Biomedical doctoral students' research practices when facing dilemmas: two vignette-based randomized control trials.

Our aim was to describe the research practices of doctoral students facing a dilemma to research integrity and to assess the impact of inappropriate research environments, i.e. exposure to (a) a post-doctoral researcher who committed a Detrimental Research Practice (DRP) in a similar situation and (b) a supervisor who did not oppose the DRP. We conducted two 2-arm, parallel-group randomized controlled trials. We created 10 vignettes describing a realistic dilemma with two alternative courses of action (good practice versus DRP). 630 PhD students were randomized through an online system to a vignette (a) with (n = 151) or without (n = 164) exposure to a post-doctoral researcher; (b) with (n = 155) or without (n = 160) exposure to a supervisor. The primary outcome was a score from - 5 to + 5, where positive scores indicated the choice of DRP and negative scores indicated good practice. Overall, 37% of unexposed participants chose to commit DRP with important variation across vignettes (minimum 10%; maximum 66%). The mean difference [95%CI] was 0.17 [- 0.65 to 0.99;], p = 0.65 when exposed to the post-doctoral researcher, and 0.79 [- 0.38; 1.94], p = 0.16, when exposed to the supervisor. In conclusion, we did not find evidence of an impact of postdoctoral researchers and supervisors on student research practices.Trial registration: NCT04263805, NCT04263506 (registration date 11 February 2020).

[Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. / Prédiction échographique du risque de rupture utérine après césarienne : LUSTrial, un essai randomisé pragmatique.

BACKGROUND: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. METHODS/DESIGN: This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be performed by expert sonographers after certification by the main investigator. Women aged 18 years or older are eligible for this trial if they have a singleton pregnancy in cephalic presentation at a gestational age from 36 to 38 weeks, a previous low transverse cesarean delivery and sign the informed consent sheet. Women will be asked to participate in this study when they reach a term of 36 to 38 weeks of gestation. After agreement, women will be randomized into two groups: in the study group, they will have the LUS measured by ultrasound and the patient will be informed that, based on a threshold value of 3.5mm for the ultrasound measurement of the LUS thickness, the patient with a higher measurement will be considered at low risk and will be encouraged to choose a trial of labor whereas the patient with a measurement is equal to or less than this threshold will be considered at risk and encouraged to choose an elective repeat cesarean; in the control group, ultrasound LUS measurement will not be performed. The mode of delivery will be decided according to standard practice at the center. The primary composite outcome will include: uterine rupture, uterine dehiscence, hysterectomy, thromboembolic complications, transfusion, endometritis, maternal mortality, fetal prenatal and intrapartum mortality, hypoxic-ischemic encephalopathy and neonatal mortality. DISCUSSION: This trial assesses the efficacy of ultrasound measurement of the lower uterine segment in women with a prior cesarean delivery in reducing fetal and maternal morbidity and mortality and it will provide evidence in order to establish clinical recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01916044 (date of registration: 5 August 2013).

[Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide]. / Die TIDieR Checkliste und Anleitung - ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation.

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face-to-face panel meeting. The resultant 12-item TIDieR checklist (brief name, why, what (materials), what (procedure), who intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with a detailed explanation of each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

Calidad y transparencia de FISIOTERAPIA mediante guías de publicación / Quality and transparency of FISIOTERAPIA by means of publication guidelines

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Day surgery: Results after restructuration of a university public general surgery unit.

INTRODUCTION: Nowadays, in France, development of the ambulatory surgery has stalled. This is probably related to the fact that ambulatory surgery is restricted by the law to the "day surgery" in 12 hours, and only 17 procedures are referenced for this surgery. Thus, conventional hospitalization remained the rule after surgery. In January 2010, our university general surgery unit was restructured. It evolved from a conventional unit to a predominantly ambulatory unit. Otherwise, our unit adjoins a hotel, even inside our institution, which accommodates patients, patient visitors and tourists. AIM: The aim of this retrospective study was to compare the postoperative accommodation modalities between two groups of patients. The first group consisted of patients admitted before January 2010, at the time of conventional activity, whereas the second group consisted of patients admitted after January 2010 in a restructured unit. METHODS: Inclusion of patients admitted from April 1, 2008 to March 31, 2009 (conventional hospitalization period) and from April 1, 2010 to March 31, 2011 (ambulatory management period), scheduled for one single surgical procedure excluding emergency. RESULTS: A total of 360 patients were retained: 229 for the conventional period and 131 for the ambulatory period, with a median age of 55 (range 15-87). No statistically significant difference was noted between the two groups as concerned median age, gender or ASA status. The number of postoperative nights varied significantly between the two groups with a mean of 3.8 nights (median three nights, range 0-32) for the conventional period versus 0.4 nights (median 0 night, range 0-10) for the ambulatory period (P<0.0001 by the unadjusted Mann-Whitney test and P<0.0001 by the Wald test [with adjustment]). DISCUSSION: Our results show that it is clearly possible to distinguish the need for care of the need for accommodation and significantly reduce postoperative conventional accommodation. They also raise the question of extending the legal period of 12 hours to 24 hours in order to expand the list of the referenced procedures.

