Assessing the Reporting and Frequency of Harms in Systematic Reviews Focused on Minimally Invasive Hysterectomies: A Cross-sectional Analysis.

OBJECTIVE: To assess the quality of harms reporting in systematic reviews (SRs) regarding minimally invasive hysterectomies (MIHs). DATA SOURCES: We performed a cross-sectional analysis on SRs addressing MIHs to assess completeness of harms reporting. Hysterectomies are common gynecologic procedures and are associated with complications. Such adverse events can directly affect physician decision making and patient outcomes. Thus, it is important that SRs equally weigh the harms and benefits surrounding MIHs. METHODS OF STUDY SELECTION: On May 15, 2022, we searched MEDLINE (PubMed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews for SRs with or without a meta-analysis on MIH for any indication. Eligible studies underwent full-text screening, data extraction, harms reporting assessment, and A Measurement Tool to Assess Systematic Reviews-2 quality assessment in a masked, duplicate fashion. The corrected covered area was calculated to indicate any overlap between SR dyads. TABULATION, INTEGRATION, AND RESULTS: A total of 52 SRs met the inclusion criteria for data extraction. We found that >44 of included SRs (of 52; 84.6%) reported >50% of the harms items. Completeness of harms reporting was significantly associated with harms specification as a primary outcome (p <.05). The corrected covered area was 0.60%. CONCLUSION: The harms reporting was more complete than hypothesized, but still had deficiencies throughout, such as inconsistent use of severity scales to classify harms. Even though MIH harms reporting in sample SRs was more complete than other fields of medicine, it was still suboptimal overall and requires refinement.

Harms reporting by systematic reviews for functional endoscopic sinus surgery: a cross-sectional analysis.

OBJECTIVES: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). METHODS: Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables. RESULTS: Fifty-five SR's were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as "critically low" quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. CONCLUSIONS: Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.

Assessment of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Interventions of Post-Traumatic Stress Disorder.

BACKGROUND: Post-traumatic stress disorder (PTSD) has debilitating effects on quality of life. Patient-reported outcomes (PROs) assess changes in quality of life and serve as subjective measurements of patient experience. The aim of this study is to assess the completeness of PRO reporting within randomized controlled trials with interventions pertaining to PTSD. METHODS: This cross-sectional, meta-epidemiological study assessed the completeness of PRO reporting in RCTs investigating PTSD interventions. We searched multiple databases for published RCTs of PTSD interventions that used PROs as a primary or secondary outcome. We assessed PRO completeness using the PRO adaptation of the Consolidated Standards of Reporting Trial (CONSORT). We used a bivariate regression model to determine the association between trial characteristics and the completeness of reporting. RESULTS: After an initial screening of 5906 articles, our final sample of RCTs for inclusion was 43. The mean completeness of reporting of PROs was 58.4% (SD = 14.50). We found no significant associations between trial characteristics and completeness of the CONSORT-PRO adaptation. CONCLUSION: Reporting of PROs was often incomplete among RCTs focused on PTSD. We believe that adherence to CONSORT-PRO will improve both PRO reporting and implementation into clinical practice to improve assessment of quality of life.

An analysis of harms reporting in systematic reviews regarding ketorolac for management of perioperative pain.

