Outcome measures in chronic low back pain

Background. The interpretation of the change scores of the Barthel Index (BI) in follow-up or outcome studies has been hampered by the fact that its minimal clinically important difference (MCID) has not been determined. Objective. This article was written to establish the MCID of the BI in stroke patients. Methods. Both anchor-based and distribution-based methods were used to establish the MCID. In the anchor-based method, 43 stroke inpatients participated in a follow-up study designed to determine the MCID of the BI using patients' global ratings of the activities of daily living function on a 15-point Likert-type scale. The mean change scores on the 20-point scale of the BI of the MCID group, based on the patients' ratings on the Likert-type scale, served as the first estimate of the MCID. In the distribution-based method, 56 chronic stroke patients participated in the test-retest reliability study to determine the MCID of the BI. One standard error of measurement (SEM) served as the second estimate for the MCID. The larger MCID value of the 2 estimates was chosen as the MCID of the BI. Results. In the anchor-based study, there were 20 patients in the MCID group, with a mean change score of 1.85 points (ie, the first MCID estimate). In the distribution-based study, the SEM based on test-retest agreement was 1.45 points (ie, the second MCID estimate). The MCID of the BI in stroke patients was estimated to be 1.85 points. Conclusion. The authors' results, within the limitations of their design, suggest that if the mean BI change score within a stroke group has reached 1.85 points in a study, the change score on the BI can be perceived by patients as important and beyond measurement error (ie, such a change score is clinically important).

Prospective study of two samples of patients with acute and chronic low back pain, respectively. To compare the responsiveness of four functional status questionnaires, Roland Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), Disability Rating Index (DRI), and Physical Functioning scale of the SF-36 (PFSF-36), and two pain scales, a Numerical Pain Rating Scale (NRS) and Visual Analogue Scale (VAS). Concurrent comparisons of different outcome measurements in back patients have been requested. Norwegian versions of the scales and questionnaires were completed by 54 patients with acute (<3 weeks) and 50 patients with chronic low back pain (>3 months). Clinical change was estimated on a global change index. An alternative external criterion was the expected clinical course in the two cohorts. Mean changes, standardized response mean (SRM), and area under the receiver operating characteristic (ROC) curves with cutoff point for highest sensitivity and specificity were calculated. At the follow-up, 63% of the acute and 41% of the chronic sample reported improvement on the global change index. Large SRMs (1.3-2.0) and areas under the ROC curves (0.84-0.93) were found for the measurements in the acute sample. In the chronic sample, the SRMs (0.4-1.1) and areas under the ROC curves (0.65-0.83) were lower, in particular for the PFSF-36 and the VAS. There was no statistically significant difference between the responsiveness in the measurements, except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change. The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain, whereas among chronic patients the RMDQ, ODI, DRI, and NRS were most appropriate.

Developing successful interventions for chronic musculoskeletal pain requires valid, responsive, and reliable outcome measures. The Minneapolis VA Evidence-based Synthesis Program completed a focused evidence review on key psychometric properties of 17 self-report measures of pain severity and pain-related functional impairment suitable for clinical research on chronic musculoskeletal pain. Pain experts of the VA Pain Measurement Outcomes Workgroup identified 17 pain measures to undergo systematic review. In addition to a MEDLINE search on these 17 measures (1/2000-1/2017), we hand-searched (without publication date limits) the reference lists of all included studies, prior systematic reviews, and-when available-Web sites dedicated to each measure (PROSPERO registration CRD42017056610). Our primary outcome was the measure's minimal important difference (MID). Secondary outcomes included responsiveness, validity, and test-retest reliability. Outcomes were synthesized through evidence mapping and qualitative comparison. Of 1635 abstracts identified, 331 articles underwent full-text review, and 43 met inclusion criteria. Five measures (Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Bodily Pain Scale (SF-36 BPS), Numeric Rating Scale (NRS), and Visual Analog Scale (VAS)) had data reported on MID, responsiveness, validity, and test-retest reliability. Seven measures had data reported on three of the four psychometric outcomes. Eight measures had reported MIDs, though estimation methods differed substantially and often were not clinically anchored. In this focused evidence review, the most evidence on key psychometric properties in chronic musculoskeletal pain populations was found for the ODI, RMDQ, SF-36 BPS, NRS, and VAS. Key limitations in the field include substantial variation in methods of estimating psychometric properties, defining chronic musculoskeletal pain, and reporting patient demographics. Registered in the PROSPERO database: CRD42017056610.

