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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 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).

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.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.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;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.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.

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.

Context Osteopathic medicine in the United States continues to produce a substantial number of physicians and medical educators. However, recently popularized misconceptions about osteopathic medical practice, education, and manual therapy suggest an unsettling prevalence of inaccurate beliefs held by the public. The public often searches the internet to find out information about osteopathic medicine, but the content of questions and the transparency of the resulting information is unknown. Objectives We sought to explore frequently asked questions (FAQs) generated by Google to assess commonly searched questions about the osteopathic profession and to determine the level of information transparency associated with resulting sources. Methods On June 16, 2021, we searched Google for three terms: “osteopathic medicine,” “doctor of osteopathic medicine,” and “DO,” until a minimum of 100 FAQs and their answer links were extracted from each search. After excluding irrelevant FAQs, we used Rothwell’s Classification of Questions to categorize the FAQs. We then used the Journal of the American Medical Association’s Benchmark Criteria to assess information transparency for each corresponding answer source provided by Google. The answer sources were screened for the inappropriate use of “osteopathy” in place of “osteopathic medicine” and for “osteopath” in place of “DO,” “Doctor of Osteopathic Medicine,” or “Osteopathic Physician.” We performed statistical tests to ascertain the differences in information transparency between osteopathic and nonosteopathic information sources. Results Our Google search revealed 110 unique FAQs about osteopathic medicine. The majority of FAQs were classified as fact-based (82/110; 74.55%), nearly half of which (45.12%) were related to the medical practicing privileges of DOs. The FAQs were most commonly answered by academic institutions (44/110, 40.0%). Nearly half (49.09%) of the linked answer sources were deemed inadequate by JAMA benchmark criteria. Of the 110 linked answer sources, 19 (17.27%) misused either osteopathy, osteopath, or both to describe osteopathic physicians. Only 30 sources were linked to US-based osteopathic organizations. Osteopathic organizations were statistically less likely to meet high-transparency criteria than nonosteopathic organizations (p=0.002). Conclusions Our study shows that the US public may be unsure about the physician status of DOs, which may prevent securing the professional identity of osteopathic physicians in the eyes of the public. Osteopathic organizations should tailor awareness campaigns toward addressing the common misconceptions revealed by our study. Osteopathic organizations should use transparency criteria as a rubric when publishing information to enhance transparency.

Background Spin, or the inappropriate formatting of information to emphasize certain outcomes, should not be present in research. This study focuses on identifying and characterizing the presence of spin in systematic review and meta-analysis abstracts that focus on the treatment of opioid use disorder. Methods Search strategies were developed to identify studies pertaining to the treatment of opioid use disorder. The studies were then screened by two authors. These qualifying studies were then evaluated for the presence of spin within their abstracts by two trained authors. These studies were also evaluated by the AMSTAR-2 standards to evaluate the quality of the qualifying systematic reviews by two trained reviewers. Results The sample in this study included 113 systematic reviews and meta-analyses. Spin was present in 20 of these studies (20/113, 17.7%). The most common spin form was spin type 3 (6/20, 30%), followed by types 5 and 9 (both 4/20, 20%), type 6 (3/20, 15%), type 7 (2/20, 10%), and type 8 (1/20, 5%). The remaining spin types 1, 2, and 4 were not present in the sample. Of the 113 included studies, the most common intervention type was pharmacologic (93/113, 82%). No significant association was found between the quality of a systematic review and the presence of spin. Conclusions Findings in this study show positive trends in prevalence of five forms of spin evaluated in abstracts of systematic reviews and meta-analyses looking at treatments for opioid use disorder. However, study quality had no significant association with the presence of spin. Misrepresentation of results, or spin, may alter a clinician's perceptions about treatment efficacies. Therefore, increasing physician awareness of spin may improve clinical decision-making.

