Volume VII, Number 1 | April 2023

Reporting Quality and Adherence to the CONSORT Checklist of Randomized Controlled Trials Underpinning the American Academy of Orthopaedic Surgeons Upper Extremity Clinical Practice Guidelines

Authors
  1. Bryan Dunford BS, OMS II – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
  2. Rigel Bacani BA, BS, OMS II – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
  3. J. Michael Anderson BS, OMS IV – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
  4. Jake Checketts DO – Department of Orthopaedic Surgery, Oklahoma State Medical Center, Tulsa, Oklahoma
  5. Jared Scott DO – Department of Orthopaedic Surgery, Oklahoma State Medical Center, Tulsa, Oklahoma
  6. Trevor Torgerson BS, OMS IV – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
  7. Micah Hartwell PhD – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
  8. Matt Vassar PhD – Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma

Role of Funding Source: This study was not funded.
Conflict of Interest: Dr. Hartwell reports receiving funding from the National Institute of Justice for work unrelated to the current subject. Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences — all outside of the present work.

Abstract

Objective: Decision making in orthopaedics is strongly influenced by evidence-based medicine in the form of clinical practice guidelines (CPGs). Orthopaedic CPGs use randomized control trials (RCTs) to underpin recommendations. It is imperative that the RCTs included in these CPGs have sufficient reporting quality and transparency to ensure the guidelines are based on the best evidence. To evaluate the quality of the studies, we used the 2010 CONSORT (Consolidated Standards Of Reporting Trials) statement checklist to score RCT adherence.

Methods: Four American Academy of Orthopaedic Surgeons Upper Extremity CPGs were selected and screened for RCTs. We extracted and scored 164 RCTs using a Google form in a blinded, duplicate fashion. Disagreements between investigators were resolved for accuracy. Scores were given as a percentage out of 31 items, with a score of >75% signifying adequate adherence to CONSORT guidelines. Descriptive statistics were calculated for CONSORT scores.

Results: The mean adherence score of RCTs for all 4 CPGs was 67.3%. Items that had low adherence across guidelines were related to reporting of trial description, randomization methodology and descriptions of generalizability. Items that scored highly across guidelines were reporting of outcomes, statistical methods, and background and rationale.

Conclusion: There has been improvement in the quality of reporting since the CONSORT statement was published in 2010. Despite this improvement, there is variability among published RCTs and their adherence to the checklist.

Keywords: CONSORT, evidence-based medicine, randomized controlled trials, clinical practice guidelines, reporting quality, AAOS upper extremity

Introduction
Clinical practice guidelines (CPGs) serve as the cornerstone for the practice of evidence-based medicine. These guidelines provide recommendations for medical or surgical practice by compiling the most up to date findings in research, and creating a recommendation with a corresponding grade. In order to make strong recommendations, it is typically necessary for a recommendation to be founded by studies with a high level of evidence, such as randomized controlled trials (RCTs). In the field of orthopaedic surgery, RCTs are considered as Level-I evidence by several prominent journals,1 and results from these studies often serve as the supporting evidence by which CPG authors develop recommendations. One potential limiting factor for having quality recommendations is whether the studies providing the evidence are of sound methodological quality.

Despite the direct influence of RCTs on CPG recommendations, previous research suggests significant gaps exist in the reporting of orthopaedic trials.2–5 For example, previous studies investigating adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement6 ––a list of recommendations created to better reporting of RCTs –– indicate the methodological quality of orthopaedic trials is often suboptimal and highly variable.3,4 For instance, Chess and Gagnier found suboptimal reporting in 42% of orthopaedic RCTs7, whereas Montané et al. found that upwards of 75% of RCTs failed to adequately report half of the CONSORT items.4  Thus, when taking these published studies into account, the availability and quality of RCTs for guiding CPG recommendations is suboptimal.

Due to the importance of CPGs for the practice of orthopaedic surgery –– and due to the importance RCTs play in the creation of CPGs –– it is essential that the RCTs providing the evidence for guideline recommendations are of the utmost methodological quality. To our knowledge, an evaluation of the quality of RCTs underpinning orthopaedic CPGs has not been undertaken. More specifically, this evaluation is not in the published literature focusing on the American Academy of Orthopaedic Surgery (AAOS) upper extremity CPGs. Therefore, the primary objective of our study is to evaluate the methodological transparency and quality of reporting in RCTs used to develop the AAOS upper extremity CPGs using the Consolidated Standards Of Reporting Trials (CONSORT) checklist.

