Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation
Abstract Background To understand our performance with respect to the collection and reporting of patient-reported outcome (PRO) measure (PROM) data, we examined the protocol content, data completeness and publication of PROs from interventional trials conducted at the Royal Marsden NHS Foundation T...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2022-12-01
|
| Series: | Journal of Patient-Reported Outcomes |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41687-022-00529-9 |
| _version_ | 1797977429281603584 |
|---|---|
| author | Emma Lidington Holly Hogan Ann Gandolfi Jane Lawrence Eugenie Younger Helena Cho Clare Peckitt Kabir Mohammed Sheila Matharu Lisa Scerri Olga Husson Susanne Cruickshank Rachel Turner Linda Wedlake |
| author_facet | Emma Lidington Holly Hogan Ann Gandolfi Jane Lawrence Eugenie Younger Helena Cho Clare Peckitt Kabir Mohammed Sheila Matharu Lisa Scerri Olga Husson Susanne Cruickshank Rachel Turner Linda Wedlake |
| author_sort | Emma Lidington |
| collection | DOAJ |
| description | Abstract Background To understand our performance with respect to the collection and reporting of patient-reported outcome (PRO) measure (PROM) data, we examined the protocol content, data completeness and publication of PROs from interventional trials conducted at the Royal Marsden NHS Foundation Trust (RM) and explored factors associated with data missingness and PRO publication. Design From local records, we identified closed, intervention trials sponsored by RM that opened after 1995 and collected PROMs as primary, secondary or exploratory outcomes. Protocol data were extracted by two researchers and scored against the SPIRIT-PRO (PRO protocol content checklist; score 0–100, higher scores indicate better completeness). For studies with locally held datasets, the information team summarized for each study, PRO completion defined as the number of expected (as per protocol) PRO measurements versus the number of actual (i.e. completed) PRO measurements captured in the study data set. Relevant publications were identified by searching three online databases and chief investigator request. Data were extracted and each publication scored against the CONSORT-PRO (PRO manuscript content checklist; scored as SPIRIT-PRO above). Descriptive statistics are presented with exploratory comparisons of point estimates and 95% confidence intervals. Results Twenty-six of 65 studies were included in the review. Nineteen studies had accessible datasets and 18 studies published at least one article. Fourteen studies published PRO results. Most studies had a clinical (rather than PRO) primary outcome (16/26). Across all studies, responses in respect of 35 of 69 PROMs were published. Trial protocols scored on average 46.7 (range 7.1–92.9) on the SPIRIT-PRO. Among studies with accessible data, half (10/19) had less than 25% missing measurements. Publications scored on average 80.9 (range 36–100%) on the CONSORT-PRO. Studies that published PRO results had somewhat fewer missing measurements (19% [7–32%] vs 60% [− 26 to 146%]). For individual PROMs within studies, missing measurements were lower for those that were published (17% [10–24%] vs 41% [18–63%]). Studies with higher SPIRIT-PRO scores and PROs as primary endpoints (13% [4–22%] vs 39% [10–58%]) had fewer missing measurements. Conclusions Missing data may affect publication of PROs. Extent of inclusion of SPIRIT-PRO protocol items and PROs as primary endpoints may improve data completeness. Preliminary evidence from the study suggests a future larger study examining the relationship between PRO completion and publication is warranted. |
| first_indexed | 2024-04-11T05:06:48Z |
| format | Article |
| id | doaj.art-c1780ba2f12d44dfae66fc7b4666ee16 |
| institution | Directory Open Access Journal |
| issn | 2509-8020 |
| language | English |
| last_indexed | 2024-04-11T05:06:48Z |
| publishDate | 2022-12-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj.art-c1780ba2f12d44dfae66fc7b4666ee162022-12-25T12:18:11ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202022-12-016111010.1186/s41687-022-00529-9Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluationEmma Lidington0Holly Hogan1Ann Gandolfi2Jane Lawrence3Eugenie Younger4Helena Cho5Clare Peckitt6Kabir Mohammed7Sheila Matharu8Lisa Scerri9Olga Husson10Susanne Cruickshank11Rachel Turner12Linda Wedlake13PROFILES Team, The Royal Marsden NHS Foundation TrustPROFILES Team, The Royal Marsden NHS Foundation TrustResearch & Development, The Royal Marsden NHS Foundation TrustResearch & Development, The Royal Marsden NHS Foundation TrustSarcoma Unit, The Royal Marsden NHS Foundation TrustPROFILES Team, The Royal Marsden NHS Foundation TrustResearch & Development, The Royal Marsden NHS Foundation TrustResearch & Development, The Royal Marsden NHS Foundation TrustDigital Services, The Royal Marsden NHS Foundation TrustDigital Services, The Royal Marsden NHS Foundation TrustDivision of Clinical Studies, Institute of Cancer