Purpose The purpose of this study is to determine the prevalence of spin in the abstracts of systematic reviews and meta-analyses on treatments for rotator cuff tears and whether various study and publishing journal characteristics were associated with the presence of spin. Methods A search strategy was developed for Ovid MEDLINE and Ovid Embase to retrieve systematic reviews focused on treatments for rotator cuff tears. For an article to be included, it must meet the following criteria: (1) the article must be a systematic review with or without a meta-analysis, (2) the article must pertain to the treatment of rotator cuff tears, (3) the article must only contain human subjects, and (4) the article must be accessible in English. Systematic reviews were analyzed for spin using a previously developed classification scheme in a masked, duplicate manner. Binary logistic regression was used to examine independent associations via unadjusted odds ratios and 95% confidence intervals between the presence of spin and study characteristics. Results Search queries returned 932 articles, of which 121 systematic reviews and meta-analyses were eligible. A total of 36.4% (44/121) of systematic reviews contained spin. Among the general characteristics evaluated, there were no correlations with spin. Conclusions Spin was present in more than one-third of systematic reviews and meta-analyses covering rotator cuff tear treatments. Spin was not associated with any general study or journal characteristics, which indicates that clinicians must be aware of the potential presence of spin in all such abstracts. Clinical Relevance Clinicians rely on systematic reviews and meta-analyses, especially abstracts of these articles, to provide succinct guidance on best practices in patient care. The presence of spin could adversely affect patient care; thus, steps should be taken to improve the reporting quality of abstracts on rotator cuff tear treatment.

Objectives A cross-sectional analysis of orthopedic trauma randomized controlled trial (RCT) abstracts to assess the frequency and manifestations of spin, the misrepresentation or distortion of research findings, in orthopedic trauma clinical trials. Methods The top 5 orthopedic trauma journals were searched from January 1, 2012, to December 31, 2017. RCTs with nonsignificant endpoints (p > .05) were analyzed for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Due to the low reporting of funding sources no statistics were able to be computed for this outcome. Results Our PubMed search yielded 517 articles. Primary screening excluded 303 articles, and full text evaluation excluded an additional 161. Overall, 53 articles were included. Spin was identified in 35 of the 53 (66.0%) abstracts analyzed. Evidence of spin was found in 21 (39.6%) abstract results sections and 22 (41.5%) abstract conclusion sections. Of the 21 RCTs reporting a clinical trial registry, 3 (14.3%) had evidence of selective reporting bias. Conclusions Orthopedic trauma RCTs from highly ranked journals with nonsignificant endpoints published from 2012 to 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. In orthopedic trauma, the implications of spin may affect the treatment of patients with orthopedic trauma, so efforts to mitigate spin in RCT abstracts must be prioritized.

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 (x 2=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.

ObjectivesCurrently, 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 settingMeta-epidemiological study.MethodsWe 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 measuresPRO completeness of reporting, identification of factors associated with completeness of reporting and PRO measures used in RCTs to evaluate patients with AUD.ResultsNineteen 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.ConclusionsWe 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.

Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL). Use of patient-reported outcomes (PROs) is increasing in randomized control 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).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.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.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.

Background: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy. Patients often search online for health information regarding common musculoskeletal complaints. Thus, the purpose of this study was to use language processing information from Google to assess the content of CTS frequently asked questions (FAQs) searched online and the transparency and quality of online CTS information. Methods: On March 11, 2021, we searched Google for 3 terms “carpal tunnel syndrome treatment,” “carpal tunnel syndrome surgical treatment,” and “carpal tunnel syndrome non-surgical treatment” until a minimum of 100 FAQs and their answer links were extracted from each search. We used Rothwell classification to categorize the FAQs. The Journal of the American Medical Association’s benchmark criteria were used to assess information transparency. Information quality was assessed using the Brief DISCERN tool. Results: Our Google search returned 124 unique FAQs. Fifty-six (45.2%) were value based and most were related to the evaluation of treatment options (45/56, 80.4%). The most common source type was medical practices (26.6%). Nearly half of the answer sources (45.9%) were found to be lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4, 119) = 5.93, P = .0002, with medical practices averaging the worst score (13.73/30). Conclusions: Patients are most commonly searching Google to gain information regarding CTS treatment options. Online sources such as medical practices should use widely accepted rubrics for ensuring transparency and quality prior to publishing CTS information.

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.

