Reporting quality and spin in abstracts of randomized clinical trials related to Oral Mucositis

Reporting quality and spin in abstracts of randomized clinical trials related to Oral Mucositis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Reporting quality and spin in abstracts of randomized clinical trials related to Oral Mucositis Khadijeh Al-Abedalla, Ahmad A Hamdan, Qais AlSaghir, Yazan Hassona, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8544979/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Purpose : Oral mucositis is a common debilitating side effect of radiotherapy and chemotherapy in cancer patients. Numerous randomized controlled trials have examined different remedies for the management of this complication. Accurate reporting of Randomized Controlled Clinical Trials (RCTs) results in abstracts is crucial for treatment decisions. This study evaluates the reporting quality and potential spin in abstracts of RCTs addressing mucositis treatment according to MASCC/ISOO guidelines. Factors that can affect reporting quality and spin were also assessed. Methods : We systematically searched PubMed, Cochrane, and Scopus databases for RCTs related to oral mucositis treatments published until September 2024. We applied the CONSORT and SPIN checklists to assess reporting quality and spin in the abstracts. Results : Out of 112 RCTs analyzed, the overall CONSORT score for reporting quality was low, with key elements such as study design and outcome reporting frequently omitted. Only 16 RCTs were analyzed for spin, which revealed that only 2 RCTs had no spin. Higher reporting quality significantly correlated with greater word count (r=0.37, P=0.000), pharmaceutical funding compared to non-funded articles (P=0.015), and trials that were conducted in more than 1 country (P<0.03). Spin was negatively correlated with Altmetric score (r=−0.652, P=0.006). Conclusions : The reporting quality of RCT abstracts on oral mucositis interventions is severely lacking. Considerable spin also undermines the integrity of the information presented. This compromises evidence-based practice. These findings underscore the need for enhanced adherence to reporting guidelines to support evidence-based clinical practices. Quality of Reporting Clinical Trials Mucositis Spin Abstracts Cancer Treatment Figures Figure 1 Figure 2 Introduction Worldwide, cancer is a leading cause of morbidity and mortality; being responsible for nearly 10 million deaths per year [ 1 – 3 ]. The global economic burden of cancer is escalating. From 2020 to 2050, the estimated global economic cost of cancer is projected to be $ 25.2 trillion in international [ 4 ]. Advancements in cancer treatment modalities, particularly chemotherapy, radiotherapy, immunotherapy, target specific therapeutic interventions, and hematopoietic stem cell transplant, have resulted in significant survival benefits In various types of human cancer [ 5 , 6 ]. Nevertheless, these advances in cancer therapies have been associated with severe side effects involving various body systems, and potentially limiting their clinical benefits, increasing the overall cost of treatment, and impairing the quality of life of affected patients [ 7 ]. Oral mucositis (OM) is one potential complication of various cancer treatment modalities. It is a painful inflammatory disorder affecting the oral and oropharyngeal mucosa, resulting in pain, discomfort, dysphagia, malnutrition, increased susceptibility to local and systemic infections, impaired quality of life and increased treatment cost and duration[ 8 – 12 ]. The prevalence of mucositis is highly variable ranging from 20–100% depending on treatment modality, dose, duration, and the presence of other comorbidities [ 8 , 13 – 15 ]. Oral mucositis usually manifests as mucosal swelling, erythema, desquamation, ulceration, pain, bleeding, and difficulty in food intake and swallowing [ 6 , 16 – 18 ]. Complications of oral mucositis might result in treatment suspension or even discontinuation leading to negative consequences on patient’s care and impaired overall prognosis [ 17 , 18 ]. Prevention, early diagnosis, and timely treatment of oral mucositis are therefore essential components of the multidisciplinary care of cancer patients. Unfortunately, evidence-based guidelines regarding management of oral mucositis in patients with cancer are sparse. The first international guidelines for treatment of oral mucositis were published in 2004 by The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International. The MASCC/ISOO guidelines for management of oral mucositis are widely adopted worldwide and updated regularly [ 19 ]. Only four interventions currently hold strong evidence-based recommendations by MASCC/ISOO for treatment of oral mucositis. Those include topical benzydamine, laser therapy, cryotherapy, and keratinocyte growth factor [ 19 ]. Although the latest MASCC/ISOO guidelines (2020) incorporated a comprehensive review of new evidence, no definitive recommendations were provided for management of oral mucositis in various clinical scenarios, leaving clinicians to rely on published randomized controlled trials and emerging data to guide patient-specific management decisions, leaving clinicians to rely on published randomized controlled trials and emerging data to guide patient-specific management decisions [ 19 ]. Clinicians’ time limitations, language limitations for non-English articles, and limited access to full-texts push clinicians to rely only on published abstracts to guide their treatment decision [ 20 – 25 ]. Previous studies in other fields indicated that abstracts do not consistently reflect the methodology or outcomes reported in full publications, which may introduce bias into evidence-based clinical decision-making [ 20 – 22 , 26 , 27 ]. To the best of our knowledge, no prior study has evaluated the reporting quality of abstracts of RCTs assessing treatment modalities of oral mucositis. The purpose of our study therefore is to evaluate the reporting quality of abstracts of RCTs assessing therapeutic interventions for oral mucositis recommended by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Specific objectives of the current study are to: Assess the level of reporting quality and spin in abstracts of randomized clinical trials (RCTs) evaluating the recommended therapeutic interventions for oral mucositis by MASCC/ISOO. Assess potential factors that might affect the level of reporting quality and spin in abstracts of these RCTs. Findings of our study will help to address challenges in the available evidence regarding management of oral mucositis in patients with cancer, and support informed clinical choices. Materials and methods Search methods and study selection The protocol of this meta-research study is available online https://osf.io/d2muy. Studies were retrieved from different databases, including PubMed, Cochrane, and Scopus. In addition, we cross-checked all trial primary registration platforms included in the World Health Organization and International Clinical Trials Registry to confirm trial registration status and retrieve missing trials. The last search was conducted for all databases on September 18 th , 2024. Search keywords and limitations/filters for each database and each treatment group were as follows: Pubmed: Photo-biomodulation therapy: (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (erosive*)) OR (vesiculo*)) AND (((light) OR (photobiomodulation)) OR (laser)). Keratinocyte growth factor: ((palifermin*) OR (((keratinocyte*) OR (fibroblast*)) AND (growth*))) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)). Cryotherapy: ((((Cryotherapy*) OR (cryoablation*)) OR (ice)) OR (cold*)) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)). Benzydamine: (((benzydamine) OR (tantum verder)) OR (difflam)) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)). Scopus: Photo-biomodulation therapy: TITLE-ABS-KEY ( ( light OR laser OR photobiomodulation ) AND ( mucositis OR stomatitis ) AND random* ) Keratinocyte growth factor: TITLE-ABS-KEY ( ( palifermin* OR keratinocyte* ) AND ( mucositis OR stomatitis ) AND random* ) Cryotherapy: TITLE-ABS-KEY ( ( cryotherapy* OR cryoablation* OR ice OR cold ) AND ( mucositis OR stomatitis ) AND random* ) Benzydamine: TITLE-ABS-KEY ( ( benzydamine* OR tantum* OR difflam* ) AND ( mucositis OR stomatitis ) AND random* ) Cochrane: Photo-biomodulation therapy: (light* OR photobiomodulation OR laser*) AND (mucositis* OR stomatitis*) Keratinocyte growth factor: (palifermin* OR keratinocyte* OR kepivance* OR velafermin) AND (mucositis* OR stomatitis*) Cryotherapy: (Cryotherapy* OR cryoablation* OR ice* OR cold*) AND (mucositis* OR stomatitis*) Benzydamine: (benzydamine OR tantum verder OR difflam OR Septabene OR benzamidine OR CR3294) AND (mucositis* OR stomatitis*) Primary registries in the World Health Organization platform were searched using the key word “Mucositis” only because these platforms are limited to one or two keywords. In addition, previous reviews and systematic reviews were hand-searched for identification of additional RCT reports and then duplicates were excluded. The retrieved registers were then scanned for eligible studies, and duplicates were excluded. RCT report inclusion criteria Study Design: Only prospective RCTs related to oral mucositis treatment were included. Other study designs such as cohort, non-randomized trials or observational trials were excluded. There were no language restrictions, and RCT abstracts that are not in English were translated. Participants: Patients (both genders) who were recruited to treat oral mucositis which was developed after chemotherapy or radiotherapy. There were no restrictions regarding age. Intervention: Only recommended interventions (not suggested) by MASCC/ISOO for oral mucositis including [19]: 1. From the Anti‐inflammatory agent’s category: Only studies that have assessed the effect of Benzydamine as a mouthwash or intra-oral spray were included. 2. From the Photobiomodulation category: Only studies that have assessed the effect of intra-oral Photobiomodulation therapy were included. 3. From Cryotherapy category: Studies that have oral Cryotherapy were included. 