ResearchApplied Health Research, The Royal Marsden NHS Foundation TrustResearch & Development, The Royal Marsden NHS Foundation TrustPROFILES Team, The Royal Marsden NHS Foundation TrustAbstract Background To understand our performance with respect to the collection and reporting of patient-reported outcome (PRO) measure (PROM) data, we examined the protocol content, data completeness and publication of PROs from interventional trials conducted at the Royal Marsden NHS Foundation Trust (RM) and explored factors associated with data missingness and PRO publication. Design From local records, we identified closed, intervention trials sponsored by RM that opened after 1995 and collected PROMs as primary, secondary or exploratory outcomes. Protocol data were extracted by two researchers and scored against the SPIRIT-PRO (PRO protocol content checklist; score 0–100, higher scores indicate better completeness). For studies with locally held datasets, the information team summarized for each study, PRO completion defined as the number of expected (as per protocol) PRO measurements versus the number of actual (i.e. completed) PRO measurements captured in the study data set. Relevant publications were identified by searching three online databases and chief investigator request. Data were extracted and each publication scored against the CONSORT-PRO (PRO manuscript content checklist; scored as SPIRIT-PRO above). Descriptive statistics are presented with exploratory comparisons of point estimates and 95% confidence intervals. Results Twenty-six of 65 studies were included in the review. Nineteen studies had accessible datasets and 18 studies published at least one article. Fourteen studies published PRO results. Most studies had a clinical (rather than PRO) primary outcome (16/26). Across all studies, responses in respect of 35 of 69 PROMs were published. Trial protocols scored on average 46.7 (range 7.1–92.9) on the SPIRIT-PRO. Among studies with accessible data, half (10/19) had less than 25% missing measurements. Publications scored on average 80.9 (range 36–100%) on the CONSORT-PRO. Studies that published PRO results had somewhat fewer missing measurements (19% [7–32%] vs 60% [− 26 to 146%]). For individual PROMs within studies, missing measurements were lower for those that were published (17% [10–24%] vs 41% [18–63%]). Studies with higher SPIRIT-PRO scores and PROs as primary endpoints (13% [4–22%] vs 39% [10–58%]) had fewer missing measurements. Conclusions Missing data may affect publication of PROs. Extent of inclusion of SPIRIT-PRO protocol items and PROs as primary endpoints may improve data completeness. Preliminary evidence from the study suggests a future larger study examining the relationship between PRO completion and publication is warranted.https://doi.org/10.1186/s41687-022-00529-9PROsPROMsPREMsData completenessMissing dataSPIRIT-PRO |
| spellingShingle | Emma Lidington Holly Hogan Ann Gandolfi Jane Lawrence Eugenie Younger Helena Cho Clare Peckitt Kabir Mohammed Sheila Matharu Lisa Scerri Olga Husson Susanne Cruickshank Rachel Turner Linda Wedlake Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation Journal of Patient-Reported Outcomes PROs PROMs PREMs Data completeness Missing data SPIRIT-PRO |
| title | Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation |
| title_full | Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation |
| title_fullStr | Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation |
| title_full_unstemmed | Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation |
| title_short | Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation |
| title_sort | assessing the collection and reporting of patient reported outcome data in interventional cancer trials a single institution retrospective systematic evaluation |
| topic | PROs PROMs PREMs Data completeness Missing data SPIRIT-PRO |
| url | https://doi.org/10.1186/s41687-022-00529-9 |
| work_keys_str_mv | AT emmalidington assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT hollyhogan assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT anngandolfi assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT janelawrence assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT eugenieyounger assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT helenacho assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT clarepeckitt assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT kabirmohammed assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT sheilamatharu assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT lisascerri assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT olgahusson assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT susannecruickshank assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT rachelturner assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation AT lindawedlake assessingthecollectionandreportingofpatientreportedoutcomedataininterventionalcancertrialsasingleinstitutionretrospectivesystematicevaluation |