Search

Question Although mental pain is present in many mental disorders and is a predictor of suicide, it is rarely investigated in research or treated in care. A valid tool to measure it is a necessary first step towards better understanding, predicting and ultimately relieving this pain. Study selection and analysis Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a systematic review to identify all published standardised measures of mental pain. We used qualitative content analysis to evaluate the similarity of each measure, quantified via Jaccard Index scores ranging from no similarity (0) to full similarity (1). Finally, using the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, we evaluated each measure's development (assessing 35 features), its content validity (31 features) and if the latter was rated at least adequate, its other psychometric properties. Findings We identified 10 self-reported scales of mental pain in 2658 screened studies relying on diverse definitions of this construct. The highest average similarity coefficient for any given measure was 0.24, indicative of weak similarity (individual pairwise coefficients from 0 to 0.5). Little to no information was provided regarding the development and the content validity of all 10 scales. Therefore, their development and content validity were rated 'inadequate' or 'doubtful'. Conclusions and clinical implications There is not enough evidence of validity to recommend using one measure over others in research or clinical practice. Heterogeneous use of disparate measures across studies limits comparison and combination of their results in meta-analyses. Development by all stakeholders (especially patients) of a consensual patient-reported measure for mental pain is needed. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate to what extent the results of registered randomized controlled trials (RCTs) assessing transarterial chemoembolization (TACE) for treating hepatocellular carcinoma (HCC) are publicly available.Methods: We searched the Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform, and primary registries for RCTs assessing TACE for treating HCC, registered between January 2008 and August 2018, that had exceeded their completion date by more than 1 year. We systematically searched PubMed, EMBASE, and Google Scholar for a publication as well as the registry for results. The main outcomes were the availability of results, and the time to the first availability of results (i.e., posted on the registry or published). Secondary outcomes were the proportion of results available at 12 and 36 months after completion.Results: Among 67 identified RCTs, including a total target number to 11,599 participants, 26 had publicly available results (39%; i.e., 42% of total target number of participants). Results of 25 RCTs (37%) were published, with only 3 having results posted on the registry and 2 with both published and posted results. The median (Q1-Q3) time from completion to the first public availability of results was 18 months (11-29). The cumulative percentages of RCTs with results available were 10% (95% CI, 3-17%) and 29% (95% CI, 17-39%) at 12 and 36 months, respectively, after completion.Conclusions: Despite the ethical commitments and societal expectations for disclosure of results, the availability of results of RCTs on TACE for treating HCC is very limited.Key Points: • Underreporting of trial results is a major cause of wasted medical research since inaccessible research results fail to help both patients and clinicians. • Transarterial chemoembolization (TACE) is the most common treatment for hepatocellular carcinoma (HCC) and has called for considerable research efforts. • Yet, almost two-thirds of randomized controlled trials assessing TACE for treating HCC did not yield any public results, either on the registry platform or in scientific journals. [ABSTRACT FROM AUTHOR]

Publication in peer-reviewed journals is an essential step in the scientific process. However, publication is not simply the reporting of facts arising from a straightforward analysis thereof. Authors have broad latitude when writing their reports and may be tempted to consciously or unconsciously "spin" their study findings. Spin has been defined as a specific intentional or unintentional reporting that fails to faithfully reflect the nature and range of findings and that could affect the impression the results produce in readers. This article, based on a literature review, reports the various practices of spin from misreporting by "beautification" of methods to misreporting by misinterpreting the results. It provides data on the prevalence of some forms of spin in specific fields and the possible effects of some types of spin on readers' interpretation and research dissemination. We also discuss why researchers would spin their reports and possible ways to avoid it. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of a computer-assisted Screening, Brief Intervention, and Referral to Treatment (SBIRT) on daily consumption of alcohol by patients with hazardous drinking disorder detected after systematic screening during their admission to an emergency department (ED).Design: Two-arm, parallel group, multicentre, randomized controlled trial with a centralised computer-generated randomization procedure.Setting: Four EDs in university hospitals located in the Paris area in France.Participants: Patients admitted in the ED for any reason, with hazardous drinking disorder detected after systematic screening (i.e., Alcohol Use Disorder Identification Test score ≥5 for women and 8 for men OR self-reported alcohol consumption by week ≥7 drinks for women and 14 for men).Interventions: The experimental intervention was computer-assisted SBIRT and the comparator was a placebo-controlled intervention (i.e., a computer-assisted education program on nutrition). Interventions were administered in the ED and followed by phone reinforcements at 1 and 3 months.Main Outcome Measure: The primary outcome was the mean number of alcohol drinks per day in the previous week, at 12 months. Results From May 2005 to February 2011, 286 patients were randomized to the computer-assisted SBIRT and 286 to the comparator intervention. The two groups did not differ in the primary outcome, with an adjusted mean difference of 0.12 (95% confidence interval, -0.88 to 1.11).Conclusions: There was no additional benefit of the computer-assisted alcohol SBIRT as compared with the computer-assisted education program on nutrition among patients with hazardous drinking disorder detected by systematic screening during their admission to an ED. [ABSTRACT FROM AUTHOR]

