2 organized amateur, and 18 recreational level tennis players. All PROs significantly improved at latest follow-up: mHHS from 67.0 to 86.7 (P < 0.001), NAHS from 65.9 to 87.2 (P < 0.001), HOS-SSS from 50.0 to 77.9 (P = 0.009), and VAS from 5.4 to 1.8 (P < 0.001). There was a 75.0% return to sport rate. Additionally, 66.7% of patients achieved MCID and 83.3% achieved PASS for mHHS, and 63.6% achieved MCID and 58.3% achieved PASS for HOS-SSS. Conclusion: Regardless of the level of participation, tennis players who underwent hip arthroscopic surgery reported statistically significant PRO improvements. A favorable rate of return to sport was also achieved.


2020 ◽  
Vol 8 (7) ◽  
pp. 232596712093507
Author(s):  
David R. Maldonado ◽  
Sarah L. Chen ◽  
Jeffery W. Chen ◽  
Jacob Shapira ◽  
Philip J. Rosinksy ◽  
...  

Background: Labral tears are the most common abnormalities in patients undergoing hip arthroscopic surgery. Appropriate management is crucial, as it has been shown that better overall outcomes can be achieved with labral restoration. Purpose: To report the patient-reported outcomes (PROs) at minimum 2-year follow-up of patients who underwent hip arthroscopic surgery for labral tear repair using the knotless controlled-tension anatomic technique in the setting of femoroacetabular impingement syndrome (FAIS). Study Design: Case series; Level of evidence, 4. Methods: Data were prospectively collected for patients who underwent hip arthroscopic surgery for FAIS for labral tear repair using the knotless controlled-tension anatomic technique. Patients were excluded if they had prior hip conditions, prior ipsilateral surgery, Tönnis grade >1, a lateral center-edge angle (LCEA) <25°, or workers’ compensation claims. Preoperative and postoperative scores at minimum 2-year follow-up were recorded for the modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), Hip Outcome Score–Sport-Specific Subscale (HOS-SSS), International Hip Outcome Tool (iHOT-12), and visual analog scale (VAS) for pain. The proportion of patients who achieved the minimal clinically important difference (MCID) or patient acceptable symptomatic state (PASS) for the mHHS, HOS-SSS, and iHOT-12 were also reported. Results: A total of 309 hips were included. The mean patient age was 36.2 years (range, 12.8-75.9 years). The mean preoperative LCEA and alpha angle were 31.9° and 57.1°, respectively. A significant improvement on the mHHS (62.6 ± 15.7 preoperatively vs 86.9 ± 16.2 at 2-year follow-up), NAHS (63.1 ± 16.7 vs 86.1 ± 16.7), and HOS-SSS (39.8 ± 22.0 vs 74.2 ± 27.3) was found ( P < .001 for all). A significant decrease was shown for VAS scores ( P < .001). Also, 78.6% and 82.2% of patients achieved the MCID and PASS for the mHHS, respectively; 60.8% and 69.9% of patients met the MCID and PASS for the HOS-SSS, respectively; and the MCID for the iHOT-12 was met by 77.3% of patients. Conclusion: In the setting of FAIS and labral tears, patients who underwent hip arthroscopic surgery for labral tear repair using the knotless controlled-tension anatomic technique demonstrated significant improvement in several validated PRO measures, the VAS pain score, and patient satisfaction at a minimum 2 years of follow-up. Based on this evidence, labral tear repair using the knotless controlled-tension anatomic technique seems to be a safe option.


2019 ◽  
Author(s):  
David R. Maldonado ◽  
Mitchell J. Yelton ◽  
Philip J. Rosinsky ◽  
Jacob Shapira ◽  
Mitchell Meghpara ◽  
...  

