Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review

Silva, M Denika C; Perriman, Diana; Fearon, Angela; Couldrick, Jacqui M; Scarvell, Jennie M.

doi:10.1136/bmjopen-2022-063026

Cited by 15 publications

(4 citation statements)

References 93 publications

(268 reference statements)

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“…Similar results were observed for the other KOOS scales such as KOOS ADL, with a median of 82.35 and a 75th percentile value of 95.59. At the 9-month follow-up in this study, the relative change of 27.78, 27.94, and 18.75 in median scores of KOOS pain, ADL, and QoL, respectively, were above the highest values of what could be tentatively considered as the minimal clinically important changes in the literature for non-operative treatments [ 16 , 17 ]. The treatment responder rate was calculated at the month 6 follow-up visit according to the OMERACT-OARSI proposed set of responder criteria and was 72.7%.…”

Section: Discussionmentioning

confidence: 59%

Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany

Lynen,

Eichhorn,

Portelange

et al. 2024

Rheumatol Ther

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Introduction Evaluate the real-world efficacy of a single intra-articular injection of carboxymethyl-chitosan (CM-chitosan), a new product class for knee osteoarthritis (OA). Methods This post-marketing study included adult patients with knee OA, who received a single injection of 60 mg CM-chitosan (currently marketed as KioMedine vs one) according to the instructions for use. Follow-up was performed at weeks 1, 12, 24, and 36. Efficacy was evaluated using a Visual Analog Scale (VAS) score for pain, the Knee injury and Osteoarthritis Outcome Score (KOOS), Patient’s Global Assessment (PGA), and overall patient satisfaction. Results Forty-nine patients were included in the study. VAS pain score significantly decreased from a median of 49.0 mm at baseline to 24.0 mm at week 1 and to 18 mm at week 36. Pain improvement was stable since at week 36; 91.8% of patients confirmed pain reduction. All KOOS subscales (symptoms, pain, activities of daily living, sports and recreational activities, quality of life) improved significantly compared to baseline at all time points. KOOS pain improved progressively from a median of 58.3% at baseline (mean 56.2 ± 18.8%) to 86.1% (mean 74.1 ± 24%) at week 36 compared to baseline. Overall, more than 70% of patients reported a condition gain (PGA), matching well with the more than 75% of patients being satisfied with the treatment. At 6 months, 72.7% of the patients could be classified as responder according to the OMERACT-OARSI proposed set of responder criteria. Conclusion CM-chitosan showed a rapid onset of pain relief after 1 week and with a duration of 9 months. In a real-world setting, treatment with CM-chitosan would appear to be a potentially effective option to reduce pain and improve physical function and global condition in patients with knee OA, opening new perspectives in patients who are considered as refractory to current symptomatic therapies and where the unmet need is high. Trial Registration Number NCT04757051 (ClinicalTrials.gov).

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Section: Discussionmentioning

confidence: 59%

Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany

Lynen,

Eichhorn,

Portelange

et al. 2024

Rheumatol Ther

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“…We included studies that reported Δ knee flexion as well as Δ pain or Δ function outcomes measured using tools with established MCICs [ 32 ]. The tools included intermittent and constant osteoarthritis pain, Knee injury and Osteoarthritis Outcome Score, Lower Extremity Functional Scale, Numeric Pain Rating Scale, Patient-Reported Outcome Measurement Information System, and 36-Item Short-Form Health Survey, VAS and WOMAC.…”

Section: Methodsmentioning

confidence: 99%

Minimal clinically important change of knee flexion in people with knee osteoarthritis after non-surgical interventions using a meta-analytical approach

Silva,

Woodward,

Fearon

et al. 2024

Syst Rev

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Background Minimal clinically important change (MCIC) represents the minimum patient-perceived improvement in an outcome after treatment, in an individual or within a group over time. This study aimed to determine MCIC of knee flexion in people with knee OA after non-surgical interventions using a meta-analytical approach. Methods Four databases (MEDLINE, Cochrane, Web of Science and CINAHL) were searched for studies of randomised clinical trials of non-surgical interventions with intervention duration of ≤ 3 months that reported change in (Δ) (mean change between baseline and immediately after the intervention) knee flexion with Δ pain or Δ function measured using tools that have established MCIC values. The risk of bias in the included studies was assessed using version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). Bayesian meta-analytic models were used to determine relationships between Δ flexion with Δ pain and Δ function after non-surgical interventions and MCIC of knee flexion. Results Seventy-two studies (k = 72, n = 5174) were eligible. Meta-analyses included 140 intervention arms (k = 61, n = 4516) that reported Δ flexion with Δ pain using the visual analog scale (pain-VAS) and Δ function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale (function-WOMAC). Linear relationships between Δ pain at rest-VAS (0–100 mm) with Δ flexion were − 0.29 (− 0.44; − 0.15) (β: posterior median (CrI: credible interval)). Relationships between Δ pain during activity VAS and Δ flexion were − 0.29 (− 0.41, − 0.18), and Δ pain-general VAS and Δ flexion were − 0.33 (− 0.42, − 0.23). The relationship between Δ function-WOMAC (out of 100) and Δ flexion was − 0.15 (− 0.25, − 0.07). Increased Δ flexion was associated with decreased Δ pain-VAS and increased Δ function-WOMAC. The point estimates for MCIC of knee flexion ranged from 3.8 to 6.4°. Conclusions The estimated knee flexion MCIC values from this study are the first to be reported using a novel meta-analytical method. The novel meta-analytical method may be useful to estimate MCIC for other measures where anchor questions are problematic. Systematic review registration PROSPERO CRD42022323927.

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“…This sample size will also be sufficient to detect a minimal important change in KOOS 4 estimated at 10 points in patients with knee OA (with a common between-subject SD of 15). 62 …”

Section: Data Managementmentioning

confidence: 99%

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Law,

Heerey,

Devlin

et al. 2024

BMJ Open

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IntroductionChronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.Methods and analysisThe eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.Ethics and disseminationThe study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.Trial registration numberACTRN12622000440729.

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Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review

Cited by 15 publications

References 93 publications

Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany

Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany

Minimal clinically important change of knee flexion in people with knee osteoarthritis after non-surgical interventions using a meta-analytical approach

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

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