Background: To increase transparency in research, the International Committee of Medical Journal Editors required, in 2005, prospective registration of clinical trials as a condition to publication. However, many trials remain unregistered or retrospectively registered. We aimed to assess the association between trial prospective registration and treatment effect estimates.Methods: This is a meta-epidemiological study based on all Cochrane reviews published between March 2011 and September 2014 with meta-analyses of a binary outcome including three or more randomised controlled trials published after 2006. We extracted trial general characteristics and results from the Cochrane reviews. For each trial, we searched for registration in the report's full text, contacted the corresponding author if not reported and searched ClinicalTrials.gov and the International Clinical Trials Registry Platform in case of no response. We classified each trial as prospectively registered (i.e. registered before the start date); retrospectively registered, distinguishing trials registered before and after the primary completion date; and not registered. Treatment effect estimates of prospectively registered and other trials were compared by the ratio of odds ratio (ROR) (ROR <1 indicates larger effects in trials not prospectively registered).Results: We identified 67 meta-analyses (322 trials). Overall, 225/322 trials (70 %) were registered, 74 (33 %) prospectively and 142 (63 %) retrospectively; 88 were registered before the primary completion date and 54 after. Unregistered or retrospectively registered trials tended to show larger treatment effect estimates than prospectively registered trials (combined ROR = 0.81, 95 % CI 0.65-1.02, based on 32 contributing meta-analyses). Trials unregistered or registered after the primary completion date tended to show larger treatment effect estimates than those registered before this date (combined ROR = 0.84, 95 % CI 0.71-1.01, based on 43 contributing meta-analyses).Conclusions: Lack of trial prospective registration may be associated with larger treatment effect estimates. [ABSTRACT FROM AUTHOR]

Background: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs).Methods: We performed a 'split-manuscript' RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: 'trial design', 'randomization', 'blinding', 'participants', 'interventions', and 'outcomes'. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0-10) for all domains written with or without the WAT.Results: Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5-2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes.Conclusion: Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs.Trial Registration: Clinicaltrials.gov ( http://clinicaltrials.gov NCT02127567 , registration date first received April 29, 2014). [ABSTRACT FROM AUTHOR]

Background: The main reason to avoid trial of labor after cesarean delivery is the possibility of uterine rupture. Identifying women at risk is thus an important aim, for it would enable women at low risk to proceed with a secure planned vaginal birth.Objective: To evaluate the impact of proposing mode of delivery based on the ultrasound measurement of the lower uterine segment thickness on a composite outcome of maternal-fetal mortality and morbidity, compared with usual management, among pregnant women with a previous cesarean delivery.Study Design: This multicenter, randomized, controlled, parallel-group, unmasked trial was conducted at 8 referral university hospitals with a neonatal intensive care unit and enrolled 2948 women at 36 weeks 0 days to 38 weeks 6 days of gestation with 1 previous low transverse cesarean delivery and no contraindication to trial of labor. Women in the study group had their lower uterine segment thickness measured by ultrasound. Those with measurements >3.5 mm, were encouraged to choose a planned vaginal delivery, and those with measurements ≤3.5 mm, were encouraged to choose a planned repeat cesarean delivery. This measurement was not taken in the control group; their mode of delivery was decided according to standard management. The primary outcome was a composite criterion comprising maternal mortality, uterine rupture, uterine dehiscence, hysterectomy, thromboembolic disease, transfusion, endometritis, perinatal death, or neonatal encephalopathy. Prespecified secondary outcomes were repeat cesarean deliveries, elective or after trial of labor.Results: The study group included 1472 women, and the control group included 1476 women. These groups were similar at baseline. The primary outcome occurred in 3.4% of the study group and 4.3% of the control group (relative risk, 0.78; 95% confidence interval, 0.54-1.13: risk difference, -1.0%; 95% confidence interval, -2.4 to 0.5). The uterine rupture rate in the study group was 0.4% and in the control group 0.9% (relative risk, 0.43; 95% confidence interval, 0.15-1.19). The planned cesarean delivery rate was 16.4% in the study group and 13.7% in the control group (relative risk, 1.21; 95% confidence interval, 1.00-1.47), whereas the rates of cesarean delivery during labor were 25.1% and 25.0% (relative risk, 1.01; 95% confidence interval, 0.89-1.14) in the study and control groups, respectively.Conclusion: Ultrasound measurements of lower uterine segment thickness did not result in a statistically significant lower frequency of maternal and perinatal adverse outcomes than standard management. However, because this study was underpowered, further research should be encouraged. [ABSTRACT FROM AUTHOR]

