COSMIN guideline for systematic reviews of patient-reported outcome measures

Prinsen, Cecilia A.C.; Mokkink, Lidwine B.; Bouter, Lex M.; Alonso, Jordi; Patrick, Donald L.; Vet, Henrica C.W. de; Terwee, Caroline B.

doi:10.1007/s11136-018-1798-3

Cited by 2,038 publications

(4,122 citation statements)

References 32 publications

Supporting

Mentioning

3,798

Contrasting

Unclassified

Order By: Relevance

“…While this study is in line with COSMIN guidelines, 13 it was not powered a-priori for the analyses reported here, and the modest sample size may limit the conclusions that can be made. Only 20% of the participants were >15 months post-stroke by the end of the study; therefore, the findings here may not be generalizable to patients who are beyond that timeframe.…”

Section: Discussionmentioning

confidence: 98%

Convergent Validity and Responsiveness of the SULCS

Knutson

Friedl

Hansen

et al. 2019

Archives of Physical Medicine and Rehabilitation

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 98%

Convergent Validity and Responsiveness of the SULCS

Knutson

Friedl

Hansen

et al. 2019

Archives of Physical Medicine and Rehabilitation

View full text Add to dashboard Cite

show abstract

“…Studies were included that reported original data on cancer patients, and on at least one of the following measurement properties of the IN-PATSAT32 as defined by the COSMIN taxonomy [10–13]: internal consistency, reliability, measurement error, structural validity, hypothesis testing (for construct validity), criterion validity, cross-cultural validity, and responsiveness. Validation studies on other PROMs, which also reported original data on the IN-PATSAT32, were included.…”

Section: Methodsmentioning

confidence: 99%

“…Second, criteria for good measurement properties were applied to the results of the included studies, following the COSMIN guidelines for systematic reviews of PROMs [13]. Each measurement property in each individual study was rated as sufficient (+), insufficient (−), or indeterminate (?…”

Section: Methodsmentioning

confidence: 99%

“…Third, we used the modified GRADE approach [13] to rate the quality of the evidence available for the measurement properties of the IN-PATSAT32. This approach takes into account (i) methodological quality, (ii) directness of evidence, (iii) inconsistency of results, and (iv) precision of evidence.…”

Section: Methodsmentioning

confidence: 99%

“…Evaluating measurement properties requires weighing many variables on both the level of the study and on the level of the PROM. Therefore, the current study used the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria for assessing measurement properties of PROMs [10–13]. …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32

Neijenhuijs

Jansen

Aaronson

et al. 2018

Support Care Cancer

View full text Add to dashboard Cite

PurposeThe EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients’ satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies.MethodsWithin the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.ResultsNine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate.ConclusionIn summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.Electronic supplementary materialThe online version of this article (10.1007/s00520-018-4243-9) contains supplementary material, which is available to authorized users.

show abstract

Guidelines for Reporting Outcomes in Trial Reports

Butcher

Monsour

Mew

et al. 2022

JAMA

255

105

View full text Add to dashboard Cite

ImportanceClinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis.ObjectiveTo develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.Evidence ReviewUsing the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports.FindingsThe scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18).Conclusions and RelevanceThis CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

show abstract

COSMIN guideline for systematic reviews of patient-reported outcome measures

Cited by 2,038 publications

References 32 publications

Convergent Validity and Responsiveness of the SULCS

Convergent Validity and Responsiveness of the SULCS

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32

Guidelines for Reporting Outcomes in Trial Reports

Contact Info

Product

Resources

About