Participation in randomised clinical trials (RCTs) entails taking part in the discovery of effects of health care interventions. The question of whether participants’ outcomes are different to those of non-participants remains controversial. This umbrella review was aimed at assessing whether there are health benefits of participation in RCTs, compared to non-participation. After prospective registration (PROSPERO CRD42021287812), we searched the Medline, Scopus, Web of Science and Cochrane Library databases from inception to June 2022 to identify relevant systematic reviews with or without meta-analyses. Data extraction and study quality assessment (AMSTAR-2) were performed by two independent reviewers. Of 914 records, six systematic reviews summarising 380 comparisons of RCT participants with non-participants met the inclusion criteria. In two reviews, the majority of comparisons were in favour of participation in RCTs. Of the total of comparisons, 69 (18.7%) were in favour of participation, reporting statistically significant better outcomes for patients treated within RCTs, 264 (71.7%) comparisons were not statistically significant, and 35 (9.5%) comparisons were in favour of non-participation. None of the reviews found a harmful effect of participation in RCTs. Our findings suggest that taking part in RCTs may be beneficial compared to non-participation.

Background The publication of the report “To err is human: building a safer system” by the Institute of Medicine incited a profuse research addressing improvements in healthcare safety. However, there is still little acknowledgement of the key role of the patient in preventing adverse events of medical care. The aim of this review is to analyse and compare studies about patient's perception and opinion about care safety in hospitals. Methods We searched 10 databases (EMBASE, MEDLINE, PsychINFO, SCOPUS, Science Citation Index Expanded, Social Science Citation, IME, Sociological Abstracts, LILACS and The Cochrane Library) to identify articles and reports on patient's safety perception published between 1989 and 2006. Results From the 699 articles, 18 were selected: eight determined the frequency of experiences related to adverse events and the safety perception reported by patients, seven focused on the impact of the adverse events regarding the communication to the patient, and three included patient's opinions about the management and disclosure of adverse events and proposals to prevent them. Conclusions The incidence of adverse events reported by patients was similar to that estimated by other procedures. The patient's concept of adverse events was different from that of the physician. The quality of communication from the physician influenced the patient's perception of adverse events, and the majority wanted adverse events to be disclosed. Patients emphasised emotional consequences of the adverse events. The majority supported system modifications to prevent adverse events and to sanction the physicians when an adverse event occurs.

Dietary patterns can produce an environmental impact. Changes in people's diet, such as the increased consumption of ultra-processed food (UPF) can not only influence human health but also environment sustainability. Assessment of the impact of 2-year changes in UPF consumption on greenhouse gas emissions and water, energy and land use. A 2-year longitudinal study after a dietary intervention including 5879 participants from a Southern European population between the ages of 55-75 years with metabolic syndrome. Food intake was assessed using a validated 143-item food frequency questionnaire, which allowed classifying foods according to the NOVA system. In addition, sociodemographic data, Mediterranean diet adherence, and physical activity were obtained from validated questionnaires. Greenhouse gas emissions, water, energy and land use were calculated by means of the Agribalyse® 3.0.1 database of environmental impact indicators for food items. Changes in UPF consumption during a 2-year period were analyzed. Statistical analyses were conducted using computed General Linear Models. Participants with major reductions in their UPF consumption reduced their impact by -0.6 kg of CO₂eq and -5.3 MJ of energy. Water use was the only factor that increased as the percentage of UPF was reduced. Low consumption of ultra-processed foods may contribute to environmental sustainability. The processing level of the consumed food should be considered not only for nutritional advice on health but also for environmental protection. ISRCTN, ISRCTN89898870. Registered 05 September 2013, http://www.isrctn.com/ISRCTN89898870.