BACKGROUND: Owing to the frequent perioperative use of ketorolac tromethamine and its ability to minimise postoperative opioid requirements, it is important to continually reassess harms associated with its use. Our primary objective was to investigate the extent of harms reporting in systematic reviews (SRs) on ketorolac for perioperative pain. METHODS: In May 2022, we conducted a search of major databases, MEDLINE (PubMed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews to identify eligible SRs on ketorolac for perioperative pain. Screening and data extraction were performed in masked, duplicate fashion. A MeaSurement Tool to Assess systematic Reviews-2 (AMSTAR-2) was used to appraise the methodological quality of included SRs. Corrected covered area (CCA) was calculated to determine overlap of primary studies between SR dyads. RESULTS: A total of 28 SRs evaluating 630 primary studies met the inclusion criteria. Seven SRs (7/28, 25%) reported no harms and 17 SRs (17/28, 60.7%) reported ≤50% of harms items. A significant association was found between completeness of harms reporting and whether harms were specified as a primary outcome (P<0.001). No other associations were statistically significant. Regarding methodological quality, 22 SRs were appraised as 'critically low' (22/28, 78.6%), 5 as 'low' (5/28, 17.9%), and 1 as 'high' (1/28, 3.6%). One SR dyad had a CCA >50% but neither reported harms. CONCLUSIONS: The extent of harms reporting in systematic reviews was inadequate. Given the importance that systematic reviews have on guiding perioperative decision-making, it is essential to improve the completeness of harms reporting.

Sickle Cell Disease and Quality of Life: An Evaluation of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials.

Sickle cell disease significantly impacts one's quality of life (QOL); thus, randomized controlled trials (RCTs) have integrated patient-reported outcomes (PROs) to assess patients' health from their perspective. We aim to evaluate the completeness of reporting of PROs included in sickle cell disease RCTs. We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) for published sickle cell disease RCTs with at least one PRO measure from 2006 to 2021. In a masked, duplicate fashion, two investigators evaluated RCTs using the Consolidated Standards of Reporting in Trials (CONSORT)-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. The primary objective was mean percent completeness of the CONSORT-PRO adaptation. Additional relationships between trial characteristics and completeness of reporting were evaluated. Mean completeness of reporting of RCTs was 41.49% (SD = 20.90). Randomized controlled trials with primary outcomes were more complete (57.50%, SD = 8.33) than RCTs with secondary PROs (33.48%, SD = 20.91). We did not find a significant difference in completion between trials with primary PROs and secondary PROs (t1 = 2.07; p = 0.06). Our secondary objectives included factors that may be associated with completeness of PRO reporting. Of the 12 included studies, five were considered to be overall 'high' RoB (41.67%). In each of the five domains, the majority of studies received 'low' RoB evaluations. Incomplete PRO reporting was common within sickle cell RCTs. Therefore, we recommend future RCTs including PROs should take measures to increase completeness of reporting.

Harms Reporting Is Inadequate in Systematic Reviews Regarding Hip Arthroscopy.

Purpose: To investigate the quality of harms reporting in systematic reviews (SRs) regarding hip arthroscopy in the current literature. Methods: In May 2022, an extensive search of 4 major databases was performed identifying SRs regarding hip arthroscopy: MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and Cochrane Database of Systematic Reviews. A cross-sectional analysis was conducted, in which investigators performed screening and data extraction of the included studies in a masked, duplicate fashion. AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews-2) was used to assess the methodologic quality and bias of the included studies. The corrected covered area was calculated for SR dyads. Results: A total of 82 SRs were included in our study for data extraction. Of these SRs, 37 reported under 50% of the harms criteria (37 of 82, 45.1%) and 9 did not report harms at all (9 of 82, 10.9%). A significant relation was found between completeness of harms reporting and overall AMSTAR appraisal (P = .0261), as well as whether a harm was listed as a primary or secondary outcome (P = .0001). Eight SR dyads had corrected covered areas of 50% or greater and were compared for shared harms reported. Conclusions: In this study, we found inadequate harms reporting in most SRs concerning hip arthroscopy. Clinical Relevance: With the magnitude of hip arthroscopic procedures being performed, adequate reporting of harms-related information in the research surrounding this treatment is essential in assessing the efficacy of the treatment. This study provides data in relation to harms reporting in SRs regarding hip arthroscopy.

Assessing the reporting of harms in systematic reviews focused on platelet-rich plasma therapy: a cross-sectional analysis.

