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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-directed therapy to control coagulation. We conducted a parallel design, randomised, controlled trial comparing these two approaches. We hypothesised that a ROTEM-guided protocol would decrease the need for red blood cell transfusion.
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 such as thromboembolic complications, infections, and transfusion reactions.
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 estimated blood loss in this pilot study.A thromboelastometry-guided treatment protocol led to reduced use of fresh frozen plasma or OctaplasLG®, and possibly diminished bleeding amongst patients with severe postpartum haemorrhage compared with a conventional coagulation testing guided approach.Larger randomised and controlled studies are necessary to assess the effects on red cell administration, morbidity, and mortality.Postpartum haemorrhage (PPH) remains among the leading causes of maternal mortality worldwide including in developed countries.Conventional coagulation tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT), and Clauss fibrinogen measurement, have limitations with regard to decision-making during active PPH: turnaround times are up to an hour and certain cut-off points for plasma transfusion based on PT and aPTT (usually 1.5 times the upper normal range) are derived from trauma settings.
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 protocol was made in May 2015 at From January of 2016, women over age 18 yr with severe PPH (active bleeding of >1000 ml despite use of initial measures such as uterotonic agents and uterine massage after vaginal delivery thus requiring an intervention in the operating theatre or during/after Caesarean delivery) were included in the study.The Consolidated Standards of Reporting Trials (CONSORT) diagram is presented in CONSORT diagram. CONSORT, Consolidated Standards of Reporting Trials; PPH, postpartum haemorrhage; ROTEM, rotational thromboelastometry.After randomisation, initial blood samples were collected mainly through an arterial line including ROTEM Extem and Fibtem, blood count, aPTT, thromboplastin time as international normalised ratio (TT-INR), Clauss fibrinogen, and blood gas analysis with lactate measurement. During bleeding and postoperative surveillance, this testing was repeated if considered necessary by the anaesthesiologist, and 12–24 h after bleeding without arterial blood gas and lactate measurements. ROTEM measurements were also made in the control group but were not followed by the caregivers. The amount of blood loss was visually estimated before entering the operating theatre and after that, swabs and towels were weighed and the weight of dry items subtracted from the total to get blood weight; blood volume in suction canisters was directly measured and in Caesarean delivery, the estimated amount of amniotic fluid was subtracted from this figure.The protocols for both groups are shown in Intervention (ROTEM) group protocol. A5, clot amplitude at 5 min in ROTEM; aPTT, activated partial thromboplastin time; CT, clotting time; INR, international normalised ratio; IU, international unit; LMWH, low-molecular-weight heparin; MCF, maximal clot firmness; ML, maximal lysis percentage; ROTEM, rotational thromboelastometry; TXA, tranexamic acid. ∗For example, if systemic systolic arterial pressure under <90 mm Hg and pressured infusion of crystalloid fluids or blood products is needed to maintain arterial pressure.Control group protocol. aPTT, activated partial thrombin time; INR, international normalised ratio; IU, international unit; LMWH, low-molecular-weight heparin; SAP, systolic arterial pressure; TXA, tranexamic acid. ∗For example, if systemic systolic arterial pressure <90 mm Hg and pressured infusion of crystalloid fluids or blood products is needed to maintain arterial pressure.The anaesthesiologist was allowed to administer Ringer's acetate or albumin (Albuman®; Sanquin Plasma Products B.V.) to correct blood volume. Transfusion of blood products was not limited only according to haemoglobin or haemostatic measurements according to the protocols but also based on clinical judgement. The MTP (Participants were blinded. The attending anaesthesiologist and the anaesthetic nurse knew the assigned protocol, but the obstetric team assessing the amount of total blood loss was not informed. As for other outcome measurements, the assessor and the statistical analyst were blinded until the first draft of the manuscript. Data were collected with a case report form during and immediately after the bleeding but also afterwards through electronic patient records. Some information was tracked from manual patient files such as anaesthesia records. The number of transfused blood product units during the hospital stay was the primary endpoint; secondary endpoints were the number of transfusion reactions and thromboembolic complications within a 30-day period postpartum.