4. From Growth factors and cytokines category: Studies that have used keratinocyte growth factor intravenously as a treatment were included. Comparator(s)/control: Patients who developed oral mucositis after chemotherapy or radiotherapy but weren’t treated in the study, or received sham treatment, or received different treatment modalities than the ones that were recommended by MASS/ISOO. Outcomes: Reduction in incidence or severity of mucositis, including pain severity, mucositis duration, pain duration, or any other symptoms related to mucositis assessed in the retrieved RCTs. Selection criteria for spin assessment: Only studies with a clearly defined primary outcome in the abstract were included in the spin analysis only. Data extraction and compilation Selection of studies was carried out according to the inclusion criteria by two authors independently (KA, QA). Titles and abstracts of the search results were initially screened for eligible studies, then full texts were retrieved and further assessed for eligibility. Data extraction: Two authors (KA, QA) independently reviewed the abstracts -and the full texts, when needed- of the included RCTs. The 2 authors recorded and collected data of interest using a customized data extraction form using Microsoft Excel sheet. Any disagreement was resolved by a third author (MS). Authors (KA and QA) applied both the CONSORT checklist for abstracts [26], and the SPIN checklist that was published in 2020[28] and was derived from Boutron’s study[29]. Two items of the CONSORT abstracts guidelines were excluded because they only apply to unpublished studies or conference abstracts, including the item “recruitment” from the results section and the item “authors”. The following data was extracted: An overall CONSORT score for reporting quality (OCS) will be calculated for each abstract based on the CONSORT checklist items fulfilled. An overall SPIN score will be calculated for each abstract based on the SPIN checklist items fulfilled. Characteristics of each RCT abstract and the respective publishing journal were extracted: Abstract word count of the article, and the word count limit for its corresponding journal. Number of citations for each article as shown on Scopus and Google Scholar. Altmetric score of trial (https://www.altmetric.com). Geographic location. Trial’s funding source. Journal’s date of adherence to ICMJE guidelines. Journal’s Impact factor for 2024, and the last 5 years [30]. Journal’s Scimago Journal & Country Rank (SJR) indicator 2023 (https://www.scimagojr.com). Statistical analysis Cohen’s Kappa test was used to assess inter-rater agreement, with a value of 0.7 or higher indicating substantial agreement between the two reviewers. Categorical variables were presented as percentages (proportions) . To evaluate bivariate associations among the aforementioned variables, the Pearson correlation test was applied. To compare categorical groups with numerical outcomes, the Kruskal–Wallis’s test was applied to assess overall differences among the groups, followed by a Bonferroni-corrected post hoc test to identify which specific group comparisons were statistically significant. Statistical analysis was performed using SPSS software (IBM Corp., Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Results General findings One hundred and twelve RCTs were deemed eligible (Fig. 1 ). Among them, 14 RCTs mainly assessed the effect of keratinocytes growth factor on mucositis, 23 assessed the effect of ice, 46 assessed the effect of photobiomodulation therapy, and 29 assessed the effect of benzydamine. From : Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71 The table in the Online Resource provides the metrics for each article and journal, along with the OCS, and divided according to treatment group. Out of 112 trials, 52 of them were published in journals that reported their adherence date to ICMJE guidelines, including following the CONSORT guidelines. Nine RCTs were published in journals that are reported on ICMJE’s website that they adhere to the guidelines, but without a date. Fifteen RCTs were published in journals that do not state that they adhere to the ICMJE guidelines, but they do recommend following the guidelines. Thirty-six RCTs were published in journals that have no instructions regarding the CONSORT checklist or recommendations of following the ICMJE guidelines. Among the included RCTs, 38.4% were conducted in Asia, 21.4% in South America, and 20.5% in Europe. In North America, 12.5% of the trials were conducted, while 4.5% spanned multiple continents. Notably, no RCTs were conducted in Africa or Australia. Sixty-six RCTs were funded.24% of the RCTs were funded by governmental funding, 12% were funded by pharmaceutical companies, 11% of the RCTs by Educational associations, 8% of the RCTs by Private organizations, and 4% of them were funded by a combination of more than one type of funding source. On the other hand, 11% of the RCTs reported that they were conducted with no funds, and 20% of the RCTs did not report if they were funded or not. Table 1 also demonstrates each abstract word count and the corresponding journal’s word limit. The word limit ranged from 150–500, with some journals having no word limit in their guidelines (24 trials). Fifty-five trials (49.1%) had abstract word counts less than the limit, and 33 trials had abstract word count more than the limit (21.4%). CONSORT checklist findings Generally, Overall CONSORT score (OCS) was low ranging from 0–8 out of 15 items that should be fulfilled (Table 1 ). Eleven trials were published after their corresponding journal’s adherence date to ICMJE guidelines. The other trials were published before the adherence date. These 11 trials still showed low OCS ranging 0–4 out of 15 items. Table 1 shows that only 50.4% of the RCTs included the word “randomized” in their title. Only 11 trials reported the trial design in the abstracts. The rest only stated that it would be a control-test design. CONSORT item Fulfillment (%) Benzydamine group Photobiomodulation group Keratinocyte growth factor Cryotherapy Ice group Total Title 14 23 8 12 57 (50.4%) Trial Design 6 3 0 2 11 (9.7%) Methods Participants 0 0 0 0 0 Interventions 0 6 5 0 11 (9.7%) Objective 3 2 2 2 9 (8.0%) Outcome 0 0 2 1 3 (2.7%) Randomization (Methods) 0 0 0 0 0 Blinding (Masking) 1 9 0 0 10 (8.8%) Results Numbers randomized 7 20 6 12 45 (39.8%) Numbers analyzed 4 5 4 6 19 (16.8%) Outcome 2 0 1 1 4 (3.5%) Harms 8 8 8 3 27 (23.9%) Conclusion 25 36 13 19 93 (82.3%) Trial registration 5 4 4 2 15 (13.3%) Funding 2 1 2 0 5 (4.4%) Table 1 : CONSORT item fulfillment for each intervention. Assessment of reporting the methods: Two items in the methods section lacked reporting in all RCTs. The first item was “participants”, which mainly lacked 3 types of information. The location of the study where only 8% of the RCTs reported it, the “starting and finishing dates of the trial”, where only 6% of the RCTs reported, and the “participants age range” where only 13% of RCTs reported it. The only information that was reported under this item was the disease condition that the participants had, and 72% of the RCTs reported it. Therefore, all RCTs were considered that they have not fulfilled this item. The second item that was not fulfilled was “randomization”. This item included both the techniques of randomization and concealment. None of the trials reported the concealment technique they followed, and only 4% of the trials reported the method of randomization. Therefore, all RCTs were considered that they have not fulfilled this item. The other items under the methods section that were fulfilled are: The item “blinding” was only reported in 10 trials. Only 10 trials fulfilled the item “intervention”. This item was only fulfilled by the trials that reported the necessary detailed description of the intervention, including the intervention followed in each arm, the dosages of each intervention, frequency, duration of each intervention, and the route that was used to apply the treatment. Therefore, this item was considered not fulfilled if any of these details were missing. Only 78% reported the intervention in each arm, the rest of the abstracts had no clear information about the treatment type that each arm received. Only 30% reported the dosages for each arm. Frequency of the intervention was only reported in 28%, duration of intervention in 41% and the route was only in 58%. Nine trials reported their objective according to their primary outcome, the rest of trials either had no primary outcome reported, or their objective was based on another outcome. Interestingly, 14% of the RCTs clearly mentioned the main outcome; however, only 3 RCTs mentioned that the primary outcome was assessed. Some abstracts reported the primary outcome as a part of the abstract results rather than the materials and methods, violating the CONSORT recommendations. Assessment of reporting the results: Although almost 40% of the abstracts included the numbers of randomized populations in each group, only 17% of the abstracts included the numbers analyzed in each arm. Only 4 trials clearly mentioned the results of the primary outcome with its effect size. Most of the abstracts mentioned the results in wording only, and some only included the p-value. Twenty-seven RCTs reported harm in the abstracts (23.9%). Assessment of reporting conclusion, registration, and funding: Only 82% discussed the conclusion based on the primary outcome. Trial registration was reported in only 15 abstracts (13.3%), and 5 trials (4.4%) reported the funding source in the abstract section. Spin analysis findings Per our inclusion and exclusion criteria for Spin analysis, only 16 abstracts were included in this section (Table 2 ). The rest of the RCTs were not included because they did not report the primary outcome in their abstract section. The excluded RCTs were not assessed for Spin analysis, however, this does not mean that no Spin was found in these excluded abstracts. Table 2 SPIN item fulfillment for the included studies (16 studies) Spin item Item explanation Fulfillment (%) Title Claims/insinuation with no results supporting it 3 (18.8%) No identification of the primary outcome in the methods section No identification of the primary outcome in the methods section 5 (31.3%) Incomplete reporting of the results for the primary outcome Incomplete reporting of the results for the primary outcome for each group (a sentence isn’t enough; data should be included) 6 (37.5%) Selective reporting of statistically significant secondary outcomes Selective reporting of statistically significant secondary outcomes 2 (12.5%) No or incomplete reporting of safety data No or incomplete reporting of safety data 8 (50%) Focus on statistically significant subgroup or secondary analysis Focus on statistically significant subgroup or secondary analysis None had sub-groups Linguistic spin Linguistic spin 3 (18.8%) Conclusion with spin Claim of benefit/ equivalence/ focus on another objective/ tend towards significance 3 (18.8%) Overall Spin score ranged between 0–4 out of 7 items (Fig. 2 ). The figure also shows that Spin does not depend on the date of publication. Only two RCTs had no spin in its abstract. Out of the 16 RCTs, 3 of them had Spin in their title, basically claiming benefits without proving it in the results or extra benefits without measuring it or reporting it. Three abstracts reported the primary outcome in the results section, 2 abstracts in the objective section rather than in materials and methods section. Six abstracts showed incomplete reporting of the results for primary outcome analysis, where there was only a sentence describing the results with no numbers, p-value, or effect size. Two abstracts focused on the significant secondary outcome without mentioning the results of the outcome or focused on the significant secondary outcome and not on the non-significant primary outcome. Eight of the 16 abstracts (50%) did not report harm or safety data. Three of these abstracts had linguistic spin in results or conclusion sections, and two abstracts claimed the benefit or significance of the intervention in the conclusion section. Altmetric Altmetiric score shows how much attention surrounded research in social media. For the retrieved 112 RCTs, their Altmetric score ranged between 0–31. 