ImportanceFew studies have prospectively assessed SARS-CoV-2 community infection in children aged 0 to 4 years. Information about SARS-CoV-2 incidence and clinical and virological features in young children could help guide prevention and mitigation strategies.ObjectiveTo assess SARS-CoV-2 incidence, clinical and virological features, and symptoms in a prospective household cohort and to compare viral load by age group, symptoms, and SARS-CoV-2 lineage in young children, older children, and adults.Design, Setting, and ParticipantsThis prospective cohort study enrolled 690 participants from 175 Maryland households with 1 or more children aged 0 to 4 years between November 24, 2020, and October 15, 2021. For 8 months after enrollment, participants completed weekly symptom questionnaires and submitted self-collected nasal swabs for SARS-CoV-2 qualitative real-time reverse transcriptase polymerase chain reaction (RT-PCR) testing, quantitative RT-PCR testing, and viral lineage determination. For the analyses, SARS-CoV-2 Alpha and Delta lineages were considered variants of interest or concern. Sera collected at enrollment and at approximately 4 months and 8 months after enrollment were assayed for SARS-CoV-2 spike and nucleocapsid protein antibodies.Main Outcomes and MeasuresIncidence, clinical and virological characteristics, and symptoms of SARS-CoV-2 infection by age group and correlations between (1) highest detected viral load and symptom frequency and (2) highest detected viral load and SARS-CoV-2 lineage.ResultsAmong 690 participants (355 [51.4%] female and 335 [48.6%] male), 256 individuals (37.1%) were children aged 0 to 4 years, 100 (14.5%) were children aged 5 to 17 years, and 334 (48.4%) were adults aged 18 to 74 years. A total of 15 participants (2.2%) were Asian, 24 (3.5%) were Black, 603 (87.4%) were White, 43 (6.2%) were multiracial, and 5 (0.7%) were of other races; 33 participants (4.8%) were Hispanic, and 657 (95.2%) were non-Hispanic. Overall, 54 participants (7.8%) had SARS-CoV-2 infection during the surveillance period, including 22 of 256 children (8.6%) aged 0 to 4 years, 11 of 100 children (11.0%) aged 5 to 17 years, and 21 of 334 adults (6.3%). Incidence rates per 1000 person-weeks were 2.25 (95% CI, 1.28-3.65) infections among children aged 0 to 4 years, 3.48 (95% CI, 1.59-6.61) infections among children aged 5 to 17 years, and 1.08 (95% CI, 0.52-1.98) infections among adults. Children aged 0 to 17 years with SARS-CoV-2 infection were more frequently asymptomatic (11 of 30 individuals [36.7%]) compared with adults (3 of 21 individuals [14.3%]), with children aged 0 to 4 years most frequently asymptomatic (7 of 19 individuals [36.8%]). The highest detected viral load did not differ between asymptomatic vs symptomatic individuals overall (median [IQR], 2.8 [1.5-3.3] log10 copies/mL vs 2.8 [1.8-4.4] log10 copies/mL) or by age group (median [IQR] for ages 0-4 years, 2.7 [2.4-4.4] log10 copies/mL; ages 5-17 years: 2.4 [1.1-4.0] log10 copies/mL; ages 18-74 years: 2.9 [1.9-4.6] log10 copies/mL). The number of symptoms was significantly correlated with viral load among adults (R = 0.69; P R = 0.02; P = .91; ages 5-17 years: R = 0.18; P = .58). The highest detected viral load was greater among those with Delta variant infections (median [IQR], 4.4 [3.9-5.1] log10 copies/mL) than those with infections from variants not of interest or concern (median [IQR], 1.9 [1.1-3.6] log10 copies/mL; P = .009) or those with Alpha variant infections (median [IQR], 2.6 [2.3-3.4] log10 copies/mL; P = .006).Conclusions and RelevanceIn this study, SARS-CoV-2 infections were frequently asymptomatic among children aged 0 to 4 years; the presence and number of symptoms did not correlate with viral load. These findings suggest that symptom screening may be insufficient to prevent outbreaks involving young children.

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.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.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.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.