Abstract Background: Playing tennis is associated with various movements that can lead to labral injuries and may require arthroscopic surgery. While hip arthroscopies have demonstrated good outcomes in athletes, there is limited literature reporting Patient Reported Outcomes (PROs) and return to play in competitive or recreational tennis players after hip arthroscopic surgery. Therefore, the purpose of the present study was to (1) report minimum five-year PROs and return to sport in tennis players who underwent hip arthroscopic surgery and (2) compare outcomes between recreational and competitive tennis players. Methods: Data for patients who underwent hip arthroscopy surgery in the setting of femoroacetabular impingement (FAI) and labral tears between March 2009 and January 2014 and who played tennis at any level within one-year of surgery were retrospectively reviewed. Patients with preoperative and minimum five-year postoperative scores for the following PROs were included: modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score-Sport Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain. Patients with preoperative Tönnis osteoarthritis Grade >1, Workers’ Compensation claims, age > 60 years old, or previous ipsilateral hip surgeries or conditions were excluded. Patient Acceptable Symptomatic State (PASS) and Minimal Clinically Important Difference (MCID) for mHHS and HOS-SSS were calculated. Results: Of 28 patients, 31 hips met all inclusion and exclusion criteria of which 28 (90.3%) had minimum 5-year follow-up (mean: 72.8 ± 13.9 months). There were 3 professional, 3 collegiate, 2 high school, 2 organized amateur, and 18 recreational level tennis players. All PROs significantly improved at latest follow-up: mHHS from 67.0 to 86.7 (P < 0.001), NAHS from 65.9 to 87.2 (P < 0.001), HOS-SSS from 50.0 to 77.9 (P = 0.009), and VAS from 5.4 to 1.8 (P < 0.001). There was a 75.0% return to sport rate. Additionally, 66.7% of patients achieved MCID and 83.3% achieved PASS for mHHS, and 63.6% achieved MCID and 58.3% achieved PASS for HOS-SSS. Conclusion: Regardless of the level of participation, tennis players who underwent hip arthroscopic surgery reported statistically significant PRO improvements. A favorable rate of return to sport was also achieved.


2021 ◽  
Vol 9 (3) ◽  
pp. 232596712198967
Author(s):  
Karen Mullins ◽  
David Filan ◽  
Patrick Carton

Background: A growing body of literature supports surgical intervention for femoroacetabular impingement (FAI) in young, active athletes. However, factors likely to influence results in this cohort are less clearly defined. Purpose: To quantify changes in validated patient-reported outcome measures (PROMs) and determine whether differences in baseline athlete demographic characteristics, intraoperative findings, and surgical techniques are associated with achieving improved outcomes and minimal clinically important difference (MCID) after arthroscopic management of sports-related FAI. Study Design: Case series; Level of evidence, 4. Methods: Data were prospectively collected from competitive athletes who underwent hip arthroscopy between January 2009 and February 2017. Athletes who underwent primary arthroscopic correction of sports-related FAI with labral repair were included providing they had a Tönnis grade ≤1 and a lateral center-edge angle ≥20°, excluding significant articular cartilage injury and lateral rim dysplasia. The modified Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index, University of California Los Angeles activity scale, and 36-Item Short Form Health Survey were used to measure outcomes at the 2-year follow-up. MCID was measured using 3 methods: a mean change method, a distribution-based method, and the percentage of possible improvement (POPI) method. Multivariate regression models were used to assess a number of diagnostic and surgical variables associated with good outcome and achieving MCID at follow-up. Results: At 2-year follow-up, statistically significant improvements were observed for all PROMs ( P < .001 for all), and 84% of athletes continued to play sport. Higher preoperative PROM scores reduced the likelihood of achieving MCID; however, returning to play was the strongest predictor of reaching MCID in this athletic cohort. Using absolute score change (mean change or distribution method) to calculate MCID was less accurate owing to ceiling effects and dependence on preoperative PROM scores. Conclusion: Athletes undergoing arthroscopy for sports-related FAI can expect a successful outcome and continued sports participation at 2 years postoperatively. The majority of athletes will achieve MCID. The POPI method of MCID calculation was more applicable to higher functioning athletic cohorts. Reduced preoperative PROM scores and the ability to return to sport increased the likelihood of achieving MCID in this population.


2019 ◽  
Vol 47 (4) ◽  
pp. 870-875 ◽  
Author(s):  
Jody M. Litrenta ◽  
Brian H. Mu ◽  
Austin W. Chen ◽  
Itay Perets ◽  
Victor Ortiz-Declet ◽  
...  

