Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time
Abstract:BackgroundAn important challenge of the longitudinal analysis of health-related quality of life (HRQOL) is the potential occurrence of a Response Shift (RS) effect. While the impact of RS effect on the longitudinal analysis of HRQOL has already been studied, few studies have been conducted on its impact on the determination of the Minimal Important Difference (MID). This study aims to investigate the impact of the RS effect on the determination of the MID over time for each scale of both EORTC QLQ-C30 and QLQ-… Show more
“…Third, the possible response shift (RS) effect is a particular concern. The occurrence of the RS effect may bias the results of change in PROs measures scores (Ousmen et al, 2016(Ousmen et al, , 2018. Further research on this topic would thus be needed to investigate how it impacts MID estimates.…”
Aim
Building on previous psychometric work, we aimed to further assess the minimally important difference (MID) of the Oral Health Impact Profile for Chronic Periodontitis (OHIP‐CP).
Methods
In total, 240 consecutive patients with chronic periodontitis were recruited in the study. The OHIP‐CP was completed at baseline and after six weeks. Methodology testing included the confirmatory factor analysis (CFA) and MID. Confirmatory factor analysis (CFA) was performed to assess the fit of the previously proposed three‐factor model. The MID of this questionnaire was determined by applying anchor‐based and distribution‐based approaches.
Results
The CFA supported a three‐factor model for the OHIP‐CP with acceptable fit to the data. The fit indices were χ2/df = 2.231, GFI = 0.935, TLI = 0.969 and CFI = 0.976, RMSEA = 0.076. The OHIP‐CP scores showed significant improvements after treatment (p < .001). The anchor‐based MIDs of OHIP‐CP for “oral function restriction,” “oral pain” and “psychological and social impact,” and total score were 2, 1, 4 and 7 points, respectively. The effect sizes (ES) and standardized response mean (SRM) for the OHIP‐CP were moderate to large.
Conclusions
The MID of the OHIP‐CP is recommended for interpreting clinically meaningful change in oral health‐related quality of life (OHRQoL) over time.
“…Third, the possible response shift (RS) effect is a particular concern. The occurrence of the RS effect may bias the results of change in PROs measures scores (Ousmen et al, 2016(Ousmen et al, , 2018. Further research on this topic would thus be needed to investigate how it impacts MID estimates.…”
Aim
Building on previous psychometric work, we aimed to further assess the minimally important difference (MID) of the Oral Health Impact Profile for Chronic Periodontitis (OHIP‐CP).
Methods
In total, 240 consecutive patients with chronic periodontitis were recruited in the study. The OHIP‐CP was completed at baseline and after six weeks. Methodology testing included the confirmatory factor analysis (CFA) and MID. Confirmatory factor analysis (CFA) was performed to assess the fit of the previously proposed three‐factor model. The MID of this questionnaire was determined by applying anchor‐based and distribution‐based approaches.
Results
The CFA supported a three‐factor model for the OHIP‐CP with acceptable fit to the data. The fit indices were χ2/df = 2.231, GFI = 0.935, TLI = 0.969 and CFI = 0.976, RMSEA = 0.076. The OHIP‐CP scores showed significant improvements after treatment (p < .001). The anchor‐based MIDs of OHIP‐CP for “oral function restriction,” “oral pain” and “psychological and social impact,” and total score were 2, 1, 4 and 7 points, respectively. The effect sizes (ES) and standardized response mean (SRM) for the OHIP‐CP were moderate to large.
Conclusions
The MID of the OHIP‐CP is recommended for interpreting clinically meaningful change in oral health‐related quality of life (OHRQoL) over time.
“…After reading the full text of the remaining 49 articles, three additional articles were excluded as they explored cut-off scores and not MID. Thus, a total of 46 studies were finally included in this review [ 13 , 17 , 19 – 62 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…(2016) [ 43 ] 1262 510 FACT-F VAS of fatigue Ousmen, A. (2016) [ 62 ] 381 74 to 260 EORTC QLQ-C30; QLQ-BR23 Patient’s rating of change Pickard, A.S. (2007) [ 44 ] 534 534 EQ-5D Performance status Purcell, A. (2010) [ 45 ] 210 157 to 199 MFI-20 VAS of the EQ-5D; performance status; treatment impact on fatigue Raman, S. (2016) [ 46 ] 298 201 to 204 EORTC QLQ-BM22, QLQ-C15-PAL Global HRQOL dimension of the QLQ-C15 PAL Raman, S. (2018) [ 47 ] 850 360 to 375 EORTC QLQ-C30, BPI Global HRQOL dimension of the QLQ-C30 Sagberg, L.M.…”
BackgroundInterpretation of differences or changes in patient-reported outcome scores should not only consider statistical significance, but also clinical relevance. Accordingly, accurate determination of the minimally important difference (MID) is crucial to assess the effectiveness of health care interventions, as well as for sample size calculation. Several methods have been proposed to determine the MID. Our aim was to review the statistical methods used to determine MID in patient-reported outcome (PRO) questionnaires in cancer patients, focusing on the distribution- and anchor-based approaches and to present the variability of criteria used as well as possible limitations.MethodsWe performed a systematic search using PubMed. We searched for all cancer studies related to MID determination on a PRO questionnaire. Two reviewers independently screened titles and abstracts to identify relevant articles. Data were extracted from eligible articles using a predefined data collection form. Discrepancies were resolved by discussion and the involvement of a third reviewer.ResultsSixty-three articles were identified, of which 46 were retained for final analysis. Both distribution- and anchor-based approaches were used to assess the MID in 37 studies (80.4%). Different time points were used to apply the distribution-based method and the most frequently reported distribution was the 0.5 standard deviation at baseline. A change in a PRO external scale (N = 13, 30.2%) and performance status (N = 15, 34.9%) were the most frequently used anchors. The stability of the MID over time was rarely investigated and only 28.2% of studies used at least 3 assessment timepoints. The robustness of anchor-based MID was questionable in 37.2% of the studies where the minimal number of patients by anchor category was less than 20.ConclusionEfforts are needed to improve the quality of the methodology used for MID determination in PRO questionnaires used in oncology. In particular, increased attention to the sample size should be paid to guarantee reliable results. This could increase the use of these specific thresholds in future studies.Electronic supplementary materialThe online version of this article (10.1186/s12955-018-1055-z) contains supplementary material, which is available to authorized users.
“…Although correlations fulfilled the pre-set requirements [68], observed correlations were considered weak to moderate. Moreover, it has been argued that GRC estimates could be more related with the follow-up health status score because of a response shift, therefore not certainly representing change from baseline [75]. Next, the division between PR and RCP patients was unequal, therefore providing more weight to PR measurements.…”
Objectives: Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). Study Design and Setting: Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor-and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative Funding: The main RIMTCORE trial (#DRKS00004609) was funded by the Deutsche Rentenversicherung, Germany. The Dutch observational study on COPD health status in routine clinical practice (MCID study) as well as the current combined retrospective analysis of both studies received financial support from the Junior Scientific Masterclass (JSM) as part of the
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
