A survey of experts to identify methods to detect problematic studies: stage 1 of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews project.

Background And Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic.

[Not all published data are reliable: fabricated data in medical research].

For a long time, the reliability of medical-scientific research was, without further verification, based on real data. It is becoming increasingly clear that this assumption is unjustified and that probably at least 25% of published randomized clinical trials are based on unreliable and sometimes even fabricated data. After giving a number of examples, it is discussed what the reader can do about this problem.

Data integrity of 14 randomised controlled trials.

Background: A review of the literature on iron treatments for iron-deficient anaemia in pregnancy indicated duplication of baseline and outcome tables in two separate randomised controlled trials (RCTs) that share only a single author.

Aim: To assess the integrity of randomised clinical trials from Dr A.M.

A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic.

Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist): concept proposal and pilot.

Objectives: To propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs).

Design: A screening tool was developed using the four-stage approach proposed by Moher et al. This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting.

Assessing Research Misconduct in Randomized Controlled Trials.

Randomized controlled trials (RCTs) serve as the pillar of evidence-based medicine and guide medical practice. Compromised data integrity in RCTs undermines the authority of this valuable tool for science and puts patients at risk. Although a large number of retractions due to data issues in obstetrics and gynecology have occurred in the past few years, many problematic RCTs could still go uncovered because in general there is insufficient willingness to envisage and confront research misconduct.

Methods to assess research misconduct in health-related research: A scoping review.

Objective: To give an overview of the available methods to investigate research misconduct in health-related research.

Study Design And Setting: In this scoping review, we conducted a literature search in MEDLINE, Embase, The Cochrane CENTRAL Register of Studies Online (CRSO), and The Virtual Health Library portal up to July 2020. We included papers that mentioned and/or described methods for screening or assessing research misconduct in health-related research.

An investigation of seven other publications by the first author of a retracted paper due to doubts about data integrity.

Background: In 2019, a randomized controlled trial (RCT) authored by Dr. Ismail was retracted due to concerns about data integrity. Since there are no policies in place to investigate other publications of authors of retracted studies, we investigated Dr.

To share or not to share data: how valid are trials evaluating first-line ovulation induction for polycystic ovary syndrome?

Background: In our recent individual participant data (IPD) meta-analysis evaluating the effectiveness of first-line ovulation induction for polycystic ovary syndrome (PCOS), IPD were only available from 20 studies of 53 randomized controlled trials (RCTs). We noticed that the summary effect sizes of meta-analyses of RCTs without IPD sharing were different from those of RCTs with IPD sharing. Granting access to IPD for secondary analysis has implications for promoting fair and transparent conduct of RCTs.

Data integrity of 35 randomised controlled trials in women' health.

While updating a systematic review on the topic of ovulation of induction, we observed unusual similarities in a number of randomised controlled trials (RCTs) published by two authors from the same institute in the same disease spectrum in a short period of time. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. We made pairwise comparisons to find identical or similar values in baseline characteristics and outcome tables between trials.

Laparoscopic ovarian drilling for ovulation induction in women with anovulatory polycystic ovary syndrome.

Background: Polycystic ovary syndrome (PCOS) is a common condition affecting 8% to 13% of reproductive-aged women. In the past clomiphene citrate (CC) used to be the first-line treatment in women with PCOS. Ovulation induction with letrozole should be the first-line treatment according to new guidelines, but the use of letrozole is off-label.

First-line ovulation induction for polycystic ovary syndrome: an individual participant data meta-analysis.

Background: Polycystic ovary syndrome (PCOS) is the most frequent cause of anovulatory infertility. In women with PCOS, effective ovulation induction serves as an important first-line treatment for anovulatory infertility. Individual participant data (IPD) meta-analysis is considered as the gold standard for evidence synthesis which provides accurate assessments of outcomes from primary randomised controlled trials (RCTs) and allows additional analyses for time-to-event outcomes.

Gonadotrophins versus clomifene citrate with or without intrauterine insemination in women with normogonadotropic anovulation and clomifene failure (M-OVIN): a randomised, two-by-two factorial trial.

Background: In many countries, clomifene citrate is the treatment of first choice in women with normogonadotropic anovulation (ie, absent or irregular ovulation). If these women ovulate but do not conceive after several cycles with clomifene citrate, medication is usually switched to gonadotrophins, with or without intrauterine insemination. We aimed to assess whether switching to gonadotrophins is more effective than continuing clomifene citrate, and whether intrauterine insemination is more effective than intercourse.

Medical malpractice claims in laparoscopic gynecologic surgery: a Dutch overview of 20 years.

Background: The success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago.

Metformin during ovulation induction with gonadotrophins followed by timed intercourse or intrauterine insemination for subfertility associated with polycystic ovary syndrome.

Background: Clomiphene citrate (CC) is generally considered first-line treatment in women with anovulation due to polycystic ovary syndrome (PCOS). Ovulation induction with follicle-stimulating hormone (FSH; gonadotrophins) is second-line treatment for women who do not ovulate or conceive while taking CC. Metformin may increase the effectiveness of ovulation induction with gonadotrophins and may promote safety by preventing multiple pregnancy.