48.2% of the RCTs had zero Altemtric score. Correlation analyses OCS only showed a significant positive correlation with: Abstract word count (P-value = 0.000, r = 0.37). Therefore, the higher the number of word count allowed, the higher the number of fulfilled items of OCS. Pharmaceutical companies showed better adherence to CONSORT compared to articles that did not report on their funding source (P-value = 0.015). Multi-country trials showed better fulfillment in OCS compared to trials published in South America (p-value = 0.006) and Asia(p-value = 0.03). Journal’s impact factor for the last 5 years showed a nearly significant positive correlation with OCS (P-value = 0.055, r = 0.19). Therefore, the higher the journal’s impact factor for the last 5 years, the higher the number of fulfilled items of OCS. Other parameters that were extracted from the articles showed no significant correlation with OCS (P-value > 0.05). Altmetric score showed generally positive and significant correlations with the citations of the article and the journal’s impact factors: Citation in Scopus (P-value = 0.00, r = 0.593). Citation in Google scholar (P-value = 0.00, r = 0.589) SJR index (P-value = 0.00, r = 0.431) Abstract word limit from the corresponding journal (P-value = 0.033, r = 0.211) Journal’s impact factor (P-value = 0.00, r = 0.441). Therefore, the higher the journal’s impact factor, the higher the Altmetric score of that article. Journal’s impact factor during the last 5 years (P-value = 0.00, r = 0.459) Other parameters that were extracted from the articles showed no significant correlation with Altmetric score (P-value > 0.05). SPIN correlation analysis: Spin showed significant negative correlation with Altmetric score (p-value of 0.006, and r= -0.652). Therefore, the higher Altmetric score, the less SPIN in the abstract. Spin showed a non-significant correlation with the other variables (p-value > 0.05) Discussion The prevalence of therapy-induced oral mucositis is expected to rise in parallel with the increasing global burden of cancer, and the development of new cancer therapies. Consequently, there is an expanding need to critically appraise the effectiveness of available preventive and therapeutic strategies, particularly in light of the wide range of treatment protocols and approaches proposed in the literature [ 31 ]. Over recent decades, numerous randomized controlled trials (RCTs) have investigated interventions for the prevention and management of therapy-induced oral mucositis. While this growing body of evidence has the potential to inform clinical practice, it also places a considerable burden on clinicians, who must navigate an increasingly complex and rapidly expanding literature. In time-pressured clinical settings, healthcare providers often rely primarily on abstracts when seeking evidence. However, previous studies have demonstrated that abstracts do not consistently reflect the methodology or outcomes reported in full publications, which may introduce bias into evidence-based clinical decision-making [ 26 , 27 ]. To the best of our knowledge, this is the first study to evaluate both reporting quality and spin in abstracts of RCTs assessing therapeutic interventions for oral mucositis recommended by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Focusing exclusively on MASCC/ISOO-recommended modalities ensured inclusion of interventions supported by the strongest available evidence. Our analysis of 112 RCTs demonstrated consistently poor abstract reporting quality, with overall CONSORT scores ranging from 0 to 8 out of a possible 15, indicating substantial non-adherence to established reporting standards. These findings are consistent with previous studies across oncology and related healthcare fields, where abstract reporting quality has similarly been described as suboptimal [ 32 – 35 ]. Importantly, even among RCTs published in journals claiming adherence to ICMJE or CONSORT guidelines, reporting quality remained low, including among 11 trials published after formal guideline endorsement (OCS range 0–4), suggesting limited enforcement of reporting standards during peer review. Reporting methodological characteristics within abstracts was particularly inadequate. Only 9.82% of trials reported study design, and none of the included RCTs reported participant characteristics or randomization procedures. These findings are consistent with previous evaluations of methodological reporting in clinical trial abstracts [ 32 , 34 , 36 ] and represent a critical limitation, as omission of these elements prevents accurate assessment of internal validity and applicability. Several factors may explain these deficiencies, including restrictive abstract word or character limits imposed by journals [ 26 ]. Under such constraints, authors may prioritize reporting results perceived as more appealing or clinically relevant at the expense of essential methodological details. Inadequate reporting of trial design and conduct in abstracts may lead to misinterpretation of findings and inappropriate application in clinical practice [ 34 , 36 ]. For clinicians seeking to implement evidence-based protocols for oral mucositis management, insufficient methodological transparency hinders meaningful appraisal of trial relevance and reliability. Analysis of factors associated with reporting quality yielded findings consistent with previous studies [ 34 , 37 ]. Higher journal impact factor, greater abstract word count, multicenter study design, and publication in journals endorsing CONSORT were associated with higher overall CONSORT scores and improved reporting quality. In contrast, journal-specific word count limits did not demonstrate a significant association with overall CONSORT scores, suggesting that editorial practices and reviewer expectations may be more influential than formal word limits alone. Pharmaceutical-funded studies (13 of 112 RCTs) demonstrated better adherence to CONSORT reporting standards compared with studies that did not report funding sources. This may reflect greater access to methodological expertise, additional resources, or stricter oversight. However, the high proportion of trials failing to disclose funding sources raises concerns regarding transparency and potential conflicts of interest [ 38 ]. Outcome reporting was also suboptimal. The majority of included RCTs failed to report primary outcome results in the abstract, with only four trials (3.5%) doing so. Poor reporting of results may result in the omission of potentially valuable information, even when findings are non-significant, and may contribute to exclusion of such studies from systematic reviews and clinical practice guidelines [ 26 , 39 ]. Furthermore, only 14% of RCTs clearly stated the primary outcome, and in some cases this information was inappropriately reported in the results section rather than the methods, contrary to CONSORT recommendations and potentially confusing readers regarding trial intent [ 40 ]. Biased or distorted reporting of trial results may further mislead readers and lead to erroneous conclusions [ 28 ]. In the present study, spin analysis was limited to trials that clearly defined a primary outcome in the abstract, resulting in eligibility of only 16 studies (14.3%). Among these, only two abstracts (12.5%) were free of spin, while varying degrees of spin were observed in the remaining studies. Notably, 18.9% of studies exhibited spin in their titles, claiming benefits not supported by the reported results or suggesting additional outcomes that were not measured. In two abstracts (21.5%), authors emphasized statistically significant secondary outcomes while omitting mention of non-significant primary outcomes. Previous research has shown that studies reporting positive or significant results are more likely to be published, cited, and accepted by high-impact journals [ 26 , 41 , 42 ]. Interestingly, our analysis demonstrated a negative correlation between the degree of spin and Altmetric score, suggesting that abstracts containing greater spin may attract less online attention. This finding may reflect the ability of critically engaged readers, particularly on social media platforms, to identify and avoid amplifying misleading content. Additionally, the specialized nature of oral mucositis research likely contributes to limited online visibility, as evidenced by nearly half of included RCTs (48.2%) receiving zero Altmetric scores. Previous studies have demonstrated that Altmetric attention is more strongly influenced by journal characteristics and dissemination practices than by methodological rigor alone [ 43 ]. This study has several limitations. First, restricting inclusion to MASCC/ISOO-recommended interventions may limit generalizability to non-recommended modalities, although this approach ensured focus on treatments supported by the strongest evidence. Second, journal impact factors were obtained for the year 2024 rather than the year of publication, which may have influenced observed associations [ 32 ]. Third, geographic clustering of RCTs and underrepresentation of studies from certain regions may limit the global applicability of our findings and reflect disparities in funding or research infrastructure. Finally, the small number of trials eligible for spin analysis may have resulted in underestimation of the true prevalence of spin among oral mucositis RCT abstracts. Numerous studies have recommended that journals adopt editorial policies endorsing CONSORT guidelines and ensure adherence through rigorous peer-review processes to improve reporting completeness and abstract quality. Empirical evidence supports this recommendation, demonstrating that journal adoption of CONSORT guidelines is associated with significantly improved reporting of sequence generation, allocation concealment, and overall completeness in RCTs [ 44 ]. Nevertheless, despite repeated recommendations, substantial improvements in abstract reporting remain limited. More feasible and immediately actionable strategies include modest increases in abstract word limits, which have been shown to correlate positively with improved reporting quality [ 45 ], and targeted training for authors, peer reviewers, and editors on the importance of adhering to reporting guidelines such as CONSORT for Abstracts. Collectively, these measures may enhance transparency, reduce reporting bias, and improve the clinical utility of abstracts in oral mucositis research. Declarations The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. The authors have no relevant financial or non-financial interests to disclose. Author Contribution All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by K.A and Q.A. The first draft of the manuscript was written by K.A, A.H, and M.S. Y.Z, M.S. and E.I commented on previous versions of the manuscript. 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Trans Am Clin Climatol Assoc.122:48–58. Hopewell S, Clarke M, Moher D, et al.