Objective: To compare the long-term effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme, in terms of back-specific disability, in patients with chronic low back pain. Design: A single-centre, pragmatic, two-arm parallel, randomised controlled trial. Setting: A rheumatology rehabilitation centre in Denmark. Subjects: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. Interventions: An integrated programme (a pre-admission day, two weeks at home, two weeks inpatient followed by home-based activities, plus two 2-day inpatient booster sessions, and six-month follow-up visit) was compared with an existing programme (four-week inpatient, and six-month follow-up visit). Main measure: The primary outcome was disability measured using the Oswestry Disability Index after one year. Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). Analysis was by intention-to-treat, using linear mixed models. Results: 303 patients were assessed for eligibility of whom 165 patients (mean age 50 years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11)) were randomly allocated (1:1 ratio) to the integrated programme (n = 82) or the existing programme (n = 83). The mean difference (integrated programme minus existing programme) in disability was –0.53 (95% CI –4.08 to 3.02); p = 0.770). No statistically significant differences were found in the secondary outcomes. Conclusion: The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.

Evaluating the psychometric and clinical performances of the RM-18, the shorter version of the Roland Morris Disability Questionnaire (RMQ), in Italian people with non-specific low back pain (NSLBP) as a time-saving and clinically useful method of assessing disability. This cross-sectional study included 74 people (52 females and 22 males, 53.03 ± 15.25 years old) with NSLBP. The RM-18, the RMQ, the Oswestry Disability Index (ODI), and a pain intensity numerical rating scale (NRS) were administered. Psychometric testing included reliability by internal consistency (Cronbach's alpha) and test-retest measurement (Intraclass Correlation Coefficient, ICC2.1), and concurrent validity by comparing the RM-18 with the RMQ and the ODI (Pearson's r correlation). Two separate regression analyses were performed to investigate the different impact of RM-18 and RMQ on NRS. Cronbach's α of RM-18 was 0.92 and ICC (2,1) = 0.96. Strong correlations were found with the RMQ and the ODI (r = 0.98; r = 0.78, respectively). The regression models showed that the RM-18 and the RMQ similarly impacted the NRS (p < 0.001). The RM-18 showed satisfactory psychometric testing and similarly impacted the NRS when compared to the RMQ. It can be recommended for clinical and research purposes in Italian people with NSLBP.

BackgroundTo assess the 10-item Spine Functional Index (SFI-10) clinimetric properties in a general musculoskeletal disorder (MSD) spine population. Ascertain the psychometric characteristics’ consistency with the developmental study findings for structural and criterion validity, internal consistency, and floor/ceiling effect; establish the longitudinal characteristics for test–retest reliability, responsiveness, construct validity, and error scores; and clarify practical characteristics of readability, missing responses, and time/errors for completion/scoring related to administrative burden.MethodsA longitudinal study of deidentified spine MSD patients (n = 1317, 53.4% female, age = 18-91yrs, av = 49.5 ± 16.4yrs; neck = 36.5%, mid-back = 8.4%, low back = 56.0%, multi-site = 0.3%) who completed the SFI-10, the Patient Specific Functional Scale (PSFS), and Numerical Rating Scales for Global-function (G-NRS) and Pain (P-NRS). Structural validity used factor analysis, exploratory (EFA) and confirmatory (CFA), plus Rasch analysis. Criterion validity used Spearman's correlation coefficient (r) between the SFI-10 and criteria (PSFS, G-NRS and P-PRS) scores, and construct validity (n = 91, known-groups independent t-test). Internal consistency used Cronbach's alpha (α) and floor/ceiling effects were determined. Subgroups determined reliability (n = 104, intraclass correlation coefficient, ICC2.1); error (n = 171) through the standard error of measurement (SEM) and minimum detectable change (MDC90). Responsiveness (n = 171) was calculated using effect-size (ES), standard response mean (SRM), and area under the curve (AUC); and interpretability through the minimal clinically important difference (MCID). Practicality (n = 16) clarified missing responses, readability, and time/errors for completion/scoring.ResultsThe SFI-10’s structural validity was unequivocally one-dimensional from EFA and verified by CFA with acceptable fit-indices (chi-square/df = 2.88, CFI = 0.981, TLI = 0.975, RMSEA = 0.061), and supported by Rasch analysis (PSR = 0.79, Infit = 0.678–1.216, Outfit = 0.604–1.279, Item-difficulties = -1,215–2.488). Criterion validity varied from high (G-NRS, r = 0.60) and moderate (PSFS, r = 0.43) to low-inverse (P-NRS, r = -0.24). Internal consistency was strong (α = 0.84) and no floor/ceiling effects were present. Reliability was excellent (ICC2.1 = 0.97), responsiveness substantial (ES = 1.54; SRM = 1.64; AUC = 0.89), and measurement error robust (SEM = 3.84; MDC90 = 8.98%, MDIC = 10.4%), with construct validity confirmed (p < 0.001). Practicality showed no missing responses, completion/scoring errors < 1%, excellent readability (Grade = 5.1, Ease = 74.1%), short completion (39.2 ± 10.3 s) and scoring times (8.5 ± 1.8 s).ConclusionsThe SFI-10 demonstrates sound measurement properties in a general physiotherapy outpatient MSD spine population for both psychometric and practical characteristics. Further investigation in culturally diverse settings that include both inpatients and community settings with whole-spine and regional-spine criteria is required.

