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Table 2 Barriers and facilitators to maximising PRO trial data

From: The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

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
 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] 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
  1. 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
  2. aAdditional resources identified through expert communication