(2008) CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med.5(1):e20. https://doi.org/10.1371/journal.pmed.0050020 McKechnie T, Kazi T, Shi V, et al.(2025) Inconsistency between abstract and main text reporting is common in pilot randomized controlled trials of surgical interventions: A methodological survey. The American Journal of Surgery.243. https://doi.org/10.1016/j.amjsurg.2025.116250 Roberts WB, Cooper CM, Khattab M, et al.(2020) Evaluation of "Spin" in the Abstracts of Randomized Controlled Trial Reports in Cardiology. J Am Osteopath Assoc.732-9. https://doi.org/10.7556/jaoa.2020.133 Boutron I, Dutton S, Ravaud P, Altman DG(2010) Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA.303(20):2058-64. https://doi.org/10.1001/jama.2010.651 Scopus [Internet]. Elsevier B.V. Available from: https://www.scopus.com/search/form.uri?display=basic#basic . [accessed September 29 2024] Gholizadeh N, Sheykhbahaei N, Sadrzadeh-Afshar M-S(2016) New Treatment Approaches of Oral Mucositis: A Review of Literature. Advances in Human Biology.6(2):66–72. https://doi.org/10.4103/2321-8568.190319 Sucic A, Perisin AS, Zuvela T, et al.(2023) Reporting Quality of Randomized Controlled Trial Abstracts on Aesthetic Use of Botulinum Toxin: How Much Do Abstracts Actually Tell Us? Cosmetics.10(5):119. Knippschild S, Loddenkemper J, Tulka S, Loddenkemper C, Baulig C(2021) Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016. BMJ Open.11(8):e045372. https://doi.org/10.1136/bmjopen-2020-045372 Vrebalov Cindro P, Bukic J, Pranić S, et al.(2022) Did an introduction of CONSORT for abstracts guidelines improve reporting quality of randomised controlled trials' abstracts on Helicobacter pylori infection? Observational study. BMJ Open.12(3):e054978. https://doi.org/10.1136/bmjopen-2021-054978 Wiehn J, Nonte J, Prugger C(2022) Reporting quality for abstracts of randomised trials on child and adolescent depression prevention: a meta-epidemiological study on adherence to CONSORT for abstracts. BMJ Open.12(8):e061873. https://doi.org/10.1136/bmjopen-2022-061873 Gallo L, Wakeham S, Dunn E, Avram R, Thoma A, Voineskos S(2020) The Reporting Quality of Randomized Controlled Trial Abstracts in Plastic Surgery. Aesthet Surg J.40(3):335–41. https://doi.org/10.1093/asj/sjz199 Bothra M, Motiani P, Ahmad Z(2022) Evaluation of quality of abstracts of randomized controlled trials on procedural sedation in children after publication of CONSORT guidelines for abstracts: A systematic review. Journal of Anaesthesiology Clinical Pharmacology.38(3):384–90. https://doi.org/10.4103/joacp.JOACP_514_20 Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L(2018) Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive care medicine.44(10):1603–12. https://doi.org/10.1007/s00134-018-5293-7 Copeland A, Gallo L, Alolabi N. The Surgeon’s Guide to Systematic Review and Meta-Analysis. In: Thoma A, Sprague S, Voineskos SH, Goldsmith CH, editors. Evidence-Based Surgery: A Guide to Understanding and Interpreting the Surgical Literature. Cham: Springer International Publishing; 2019. p. 145–57. Boutron I, Altman DG, Hopewell S, Vera-Badillo F, Tannock I, Ravaud P(2014) Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. Journal of clinical oncology: official journal of the American Society of Clinical Oncology.32(36):4120–6. https://doi.org/10.1200/jco.2014.56.7503 Duyx B, Urlings MJE, Swaen GMH, Bouter LM, Zeegers MP(2017) Scientific citations favor positive results: a systematic review and meta-analysis. J Clin Epidemiol.88:92–101. https://doi.org/10.1016/j.jclinepi.2017.06.002 Fanelli D(2012) Negative results are disappearing from most disciplines and countries. Scientometrics.90(3):891–904. https://doi.org/10.1007/s11192-011-0494-7 Araujo AC, Vanin AA, Nascimento DP, Gonzalez GZ, Costa LOP(2021) What are the variables associated with Altmetric scores? Systematic Reviews.10(1):193. https://doi.org/10.1186/s13643-021-01735-0 Plint AC, Moher D, Morrison A, et al.(2006) Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. The Medical journal of Australia.185(5):263–7. https://doi.org/10.5694/j.1326-5377.2006.tb00557.x Helbach J, Hoffmann F, Pieper D, Allers K(2023) Reporting according to the preferred reporting items for systematic reviews and meta-analyses for abstracts (PRISMA-A) depends on abstract length. Journal of Clinical Epidemiology.154:167 – 77. https://doi.org/https://doi.org/10.1016/j.jclinepi.2022.12.019 Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8544979","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":588195685,"identity":"585b7428-cd66-4a62-b03e-c30e7bd6661f","order_by":0,"name":"Khadijeh Al-Abedalla","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAuklEQVRIiWNgGAWjYBACCSBmZjCwYYZy2IjWkkayFobDcA5hINnA/ky6oOA8u8EB5oO3eRj45AhqkWZgSJOeYXCb2eAAW7I1DwObMUEtQEOPSfOAtfCYSQO1JDYQ1sLYBtRyDqiF/xtxWqQZmNmAWg6AbGEjTotkMxuz9QyDZGbJw2zGlnMMiPCLxPH2h7cL/tgl8x1vfnjjTcUxwiHGwAyhkiEMg2OEdcCAHZSuIV7LKBgFo2AUjBgAAIKEKiNnnouRAAAAAElFTkSuQmCC","orcid":"","institution":"University of Jordan","correspondingAuthor":true,"prefix":"","firstName":"Khadijeh","middleName":"","lastName":"Al-Abedalla","suffix":""},{"id":588195686,"identity":"48726c30-34ff-4e6e-9759-0cae4677c01a","order_by":1,"name":"Ahmad A Hamdan","email":"","orcid":"","institution":"University of Jordan","correspondingAuthor":false,"prefix":"","firstName":"Ahmad","middleName":"A","lastName":"Hamdan","suffix":""},{"id":588195688,"identity":"859732d8-f0df-4836-a297-0a01a4ac99d8","order_by":2,"name":"Qais AlSaghir","email":"","orcid":"","institution":"University of Pittsburgh","correspondingAuthor":false,"prefix":"","firstName":"Qais","middleName":"","lastName":"AlSaghir","suffix":""},{"id":588195689,"identity":"d587ecf8-10e3-4865-8025-d5387c77f6f2","order_by":3,"name":"Yazan Hassona","email":"","orcid":"","institution":"University of Jordan","correspondingAuthor":false,"prefix":"","firstName":"Yazan","middleName":"","lastName":"Hassona","suffix":""},{"id":588195690,"identity":"3cb9224b-84f3-40a3-87e2-a0949328b0b8","order_by":4,"name":"Effie Ioannidou","email":"","orcid":"","institution":"University of California, San Francisco","correspondingAuthor":false,"prefix":"","firstName":"Effie","middleName":"","lastName":"Ioannidou","suffix":""},{"id":588195692,"identity":"e4a97bce-45c6-477b-a641-63a7d7504cc8","order_by":5,"name":"Murad Shaqman","email":"","orcid":"","institution":"University of Jordan","correspondingAuthor":false,"prefix":"","firstName":"Murad","middleName":"","lastName":"Shaqman","suffix":""}],"badges":[],"createdAt":"2026-01-07 20:23:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8544979/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8544979/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102447520,"identity":"b271180d-6341-486a-8a3e-5e7fc93f64b8","added_by":"auto","created_at":"2026-02-11 17:55:19","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":61533,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePRISMA 2020 flow diagram for new systematic reviews which included searches of databases and registers only\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8544979/v1/78e90f81a3c429c9e82104e2.png"},{"id":102447558,"identity":"33f705ef-8217-475a-bedf-32c2bc64308b","added_by":"auto","created_at":"2026-02-11 17:55:20","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":117186,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTotal Spin Score for each article\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8544979/v1/796690aaa27a45c44b4564ef.png"},{"id":102962217,"identity":"81f60685-b7ea-4b70-8f90-227e0e0a2dfd","added_by":"auto","created_at":"2026-02-19 04:05:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1131868,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8544979/v1/d2f5ebf6-e665-4623-9f71-bc79514486da.pdf"},{"id":102447559,"identity":"cb524034-9a73-4b4a-a550-83e6be549acf","added_by":"auto","created_at":"2026-02-11 17:55:21","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":408002,"visible":true,"origin":"","legend":"","description":"","filename":"OnlineResource.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8544979/v1/99ee08e886bd18afc868a771.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Reporting quality and spin in abstracts of randomized clinical trials related to Oral Mucositis","fulltext":[{"header":"Introduction","content":"\u003cp\u003eWorldwide, cancer is a leading cause of morbidity and mortality; being responsible for nearly 10\u0026nbsp;million deaths per year [\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e]. The global economic burden of cancer is escalating. From 2020 to 2050, the estimated global economic cost of cancer is projected to be \u003cspan\u003e$\u003c/span\u003e25.2 trillion in international [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eAdvancements in cancer treatment modalities, particularly chemotherapy, radiotherapy, immunotherapy, target specific therapeutic interventions, and hematopoietic stem cell transplant, have resulted in significant survival benefits In various types of human cancer [\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Nevertheless, these advances in cancer therapies have been associated with severe side effects involving various body systems, and potentially limiting their clinical benefits, increasing the overall cost of treatment, and impairing the quality of life of affected patients [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eOral mucositis (OM) is one potential complication of various cancer treatment modalities. It is a painful inflammatory disorder affecting the oral and oropharyngeal mucosa, resulting in pain, discomfort, dysphagia, malnutrition, increased susceptibility to local and systemic infections, impaired quality of life and increased treatment cost and duration[\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e]. The prevalence of mucositis is highly variable ranging from 20\u0026ndash;100% depending on treatment modality, dose, duration, and the presence of other comorbidities [\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eOral mucositis usually manifests as mucosal swelling, erythema, desquamation, ulceration, pain, bleeding, and difficulty in food intake and swallowing [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. Complications of oral mucositis might result in treatment suspension or even discontinuation leading to negative consequences on patient\u0026rsquo;s care and impaired overall prognosis [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. Prevention, early diagnosis, and timely treatment of oral mucositis are therefore essential components of the multidisciplinary care of cancer patients. Unfortunately, evidence-based guidelines regarding management of oral mucositis in patients with cancer are sparse.\u003c/p\u003e\n\u003cp\u003eThe first international guidelines for treatment of oral mucositis were published in 2004 by The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International.