Few studies have established the minimum clinically important difference (MCID) in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for physical function and pain. To establish MCID for physical function and pain patient-reported outcome measures (PROMs) for MIS-TLIF through anchor- and distribution-based methods using the Oswestry Disability Index (ODI) as the anchor. Ninety-eight patients undergoing primary MIS-TLIF with preoperative and 1-year postoperative ODI scores were identified. MCID was calculated using anchor- and distribution-based methods. ODI responders were classified as patients who decreased by 1 disability classification. PROMs of Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF), 12-Item Short Form Physical Component Score (SF-12 PCS), Visual Analog Scale (VAS) back/leg, and ODI were collected preoperatively and 1-year postoperatively. Anchor-based methods were average change, minimum detectable change, change difference, receiver operating characteristic curve, and cross-sectional analysis. Distribution-based methods were standard error of measurement, receiver change index, effect size, and 0.5 ∗ ΔSD. Anchor-based methods ranged from 4.2 to 11.9 for PROMIS-PF, 6.0 to 15.8 for SF-12 PCS, 1.8 to 4.6 for VAS back, and 2.1 to 4.0 for VAS leg. The area under the curve for receiver operating characteristic analysis ranged from 0.66 to 0.81. Distribution-based methods ranged from 1.1 to 3.9 for PROMIS-PF, 1.6 to 10.4 for SF-12 PCS, 0.5 to 1.6 for VAS back, and 0.6 to 1.8 for VAS leg. Patients undergoing MIS-TLIF had a wide range of MCID values. The receiver operating characteristic curve was selected as the most clinically appropriate method. The corresponding MCID values were 4.2 for PROMIS-PF, 6.8 for SF-12 PCS, 1.8 for VAS back, and 2.4 for VAS leg.

Background: Generic preference-based measures are used to evaluate disability and health-related quality of life (HRQoL). Objective: To evaluate if Short Form Six-Dimensions (SF-6Dv2) is correlated with specific current questionnaires used in chronic low back pain (CLBP) and if a predictive equation of SF-6Dv2 could be established. Methods: Between October 2018 and January 2019, an online survey on CLBP was conducted. HRQoL was measured with two specific questionnaires, i.e. Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire (RMDQ), and with the new version of the SF-6Dv2 as a generic preference-based measure. Results: 402 subjects completed at least two of the three HRQoL questionnaires. Mean (95% confidence interval) of SF-6Dv2, ODI, or RMDQ were, respectively, 0.561 (0.553–0.569), 43.7 (42.1–45.2), and 10.3 (9.8–10.8). SF-6Dv2 was moderately correlated with ODI and RMDQ (r = −0.635 and r = −0.542, p < 0.001). The best model to predict SF-6Dv2 explained 50.6% of variability and included ODI. The correlation between actual and predicted SF-6Dv2 was 0.71. Conclusion: This study demonstrated that SF-6Dv2 was moderately correlated with ODI and RMDQ and that ODI was a better predictor. There was a strong correlation between actual and predicted SF-6Dv2 from multivariate models. These results suggest that the model can be used in similar studies to estimate the SF-6Dv2 when it was not measured.