Aim: Our objectives are: to evaluate the completeness of harms reporting in systematic reviews (SRs) on platelet-rich plasma therapy; to assess the overall methodological quality of the SR using AMSTAR-2 tool; to assess harms reporting overlap in primary studies between SRs. Materials & methods: The authors searched five database systems for relevant literature on platelet rich plasma therapy. The authors screened and extracted in masked, duplicate fashion. Results: All SRs reported less than 50% completeness in harms reporting. The most frequently reported item was harms being stated in the abstract or title (26/103, 25.2%). AMSTAR-2 assessed 96 SRs as 'critically low', 6 SRs as 'low' and 1 'moderate'. Conclusion: Our study highlights that reporting of harms should become more standardized and transparent.

This study looked at how well the negative effects (harms) of platelet-rich plasma therapy are reported in systematic reviews (SRs). The researchers carefully reviewed and extracted data of SRs from different databases. They found that less than 50% of the SRs reported the harms associated with platelet rich plasma therapy. The researchers also used a tool called AMSTAR to assess the value of each of the SRs, and most were found to be 'critically low' reviews. In conclusion, this study highlights the importance of platelet rich plasma therapy negative effect reporting by SRs.

Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials.

BACKGROUND: Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL). Use of patient-reported outcomes (PROs) is increasing in randomized controlled trials (RCTs), thus standardization is important to ensure reporting completeness. We aim to evaluate completeness of reporting of RCTs for surgical management of SUI in women based on an adaptation of the Consolidated Standards of Reporting Trials statement with PRO extension (CONSORT-PRO). STUDY DESIGN: A literature search was conducted and all RCTs meeting inclusion criteria were evaluated using the CONSORT-PRO adapted checklist and the Cochrane Collaboration risk of bias assessment tool (RoB). We calculated a completion percentage score for each trial's adherence to the CONSORT-PRO adapted checklist and used bivariate regression analysis to examine associations between trial characteristics and completion percentage scores. RESULTS: Forty-three RCTs underwent data extraction and analysis. Mean completion percentage of the CONSORT-PRO was 50.53% (SD = 15.63). A total of 38 (of 43; 88.37%) RCTs received an RoB 2.0 rating of "some concern." RCTs with follow-up longer than 3 months had statistically significantly higher CONSORT-PRO completion: 3-6 months (p = .049), 6-12 months (p = .009), more than 12 months (p = .021). Compared with studies without a conflict of interest statement, studies reporting a conflict of interest (p < .001) or reporting no conflict of interest (p = .048) had higher reporting completeness. CONCLUSIONS: Our results suggest many RCTs addressing surgical management of SUI in women have poor adherence to CONSORT-PRO reporting guidelines. Improving reporting completeness through adherence to the CONSORT-PRO checklist can better inform clinical decision making and improve QoL.

A cross-sectional analysis of harms reporting in systematic reviews evaluating laminectomy.

Background Context: Laminectomy is a common vertebral decompression procedure that has multiple potential adverse events which are not always reported in SRs. Purpose: To evaluate the completeness of harms reporting in systematic reviews (SRs) on laminectomy. Study Design: Cross-sectional analysis. Methods: Eligible studies were SRs that evaluated laminectomy for any indication. MEDLINE (PubMed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews were searched in May 2022 to locate studies for inclusion. Screening and data extraction on harms reporting and study characteristics were performed in duplicate. AMSTAR-2 was used to evaluate the methodological quality of included SRs. Corrected covered area (CCA) was calculated for SR pairs. Results: We included 26 SRs comprising 426 primary studies. Most SRs studied laminectomy for spinal stenosis, declared harms as a secondary outcome, and lacked or did not mention funding. Two SRs completely omitted harms, 9 had between 0% and 50.0% completion of harms items, and 15 had more than 50.1% completion. AMSTAR-2 graded 25 SRs (25/26, 96.2%) as 'critically low' and 1 SR (1/26, 3.8%) as 'low'. We found a statistically significant association between completeness of harms reporting and outcome specification. No other associations were statistically significant. Three SR pairs had CCAs >50% and were compared for unique and shared harms. Conclusions: The completeness of harms reporting in SRs was inadequate. Because SRs often serve as tools for constructing clinical practice guidelines and clinical decision making, improvements must be made to enhance and refine harms reporting.

Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2.0.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly used in randomized controlled trials (RCTs) to foster patient-centered healthcare. The aim of this investigation was to assess the completeness of reporting of PROs in RCTs pertaining to cystic fibrosis (CF). METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for RCTs concerning CF that included PROs as a primary or secondary outcome. The RCTs were assessed by 2 independent investigators using an adaptation of the Consolidated Standards of Reporting Trials for Patient-Reported Outcomes (CONSORT-PRO) and the Cochrane Risk of Bias (RoB) 2.0 assessment. We calculated the mean completion percentage of adherence to the CONSORT-PRO adaptation and used bivariate regression models to evaluate for associations with particular trial characteristics. RESULTS: Our systematic search returned 2302 potential studies. Fifty-nine eligible RCTs were included after full-text screening. The RCT mean completeness of reporting was 38.38% (SD = 12.74). We found the following associations between trial characteristics and completeness of PRO reporting: (1) significantly higher reporting completeness for RCTs published in journals requiring adherence to the CONSORT guideline (p-value = 0.049), (2) improved reporting completeness in studies with 'some concerns' of RoB versus 'high' RoB (p-value = 0.042), and (3) significantly better reporting completeness when the PRO is the primary outcome of a RCT (p-value = 0.006). CONCLUSION: Inadequate PRO reporting exists within RCTs focused on CF. Given that CF has substantial effects on quality of life, PROs are imperative to understand patients' experiences. We believe greater adherence to CONSORT-PRO will promote the standardization of PRO reporting and will facilitate comprehension of PROs by stakeholders, patients, and clinicians.

An Evaluation of Research Publications for General Surgery Residents And its Influence on the Future Pursuit of Fellowship or Academic Career.

INTRODUCTION: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, the rate of research outcomes among general surgery residents remains unknown. Our study aims to determine associated factors that influence publication rates before, during, and after general surgery residency. METHODS: This observational study employed a cross-sectional design. We examined whether research outcomes during general surgery residency was associated with academic advancement or continued research involvement after residency. We identified 321 general surgery residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 405 residency graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia. RESULTS: Among the 405 physicians analyzed, 3815 total publications were identified with a mean of 9.4 (SD 11.8) per person. The most reported study design was observational studies (46.5%; 1775/3815) and the least reported was systematic reviews/meta-analyses (1.4%; 52/3815). The number of publications before residency positively correlated with having a higher h-index (r = 0.4). We also found that physicians who completed a fellowship had more publications during residency (mean = 4.7, SD = 6.5) than those not pursuing a fellowship (mean = 1.5, SD = 2.7; t= -4.3. p ≤ 0.001). We observed a statistically significant increase in the likelihood a physician pursued a career in academic medicine if they pursued a fellowship (OR: 3.77, 95% CI: 2.0-7.2) and if they had published research as a primary author (OR 1.25, 95% CI: 1.0-1.5). CONCLUSION: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.

Harms Reporting in Systematic Reviews of the Microvascular Free Flap in Head and Neck Reconstruction.

OBJECTIVE: To evaluate harms reporting in systematic reviews (SRs) of microvascular free flap (MFF) in head and neck reconstruction. DATA SOURCES: This cross-sectional analysis included searches from the following major databases from 2012 to June 1, 2022: MEDLINE (Pubmed and Ovid), Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews. REVIEW METHODS: In a masked duplicate manner, screening was performed using Rayyan, and data were extracted using a pilot-tested Google form. A MeaSurement Tool to Assess systematic Reviews-2 (AMSTAR-2) was used to appraise the methodological quality of reviews and the corrected covered area was calculated to detect primary study overlap across all reviews. Reviews were then grouped in pairs of 2, called dyads, and the corrected covered area was calculated again for each individual dyad. Dyads with high overlap (≥50%) were further investigated for the accuracy of harms reporting. RESULTS: Our initial search yielded 268 records, with 50 SRs meeting the inclusion criteria. A total of 46 (92%) of the included reviews demonstrated 50% or more adherence to the items assessed in our harms checklist. Our corrected covered area tool revealed 0.6% primary study overlap across all reviews, and 1 dyad with high overlap (≥50%). No statistically significant relationship was observed between the completeness of harms reporting and reviews listing harms as a primary outcome, reviews reporting adherence to Preferred Reporting Items of Systematic Reviews and Meta-Analyses, or a review's AMSTAR rating. CONCLUSION: This study identifies how harms reporting in SRs of MFF reconstruction of the head and neck can be improved and provides suggestions with the potential to mitigate the paucity in current literature.

