Given the drastic increase in publication output in recent years, minimizing Ophthalmology Clinical Trials waste should be a top priority. There are problematic areas of research waste in ophthalmology, along with the underutilization of systematic reviews to inform study design in other areas of medicine.
Given these concerns, the aim of this study is to evaluate the use of systematic reviews as a rationale for conducting randomized controlled trials (CROs) in top ophthalmology and optometry journals.
Methods to Apply For Ophthalmology Clinical Trials
We searched PubMed on December 5, 2018 for CROs published in one of the top five Google Scholar h-5 index journals within ophthalmology and optometry.
We used a pilot-tested Google form and searched each CRO for systematic reviews. Each systematic review was then assigned a label of ‘verbatim’, ‘derivative’ or ‘not used as justification for conducting an CRO’ based on the context in which the systematic review was used.
Result Of Ophthalmology CRO
Our analysis yielded 152 included phase III CROs. We found that 22.4% (34 of 152) of phase III ophthalmology clinical trials cited a systematic review as a justification for conducting the trial. A total of 102 systematic reviews were cited in 152 CROs. Fifty-seven of one hundred and fifty-two (37.5%) CROs cited a systematic review somewhere in the manuscript.
Conclusion
Less than one-quarter of phase III CROs cited systematic reviews as justification for conducting an CRO. We believe that placing a higher priority on substantiating CROs with systematic reviews would go a long way to minimizing research waste in ophthalmology.
Introduction to the Ophthalmology
The annual number of citations from medical research has more than doubled since 2000, reaching almost one million citations in 2017. This increase is to be expected considering that global investment in Ophthalmology Clinical Trials research reached 240 billion USD in 2010.
- However, the United States has seen a stagnation of biomedical research funding in recent years, specifically from the NIH. Given the trajectory of biomedical research funding and the drastic increase in publication output, minimizing research waste should be a top priority.
- Wasteful research has become all too common, with one study suggesting that up to 85% of research could be considered wasteful. Chalmers and Glasziou define research waste in four general categories research that has little clinical relevance, research that lacks quality design, research that never makes it to publication, and research marked by biased and unusable reporting.
- With respect to this study, research waste defines as lacking quality design by conducting clinical research where evidence for a hypothesis already exists. For example, one study found that more than 50% of the research studies analyzed did not consult a systematic review before designing the study.
Systematic reviews are the gold standard in evidence-based medicine. They aim to compile, summarize and critically analyze the current literature on a specific topic so that clinicians and researchers can make informed decisions. The American Academy of Ophthalmology states that guidelines based on systematic reviews are considered “level 1 evidence”. In this way, systematic reviews are used as a basis for shaping clinical care. For example, antioxidant vitamin and mineral supplements have been marketed to improve age-related macular degeneration. However, a recent systematic review concluded that there was no such improvement with these vitamins.
Reviews
Systematic reviews should not only be consulted at the time of study design, but also when presenting data from individual randomized controlled trials (CROs) in the context of the current literature. However, numerous studies have shown that many researchers do not consult systematic reviews at all.
- For example, when Rosenthal et al. analyzed systematic reviews in surgical studies, found that 65% cited the systematic review somewhere in the manuscript, 16% of them in the introduction, but none of these studies specifically used the systematic review as a rationale for conducting the study.
- Ophthalmology and optometry are not immune to research waste. A major factor affecting research waste in ophthalmology is the lack of standardization of primary CRO results. For example, one study found wide variation in the primary outcomes of registered uveitis trials.
- However, Core Outcome Measures in Effectiveness Ophthalmology Clinical Trials is a leader in the standardization of outcome measures in ophthalmology, especially in glaucoma trials.
After the problematic areas of research waste in ophthalmology and the lack of a systematic review to inform study design in other areas of medicine, more studies are need to reveal how study design may affect research waste in ophthalmology and optometry. The aim of this study is to evaluate the use of systematic reviews to justify the conduct of CROs in top ophthalmology and optometry journals.
