Dataset Information

A Prospective Study to Examine Responsiveness and Minimally Important Differences (MIDs) for the CLEFT-Q Scales Following Three Cleft-Specific Operations.

ABSTRACT: The aim of this study was to examine internal responsiveness and estimate minimally important differences (MIDs) for CLEFT-Q scales.In this prospective cohort study, participants completed the CLEFT-Q appearance and health-related quality of life (HRQL) scales before and six months after cleft-related surgery.Seven cleft centres in Canada, USA and UK participated.Patients were ages 8-29 years with CL/P.Patients underwent rhinoplasty, orthognathic or cleft lip scar revision surgery.Internal responsiveness was examined using Cohen's d effect sizes (ESs) based on the following interpretation: 0.20-0.49 small, 0.50-0.79 moderate and ≥ 0.80 large. MIDs were estimated using two distribution-based approaches.Participants had a rhinoplasty (n = 31), orthognathic (n = 21) or cleft lip scar revision (n = 18) surgery. Most participants were males (56%) and aged 8-11 years (41%). Following rhinoplasty, ESs were larger for the nose (0.92, p = 0.001) and nostrils (0.94, p < 0.001) scales than for the face scale (0.51, p = 0.003). MIDs ranged between 6.2-10.4. For orthognathic surgery, larger ES was observed for the jaws scale (1.80, p < 0.001) compared with the teeth (1.16, p < 0.001), face (1.15, p = 0.001) and lips (0.94, p < 0.001) scales. MIDs ranged between 5.9-14.4. In the cleft lip scar revision sample, the largest ES was observed for the nose scale (0.76, p = 0.03), followed by lips (0.58, p = 0.009) and cleft lip scar (0.50, p = 0.043) scales. MIDs ranged between 6.4-12.3.CLEFT-Q detected change in key outcomes for three cleft-specific surgeries, providing evidence of its responsiveness. Estimated MIDs will aid in interpreting this PROM.

SUBMITTER: Miroshnychenko A

PROVIDER: S-EPMC10018053 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Prospective Study to Examine Responsiveness and Minimally Important Differences (MIDs) for the CLEFT-Q Scales Following Three Cleft-Specific Operations.

Miroshnychenko A A Rae C C Wong Riff K K Forrest C R CR Goodacre T T Swan M C MC Slator R R Goldstein J J Thoma A A Harman K K Klassen A A

The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association 20211214 4

The aim of this study was to examine internal responsiveness and estimate minimally important differences (MIDs) for CLEFT-Q scales.In this prospective cohort study, participants completed the CLEFT-Q appearance and health-related quality of life (HRQL) scales before and six months after cleft-related surgery.Seven cleft centres in Canada, USA and UK participated.Patients were ages 8-29 years with CL/P.Patients underwent rhinoplasty, orthognathic or cleft lip scar revision surgery.Internal respo ...[more]

PMID: 34904896

Similar Datasets

Project description:BackgroundWe managed a cohort of patients treated with minimally invasive surgery (MIS) for a kidney tumor presenting with atypical tumor recurrence (ATR) involving port sites, intraperitoneal carcinomatosis, and nephrectomy bed/perinephric tumor implants.ObjectiveTo determine the clinical characteristics, management, and oncologic outcomes for patients with localized renal cell carcinoma (RCC) who develop ATR following curative-intent MIS for partial or radical nephrectomy.Design setting and participantsThe study cohort comprised patients from 1999 to 2021 with localized RCC managed at Memorial Sloan Kettering Cancer Center (New York, NY, USA) after MIS for partial or radical nephrectomy who developed ATR. Outcome measurements and statistical analysis: We collected data on clinicopathologic characteristics, treatments, time to ATR, and overall survival.Results and limitationsThe median age of the 58 RCC patients was 61 yr. Forty-one patients (71%) were male, 26 (45%) had robot-assisted operations, and 39 (67%) had clear cell RCC. Twenty-nine patients had stage pT1 disease (50%) and ten (17%) had positive surgical margins. The most common ATR site was perinephric/nephrectomy bed implants (n = 28, 48%). Management included: surgical resection alone (n = 11, 19%), systemic therapy alone (n = 12, 21%), surgical resection and systemic therapy (n = 17, 29%), and palliative care (n = 8, 14%). At median follow-up of 59 mo (interquartile range [IQR] 28-92), the median time to ATR was 12 mo (IQR 5-28). Overall survival at 5 yr was 69.0% (95% confidence interval 57.4-83.1%) with only nine patients alive with no evidence of disease. Limitations include the potential for referral, detection, and selection biases, as well as uncertainty regarding the true incidence of ATR.ConclusionsATR following MIS for partial or radical nephrectomy is an understudied, poor prognostic event which leads to a heavy treatment burden. Further investigation into its etiology and means of prevention is warranted.Patient summaryPatients experiencing recurrence of kidney cancer in an atypical site require a heavy treatment burden and have a guarded overall prognosis. Continued research is needed to determine the precise incidence of these recurrences and identify methods for mitigating them.

Project description:BackgroundIn network meta-analysis (NMA), the magnitude of difference between treatment effects is typically ignored in the calculation of ranking metrics, such as probability best and surface under the cumulative ranking curve (SUCRAs). This leads to treatment rankings which may not reflect clinically meaningful differences. Minimally important differences (MIDs) represent the smallest value in a given outcome that is considered by patients or clinicians to represent a meaningful difference between treatments. There is a lack of literature on how MIDs can be incorporated into common NMA ranking metrics such as SUCRAs to give more clinically oriented treatment rankings.MethodsAnalogues to commonly available NMA ranking metrics that account for minimally important differences (MIDs) are provided. In particular, definitions are provided for MID-adjusted median ranks, MID-adjusted probability j th best, MID-adjusted cumulative probability j th best, and MID-adjusted SUCRA values. Since adjustment for MIDs allows for ties between treatments in a network, methods for handling ties in ranking are discussed, with it shown that the midpoint method for handling ties retains the property that the average value of all SUCRA values in a network is one half. Comparability of MID-adjusted P-scores and MID-adjusted SUCRA values is discussed, and a Bayesian software implementation of the MID-adjusted ranking metrics is provided.ResultsTwo real-world applications of MID-adjusted ranking metrics are presented to illustrate their use. Specifically, NMAs are conducted based on published networks on treatments for diabetes and Parkinson's disease. To present the results, MIDs are selected from relevant literature to interpret MID-adjusted ranking metrics for these networks.ConclusionsFailure to consider MIDs when ranking treatments can lead to ranking metrics which are not clinically relevant. Our proposed MID-adjusted Bayesian ranking metrics address this challenge. Further, we show that the use of the midpoint method for addressing ties ensures comparability between standard ranking metrics and MID-adjusted ranking metrics. The methods are easily applied in a Bayesian framework using the R package mid.nma.rank.

Project description:Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice.PerspectiveThis study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates for each measure. This standard of reference can help apply or interpret these instruments in the future.

Dataset Information

A Prospective Study to Examine Responsiveness and Minimally Important Differences (MIDs) for the CLEFT-Q Scales Following Three Cleft-Specific Operations.

Publications

A Prospective Study to Examine Responsiveness and Minimally Important Differences (MIDs) for the CLEFT-Q Scales Following Three Cleft-Specific Operations.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets