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Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10644667 | ||
References | PMC10644667 | |||
Background | POSTPARTUM HAEMORRHAGE, POSTPARTUM HAEMORRHAGE | Postpartum haemorrhage causes significant mortality among parturients. Early transfusion of blood products based on clinical judgement and conventional coagulation testing has been adapted to the treatment of postpartum haemorrhage, but rotational thromboelastometry (ROTEM) may provide clinicians means for a goal-direc... | PMC9900729 | |
Methods | blood loss, thromboembolic, infections | BLOOD LOSS, INFECTIONS, POSTPARTUM HAEMORRHAGE, COMPLICATIONS, TRANSFUSION REACTIONS | We randomised 60 parturients with postpartum haemorrhage of more than 1500 ml to receive either ROTEM-guided or conventional treatment, with 54 patients included in the final analysis. The primary outcome was consumption of blood products, and secondarily we assessed for possible side-effects of managing blood loss suc... | PMC9900729 |
Results | The median (25th–75th percentile) number of RBC units transfused was 2 (1–4) in the ROTEM group and 3 (2–4) in the control group ( | PMC9900729 | ||
Conclusions | blood loss | BLOOD LOSS, POSTPARTUM HAEMORRHAGE | ROTEM-guided treatment of postpartum haemorrhage could have a plasma-sparing effect but possibly only a small reduction in total blood loss. | PMC9900729 |
Clinical trial registration | NCT02461251. | PMC9900729 | ||
Keywords | Handling editor: Hugh C Hemmings Jr
| PMC9900729 | ||
Editor's key points | Thromboelastometry-guided, bleeding, blood loss, PPH, trauma | BLOOD LOSS, BLEEDING, POSTPARTUM HAEMORRHAGE, POSTPARTUM HAEMORRHAGE |
Postpartum haemorrhage remains a leading cause of maternal morbidity and mortality frequently requiring massive transfusion.This RCT compared goal-directed therapy with standard care in the treatment of postpartum haemorrhage.Thromboelastometry-guided transfusion therapy resulted in reduced plasma transfusion and esti... | PMC9900729 |
Methods | PPH, thromboembolic, bleeding, blood loss | BLEEDING, CLOT, BLOOD LOSS, LYSIS, MAY, SECONDARY, POSTPARTUM HAEMORRHAGE, COMPLICATIONS, TRANSFUSION REACTIONS | This was a single-centre, single-blinded, randomised controlled trial. The protocol was approved by the ethics committee of Pirkanmaa Hospital District (PSHP) and conducted in its tertiary referral centre, Tampere University Hospital (Tampere, Finland; ethics committee reference number R15054). Registration of the prot... | PMC9900729 |
Statistical analysis | For sample size calculation, the relevant information needed in this patient group was not available. In an earlier study, the median RBC given was 4 units.All analyses on outcomes were made with intention-to-treat and blinded. When not imminent, distributions of continuous variables were tested for normality using the... | PMC9900729 | ||
Results | bleeding, Administered, ®, allergic reaction, blood loss, thromboembolic, haemorrhage, rupture, mastitis, Fever, PPH | ENDOMETRITIS, BLEEDING, ALLERGIC REACTION, BLOOD LOSS, HAEMORRHAGE, SECONDARY, TRANSFUSION-ASSOCIATED CIRCULATORY OVERLOAD, MASTITIS, PYELONEPHRITIS, LYSIS, POSTPARTUM HAEMORRHAGE, COMPLICATIONS | The first participant was recruited on February 8, 2016, and the study ended on September 2, 2019; a total of 60 patients were randomised and 54 subjects were included in the final analysis. Subjects' baseline characteristics are presented in Baseline subject characteristics. For binominal variables, The primary endpoi... | PMC9900729 |
Discussion | bleeding, ®, trauma, blood loss, haemorrhage, PPH, unawareness, hypocoagulation, blood coagulation | BLEEDING, BLOOD LOSS, HAEMORRHAGE, CARDIOVASCULAR COLLAPSE, UTERINE ATONY | Use of ROTEM® thromboelastometry might decrease administration of plasma by avoiding unnecessary OctaplasLG® transfusions. This finding agrees with similar studies conducted in other patient groups, such as those who underwent aorticAs experience from trauma patients suggested the benefit of a greater FFP/RBC ratio, th... | PMC9900729 |
Authors' contributions | RECRUITMENT | Recruitment of subjects: SJ, AY-HStatistical analyses: SJPreparation of the first draft of the manuscript: SJManuscript revision: AY-H, AK, JUAll authors participated in the study design and analysis of results, and read and approved the final version of the manuscript. | PMC9900729 | |
References | PMC9900729 | |||
Declaration of interest | The authors have no conflict of interest to declare. | PMC9900729 | ||
Funding | Orion Research Foundation and Tampere University Hospital. | PMC9900729 | ||
Acknowledgements | The authors thank the anaesthesiologists (especially Susanna Mennander, Anne Mäyrä, and Kati Rautaneva) and nurses of the obstetric–gynaecologic operating department of Tampere University Hospital for helping to enrol patients. | PMC9900729 | ||
1.1. Literature Review | Various interventions have been developed aiming at improving parenting styles and parent–child interaction. For example, a positive shift in the engagement level of parents with children with Sp.L.D.s and behavioral, emotional and social challenges was reported by Lendrum et al. [ | PMC10742889 | ||
