scholarly journals Fibromyalgia Outcomes Over Time: Results from a Prospective Observational Study in the United States

2016 ◽  
Vol 10 (1) ◽  
pp. 109-121 ◽  
Author(s):  
Caroline P. Schaefer ◽  
Edgar H. Adams ◽  
Margarita Udall ◽  
Elizabeth T. Masters ◽  
Rachael M. Mann ◽  
...  

Background:Longitudinal research on outcomes of patients with fibromyalgia is limited.Objective:To assess clinician and patient-reported outcomes over time among fibromyalgia patients.Methods:At enrollment (Baseline) and follow-up (approximately 2 years later), consented patients were screened for chronic widespread pain (CWP), attended a physician site visit to determine fibromyalgia status, and completed an online questionnaire assessing pain, sleep, function, health status, productivity, medications, and healthcare resource use.Results:Seventy-six fibromyalgia patients participated at both time points (at Baseline: 86.8% white, 89.5% female, mean age 50.9 years, and mean duration of fibromyalgia 4.1 years). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively; 11 patients no longer screened positive for CWP at follow-up. A majority reported medication use for pain (59.2% at Baseline, 62.0% at Follow-up). The most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at Follow-up. Significant mean changes over time were observed for fibromyalgia symptoms (modified American College of Rheumatology 2010 criteria: 18.4 to 16.9;P=0.004), pain interference with function (Brief Pain Inventory-Short Form: 5.9 to 5.3;P=0.013), and sleep (Medical Outcomes Study-Sleep Scale: 58.3 to 52.7;P=0.004). Patients achieving ≥2 point improvement in pain (14.5%) experienced greater changes in pain interference with function (6.8 to 3.4;P=0.001) and sleep (62.4 to 51.0;P=0.061).Conclusion:Fibromyalgia patients reported high levels of burden at both time points, with few significant changes observed over time. Outcomes were variable among patients over time and were better among those with greater pain improvement.

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S2-S3
Author(s):  
Callie Abouzeid ◽  
Audrey E Wolfe ◽  
Gretchen J Carrougher ◽  
Nicole S Gibran ◽  
Radha K Holavanahalli ◽  
...  

Abstract Introduction Burn survivors often face many long-term physical and psychological symptoms associated with their injury. To date, however, few studies have examined the impact of burn injuries on quality of life beyond 2 years post-injury. The purpose of this study is to examine the physical and mental well-being of burn survivors up to 20 years after injury. Methods Data from the Burn Model System National Database (1997–2020) were analyzed. Patient-reported outcome measures were collected at discharge with a recall of preinjury status, and then at 5, 10, 15, and 20 years after injury. Outcomes examined were the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short Form-12. Trajectories were developed using linear mixed methods model with repeated measures of PCS and MCS scores over time and controlling for demographic and clinical variables. The model fitted score trajectory was generated with 95% confidence intervals to demonstrate score changes over time and associations with covariates. Results The study population included 420 adult burn survivors with a mean age of 42.4 years. The population was mainly male (66%) and white (76.4%) with a mean burn size of 21.5% and length of hospital stay of 31.3 days. Higher PCS scores were associated with follow-up time points closer to injury, shorter hospital stay, and younger age. Similarly, higher MCS scores were associated with earlier follow-up time points, shorter hospital stay, female gender, and non-perineal burns. MCS trajectories are demonstrated in the Figure. Conclusions Burn survivors’ physical and mental health worsened over time. Such a trend is different from previous reported results for mental health in the general population. Demographic and clinical predictors of recovery over time are identified.


2019 ◽  
Vol 31 (5) ◽  
pp. 691-696 ◽  
Author(s):  
Timothy J. Yee ◽  
Brandon W. Smith ◽  
Jacob R. Joseph ◽  
Yamaan S. Saadeh ◽  
Jay K. Nathan ◽  
...  