\u003c/p\u003e\n\u003cp\u003eThe MASCC/ISOO guidelines for management of oral mucositis are widely adopted worldwide and updated regularly [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e]. Only four interventions currently hold strong evidence-based recommendations by MASCC/ISOO for treatment of oral mucositis. Those include topical benzydamine, laser therapy, cryotherapy, and keratinocyte growth factor [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eAlthough the latest MASCC/ISOO guidelines (2020) incorporated a comprehensive review of new evidence, \u003cstrong\u003eno\u003c/strong\u003e definitive recommendations were provided for management of oral mucositis in various clinical scenarios, leaving clinicians to rely on published randomized controlled trials and emerging data to guide patient-specific management decisions, leaving clinicians to rely on published randomized controlled trials and emerging data to guide patient-specific management decisions [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eClinicians\u0026rsquo; time limitations, language limitations for non-English articles, and limited access to full-texts push clinicians to rely only on published abstracts to guide their treatment decision [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e]. Previous studies in other fields indicated that abstracts do not consistently reflect the methodology or outcomes reported in full publications, which may introduce bias into evidence-based clinical decision-making [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eTo the best of our knowledge, no prior study has evaluated the reporting quality of abstracts of RCTs assessing treatment modalities of oral mucositis. The purpose of our study therefore is to evaluate the reporting quality of abstracts of RCTs assessing therapeutic interventions for oral mucositis recommended by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Specific objectives of the current study are to:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003e\n \u003cp\u003eAssess the level of reporting quality and spin in abstracts of randomized clinical trials (RCTs) evaluating the recommended therapeutic interventions for oral mucositis by MASCC/ISOO.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eAssess potential factors that might affect the level of reporting quality and spin in abstracts of these RCTs.\u003c/p\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eFindings of our study will help to address challenges in the available evidence regarding management of oral mucositis in patients with cancer, and support informed clinical choices.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003ch2\u003eSearch methods and study selection\u003c/h2\u003e\n\u003cp\u003eThe protocol of this meta-research study is available online https://osf.io/d2muy.\u003c/p\u003e\n\u003cp\u003eStudies were retrieved from different databases, including PubMed, Cochrane, and Scopus. In addition, we cross-checked all trial primary registration platforms included in the World Health Organization and International Clinical Trials Registry to confirm trial registration status and retrieve missing trials. The last search was conducted for all databases on September 18\u003csup\u003eth\u003c/sup\u003e, 2024.\u003c/p\u003e\n\u003cp\u003eSearch keywords and limitations/filters for each database and each treatment group were as follows:\u003c/p\u003e\n\u003cp\u003ePubmed:\u0026nbsp;\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003ePhoto-biomodulation therapy: (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (erosive*)) OR (vesiculo*)) AND (((light) OR (photobiomodulation)) OR (laser)).\u003c/li\u003e\n \u003cli\u003eKeratinocyte growth factor: ((palifermin*) OR (((keratinocyte*) OR (fibroblast*)) AND (growth*))) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)).\u003c/li\u003e\n \u003cli\u003eCryotherapy: ((((Cryotherapy*) OR (cryoablation*)) OR (ice)) OR (cold*)) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)).\u003c/li\u003e\n \u003cli\u003eBenzydamine: (((benzydamine) OR (tantum verder)) OR (difflam)) AND (((((oral ulcer[MeSH Terms]) OR (mucositis[MeSH Terms])) OR (stomatitis[MeSH Terms])) OR (vesiculo*)) OR (erosive*)).\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eScopus:\u0026nbsp;\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003ePhoto-biomodulation therapy: TITLE-ABS-KEY ( ( light \u0026nbsp;OR \u0026nbsp;laser \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;OR \u0026nbsp;photobiomodulation ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;( mucositis \u0026nbsp;OR \u0026nbsp;stomatitis ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;random* )\u003c/li\u003e\n \u003cli\u003eKeratinocyte growth factor: TITLE-ABS-KEY ( ( palifermin* \u0026nbsp;OR \u0026nbsp;keratinocyte* ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;( mucositis \u0026nbsp;OR \u0026nbsp;stomatitis ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;random* )\u003c/li\u003e\n \u003cli\u003eCryotherapy:\u0026nbsp;TITLE-ABS-KEY ( ( cryotherapy* \u0026nbsp;OR \u0026nbsp;cryoablation* \u0026nbsp;OR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;ice \u0026nbsp;OR \u0026nbsp;cold ) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;AND \u0026nbsp;( mucositis \u0026nbsp;OR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;stomatitis ) \u0026nbsp;AND \u0026nbsp;random* )\u003c/li\u003e\n \u003cli\u003e\u0026nbsp;Benzydamine: TITLE-ABS-KEY ( ( benzydamine* \u0026nbsp;OR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;tantum* \u0026nbsp;OR \u0026nbsp;difflam* ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;( mucositis \u0026nbsp;OR \u0026nbsp;stomatitis ) \u0026nbsp;AND \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;random* )\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eCochrane:\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003ePhoto-biomodulation therapy: (light* OR photobiomodulation OR laser*) AND (mucositis* OR stomatitis*)\u003c/li\u003e\n \u003cli\u003eKeratinocyte growth factor: (palifermin* OR keratinocyte* OR kepivance* OR velafermin) AND (mucositis* OR stomatitis*)\u003c/li\u003e\n \u003cli\u003eCryotherapy:\u0026nbsp;(Cryotherapy* OR cryoablation* OR ice* OR cold*) AND (mucositis* OR stomatitis*)\u003c/li\u003e\n \u003cli\u003eBenzydamine: (benzydamine OR tantum verder OR difflam OR Septabene OR benzamidine OR CR3294) AND (mucositis* OR stomatitis*)\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003ePrimary registries in the World Health Organization platform were searched using the key word \u0026ldquo;Mucositis\u0026rdquo; only because these platforms are limited to one or two keywords.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition, previous reviews and systematic reviews were hand-searched for identification of additional RCT reports and then duplicates were excluded.\u003c/p\u003e\n\u003cp\u003eThe retrieved registers were then scanned for eligible studies, and duplicates were excluded.\u003c/p\u003e\n\u003ch2\u003eRCT report inclusion criteria\u003c/h2\u003e\n\u003ch3\u003e\u003cem\u003eStudy Design:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003eOnly prospective RCTs related to oral mucositis treatment were included. Other study designs such as cohort, non-randomized trials or observational trials were excluded. There were no language restrictions, and RCT abstracts that are not in English were translated.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eParticipants:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003ePatients (both genders) who were recruited to treat oral mucositis which was developed after chemotherapy or radiotherapy. There were no restrictions regarding age.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eIntervention:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003eOnly recommended interventions (not suggested) by MASCC/ISOO for oral mucositis including\u0026nbsp;[19]:\u003c/p\u003e\n\u003cp\u003e1. From the Anti‐inflammatory agent\u0026rsquo;s category: Only studies that have assessed the effect of Benzydamine as a mouthwash or intra-oral spray were included.\u003c/p\u003e\n\u003cp\u003e2. From the Photobiomodulation category: Only studies that have assessed the effect of intra-oral Photobiomodulation therapy were included.\u003c/p\u003e\n\u003cp\u003e3. From Cryotherapy category: Studies that have oral Cryotherapy were included.\u003c/p\u003e\n\u003cp\u003e4. From Growth factors and cytokines category: Studies that have used keratinocyte growth factor intravenously as a treatment were included.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eComparator(s)/control:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003ePatients who developed oral mucositis after chemotherapy or radiotherapy but weren\u0026rsquo;t treated in the study, or received sham treatment, or received different treatment modalities than the ones that were recommended by MASS/ISOO.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eOutcomes:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003eReduction in incidence or severity of mucositis, including pain severity, mucositis duration, pain duration, or any other symptoms related to mucositis assessed in the retrieved RCTs.\u003c/p\u003e\n\u003ch3\u003eSelection criteria for spin assessment:\u003c/h3\u003e\n\u003cp\u003eOnly studies with a clearly defined primary outcome in the abstract were included in the spin analysis only.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eData extraction and compilation\u003c/h2\u003e\n\u003cp\u003eSelection of studies was carried out according to the inclusion criteria by two authors independently (KA, QA). Titles and abstracts of the search results were initially screened for eligible studies, then full texts were retrieved and further assessed for eligibility.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eData extraction: Two authors (KA, QA) independently reviewed the abstracts -and the full texts, when needed- of the included RCTs. The 2 authors recorded and collected data of interest using a customized data extraction form using Microsoft Excel sheet. Any disagreement was resolved by a third author (MS). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAuthors (KA and QA) applied both the CONSORT checklist for abstracts\u0026nbsp;[26], and the SPIN checklist that was published in 2020[28] and was derived from Boutron\u0026rsquo;s study[29]. Two items of the CONSORT abstracts guidelines were excluded because they only apply to unpublished studies or conference abstracts, including the item \u0026ldquo;recruitment\u0026rdquo; from the results section and the item \u0026ldquo;authors\u0026rdquo;.\u003c/p\u003e\n\u003cp\u003eThe following data was extracted:\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003eAn overall CONSORT score for reporting quality (OCS) will be calculated for each abstract based on the CONSORT checklist items fulfilled.\u003c/li\u003e\n \u003cli\u003eAn overall SPIN score will be calculated for each abstract based on the SPIN checklist items fulfilled.\u003c/li\u003e\n \u003cli\u003eCharacteristics of each RCT abstract and the respective publishing journal were extracted:\u0026nbsp;\u003col start=\"1\" type=\"a\" style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eAbstract word count of the article, and the word count limit for its corresponding journal.