1. David Tanner OMS-III – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
2. Jaydeep Dhillon OMS-III – Rocky Vista University College of Osteopathic Medicine, Parker, CO
3. Ryan McIntire OMS-III – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
4. Philo Waters OMS-III – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
5. Samuel Shepard OMS-IV – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
6. Audrey Wise OMS-IV – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
7. Benjamin Heigle OMS-IV – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
8. Micah Hartwell PhD – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
9. Matt Vassar PhD – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma

Abstract

Background
Clear and complete reporting of clinical trial publications are critical for adequate reader appraisal. Given the proliferation of patient-reported outcomes in clinical trials, an investigation of their reporting is warranted. 

Objective
Our primary objective was to examine the completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of DRF based on the CONSORT-PRO extension. Our secondary objective was to identify factors associated with more complete reporting.

Methods
We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to locate RCTs published between 2006-2020. To improve the sensitivity of our search, the American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines for the management of DRF were cross-referenced for eligible RCTs. Following duplicate, masked screening by two investigators, the included RCTs were evaluated using the CONSORT-PRO adaptation and assessed each trial for risk of bias using the Cochrane Risk of Bias (RoB) 2.0 tool. Study characteristics were extracted from the trial publications. Data extraction, CONSORT evaluations, and RoB assessments were performed by two independent investigators in a masked, duplicate approach.

Results
Fifty-nine RCTs met inclusion criteria. CONSORT-PRO mean completeness of reporting was 53%. Completeness of reporting was associated with PRO as a primary outcome (t=-2.78, p = .008), increasing sample (Coef: 0.07%, SE=.02; t=2.87, P=.006), and studies published after 2014 (Coef: 11.92%, SE=4.35; t=2.74, P=.008). No significant associations were found with RoB or length of PRO follow-up. 

Conclusion
While the completeness of PRO reporting in RCTs on the management of DRFs has slowly improved since the release of CONSORT-PRO, it still needs significant improvement. If reporting practices can be improved through complete reporting of PROs, the research community could produce high-quality evidence that can be used by clinicians to better inform patient care.

Keywords
Distal Radius Fracture, Evidence-Based Medicine, Patient-Reported Outcome, CONSORT-PRO, Clinical Trial Methodology.

Level of Evidence
N/A

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Introduction
The distal radius is the most common site of fracture in the upper extremity, accounting for nearly one-sixth of all fractures treated in United States emergency departments.^1,2 These injuries are amenable to various treatment strategies, including operative and nonoperative management. Patient outcomes in orthopedics have historically been judged by radiological parameters and objective measures such as the patient’s range of motion and grip strength.³ However, in the last 20 years, a paradigm shift has taken place with patient-reported outcomes (PROs) garnering more value to improve the patient-centered healthcare model.^4,5

The change in focus is represented in a statement from the American Academy of Orthopedic Surgeons 
that for an orthopedic procedure, the best measure of success is the change in patient-reported outcome.⁶ PROs are directly reported by patients to identify how they perceive their health, their response to a particular intervention, or the intervention’s effects on their daily living.⁷ Combining PROs with traditional clinical measures allows physicians to provide comprehensive information to patients when selecting treatment options. This shared decision-making process can help promote the best possible patient outcomes. However, improving patient outcomes depends on accurate, complete, and valid PRO reporting.

In response to the increasing emphasis on patient-centered care, the Consolidated Standards of Reporting Trials (CONSORT) group developed an extension (CONSORT-PRO) to guide reporting of PROs in randomized controlled trials (RCTs).⁸ Created in 2013, CONSORT-PRO aims “to promote transparent reporting of RCTs in which PROs are primary or important secondary outcomes.”⁸ In the field of oncology, previous investigations have illustrated the quality and completeness of reporting PROs evaluating them with CONSORT-PRO.^9–11 Within orthopedics, the use of PRO registries and specific PRO measures have yet to be widely adopted owing to limited time and resources.¹² Despite these limitations, reporting of PROs continues to become more prevalent.^5,13

Because of the prevalence of distal radius fractures (DRFs) and the importance of patient-centered care, a standardized appraisal to assess the completeness of PROs reported in orthopedic RCTs is necessary to reflect accurate PROs. To our knowledge, no research has been conducted on the completeness of PROs in RCTs focused on DRFs. Therefore, this study aims to examine the completeness of reporting of PROs in DRF trials using the CONSORT-PRO adaptation.