1.2. Research Goals and Questions | This study aimed to evaluate the effectiveness of a new intervention program in improving both parenting styles and the overall family quality of life. This study aimed to answer the following research questions: does the intervention improve parenting style? Does it improve family quality of life? | PMC10742889 | ||
2. Materials and Methods | PMC10742889 | |||
2.1. Study Design | This is a randomized controlled trial with two-groups (intervention and control) and a pre- and post-evaluation design. The current paper reports on the data collected at baseline and immediately after the intervention, and an annual follow up has been planned. | PMC10742889 | ||
2.2. Participants’ Recruitment | learning disabilities | Study participants were recruited from a population that used a community-based university-led mobile unit in charge of evaluating children for learning disabilities across the Crete Region of Greece. This unit is unique in Greece and is accessible through the Social Services Departments of the local municipalities. In... | PMC10742889 | |
2.3. Outcome Measures | To assess the quality of life and the parenting style of the participants, two self-administered validated questionnaires were used, which were translated into the Greek language and free of charge with secured permission by the developers: The Parenting Style Questionnaire [The Family Quality of Life Scale (FQOL) ques... | PMC10742889 | ||
2.4. Content of the Intervention | The current study used, upon permission, an adapted version of Cipani’s [ | PMC10742889 | ||
2.5. Statistical Analysis | INTERACTION | A data analysis was conducted using Statistical Package for Social Sciences (SPSS) version 25.0 software. The significance level of this study was set at α = 0.05. We employed a combination of parametric and non-parametric tests to assess the mean differences between two groups, selecting the appropriate test based on ... | PMC10742889 | |
3. Results | PMC10742889 | |||
3.1. Participants’ Profile | Most of the participants were female (89.74%); 43.59% fell in the age range of 41–50, and 56.41% had two children. The majority of them were married (74.36%), high school graduates (53.85%), employed (64.10%) and reporting an income between EUR 10,001 and 15,000 (38.46%). More information is shown in | PMC10742889 | ||
3.2. Reliability of the Study Dimensions | INTERACTION | The dimensions of the “quality of life” questionnaire (“Family Interaction”, “Parenting”, “Emotional Wellbeing”, “Physical/Material Wellbeing” and “Disability-Related Support”) and “parenting style” questionnaire (“Authoritative Parenting Style”, “Authoritarian Parenting Style” and “Permissive Parenting Style”) were su... | PMC10742889 | |
3.3. Effectiveness of the Intervention in Improving Parenting Style and Quality of Life | INTERACTION | We performed baseline (pre-intervention) comparisons between the intervention and the control group. The results show that all the “Quality of life” dimensions (“Family Interaction”, “Parenting”, “Emotional Well-being”, “Physical/Material Well-being” and “Disability-Related Support”) had no statistically different mean... | PMC10742889 | |
4. Discussion | Summarizing the main findings, it appears that the intervention program introduced improvements in the parenting style and the quality of life dimensions of our participants but did not succeed in bringing a statistically significant change, as initially expected. Most importantly, these positive outcomes, although not... | PMC10742889 | ||
5. Study Limitations | This study has a number of limitations that need to be mentioned. Firstly, while the findings provide valuable insights into this specific area, they may not be fully representative of broader populations as the sample was derived from a population that used a community service under certain circumstances. Secondly, th... | PMC10742889 | ||
6. Conclusions | The current study, despite not bringing a statistically significant change in participants’ parenting style and quality of life, found that the intervention program improved the parenting style of the participants, specifically by reducing authoritarianism and by increasing the interaction of parents with their childre... | PMC10742889 | ||
Author Contributions | Conceptualization, N.P. and M.P.; methodology, N.P., S.L., K.K., S.P. and M.P.; formal analysis, N.P., S.L., K.K., S.P. and M.P.; investigation, N.P. and S.L.; writing—original draft, N.P. and M.P.; writing—review and editing, N.P., S.L., K.K., S.P. and M.P.; supervision, K.K., S.P. and M.P. All authors have read and a... | PMC10742889 | ||
Institutional Review Board Statement | Ethical approval was obtained from the university ethical committee. Institutional review board approval was obtained (ref. number 01/17.07.2019). | PMC10742889 | ||
Informed Consent Statement | Informed consent was obtained from all the study participants. | PMC10742889 | ||
Data Availability Statement | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10742889 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10742889 | ||
References | SEPARATION | Randomized controlled trial flowchart.Demographic profile of study participants.Scale reliability analysis at pre- and post-intervention level.Baseline (pre-intervention) comparisons between the intervention and the control group (independent Post-intervention comparisons between the intervention and the control group ... | PMC10742889 | |
Background | Shared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on pa... | PMC10408234 | ||
Methods | We conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis ... | PMC10408234 | ||
Results | Transcripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived persona... | PMC10408234 | ||
Conclusions | This comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future. | PMC10408234 | ||
Trial registration | clinicaltrials.gov, NCT03393351, registered 8 January 2018, | PMC10408234 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12913-023-09778-w. | PMC10408234 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10408234 | ||
Background | cancer | CANCER | Shared decision-making (SDM), a medical decision-making process between patients and health care professionals (HCP) on an equal footing [Influencing factors on the uptake of SDM in routine care have been examined on different levels. A systematic review assessing barriers and facilitators on the individual HCP level f... | PMC10408234 |
Methods | PMC10408234 | |||
Study design | cancer | CANCER | This is a qualitative study describing the process evaluation within the cluster-randomized implementation trial “Evaluation of a program for routine implementation of shared decision-making in cancer care: a stepped wedge cluster randomized trial” (PREPARED) [ | PMC10408234 |
Overview of the underlying cluster-randomized SDM implementation trial | cancer, Cancer | CANCER, CANCER | The cluster-randomized PREPARED trial followed a stepped wedge design to evaluate a theoretically and empirically based multi-component SDM implementation program [Overview of the cluster-randomized SDM implementation trialThe SDM implementation program was implemented at three departments (clusters) of the University ... | PMC10408234 |
Data collection | Qualitative process evaluation data was collected systematically throughout the trial. The implementation program was sequentially introduced to the participating departments in a randomized order through three implementation intervals with a duration of six months each (cp. Fig. Qualitative process interviews with HCP... | PMC10408234 | ||
Data analysis | MINOR | Data was analyzed using qualitative content analysis as described by Hsieh and Shannon [Data analysis was conducted as follows: 1) Creation of a coding scheme with deductive codes (PH), 2) meeting to review the coding scheme with the research team (PH, IS, HC (cp. acknowledgements)), 3) coding of approximately 25% of t... | PMC10408234 | |
Researchers’ characteristics | cancer | CANCER | All researchers involved in this study had comprehensive experiences in conducting qualitative interviews and qualitative content analysis prior to this trial. Process interviews were conducted by WF and JZ. WF is a female health scientist (M.Sc.) and doctoral researcher with experience in oncological health services r... | PMC10408234 |
Results | PMC10408234 | |||
Discussion | SECONDARY, POSITIVE | We performed a comprehensive qualitative process evaluation of a theoretically and empirically based SDM implementation program with six strategies within a cluster-randomized SDM implementation trial. Data collection integrated various stakeholders’ perspectives through qualitative process interviews with nurses and p... | PMC10408234 | |
Strengths and limitations | cancer | CANCER, RECRUITMENT | This multi-faceted implementation trial can guide future research with an exemplary function. We followed established frameworks and recommendations for implementation research [However, generalizability has to be assumed with caution since this was a single-center study including three departments only. Replication of... | PMC10408234 |
Conclusion | The comprehensive process evaluation at hand was theoretically based on the CFIR, complements the outcome evaluation of the SDM implementation trial, and adds to our understanding of influencing factors on SDM implementation. To our knowledge this is the first SDM implementation trial following a stepped-wedge cluster ... | PMC10408234 | ||
Acknowledgements | HC, Cancer | NEUMANN, CANCER | We thank all patients and HCPs who participated in this study. We are also thankful to all research associates, student research assistants and research interns who contributed to the study: Lisa Bußenius, Eva Christalle, Hannah Cords (HC), Lara Dreyer, Marie-Kristin Eilert, Nina Elpers, Merisa Ferati, Rabea Friedrich,... | PMC10408234 |