OBJECTIVEThe Oswestry Disability Index (ODI) is one of the most commonly used patient-reported outcome instruments, but completion of this 10-question survey can be cumbersome. Tools from the Patient-Reported Outcomes Measurement Information System (PROMIS) are an alternative, and potentially more efficient, means of assessing physical, mental, and social outcomes in spine surgery. Authors of this retrospective study assessed whether scores on the 4-item surveys of function and pain from the PROMIS initiative correlate with those on the ODI in lumbar spine surgery.METHODSPatients evaluated in the adult neurosurgery spine clinic at a single institution completed the ODI, PROMIS Short Form v2.0 Physical Function 4a (PROMIS PF), and PROMIS Short Form v1.0 Pain Interference 4a (PROMIS PI) at various time points in their care. Score data were retrospectively analyzed using linear regressions with calculation of the Pearson correlation coefficient.RESULTSThree hundred forty-three sets of surveys (ODI, PROMIS PF, and PROMIS PI) were obtained from patients across initial visits (n = 147), 3-month follow-ups (n = 107), 12-month follow-ups (n = 52), and 24-month follow-ups (n = 37). ODI scores strongly correlated with PROMIS PF t-scores at baseline (r = −0.72, p < 0.0001), 3 months (r = −0.79, p < 0.0001), 12 months (r = −0.85, p < 0.0001), and 24 months (r = −0.89, p < 0.0001). ODI scores also correlated strongly with PROMIS PI t-scores at baseline (r = 0.71, p < 0.0001), at 3 months (r = 0.82, p < 0.0001), at 12 months (r = 0.86, p < 0.0001), and at 24 months (r = 0.88, p < 0.0001). Changes in ODI scores moderately correlated with changes in PROMIS PF t-scores (r = −0.68, p = 0.0003) and changes in PROMIS PI t-scores (r = 0.57, p = 0.0047) at 3 months postoperatively.CONCLUSIONSA strong correlation was found between the ODI and the 4-item PROMIS PF/PI at isolated time points for patients undergoing lumbar spine surgery. Large cohort studies are needed to determine longitudinal accuracy and precision and to assess possible benefits of time savings and improved rates of survey completion.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5068-5068
Author(s):  
Neeraj Agarwal ◽  
Simon Chowdhury ◽  
Anders Bjartell ◽  
Byung Ha Chung ◽  
Andrea Juliana Pereira de Santana Gomes ◽  
...  

5068 Background: The phase 3 TITAN study evaluated APA vs PBO in pts with mCSPC receiving ADT. At primary analysis with 22.7 mo median follow-up, APA significantly improved overall survival (OS) and radiographic progression-free survival vs PBO (Chi NEJM 2019) while preserving HRQoL (Agarwal Lancet Oncol 2019). The study was unblinded; pts on PBO were allowed to cross over to APA. At final analysis with 44 mo median follow-up, APA significantly improved OS vs PBO, reducing risk of death by 35% despite crossover (Chi ASCO GU 2021). We evaluated HRQoL and treatment bother at final analysis. Methods: mCSPC pts (N = 1052) were randomized 1:1 to APA (240 mg QD; n = 525) or PBO (n = 527). All pts received ADT. Patient-reported outcomes were assessed using Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P). BPI was completed for 7d consecutively (Days -6 to 1 of each 28-d cycle [C]) through end of treatment (EOT). FACT-P was completed at baseline (BL), C2-C7, then every other C through EOT. Mean scores were reported by treatment group and over time. Time to deterioration on BPI and FACT-P scores was calculated by Kaplan-Meier methods and compared between groups by fitting proportional hazards regression models. Results: Of eligible pts per C, > 62% completed BPI through C32 and > 50% completed FACT-P through C31. Pts were relatively asymptomatic with good BL HRQoL: on 0-10 worst pain severity scale (BPI), median scores were 1.1 (APA) and 1.0 (PBO); on 0-156 HRQoL scale (FACT-P total; higher score = better HRQoL), median scores were 113.0 (APA) and 113.3 (PBO). Low BL BPI scores remained stable over time in both groups. On average, favorable BL FACT-P scores did not notably worsen over time in APA or PBO groups. There were no significant differences between groups in median time to deterioration in any BPI or FACT-P scores (Table). At each C at least 86% (APA) and 85% (PBO) of pts were either “not at all” or “a little bit” bothered by side effects. At BL, 76% (APA) and 72% (PBO) had favorable energy levels (reporting lack of energy “not at all” or “a little bit”). Energy levels remained stable or improved at each C for > 78% (APA) and > 71% (PBO) of pts. Conclusions: In the final analysis of TITAN, survival benefit with addition of APA to ADT was achieved without significant patient-reported side effect burden or reduced HRQoL compared with PBO in pts with mCSPC. Clinical trial information: NCT02489318. [Table: see text]