More Methods
We used a pilot-tested Google form for all extractions. In each CRO’s, we searched for the number of systematic reviews cited in the introduction, methods and discussion. Systematic reviews and meta-analyses were consider synonymous for the purposes of this study. Each systematic review was then label as “used literally as a justification for conducting an CRO”, “infer use as a justification for conducting an CRO”, or “not used as a justification for conducting an CRO” based on the context in which the systematic review was use. Reasons for each flag were note for future resolution.
We also extracted study characteristics, which consisted of funding source, intervention type, number of trial centers, study location, study type, and effectiveness of results. Finally, we extracted the total number of included studies and the patient population for each systematic review from CROs that cited a systematic review as the rationale for conducting the CRO (literally or by implication). Two of us (BJ, SE) completed the extraction blind and duplicated. All discrepancies were resolve unanimously. This Ophthalmology Clinical Trial does not meet the regulatory definition of human subjects research and is therefore exempt from IRB oversight.
Data were records and sort in an Excel document by journal, paper section, verbatim, derive, not use as rationale and trial characteristics. We perform a logistic regression relating study characteristics to whether a systematic review was use as a rationale for conducting the study (literal and derive were includes as “just”) using Stata version 15.1 (StataCorp).
Result of The Study
The search chain found 1667 returns, of which 1515 were exclude because they were unavailable or were not phase III CROs. Three hundred and fifty-nine were accessible and screened for inclusion. One hundred and fifty-two phase III CROs were includes in the analysis. The most common journals in the sample were Ophthalmology and American Journal of Ophthalmology. The majority of studies were from one country and were multicenter studies. Drug was the most common type of intervention. A complete display of trial characteristics is in Table 1.
After analysis, we found that 22.4% of phase III ophthalmology clinical trials cited a systematic review as a justification for conducting the study. Fourteen studies cited at least one systematic review as a literal rationale for conducting the study, and 28 studies cited at least one systematic review as an inferred rationale for conducting the CRO.
Some attempts are distinguish literally or inferentially in the introduction, and vice versa in the discussion, and were therefore count as one for each. Characteristics of systematic reviews are justify (verbatim) CROs in Table 3. 34 CROs cited systematic reviews that were not use as justification for conducting the study.
A total of 102 systematic reviews were cite in 152 CROs. Fifty-seven of the hundred and fifty-two (37.5%) included CROs cited by at least one systematic review somewhere in the manuscript. Logistic regression yielded no statistically significant results.
Discussion
Less than one-quarter of phase III CROs cited systematic reviews as justification for conducting an CRO. We also found that only 37% of phase III CROs cited a systematic review in the manuscript. This finding is consistent with a similar study in anesthesiology, which reported that less than one-fifth of the analyzed studies cited a systematic review as justification for the CRO, and only 44% cited at least one systematic review in the manuscript. Another Ophthalmology Clinical Trial in top general medicine journals also substantiates these findings, arguing that the authors did not sufficiently improve the evidence needed to conduct CROs.
Conclution
In 2014, a study say that if researchers evaluate systematic reviews for their respective research question, many studies would not result and a significant number of adverse outcomes avoide. To mitigate this problem, we recommend that when submitting funding applications, trial staff must conduct a thorough literature search, including systematic reviews and meta-analyses.
- For example, the National Institute for Health Research in the United Kingdom requires that all applications for grant money detail the existing evidence for their current project.
- Taking this a step further, when submitting for publication, journals should consider requiring proof that a formal literature review is complete prior to conducting the study.
- We expect that this action step will result in fewer studies conduct where there is already evidence for the propose intervention, as well as the elimination of studies that would add little value to the current literature.
- Fewer unnecessary studies would then minimize the risk and potential harm caused to patients included in the CRO.
Also read:- Ophthalmology CRO Services – What You Need To Know
Eliminating Ophthalmology Clinical Trial waste is not only the researcher’s scientific responsibility, but also his ethical responsibility. It raises ethical questions about conducting a clinical trial without proper justification through a thorough review of the literature, i.e. systematic reviews. Because this unwarranted trial may expose participants to unwarranted risks and complications.