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 Kolmogorov–Smirnov test for goodness-of-fit. If applicable, an independent samples
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 endpoint data were available for 54 subjects. The median (25th–75th percentile) amount of transfused RBC units was 2 (1–4) in the ROTEM group and 3 (2–4) in control group (Administered OctaplasLG® units, medications, and surgical treatment modalities of PPH are listed in Use of procoagulant and uterotonic medications and other methods in treatment of postpartum haemorrhage. Laboratory values measuring the quality of haemostatic and haemodynamic management, such as haemoglobin, platelet count, TT-INR, aPTT, lactate, base excess, and ROTEM Extem and Fibtem values were determined at the beginning of treatment and 12–24 h afterwards. These parameters were also measured during treatment if considered necessary by the anaesthesiologist. Only Extem Maximal Lysis measured 12–24 h after treatment showed a significant difference (Key laboratory values at the beginning and 12–24 h after treatment. Clinically worse (lowest or highest) values during the study period and number of subjects exceeding protocol limits are also presented. Data expressed as mean (As a secondary endpoint, we assessed the number of complications possibly linked to treatment of haemorrhage. One transfusion-associated circulatory overload was noted in the ROTEM group. Fever was reported after transfusion in 4 (14.8%) subjects in each group. There were no reported thromboembolic complications. Two subjects (7.4%; endometritis, rupture of the incision) in the ROTEM group and 4 subjects (14.8%; pyelonephritis, bleeding, allergic reaction caused by antibiotics, mastitis) in the control group were admitted to hospital during the 30-day postpartum period (As a quality control, we monitored the blood product transfusion threshold during the study. This remained unchanged: among the first 15 consecutive patients recruited the median of total blood loss divided by number of RBC units administered was 1000 (762–1400), and the last 15 patients had a ratio of 825 (550–1050) (
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, there has been a tendency among clinicians to administer FFP at a lower threshold, even against current guidelines.Fibrinogen concentrate was also used more often (25.9% We did not find a significant difference in RBC transfusions as presumed, although the median number of RBC units administered was lower in the ROTEM group. When moving from the ‘shock-pack’ era towards more individualised care of bleeding, this might be expected but is seen also in randomised and prospective studies.Other laboratory parameters measuring blood coagulation and adequacy of fluid therapy were comparable and within accepted limits. The difference in post-treatment Extem ML measurement (6% in the ROTEM group, 8% in the control group; Of interventions to control haemorrhage, only sulprostone infusion was more often frequent in the control group. Sulprostone is a synthetic prostaglandin E2 derivative and a prostaglandin E3 agonist, a second-line therapy used to control uterine atony,To our knowledge, this is the only randomised controlled study among parturients comparing a ROTEM-guided treatment protocol with a conventional coagulation testing-guided approach. In this pragmatic study, the protocols were made simple enough to ensure implementation, patients were recruited no matter the day or time and by 22 different anaesthesiologists, and not only those involved in the study group. As this might have led to some heterogeneity in how subjects were treated and protocols followed, this is often the case even when using standard operating procedures.Our study had several weaknesses. As the median blood loss was 2.5–3.0 L and 1:1:1 transfusion was seldom needed, we might have missed parturients with lack of fibrinogen or other situations where early diagnosis of hypocoagulation could change the course of haemorrhage. Also, in a true emergency with patients on the verge of cardiovascular collapse, perhaps combined with shortage of personnel, suitable patients might not have been recruited. The attending anaesthesiologist was primarily taking care of the patient, not the study and we had no study personnel to help during on-call hours. Some patients were also missed because of unawareness of the ongoing study. This might explain why the study period was longer than planned. However, the treatment protocols remained unchanged during the study period.Subjects had a mean RBC transfusion amount of 2.6 units (In conclusion, we provide evidence that viscoelastic testing leads to more reasonable use of FFP or OctaplasLG®, and possibly diminishes bleeding, amongst patients with severe PPH. Larger randomised and controlled studies that apply a greater bleeding threshold for inclusion are warranted to assess the effects on red cell administration, morbidity, and mortality.