Methods

Study Design
We performed a meta-epidemiological study of RCTs relating to distal radius fracture management. We abstracted our data only from published RCTs. Human participants were not involved in our study; thus, Institutional Review Board oversight was not acquired, as it was not defined as a human participant study. Promotion of complete reporting was ensured by following reporting guidelines for meta-epidemiological studies.¹⁴ 

Search Strategy
Through the assistance of a medical research librarian, the Ovid interface was used by one investigator (RO) to search for published RCTs relating to DRF. The following databases were searched: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL). In order to maximize sensitivity for selecting trials, the Cochrane highly sensitive search strategy, a filter validated for OVID interfaces, was used.¹⁵ In order to promote transparency, we uploaded this search string onto Open Science Framework (OSF).¹⁶ To further improve the sensitivity of our search, the American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines for the management of DRF17 were cross-referenced for eligible RCTs.

Eligibility 
We included RCTs, published between the years 2006 and 2020, that address DRF management in which PRO measures were either a primary or secondary outcome. We excluded all studies not written in English. Observational studies, non-human studies, letters to the editor, cost-effectiveness studies, case reports, secondary analyses, meta-analyses, systematic reviews, other reviews, clinical trial protocols, and clinical trials without a PRO measure were excluded. 

Selection Process
We compiled the returns of our literature search and uploaded them to Rayyan (https://rayyan.qcri.org/), a title and abstract screening platform. After deduplication, in a masked, duplicate approach, two independent researchers (DT, JD) carried out the title and abstract screening. Following completion of the initial screening, investigators reconciled all differences in screening through discussion. A third investigator (SS) was available for arbitration but was not required. 

Data Collection Process
We used work published by guideline authors to train for data extraction of the CONSORT-PRO adaptation.^8,18 We carried out a masked, duplicate extraction of CONSORT-PRO, with a pilot-tested Google form, from 3 RCTs not in our sample. We resolved any discrepancies until a consensus was reached for all items on the checklist. This CONSORT-PRO training was done by two investigators (DT, PW). Two other investigators (JD, RM) were trained on the Cochrane RoB 2.0 Tool through the use of videos supplied by Cochrane.19 Similar to our CONSORT-PRO training methodology, in a masked, duplicate fashion, these two investigators (JD, RM) carried out 3 RoB evaluations of RCTs not included in our study. All discrepancies were resolved by the investigators until a consensus was reached. A third investigator (SS) was available for adjudication but was not needed.

Data Items
We evaluated the completion of the CONSORT-PRO adaptation developed by Mercieca-Bebber et al. for all included trials (see scoring of CONSORT-PRO adaptation).¹⁸ Our secondary objective assessed relationships between the mean completeness of PRO reporting and various study characteristics. These study characteristics that we analyzed were: (1) year of publication, (specifically, before or after 2014 –– the year following the publication of CONSORT-PRO) (2) conflict of interest statement, (3) intervention category of RCT, (e.g. device or surgical technique) (4) journal endorsement of CONSORT-PRO, (5) whether an RCT used a PRO as a primary or secondary outcome, (6) reference to CONSORT-PRO within the publication, (7) the length of PRO follow-up time, (8) sample of the trial, and (9) RoB assessed by the Cochrane RoB 2.0 tool (see Scoring RoB). 

The publishing journal’s endorsement of CONSORT guidelines was coded as either: not mentioned, recommended, or required. This data item was evaluated by screening the instructions to authors’ pages for mention of EQUATOR, CONSORT, or CONSORT-PRO guidelines.

The following bias domains were evaluated: (1) bias arising from the randomization process, (2) bias due to deviations from intended interventions, (3) bias due to missing outcome data, (4) bias in measurement of the outcome, (5) bias in selection of the reported result, and (6) overall risk of bias. 

Scoring CONSORT-PRO 
The scoring methodology was adapted from Mercieca-Bebber et al. 2017 as follows.¹⁸ We excluded item 4a of CONSORT-PRO (the use of PROs in eligibility or stratification) from scoring due to the difficulty of verification for this criteria. Instead, we recorded a ‘yes’ or ‘no’ as to whether a study described adherence to this item. We allocated a maximum score value of 0.5 or 1 when reporting for an item was present. Items that were considered ‘complete’ received the maximum value, (1 or 0.5 if the item is double-barreled) whereas items that did not reach maximum value were reported as ‘not complete.’ Item P1b was potentially scored as ‘partially complete’ if the trial reported the PRO measure used, but failed to identify the endpoint of that PRO. Therefore, Item P1b was potentially scored as 0, 0.5, or 1, based on the reported information. Item 7a was dependent on the PRO being reported as the primary outcome of the study. Due to this dependency, RCTs with the PRO as a primary outcome had a maximum score of 15, whereas RCTs with the PRO as a secondary outcome had a maximum score of 14. For each RCT, we calculated a percent completeness of the checklist by summing the total score and dividing by the maximum possible score. 