Authors’ contributions | MP | IS was the principal investigator of the study. PH and IS made substantial contributions to the conceptualization, design and preparation of the study and wrote the grant proposal. VM was involved in the conceptualization and design of the study and preparation of the study. AL and HH were involved in the preparation o... | PMC10408234 | |
Funding | The study was funded by the German Research Foundation (Deutsche Forschungsgemeinschaft, grant number 232160533). Open Access funding enabled and organized by Projekt DEAL. We acknowledge financial support from the Open Access Publication Fund of UKE – Universitätsklinikum Hamburg-Eppendorf and DFG – German Research Fo... | PMC10408234 | ||
Availability of data and materials | Deidentified data that support the findings of this study are available on reasonable request. Investigators who propose to use the data have to provide a methodologically sound proposal directed to the corresponding author. Signing a data use/sharing agreement will be necessary, and data security regulations both in G... | PMC10408234 | ||
Declarations | PMC10408234 | |||
Ethics approval and consent to participate | The study was approved by the Ethics Committee of the Medical Association Hamburg (Germany, study ID PV5368). The study was carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association. Principles of good clinical practice were respected. Data protection requirements were... | PMC10408234 | ||
Consent to publication | Not applicable. | PMC10408234 | ||
Competing interests | AL, WF, JZ, HH, VM, and MCP declare that they have no competing interests. PH and IS declare that they currently are (PH) or have been (IS) members of the executive board of the International Shared Decision Making Society, which has the mission to foster SDM implementation. PH and IS have no further competing interest... | PMC10408234 | ||
References | PMC10408234 | |||
Background | HBP | Subcuticular suture has proven to reduce superficial incisional SSI (si-SSI) in clean surgery. However, question remains regarding clean-contaminated procedures. The aim of this study is to assess if subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery. | PMC9837932 | |
Methods | SECONDARY, COMPLICATIONS, HBP | Single-centre, open-label, parallel, pragmatic randomized clinical trial conducted at a referral tertiary Hospital between January 2020 and April 2022. Patients eligible for elective HBP surgery were randomly assigned (1:1) to subcuticular suture or surgical staples wound closure using a minimisation method based on pr... | PMC9837932 | |
Results | ADVERSE EVENTS, SECONDARY, COMPLICATIONS | Of the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n = 173) or subcuticular suture (n = 173). After further exclusion of 11 participants, 167 and 168 patients, respectively in the control and the experimental group received their allocated intervention. For the primary endpoi... | PMC9837932 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12893-023-01911-0. | PMC9837932 | ||
Keywords | PMC9837932 | |||
Background | infection, SSI, surgical-site infections | INFECTION, DISEASE, HBP | The U.S. Centre for Disease Control and Prevention (CDC) defines surgical-site infections (SSIs) as an infection that occurs in the surgical wound within 30 days after surgery [According to the National Healthcare Safety Network of the CDC, and data reported in recent series, superficial incisional SSI (si-SSI) rates a... | PMC9837932 |
Methods | PMC9837932 | |||
Study design | intraabdominal infectious | HBP, POSTOPERATIVE COMPLICATIONS | This is a single-centre, open-label, parallel, pragmatic, superiority randomized clinical trial. Patients were recruited from the Hepatobiliary and Pancreatic (HBP) surgery unit in a referral tertiary Hospital. Patients were eligible if they were planned to undergo elective HBP surgery, irrespective to the surgical ind... | PMC9837932 |
Randomisation and masking | alcohol abuse | Patients were recruited by participating staff surgeons and enrolled in the study prior to elective surgery. Randomisation was performed before elective surgery, once the operation date was scheduled, in a 1:1 allocation ratio in order to balance treatment over the following factors: active smoking or clinically releva... | PMC9837932 | |
Patients and procedures | All patients must comply with a specific study protocol including the aforementioned bundle of preventive perioperative interventions for SSI: preoperative antibiotic prophylaxis following WHO specific recommendations [In the control group skin staples were used for dermal closure, with intervals of 10–15 mm. On the ot... | PMC9837932 | ||
Outcomes | SECONDARY, HBP | The primary endpoint was the incidence of si-SSI, defined according to CDC criteria for SSI [A specific subgroup analysis was planned for the primary endpoint evaluating outcomes in the following subgroups: major hepatic resection, pancreatic resection, bilioenteric reconstruction and open or laparoscopic approach. The... | PMC9837932 | |
Statistical analysis | HBP | Assuming an incidence of si-SSI in elective HBP surgery of 11% in staples group and 3% in subcuticular suture group [Data was collected prospectively by the investigators, and all patients were followed-up as per protocol using individual electronic patient records. Quantitative data is presented as mean (SD) or median... | PMC9837932 | |