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. Individuals interested in having their children evaluated may apply for the service on a voluntary basis without charge. Those eligible to participate in the current study were those that fulfilled the following criteria: (a) parents of children in the 3rd to 6th grade, (b) children with an Sp.L.D. diagnosis, (c) residents of the Crete region, (d) competency in the Greek language and (e) availability and willingness to participate in the study. In total, 71 individuals fulfilled the inclusion criteria out of the 158 evaluated by the mobile unit. Two independent researchers performed the eligibility check. The participants were randomly allocated to the intervention and control group. Randomization was performed via a computer-generated list of random numbers. The list was then re-sorted to its original order. Randomization was conducted by two researchers, who were neither involved in the eligibility check nor performed data collection. Out of the 71 individuals that were eligible for randomization, 42 were allocated to the intervention group (to receive the 6 week parenting program), and 29 to the control group (to receive no intervention/be added to wait list for the intervention). Upon allocation to the groups, three individuals dropped from the intervention group and 20 from the control group, primarily due to limited availability, health problems and change of residence (see Prior to participation, individuals were requested written consent be provided upon being offered information on the study aim and procedures and upon receiving guarantees about confidentiality, protection of their personal data and the right to withdraw at any time during the intervention.
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) questionnaire [Besides the above-mentioned study questionnaires, a semi-structured interview schedule was designed based on past research to explore parents’ attitude and knowledge [Pre- and post-intervention questionnaires, assessing the outcome measures of interest (parenting style and quality of life) were collected through online forms that were delivered by members of the research team.
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 the normality distribution of the data. For statistical inference, the non-parametric equivalents of independent 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 calculated, with the control and exclusion of cases from the sample that did not meet the criteria for correct completion.Specifically, the analysis included the following steps: Comparisons of dimensions of “quality of life” and dimensions of “parenting style” scores were implemented, before and after the intervention, mainly for the intervention group, using paired Comparisons of “quality of life” and “parenting style” scores were implemented before the intervention between the intervention and the control group. We used an independent samples First, we determine the normality of the data distribution using the Shapiro–Wilk test [In our study, we consider the intervention phase as the factor, specifically whether measurements were taken pre-intervention or post-intervention. A significant factor indicates an effect on both the central tendency and variability of the dependent variable. The direction of this effect (positive or negative) can be inferred from mean value plots based on the two intervention stages.In cases where the observed results deviate from our expectations, either due to unexpected directions or a lack of statistical significance, we employ a cluster analysis methodology. This involves cluster analysis in two stages: First, we classify subjects as having either successful or unsuccessful interventions based on a new variable, “intervention”, indicating a success post-intervention and failure post-intervention. The second stage employs an algorithm to reclassify subjects into clusters based on their proximity to the cluster means. This enables the reclassification of subjects from “successful” to “unsuccessful” intervention clusters if their control variable values are closer to the “unsuccessful” cluster’s mean. In our study, the results of the analysis showed that there was an increase in all dimensions after the intervention, but they were not statistically significant at the 95% level of significance. That was our basic motivation: to examine cluster analysis for our sample (intervention group) in order to classify cases with a statistically significant improvement after the intervention. More precisely, in our analysis, we employed an embedded algorithm, offered through statistical software (SPSS 25.0), which classifies cases into clusters. The basic steps for the algorithm classification process were as follows: firstly, cases with common characteristics (in our case “dimensions’ results”) are selected, and secondly, cases in groups (here, we selected 2 groups) are classified using the Euclidean distance (there are many alternative metrics) between the examined cases and the previously created clusters as a metric. This algorithm resulted in the classification of the intervention group into 2 groups (70% of cases were successful, and 30% of cases were unsuccessful).