Evaluating Risk of Bias
To evaluate RoB, we used a decision algorithm developed by the Cochrane Collaboration. If investigators concluded on slightly differing assessments of bias domains (e.g. one investigator answered ‘yes’ and another investigator answered ‘partial yes’), the overall RoB outcome for that particular trial was not altered. Using the Excel tool provided by Cochrane, we assessed the overall risk of bias domain as ‘high’ risk, ‘some concerns’, or ‘low’ risk.^20–22 

Data Analysis
First, we report our search return followed by the frequencies of study characteristics among our sample of RCTs. Next, we calculated the mean completion percentage of each RCT in our sample, and RCTs by outcome category (i.e. RCTs with a primary or secondary PRO outcome). We then report the frequency and percentages of reporting by item of the CONSORT-PRO checklist for each RCT and by outcome category. Finally, we explored relationships between study characteristics and completeness of reporting using bivariate regression analyses.

Reproducibility
Our study protocol, analysis scripts, raw data, extraction forms, and data dictionaries were uploaded to OSF, with the aim of promoting transparency, reproducibility, validity, and reliability of our study.¹⁶ We conducted this investigation in tandem with other studies addressing completeness of reporting in other fields of medicine using similar methodology. 

Results

General characteristics
Our systematic search returned 254 records with 172 remaining after the removal of duplicates. After title and abstract review, 52 studies were included for full-text review. Following our manual search of the AAOS clinical practice guideline, 33 additional RCTs were included for full-text review. Of the 85 full-text articles, 59 studies were included for data extraction. All rationales for excluded studies can be found in Figure 1. 

Across the included RCTs, 39% (23/59) were published prior to 2014 (Table 1). The most common intervention was surgical (30/59, 50.85%). Of the 48 studies that included a conflict of interest statement, 36 (75%) reported no conflicts. Forty-nine (of 59, 83.05%) studies were published in journals that recommended or required CONSORT reporting guidelines. No studies mentioned following CONSORT-PRO guidelines, and one study (of 59, 1.69%) used a PRO measure for eligibility or stratification criteria. The mean sample of included RCTs was 105.98 (SD=92.08). Forty-one (of 59, 69.49%) RCTs had a PRO as a primary outcome, and 18 included a PRO as a secondary outcome.

Completeness of reporting according to the CONSORT-PRO adaptation
The mean percent completion of the CONSORT-PRO checklist adaptation across all RCTs was 53.62% (SD=17.18). The mean completion of reporting among RCTs with a PRO as a primary outcome was 57.40% (SD=16.05), and RCTs with a PRO as a secondary outcome was 44.84% (SD=16.85). 

For all RCTs in this study, item 17aii — results include an estimate of precision –– was the most consistently reported item (56/59; 94.92%; Table 2, Figure 2). Item 6aiii –– mode of questionnaire administration –– was the least reported item. Greater than 90% of RCTs with a PRO as a primary outcome reported the following items: PRO identified as RCT outcome in abstract (P1b) (37/41, 90.24%), evidence of PRO validity (P6ai) (37/41 90.24%), inclusion of baseline PRO in demographics table (15) (37/41, 90.24%), results include an estimate of precision (17aii) (40/41, 97.56%). Less than 25% of studies with primary PRO outcomes reported the following: PRO domains specified in the hypothesis (P2bii) (0/41, 0%), mode of questionnaire administration (P6aiii) (4/41, 9.76%), statistical approach for missing data (P12a) (10/41, 24.39%), reporting results of PRO domains (17ai) (9/41, 21.95%), results of subgroup analyses (18) (7/41, 17.07%). Among studies with secondary PRO outcomes, item 17aii — results include an estimate of precision — was most consistently reported (16/18, 88.89%). RCTs with a PRO as a secondary outcome did not report the following: PRO hypothesis and domains specified in the hypothesis (P2bi and P2bii) and a rationale for PRO outcome (2a). 

Associations between PRO reporting completeness and study characteristics
There were several associations revealed from the bivariate analyses. First, RCTs published in 2014 or later were 11.192% (SE=4.35; Table 1) more complete than RCTs published prior to 2014 (t=2.74, P=.008). Second, RCTs with non-surgical interventions reported 25.04% (SE=11.72) better than RCTs with a combination of interventions (t=2.14, P=.037). Third, RCTs with PROs as primary outcomes reported 12.56% (SE=4.61) more completely compared to RCTs with PROs as a secondary outcome. (t=-2.73, P= .008). Lastly, RCTs with larger sample s were associated with more complete reporting (t=2.87, P=.006). No other significant associations were found. 