\u003c/li\u003e\n \u003cli\u003eNumber of citations for each article as shown on Scopus and Google Scholar.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAltmetric score of trial (https://www.altmetric.com).\u003c/li\u003e\n \u003cli\u003eGeographic location.\u003c/li\u003e\n \u003cli\u003eTrial\u0026rsquo;s funding source.\u003c/li\u003e\n \u003cli\u003eJournal\u0026rsquo;s date of adherence to ICMJE guidelines.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eJournal\u0026rsquo;s Impact factor for 2024, and the last 5 years [30].\u003c/li\u003e\n \u003cli\u003eJournal\u0026rsquo;s Scimago Journal \u0026amp; Country Rank (SJR) indicator 2023 (https://www.scimagojr.com).\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\n\u003ch2\u003eStatistical analysis\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eCohen\u0026rsquo;s Kappa\u003c/strong\u003e test was used to assess inter-rater agreement, with a value of \u003cstrong\u003e0.7 or higher\u003c/strong\u003e indicating substantial agreement between the two reviewers. \u003cstrong\u003eCategorical variables\u003c/strong\u003e were presented as \u003cstrong\u003epercentages (proportions)\u003c/strong\u003e\u003cstrong\u003e.\u003c/strong\u003e To evaluate \u003cstrong\u003ebivariate associations\u003c/strong\u003e among the aforementioned variables, the \u003cstrong\u003ePearson correlation test\u003c/strong\u003e was applied. To compare categorical groups with numerical outcomes, the \u003cstrong\u003eKruskal\u0026ndash;Wallis\u0026rsquo;s test\u003c/strong\u003e was applied to assess overall differences among the groups, followed by a \u003cstrong\u003eBonferroni-corrected post hoc test\u003c/strong\u003e to identify which specific group comparisons were statistically significant. Statistical analysis was performed using SPSS software (IBM Corp., Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.).\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eGeneral findings\u003c/h2\u003e \u003cp\u003eOne hundred and twelve RCTs were deemed eligible (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Among them, 14 RCTs mainly assessed the effect of keratinocytes growth factor on mucositis, 23 assessed the effect of ice, 46 assessed the effect of photobiomodulation therapy, and 29 assessed the effect of benzydamine.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e\u003cem\u003eFrom\u003c/em\u003e: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/bmj.n71\u003c/span\u003e\u003cspan address=\"10.1136/bmj.n71\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e \u003cp\u003eThe table in the Online Resource provides the metrics for each article and journal, along with the OCS, and divided according to treatment group.\u003c/p\u003e \u003cp\u003e Out of 112 trials, 52 of them were published in journals that reported their adherence date to ICMJE guidelines, including following the CONSORT guidelines. Nine RCTs were published in journals that are reported on ICMJE\u0026rsquo;s website that they adhere to the guidelines, but without a date. Fifteen RCTs were published in journals that do not state that they adhere to the ICMJE guidelines, but they do recommend following the guidelines. Thirty-six RCTs were published in journals that have no instructions regarding the CONSORT checklist or recommendations of following the ICMJE guidelines.\u003c/p\u003e \u003cp\u003eAmong the included RCTs, 38.4% were conducted in Asia, 21.4% in South America, and 20.5% in Europe. In North America, 12.5% of the trials were conducted, while 4.5% spanned multiple continents. Notably, no RCTs were conducted in Africa or Australia.\u003c/p\u003e \u003cp\u003eSixty-six RCTs were funded.24% of the RCTs were funded by governmental funding, 12% were funded by pharmaceutical companies, 11% of the RCTs by Educational associations, 8% of the RCTs by Private organizations, and 4% of them were funded by a combination of more than one type of funding source. On the other hand, 11% of the RCTs reported that they were conducted with no funds, and 20% of the RCTs did not report if they were funded or not.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e also demonstrates each abstract word count and the corresponding journal\u0026rsquo;s word limit. The word limit ranged from 150\u0026ndash;500, with some journals having no word limit in their guidelines (24 trials). Fifty-five trials (49.1%) had abstract word counts less than the limit, and 33 trials had abstract word count more than the limit (21.4%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCONSORT checklist findings\u003c/h2\u003e \u003cp\u003eGenerally, Overall CONSORT score (OCS) was low ranging from 0\u0026ndash;8 out of 15 items that should be fulfilled (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e Eleven trials were published after their corresponding journal\u0026rsquo;s adherence date to ICMJE guidelines. The other trials were published before the adherence date. These 11 trials still showed low OCS ranging 0\u0026ndash;4 out of 15 items.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eshows that only 50.4% of the RCTs included the word \u0026ldquo;randomized\u0026rdquo; in their title. Only 11 trials reported the trial design in the abstracts. The rest only stated that it would be a control-test design.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eCONSORT item\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"5\" nameend=\"c6\" namest=\"c2\"\u003e \u003cp\u003eFulfillment (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBenzydamine group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePhotobiomodulation group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eKeratinocyte growth factor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCryotherapy Ice group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTitle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e57 (50.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrial Design\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (9.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMethods\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInterventions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (9.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eObjective\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (8.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (2.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRandomization (Methods)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlinding (Masking)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e10 (8.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResults\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumbers randomized\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e45 (39.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumbers analyzed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e19 (16.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (3.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHarms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27 (23.9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConclusion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e93 (82.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrial registration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (4.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e: \u003cb\u003eCONSORT item fulfillment for each intervention.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of reporting the methods:\u003c/h2\u003e \u003cp\u003eTwo items in the methods section lacked reporting in all RCTs. The first item was \u0026ldquo;participants\u0026rdquo;, which mainly lacked 3 types of information. The location of the study where only 8% of the RCTs reported it, the \u0026ldquo;starting and finishing dates of the trial\u0026rdquo;, where only 6% of the RCTs reported, and the \u0026ldquo;participants age range\u0026rdquo; where only 13% of RCTs reported it. The only information that was reported under this item was the disease condition that the participants had, and 72% of the RCTs reported it. Therefore, all RCTs were considered that they have not fulfilled this item.\u003c/p\u003e \u003cp\u003eThe second item that was not fulfilled was \u0026ldquo;randomization\u0026rdquo;. This item included both the techniques of randomization and concealment. None of the trials reported the concealment technique they followed, and only 4% of the trials reported the method of randomization. Therefore, all RCTs were considered that they have not fulfilled this item.\u003c/p\u003e \u003cp\u003eThe other items under the methods section that were fulfilled are:\u003c/p\u003e \u003cp\u003eThe item \u0026ldquo;blinding\u0026rdquo; was only reported in 10 trials.\u003c/p\u003e \u003cp\u003eOnly 10 trials fulfilled the item \u0026ldquo;intervention\u0026rdquo;. This item was only fulfilled by the trials that reported the necessary detailed description of the intervention, including the intervention followed in each arm, the dosages of each intervention, frequency, duration of each intervention, and the route that was used to apply the treatment. Therefore, this item was considered not fulfilled if any of these details were missing.\u003c/p\u003e \u003cp\u003eOnly 78% reported the intervention in each arm, the rest of the abstracts had no clear information about the treatment type that each arm received. Only 30% reported the dosages for each arm. Frequency of the intervention was only reported in 28%, duration of intervention in 41% and the route was only in 58%.\u003c/p\u003e \u003cp\u003eNine trials reported their objective according to their primary outcome, the rest of trials either had no primary outcome reported, or their objective was based on another outcome.\u003c/p\u003e \u003cp\u003eInterestingly, 14% of the RCTs clearly mentioned the main outcome; however, only 3 RCTs mentioned that the primary outcome was assessed. Some abstracts reported the primary outcome as a part of the abstract results rather than the materials and methods, violating the CONSORT recommendations.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of reporting the results:\u003c/h2\u003e \u003cp\u003eAlthough almost 40% of the abstracts included the numbers of randomized populations in each group, only 17% of the abstracts included the numbers analyzed in each arm.\u003c/p\u003e \u003cp\u003eOnly 4 trials clearly mentioned the results of the primary outcome with its effect size. Most of the abstracts mentioned the results in wording only, and some only included the p-value.\u003c/p\u003e \u003cp\u003eTwenty-seven RCTs reported harm in the abstracts (23.9%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of reporting conclusion, registration, and funding:\u003c/h2\u003e \u003cp\u003eOnly 82% discussed the conclusion based on the primary outcome. Trial registration was reported in only 15 abstracts (13.3%), and 5 trials (4.4%) reported the funding source in the abstract section.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eSpin analysis findings\u003c/h2\u003e \u003cp\u003ePer our inclusion and exclusion criteria for Spin analysis, only 16 abstracts were included in this section (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The rest of the RCTs were not included because they did not report the primary outcome in their abstract section. The excluded RCTs were not assessed for Spin analysis, however, this does not mean that no Spin was found in these excluded abstracts.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSPIN item fulfillment for the included studies (16 studies)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpin item\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eItem explanation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFulfillment (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTitle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eClaims/insinuation with no results supporting it\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo identification of the primary outcome in the methods section\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo identification of the primary outcome in the methods section\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncomplete reporting of the results for the primary outcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIncomplete reporting of the results for the primary outcome for each group (a sentence isn\u0026rsquo;t enough; data should be included)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (37.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSelective reporting of statistically significant secondary outcomes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSelective reporting of statistically significant secondary outcomes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo or incomplete reporting of safety data\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo or incomplete reporting of safety data\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFocus on statistically significant subgroup or secondary analysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFocus on statistically significant subgroup or secondary analysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNone had sub-groups\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLinguistic spin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLinguistic spin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConclusion with spin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eClaim of benefit/ equivalence/ focus on another objective/ tend towards significance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eOverall Spin score ranged between 0\u0026ndash;4 out of 7 items (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The figure also shows that Spin does not depend on the date of publication. Only two RCTs had no spin in its abstract.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eOut of the 16 RCTs, 3 of them had Spin in their title, basically claiming benefits without proving it in the results or extra benefits without measuring it or reporting it.\u003c/p\u003e \u003cp\u003eThree abstracts reported the primary outcome in the results section, 2 abstracts in the objective section rather than in materials and methods section.\u003c/p\u003e \u003cp\u003eSix abstracts showed incomplete reporting of the results for primary outcome analysis, where there was only a sentence describing the results with no numbers, p-value, or effect size.\u003c/p\u003e \u003cp\u003eTwo abstracts focused on the significant secondary outcome without mentioning the results of the outcome or focused on the significant secondary outcome and not on the non-significant primary outcome.\u003c/p\u003e \u003cp\u003eEight of the 16 abstracts (50%) did not report harm or safety data.\u003c/p\u003e \u003cp\u003eThree of these abstracts had linguistic spin in results or conclusion sections, and two abstracts claimed the benefit or significance of the intervention in the conclusion section.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eAltmetric\u003c/h2\u003e \u003cp\u003eAltmetiric score shows how much attention surrounded research in social media. For the retrieved 112 RCTs, their Altmetric score ranged between 0\u0026ndash;31.\u003c/p\u003e \u003cp\u003e48.2% of the RCTs had zero Altemtric score.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eCorrelation analyses\u003c/h2\u003e \u003cp\u003eOCS only showed a significant positive correlation with:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAbstract word count (P-value\u0026thinsp;=\u0026thinsp;0.000, r\u0026thinsp;=\u0026thinsp;0.37). Therefore, the higher the number of word count allowed, the higher the number of fulfilled items of OCS.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePharmaceutical companies showed better adherence to CONSORT compared to articles that did not report on their funding source (P-value\u0026thinsp;=\u0026thinsp;0.015).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eMulti-country trials showed better fulfillment in OCS compared to trials published in South America (p-value\u0026thinsp;=\u0026thinsp;0.006) and Asia(p-value\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eJournal\u0026rsquo;s impact factor for the last 5 years showed a nearly significant positive correlation with OCS (P-value\u0026thinsp;=\u0026thinsp;0.055, r\u0026thinsp;=\u0026thinsp;0.19). Therefore, the higher the journal\u0026rsquo;s impact factor for the last 5 years, the higher the number of fulfilled items of OCS. Other parameters that were extracted from the articles showed no significant correlation with OCS (P-value\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003eAltmetric score showed generally positive and significant correlations with the citations of the article and the journal\u0026rsquo;s impact factors:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eCitation in Scopus (P-value\u0026thinsp;=\u0026thinsp;0.00, r\u0026thinsp;=\u0026thinsp;0.593).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eCitation in Google scholar (P-value\u0026thinsp;=\u0026thinsp;0.00, r\u0026thinsp;=\u0026thinsp;0.589)\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eSJR index (P-value\u0026thinsp;=\u0026thinsp;0.00, r\u0026thinsp;=\u0026thinsp;0.431)\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAbstract word limit from the corresponding journal (P-value\u0026thinsp;=\u0026thinsp;0.033, r\u0026thinsp;=\u0026thinsp;0.211)\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eJournal\u0026rsquo;s impact factor (P-value\u0026thinsp;=\u0026thinsp;0.00, r\u0026thinsp;=\u0026thinsp;0.441). Therefore, the higher the journal\u0026rsquo;s impact factor, the higher the Altmetric score of that article.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eJournal\u0026rsquo;s impact factor during the last 5 years (P-value\u0026thinsp;=\u0026thinsp;0.00, r\u0026thinsp;=\u0026thinsp;0.459)\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eOther parameters that were extracted from the articles showed no significant correlation with Altmetric score (P-value\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eSPIN correlation analysis:\u003c/h2\u003e \u003cp\u003eSpin showed significant negative correlation with Altmetric score (p-value of 0.006, and r= -0.652). Therefore, the higher Altmetric score, the less SPIN in the abstract.\u003c/p\u003e \u003cp\u003eSpin showed a non-significant correlation with the other variables (p-value\u0026thinsp;\u0026gt;\u0026thinsp;0.05)\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe prevalence of therapy-induced oral mucositis is expected to rise in parallel with the increasing global burden of cancer, and the development of new cancer therapies. Consequently, there is an expanding need to critically appraise the effectiveness of available preventive and therapeutic strategies, particularly in light of the wide range of treatment protocols and approaches proposed in the literature [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. Over recent decades, numerous randomized controlled trials (RCTs) have investigated interventions for the prevention and management of therapy-induced oral mucositis. While this growing body of evidence has the potential to inform clinical practice, it also places a considerable burden on clinicians, who must navigate an increasingly complex and rapidly expanding literature. In time-pressured clinical settings, healthcare providers often rely primarily on abstracts when seeking evidence. However, previous studies have demonstrated that abstracts do not consistently reflect the methodology or outcomes reported in full publications, which may introduce bias into evidence-based clinical decision-making [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e To the best of our knowledge, this is the first study to evaluate both reporting quality and spin in abstracts of RCTs assessing therapeutic interventions for oral mucositis recommended by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Focusing exclusively on MASCC/ISOO-recommended modalities ensured inclusion of interventions supported by the strongest available evidence. Our analysis of 112 RCTs demonstrated consistently poor abstract reporting quality, with overall CONSORT scores ranging from 0 to 8 out of a possible 15, indicating substantial non-adherence to established reporting standards. These findings are consistent with previous studies across oncology and related healthcare fields, where abstract reporting quality has similarly been described as suboptimal [\u003cspan additionalcitationids=\"CR33 CR34\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. Importantly, even among RCTs published in journals claiming adherence to ICMJE or CONSORT guidelines, reporting quality remained low, including among 11 trials published after formal guideline endorsement (OCS range 0\u0026ndash;4), suggesting limited enforcement of reporting standards during peer review.\u003c/p\u003e \u003cp\u003eReporting methodological characteristics within abstracts was particularly inadequate. Only 9.82% of trials reported study design, and none of the included RCTs reported participant characteristics or randomization procedures. These findings are consistent with previous evaluations of methodological reporting in clinical trial abstracts [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e] and represent a critical limitation, as omission of these elements prevents accurate assessment of internal validity and applicability.\u003c/p\u003e \u003cp\u003eSeveral factors may explain these deficiencies, including restrictive abstract word or character limits imposed by journals [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Under such constraints, authors may prioritize reporting results perceived as more appealing or clinically relevant at the expense of essential methodological details. Inadequate reporting of trial design and conduct in abstracts may lead to misinterpretation of findings and inappropriate application in clinical practice [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. For clinicians seeking to implement evidence-based protocols for oral mucositis management, insufficient methodological transparency hinders meaningful appraisal of trial relevance and reliability.