Background: Patients' participation is crucial to the success of randomized controlled trials (RCTs). However, recruiting and retaining patients in trials remain a challenge.Objective: This study aims to describe patients' preferences for the organization of RCTs (visits on- site or remotely) and evaluate the potential impact of fulfilling preferences on their willingness to participate in a clinical trial.Methods: This was a vignette-based survey. Vignettes were case scenarios of real clinical trials assessing pharmacological treatments. These RCTs evaluated 6 prevalent chronic diseases (ie, osteoporosis, osteoarthritis, asthma, cardiovascular diseases, diabetes, and endometriosis). Each vignette described (1) the RCT and characteristics of the treatment tested (ie, doses, administration routes) and (2) the trial procedures and different options (on-site or remotely) for how the trial was organized for informed consent, follow-up visits, and communication of results when the trial was completed. We recruited 628 participants from ComPaRe (www.compare.aphp.fr), a French e-cohort of patients with chronic diseases. The outcomes were the participants' preferences for the way the trial was organized (on-site or remotely) and their willingness to participate in the trial.Results: Of the 628 participants who answered the vignettes, 491 (78.2%) were female (median age 55 years), with different chronic diseases ranging from endometriosis in 59 of 491 (12%) patients to asthma in 133 of 628 (21.2%) patients. In addition, 38 (6.1%) participants wanted to provide informed consent and all trial visits on-site, 176 (28%) wished to participate in the trial entirely remotely, and 414 (65.9%) wanted to combine remote-based and hospital-based visits. Considering the trial as a whole, when the trial was organized in a way that the patients preferred, the median (Q1-Q3) likelihood of participation in the trial was 90% (80-100) versus 60% (30-80) if the trial followed the patients' nonpreferred model. Furthermore, 256 (40.8%) patients responded to open-ended questions expressing their experience with trial participation and visits to the hospital and providing suggestions for improvement. The patients emphasized the need to personalize the way a trial is organized according to each patient's needs and conditions.Conclusions: There was a significant diversity in the participants' preferences. Most participants preferred hybrid organization involving both on-site and remote visits. Participants were more likely to participate in a trial organized according to their preferences. [ABSTRACT FROM AUTHOR]

Background: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life). Methods: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient- important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. Principal Findings: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patientimportant outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months). Conclusions: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs. [ABSTRACT FROM AUTHOR]

Background: Innovative ways of planning and conducting research have emerged recently, based on the concept of collective intelligence. Collective intelligence is defined as shared intelligence emerging when people are mobilized within or outside an organization to work on a specific task that could result in more innovative outcomes than those when individuals work alone. Crowdsourcing is defined as "the act of taking a job traditionally performed by a designated agent and outsourcing it to an undefined, generally large group of people in the form of an open call."Objective: This qualitative study aimed to identify the barriers to mobilizing collective intelligence and ways to overcome these barriers and provide good practice advice for planning and conducting collective intelligence projects across different research disciplines.Methods: We conducted a multinational online open-ended question survey and semistructured audio-recorded interviews with a purposive sample of researchers who had experience in running collective intelligence projects. The questionnaires had an interactive component, enabling respondents to rate and comment on the advice of their fellow respondents. Data were analyzed thematically, drawing on the framework method.Results: A total of 82 respondents from various research fields participated in the survey (n=65) or interview (n=17). The main barriers identified were the lack of evidence-based guidelines for implementing collective intelligence, complexity in recruiting and engaging the community, and difficulties in disseminating the results of collective intelligence projects. We drew on respondents' experience to provide tips and good practice advice for governance, planning, and conducting collective intelligence projects. Respondents particularly suggested establishing a diverse coordination team to plan and manage collective intelligence projects and setting up common rules of governance for participants in projects. In project planning, respondents provided advice on identifying research problems that could be answered by collective intelligence and identifying communities of participants. They shared tips on preparing the task and interface and organizing communication activities to recruit and engage participants.Conclusions: Mobilizing collective intelligence through crowdsourcing is an innovative method to increase research efficiency, although there are several barriers to its implementation. We present good practice advice from researchers with experience of collective intelligence across different disciplines to overcome barriers to mobilizing collective intelligence. [ABSTRACT FROM AUTHOR]

