. 2019 Oct 16;17:156. doi: 10.1186/s12955-019-1220-z

Table 2.

Barriers and facilitators to maximising PRO trial data

Barriers to impact	Impact Facilitators
PRO trial design
Authors not using/citing guidelines to design PRO trials [69, 75, 76]	●SPIRIT ●SPIRIT-PRO Ext^a
Selection of inappropriate PRO time frames of assessment [38, 42, 44, 58]	●SPIRIT ●SPIRIT-PRO Ext^a
Failure to define PRO/HRQL endpoints [47]	●SPIRIT-PRO Ext^a
Selection of inappropriate or invalid PRO measures [42, 44, 50, 52, 54, 57, 60, 66, 67, 69]	●SPIRIT-PRO Ext^a ●ISOQOL Minimum Standards for PRO Measures in patient-centered outcomes and comparative effectiveness research^a
Inappropriate PRO sample size and population [38, 48, 54, 56, 59]	●SPIRIT ●SPIRIT-PRO Ext^a
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 Ext^a
PRO trial conduct and analysis
Low PRO compliance rates [38, 39, 42, 44, 50, 60, 61, 77, 79, 82]	●SPIRIT-PRO Ext^a ●SISAQOL^a
Lack of personnel training on administration of PRO instruments [44, 57, 61]	●SPIRIT-PRO Ext^a ●SISAQOL^a
Lack of communication between researchers and administrators regarding PRO questionnaires involved in the trial [44]	●SPIRIT-PRO Ext^a ●SISAQOL^a
Lack of standardisation of the PRO questionnaire administration process [44, 61]	●SPIRIT-PRO Ext^a ●SISAQOL^a
Lack of patient adherence to the PRO component of the study due to questionnaire length or irrelevant content [44, 52, 61]	●SPIRIT-PRO Ext^a ●SISAQOL^a
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
Failure to report timing of PRO assessment [37, 58, 59]	●CONSORT ●SPIRIT-PRO Ext
Failure to report methods of PRO data collection [62, 63]	●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
Selective reporting of PRO results [7, 75, 76]	●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]
Journal word restrictions [54, 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]	●PROlearn^a ●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]	●PROlearn^a ●Training for clinicians to understand clinical interpretation of HRQL data [48, 50] ●Clinician’s checklist for reading and using an article about patient-reported outcomes^a
Clinicians concerns about the PRO results being biased by missing data [77]	●PROlearn^a ●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 outcomes^a
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 outcomes^a
Concerns that the PRO results were chance findings arising from multiple testing [77]	●PROlearn^a ●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 outcomes^a
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 practice^a
Lack of time to discuss PRO outcomes with patients [67]	●PROlearn^a ●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 Ext^a

ISOQOL Minimum Standards for PRO Measures in patient-centred outcomes and comparative effectiveness research [83]. CONSORT (Consolidated Standards of Reporting Trials) [84]. CONSORT-PRO Extension [58]. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trial) [85]. SPIRIT-PRO Extension [3]. SISAQOL (The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data) [86]. Stakeholder-driven, evidence-based standards for presenting PROs in clinical practice [87]. Clinician’s checklist for reading and using an article about patient-reported outcomes [88]. PRO Learn [89]. Ext Extension

^aAdditional resources identified through expert communication