scholarly journals Minimal clinically important difference for chest discomfort in patients undergoing pleural interventions

2020 ◽  
Vol 7 (1) ◽  
pp. e000667
Author(s):  
Greta Jean Dahlberg ◽  
Fabien Maldonado ◽  
Heidi Chen ◽  
Otis Rickman ◽  
Lance Roller ◽  
...  
Keyword(s):  
Pleural Fluid ◽  
Minimal Clinically Important Difference ◽  
Likert Scale ◽  
Moderate Increase ◽  
Chest Discomfort ◽  
Vas Score ◽  
Clinically Important Difference ◽  
Academic Medical ◽  
Likert Scale Response ◽  
The Mean

RationaleTherapeutic thoracentesis is among the most frequently performed medical procedures. Chest discomfort is a common complication and has been associated with increasingly negative pleural pressure as fluid is withdrawn in the setting of non-expendable lung. Visual analogue scales (VASs) are commonly employed to measure changes in discomfort and dyspnoea related to pleural interventions. The minimal clinically important difference (MCID), defined as the smallest change in VAS score associated with patient report of significant change in a symptom, is required to interpret the results of studies using VAS scores and is used in clinical trial power calculations. The MCID for chest discomfort in patients undergoing pleural interventions has not been determined.MethodsProspectively collected data from two recent randomised trials of therapeutic thoracentesis were used for this investigation. Adult patients with symptomatic pleural effusions referred for therapeutic thoracentesis were enrolled across ten US academic medical centres. Patients were asked to rate their level of chest discomfort on 100 mm VAS before, during and following thoracentesis. Patients then completed a 7-point Likert scale indicating the significance of any change in chest discomfort from preprocedure to postprocedure. The mean difference between discomfort 5 min postprocedure and discomfort just prior to the start of pleural fluid drainage was categorised by Likert scale response.ResultsData from a total of 262 thoracenteses were included in the analysis. Thirty-four of 262 patients experienced a ‘small but significant increase’ or a ‘large or moderate increase’ in discomfort following thoracentesis. The mean increase in VAS score in those reporting a ‘small but significant increase’ in chest discomfort (n=23) was 16 mm (SD 22.44, 95% CI 6.87 to 25.21).ConclusionsThe MCID for thoracentesis-related chest discomfort measured by 100 mm VAS is 16 mm. This MCID specific to discomfort resulting from pleural fluid interventions can inform the design and analysis of future pleural intervention studies.

scholarly journals The King’s Brief Interstitial Lung Disease (KBILD) questionnaire: an updated minimal clinically important difference

2019 ◽  
Vol 6 (1) ◽  
pp. e000363 ◽  
Author(s):  
Aish Sinha ◽  
Amit Suresh Patel ◽  
Richard J Siegert ◽  
Sabrina Bajwah ◽  
Toby M Maher ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Minimal Clinically Important Difference ◽  
Scale Transformation ◽  
Global Rating ◽  
Longitudinal Assessment ◽  
Hrqol Questionnaire ◽  
Clinically Important Difference ◽  
The Mean ◽  
Small Change

IntroductionThe King’s Brief Interstitial Lung Disease (KBILD) is a 15-item validated health-related quality of life (HRQOL) questionnaire. The method of scoring the KBILD has recently changed to incorporate a logit-scale transformation from one that used raw item responses, as this is potentially a more linear scale. The aim of this study was to re-evaluate the KBILD minimal clinically important difference (MCID) using the new logit -transformed scoring.Methods57 patients with interstitial lung disease (17 idiopathic pulmonary fibrosis, IPF) were asked to complete the KBILD questionnaire on two occasions in outpatient clinics. At the second visit, patients also completed a 15-item global rating of change of health status questionnaire (GRCQ). The MCID was calculated as the mean of four different methods: the change in KBILD for patients indicating a small change in GRCQ, patients with a 7%–12% change in FVC, 1 SE of measurement of baseline KBILD and effect size (ES) of 0.3.ResultsThe mean (SD) KBILD total score for all patients was 55.3 (15.6). 16 patients underwent a therapeutic intervention. 36 patients reported a change in their condition on the GRCQ; 22 deteriorated, 14 improved and 21 were unchanged. There was a significant change in KBILD total score in patients reporting a change in GRCQ; mean (SD) 57.0 (13.6) versus 50.0 (9.7); mean difference 7.0; 95% CI of difference 3.0 to 11.0; p<0.01. The change in KBILD total score correlated with the GRCQ scale; r=−0.49, p<0.01. The mean KBILD total score MCID was 5. The MCID of KBILD domains were 6 for Psychological, 7 for Breathlessness and Activities, and 11 for Chest Symptoms.ConclusionThe KBILD is a responsive tool for longitudinal assessment of HRQOL in patients with ILD. The MCID of the KBILD total score is a 5-unit change.

scholarly journals Articular Cartilage Repair of the Pediatric and Adolescent Knee with Regard to Minimal Clinically Important Difference: A Systematic Review

Cartilage ◽  
2018 ◽  
Vol 11 (1) ◽  
pp. 9-18 ◽  
Author(s):  
Rosa S. Valtanen ◽  
Armin Arshi ◽  
Benjamin V. Kelley ◽  
Peter D. Fabricant ◽  
Kristofer J. Jones
Keyword(s):  
Systematic Review ◽  
Articular Cartilage ◽  
Clinical Outcomes ◽  
Cartilage Repair ◽  
Minimal Clinically Important Difference ◽  
Cochrane Library ◽  
Clinically Important Difference ◽  
Outcome Score ◽  
The Mean

Objective To perform a systematic review of clinical outcomes following microfracture (MFX), autologous chondrocyte implantation (ACI), osteochondral allograft transplantation (OCA), and osteochondral autograft transplantation system (OATS) to treat articular cartilage lesions in pediatric and adolescent patients. We sought to compare postoperative improvements for each cartilage repair method to minimal clinically important difference (MCID) thresholds. Design MEDLINE, Web of Science, Scopus, and Cochrane Library databases were searched for studies reporting MCID-validated outcome scores in a minimum of 5 patients ≤19 years treated for symptomatic knee chondral lesions with minimum 1-year follow-up. One-sample t tests were used to compare mean outcome score improvements to established MCID thresholds. Results Twelve studies reporting clinical outcomes on a total of 330 patients following cartilage repair were identified. The mean age of patients ranged from 13.7 to 16.7 years and the mean follow-up was 2.2 to 9.6 years. Six studies reported on ACI, 4 studies reported on MFX, 2 studies reported on OATS, and 1 study reported on OCA. ACI ( P < 0.001, P = 0.008) and OCA ( P < 0.001) showed significant improvement for International Knee Documentation Committee (IKDC) scores with regard to MCID while MFX ( P = 0.66) and OATS ( P = 0.11) did not. ACI ( P < 0.001) and OATS ( P = 0.010) both showed significant improvement above MCID thresholds for Lysholm scores. MFX ( P = 0.002) showed visual analog scale (VAS) pain score improvement above MCID threshold while ACI ( P = 0.037, P = 0.070) was equivocal. Conclusions Outcomes data on cartilage repair in the pediatric and adolescent knee are limited. This review demonstrates that all available procedures provide postoperative improvement above published MCID thresholds for at least one reported clinical pain or functional outcome score.

scholarly journals Engaging Patients in Clinical Trial Planning: Exploring the Concept of a Minimal Clinically Important Difference Among Patients with Obstetrical Antiphospholipid Syndrome