\u003c/p\u003e \u003cp\u003eAnalysis of factors associated with reporting quality yielded findings consistent with previous studies [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Higher journal impact factor, greater abstract word count, multicenter study design, and publication in journals endorsing CONSORT were associated with higher overall CONSORT scores and improved reporting quality. In contrast, journal-specific word count limits did not demonstrate a significant association with overall CONSORT scores, suggesting that editorial practices and reviewer expectations may be more influential than formal word limits alone.\u003c/p\u003e \u003cp\u003ePharmaceutical-funded studies (13 of 112 RCTs) demonstrated better adherence to CONSORT reporting standards compared with studies that did not report funding sources. This may reflect greater access to methodological expertise, additional resources, or stricter oversight. However, the high proportion of trials failing to disclose funding sources raises concerns regarding transparency and potential conflicts of interest [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eOutcome reporting was also suboptimal. The majority of included RCTs failed to report primary outcome results in the abstract, with only four trials (3.5%) doing so. Poor reporting of results may result in the omission of potentially valuable information, even when findings are non-significant, and may contribute to exclusion of such studies from systematic reviews and clinical practice guidelines [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. Furthermore, only 14% of RCTs clearly stated the primary outcome, and in some cases this information was inappropriately reported in the results section rather than the methods, contrary to CONSORT recommendations and potentially confusing readers regarding trial intent [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBiased or distorted reporting of trial results may further mislead readers and lead to erroneous conclusions [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. In the present study, spin analysis was limited to trials that clearly defined a primary outcome in the abstract, resulting in eligibility of only 16 studies (14.3%). Among these, only two abstracts (12.5%) were free of spin, while varying degrees of spin were observed in the remaining studies. Notably, 18.9% of studies exhibited spin in their titles, claiming benefits not supported by the reported results or suggesting additional outcomes that were not measured. In two abstracts (21.5%), authors emphasized statistically significant secondary outcomes while omitting mention of non-significant primary outcomes. Previous research has shown that studies reporting positive or significant results are more likely to be published, cited, and accepted by high-impact journals [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. Interestingly, our analysis demonstrated a negative correlation between the degree of spin and Altmetric score, suggesting that abstracts containing greater spin may attract less online attention. This finding may reflect the ability of critically engaged readers, particularly on social media platforms, to identify and avoid amplifying misleading content. Additionally, the specialized nature of oral mucositis research likely contributes to limited online visibility, as evidenced by nearly half of included RCTs (48.2%) receiving zero Altmetric scores. Previous studies have demonstrated that Altmetric attention is more strongly influenced by journal characteristics and dissemination practices than by methodological rigor alone [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study has several limitations. First, restricting inclusion to MASCC/ISOO-recommended interventions may limit generalizability to non-recommended modalities, although this approach ensured focus on treatments supported by the strongest evidence. Second, journal impact factors were obtained for the year 2024 rather than the year of publication, which may have influenced observed associations [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Third, geographic clustering of RCTs and underrepresentation of studies from certain regions may limit the global applicability of our findings and reflect disparities in funding or research infrastructure. Finally, the small number of trials eligible for spin analysis may have resulted in underestimation of the true prevalence of spin among oral mucositis RCT abstracts.\u003c/p\u003e \u003cp\u003e Numerous studies have recommended that journals adopt editorial policies endorsing CONSORT guidelines and ensure adherence through rigorous peer-review processes to improve reporting completeness and abstract quality. Empirical evidence supports this recommendation, demonstrating that journal adoption of CONSORT guidelines is associated with significantly improved reporting of sequence generation, allocation concealment, and overall completeness in RCTs [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. Nevertheless, despite repeated recommendations, substantial improvements in abstract reporting remain limited.\u003c/p\u003e \u003cp\u003eMore feasible and immediately actionable strategies include modest increases in abstract word limits, which have been shown to correlate positively with improved reporting quality [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e], and targeted training for authors, peer reviewers, and editors on the importance of adhering to reporting guidelines such as CONSORT for Abstracts. Collectively, these measures may enhance transparency, reduce reporting bias, and improve the clinical utility of abstracts in oral mucositis research.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThe authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\n\u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by K.A and Q.A. The first draft of the manuscript was written by K.A, A.H, and M.S. Y.Z, M.S. and E.I commented on previous versions of the manuscript. All authors read and approved of the final manuscript.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eAll data supporting the findings of this study are available within the paper and its Supplementary Information.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBray F, Laversanne M, Sung H, et al.(2024) Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin.74(3):229\u0026ndash;63. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3322/caac.21834\u003c/span\u003e\u003cspan address=\"10.3322/caac.21834\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBizuayehu HM, Ahmed KY, Kibret GD, et al.(2024) Global Disparities of Cancer and Its Projected Burden in 2050. 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The Medical journal of Australia.185(5):263\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.5694/j.1326-5377.2006.tb00557.x\u003c/span\u003e\u003cspan address=\"10.5694/j.1326-5377.2006.tb00557.x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHelbach J, Hoffmann F, Pieper D, Allers K(2023) Reporting according to the preferred reporting items for systematic reviews and meta-analyses for abstracts (PRISMA-A) depends on abstract length. Journal of Clinical Epidemiology.154:167\u0026thinsp;\u0026ndash;\u0026thinsp;77. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/https://doi.org/10.1016/j.jclinepi.2022.12.019\u003c/span\u003e\u003cspan address=\"10.1016/j.jclinepi.2022.12.019\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Quality of Reporting, Clinical Trials, Mucositis, Spin, Abstracts, Cancer, Treatment","lastPublishedDoi":"10.21203/rs.3.rs-8544979/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8544979/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e: Oral mucositis is a common debilitating side effect of radiotherapy and chemotherapy in cancer patients. Numerous randomized controlled trials have examined different remedies for the management of this complication. Accurate reporting of Randomized Controlled Clinical Trials (RCTs) results in abstracts is crucial for treatment decisions. This study evaluates the reporting quality and potential spin in abstracts of RCTs addressing mucositis treatment according to MASCC/ISOO guidelines. Factors that can affect reporting quality and spin were also assessed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: We systematically searched PubMed, Cochrane, and Scopus databases for RCTs related to oral mucositis treatments published until September 2024. We applied the CONSORT and SPIN checklists to assess reporting quality and spin in the abstracts.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Out of 112 RCTs analyzed, the overall CONSORT score for reporting quality was low, with key elements such as study design and outcome reporting frequently omitted. Only 16 RCTs were analyzed for spin, which revealed that only 2 RCTs had no spin. Higher reporting quality significantly correlated with greater word count (r=0.37, P=0.000), pharmaceutical funding compared to non-funded articles (P=0.015), and trials that were conducted in more than 1 country (P\u0026lt;0.03). Spin was negatively correlated with Altmetric score (r=−0.652, P=0.006).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: The reporting quality of RCT abstracts on oral mucositis interventions is severely lacking. Considerable spin also undermines the integrity of the information presented. This compromises evidence-based practice. These findings underscore the need for enhanced adherence to reporting guidelines to support evidence-based clinical practices.\u003c/p\u003e","manuscriptTitle":"Reporting quality and spin in abstracts of randomized clinical trials related to Oral Mucositis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-11 17:55:11","doi":"10.21203/rs.3.rs-8544979/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-04-08T16:48:54+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-04T06:13:26+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-11T13:18:35+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"69011640094169870216604147220005728677","date":"2026-03-11T12:34:28+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"76976246397273210668351070051833561602","date":"2026-03-02T03:20:34+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-09T10:47:34+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-08T17:48:34+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-14T09:01:03+00:00","index":"","fulltext":""},{"type":"submitted","content":"Supportive Care in Cancer","date":"2026-01-07T20:02:35+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"771658ea-2ddb-4ed3-9b25-ab36478a62dd","owner":[],"postedDate":"February 11th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-09T16:09:29+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-11 17:55:11","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8544979","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8544979","identity":"rs-8544979","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}