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 subjected to reliability analysis with the Cronbach a coefficient ranging between 0.55 and 0.858 (see
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 values at baseline. In regard to the “Parenting style” dimensions, the results indicate that except for the “Authoritative Parenting Style”, the “Authoritarian Parenting Style” and the “Permissive Parenting Style” had statistically significant different mean values at baseline (see We also conducted post-intervention comparisons between the intervention and the control group (see According to the results of the intervention group, no variable showed a statistically significant difference in the mean values between the pre-intervention and the post-intervention scores greater than 95% (or According to the results presented in Unlike the initial clusters table, the final clusters presented in the table below take into account the actual mean values for most variables per intervention stage. Therefore, the analysis appears to be consistent with the descriptive statistics initially presented in the table of the characteristic elements of the sample of the experimental group (measures of position and dispersion). Therefore, the clustering should be considered successful.According to the results of the ANOVA test (see The analysis (In summary, the ANOVA results suggest that several factors related to “family interactions”, “parenting”, “emotional well-being”, “physical/material well-being” and “disability-related support” show significant differences between the initial and final clusters. This indicates that the intervention program had a notable impact on these aspects of the participants’ lives. However, “Authoritarian” and “Permissive Parenting Styles” did not significantly change between the clusters, while “Authoritative Parenting Style”, with a new, dimension did exhibit a significant difference.
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 statistically significant, occurred in the absence of other system changes, and this makes the current program even more successful. The major success of the intervention is that it achieved changes in the intervention group and not in the control group. Most importantly, the program had overwhelming acceptance and was regarded as beneficial to those who participated. Results though are mixed in terms of effectiveness, and further research is necessary to capture these changes in larger samples. In our study, we captured the small changes using a cluster analysis, and this offered important information and directions for future research. Specifically, a decrease in parental authoritarianism and an increase in support were observed, which is in accordance with Carroll [Also, an increase in child–parent interactions as well as emotional and general well-being was observed. As the findings of Maddah’s et al.’s [Certainly, the intervention program yielded positive outcomes, notably enhancing the quality of life (QoL) for the children involved in the study and their families. These findings align with a study conducted by Ginieri-Coccossis et al. [
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, the tools employed in the current study were tested individually in past research but were used together for the first time here. Consequently, there are no comparable studies using this combination of tools. Third and of critical importance, the high drop-out rate in the control group may have affected the results of this study, as it did not allow for a more elaborate analysis and conclusions. The high rate of attrition has significantly reduced the amount of data and potentially the statistical power of analysis. If the subjects who dropped out differed from those who completed the intervention in terms of key study parameters, this may have significantly affected the outcome measures of this study, resulting in biased conclusions.
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 children. It further became evident that the intervention program improved the QoL of the children by increasing all the dimensions of QoL. Most importantly, the current study offers evidence on the feasibility of the intervention in low-resource countries, its acceptability by people of various backgrounds including those with vulnerabilities, as well as its practicality for busy service providers and environments.
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 agreed to the published version of the manuscript.
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 (independent Comparison between pre- and post-intervention performance in the intervention group (paired samples test).Results of ANOVA control with factor separation in the new clusters.
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 patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program.
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 of the Consolidated Framework for Implementation Research (CFIR).
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 personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains.
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 found limited time and SDM not being applicable due to patient characteristics or due to the clinical situation to be the most frequently reported barriers to SDM implementation [Multi-component implementation programs (also called complex interventions, [Implementation science advises to base trials evaluating implementation programs on theory [Thus, the aim of this study was to investigate influencing factors on SDM implementation in the context of a theoretically and empirically based multi-component SDM implementation program by means of an a priori planned process evaluation. The exploration of these influencing factors complemented the outcomes evaluation of a cluster-randomized implementation trial to foster SDM in routine cancer care and added to the understanding of its results [
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 Cancer Center Hamburg (UCCH), a comprehensive cancer center at the University Medical Center Hamburg-Eppendorf (UKE) in Germany. It consisted of six implementation strategies: 1) SDM group training for physicians and nurses, 2) individual coaching sessions for physicians, 3) provision of the patient empowerment strategy Ask 3 Questions (Ask3Q, [The collection of outcome data occurred in four two-months waves before, between, and after the implementation intervals (cp. Fig.