Reporting of patient-reported outcomes in trials on alcohol use disorder: a meta-epidemiological study.

OBJECTIVES: Currently, limited research exists to assess the extent of patient-reported outcome (PRO) reporting among randomised controlled trials (RCTs) evaluating alcohol use disorder (AUD). We sought to investigate the completeness of reporting of PROs using the Consolidated Standards of Reporting Trials-PRO (CONSORT-PRO) extension in AUD RCTs. DESIGN SETTING: Meta-epidemiological study. METHODS: We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) on 29 June 2021 for published RCTs focused on AUD. Following these searches, title and abstract screening, and full-text screening were performed by two investigators. To be included, a study must have employed a randomised trial design, published in English, focused on treatment of AUD and included at least one PRO. Trials meeting inclusion criteria were evaluated for completeness of reporting using the CONSORT-PRO extension adaptation. These trials were also evaluated for risk of bias (RoB) using the Cochrane RoB V.2.0 tool. Additionally, an exploratory analysis of each RCT's therapeutic area was extracted using the Mapi Research Trust's ePROVIDE platform. Screening and data collection were all performed in masked, duplicate fashion. MAIN OUTCOME MEASURES: PRO completeness of reporting, identification of factors associated with completeness of reporting and PRO measures used in RCTs to evaluate patients with AUD. RESULTS: Nineteen RCTs were evaluated in our analysis. Our primary outcome, the mean completion score for CONSORT-PRO, was 40.8%. Our secondary outcome-the identification of factors associated with completeness of reporting-found that trials published after 2014 (ie, 1 year after the publication of the CONSORT-PRO extension) were 15.0% more complete than trials published before 2014. We found no additional associations with better reporting. CONCLUSIONS: We found that the completeness of PRO reporting in RCTs involving AUD was deficient. Complete reporting of PROs is instrumental in understanding the effects of interventions, encourages patient participation in their treatment and may increase clinician confidence in the value of PROs. High quality treatment strategies for AUD require properly reported PROs.

Evaluating reporting of patient-reported outcomes in randomized controlled trials regarding inflammatory bowel disease: a methodological study.

Patient-reported outcomes (PROs) in randomized controlled trials pertaining to inflammatory bowel disease are important in identifying patients' perspective of treatment. Incompletely reported PROs within trials could misrepresent information for clinicians and may contribute to treatment which lacks accommodation of patient input. Our study evaluates completeness of reporting of PROs and risk of bias (RoB) to identify how well trialists are adhering to known resources for trials. We used MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify eligible trials from 2006 to 2020 with at least 1 PRO measure related to inflammatory bowel disease. The trials were screened in duplicate using Rayyan. We then compared trial completion of reporting to the Consolidated Standards of Reporting Trials (CONSORT)-PRO adaptation, and assessed RoB using the Cochrane Collaboration RoB 2.0 tool. To measure trial and reporting characteristics, we performed bivariate regression analyses. Among a sample of 29 trials, the mean completion percentage for CONSORT-PRO was 46.77%. We found PROs as a secondary outcome had significantly lower CONSORT-PRO reporting (p<0.05). In addition, per cent completeness of reporting was significantly higher with both a 'therapy' intervention, and trials published following the development of CONSORT-PRO (p<0.05). Incomplete PRO reporting is common in trials focused on inflammatory bowel disease. This suboptimal reporting indicates the need for adherence to reporting guidelines. Trialists should use the CONSORT-PRO checklist, as endorsed by Patient-Reported Outcomes Tools: Engaging Users and Stakeholders, to assess their studies in order to enhance reporting adherence.

