Dataset Information

Development and validation of a set of patient reported outcome measures to assess effectiveness of asthma prophylaxis.

ABSTRACT:

Background

In the local setting, asthma control is assessed by symptoms and signs elicited by clinicians because of the limited availability of spirometry. Hence, we intended to develop a patient reported outcome measure (PROM) with more holistic interpretation that could also serve as a tool to measure the asthma control in resource limited settings. Therefore, this study was carried out in Northern Sri Lanka to develop and validate the Asthma Control PROM (AC-PROM) Tamil to measure the effectiveness of asthma prophylaxis based on symptoms, exacerbation and limitation of activity which could also serve as an easy measure of asthma control to the provider.

Methods

The AC-PROM Tamil was developed in 3 steps: item generation, item reduction and psychometric evaluation. Items were generated through thematic analysis from focus group discussions among patients with asthma. Items were converted to an interviewer administered questionnaire in Tamil in the format of 5-point Likert scale. Item reduction was done by two rounds of online Delphi surveys among 10 experts and an exploratory factor analysis among 200 patients with asthma. The face and content validity were assessed by a panel of experts during Delphi survey and patients during the pre-test of the tool. Criterion validity of the tool was assessed against the forced expiratory volume in one second of 187 patients with asthma. The cut-off value to assess the asthma control was determined by receiver operating characteristic curve. Reliability was verified by Cronbach's alpha coefficient.

Results

From thematic analysis of focus group discussions 10 items were generated. One item was removed during Delphi survey. Exploratory factor analysis indicated removal of another item with 8 items categorised into two factors. Cronbach's alpha coefficient of factors 1 and 2 were 0.821 and 0.903 respectively, indicating good reliability. Observations made by experts and responses made by patients were incorporated to improve the clarity and relevance of the items. Criterion validity was demonstrated by significant correlation between the AC-PROM Tamil and forced expiratory volume in one second (r = 0.66, p = 0.001). The cut-off value of the AC-PROM Tamil to detect asthma control was 28.5 with 79% (95% CI 71.3-86.9) sensitivity and 71% (95% CI 61.9-79.6) specificity. The AC-PROM Tamil showed moderate accuracy (the area under the receiver operating characteristic curve = 0.796; 95% CI 0.73-0.86). Response rate of the AC-PROM Tamil was 100% and time taken to complete was 3-4 min.

Conclusion

The AC-PROM Tamil is a simple, feasible and reasonably accurate tool to assesses the effectiveness of asthma prophylaxis, particularly in resource limited settings.

SUBMITTER: Guruparan Y

PROVIDER: S-EPMC8449463 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceOutpatient postpartum recovery is an underexplored area of obstetrics. There is currently no consensus regarding which patient-reported outcome measure (PROM) clinicians and researchers should use to evaluate postpartum recovery.ObjectiveTo evaluate PROMs of outpatient postpartum recovery using Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.Evidence reviewAn initial literature search performed in July 2019 identified postpartum recovery PROMs and validation studies. A secondary search in July 2020 identified additional validation studies. Both searches were performed using 4 databases (Web of Science, Embase, PubMed, and CINAHL), with no date limiters. Studies with PROMs evaluating more than 3 proposed outpatient postpartum recovery domains were considered. Studies were included if they assessed any psychometric measurement property of the included PROMs in the outpatient postpartum setting. The PROMs were assessed for the following 8 psychometric measurement properties, as defined by COSMIN: content validity, structural validity, internal consistency, cross-cultural validity and measurement invariance, reliability, measurement error, hypothesis testing, and responsiveness. Psychometric measurement properties were evaluated in each included study using the COSMIN criteria by assessing (1) the quality of the methods (very good, adequate, doubtful, inadequate, or not assessed); (2) overall rating of results (sufficient, insufficient, inconsistent, or indeterminate); (3) level of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations assessment tool; and (4) level of recommendation, which included class A (recommended for use; showed adequate content validity with at least low-quality evidence for sufficient internal consistency), class B (not class A or class C), or class C (not recommended).FindingsIn total, 15 PROMs (7 obstetric specific and 8 non-obstetric specific) were identified, evaluating outpatient postpartum recovery in 46 studies involving 19 165 women. The majority of psychometric measurement properties of the included PROMs were graded as having very-low-level or low-level evidence. The best-performing PROMs that received class A recommendations were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF. The remainder of the evaluated PROMs had insufficient evidence to make recommendations regarding their use (and received class B recommendations).Conclusions and relevanceThis review found that the best-performing PROMs currently available to evaluate outpatient postpartum recovery were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF; however, these tools all had significant limitations. This study highlights the need to focus future efforts on robustly developing and validating a new PROM that may comprehensively evaluate outpatient postpartum recovery.