Research Type: Level 4 – Case series Introduction/Purpose: Haglund’s deformity is a common cause of posterior heel pain, often necessitating surgical intervention when conservative management fails. However, current literature about clinical significance thresholds for patient-reported outcome measures (PROMs) following Haglund’s excision surgery and Achilles tendon repair for Haglund’s deformity has been poorly defined. This study aims to establish the Minimal Clinically Important Difference (MCID), Patient Acceptable Symptom State (PASS), and Substantial Clinical Benefit (SCB) for the Foot and Ankle Ability Measure (FAAM), Visual Analog Scale (VAS) for pain, and the Patient-Reported Outcomes Measurement Information System Physical and Mental Health (PROMIS-PH/MH) in patients undergoing surgical treatment for Haglund’s deformity. By quantifying these thresholds, we seek to enhance clinical decision-making and improve patient counseling regarding expected surgical outcomes. Methods: This sample was drawn from a prospectively collected institutional database of consecutive patients who underwent Haglund’s excision surgery by multiple surgeons from a single institution between June 2016 and February 2023. The MCID, PASS, and SCB were calculated for the FAAM Activities of Daily Living (ADL), VAS, PROMIS-10 MH, and PROMIS-10 PH utilizing either anchor- or distribution-based methods. For MCID, the two distribution-based methods used were the Standard Error of Measurement (SEM) and the 95% Minimum Detectable Change (MDC) as these have been shown to best align with the anchor-based clinical cutoffs. For PASS and SCB, anchor-based methods were used receiver operating characteristic (ROC) curve analysis to identify optimal cutoffs using the Youden J statistic. Results: 74 patients were included in the final analysis. This cohort was aged 54.4 ± 20.1 with mean follow-up of 11.7 months. 6 (8.1%) patients experienced complications. The MCID values for SEM and MDC methods were 6.56 and 18.2 for FAAM ADL, 0.43 and 1.19 for VAS, 1.41 and 3.91 for PROMIS-10 MH, and 0.99 and 2.75 for PROMIS-10 PH, respectively. The PASS values for ROC methods were 66.07 for FAAM ADL, 1.50 for VAS, 14.50 for PROMIS-10 MH, and 15.50 for PROMIS-1 PH, respectively. Finally, the SCB values for ROC methods were 69.04 for FAAM ADL, 2.50 for VAS, 14.50 for PROMIS-10 MH, and 16.50 for PROMIS-10 PH, respectively. Conclusion: This study adds to the growing body of literature characterizing clinically significant differences in patient-reported outcomes in the setting of Haglund’s excision surgery for patients with posterior instability. Thresholds defined in this study may provide additional information for physicians to better interpret patient-reported outcome measures and enhance the detection of an unsuccessful outcome following surgical management for Haglund’s deformity. Rate of Patients Meeting Clinical Significance for MCID (SEM and MDC), PASS, &amp; SCB.