Evaluating reporting of patient-reported outcomes in peptic ulcer disease: a meta-epidemiological study of randomized controlled trials.

OBJECTIVES: Peptic ulcer disease (PUD) can significantly affect quality of life (QoL). These QoL outcomes are often patient-reported, and their inclusion in clinical trials supplements efficacy outcomes to provide the patients' perspective. This assese existing literature for completeness of PRO reporting across randomized controlled trials (RCTs) evaluating PUD. METHODS: This meta-epidemiological, cross-sectional study that assessed completeness of reporting among RCTs addressing management of PUD. We conducted a comprehensive literature search] to identify RCTs with a PRO as a primary or secondary outcome. These RCTs were assessed for completion of reporting according to the PRO adaptation of CONSORT checklist. RCTs were also assessed for Risk of Bias (RoB) using the Cochrane RoB 2.0 tool. RESULTS: Masked, duplicate screening of 829 results = yielded a final sample of 35 RCTs. The average completeness of reporting was 32.9% according to the CONSORT-PRO adaptation. Twenty-one (of 35; 60%) of the RCTs were assessed as having 'high' risk of bias and nine (of 35; 25.71%) were assessed as having 'some concerns' for risk of bias. Bivariate regression found completeness of reporting to be positively associated with increased PRO follow-up duration, sample size, and studies with conflicts of interest. CONCLUSION: RCTs examining the treatment and prevention of PUD with PROs as an outcome measure have deficient reporting and 'high' risk of bias according to the CONSORT-PRO and Cochrane RoB guidelines.

Spin within systematic review abstracts on antiplatelet therapies after acute coronary syndrome: a cross-sectional study.

OBJECTIVES: Spin is a reporting practice in which study results are misrepresented by overestimating efficacy or underestimating harm. Prevalence of spin varies between clinical specialties, and estimates are based almost entirely on clinical trials. Little is known about spin in systematic reviews. DESIGN: We performed a cross-sectional analysis searching MEDLINE and Embase for systematic reviews and meta-analyses pertaining to antiplatelet therapies following acute coronary syndrome on 2 June 2020. Data were extracted evaluating the presence of spin and study characteristics, including methodological quality as rated by A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2). All data extraction was conducted in a masked, duplicate manner from 2 June 2020 to 26 June 2020. PARTICIPANTS AND SETTING: Not applicable. PRIMARY AND SECONDARY OUTCOME MEASURES: We assessed abstracts of systematic reviews on antiplatelet therapy following acute coronary syndrome and evaluated the prevalence of the nine most severe types of spin. We additionally explored associations between spin and certain study characteristics, including quality. RESULTS: Our searches returned 15 263 articles, and 185 systematic reviews met inclusion criteria. Of these 185 reviews, 31.9% (59/185) contained some form of spin in the abstract. Seven forms of spin (1, 2, 3, 4, 5, 7 and 9) among the nine most severe were identified. No instances of types 6 or 8 were found. There were no statistically significant relationships between spin and the evaluated study characteristics or AMSTAR-2 appraisals. CONCLUSIONS: Spin was present in abstracts for systematic reviews and meta-analyses; subsequent studies are needed to identify correlations between spin and specific study characteristics. There were no statistically significant associations between spin and study characteristics or AMSTAR-2 ratings; however, implementing changes will ensure that spin is reduced in the field of cardiology as well as other fields of medicine.

The evaluation of reporting of patient-reported outcomes in MDD: A meta-epidemiological study of clinical trials.

Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = -3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.

Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials.

