A review of patient-reported outcome measures to assess female infertility-related quality of life
Abstract Background Infertility 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 d...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Health and Quality of Life Outcomes |
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| Online Access: | http://link.springer.com/article/10.1186/s12955-017-0666-0 |
| _version_ | 1818536336006578176 |
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| author | Helen Kitchen Natalie Aldhouse Andrew Trigg Roberto Palencia Stephen Mitchell |
| author_facet | Helen Kitchen Natalie Aldhouse Andrew Trigg Roberto Palencia Stephen Mitchell |
| author_sort | Helen Kitchen |
| collection | DOAJ |
| description | Abstract Background Infertility 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. Methods A 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. Results The 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. Conclusion The 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. |
| first_indexed | 2024-12-11T18:36:38Z |
| format | Article |
| id | doaj.art-e7033b5a1e7941e38c437d147b755f90 |
| institution | Directory Open Access Journal |
| issn | 1477-7525 |
| language | English |
| last_indexed | 2024-12-11T18:36:38Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Health and Quality of Life Outcomes |
| spelling | doaj.art-e7033b5a1e7941e38c437d147b755f902022-12-22T00:54:44ZengBMCHealth and Quality of Life Outcomes1477-75252017-04-0115111210.1186/s12955-017-0666-0A review of patient-reported outcome measures to assess female infertility-related quality of lifeHelen Kitchen0Natalie Aldhouse1Andrew Trigg2Roberto Palencia3Stephen Mitchell4DRG AbacusDRG AbacusDRG AbacusFerring Pharmaceuticals A/SDRG AbacusAbstract Background Infertility 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. Methods A 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. Results The 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. Conclusion The 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.http://link.springer.com/article/10.1186/s12955-017-0666-0Female infertilityQuality of lifePatient-reported outcomesPsychometricValidation |
| spellingShingle | Helen Kitchen Natalie Aldhouse Andrew Trigg Roberto Palencia Stephen Mitchell A review of patient-reported outcome measures to assess female infertility-related quality of life Health and Quality of Life Outcomes Female infertility Quality of life Patient-reported outcomes Psychometric Validation |
| title | A review of patient-reported outcome measures to assess female infertility-related quality of life |
| title_full | A review of patient-reported outcome measures to assess female infertility-related quality of life |
| title_fullStr | A review of patient-reported outcome measures to assess female infertility-related quality of life |
| title_full_unstemmed | A review of patient-reported outcome measures to assess female infertility-related quality of life |
| title_short | A review of patient-reported outcome measures to assess female infertility-related quality of life |
| title_sort | review of patient reported outcome measures to assess female infertility related quality of life |
| topic | Female infertility Quality of life Patient-reported outcomes Psychometric Validation |
| url | http://link.springer.com/article/10.1186/s12955-017-0666-0 |
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