The purpose of this study is to examine the validity and reliability of the Arabic version of the Patient-Specific Functional Scale (PSFS-Ar) in patients with low back pain (LBP). A total of 94 participants were recruited from different outpatient physical therapy departments in the central province of the Kingdom of Saudi Arabia and completed the PSFS-Ar, Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ), and Numeric Pain Rating Scale (NPRS). Thirty participants completed the PSFS-Ar twice at appropriate time intervals. The test–retest reliability was assessed using the intraclass correlation coefficient model (ICC2,1). The measurement error was examined by the standard error of measurement (SEM) and minimal detectable change at the 90% confidence level. The construct validity of the PSFS-Ar was determined by examining predefined hypotheses regarding correlations between the PSFS-Ar and the ODI, RMDQ, and NPRS using the Spearman correlation coefficient. The PSFS-Ar demonstrated insufficient test–retest reliability, with an ICC2,1 = 0.46 (95% confidence interval 0.14-0.70). The SEM of the PSFS-Ar was 1.08 points, while the minimal detectable change (MDC) was 2.51 points, indicating possible acceptable measurement error, with no floor or ceiling effects. The construct validity was supported by 80% of the predefined hypotheses, with the PSFS-Ar showing the following correlations with other measures: ODI (r = −0.24), RMDQ (r = −0.34), and NPRS (r = −0.03). The PSFS-Ar showed evidence supporting its construct validity for functional limitations in patients with LBP with no floor or ceiling effects. The PSFS-Ar had insufficient test–retest reliability with possible acceptable measurement error. A clinician can use the Arabic version of PSFS to document and evaluate changes associated with patients suffering from LBP. Furthermore, the PSFS can be used as an evaluation tool to compare a patient’s functional level at different points in time.

Background: Discogenic pain is an important cause of low back pain (LBP). We have developed a pulsed radiofrequency (PRF) technique, using Diskit II® needles (NeuroTherm, Middleton, MA, USA) placed centrally in the disk, for applying radiofrequency current in the disc (Intradiscal PRF method). Objective: The purpose of this study was to investigate the effect of this intradiscal pulsed radiofrequency method in patients with chronic discogenic LBP diagnosed by discoblock, in terms of pain relief and reduction of disability. Study Design: Prospective case series clinical outcome study. Methods: The participants consisted of 23 patients with a mean age of 35.3 ± 9.86 years with chronic discogenic LBP that was not responsive to aggressive nonoperative care. A Diskit II needle (15-cm length, 20G needle with a 20-mm active tip) was placed centrally in the disc. PRF was applied for 15 minutes at a setting of 5 × 5 ms/s and 60 V. Outcome measures included the pain intensity score on a 0-10 numeric rating scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ) at pre-treatment, one, 3, 6, and 12 months post-treatment. Results: The mean pain severity scores (NRS) improved significantly from 7.47 ± 0.85 pretreatment to 3.13 ± 2.58 at the 12 month follow-up (P &lt; 0.01). The RMDQ showed significant (P &lt; 0.01) improvement from 11.4 ± 1.57 pre-treatment to 2.90 ± 2.97 at the 12 month follow-up (P &lt; 0.01). Nineteen of 23 (82.6%) of the patients demonstrated NRS improvements of greater than 2, and 15 of 23 (65.2%) had &gt; 50% pain reduction, 12 months after treatment. Limitations: The number of patients was relatively low and secondary outcomes such as medication requirement or psychological effects were not addressed. Conclusions: This intradiscal PRF method with consecutive PRF 5/5/60V, 15 min (with Diskit needle) appears to be a safe, minimally invasive treatment option for patients with chronic discogenic LBP. Key words: Pulsed radiofrequency, discogenic pain, intradiscal procedures, chronic low back pain, Roland-Morris Disability Questionnaire

Background and purposeThere is conflicting evidence regarding treatment outcomes after minimally invasive sacroiliac joint fusion for long-lasting severe sacroiliac joint pain. The primary aim of our cohort study was to investigate change in patient-reported outcome measures (PROMs) after minimally invasive sacroiliac joint surgery in daily practice in the Swedish Spine Registry. Secondary aims were to explore the proportion of patients reaching a patient acceptable symptom score (PASS) and the minimal clinically important difference (MCID) for pain scores, physical function, and health-related quality of life outcomes; furthermore, to evaluate self-reported satisfaction, walking distance, and changes in proportions of patients on full sick leave/disability leave and report complications and reoperations.MethodsData from the Swedish Spine Registry was collected for patients with first-time sacroiliac joint fusion, aged 21 to 70 years, with PROMs available preoperatively, at 1 or 2 years after last surgery. PROMs included Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for low back pain (LBP) and leg pain, and EQ-VAS, in addition to demographic variables. We calculated mean change from pre- to postoperative and the proportion of patients achieving MCID and PASS.Results68 patients had available pre- and postoperative data, with a mean age of 45 years (range 25–70) and 59 (87%) were female. At follow-up the mean reduction was 2.3 NRS points (95% confidence interval [CI] 1.6–2.9; P < 0.001) for LBP and 14.8 points (CI 10.6–18.9; P < 0.001) for ODI. EQ-VAS improved by 22 points (CI 15.4–30.3, P < 0.001) at follow-up. Approximately half of the patients achieved MCID and PASS for pain (MCID NRS LBP: 38/65 [59%] and PASS NRS LBP: 32/66 [49%]) and physical function (MCID ODI: 27/67 [40%] and PASS ODI: 24/67 [36%]). The odds for increasing the patient’s walking distance to over 1 km at follow-up were 3.5 (CI 1.8–7.0; P < 0.0001), and of getting off full sick leave or full disability leave was 0.57 (CI 0.4–0.8; P = 0.001). In the first 3 months after surgery 3 complications were reported, and in the follow-up period 2 reoperations.ConclusionWe found moderate treatment outcomes after minimally invasive sacroiliac joint fusion when applied in daily practice with moderate pain relief and small improvements in physical function.