BACKGROUND: Multiple Sclerosis significantly affects quality of life, which is often measured by patient-reported outcomes. The incorporation of patient-reported outcomes within clinical trials supplements the efficacy of outcomes in order to provide a patient's perspective for clinicians. Our objective was to evaluate current literature for completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of MS. METHODS: We used MEDLINE, Embase, and Cochrane Central Register of Controlled Trials to search for RCT publications investigating the management of MS. After duplicate screening via Rayyan, RCTs fitting our inclusion criteria were abstracted employing the Consolidated Standards of Reporting Trials - Patient-Reported Outcome (CONSORT-PRO) adaptation and the Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Mean percent completion of an adaptation of CONSORT-PRO was calculated to address completeness of reporting. In addition, bivariate regression models were used to evaluate relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 3,966 results and 92 RCTs were included for data abstraction and analysis. We found an overall completion of 48.68% (SD=19.03). Sixty-five (of 92; 70.65%) of the RCTs were evaluated as having 'high' RoB. There were significant associations between completeness of reporting and the following: mention of CONSORT within published RCTs (t=2.55, p=.013), length of PRO follow-up (t=2.9, p=.005; t=2.14, p=.035), and sample size (t=3.12, p=.002). No other significant associations were found. CONCLUSION: Our study found incomplete adherence to the CONSORT-PRO adaptation among RCTs pertaining to MS. Of the most underreported items, the failure to report a hypothesis and define an approach to missing data threaten the validity of the evidence acquired from RCTs. Furthermore, PROs provide an opportunity to supplement trial outcomes with the patient's perspective. Thus, trialists of future RCTs may improve PRO reporting with increased adherence to the CONSORT-PRO adaptation.

Are randomized controlled trials in urology being conducted with justification?

CONTEXT: Considering the substantial increase in research funding in the field of urology, minimizing research waste should be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste. OBJECTIVES: To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index. METHODS: On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology, BJU International, The Journal of Urology, and Urology. For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as "yes - verbatim," "yes - inferred," or "not used as justification" and the location in the manuscript where the SR was cited was recorded. RESULTS: Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention (x2=20.23, p=0.017), with 18 of 31 (58.1%) "other" interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section. CONCLUSIONS: We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.

Do Author Conflicts of Interest and Industry Sponsorship Influence Outcomes of Systematic Reviews and Meta-Analyses Regarding Glaucoma Interventions? A Cross-sectional Analysis.

PRCIS: In our sample of systematic reviews focusing on treatments for glaucoma, reviews conducted by authors with a conflict of interest were more likely to reach favorable conclusions compared with reviews without conflicted authors. PURPOSE: Previous studies have demonstrated that authors' conflict of interest can influence outcomes of systematic reviews. Therefore, we aimed to determine whether the presence of 1 of more conflicts was associated with more favorable results and conclusions in systematic reviews of glaucoma interventions. MATERIALS AND METHODS: MEDLINE and Embase were searched for systematic reviews of glaucoma treatments published between September 1, 2016 and June 2, 2020. Author conflicts of interest were located using multiple databases (eg, CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office USPTO) and previously published disclosure statements. Study sponsorship was determined using each review's funding disclosure statement. RESULTS: Our study included 26 systematic reviews conducted by 108 authors. Of these reviews, 9 (35%) were conducted by at least 1 author with an undisclosed conflict of interest. Of those 9, 3 (33%) reported results favoring the treatment group, and 5 (56%) reported conclusions favoring the treatment group. Of the 17 systematic reviews with no conflicted authors, 1 (6%) reported results favoring the treatment group, and 2 (12%) reported conclusions favoring the treatment group. The Fisher exact tests demonstrated that these differences held a statistically significant association between author conflicts and the favorability of the reviews' conclusions toward the treatment group (P=0.04). CONCLUSIONS: We found that systematic reviews conducted by 1 or more authors with conflicts of interest were more likely than those with no conflicted authors to draw favorable conclusions about the investigated intervention.