Dataset Information

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

ABSTRACT:

Objective

CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales.

Design

Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs.

Setting

Seven cleft centres in Canada, the USA, and UK were involved.

Patients/participants

Patients were aged eight to 29 years with CL/P.

Interventions

Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale).

Main outcome measure(s)

The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong.

Results

Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported.

Conclusions

Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

SUBMITTER: Miroshnychenko A

PROVIDER: S-EPMC9900191 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

Miroshnychenko Anna A Rae Charlene C Riff Karen Wong KW Forrest Christopher C Goodacre Tim T Swan Marc M Slator Rona R Goldstein Jesse J Thoma Achilleas A Harman Karen K Klassen Anne A

The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association 20211217 3

<h4>Objective</h4>CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales.<h4>Design</h4>Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs.<h4>Setting</h4>Seven cleft centres in Canada, the USA, and UK were involved.<h4>P ...[more]

PMID: 34919453

Similar Datasets

Project description:Background Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research. This study, provides the evidence for construct validity of the HM-PRO, specifically focusing on the convergent and divergent validity compared to the other established instruments used in hematology. Methods This validation study adopted a prospective cross-sectional design where a heterogeneous group of patients diagnosed with different HMs and different disease state were recruited. A total of 905 patients were recruited from seven secondary care hospitals in the UK and online through five patient organizations. Patients were asked to complete the HM-PRO and other cancer specific PRO’s, FACT-G and EORTC QLQ C-30. Data analysis was performed using IBM SPSS 23 statistical software. Results A total of 486 males (53.7%) and 419 females (46.3%), with a mean age of 64.3 (± 12.4) years and mean time since diagnosis of 4.6 ( ± 5.2) were recruited. The total score of Part A of the HM-PRO highly correlated with the five functional scales of the EORTC QLQ-C30 (Physical = ?0.71, Role = ?0.72, Emotional = ?0.64, Cognitive = ?0.58, Social = ?0.74—p < 0.001). With respect to correlation with FACT-G, the total score of Part A of the HM-PRO highly correlated with Physical (?0.74), Emotional (?0.57), Functional (?0.66) domains and overall score of FACT-G (?0.74). Similarly, the total score of Part B of the HM-PRO highly correlated with three symptoms scales of EORTC QLQ-C30 (Fatigue scale = ?0.74, Nausea and Vomiting = ?0.52, Pain = ?0.59—p < 0.001) and individual symptom items (Dyspnea = 0.51, Insomnia= 0.43, Appetite loss = 0.54—p < 0.001). Conclusion The construct validity evidence presented in this research is a testimony to the HM-PRO’s ability to measure HRQoL issues which it intends to measure. This is of utmost importance when a PRO is used in routine clinical practice so that the interpretation of the scores or response to an individual item is understood by the clinicians/nurses as intended by the patients.

Project description:BackgroundDespite a focus on patient-reported outcome measures (PROM) in maternity care, a standardized tool is lacking. Current existing measures often focus on a single dimension of postpartum health.ObjectiveThis study evaluated the construct validity of using a suite of PROMs based on the top psychometrically validated tools available. They were combined to achieve coverage of all important aspects of postpartum well-being outlined by the International Consortium of Health Outcomes (ICHOM).MethodsRecruitment took place in a tertiary university maternity hospital between April 3rd 2023, and October 28th 2023, with final responses collected in January 2024. Postnatal women were recruited before hospital discharge and consented to completing the PROM tool which consisted of the Postpartum Quality of Life (PQoL) tool, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and 2 additional questions on pelvic pain with sexual intercourse. The PROM was administered at T1=first week postpartum, T2=6 weeks and T3=12 weeks postpartum. We evaluated the construct validity of these tools through hypothesis testing, proposing that: (1) the instrument should differentiate between groups with and without morbidity, (2) the instrument should differentiate between groups based on delivery type, and (3) should detect change over the postpartum period. Statistical analyses, including chi-square tests, repeated measures ANOVA, and independent t-tests, were used for data analysis.Results534 women were recruited, with an average age of 32 years (±5.0), 90.6% (n=484) had term deliveries, 59% (n=316) were multiparous, 40% (n=216) had spontaneous vaginal deliveries (SVD), 12% (n=63) had operative vaginal deliveries and 47.7% (n= 255) had caesarean sections. Examining the tools' ability to detect changes based on morbidity found no significant differences in PQoL, ICIQ-UI SF or pelvic pain scores between groups with and without maternal morbidity. There were also no differences found in the scores of mothers who had babies admitted to the Neonatal Unit (NNU). Examining score differences based on delivery type, found no variations in total PQoL scores across all timepoints. There were no score differences at other time points in the ICIQ-UI SF or pelvic pain question scores. The PQoL, ICIQ-UI SF and the pelvic pain with sexual intercourse questions had statistically significant difference in their overall scores over the 3 timepoints of the study. The PQoL scores were T1: 128 [ ± 9.67], T2: 125 [ ± 8.47], and T3: 126 [ ± 8.51] P=.002. The ICIQ-UI SF had a median score and interquartile ranges of T1: 7.7 (IQR=6), T2: 9 (IQR=7), and T3: 9 (IQR=7), P=<.001. The pelvic pain with intercourse questions median score was T1: 6 (IQR=2), T2: 5.5 (IQR=2) and T3: 4 (IQR=2), P=.4957.ConclusionWhile this suite of PROMs demonstrated sensitivity in detecting changes in postpartum well-being over time, it did not consistently discern differences based on morbidity (maternal or neonatal) or on delivery type. These findings suggest the need for a more clinically relevant postpartum PROM.

