Minimal Important Difference Scores Research Articles

Improving the Impact of BODY-Q Scores Through Minimal Important Differences in Body Contouring Surgery: An International Prospective Cohort Study.

The BODY-Q is a widely used patient-reported outcome measure for comprehensive assessment of treatment outcomes specific to patients undergoing body contouring surgery (BCS). However, for the BODY-Q to be meaningfully interpreted and used in clinical practice, minimal important difference (MID) scores are needed. A MID is defined as the smallest change in outcome measure score that patients perceive as important. The aim of this study was to determine BODY-Q MID estimates for patients undergoing BCS to enhance the interpretability of the BODY-Q. Data from an international, prospective cohort from Denmark, Finland, Germany, Italy, the Netherlands, and Poland were included. Two distribution-based methods were used to estimate MID: 0.2 standard deviations of mean baseline scores and the mean standardized response change of BODY-Q scores from baseline to 3 years postoperatively. A total of 12,554 assessments from 3237 participants (mean age 42.5 ± 9.3 years; BMI 28.9 ± 4.9 kg/m2) were included. Baseline MID scores ranged from 1 to 5 on the health-related quality of life (HRQL) scales and 3 to 6 on the appearance scales. The estimated MID scores from baseline to 3-year follow-up ranged from 4 to 5 for HRQL and from 4 to 8 on the appearance scales. The BODY-Q MID estimates from before BCS to 3 years postoperatively ranged from 4 to 8 and are recommended for interpretation of patients' BODY-Q scores, evaluation of treatment effects of different BCS procedures, and calculation of sample size for future studies.

CTNI-48. SURVIVAL, TOXICITY, AND PATIENT REPORTED QOL OUTCOMES FOLLOWING PULSED REDUCED DOSE RATE RE-IRRADIATION WITH CONCURRENT BEVACIZUMAB FOR RECURRENT GRADE 4 GLIOMAS: RESULTS OF A PHASE II STUDY

Abstract Grade 4 gliomas are aggressive primary brain tumors with dismal prognosis despite maximal treatment. Recurrent disease is typically found within the prior radiation treatment field, complicating reirradiation. Pulsed reduced dose rate (PRDR) radiation is a treatment technique that reduces effective dose rate and increases treatment time allowing for intrafraction repair. Bevacizumab is a systemic VEGF inhibitor with efficacy in treating gliomas. We conducted a phase 2 prospective trial combining PRDR radiation with biweekly bevacizumab (10 mg/kg) in patients with recurrent grade 4 gliomas. Radiation was delivered with reduced dose rate delivered in 20 cGy pulses every 3 minutes in 2 Gy daily fractions to a total dose of 54 Gy. Kaplan Meier analysis was utilized to calculate progression free survival (PFS) and overall survival (OS). Toxicities were evaluated based on Common Terminology Criteria for Adverse Event v5.0 criteria. Mini Mental Status Examination (MMSE), as well as FACT-Brain, and FACIT-Fatigue patient reported quality of life (QoL) surveys were collected at baseline and follow up visits. Minimal important difference scores were calculated using by ½ standard deviation method. A total of 36 patients were enrolled, with 77% having previously received additional therapy for recurrent disease prior to study enrollment. Median PFS was 4.9 months and median OS was 6.9 months. No grade 4+ toxicity was observed. Two patients had grade 3 treatment related toxicity (seizure and radiation necrosis, both PRDR related). Treatment related grade 2 toxicity was seen in 44% of patients, primarily fatigue (30%). Clinically significant decrease in mean MMSE score, and FACT-BR QoL metrics across all sub-domains were noted in follow up. No clinically significant difference in mean FACIT-Fatigue QoL metric was observed. In this prospective phase 2 trial, PRDR with concurrent bevacizumab resulted in encouraging survival outcomes with acceptable toxicity in patients with recurrent grade 4 gliomas.

Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients

The reconstruction module of the BREAST-Q patient-reported outcome measure is frequently used by investigators and in clinical practice. A minimal important difference establishes the smallest change in outcome measure score that patients perceive to be important. To enhance interpretability of the BREAST-Q reconstruction module, the authors determined minimal important difference estimates using distribution-based methods. An analysis of prospectively collected data from 3052 Mastectomy Reconstruction Outcomes Consortium patients was performed. The authors used distribution-based methods to investigate the minimal important difference for the entire patient sample and three clinically relevant groups. The authors used both 0.2 SD units (effect size) and the standardized response mean value of 0.2 as distribution-based criteria. Clinical experience was used to guide and assess appropriateness of results. A total of 3052 patients had BREAST-Q data available for analysis. The average age and body mass index were 49.5 and 26.8, respectively. The minimal important difference estimates for each domain were 4 (Satisfaction with Breasts), 4 (Psychosocial Well-being), 3 (Physical Well-being), and 4 (Sexual Well-being). The minimal important difference estimates for each domain were similar when compared within the three clinically relevant groups. The authors propose that a minimal important difference score of 4 points on the transformed 0 to 100 scale is clinically useful when assessing an individual patient's outcome using the reconstruction module of the BREAST-Q. When designing research studies, investigators should use the minimal important difference estimate for their domain of interest when calculating sample size. The authors acknowledge that distribution-based minimal important differences are estimates and may vary based on patient population and context.

Symptom Profiles in Patients With Irritable Bowel Syndrome or Functional Abdominal Pain Compared With Healthy Controls.

Patient-reported outcome (PRO) measures of gastrointestinal symptoms are recommended to determine treatment effects for irritable bowel syndrome (IBS) and functional abdominal pain (FAP). Study objectives were to compare the symptom profiles of pediatric patients with IBS or FAP with healthy controls and with each other using the PedsQL Gastrointestinal Symptoms and Gastrointestinal Worry Scales, and to establish clinical interpretability of PRO scale scores through identification of minimal important difference (MID) scores. Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 154 pediatric patients and 161 parents (162 families; IBS n = 46, FAP n = 119). Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were administered along with Gastrointestinal Worry Scales. A matched sample of 447 families with healthy children completed the scales. Gastrointestinal Symptoms and Worry Scales distinguished between patients with IBS or FAP compared with healthy controls (P < 0.001), with larger effect sizes (>1.50) for symptoms indicative of IBS or FAP, demonstrating a broad multidimensional gastrointestinal symptom profile and clinical interpretability with MID scores for individual PRO scales. Patients with IBS manifested more symptoms of constipation, gas and bloating, and diarrhea than patients with FAP. Patients with IBS or FAP manifested a broad gastrointestinal symptom profile compared with healthy controls with large differences, indicating the critical need for more effective interventions to bring patient functioning within the range of healthy functioning.

Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores

BackgroundThe Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8...

First MTP joint arthrodesis for the treatment of hallux rigidus: Results of 29 consecutive cases using the foot health status questionnaire validated measurement tool

Background Arthrodesis of the first MTP joint is an accepted and long established joint destructive procedure for the management of hallux rigidus. Objectives This paper presents the results of 29 consecutive first MTP joint arthrodesis procedures for the treatment of hallux rigidus. Method The outcomes of 29 (18 female and 11 male) consecutive arthrodesis procedures were analysed with the Foot Health Status Questionnaire (FHSQ), minimal important difference scores, and a patient satisfaction questionnaire. Results FHSQ foot pain scores improved for 27 (93%) patients; foot function improved for 23 (79%) patients; shoe scores improved for 18 (62%) patients; foot health improved for 20 (68%) patients; general health improved for 12 (41%) patients; physical activity improved for 21 (72%) patients; social capacity improved for 21 (21%) patients; vigour improved for 15 (51%) patients. FHSQ minimal important difference scores were achieved for foot pain in 25 patients (86%); foot function in 17 patients (58%); and general foot health in 19 (65%) patients. Analysis with the matched pairs Wilcoxon rank sum test ( p < 0.05) revealed statistically significant improvement in all FHSQ domains. Female patients appeared to fare better than male patients in all FHSQ categories other than general health and vigour. Conclusion Arthrodesis of the first MTP joint can reliably reduce pain relating to hallux rigidus and can improve foot function and allow a return to physical activity.