Discussion
With the shift to improve patient-centered care through PROs, their complete and accurate reporting in RCTs is essential. To evaluate PRO reporting in RCTs focused on the management of DRFs, we used the adapted CONSORT-PRO checklist. We found substantial gaps in PRO reporting that researchers should address to optimize reporting completeness. 

Among the RCTs in our sample, the mean completeness of PRO reporting was less than optimal. Incomplete reporting has been previously shown to limit the reproducibility of clinical trials.²³ Reproducibility is necessary to evaluate the validity of trial results when the efficacy of a treatment is brought into question.^24,25 Additionally, incomplete reporting is subject to potential bias through selective reporting of outcomes. This changing of outcomes in RCTs can lead to spurious results, reducing the quality of evidence and limiting their use in meta-analyses.26 In our study, complete reporting occurred 53% of the time. This compares to a study in oncology that assessed 557 RCTs and found the mean completeness of PRO reporting to be 45%.¹¹ Despite efforts to improve reporting through published guidelines like CONSORT-PRO, our results show that the completeness of PRO reporting remains variable. 

A commonly underreported item in DRF trials involved the mode of administration of the PRO questionnaire. The primary purpose of PROs is to serve as a subjective measure reported directly by the patient without interpretation by administrators. However, the mode of questionnaire administration can bias the patient’s responses. For example, a systematic review found that patients’ responses were more likely to contain bias when they were assisted by an interviewer versus if they completed the questionnaire privately.²⁷ Additionally, Rutherford et al. reported that the largest bias in the mode of administration was due to variability in setting (home versus clinic) but found no difference in format (paper versus electronic).²⁸ Therefore, accurate appraisal of results is dependent on reporting the context and setting of questionnaire administration regardless of how questionnaire format changes over time. 

To evaluate possible factors associated with improved completeness of PRO reporting, we analyzed the RCT’s study characteristics and found several significant results. We found that studies published after 2014 were associated with greater CONSORT-PRO adherence; this finding is in contrast with Mercieca-Bebber et al., which did not find a significant association with studies published after 2014 and CONSORT-PRO adherence.¹⁸ The improvement in reporting is likely due to greater awareness of CONSORT-PRO over time, similar to improvements seen with other guidelines.²⁹ While this finding is encouraging and further supports the idea that guidelines can effectively increase reporting, there is room for improvement.

Additionally, we found that RCTs using a PRO as a secondary outcome had less complete reporting than if the PRO was a primary outcome. This dichotomy of reporting is evident in the PRO reporting in the abstract. For example, Sharma et al. –– an RCT in our sample with a PRO as a secondary outcome –– reported in the abstract that they compared the range of movement, grip strength, functional outcome scores, and radiological parameters.³⁰ While the authors mentioned that functional outcomes were measured, the authors did not report which PRO tool specifically was used, nor did they provide a clear endpoint of measurement. In contrast, an RCT from our sample with the PRO as a primary outcome reported in the abstract that the DASH questionnaire was measured after 12 months.³¹ While the primary outcome is the motivation for a study, secondary outcomes lend supporting evidence for the primary outcome.³² Therefore, complete reporting of secondary outcomes may promote the reliable interpretation of trial results. 

Recommendations
We acknowledge the logistic and time burdens associated with obtaining PROs in clinical trials.^33–35 However, we believe these barriers should not discourage researchers from including PROs in clinical trials and should not affect the reporting quality of RCTs. To address these barriers in PRO reporting, we recommend researchers follow the CONSORT-PRO checklist to optimize reporting, regardless of the PRO outcome designation. Additionally, we support the AAOS recommendation of and encourage the use of the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS uses targeted question banks to reduce the time burden of administering questionnaires and improves capturing PRO data compared to traditional measures.^36,37 Furthermore, the consistent use of PROMIS will streamline the outcome reporting process across orthopedic literature.³⁸

Strengths and Limitation
Our study was subject to both strengths and limitations. Its strengths include a reproducible methodology based upon an a priori publicly available protocol, public sharing of study artifacts, rigorous training of data extractors on CONSORT-PRO, and extracting data in a masked, duplicate approach.¹⁶ Its limitations include a cross-sectional design which does not permit inferences to a broader population of studies, the possibility for subjective judgments concerning the risk of bias evaluations and CONSORT-PRO data extraction and the chance that relevant RCTs were not retrieved from our searches. Additionally, our study only included RCTs published from 2006-2020 (seven years before and after the CONSORT-PRO release). 

Conclusion
The level of PRO reporting within RCTs for DRF was found to be deficient, yet, publications after 2014 were associated with more complete reporting. Therefore, if these reporting practices continue to improve through complete, accurate, and valid reporting, the research community could produce high-quality PRO evidence that clinicians can use to better inform patient care.

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