Blinding in randomized clinical trials: imposed impartiality.

Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used to ensure blinding.

Scientific production and impact of national registers: the example of orthopaedic national registers.

OBJECTIVE: National arthroplasty registers are often cited as examples of a non-randomized design that have made an essential contribution to advances in assessing arthroplasty procedures. We aimed to compare national registers to randomized controlled trials (RCTs) and meta-analyses in the field of arthroplasty in terms of scientific production and impact. METHOD: We systematically searched Medline via PubMed and the registers' websites to select all articles from national registers, RCTs and meta-analyses assessing hip and knee arthroplasty. The scientific production and impact were evaluated by number of publications, number of citations (total and the 3-year citation counts), and information on the 2008 journal impact factor (IF), for each design and identified articles. We also contacted representatives of all the selected registers to determine the availability of the data for external research projects. RESULTS: We retrieved information on 13 active national hip or knee arthroplasty registers; for 9, data were available for research projects under specific conditions. Overall, 190 publications in peer-reviewed journals resulted from national arthroplasty registers, 476 from RCTs, and 40 from meta-analyses. We found 4,112 citations for national register reports, 7,328 for RCT reports and 552 for meta-analysis reports. The median [interquartile [IQR] range] number of citations for register, RCT and meta-analysis reports in the 3-year period after publication was 3.5 [1.0-6.0], 2.0 [1.0-6.0], and 2.5 [0.5-7.5], respectively. CONCLUSION: Publications from national registers may have the highest impact among the 3 designs in terms of median citation counts, but data from RCTs remain the most productive evidence in the arthroplasty field. Because of the number of patients recruited by registers, the quality of data collected, and the potential availability of data, scientific production and impact from national registers should be improved.

ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial.

OBJECTIVE: To evaluate the impact of standardised consultations on patients with osteoarthritis of the knee. DESIGN: Open pragmatic cluster randomised controlled trial. SETTING: Primary care in France. PARTICIPANTS: 198 primary care rheumatologists, each of whom had to include two consecutive patients who met the American College of Rheumatology criteria for osteoarthritis of the knee. INTERVENTIONS: Standardised consultation was provided during three goal oriented visits (education on osteoarthritis and treatment management; information on physical exercises; information on weight loss) or usual care. MAIN OUTCOME MEASURES: Change in body weight and in time spent on physical exercises (Baecke index) at four months. RESULTS: 336 patients were included (154 allocated to standardised consultation and 182 to usual care). Nine patients were excluded because of lack of baseline data (standardised consultation, n=8; usual care, n=1). At four months, taking into account the clustering effect, the decrease in weight was greater in the standardised consultation group than in the usual care group (mean -1.11 (SD 2.49) kg v -0.37 (2.39) kg; P=0.007). The physical activity score was higher for the standardised consultation group than for the usual care group (mean 0.20 (0.65) v 0.04 (0.78); P=0.013). The standardised consultation and usual care groups did not differ in secondary outcomes, except for global assessment of disease activity (0-10 numeric scale: mean -1.66 (2.26) v -0.90 (2.48); P=0.003) and pain level (0-10 numeric scale: mean -1.65 (2.32) v -1.18 (2.58); P=0.04). CONCLUSIONS: A structured consultation programme for patients with osteoarthritis of the knee resulted in short term improvement in weight loss and time spent on physical activity. TRIAL REGISTRATION: Clinical trials NCT00462319.

Disability and quality of life of patients with knee or hip osteoarthritis in the primary care setting and factors associated with general practitioners' indication for prosthetic replacement within 1 year.