2021 ◽  
pp. 107110072110078
Author(s):  
Peter Y. Joo ◽  
Judith F. Baumhauer ◽  
Olivia Waldman ◽  
Samantha Hoffman ◽  
Jeffrey Houck ◽  
...  

Background: Hallux rigidus is a common and painful degenerative condition of the great toe limiting a patient’s physical function and quality of life. The purpose of this study was to investigate pre- and postoperative physical function (PF) and pain interference (PI) levels of patients undergoing synthetic cartilage implant hemiarthroplasty (SCI) vs arthrodesis (AD) for treatment of hallux rigidus using the Patient-Reported Outcomes Measurement Information System (PROMIS). Methods: PROMIS PF and PI t scores were analyzed for patients who underwent either SCI or AD. Postoperative final PROMIS t scores were obtained via phone survey. Linear mixed model analysis was used to assess differences in PF and PI at each follow-up point. Final follow-up scores were analyzed using independent sample t tests. Results: Total 181 (59 SCI, 122 AD) operatively managed patients were included for analysis of PROMIS scores. Final phone survey was performed at a minimum of 14 (mean 33, range, 14-59) months postoperatively, with 101 patients (40 SCI, 61 AD) successfully contacted. The mean final follow-up was significantly different for SCI and AD: 27 vs 38 months, respectively ( P < .01). The mean age of the SCI cohort was lower than the AD cohort (57.5 vs 61.5 years old, P = .01). Average PF t scores were higher in the SCI cohort at baseline (47.1 and 43.9, respectively, P = .01) and at final follow-up (51.4 vs 45.9, respectively, P < .01). A main effect of superior improvement in PF was noted in the SCI group (+4.3) vs the AD group (+2) across time intervals ( P < .01). PI t scores were similar between the 2 procedures across time points. Conclusion: The SCI cohort reported slightly superior PF t scores preoperatively and at most follow-up time points compared with the arthrodesis group. No differences were found for PI or complication rates between the 2 treatment groups during this study time frame. Level of Evidence: Level III.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brittany R. Lapin ◽  
Nicolas R. Thompson ◽  
Andrew Schuster ◽  
Irene L. Katzan

Abstract Objectives Research has indicated proxies overestimate symptoms on patients’ behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. Methods Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. Results Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5–75.6%. Only a small proportion indicated meaningful worsening. Conclusions Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies.


2013 ◽  
Vol 93 (12) ◽  
pp. 1603-1614 ◽  
Author(s):  
Karin Verkerk ◽  
Pim A.J. Luijsterburg ◽  
Martijn W. Heymans ◽  
Inge Ronchetti ◽  
Annelies L. Pool-Goudzwaard ◽  
...  

Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on the QBPDS ranged from 51.7 (SD=15.6) at baseline to 31.7 (SD=15.2), 31.1 (SD=18.2), and 29.1 (SD=20.0) at 2, 5, and 12 months, respectively. The prognostic factors identified for recovery at 5 and 12 months were younger age and high scores on disability and on the 36-Item Short-Form Health Survey (SF-36) (Physical and Mental Component Summaries) at baseline. In addition, at 5-month follow-up, a shorter duration of complaints was a positive predictor, and having no comorbidity and less pain at baseline were additional predictors at 12-month follow-up. Limitations Missing values at 5- and 12-month follow-ups were 11.1% and 45.2%, respectively. Conclusion After multidisciplinary treatment, the course of disability in patients with CNSLBP continued to decline over a 12-month period. At 5- and 12-month follow-ups, prognostic factors were identified for a clinically relevant decrease in disability scores on the QBPDS.


2017 ◽  
Vol 33 (6) ◽  
pp. 425-429 ◽  
Author(s):  
Yung-Wei Chi ◽  
Blythe Durbin-Johnson ◽  
Marlin Schul

Objective The goal of this American College of Phlebology Patient Reported Outcome Venous Registry analysis was to examine the clinical efficacy of compression stockings using short-form 6D questionnaire (SF-6D). Method SF-6D scores were modeled over time using linear mixed effects model. Changes of SF-6D score from baseline to the last encounter were examined using a paired t-test. Analysis of variance was used to compare changes from baseline in SF-6D scores between C classifications. All analyses were conducted using SAS software, version 9.4 (SAS Institute, Cary NC). Results Baseline mean SF-6D score was 0.83 and at follow-up, 0.85. Mean SF-6D change was +0.02 points (P = .001) over an average time period of 5.5 months. Patients’ SF-6D scores were estimated to increase by +0.03 points (P = .005) per year of usage of compression stockings. SF-6D score changes across C classifications did not demonstrate significant differences (P = .265). Conclusion There was an improvement of SF-6D score in the registry participants who used circular knit compression stockings.


2016 ◽  
Vol 130 (8) ◽  
pp. 706-711 ◽  
Author(s):  
O Hilly ◽  
E Hwang ◽  
L Smith ◽  
D Shipp ◽  
J M Nedzelski ◽  
...  

AbstractBackground:Cochlear implantation is the standard of care for treating severe to profound hearing loss in all age groups. There is limited data on long-term results in elderly implantees and the effect of ageing on outcomes. This study compared the stability of cochlear implantation outcome in elderly and younger patients.Methods:A retrospective chart review of cochlear implant patients with a minimum follow up of five years was conducted.Results:The study included 87 patients with a mean follow up of 6.8 years. Of these, 22 patients were older than 70 years at the time of implantation. Hearing in Noise Test scores at one year after implantation were worse in the elderly: 85.3 (aged under 61 years), 80.5 (61–70 years) and 73.6 (aged over 70 years;p= 0.039). The respective scores at the last follow up were 84.8, 85.1 and 76.5 (p= 0.054). Most patients had a stable outcome during follow up. Of the elderly patients, 13.6 per cent improved and none had a reduction in score of more than 20 per cent. Similar to younger patients, elderly patients had improved Short Form 36 Health Survey scores during follow up.Conclusion:Cochlear implantation improves both audiometric outcome and quality of life in elderly patients. These benefits are stable over time.


2017 ◽  
Vol 45 (12) ◽  
pp. 2784-2790 ◽  
Author(s):  
Benedict U. Nwachukwu ◽  
Brenda Chang ◽  
Pramod B. Voleti ◽  
Patricia Berkanish ◽  
Matthew R. Cohn ◽  
...  