Methods
This study did not meet criteria for human subject research and thus was not subject to Institutional Review Board oversight. Our protocol, which was developed a priori, has been made available via the Open Science Framework.8 All analyses were performed twice in an independent manner by blinded statisticians to ensure reproducibility and validity of our study results.

Outcomes
The primary objective of our study was to determine the reporting and methodological quality of RCTs underpinning the 4 AAOS upper extremity CPGs –– Management of Rotator Cuff Injuries, Management of Glenohumeral Joint Osteoarthritis, Management of Carpal Tunnel Syndrome, and Management of Distal Radius Fractures.

Identification of Clinical Practice GuidelinesOne of us (T.T.) searched the AAOS website (OrthoGuidelines.org) for all CPGs providing recommendations for the management of upper extremity-related surgical and non-surgical orthopaedic injuries.  Our criteria for identifying a CPG was based on the definition provided by the Institute of Medicine.9 To be included, all CPGs must have met the following criteria: (1) the CPG must be related to the management of upper extremity orthopaedic-related conditions; (2) the CPG must be the most up to date version of that respective CPG; and (3) the CPG must be retrievable and in the English language.

Identification of RCTs
After relevant CPGs were identified, two investigators (B.D. and R.B.) screened the reference sections of all included CPGs for RCTs cited within the guidelines. To be included, each reference must have: (1) met the definition of a RCT, as defined by the International Committee of Medical Journal Editors (ICMJE)10; (2) been retrievable in the English language; and (3) been cited in at least one of the included CPGs.

Data Extraction and Scoring
Two investigators (B.D. and R.B.) scored all included RCTs using pilot-tested Google forms. Prior to the commencement of data extraction, T.T. conducted a training session which highlighted the purpose of the CONSORT checklist, the usefulness in assessing the methodological quality of the RCTs cited in the AAOS CPG, as well as provided instruction on how to complete the step-by-step data extraction process. Each included RCT was scored and critically appraised according to the instruments’ instructions. After training, five RCTs were scored using the CONSORT instrument. Results were discussed and responses were standardized to ensure accuracy between investigators before continuing. In addition to the CONSORT items, study characteristics were extracted and included the following items: year of publication, funding statement, conflict of interest statement, and intervention type. As with scoring, all data extraction was conducted in a duplicate, masked fashion. Disagreements were resolved by a third investigator (T.T.).

Sample Size Determination
We used OpenEpi 3.0 (openepi.com) to determine the required sample. We considered an RCT to have adequate compliance with the CONSORT guidelines if  ≥75% of CONSORT items were sufficiently met, as done in previously published investigations on CONSORT adherence.11 Estimated parameters using a population  of 299 RCTs included a hypothesized % frequency of 37% for adequate adherence to CONSORT reporting (based upon data obtained by Ngah et al.11); a confidence limit of 5%; and a design factor of 1, which is used in random sampling. Based on these factors, we anticipated a sample  of 164. Following screening of the AAOS upper extremity CPG references, we used Excel’s random number function to generate a random sample of 164 RCTs to be analyzed.

CONSORT
The CONSORT statement provides guidance on proper methodological reporting of RCTs.12 The decision to use this tool for our methodological analysis was based on the fact that CONSORT is endorsed by upwards of 50% of all core medical journals currently indexed through the Abridged Index Medicus on PubMed.13 Similar to prior investigations, we scored each RCT according to the degree of adherence to each checklist item.11,14,15 An overall mean percent score was determined for each RCT analyzed. Scores were reported as percentages, with a possible overall score of 31 points.

Statistical Analysis
Descriptive statistics were calculated for CONSORT scores. Measures of central tendency were based upon the distributional characteristics of these scores. In cases where nonnormality was observed, we reported medians and interquartile ranges. Multiple regression analysis was used to evaluate whether the coded study characteristics account for variance in CONSORT scores. All analyses were performed using Stata 16.1 (StataCorp, LLC, College Station, TX).

