| Literature DB >> 30789024 |
Linzy Houchen-Wolloff1,2,3, Rachael A Evans1,2,4.
Abstract
It is important for clinicians and researchers to understand the effects of treatments on their patients, both at an individual and group level. In clinical studies, treatment effects are often reported as a change in the outcome measure supported by a measure of variability; for example, the mean change with 95% confidence intervals and a probability ( p) value to indicate the level of statistical significance. However, a statistically significant change may not indicate a clinically meaningful or important change for clinicians or patients to interpret. The minimum clinically important difference (MCID) or minimally important difference (MID) has therefore been developed to add clinical relevance or patient experience to the reporting of an outcome measure. In this article, we consider the concept of the MID using the example of practical outcome measures in patients with CRD. We describe the various ways in which an MID can be calculated via anchor- and distribution-based methods, looking at practical examples and considering the importance of understanding how an MID was derived when seeking to apply it to a particular situation. The terms MID and MCID are challenging and often used interchangeably. However, we propose all MIDs are described as such, but they could be qualified by a suffix: MIDS (MID - Statistical), MID-C (MID - Clinical outcome), MID-P (MID - Patient determined). However, this type of classification would only work if accepted and adopted. In the meantime, we advise clinicians and researchers to use an MID where possible to aid their interpretation of functional outcome measures and effects of interventions, to add meaning above statistical significance alone.Entities:
Keywords: Exercise; MCID; MID; lung disease; outcome assessment; physical function; respiratory disease
Mesh:
Year: 2019 PMID: 30789024 PMCID: PMC6323555 DOI: 10.1177/1479973118816491
Source DB: PubMed Journal: Chron Respir Dis ISSN: 1479-9723 Impact factor: 2.444
Figure 1.Example data of the repeatability of the incremental shuttle walk test distance. An example from unpublished data where the mean difference for the two tests is zero, so there is no bias. However, there is significant individual variability described by 2 SD approximately 55 metres for the dataset below. These data can aid clinical interpretation within an individual patient; to be 95% confident that a true change had occurred over time or with an intervention an individual would have to improve by >55 metres.
Described MIDs of commonly used practical outcome measures in CRD with their methods of derivation.
| Exercise test | Primary outcome | Population demographics | Suggested MID | Assessment method | Author |
|---|---|---|---|---|---|
| 6MWT | Distance (m) | Non-CF bronchiectasis, MRC dyspnoea grade ≥1 | 22.3–24.5 m in response to PR | Anchor (ROC) | Lee et al.[ |
| COPD, aged 40–75 years, ≥10 pack-year history | 30 m reduction in response to no intervention (12-month FU) | Anchor (death and/ or hospitalization) | Polkey et al.[ | ||
| Severe COPD, bilateral emphysema, suitable for LVRS | 18.9–30.6 m in response to pre-LVRS PR | Anchor (SGRQ, SOBQ) | Puhan et al.[ | ||
| IPF, baseline 6MWT ≥150 m | 24–45 m in response to interferon gamma-1b | Anchor (death and/or hospitalization) | du Bois et al.[ | ||
| Stable COPD, eligible for PR | 25 m in response to PR | Anchor (patient global rating of change on a 7-point
Likert-type scale, ROC) | Holland et al.[ | ||
| IPF, diagnosed between 3-36 months prior to enrolment, baseline 6MWT 150-499 m | 28 m in response to no intervention (FU for 12-months) | Anchor (SGRQ, FVC %) | Swigris et al.[ | ||
| Diffuse parenchymal disease (50% had IPF), | 29–34 m in response to PR | Anchor (ROC) | Holland et al.[ | ||
| SOBOE Stable COPD | 54 m in response to no intervention | Anchor (social comparison to another patient) | Redelmeier et al.[ | ||
| ISWT | Distance (m) | IPF, eligible for PR | 31–46 m in response to PR | Anchor (patient global rating of change on a 5-point
Likert-type scale) | Nolan et al.[ |
| COPD, eligible for PR | 35.5 m | Anchor (patient global rating of change for ‘changed’ or unchanged’, ROC) | Evans et al.[ | ||
| Non-CF bronchiectasis, MRC dyspnoea grade ≥1 | 35–37 m | Anchor (ROC) | Lee et al.[ | ||
| COPD, eligible for PR | 47.5 m in response to PR | Anchor (patient global rating of change on a 5-point Likert-type scale) | Singh et al.[ | ||
| ESWT | Duration (sec) | COPD, GOLD stage IV, chronic respiratory failure | 186–199 sec in response to PR ± NIPPV (severe hypercapnic COPD) | Anchor (6MWT distance, WR peak, CRQ) | Altenburg et al.[ |
| COPD, mild–severe airflow obstruction | 45–85 sec in response to bronchodilation, unable to confidently estimate a value for response to PR | Anchor (patient global rating of change on a 5-point
Likert-type scale) | Pepin et al.[ | ||
| Incremental cycle test | WR peak (W) | Severe COPD, bilateral emphysema, suitable for LVRS | 4 W in response to pre-LVRS PR (severe COPD) | Anchor (SGRQ, SOBQ) | Puhan et al.[ |
| CWR cycle test | Duration (sec) | Stable COPD, currently not smoking or requiring oxygen | 90–101 sec in response to PR | Anchor (patient global rating of change on a 5-point
Likert-type scale, CRQ-D, ROC curve) | Puente-Maestu et al.[ |
| 5STS | Duration (sec) | Stable COPD, eligible for PR | 1.7 sec in response to PR | Anchor (patient global rating of change on a 5-point Likert-type scale, ISWT, SGRQ) | Jones et al.[ |
| 4MGS | Duration (m.s−1) | Fibrotic ILD, eligible for PR | 0.08–0.11 (m.s−1) in response to PR | Distribution (half SD of the change, MDC 95%) | Nolan et al.[ |
| COPD, eligible for PR | 0.08–0.11 (m.s−1) in response to PR | Anchor (patient global rating of change on a 5-point
Likert-type scale, ISWT) | Kon et al.[ | ||
| TUG | Duration (sec) | COPD, eligible for PR | 0.9–1.4 sec in response to PR | Anchor (6MWT) | Mesquita et al.[ |
CRD: chronic respiratory disease; MID: minimal important difference; 6MWT: six-minute walk test; ISWT: incremental shuttle walking test; ESWT: endurance shuttle walk test; CWR: constant work rate; 5STS: five repetition sit-to-stand; 4MGS: four-metre gait speed; TUG: timed up and go; m: metres; sec: seconds; WR: work rate; W: watts; m.s−1: metres per second; CF: cystic fibrosis; MRC: Medical Research Council; COPD: chronic obstructive pulmonary disease; LVRS: lung volume reduction surgery; IPF: idiopathic pulmonary fibrosis; PR: pulmonary rehabilitation; SOBOE: shortness of breath on exertion; GOLD: global initiative for obstructive lung disease; ILD: interstitial lung disease; FU: follow-up; NIPPV: non-invasive positive pressure ventilation; ROC: receiver operator curve; SEM: standard error of the measurement; SGRQ: St George’s Respiratory Questionnaire; SOBQ: San Diego shortness of breath questionnaire; FVC%: forced vital capacity percent predicted; SD: standard deviation; CRQ: Chronic Respiratory Questionnaire; CRQ-D: dyspnoea domain of the CRQ; MDC95%: minimal detectable change with 95% confidence.