The Lower-Limb Tasks Questionnaire: An Assessment of Validity, Reliability, Responsiveness, and Minimal Important Differences

McNair PJ, Prapavessis H, Collier J, Bassett S, Bryant A, Larmer P. The Lower-Limb Tasks Questionnaire: an assessment of validity, reliability, responsiveness, and minimal important differences. Objectives To develop a questionnaire that focuses only on physical tasks related to lower-limb function and, within that questionnaire, to explore the psychometric properties of a series of questions that are related specifically to activities of daily living (ADLs) and a series of activities more often associated with recreation. Design Inception cohort. Setting Private practice. Participants Data were primarily from patients who had experienced a lower-limb injury that would typically involve rehabilitation up to 6 weeks. Interventions Not applicable. Main Outcome Measures Through 5 studies, the following psychometric qualities were evaluated: content and factor validity, construct and concurrent validity, test-retest reliability (intraclass correlation coefficient [ICC], typical error), responsiveness (effect size, standardized response mean, Guyatt’s responsiveness statistic), and the minimum important difference (distribution, anchor-based approaches). Results Factor analysis supported the theoretical perspective that ADLs and recreational activities can be treated as different domains within the construct of function. Internal consistency was high (Cronbach α: ADLs, .91; recreational activities, .95) and the 2 domains explained a moderate level of the response variance (61%). In the ADL domain, 7 tasks had greater than 80% of participants regarding them as having some importance. For recreational activities, 6 tasks had 79% or more of participants regarding them as having some importance. Both domains were moderately correlated to actual performance of tasks ( r = .62, r = .72), and to other questionnaires used for lower-limb injuries ( r range, .51−.86). The floor and ceiling effects of the domains followed an expected pattern that could be related to the loading forces experienced on the injured limb during activities. The reliability of the 2 domains was high (ICCs >.95), and the Bland-Altman plots showed that the distribution of error across the range of scores was random with low bias scores (<1.0 point). Typical error scores were 2 points for each domain. All measures of responsiveness were high (1.2−6.7). Measures of the minimal important difference varied (3−10 points) according to the methodologic approach used. Conclusions The questionnaire possesses good factor structure and composition, relates well with other measures of function, differentiates patients with regard to certain characteristics or processes known to occur after injury, shows high levels of reliability and responsiveness, and shows evidence of good minimal important difference scores. The findings support the use of the questionnaire in both clinical scenarios and in research.

Four methods of estimating the minimal important difference score were compared to establish a clinically significant change in Headache Impact Test

Objective To estimate the smallest decrease in Headache Impact Test (HIT) scores that reflects meaningful clinical change among patients with chronic daily headache (CDH). Study Design and Setting We applied four methods of estimating the minimum important difference (MID) to data from 71 patients with CDH who participated in a clinical trial. The HIT was administered at baseline and at the 6-week follow-up assessment. Patients were considered to have experienced meaningful improvement if they reported that their headache condition was “somewhat better” or “much better” at the 6-week follow-up. Results Mean HIT scores at baseline and 6 weeks for all patients were 64.5 (standard deviation SD = 6.0) and 62.6 (SD = 5.7), respectively. HIT scores decreased 3.7 (SD = 4.4) and 1.4 (SD = 3.6) units, respectively, among patients who reported “somewhat better” change and those who reported no change at 6 weeks. Estimates of the MID of the HIT ranged from −2.7 to −2.3. Conclusions The method that we judge to be most valid estimated the MID of the HIT at −2.3 units (95% confidence interval = −4.3, −0.3). This suggests that a between-group difference in HIT change scores of 2.3 units over time among patients with CDH reflects improvement in patients' headache condition that may be considered clinically significant.