IntroductionAs a possible treatment option for chronic lower back pain (CLBP) due to single-level degenerative disc disorder (DDD), the efficacy of anterior lumbar interbody fusion (ALIF) has been reviewed various times in the existing literature. Nevertheless, a scarcity of data exists pertaining to ALIF procedures carried out in a short-stay setting using an Enhanced Recovery after Surgery (ERAS) protocol, particularly concerning the safety.MethodsProspectively collected data are analyzed to study the efficacy and safety of short-stay ERAS ALIF in treatment of single-level DDD. Visual Analog Scale (VAS) in both back and leg pain along with the Oswestry Disability Index (ODI) were used to collect measure outcomes. The primary endpoint was a minimum clinically important difference (MCID) of ≥30% for the ODI at 12 months.ResultsForty-four patients underwent surgery after failed long-term conservative treatment. MCID was achieved in 78%. Age was the only significant factor in association with MCID (p = 0.03), while gender, Modic changes, results of prognostic tests, prior surgery and smoking status had no significant influence on either MCID or change scores for any outcome measure. One complication in the form of transient new radiculopathy occurred in one patient (2.3%).ConclusionWith overall positive outcomes in terms of both efficacy and safety, an ALIF procedure with subsequent implementation of an ERAS protocol in a short-stay setting can be an option for strictly selected patients with CLBP. Further study, however, possibly with a larger sample size, would be necessary to substantiate these findings.

Background/Objectives: Chronic low back pain (LBP) remains a leading cause of disability and healthcare utilization globally, with complex, multifactorial pathophysiology. Despite advances in imaging, diagnosis often remains challenging due to poor correlation between structural findings and clinical symptoms. Recent evidence suggests inflammatory mechanisms may underlie persistent pain. This study investigated whether systemic inflammatory cytokines are altered in military personnel with chronic LBP and examined their relationships with clinical manifestations, psychological factors, and radiological findings. Methods: In this cross-sectional study, we enrolled 50 patients with chronic non-specific LBP (duration ≥ 3 months) and 50 age-, sex-, and BMI-matched healthy controls. All patients underwent a comprehensive clinical assessment, which included evaluation of pain intensity (VAS), neuropathic pain screening (DN4), psychological assessment (HADS), fibromyalgia screening (FIRST), and assessment of functional disability (Oswestry Disability Index and Roland-Morris Disability Questionnaire, EIFEL). Serum levels of IL-6, IL-8, IL-1β, TNF-α, and IL-10 were measured using chemiluminescence and enzyme-linked immunosorbent assay (ELISA) techniques. Radiological findings were documented through MRI and CT imaging of the lumbar spine. Results: Serum IL-8 levels were significantly elevated in patients with chronic LBP compared to healthy controls (8.52 ± 6.7 vs. 4.8 ± 0.56 pg/mL, p < 0.001). Weak positive correlations were observed between IL-8 levels and anxiety scores (r = 0.3, p = 0.02) and functional disability, as measured by the EIFEL questionnaire (r = 0.3, p = 0.04); however, these associations did not remain significant after Bonferroni correction for multiple testing. Similarly, IL-6 showed a weak positive correlation with BMI (r = 0.21, p = 0.03) and a weak negative correlation with lumbar mobility, as assessed by Schober's test (r = -0.38, p = 0.03), which also did not survive correction for multiple comparisons. Conclusions: This study identified serum IL-8 as a potential biomarker for chronic LBP. While we observed associations between specific inflammatory markers and psychological distress and functional disability, these correlations were weak and did not remain significant after correction for multiple testing. These preliminary findings suggest possible connections between inflammation and the psychophysiological aspects of chronic LBP that warrant further investigation in larger cohorts.