BACKGROUND Colorectal cancer (CRC) has the third highest cancer mortality rate in the United States. Enhanced screening has reduced mortality rates; however, certain populations remain at high risk, notably African Americans. Raising awareness among at-risk populations may lead to improved CRC outcomes. The influence of celebrity death and illness is an important driver of public awareness. As such, the death of actor Chadwick Boseman from CRC may have influenced CRC awareness. OBJECTIVE We sought to assess the influence of Chadwick Boseman’s death on public interest in CRC in the United States, evidenced by internet searches, website traffic, and donations to prominent cancer organizations. METHODS We used an auto-regressive integrated moving average model to forecast Google searching trends for the topic “Colorectal cancer” in the United States. We performed bivariate and multivariable regressions on state-wise CRC incidence rate and percent Black population. We obtained data from the American Cancer Society (ACS) and the Colon Cancer Foundation (CCF) for information regarding changes in website traffic and donations. RESULTS The expected national relative search volume (RSV) for colorectal cancer was 2.71 (95% CI 1.76-3.66), reflecting a 3590% (95% CI 2632%-5582%) increase compared to the expected values. With multivariable regression, the statewise RSV increased for each percent Black population by 1.09 (SE 0.18, PP CONCLUSIONS Our results suggest that Chadwick Boseman’s death was associated with substantial increases in awareness of CRC. Increased awareness of CRC may support earlier detection and better prognoses.

BACKGROUND The emergency authorization of COVID-19 vaccines has offered the first means of long-term protection against COVID-19–related illness since the pandemic began. It is important for health care professionals to understand commonly held COVID-19 vaccine concerns and to be equipped with quality information that can be used to assist in medical decision-making. OBJECTIVE Using Google’s RankBrain machine learning algorithm, we sought to characterize the content of the most frequently asked questions (FAQs) about COVID-19 vaccines evidenced by internet searches. Secondarily, we sought to examine the information transparency and quality of sources used by Google to answer FAQs on COVID-19 vaccines. METHODS We searched COVID-19 vaccine terms on Google and used the “People also ask” box to obtain FAQs generated by Google’s machine learning algorithms. FAQs are assigned an “answer” source by Google. We extracted FAQs and answer sources related to COVID-19 vaccines. We used the Rothwell Classification of Questions to categorize questions on the basis of content. We classified answer sources as either academic, commercial, government, media outlet, or medical practice. We used the Journal of the American Medical Association’s (JAMA’s) benchmark criteria to assess information transparency and Brief DISCERN to assess information quality for answer sources. FAQ and answer source type frequencies were calculated. Chi-square tests were used to determine associations between information transparency by source type. One-way analysis of variance was used to assess differences in mean Brief DISCERN scores by source type. RESULTS Our search yielded 28 unique FAQs about COVID-19 vaccines. Most COVID-19 vaccine–related FAQs were seeking factual information (22/28, 78.6%), specifically about safety and efficacy (9/22, 40.9%). The most common source type was media outlets (12/28, 42.9%), followed by government sources (11/28, 39.3%). Nineteen sources met 3 or more JAMA benchmark criteria with government sources as the majority (10/19, 52.6%). JAMA benchmark criteria performance did not significantly differ among source types (χ24=7.40; P=.12). One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores by source type (F4,23=10.27; P CONCLUSIONS The most frequently asked COVID-19 vaccine–related questions pertained to vaccine safety and efficacy. We found that government sources provided the most transparent and highest-quality web-based COVID-19 vaccine–related information. Recognizing common questions and concerns about COVID-19 vaccines may assist in improving vaccination efforts.

Background We evaluated (1) whether the public interest in prostate cancer and prostate cancer screening increased following Prostate Cancer Awareness Month (PCAM) and (2) whether PCAM was as effective as Breast Cancer Awareness Month (BCAM) at generating public interest. Methods Using Google Trends, we measured search volume in PCAM and BCAM. We used the search volume in Google Trends as a proxy for changes in public interest from January 01, 2009 to December 31, 2018 worldwide, including the specific keywords: “Prostate Cancer”; “Prostate-Specific Antigen”; “Prostate Cancer Screening”; “Prostate Cancer Management”; “Breast Cancer”; “Breast Cancer Screening”; “Mammography”; and “Breast Cancer Management”. Also, we measured tweets containing “prostate cancer” and “breast cancer”. We used an autoregressive integrated moving algorithm (ARIMA) to forecast expected weekly search volumes during PCAM and BCAM. We then compared the Google Trends data from during PCAM and BCAM to the forecasted values and determined a “greater than expected” range. Results The mean pooled percent increase in tweets associated with “prostate cancer” during PCAM from 2012 through 2018 was 15.9% (95% CI, -1% - 33%). The mean pooled percent increase in tweets associated with “breast cancer” during BCAM from 2012 through 2018 was 318.5% (95% CI, 268% - 369%). BCAM was associated with a 302.6% greater effect on increasing tweets referencing the disease of interest than PCAM from 2012-2018. “Breast cancer” Google searches were found to be 36.7% (95% CI, 34% - 39%) more frequent than “prostate cancer” per month from 2009-2019. Google Searches for “breast cancer screening” were 29.6% (95% CI, 28% - 31%) greater than “prostate cancer screening”. Conclusions Our results indicate that PCAM is not generating substantial internet interest, especially when compared to BCAM. The search volume for Google Trends search terms related to PCAM was less than BCAM in every comparison, and Twitter indicated only a slight increase of Tweets during the month of PCAM. Suggestions are provided to improve the effect of PCAM and men’s health.