Project description:ObjectivesTo examine the acceptability and validity of two patient-reported outcome measures (PROMs) for adult acne, comparing them to the validated Acne-specific Quality of Life (Acne-QoL) measure.DesignMixed-methods validation study.SettingParticipants were recruited by (1) mail-out through primary care if they had ever consulted for acne and received a prescription for acne treatment within the last 6 months, (2) opportunistically in secondary care and (3) poster advertisement in community venues.Participants221 (204 quantitative and 17 qualitative) participants with acne, aged 18-50 years.Outcome measuresQuantitative sub-study participants completed Acne-QoL, Skindex-16 and Comprehensive Acne Quality of Life Scale (CompAQ) at baseline, 24 hours and 6 weeks. Qualitative sub-study participants took part in cognitive think-aloud interviews, while completing the same measures. Transcribed audio recordings were analysed using inductive thematic analysis.ResultsQuantitative analyses suggested high internal consistency (Cronbach's alpha 0.74-0.96) and reliability (intraclass correlation coefficient values 0.88-0.97) for both questionnaires. Both scales showed floor effects on some subdomains. Skindex-16 and CompAQ showed good evidence of construct validity when compared with Acne-QoL with Spearman's correlation coefficients 0.54-0.81, and good repeatability over 24 hours.Qualitative data uncovered wide-ranging views regarding usability and acceptability. Interviewees held strong but differing views about layout, question/response wording, redundant/similar questions and guidance notes. Similarly, interviewees differed in perceptions of acceptability of the different scales, particularly on relatability of questions and emotive reactions to scales.ConclusionsAll PROMs performed well in statistical analyses. No PROM showed superior usability and acceptability in the qualitative study. Any PROM should be acceptable for further research in adult acne but researchers should consider the different domains and whether they will measure only facial or facial and trunk acne before making a selection. A new PROM or further evaluation of novel PROMs may be beneficial.

Project description:BackgroundInfertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. A variety of patient-reported outcome (PRO) measures to assess infertility-related QoL are available; however, there is a concern regarding potential issues with their development methodology, validation and use. This review aimed to i) identify PRO measures used in infertility interventional studies ii) assess validation evidence to identify a reliable, valid PRO measure to assess changes in QoL or treatment satisfaction in clinical studies with female patients following treatment with novel therapies iii) identify potential gaps in evidence for validity.MethodsA structured literature search of Medline, Embase, and the Cochrane Library (accessed in September 2015) was conducted using pre-defined search terms. The identified publications were reviewed applying eligibility criteria to select interventional female infertility studies using PROs. Infertility-specific PRO measures assessing QoL, treatment satisfaction or psychiatric health, and included in studies by ≥2 research groups were selected and critically reviewed in light of scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity, psychometric strength, and patient acceptability.ResultsThe literature search and hand-searching yielded 122 publications; 78 unique PRO measures assessing QoL, treatment satisfaction or psychiatric health were identified. Five PRO measures met the selection criteria for detailed review: Fertility Quality of Life (FertiQoL); Fertility Problem Inventory (FPI); Fertility Problem Stress (FPS); Infertility Questionnaire (IFQ); Illness Cognitions Questionnaire adapted for Infertility (ICQ-I). None of the PRO measures met all validation criteria. The FertiQoL was the most widely used infertility-specific PRO measure to assess QoL in interventional studies, with reasonable evidence for adequate content validity, psychometric strength, and linguistic validation. However, gaps in evidence remain including test-retest reliability and thresholds for interpreting clinically important changes. While the FPI demonstrated reasonable evidence for content and psychometric validity, its utility as an outcome measure is limited by a lack of recall period.ConclusionThe FertiQoL and the FPI are potentially useful measures of infertility-related QoL in interventional studies. Further research is recommended to address gaps in evidence and confirm both PRO measures as reliable assessments of patient outcomes.

Project description:ObjectiveThe objectives of the study were to (1) map questions in epilepsy-specific patient-reported outcome measures (PROMs) of children's health-related quality of life (HRQoL) to a proposed core outcome set (COS) for childhood epilepsy research and (2) gain insight into the acceptability of two leading candidate PROMs.MethodWe identified 11 epilepsy-specific PROMs of children's HRQoL (17 questionnaire versions) in a previous systematic review. Each item from the PROMs was mapped to 38 discrete outcomes across 10 domains of the COS: seizures, sleep, social functioning, mental health, cognition, physical functioning, behavior, adverse events, family life, and global quality of life. We consulted with three children with epilepsy and six parents of children with epilepsy in Patient Public Involvement and Engagement (PPIE) work to gain an understanding of the acceptability of the two leading PROMs from our review of measurement properties: Quality of Life in Childhood Epilepsy (QOLCE-55) and Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL).ResultsSocial Functioning is covered by all PROMs except DISABKIDS and G-QOLCE and Mental Health is covered by all PROMs except G-QOLCE and Hague Restrictions in Childhood Epilepsy Scale (HARCES). Only two PROMs (Epilepsy and Learning Disability Quality of Life (ELDQOL) and Glasgow Epilepsy Outcome Scale (GEOS-YP)) have items that cover the Seizure domain. The QOLCE-55 includes items that cover the domains of Physical Functioning, Social Functioning, Behavior, Mental Health, and Cognition. The CHEQOL parent and child versions cover the same domains as QOLCE-55 except for Physical Functioning and Behavior, and the child version has one item that covers the discrete outcome of Overall Quality of Life and one item that covers the discrete outcome of Relationship with parents and siblings. The QOLCE-55 parent version was acceptable to the parents we consulted with, and CHEQOL parent and child versions were described as acceptable to our child and parent advisory panel members.SignificanceMapping items from existing epilepsy-specific PROMs for children is an important step in operationalizing our COS for childhood epilepsy research, alongside evaluation of their measurement properties. Two leading PROMS, QOLCE-55 and CHEQOL, cover a wide range of domains from our COS and would likely be used in conjunction with assessment tools selected for specific study objectives. The PPIE work provided practical insights into the administration and acceptability of candidate PROMs in appropriate context. We promote our COS as a framework for selecting outcomes and PROMs for future childhood epilepsy evaluative research.