Purpose To explore the feasibility of transient elastography (TE) to quantify cervical stiffness changes during normal pregnancy and its spatial variability. Materials and Methods TE was used to quantify the cervical stiffness in four anatomical regions. 42 women between 17 and 43 years of age and at 6 – 41 weeks of gestation were studied. The stiffness was related to gestational age at the time of examination, interval from ultrasound examination to delivery and cervical length to evaluate the potential of TE to assess cervical ripening. In addition, a sensitivity analysis based on Cronbach’s alpha coefficient was carried out to assess the concordance between inter/intra-operator measurements. Results There were significant correlations between cervical stiffness measured in the four regions with gestational age and the remaining time for delivery. Results confirm stiffness variability within the cervix. No significant association was found between cervical length and stiffness in the four ROIs. Associations between gestational age and remaining time for delivery with cervical length present weaker correlations than with cervical stiffness. The external part of the cervix was significantly softer than the internal one, and these stiffness values vary significantly in the anterior compared to the posterior cervix. The measurements taken by the same and by two different observers for different regions in the cervix were reliable and reproducible. Conclusion It is feasible to objectively quantify the decrease of cervical stiffness correlated to gestational age. Transient elastography is a valuable promising tool to provide additional information on the process of cervical effacement to that obtained from digital examination and conventional ultrasound. Further studies are needed to assess the feasibility of the technique in obstetric clinical applications, such as prediction of preterm birth or success in labor induction. Ziel Machbarkeitsprüfung der transienten Elastografie (TE), um räumliche Veränderungen der Zervixsteifkeit (CS) zum Laufe einer Normalschwangerschaft zu erfassen Material und Methoden Die CS wurde mittels TE in 4 Regionen bei 40 Frauen im Alter von 17 bis 43 Jahren in der 6. – 41. Schwangerschaftswoche bestimmt. Die CS wurde mit dem Gestationsalter zum Untersuchungszeitpunkt, dem Intervall zwischen US-Untersuchung und Entbindung und die Zervixlänge korreliert, um das Potenzial der TE hinsichtlich der Zervixreife zu beurteilen. Danach wurde eine Sensitivitätsanalyse (α-Koeffizienten nach Cronbach) durchgeführt, um die Übereinstimmung der Inter-/Intra-Operator-Messungen zu bestimmen. Ergebnisse Die CS korrelierte in 4 Regionen mit dem Gestationsalter und der Zeit bis zur Entbindung signifikant. Die Ergebnisse bestätigen die Variabilität der Steifigkeit innerhalb der Zervix. Kein signifikanter Zusammenhang zwischen Zervixlänge und CS in den 4 ROIs. Gestationsalter und Zeit bis zur Entbindung zeigten eine schwächere Korrelation der Zervixlänge als mit der CS. Der äußere Bereich der Zervix war signifikant weicher als der innere Bereich, und diese CS-Werte variierten signifikant in der vorderen Zervix im Vergleich zur hinteren Zervix. Die Intra und Inter-Observervarianz der Messwerte in den 4 Regionen waren zuverlässig und reproduzierbar. Schlussfolgerung Man kann die sinkende Zervixsteifigkeit im Laufe des Gesationsalters bestimmen. Die TE ist wertvoll und vielversprechend. Sie liefert Zusatzinformationen zur Muttermundöffnung, die über die manuelle Untersuchung und den herkömmlichen US hinaus gehen. Weitere Untersuchungen sind nötig um den Einsatz der TE bei geburtshilflichen Anwendungen, wie Vorhersage von Frühgeburten und erfolgreicher Geburtseinleitung, zu bewerten.

A novel torsional wave sensor designed to characterize mechanical properties of soft tissues is presented in this work. Elastography is a widely used technique since the 1990s to map tissue stiffness. Moreover, quantitative elastography uses the velocity of shear waves to achieve the shear stiffness. This technique exhibits significant limitations caused by the difficulty of the separation between longitudinal and shear waves and the pressure applied while measuring. To overcome these drawbacks, the proposed torsional wave sensor can isolate a pure shear wave, avoiding the possibility of multiple wave interference. It comprises a rotational actuator disk and a piezoceramic receiver ring circumferentially aligned. Both allow the transmission of shear waves that interact with the tissue before being received. Experimental tests are performed using tissue mimicking phantoms and cervical tissues. One contribution is a sensor sensitivity study that has been conducted to evaluate the robustness of the new proposed torsional wave elastography (TWE) technique. The variables object of the study are both the applied pressure and the angle of incidence sensor–phantom. The other contribution consists of a cervical tissue characterization. To this end, three rheological models have fit the experimental data and a static independent testing method has been performed. The proposed methodology permits the reconstruction of the mechanical constants from the propagated shear wave, providing a proof of principle and warranting further studies to confirm the validity of the results.

Randomized clinical trials (RCTs) of lifestyle modification have reported beneficial effects of interventions, compared to control. Whether participation in the control group has benefits is unknown. To determine whether control group participants experience weight loss during the course of RCTs. After prospective registration (PROSPERO CRD42021233070), we conducted searches in Medline, Scopus, Web of Science, Cochrane library and Clinicaltrials.gov databases from inception to May 2021 without language restriction to capture RCTs on dietary advice or physical activity interventions in adults with overweight, obesity or metabolic syndrome. Data extraction and study quality assessment was performed by two independent reviewers. Weight loss in the control group, i.e., the difference between baseline and post-intervention, was pooled using random effects model generating mean difference and 95% confidence interval (CI). Heterogeneity was assessed using the I² statistical test. Subgroup meta-analysis was performed stratifying by follow-up period, type of control group protocols and high-quality studies. Among the 22 included studies (4032 participants), the risk of bias was low in 9 (40%) studies. Overall, the controls groups experienced weight loss of − 0.41 kg (95% CI − 0.53 to − 0.28; I² = 73.5% p < 0.001). To identify a result that is an outlier, we inspected the forest plot for spread of the point estimates and the confidence intervals. The magnitude of the benefit was related to the duration of follow-up (− 0.51 kg, 95% CI − 0.68, − 0.3, for 1–4 months follow-up; − 0.32 kg, 95% CI − 0.58, − 0.07, 5–12 months; − 0.20 kg, 95% CI − 0.49, 0.10, ≥ 12 months). In high-quality studies we found an overall weight loss mean difference of − 0.16 (95% CI − 0.39, 0.09) with a considerable heterogeneity (I² = 74%; p < 0.000). Among studies including control group in waiting lists and combining standard care, advice and material, no heterogeneity was found (I² = 0%, p = 0.589) and (I² = 0%, p = 0.438); and the mean difference was − 0.84 kg (95% CI − 2.47, 0.80) and − 0.65 kg (95% CI − 1.03, − 0.27) respectively. Participation in control groups of RCTs of lifestyle interventions had a benefit in terms of weight loss in meta-analysis with heterogeneity. These results should be used to interpret the benefits observed with respect to intervention effect in trials. That control groups accrue benefits should be included in patient information sheets to encourage participation in future trials among patients with overweight and obesity.