Results
Our search of the 4 AAOS upper extremity CPG references yielded 690 returns. Of these, 299 were RCTs and subsequently included. A power analysis run a priori yielded a random sample of 164 studies, which were selected for further extraction using a random number generator in Excel. (Figure 1)

Study Characteristics
All included RCTs were published between 1988-2019, with the majority of studies published after CONSORT guidelines were released in 2010 (105/164; 64.0%). (Table 1) The most common intervention was surgical technique (66/164; 40.2%). Almost half of the RCTs included did not provide a funding statement (77/164; 47.0%). Sixteen RCTs (of 164; 9.8%) reported industry support and 38 RCTs (of 164; 23.2%) reported public funding sources.

CONSORT
Mean adherence to the CONSORT guidelines was 67.3% (SD=14.2). Items with the lowest percent adherence included: item 3a (description of trial design and allocation ratio; 16.8%), item 21 (discussion of generalizability of trial findings; 24.1%); and item 10 (description of who generated the random allocation sequence, who enrolled patients, and who assigned patients to their interventions; 26.2%). Conversely, CONSORT items with the highest percent adherence included: item 2a (scientific background and explanation of rationale; 97.9%); item 12a (statistical methods used to compare groups for outcomes; 97.9%); and item 6a (completely defined pre-specified primary and secondary outcomes; 97.3%). (Table 2) The mean percent adherence among RCTs cited within each of the included CPGs ranged from 63.2% to 69.6%. (Table 2) Among all included RCTs, CONSORT percent adherence ranged from 35.5% to 95.7%. (Table 3)

Multiple Regression
A multiple regression analysis was performed for CONSORT scores by intervention type, presence of conflict of interest statements, funding source, and year of publication. According to the model, RCTs published after CONSORT were more completely reported than RCTs published before CONSORT (Coef: 12.11%, SE=2.2, t = 5.56, P < .001; Table 4). We also found a statistically significant association between CONSORT completion and type of RCT funding, showing that compared to studies reporting to have received no funding, RCTs that did not include a funding statement were less complete (Coef: -6.14%, SE = 2.6, t = -2.39, P = 0.018), and studies that were publicly funded, on average, were more complete (Coef: 7.28%, SE = 2.7, t = 2.71, P = 0.008; Table 4). We found no statistically significant difference in reporting quality when CONSORT adherence was regressed by intervention type or by the absence of conflict of interest disclosure statements.

Discussion
Clinical practice guidelines are strongly influenced by RCTs, as such it is imperative their methods and quality of reporting are sound. The 2010 CONSORT statement serves as the gold standard for RCTs to follow, and our primary outcome for this study was to determine the quality of reporting among RCTs underpinning recommendations in the AAOS upper extremity CPGs. Our study found that RCTs underpinning AAOS upper extremity CPG recommendations had inadequate adherence to the CONSORT guidelines. Similarly, others evaluating CONSORT adherence in orthopaedics also found suboptimal CONSORT adherence.16–18 However, this issue is not unique to orthopaedics, as other studies have found low adherence to CONSORT to be a common finding throughout different specialties in medicine.19–23

In our study, RCTs generally displayed strong adherence to describing interventions and outcome measurements, but there were several CONSORT items that RCTs consistently underreported. CONSORT items 8a-10 –– which primarily focus on participant enrollment, randomization, and allocation concealment –– were inadequately reported across RCTs cited in the AAOS upper extremity CPGs. More specifically, these items were incompletely reported in nearly 40-75% of the RCTs included in our sample. Failing to adhere to these key methodological reporting safeguards is problematic and discouraging. In an effort to avoid bias, surgical specialties must employ rigorous randomization methodology, as well as report these randomization processes appropriately according to the CONSORT guidelines to allow for outside evaluation and replication of their methods.16 Similar to our results, studies in other fields found insufficient reporting of the randomization methods. For example, a 2021 systematic review synthesizing CONSORT adherence among head and neck cancer surgical RCTs, these authors found that detailed accounts of randomization processes were reported in only 14.6% of included RCTs.23 Other investigations found that inadequate reporting of randomization methods are far more variable, with reports ranging from 2.4% in plastic surgery RCTs to 56% in pharmacy-related RCTs.24–26 Omission of these methodological details limits the reader’s ability to reliably interpret the validity and potential bias. For example, previous studies have shown that when these key methodological safeguards are omitted, the benefit of the intervention is likely to be exaggerated due to the introduction of selection bias and the inability to assess it.27 The risk of this exaggeration becomes magnified when RCTs with low reporting quality are used to underpin CPGs that can influence clinicians’ decision making, treatment algorithms, insurance coverage, and billing.28–30