Role of funding source | The present study funders had no role in study design, data collection, data analysis, data interpretation, or writing the report and neither had access to study raw data. The corresponding author had final responsibility for the decision to submit for publication. All authors approved the final version of the manuscri... | PMC9837932 | ||
Discussion | blood loss, HBP diseases, comorbidity | HBP, BLOOD LOSS, MINOR, CATHETER RELATED INFECTION, SURGICAL SITE INFECTION, HOSPITAL-ACQUIRED PNEUMONIA, URINARY TRACT INFECTION | In this RCT we investigated the incidence of si-SSI in patients undergoing regular elective HBP procedures, comparing subcuticular suturing for surgical wound closure versus conventional staples. All procedures were conducted in a dedicated HBP unit, with both groups of patients following the same perioperative managem... | PMC9837932 |
Conclusions | HBP | In conclusion, subcuticular suture might offer a certain decrease on si-SSI incidence, compared to conventional staples, for skin closure after elective HBP surgery. However, this difference is found not to be not statistically significant and thus, wound closure strategy should not be based on these grounds. Either su... | PMC9837932 | |
Acknowledgements | The authors thank the patients and clinical staff for their support in delivering the study. The authors also thank Dr. Jose Ignacio Emparanza-Knorr for his support and assistance with statistical analyses. | PMC9837932 | ||
Author contributions | All authors contributed to the study conception and design. Methodological conceptualization, funding acquisition and supervision were performed by IAA, MAZ, MTIG, IUB and RJA. Data collection, curation and forma analysis were performed by IAA, AGD, ABG, MAMG, APRA and IRM. The first draft of the manuscript was written... | PMC9837932 | ||
Funding | The present study was funded by a grant from “Bottom-up” strategic projects for 2019 of Osakidetza-Basque Health Department (Osakidetza Servicio Vasco de Salud, Departamento de Salud, Gobierno Vasco). Funders had no role in study design, data collection, data analysis, data interpretation, or writing the report and nei... | PMC9837932 | ||
Availability of data and materials | The dataset supporting the conclusions of this article are included within the article and its additional files. The authors are willing to make any additional data, analytic methods and study materials used in this study available to other researchers. Therefore, the datasets used and/or analyzed during the current st... | PMC9837932 | ||
Declarations | PMC9837932 | |||
Ethics approval and consent to participate | All participating patients provided written informed consent before enrolment and undergoing study related procedures. The study was approved by the local Ethics Committee for Clinical Research of Donostia University Hospital (HBP2019, approved on 30 June 2019) and was conducted in accordance with the Declaration of He... | PMC9837932 | ||
Consent for publication | Not applicable. | PMC9837932 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9837932 | ||
References | PMC9837932 | |||
Background | deaths, ®, typhoid | TYPHOID FEVER, TYPHOID | Typhoid fever causes nearly 110,000 deaths among 9.24 million cases globally and disproportionately affects developing countries. As a control measure in such regions, typhoid conjugate vaccines (TCVs) are recommended by the World Health Organization (WHO). We present here the protocol of a cluster randomised vaccine t... | PMC10399005 |
Methods | The primary objective is to determine the relative and absolute rate reduction of symptomatic, blood-culture-confirmed | PMC10399005 | ||
Discussion | The results from our trial will allow countries to make better-informed decisions regarding the TCV that they will roll-out and may improve the global supplies and affordability of the vaccines. | PMC10399005 | ||
Trial registration | Clinical Trials Registry of India (CTRI) CTRI/2022/03/041314. Prospectively registered on 23 March 2022 ( | PMC10399005 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07555-y. | PMC10399005 | ||
Keywords | PMC10399005 | |||
Background | deaths, typhoid fever, typhoid | DISEASE, TYPHOID FEVER, ENTERIC FEVER, TYPHOID | Globally, typhoid fever remains a major cause of high morbidity and mortality, with an estimated 9.24 million cases and 110,000 deaths being associated with the disease in 2019 [The rise in drug-resistant cases of enteric fever limits treatment options and necessitates the implementation of other control measures such ... | PMC10399005 |
Aims | To determine the relative and absolute rate reduction of symptomatic, blood culture-confirmed | PMC10399005 | ||
Objectives | PMC10399005 | |||
Primary |
To estimate the relative and absolute rate reduction (derived from the same model) of symptomatic culture-confirmed | PMC10399005 |
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