OBJECTIVE: To assess disability and health-related quality of life (HRQoL) of patients with knee or hip OA in primary care and to determine factors associated with GPs' opinion that their patients will need prosthetic replacement within 1 year after the consultation. DESIGN: A cross-sectional national survey. SETTING: Primary care in France. PARTICIPANTS: 1471 GPs and 4183 patients with hip or knee OA. MEASURES: Pain on an 11-point numeric scale (0-10), disability on the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) (1-100) and Lequesne index (0-24), and quality of life on the Medical Outcomes Study 36-item Short Form (MOS SF-36; 0-100). RESULTS: We analyzed records of 4121 patients (2540 knee, 1581 hip OA). Patients with knee or hip OA exhibited high and similar levels of pain (5.2+/-2.1 and 5.3+/-2.3) and disability (Lequesne score: 12.0+/-4.2 and 11.8+/-4.3; WOMAC score: 45.7+/-19.3 and 45.2+/-17.3) The decrease in HRQoL was similar for patients with either location of the disease. GPs more often considered that their patients with hip OA would need prosthetic replacement within 1 year (28.1%) than those with knee OA (15.8%). Most factors associated with GPs' opinion were identified for both locations of disease and were related to disability and pain levels. CONCLUSIONS: In the primary care setting, patients with knee or hip OA have similar, high disability levels and substantially low HRQoL. Patients' disability seems to play a central role in GPs' opinion of the need for their patients with either type of OA to undergo prosthetic replacement within 1 year.

The design and assessment of prospective randomised, controlled trials in orthopaedic surgery.

Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.

Should aggregate scores of the Medical Outcomes Study 36-item Short Form Health Survey be used to assess quality of life in knee and hip osteoarthritis? A national survey in primary care.

OBJECTIVE: To assess the relevance of using the aggregate physical component score (PCS) and mental component score (MCS) of the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) for patients with knee and hip osteoarthritis (OA). METHODS: We conducted a cross-sectional national survey in a primary care setting in France. A total of 1474 general practitioners enrolled 4183 patients with hip or knee OA. Construct validity of PCS and MCS was assessed by convergent and divergent validity and factor analysis. RESULTS: Records of 4133 patients (98.8%) were analyzed (2540 knee, 1593 hip OA). PCS mean scores were 32.0+/-8.4 and 31.8+/-8.4 and MCS scores 47.1+/-11.0 and 46.8+/-11.1, for knee and hip OA, respectively. Acceptable convergent and divergent validity was observed, and correlation between PCS and MCS mean scores was low (r=0.14). However, factor analysis performed on the eight subscale scores failed to support the use of PCS and MCS aggregate scores. It extracted two factors which were similar for both OA types and differed from the a priori stratification. Scores for two subscales usually attributed to MCS - emotional role and social functioning - were shared between factors, and scores for another subscale - general health perception - usually belonging to the PCS was in the mental component factor. CONCLUSIONS: Our results suggest that aggregate scores from the PCS and MCS of the SF-36 as they are currently defined may not be optimal for used in hip and knee OA patients to assess health-related quality of life.

Disability in adults with hip and knee arthroplasty: a French national community based survey.

OBJECTIVES: To compare levels of disability of people with and without hip and knee arthroplasty in a random national sample. METHODS: In 1999 a screening questionnaire to classify people into groups of increasing probabilities of disability was sent to 417 500 people; response rate 86%. The study population was obtained by a stratified randomisation, with a high sampling rate for the most severely disabled group and a minimum sampling rate for people without daily living restrictions. A computer assisted interview to assess levels of disability, dependence, and handicap was given to 21 760 people; response rate 78%. A weighting factor was applied to obtain estimates representative of the French population. The presence of chronic conditions, impairments, and disability was ascertained from the subjects' reports. RESULTS: The hip and knee arthroplasty group comprised 815 subjects in the sample, indicating an estimated 691 000 subjects (95% confidence interval (CI) 597 000 to 785 000) in the French non-institutionalised population. The prevalence of arthroplasty is estimated at 1.2%. After adjustments for confounding factors, activity limitations were greater among subjects with arthroplasty for the following activities: climbing stairs (odds ratio (OR)=4.0, 95% CI 2.8 to 5.8); walking distance (OR=3.4, 95% CI 2.5 to 4.6 for a walking distance less than 500 m); bending forward (OR=3.2, 95% CI 2.2 to 4.7); cutting toenails (OR=2.8, 95% CI 1.9 to 3.9); carrying (OR=2.6, 95% CI= 1.8 to 3.8); shopping (OR=2.1, 95% CI 1.5 to 2.9). CONCLUSIONS: This study would be useful to policy-makers considering population strategies for managing disabling arthritis.