Background: Active discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms.Objective: To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy.Design: Prospective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531).Setting: 3 tertiary care centers in France.Patients: 135 patients with chronic LBP with active discopathy on magnetic resonance imaging (MRI).Intervention: A single GC IDI (25 mg prednisolone acetate) during discography (n = 67) or discography alone (n = 68).Measurements: The primary outcome was the percentage of patients with LBP intensity less than 40 on an 11-point numerical rating scale (0 [no pain] to 100 [maximum pain] in 10-point increments) in the previous 48 hours at 1 month after the intervention. The main secondary outcomes were LBP intensity and persistent active discopathy on MRI at 12 months and spine-specific limitations in activities, health-related quality of life, anxiety and depression, employment status, and use of analgesics and nonsteroidal anti-inflammatory drugs at 1 and 12 months.Results: All randomly assigned patients were included in the primary efficacy analysis. At 1 month after the intervention, the percentage of responders (LBP intensity <40) was higher in the GC IDI group (36 of 65 [55.4%]) than the control group (21 of 63 [33.3%]) (absolute risk difference, 22.1 percentage points [95% CI, 5.5 to 38.7 percentage points]; P = 0.009). The groups did not differ in LBP intensity at 12 months and in most secondary outcomes at 1 and 12 months.Limitation: Tertiary care setting.Conclusion: In chronic LBP associated with active discopathy, a single GC IDI reduces LBP at 1 month but not at 12 months.Primary Funding Source: French Ministry of Health. [ABSTRACT FROM AUTHOR]

The article offers information on a methodological systematic review to study and determine whether the reporting of applicability data is consistent between randomized controlled trials and non-randomized studies of four orthopaedic procedures. Researchers analyzed Medline and the Cochrane central register of controlled studies examining minimally invasive or computer-assisted arthroplasty of the hip or knee. It mentions the primary outcomes of the systematic review as well as its main results.

Objectives: The Fragility Index, which represents the number of patients responsible for a statistically significant finding, has been suggested as an aid for interpreting the robustness of results from clinical trials. A small Fragility Index indicates that the statistical significance of a trial depends on only a few events. Our objectives were to calculate the Fragility Index of statistically significant results from randomized controlled trials of anesthesia and critical care interventions and to determine the frequency of distorted presentation of results or "spin".Data Sources: We systematically searched MEDLINE from January 01, 2007, to February 22, 2017, to identify randomized controlled trials exploring the effect of critical care medicine or anesthesia interventions.Study Selection: Studies were included if they randomized patients 1:1 into two parallel arms and reported at least one statistically significant (p < 0.05) binary outcome (primary or secondary).Data Extraction: Two reviewers independently assessed eligibility and extracted data. The Fragility Index was determined for the chosen outcome. We assessed the level of spin in negative trials and the presence of recommendations for clinical practice in positive trials.Data Synthesis: We identified 166 eligible randomized controlled trials with a median sample size of 207 patients (interquartile range, 109-497). The median Fragility Index was 3 (interquartile range, 1-7), which means that adding three events to one of the trials treatment arms eliminated its statistical significance. High spin was identified in 42% (n = 30) of negative randomized controlled trials, whereas 21% (n = 20) of positive randomized controlled trials provided recommendations. Lower levels of spin and recommendations were associated with publication in journals with high impact factors (p < 0.001 for both).Conclusions: Statistically significant results in anesthesia and critical care randomized controlled trials are often fragile, and study conclusions are frequently affected by spin. Routine calculation of the Fragility Index in medical literature may allow for better understanding of trials and therefore enhance the quality of reporting. [ABSTRACT FROM AUTHOR]