Background:Minimal clinically important difference (MCID) of a patient‐reported outcome (PRO) measure is the smallest change in the scores that is meaningful from a patient's perspective. The responsiveness, on the other hand, is an important measurement property which is required to show that the instrument is capable of detecting change over time or after a therapeutic intervention. Evaluating both responsiveness and MCID of a newly developed PRO instrument is a measurement necessity. A novel haematological malignancy (HM) specific PRO, HM‐PRO, has been developed for use in daily clinical practice as well as clinical research. The HM‐PRO is a composite measure consisting of two scales: Part A‐measuring the impact on patients’ quality of life (QoL); and Part B‐measuring the effect of signs and symptoms experienced by the patients.Aims:The aims of this study were to evaluate the responsiveness and estimate the MCID of the newly developed HM‐PRO.Methods:In a prospective multicenter cross‐sectional study, a total of 299 patients: male 167 (55.9%); mean age 64.9 (±11.5) years, range 17.9–88.5 years; mean time since diagnosis 4.9 (±4.8) years, range 0.003 – 27.4 years; with different HMs (acute lymphoid leukaemia‐8, acute myeloid leukaemia‐18, aggressive non‐Hodgkin lymphoma‐21, chronic lymphoid leukaemia‐24, chronic myeloid leukaemia‐11, Hodgkin lymphoma‐12, indolent non‐Hodgkin lymphoma‐8, myelodysplastic syndrome‐65, multiple myeloma‐85, myeloproliferative neoplasm‐47); in different disease state (stable‐139, remission‐82, progressing‐78), were recruited. Patients were asked to complete the HM‐PRO at baseline (t0) and after three months (t1). Data analysis was performed using IBM SPSS 23 statistical software. Paired t‐test, effect size (ES) and standard response mean (SRM) analysis were performed to test HM‐PRO's responsiveness as the ability to detect change. An anchor question (5‐point Likert scale from ‘much worse’ to ‘much better’) measuring change in HRQoL from patients’ perspective was used. The distribution‐based approach was employed to estimate the MCID, using standard deviation (SD) and the standard error of measurement (SEM).Results:Both parts of the HM‐PRO were assessed individually for responsiveness. The paired sample t‐test was significant in the ‘slightly better’ group for Part A (mean score change = 6.8, SD = 13.7, t = 3.343, df = 44, p = 0.002; Cohen's d = 0.35; SRM = 0.50), and Part B (mean score change = 3.68, SD = 8.7, t = 2.7, df = 42, p = 0.009; Cohen's d = 0.31; SRM = 0.42) showing significant decrease in score over time and with moderate effect size. In contrast, patient group with ‘about the same’ HRQoL did not show significant change in scores over time for both Part A (mean score change = 1.7, SD = 12.7, t = 1.7, df = 154, p = 0.09; Cohen's d = 0.08; SRM = 0.13) and Part B (mean score change = 0.57, SD = 8.93, t = 0.80, df = 153, p = 0.42; Cohen's d = 0.04; SRM = 0.06) (Table 1a). In order to establish MCID, statistical characteristics of a sample of baseline patient response were studied for both Part A and Part B. The analysis of Part A showed an SEM of 6.2 and 1/2 SD of 11.2, and for Part B showed an SEM of 5.9 and 1/2 SD of 7.3 (Table 1b).Summary/Conclusion:This study has established the responsiveness and MCID for both Part A and Part B of the HM‐PRO. The HM‐PRO is capable of detecting a small but clinically important change in patients’ HRQoL over time. The MCID for Part A based on SEM was 6.2 and for PART B 5.9 points. It would, therefore, be prudent, for practical reason, to propose an MCID of ‘6’ for the HM‐PRO.image