Background: The success of hip arthroscopy has led to increased application in younger populations. However, hip arthroscopy remains a challenging procedure, and its safety and efficacy in the adolescent population have been controversial. Most existing literature on outcomes in such patients contains only short-term follow-up, and a paucity of evidence is available regarding long-term outcomes in adolescents. Purpose: To report on clinical outcomes at a minimum 5-year follow-up in patients younger than 18 years who underwent arthroscopic treatment of labral tears. Study Design: Case series; Level of evidence, 4. Methods: Data were prospectively collected and retrospectively reviewed on all patients younger than 18 years who underwent hip arthroscopy in a tertiary hip preservation setting at a single institution. Patients were excluded if they had previous ipsilateral hip conditions or surgery. All patients underwent either labral repair or debridement for treatment of a labral tear. Patient-reported outcome measures were recorded at 3 months and at 1, 2, or a minimum of 5 years. These included the modified Harris Hip Score (mHHS), Nonarthritic Hip Score, Hip Outcome Score–Sports Specific Subscale (HOS-SSS), visual analog scale, and patient satisfaction. Additionally, the abbreviated International Hip Outcome Tool and Short Form Health Survey were collected at latest follow-up. Results: The study included 44 hips in 32 patients that underwent arthroscopic labral repair (86.4%) or labral debridement (13.6%) between April 2008 and April 2011, with latest follow-up at a mean of 69.2 months (range, 60.0-89.9 months) postoperatively. The average age at surgery was 16.3 years (range, 14.2-17.9 years), and 39 hips from female patients. Statistically significant improvements were seen in all patient-reported outcome measures from preoperative to minimum 5-year follow-up. Improvements were noted at 1-year follow-up and maintained at minimum 5-year follow-up. At the latest follow-up, the Patient Acceptable Symptomatic State was achieved in 95.5% of patients for the mHHS and 72.7% for the HOS-SSS. Two patients subsequently underwent secondary arthroscopy on the ipsilateral hip; however, the survivorship of all hips was 100%. Conclusion: Hip arthroscopy for the treatment of labral tears in adolescents remains a technically challenging procedure that should be approached with appropriate caution. The results of the present study on a population treated in a specialized hip preservation center demonstrate that hip arthroscopy is a safe procedure with stable improvement in patient-reported outcome measures at 5 years.


2018 ◽  
Vol 47 (10) ◽  
pp. 2494-2500 ◽  
Author(s):  
Zheci Ding ◽  
Yaying Sun ◽  
Shaohua Liu ◽  
Jiwu Chen

Background: It remains controversial whether hip arthroscopic surgery should be applied to patients with a borderline developmental dysplastic hip (BDDH). Purpose: To review the outcomes of hip arthroscopic surgery for a BDDH and which factors influence these outcomes. Study Design: Systematic review. Methods: PubMed, Embase, and the Cochrane Library were searched through March 2018 for studies reporting the outcomes of primary hip arthroscopic surgery in patients with a BDDH. Inclusion in the review was based on the definition of a BDDH, patient-reported outcomes, and duration of follow-up. The primary outcome was the modified Harris Hip Score (mHHS). The failure rate, visual analog scale, satisfaction score, and patient-reported outcomes such as the Hip disability and Osteoarthritis Outcome Score were defined as secondary outcomes. Results: Nine studies with 425 patients who underwent hip arthroscopic surgery were included in this review. The mean follow-up times ranged from 25.4 to 28.8 months across the studies. A significant improvement was obtained in the mHHS, with a mean score of 61.8 preoperatively to 82.8 postoperatively; all other patient-reported outcomes also improved significantly, except the 12-Item Short Form Health Survey mental component summary. The overall failure rate was 14.1%, and the mean reoperation rate was 8.5%. The rate of conversion to total hip arthroplasty ranged from 4.4% to 26.0%, and the rate of conversion to periacetabular osteotomy was 4.0%. Combined defects such as cartilage damage, hip osteoarthritis, ligamentum teres tears, and femoroacetabular impingement could influence the outcomes after arthroscopic surgery in BDDHs. Conclusion: Hip arthroscopic surgery was demonstrated to be a promising approach for BDDHs, but the outcomes could be influenced by multiple risk factors. A higher level of evidence is still needed to support current findings.


2021 ◽  
pp. 036354652110398
Author(s):  
Rachel M. Glein ◽  
Andrew E. Jimenez ◽  
Kara B. Miecznikowski ◽  
Benjamin R. Saks ◽  
Hari K. Ankem ◽  
...  

Background: No studies have compared outcomes and return to sport (RTS) after hip arthroscopic surgery between matched groups of male and female athletes with a minimum 2-year follow-up. Purpose: (1) To report minimum 2-year postoperative patient-reported outcome (PRO) scores and the RTS rate for elite female athletes undergoing hip arthroscopic surgery for femoroacetabular impingement (FAI) and (2) to compare clinical results with a matched control group of elite male athletes. Study Design: Cohort study; Level of evidence, 3. Methods: Data on all consecutive female athletes who underwent primary hip arthroscopic surgery performed at our institution between March 2009 and July 2018 were collected. Patients were eligible if they underwent hip arthroscopic surgery for labral tears or FAI and participated in collegiate or professional athletics within 1 year of surgery. Minimum 2-year postoperative PRO scores were collected for the modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), Hip Outcome Score–Sport-Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain as well as RTS status. The percentages of patients achieving the minimal clinically important difference (MCID) and patient acceptable symptomatic state were recorded. These patients were matched to elite male athletes for comparison. Results: A total of 73 female hips were included, with a mean follow-up of 65.1 ± 27.9 months. They demonstrated a significant improvement from preoperatively to latest follow-up on the mHHS, NAHS, HOS-SSS, and VAS ( P < .05). When outcomes were compared with a control group of male athletes, female athletes demonstrated lower preoperative scores, similar postoperative scores, and a significantly greater magnitude of improvement (delta value) on the mHHS, NAHS, and VAS. Female athletes also achieved the MCID at higher rates than did male athletes for the HOS-SSS (85.1% vs 70.0%, respectively; P = .035) and NAHS (79.1% vs 62.9%, respectively; P = .037). RTS rates among patients who attempted were similar between the 2 groups (female: 75.4%; male: 83.1%; P = .409). Conclusion: Elite female athletes undergoing primary hip arthroscopic surgery for FAI demonstrated a significant improvement in PRO scores and a high RTS rate. Female athletes exhibited a greater improvement in PRO scores (mHHS, NAHS, VAS) and achieved the MCID (HOS-SSS, NAHS) at higher rates compared with a control group of male athletes.


2020 ◽  
Author(s):  
David R. Maldonado ◽  
Mitchell J. Yelton ◽  
Philip J. Rosinsky ◽  
Jacob Shapira ◽  
Mitchell Meghpara ◽  
...  

Abstract Background: Playing tennis is associated with various movements that can lead to labral injuries and may require arthroscopic surgery. While hip arthroscopies have demonstrated good outcomes in athletes, there is limited literature reporting Patient Reported Outcomes (PROs) and return to play in competitive or recreational tennis players after hip arthroscopic surgery. Therefore, the purpose of the present study was to (1) report minimum five-year PROs and return to sport in tennis players who underwent hip arthroscopic surgery and (2) compare outcomes between recreational and competitive tennis players.Methods: Data for patients who underwent hip arthroscopy surgery in the setting of femoroacetabular impingement (FAI) and labral tears between March 2009 and January 2014 and who played tennis at any level within one-year of surgery were retrospectively reviewed. Patients with preoperative and minimum five-year postoperative scores for the following PROs were included: modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score-Sport Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain. Patients with preoperative Tönnis osteoarthritis Grade >1, Workers’ Compensation claims, age > 60 years old, or previous ipsilateral hip surgeries or conditions were excluded. Patient Acceptable Symptomatic State (PASS) and Minimal Clinically Important Difference (MCID) for mHHS and HOS-SSS were calculated. Results: Of 28 patients, 31 hips met all inclusion and exclusion criteria of which 28 (90.3%) had minimum 5-year follow-up (mean: 72.8 ± 13.9 months). There were 3 professional, 3 collegiate, 2 high school, 2 organized amateur, and 18 recreational level tennis players. All PROs significantly improved at latest follow-up: mHHS from 67.0 to 86.7 (P < 0.001), NAHS from 65.9 to 87.2 (P < 0.001), HOS-SSS from 50.0 to 77.9 (P = 0.009), and VAS from 5.4 to 1.8 (P < 0.001). There was a 75.0% return to sport rate. Additionally, 66.7% of patients achieved MCID and 83.3% achieved PASS for mHHS, and 63.6% achieved MCID and 58.3% achieved PASS for HOS-SSS.Conclusion: Regardless of the level of participation, tennis players who underwent hip arthroscopic surgery reported statistically significant PRO improvements. A favorable rate of return to sport was also achieved by players with a continued interest in playing. The severity of cartilage damage was shown to not influence rate of returned to sport nor PROs in this population. The data here may be useful in counseling tennis players of various levels who are considering arthroscopic treatment of a hip injury.


2021 ◽  
Vol 10 (15) ◽  
pp. 3216
Author(s):  
Anne Puchar ◽  
Pierre Panel ◽  
Anne Oppenheimer ◽  
Joseph Du Cheyron ◽  
Xavier Fritel ◽  
...  

Objectives: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. Methods: A prospective, observational, multicentre study was conducted including all women ≥18 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire's measurement properties. The minimal clinically important difference was estimated by the anchor-based method. Results: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach α): I) pain-related disability (α = 0.79), II) painful bowel symptoms (α = 0.80), III) dyspareunia (α = 0.83), and IV) painful urinary tract symptoms (α = 0.77). They produced four subscores that can be summed to obtain a single score (α = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean ± SD: 46.7 ± 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10−7, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. Conclusions: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.


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