Background: There is increased interest in understanding the preoperative determinants of postoperative outcomes. Return to play (RTP) and the patient-reported minimal clinically important difference (MCID) are useful measures of postoperative outcomes after anterior cruciate ligament reconstruction (ACLR). Purpose: To define the MCID after ACLR and to investigate the role of preoperative outcome scores for predicting the MCID and RTP after ACLR. Study Design: Case-control study; Level of evidence, 3. Methods: There were 294 active athletes enrolled as part of an institutional ACL registry with a minimum 2-year follow-up who were eligible for inclusion. A questionnaire was administered to elicit factors associated with RTP. Patient demographic and clinical data as well as patient-reported outcome measures were captured as part of the registry. Outcome measures included the International Knee Documentation Committee (IKDC) subjective knee evaluation form, Lysholm scale, and 12-Item Short Form Health Survey (SF-12) physical component summary (PCS) and mental component summary (MCS). Preoperative outcome score thresholds predictive of RTP were determined using a receiver operating characteristic (ROC) with area under the curve (AUC) analysis. The MCID was calculated using a distribution-based method. Multivariable logistic models were fitted to identify predictors for achieving the MCID and RTP. Results: At a mean (±SD) follow-up of 3.7 ± 0.7 years, 231 patients were included from a total 294 eligible patients. The mean age and body mass index were 26.7 ± 12.5 years and 23.7 ± 3.2 kg/m2, respectively. Of the 231 patients, 201 (87.0%) returned to play at a mean time of 10.1 months. Two-year postoperative scores on all measures were significantly increased from preoperative scores (IKDC: 50.1 ± 15.6 to 87.4 ± 10.7; Lysholm: 61.2 ± 18.1 to 89.5 ± 10.4; SF-12 PCS: 41.5 ± 9.0 to 54.7 ± 4.6; SF-12 MCS: 53.6 ± 8.1 to 55.7 ± 5.7; P < .001 for all). The corresponding MCID values were 9.0 (IKDC), 10.0 (Lysholm), 5.1 (SF-12 PCS), and 4.3 (SF-12 MCS). Preoperative score thresholds predictive of RTP were the following: IKDC, 60.9; Lysholm, 57.0; SF-12 PCS, 42.3; and SF-12 MCS, 48.3. These thresholds were not independently predictive but achieved significance as part of the multivariable analysis. In the multivariable analysis for RTP, preoperative SF-12 PCS scores above 42.3 (odds ratio [OR], 2.73; 95% CI, 1.09-7.62) and SF-12 MCS scores above 48.3 (OR, 4.41; 95% CI, 1.80-10.98) were predictive for achieving RTP; an ACL allograft (OR, 0.26; 95% CI, 0.06-1.00) was negatively predictive of RTP. In the multivariable analysis for the MCID, patients with higher preoperative scores were less likely to achieve the MCID ( P < .0001); however, a higher preoperative SF-12 MCS score was predictive of achieving the MCID on the IKDC form (OR, 1.27; 95% CI, 1.11-1.52) and Lysholm scale (OR, 1.08; 95% CI, 1.00-1.16). Medial meniscal injuries, older age, and white race were also associated with a decreased likelihood for achieving the MCID. Conclusion: Preoperative SF-12 MCS and PCS scores were predictive of RTP after ACLR; patients scoring above 42.3 on the SF-12 PCS and 48.3 on the SF-12 MCS were more likely to achieve RTP. Additionally, we defined the MCID after ACLR and found that higher SF-12 MCS scores were predictive of achieving the MCID on knee-specific questionnaires.


2018 ◽  
Vol 82 (3) ◽  
pp. 351-369 ◽  
Author(s):  
Iren Johnsen ◽  
Kari Dyregrov ◽  
Stig Berge Matthiesen ◽  
Jon Christian Laberg

This article presents results from one of the first longitudinal studies exploring the effects of losing a close friend to traumatic death, focusing on complicated grief over time and how this is affected by avoidant behavior and rumination about the loss. The sample consists of 88 persons (76% women and 24% men, mean age = 21) who lost a close friend in the Utøya killings in Norway on July 22, 2011.Quantitative data were collected at three time-points; 18, 28, and 40 months postloss. Main findings are that bereaved friends are heavily impacted by the loss and their grief reactions are affected negatively by avoidant behavior and rumination. This indicates that close bereaved friends are a group to be aware of and that there is a need for better strategies for identifying individuals in need for follow-up.


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