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4723-4723
Author(s):  
Leslie Skeith ◽  
Taryn S. Taylor ◽  
Shannon M. Bates ◽  
Lisa D. Duffett ◽  
Robert M. Silver ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antiphospholipid Syndrome ◽  
Live Birth ◽  
Research Funding ◽  
Pregnancy Loss ◽  
Minimal Clinically Important Difference ◽  
Perceived Safety ◽  
Physician Group ◽  
Clinically Important Difference ◽  
The Mean

Abstract INTRODUCTION: Women with antiphospholipid syndrome are at increased risk of pregnancy loss. A large randomized controlled trial is still needed to confirm or refute the efficacy of low-molecular-weight heparin (LMWH) and aspirin (ASA) prophylaxis during pregnancy in women with antiphospholipid syndrome (APS) and past pregnancy loss. The minimal clinically important difference (MCID) is a statistical concept that quantifies the smallest amount of benefit from a treatment that a patient would identify as important, and is used to adequately power clinical trials. When planning a clinical trial, the MCID is most often determined by specialists in the field. How patients make sense of MCID as a concept, and how patients' perceptions of MCID compare to physician responses is unknown. In a challenging and high stakes situation, understanding different patients' perspectives must be considered when planning a large clinical trial. METHODS: Consecutive patients were approached from a specialty Thrombosis clinic and from the TIPPS (Thrombophilia in Pregnancy Prophylaxis Study) screening logs between January 2017 and March 2018 in Ottawa, Canada to complete a survey and interview. Patients were eligible if they met the revised Sapporo/Sydney laboratory criteria for antiphospholipid syndrome and had at least 1 late pregnancy loss or 2 early losses (<10 weeks gestation). A similar survey was distributed to 350 specialists identified through 5 professional organizations between May-Sept 2016. Both patient and physician groups had access to an introductory video. The mean MCID between the patient group and physician group was compared using an independent t-test, with p<0.05 being significant. Patient interview data were collected and analysed iteratively, in keeping with constructivist grounded theory methodology. RESULTS: There were 22 (33%) patients who completed surveys and 10 patients who completed semi-structured interviews. Among the physician group, 72 (20.6%) responded to the survey, including obstetricians (34.7%), hematologists (26.4%), general internists (18%), maternal fetal medicine specialists (6.9%) and other specialties (12.6%). Assuming a live birth rate of 60% in the ASA alone arm, the mean MCID answered by physicians was 11.6% (range 5-25%, SD 5.2), compared to the mean MCID answered by patients was 10.0% (range 5-20%, SD 6.4) (p=0.28). The mean number needed to treat (NNT) answered by both physicians and patients was 16. In the majority of cases from both groups, the related concepts of MCID and NNT did not match statistically (i.e. an MCID of 15% is a NNT of 7). An overarching theme from the patient survey comments and interviews was that statistics were somewhat irrelevant. The majority of women thought that "any increase in a chance of live birth" was worth it. However, there was variation in patient responses where some women would only accept a certain success rate of LMWH to justify its use because of drug cost or side effects. Some women acknowledged that they would not use LMWH themselves, but still advocated for other patients to have the option of LMWH use for a chance of a live birth. CONCLUSION: The mean MCID and NNT were similar between patient and physician groups. The low mean MCID and NNT values likely reflect the importance of the outcome studied (avoiding pregnancy loss) and the perceived safety of the proposed interventions of LMWH and/or ASA, which is supported by qualitative data from patient interviews. While the MCID and NNT responses were similar among physicians and patients, the understanding of statistics was somewhat limited in both groups. By better understanding patients' rationale and beliefs about LMWH use, we can better engage them in clinical trial planning and patient care and ensure that we are performing research that is relevant to patients. Disclosures Skeith: Leo Pharma: Honoraria; CSL Behring: Research Funding. Rodger:Biomerieux: Research Funding.

Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire

2009 ◽  
Vol 36 (6) ◽  
pp. 1304-1311 ◽  
Author(s):  
ROBERT M. BENNETT ◽  
ANDREW G. BUSHMAKIN ◽  
JOSEPH C. CAPPELLERI ◽  
GERGANA ZLATEVA ◽  
ALESIA B. SADOSKY
Keyword(s):  
Clinical Utility ◽  
Minimal Clinically Important Difference ◽  
Fibromyalgia Impact Questionnaire ◽  
Pooled Analysis ◽  
Meaningful Change ◽  
Clinically Important Difference ◽  
Patient Global Impression ◽  
Change In The Mean ◽  
The Mean ◽  
Global Impression Of Change

Objective.The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories.Methods.Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor.Results.A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.Conclusion.The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

Minimal Clinically Important Difference of the Standardized Cosmesis and Health Nasal Outcomes Survey

2019 ◽  
Vol 39 (8) ◽  
pp. 837-840 ◽  
Author(s):  
Cherian K Kandathil ◽  
Mikhail Saltychev ◽  
Mohamed Abdelwahab ◽  
Emily A Spataro ◽  
Sami P Moubayed ◽  
...  
Keyword(s):  
Nasal Obstruction ◽  
Minimal Clinically Important Difference ◽  
Tertiary Referral ◽  
Tertiary Referral Center ◽  
Clinically Important Difference ◽  
Symptom Evaluation ◽  
The Mean ◽  
O 18 ◽  
Preoperative Score

AbstractBackgroundThe minimal clinically important difference (MCID) for the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) has not been determined.ObjectivesThe authors sought to define the MCID for both domains of the SCHNOS questionnaire.MethodsThis prospective cohort study included patients who underwent functional, cosmetic, or combined rhinoplasty operation from June 2017 to June 2018 at a tertiary referral center. The average preoperative, postoperative, and change in scores were calculated for the nasal obstruction symptom evaluation scale (NOSE) and SCHNOS. Anchor-based MCIDs were estimated for both SCHNOS subscales to define change in obstruction and cosmesis perceived after the rhinoplasty.ResultsEighty-seven patients (69% women, 31% males) with a mean age (standard deviation [SD]) of 38 years (14.7) at the time of surgery were included. The mean postoperative follow-up period (SD) was 145 days (117). The mean preoperative score (SD) for the NOSE was 52 (32), SCHNOS for nasal obstruction (SCHNOS-O) score was 55 (33), and SCHNOS for nasal cosmesis (SCHNOS-C) score was 50 (26) points. Postoperatively, the NOSE score was 23 (22), SCHNOS-O score was 24 (23), and SCHNOS-C score was 13 (18) points. The mean change in scores (SD) for NOSE, SCHNOS-O, and SCHNOS-C was −29 (37), −31 (38), and −37 (28), respectively. The calculated MCID for SCHNOS-O was 26 (16) and for SCHNOS-C was 22 (15) points. The MCID for NOSE was 24 (13) points. A sensitivity test for the patients with a follow-up ≥3 months showed only slightly different MCID estimates: 28 (17) for SCHNOS-O, 18 (13) for SCHNOS-C, and 24 (15) points for NOSE.ConclusionsFor the obstruction domain SCHNOS-O, the MCID was 28 points. For the cosmetic domain SCHNOS-C, the MCID was 18 points.

scholarly journals Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Robert A. Hauser ◽  
Mark Forrest Gordon ◽  
Yoshikuni Mizuno ◽  
Werner Poewe ◽  
Paolo Barone ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Minimal Clinically Important Difference ◽  
Rating Scale ◽  
Immediate Release ◽  
Double Blind ◽  
Clinically Important Difference ◽  
Parallel Group ◽  
The Mean ◽  
Off Time