Project description:PurposeRecurrent urinary tract infection (rUTI) is a highly prevalent condition associated with significant poor quality of life outcomes. A patient-reported outcome measure (PROM) of rUTI-associated psychosocial impact is urgently required to supplement clinical evaluation and validate the challenges experienced by patients. This study therefore developed and validated the Recurrent UTI Impact Questionnaire (RUTIIQ).MethodsA rigorous four-stage methodology was followed: (I) concept elicitation through a qualitative survey of the experiences of people with rUTI (N = 1983); (II) Delphi expert screening of the RUTIIQ with expert rUTI clinicians (N = 15); (III) one-to-one cognitive interviews with people experiencing rUTI (N = 28) to evaluate the comprehensiveness and comprehensibility of the RUTIIQ, and (IV) full pilot testing of the RUTIIQ with people experiencing rUTI (N = 240) to perform final item reduction and psychometric analysis.ResultsExploratory factor analysis demonstrated a five-factor structure comprising: 'patient satisfaction', 'work and activity interference', 'social wellbeing', 'personal wellbeing', and 'sexual wellbeing', collectively accounting for 73.8% of the total variance in pilot scores. Results from expert clinicians and patients indicated strong item content validity (I-CVI > .75). The internal consistency and test-retest reliability of the RUTIIQ subscales were excellent (Cronbach's α = .81-.96, ICC = .66-.91), and construct validity was strong (Spearman's ρ > .69).ConclusionThe RUTIIQ is a 30-item questionnaire with excellent psychometric properties, assessing the patient-reported psychosocial impact of living with rUTI symptoms and pain. This new instrument delivers the unique opportunity to enhance patient-centred care through standardised observation and monitoring of rUTI patient outcomes.Trial registrationThis study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900).

Project description:Abstract Background We have previously described the development and content validity of a new patient-reported outcome measure (PRO) to assess patients’ subjective experience of cognitive impairment in schizophrenia: The Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). Here we assess the psychometric properties of the PRECIS PRO in patients with schizophrenia and healthy age-matched controls with the aim of developing a revised version for use in clinical studies. Methods The PRECIS PRO is a 35-item scale comprising eight concept domains (memory, communication, control, planning, handling problems, attention, sharp thinking and overall experience), each with multiple individual items. PRECIS was administered to psychiatrically-healthy controls (single visit), and a subset of patients in a large, clinical trial assessing patients with schizophrenia on stable antipsychotic treatment (NCT02281773) at baseline and Weeks 6, 9 and 12. Analysis of the original 35-item PRECIS PRO included factor structure, factor analysis (FA), internal consistency, test-retest reliability and discriminant (known groups) validity testing. FA was performed on all pre-treatment scores in the patient group (n=410) and patients and controls combined (n=498). Individual items with less than adequate reliability or validity were then identified and eliminated or modified. Results Questionnaire responses were collected from 410 patients with schizophrenia and 88 healthy controls. The mean (standard deviation [SD]) total PRECIS score was significantly lower for healthy controls (1.39 [0.7]) compared with patients (2.06 [1.2]; p<0.0001), as was overall experience domain score (1.41 [0.7] vs 2.35 [1.3]; p<0.0001). For each domain of patient experience, PRECIS mean scores were also significantly lower for healthy controls compared to patients with schizophrenia. The mean differences between groups ranged from -0.94 (overall experience domain) to -0.52 (control domain; p<0.0001, all domains). Patients with schizophrenia had wider response distributions compared with controls, while the control group had marked “floor effects” across most items. Initial exploratory FA of the 35-item PRECIS PRO identified a 6-domain solution that accounted for 62% of total item variance, and Cronbach’s alpha (0.959) indicated an extremely high level of internal consistency. Following analyses of the 35-item PRECIS PRO, a total of 11 items were eliminated based on pre-specified criteria (poor loading onto identified factors, marked floor effects in patient groups or <50% test-retest reliability). Confirmatory FA of the revised 24-item PRECIS PRO identified 1 primary domain (attention) and 3 secondary additional domains (memory, executive function, communication). An additional domain included items related to patient distress or bother related to cognitive impairment. There was a high level of internal consistency both for the overall 24-item PRECIS PRO (Cronbach’s alpha= 0.942) and individual domains (Cronbach’s alphas: 0.743–0.873). Intraclass correlation coefficients were 0.78 for the overall 24-item PRECIS PRO and ranged from 0.49–0.74 for individual domains. Finally, discriminant validity testing confirmed there were significant differences between the patient group and the control group in each of the 5 domains of the revised 24-item PRECIS PRO (p<0.0001). Discussion This large validation study demonstrated that the revised 24-item PRECIS PRO is a valid and reliable PRO measure with good internal consistency, adequate test-retest reliability and strong discriminant validity. PRECIS may therefore serve to define key patient-based endpoints for use in future clinical studies. Funding Boehringer Ingelheim (1289.20)

Dataset Information

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

Objective

Design

Setting

Patients/participants

Interventions

Main outcome measure(s)

Results

Conclusions

Publications

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets