An Uncommon Encounter of Roseomonas gilardii Bacteremia: A Case Report.

Roseomonas genus was initially described in 1993 as a "pink coccoid." It is a non-fermentative, aerobic, and gram-negative bacteria. This genus has been uncovered in diverse environmental niches, ranging from water and soil to air and plants. Despite its prevalence in the natural world, human infections stemming from Roseomonas species remain a rare occurrence. This organism is also known to be resistant to standard antibiotics. We present a case of an 85-year-old woman with Roseomonas gilardii (RG) bacteremia who is a resident at an assisted living facility. Healthcare providers should consider this bacterium in slow-developing gram-negative infections, potentially opting for broad-spectrum antibiotics as an initial treatment.

Complications of Infective Endocarditis: A Case Report of Intracerebral Hemorrhage Exacerbated by Enoxaparin.

Infective endocarditis (IE) can cause life-threatening intracerebral hemorrhage via the transformation of an embolic ischemic stroke. Navigating anticoagulant therapy for IE patients is challenging due to this risk. Hospitalized patients often receive anticoagulation to minimize venous thromboembolism (VTE). Those at higher VTE risk may require full anticoagulation, particularly if there is an initial suspicion of a blood clot. A timely IE diagnosis is crucial but is often delayed during inpatient stays, with the patient potentially already on anticoagulants for other conditions. Our case discusses a hemorrhagic stroke in a patient with IE while receiving therapeutic enoxaparin. Clinical signs and symptoms, echocardiographic findings, laboratory workup and microbiological data, and possibly other imaging techniques such as cerebral magnetic resonance imaging (MRI) need to be employed in a timely manner in determining endocarditis as a cause of stroke.

Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials.

PURPOSE: To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. METHODS: We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. RESULTS: Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X2 = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15-0.66). CONCLUSION: Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public's access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. LEVEL OF EVIDENCE: III.

Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials.

CONTEXT: In recent years, patient-centered healthcare has become a primary concern for researchers and healthcare professionals. When included in randomized controlled trials (RCTs), patient-reported outcome (PRO) measures serve a critical role in supplementing efficacy outcomes with a patient perspective. OBJECTIVES: The goals of this study are to evaluate the reporting completeness of PROs within literature concerning carpal tunnel syndrome (CTS) utilizing the Consolidated Standards of Reporting Trials Patient-Reported Outcomes (CONSORT-PRO) extension. METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for published RCTs relating to CTS with at least one PRO measure from 2006 to 2020. Two investigators screened all RCTs for inclusion utilizing Rayyan (https://rayyan.qcri.org/), a systematic review screening platform. In an independent, masked fashion, investigators then evaluated all RCTs utilizing the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Bivariate regression analyses were utilized to assess relationships between trial characteristics and completeness of reporting. RESULTS: Our search returned 374 publications, yet only 31 unique RCTs met the inclusion criteria. The mean overall percent of adherence for CONSORT-PRO was 41%. Our secondary outcome-assessing study characteristics-indicated significantly higher completeness of reporting in the absence of a conflict of interest statement (p<0.05), 'some concerns' for bias (p<0.005), and when journals required the use of the CONSORT statement (p<0.005). The RoB assessment determined overall suspicion for bias among included RCTs, with 35% (n=11/31) being labeled as 'high,' 58% (n=18/31) as 'some concerns,' and 7% (n=2/31) as 'low.' CONCLUSIONS: Our study indicated that the completeness of CONSORT-PRO reporting was deficient within CTS trials. Because of the importance placed on PROs in clinical practice, we recommend adherence to CONSORT-PRO prior to publication of RCTs to increase the understanding of various interventions on patients' quality of life (QoL).

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.

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.

Clinical trial data-sharing policies among journals, funding agencies, foundations, and other professional organizations: a scoping review.

BACKGROUND AND OBJECTIVES: To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals. METHODS: Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations. RESULTS: A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy. CONCLUSION: We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences-such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data-that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities' descriptions of each policy.

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.

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization.

Purpose: To evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries. Methods: We performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting. Results: The initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had "some concerns" for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics. Conclusions: Randomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization. Clinical Relevance: PRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.

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.

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.

Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials.

Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient's perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs.

Spin the Abstracts of Systematic Reviews and Meta-Analyses Regarding the Treatment of Ménière's Disease.

OBJECTIVES: To identify, quantify, and characterize the presence of spin-specific strategies leading to misrepresentation of study results-in the abstracts of systematic reviews and meta-analyses of Ménière's disease treatment. METHODS: Using a cross-sectional design, we searched MEDLINE and Embase on May 28, 2020, for systematic reviews and meta-analyses focused on Ménière's disease treatment. Returned searches were screened, and data were extracted in a masked, duplicate fashion. RESULTS: Our sample included 36 systematic reviews and meta-analyses. Of the 36 included studies, 22 (61.1%) abstracts contained spin while 14 (38.9%) did not. The most common spin types were selective reporting of benefit (10/36, 27.8%) or harm (8/36, 22.2%). Other types of spin occurred when findings were extrapolated to the global improvement of the disease (5/36, 13.9%), beneficial effects were reported with high risk of bias in primary studies (3/36, 8.3%), and when beneficial effects were extrapolated to an entire class of interventions (1/36, 2.8%). No instances of other spin types occurred. Abstracts containing spin were substantively associated with studies of critically low methodological quality compared with studies with low and moderate quality. No studies had a methodological rating of high quality. No associations were observed between spin and intervention types, journal recommendation of adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, or funding. We found a negative correlation (r = -.31) between abstract word limit and presence of spin. CONCLUSIONS: Our study highlights that spin in the abstracts of systematic reviews of Ménière's disease is common, and it further enhances the discussion surrounding spin in abstracts of scientific research. Spin in an abstract does not discredit a study's findings; however, its occurrence should be eliminated.

The influence of industry sponsorship and conflict of interest on results and conclusions of systematic reviews regarding treatment of knee osteoarthritis.

Objective: To assess the influence of industry sponsorship and authors' conflicts of interest on the favorability of results and conclusions of systematic reviews regarding osteoarthritis of the knee. Design: We searched MEDLINE, Embase, and the Cochrane Database of Systematic Reviews on June 26, 2020 for systematic reviews with or without meta-analyses focusing on treatment of osteoarthritis of the knee. Author COI were collected from the systematic review's COI disclosure statement, the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), as well as previously published COI disclosure statements. Study sponsorship was determined using information provided in each systematic review's funding statement. Results: Our study included 53 systematic reviews conducted by a total of 279 authors. Thirty-one authors (of 279; 11.1%) had one or more COI. Fourteen systematic reviews (of 53; 26.4%) had one or more conflicted authors. Of these reviews, only two (of 14; 14.3%) reported narrative results favoring the treatment group, whereas five (of 14; 35.7%) reported conclusions favoring the treatment group. Our results showed no statistically significant association between the presence of COI and the favorability of results (P= 0.11) and conclusions (P= 0.73). Because our sample only included one industry-sponsored systematic review, we were unable to adequately assess for a relationship between industry-sponsorship and favorability of results and conclusions. Conclusion: We found no association between the favorability of systematic review results and conclusions with either the presence of author's conflicts of interest or industry-sponsorship.

The Use of Person-Centered Language in Medical Research Journals Focusing on Psoriasis: Cross-sectional Analysis.

BACKGROUND: Person-centered language places a person's identity before any disability or medical condition they may have. Using person-centered language reduces stigma and improves the patient-physician relationship, potentially optimizing health outcomes. Patients with psoriasis often feel stigmatized due to their chronic skin condition. OBJECTIVE: We seek to evaluate the use of person-centered language in psoriasis literature and to explore whether certain article characteristics were associated with non-person-centered language. METHODS: We performed a systematic search on PubMed for recently published articles in journals that regularly publish psoriasis studies. After article reduction procedures, randomization, and screening, we reached our target sample of 400 articles. The following non-person-centered language terms were extracted from each article: "Psoriasis Patient," "Psoriasis subject," "Affected with," "Sufferer," "Suffering from," "Burdened with," "Afflicted with," and "Problems with." Screening and data extraction occurred in a masked duplicate fashion. RESULTS: Of the 400 included articles, 272 (68%) were not adherent to person-centered language guidelines according to the American Medical Association Manual of Style. The most frequent non-person-centered language term was "Psoriasis Patient," found in 174 (43.5%) articles. The stigmatizing language was associated with the type of article and funding status, with original investigations and funded studies having higher rates of stigmatizing language. CONCLUSIONS: Articles about psoriasis commonly use non-person-centered language terms. It is important to shift away from using stigmatizing language about patients with psoriasis to avoid potential untoward influences. We recommend using "patients with psoriasis" or "patient living with psoriasis" to emphasize the importance of person-centered care.

Correction: The Use of Person-Centered Language in Medical Research Journals Focusing on Psoriasis: Cross-sectional Analysis.

[This corrects the article DOI: 10.2196/28415.].