Barriers to impact | Impact Facilitators |
---|---|
PRO trial design | |
Authors not using/citing guidelines to design PRO trials [69, 75, 76] | ●SPIRIT ●SPIRIT-PRO Exta |
Selection of inappropriate PRO time frames of assessment [38, 42, 44, 58] | ●SPIRIT ●SPIRIT-PRO Exta |
Failure to define PRO/HRQL endpoints [47] | ●SPIRIT-PRO Exta |
Selection of inappropriate or invalid PRO measures [42, 44, 50, 52, 54, 57, 60, 66, 67, 69] | ●SPIRIT-PRO Exta ●ISOQOL Minimum Standards for PRO Measures in patient-centered outcomes and comparative effectiveness researcha |
Inappropriate PRO sample size and population [38, 48, 54, 56, 59] | ●SPIRIT ●SPIRIT-PRO Exta |
Issues of bias due to allocation concealment (selection bias), random sequence generation (selection bias), blinding of participants and personnel (performance bias) and blinding of outcomes assessment (detection bias) [57, 68, 69, 75, 76, 79, 82] | ●SPIRIT |
Lack of evidence of PRO translation or cross-cultural validation [53, 57] | ●SPIRIT-PRO Exta |
PRO trial conduct and analysis | |
Low PRO compliance rates [38, 39, 42, 44, 50, 60, 61, 77, 79, 82] | ●SPIRIT-PRO Exta ●SISAQOLa |
Lack of personnel training on administration of PRO instruments [44, 57, 61] | ●SPIRIT-PRO Exta ●SISAQOLa |
Lack of communication between researchers and administrators regarding PRO questionnaires involved in the trial [44] | ●SPIRIT-PRO Exta ●SISAQOLa |
Lack of standardisation of the PRO questionnaire administration process [44, 61] | ●SPIRIT-PRO Exta ●SISAQOLa |
Lack of patient adherence to the PRO component of the study due to questionnaire length or irrelevant content [44, 52, 61] | ●SPIRIT-PRO Exta ●SISAQOLa |
PRO trial reporting | |
Authors not using/citing guidelines to report PRO trials (e.g. CONSORT PRO Extension) [54, 69, 75, 76] | ●CONSORT ●CONSORT-PRO Ext |
Failure to report the a priori PRO hypothesis [39, 50, 54, 58, 59, 62, 63, 69] | ●CONSORT ●CONSORT-PRO Ext ●SPIRIT-PRO Ext |
Failure to report baseline PRO compliance [39, 50, 59, 62, 69] | ●CONSORT |
Failure to report rationale for the chosen PRO instrument [7, 39, 44, 50, 54, 58, 62, 69, 72, 76] | ●CONSORT-PRO Ext ●SPIRIT-PRO Ext |
Failure to report mode of administration of the PRO instrument [44, 47, 48, 50, 54, 58, 62, 63, 75, 76] | ●CONSORT-PRO Ext ●SPIRIT-PRO Ext |
●CONSORT ●SPIRIT-PRO Ext | |
●CONSORT ●CONSORT-PRO Ext | |
Failure to report clinical significance of PRO findings [39, 40, 47, 56, 59, 62, 67, 75] | CONSORT-PRO Ext |
Reporting levels of missing PRO data [7, 39, 52, 58, 59, 62] | ●CONSORT ●CONSORT-PRO Ext |
Failure to report statistical methods dealing with missing PRO data [39, 54, 56, 58, 62, 63, 69, 75] | ●CONSORT ●SPIRIT-PRO Ext |
Failure to report generalisability of PRO trial results in the context of clinical outcomes [54, 56, 69, 76, 82] | CONSORT-PRO Ext |
●CONSORT ●SPIRIT-PRO Ext | |
Discrepancies between PRO protocol and PRO trial report [44] | ●CONSORT ●SPIRIT-PRO Ext |
Failure to report PRO data in the main trial publication [47, 48, 54, 59, 63, 72] | ●Publication of HRQL and other clinical outcomes in the main trial report [48, 67, 69, 72] |
Late publication of PRO trial results and in a different journal to the main publication [42, 48, 56, 67, 72, 77] | ●Publication of secondary and timely PRO publication [63, 69] |
●Journals should allow space to report HRQL data alongside other clinical outcomes [50] | |
Barriers to uptake of PRO trial results in practice | |
Lack of familiarity with PRO measures [42, 44, 45, 50, 60, 67, 71] | ●PROlearna ●SPIRIT-PRO Ext ●Provide training to clinicians to gain confidence regarding the validity and reliability of HRQL instruments [67] |
Lack of training/guidance for clinicians on interpreting PRO data [40, 42, 44, 45, 48, 50, 53, 58, 66, 67, 69] | ●PROlearna ●Training for clinicians to understand clinical interpretation of HRQL data [48, 50] ●Clinician’s checklist for reading and using an article about patient-reported outcomesa |
Clinicians concerns about the PRO results being biased by missing data [77] | ●PROlearna ●Provide training to clinicians to gain confidence regarding the validity and reliability of HRQL instruments [67] ●Clinician’s checklist for reading and using an article about patient-reported outcomesa |
Lack of evidence of generalisability of PRO/HRQL results [42, 53, 67, 71] | ●CONSORT ●Clinician’s checklist for reading and using an article about patient-reported outcomesa |
Concerns that the PRO results were chance findings arising from multiple testing [77] | ●PROlearna ●Provide training to clinicians to gain confidence regarding the validity and reliability of HRQL instruments [67] ●Clinician’s checklist for reading and using an article about patient-reported outcomesa |
Researchers failure to present PRO data in a way that is accessible to patients and clinicians [54, 69] | Use of graphical methods to present PRO results [42, 44, 48, 50] ●Stakeholder-driven, evidence-based standards for presenting PROs in clinical practicea |
Lack of time to discuss PRO outcomes with patients [67] | ●PROlearna ●Provide consistent and improved HRQL data reports and a summary of the clinical implications of the HRQL results [67] ●Provide training to clinicians to gain confidence regarding the validity and reliability of HRQL instruments [67] |
Overburden of staff, clinicians, participants and resources [42, 44, 56, 61] | ●SPIRIT-PRO Exta |