Background Given the increased amount of research being funded in the field of urology, reducing the amount of research waste is vital. Systematic reviews are an essential tool in aiding in reducing waste in research; they are a comprehensive summary of the current data on a clinical question. The aim of this study is to evaluate the use of systematic reviews as justification in conducting randomized clinical trials (RCT) in high impact urology journals. Methods On December 13, 2019, one of us (BJ) conducted a PubMed search for randomized controlled trials published in the top four urology journals according to their Google Scholar h5-index. Using a masked data extraction process each RCT was searched for systematic reviews. Then each review was evaluated for if it was justification for conducting the trial based on the context the systematic review was used.Results Of the 566 articles retrieved 281 were included. Overall 60.5% (170/281) trials cited a systematic review. We found only 47.6% (134/281) studies cited a systematic review as “verbatim” justification for conducting the trial. Regression analysis yielded a finding of statistical significance in showing a correlation of studies over medical devices were more likely to cite a systematic review than other study topics ( adjusted odds ratio 2.01, 95% CI, 1.08 - 3.73) A total of 409 different systematic review citations were recorded in the 281 trials.Conclusion Less than half of clinical trials cited a systematic review as justification for conducting the trial. If clinical trials were required to support their studies with systematic reviews we believe this would greatly reduce the amount of research waste within clinical research.

Background The emergency authorization of COVID-19 vaccines has offered the first means of long-term protection against COVID-19–related illness since the pandemic began. It is important for health care professionals to understand commonly held COVID-19 vaccine concerns and to be equipped with quality information that can be used to assist in medical decision-making. Objective Using Google’s RankBrain machine learning algorithm, we sought to characterize the content of the most frequently asked questions (FAQs) about COVID-19 vaccines evidenced by internet searches. Secondarily, we sought to examine the information transparency and quality of sources used by Google to answer FAQs on COVID-19 vaccines. Methods We searched COVID-19 vaccine terms on Google and used the “People also ask” box to obtain FAQs generated by Google’s machine learning algorithms. FAQs are assigned an “answer” source by Google. We extracted FAQs and answer sources related to COVID-19 vaccines. We used the Rothwell Classification of Questions to categorize questions on the basis of content. We classified answer sources as either academic, commercial, government, media outlet, or medical practice. We used the Journal of the American Medical Association’s (JAMA’s) benchmark criteria to assess information transparency and Brief DISCERN to assess information quality for answer sources. FAQ and answer source type frequencies were calculated. Chi-square tests were used to determine associations between information transparency by source type. One-way analysis of variance was used to assess differences in mean Brief DISCERN scores by source type. Results Our search yielded 28 unique FAQs about COVID-19 vaccines. Most COVID-19 vaccine–related FAQs were seeking factual information (22/28, 78.6%), specifically about safety and efficacy (9/22, 40.9%). The most common source type was media outlets (12/28, 42.9%), followed by government sources (11/28, 39.3%). Nineteen sources met 3 or more JAMA benchmark criteria with government sources as the majority (10/19, 52.6%). JAMA benchmark criteria performance did not significantly differ among source types (χ24=7.40; P=.12). One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores by source type (F4,23=10.27; P Conclusions The most frequently asked COVID-19 vaccine–related questions pertained to vaccine safety and efficacy. We found that government sources provided the most transparent and highest-quality web-based COVID-19 vaccine–related information. Recognizing common questions and concerns about COVID-19 vaccines may assist in improving vaccination efforts.

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.