Another set of items that had low adherence in our study was trial registration, which was only reported in 29.0% of RCTs and availability of full trial protocol with 5.2% of RCTs. Prospective trial registration has also been shown to be suboptimal in other fields.20,31 For example, in dermatology only 38.1% and in plastic surgery only 50% of trials adhered to prospective trial registration. Despite recent calls32 to increase the prospective registration of trials before enrollment begins, retrospective registration of clinical trials remains a persistent problem and limits the goals of transparency that having a registry creates. A study from 2018 found that clinical trials that were rejected from BMJ for improper registration were frequently published in other journals without resolving these problems, indicating a lack of enforcement of registration requirements.33 Another 2018 study found that prospective trial registration was suboptimal among trials published in the top 20 orthopaedic surgery journals.17,34 A collaborative effort on the part of researchers, editors, and reviewers to support the prospective registration of RCTs in orthopaedic surgery may be a step in the right direction to increase the quality and transparency of RCT results.

The availability of new data that may be used to inform CPG recommendations is relevant across all of the upper extremity CPGs, but is particularly applicable to Management of Rotator Cuff Injuries. Take for example one investigation which found over 650 newly registered or published studies relevant to the 2012 AAOS CPG recommendations for rotator cuff injuries.35 These relevant studies provided new evidence which was used to address knowledge gaps and inform CPG recommendations in the 2019 update to the Management of Rotator Cuff Injuries, further emphasizing the importance of regularly updating CPG recommendations when new evidence is made available.36 Patients may face barriers to care as a result of delays to updating studies and data included in the CPGs. Additionally, insurance companies may refuse to pay for these new interventions that may be more efficacious, but have not been included in a recommendation by a CPG update.37 The need to reliably update these recommendations is further supported by our results. CONSORT adherence significantly improved following the 2010 CONSORT statement which suggests that out-of-date research, in terms of knowledge and reporting quality, is a serious limitation to CPG recommendations.

In light of our findings and those made prior to our study by other authors, we offer the following recommendations. First, it is our recommendation to update CPGs more often by creating a system to continuously review RCTs and systematic reviews related to recommendations made as these new studies are published. We recommend creation of a committee similar to the Pediatric Orthopaedic Society of North America’s (POSNA) Evidence Based Practice Committee –– a group of experts which reviews newly available evidence from Level-I RCTs and makes necessary updates to current CPG recommendations.38 Use of a model similar by the upper extremity CPG developers may expedite the process of reaching consensus on updates to upper extremity CPG recommendations.38,39 In addition, it has been shown that journals requiring both CONSORT and prospective trial adherence for publication leads to greater compliance.17,19 Therefore, we recommend all journals, funding agencies, and the AAOS adopt policies requiring these reporting and registration requirements for inclusion in their journals, funded studies, and future guidelines. Publication of these requirements by prominent journals in orthopaedic surgery, as well as by the AAOS, would set a new precedent and standard in orthopaedics and may expedite the attention and adoption of these safeguards by authors and researchers, thereby bettering the methodological transparency and research quality in orthopaedic surgery.

Our study has many strengths. Data was extracted by two authors in masked duplicate fashion, which increases the reliability of our study. In addition, we made our materials and protocols available through open science practices, further increasing our transparency and reproducibility. Another strength of our study is the use of CONSORT guidelines which have been established as a method to evaluate the reporting quality of RCTs and is currently endorsed by 585 journals worldwide.13 This study also has some limitations. While we extracted all of the RCTs cited in the AAOS upper extremity CPGs, we did not evaluate all of the included RCTs for adherence to the CONSORT statement. Additionally, the RCTs in this study made up less than one-quarter of the total studies cited by the CPGs. This study was cross-sectional in nature and focused specifically on the AAOS upper extremity CPGs. Therefore, our findings may not be generalizable to the remaining AAOS CPGs or to CPGs from other medical specialties.

Conclusion
There has been improvement in the quality of reporting since the CONSORT statement was published in 2010, however, a disparity remains in published RCTs and their adherence to the checklist. Our results show specific areas for improvement that would enhance the reporting quality of RCTs and allow readers, researchers, and clinicians to better evaluate the applicability of the study. Ultimately, by addressing the quality of reporting of RCTs in orthopaedic surgery, CPG authors may be equipped to make stronger recommendations and in turn, improve clinicians ability to use them in practice.

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The Journal of the American Osteopathic Academy of Orthopedics

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Editor-in-Chief

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