Background. The minimal clinically important difference (MCID) is the smallest change in an outcome measure that is meaningful for patients.Objectives. To calculate the MCID for Unified Parkinson’s Disease Rating Scale (UPDRS) scores in early Parkinson’s disease (EPD) and for UPDRS scores and “OFF” time in advanced Parkinson’s disease (APD).Methods. We analyzed data from two pivotal, double-blind, parallel-group trials of pramipexole ER that included pramipexole immediate release (IR) as an active comparator. We calculated MCID as the mean change in subjects who received active treatment and rated themselves “a little better” on patient global impression of improvement (PGI-I) minus the mean change in subjects who received placebo and rated themselves unchanged.Results. MCIDs in EPD (pramipexole ER, pramipexole IR) for UPDRS II were −1.8 and −2.0, for UPDRS III −6.2 and −6.1, and for UPDRS II + III −8.0 and −8.1. MCIDs in APD for UPDRS II were −1.8 and −2.3, for UPDRS III −5.2 and −6.5, and for UPDRS II + III −7.1 and −8.8. MCID for “OFF” time (pramipexole ER, pramipexole IR) was −1.0 and −1.3 hours.Conclusions. A range of MCIDs is emerging in the PD literature that provides the basis for power calculations and interpretation of clinical trials.

scholarly journals Minimal clinically important difference and minimal detectable change of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) amongst patients with chronic musculoskeletal pain

2020 ◽  
Vol 34 (12) ◽  
pp. 1506-1511
Author(s):  
Niina Katajapuu ◽  
Ari Heinonen ◽  
Mikhail Saltychev
Keyword(s):  
Musculoskeletal Pain ◽  
Minimal Clinically Important Difference ◽  
Chronic Musculoskeletal Pain ◽  
World Health ◽  
Minimal Detectable Change ◽  
Average Intensity ◽  
Detectable Change ◽  
Whodas 2.0 ◽  
Clinically Important Difference ◽  
The Mean

Objectives: The aim of this study is to estimate a minimal clinically important difference (MCID) and a minimal detectable change (MDC) of the 12-item WHODAS 2.0 amongst patients with chronic musculoskeletal pain. Design: Cross-sectional cohort study. Setting: Outpatient Physical and Rehabilitation Medicine clinic. Subjects: A total of 1988 consecutive patients with musculoskeletal pain. Interventions: A distribution-based approach was employed to estimate a minimal clinically important difference, a minimal detectable change, and a minimal detectable percent change (MDC%). Results: The mean age of the patients was 48 years, and 65% were women. The average intensity of pain was 6,3 (2.0) points (0–10 numeric rating scale) and the mean WHODAS 2.0 total score was 13 (9) points out of 48. The minimal clinically important difference ranged between 3.1 and 4.7 points. The minimal detectable change was 8.6 points and minimal detectable % change was unacceptably high 66%. Conclusions: Amongst patients with chronic musculoskeletal pain, the 12-item WHODAS 2.0 demonstrated a high minimal detectable change of almost nine points. As the minimal detectable change exceeded the level of minimal clinically important difference, nine points were considered to be the amount of change perceived by a respondent as clinically significant.

scholarly journals Weather sensitivity associated with quality of life in patients with fibromyalgia

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Kazuhiro Hayashi ◽  
Kenji Miki ◽  
Noriyuki Hayashi ◽  
Ryota Hashimoto ◽  
Masao Yukioka
Keyword(s):  
Quality Of Life ◽  
Minimal Clinically Important Difference ◽  
Rating Scale ◽  
Multivariable Analysis ◽  
Weather Sensitivity ◽  
Clinically Important Difference ◽  
Tertiary Center ◽  
Scale Scores ◽  
The Mean

Abstract Background Fibromyalgia is characterized by chronic widespread pain, and more than half of patients with fibromyalgia report that weather-related variables aggravate their symptoms. However, the differences in actual symptoms have not been measured between those with and without weather sensitivity. The present study aimed to investigate whether weather sensitivity associated with the minimal clinically important difference values of quality of life in patients with fibromyalgia, between those with and without weather sensitivity. Methods Sixty-four consecutive outpatients with fibromyalgia on their first visit to our tertiary center were included. Weather sensitivity was measured using self-perceived symptoms. Pain intensity was measured using the 0–10 Numerical Rating Scale (NRS). Quality of life was measured using the Euro Quality of life-5 Dimensions-3 level (EQ-5D-3L) scale. The variables were subjected to univariable and multivariable analysis using the EQ-5D-3L scale. Results The mean age of the patients was 50 years. Forty-eight patients (75%) were women. The mean EQ-5D-3L score was 0.55. Thirty-seven patients (58%) reported weather sensitivity. In univariable analysis, the welfare recipient, weather sensitivity, and NRS values were associated with EQ-5D-3L scale scores. In multivariable analysis, NRS value and weather sensitivity were independently associated with EQ-5D-3L scale scores. The NRS and EQ-5D-3L scale scores were significantly worse in those with weather sensitivity than those without weather sensitivity. The difference in NRS values was less than 1.5 points between groups. The differences in EQ-5D-3L scale scores were 0.16 points between groups. Conclusions Weather sensitivity was significantly associated with quality of life in patients with fibromyalgia. There was an association with weather sensitivity and the minimal clinically important difference values of quality of life in patients with fibromyalgia. The presence of weather sensitivity could have a key role in the quality of life in patients with fibromyalgia.

Long-term functional outcome of surgical treatment for degenerative cervical myelopathy

2021 ◽  
pp. 1-11
Author(s):  
Mark D. Dijkman ◽  
Martine W. T. van Bilsen ◽  
Michael G. Fehlings ◽  
Ronald H. M. A. Bartels
Keyword(s):  
Surgical Treatment ◽  
Functional Outcome ◽  
Cervical Myelopathy ◽  
Minimal Clinically Important Difference ◽  
Clinically Important Difference ◽  
Surgical Data ◽  
The Mean ◽  
Degenerative Cervical Myelopathy

OBJECTIVE Degenerative cervical myelopathy (DCM) is a major global cause of spinal cord dysfunction. Surgical treatment is considered a safe and effective way to improve functional outcome, although information about long-term functional outcome remains scarce despite increasing longevity. The objective of this study was to describe functional outcome 10 years after surgery for DCM. METHODS A prospective observational cohort study was undertaken in a university-affiliated neurosurgery department. All patients who underwent surgery for DCM between 2008 and 2010 as part of the multicenter Cervical Spondylotic Myelopathy International trial were included. Participants were approached for additional virtual assessment 10 years after surgery. Functional outcome was assessed according to the modified Japanese Orthopaedic Association (mJOA; scores 0–18) score at baseline and 1, 2, and 10 years after surgery. The minimal clinically important difference was defined as 1-, 2-, or 3-point improvement for mild, moderate, and severe myelopathy, respectively. Outcome was considered durable when stabilization or improvement after 2 years was maintained at 10 years. Self-evaluated effect of surgery was assessed using a 4-point Likert-like scale. Demographic, clinical, and surgical data were compared between groups that worsened and improved or remained stable using descriptive statistics. Functional outcome was compared between various time points during follow-up with linear mixed models. RESULTS Of the 42 originally included patients, 37 participated at follow-up (11.9% loss to follow-up, 100% response rate). The mean patient age was 56.1 years, and 42.9% of patients were female. Surgical approaches were anterior (76.2%), posterior (21.4%), or posterior with fusion (2.4%). The mean follow-up was 10.8 years (range 10–12 years). The mean mJOA score increased significantly from 13.1 (SD 2.3) at baseline to 14.2 (SD 3.3) at 10 years (p = 0.01). A minimal clinically important difference was achieved in 54.1%, and stabilization of functional status was maintained in 75.0% in the long term. Patients who worsened were older (median 63 vs 52 years, p < 0.01) and had more comorbidities (70.0% vs 25.9%, p < 0.01). A beneficial effect of surgery was self-reported by 78.3% of patients. CONCLUSIONS Surgical treatment for DCM results in satisfactory improvement of functional outcome that is maintained at 10-year follow-up.

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