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 HCPs followed a semi-structured interview guide, which was not pilot tested. Interviews were conducted to assess HCPs’ views on SDM implementation in general and the six implementation strategies of the implementation program in particular. Participants were asked about 1) their knowledge of the trial, the implementation program and its six implementation strategies, 2) their access to knowledge and information about the trial and implementation program, 3) their experience when participating in SDM group training and individual coaching sessions, 4) their attitudes and beliefs about the implementation strategies including influencing factors on their implementation, and 5) additional feedback regarding the trial, implementation program, or SDM in general. Additionally, demographic data (i.e., age, profession, work experience) were assessed from all participants. The interview guide can be found in Additional File We additionally collected qualitative observational data through field notes during the preparation phase and all implementation intervals and measurement waves of the trial [Last, minutes of meetings with clinical cooperators and of SDM training sessions were included in the qualitative process evaluation. However, minutes did not exist for every meeting or training session due to limited personnel resources.
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 the data (including transcripts, field notes, and minutes) by PH, 4) coding of another approximately 25% of the data (including transcripts, field notes, and minutes) by AL, 5) discussion of ambiguities and open questions between PH and AL and revision of the coding scheme, 6) coding of the remaining data by AL, 7) discussion and revision of codings and coding scheme between PH and AL until consensus was reached, 8) comprehensive quality control (i.e., PH reviewed all codings initially assigned by AL and vice versa), 9) discussion of ambiguities and open questions between PH and AL and revision of codings and coding scheme, 10) meeting to review the coding scheme with the research team (PH, AL, IS, HC), 11) revision and finalization of the coding scheme and the codings by PH and AL.After the coding scheme was finalized, PH and AL independently classified each code as a major, mid-level, minor, or no influencing factor within this SDM implementation trial. The results were discussed by PH and AL until consensus was reached for each code. In the main body of this manuscript, we present only codes and respective codings, which were identified as major influencing factors in this consensus process. We defined those codes as major influencing factors that both coders (PH, AL) rated as being highly relevant to explain the implementation process in this trial. Reasons for high relevance could be high frequency of codings in process interviews, field notes, and minutes and/or the perceived impact of the influencing factor by the coders. The entire coding scheme including all CFIR constructs and all additional inductive codes is described in Additional File As a quantitative analysis step, for each code the number of codings in total, the number of coded documents, and the number and percentage of codings in which the influencing factor was classified as a barrier or a facilitator to SDM implementation (cp. meta-codes) were also included in Additional File For qualitative content analysis, we used MAXQDA software (VERBI GmbH, Berlin, Germany). Descriptive statistics of demographic data were conducted with IBM SPSS Statistics 25 (IBM Corp, Armonk, NY).
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 research. JZ is a female clinical psychologist (Dipl.-Psych.), post-doctoral researcher, and licensed psychotherapist working with cancer patients. Both had prior experience in collecting qualitative data. PH and AL analyzed the process evaluation data. PH is a female clinical psychologist (Dipl.-Psych.), post-doctoral researcher, licensed psychotherapist and trained psycho-oncologist. AL is a female neurocognitive psychologist (M.Sc.), doctoral researcher, and trained psycho-oncologist. PH and AL had both conducted qualitative research before and were familiar with qualitative content analysis. IS supervised the trial as its principal investigator. She is a female clinical psychologist (Dipl.-Psych.), senior researcher, licensed psychotherapist, and trained psycho-oncologist with comprehensive knowledge and experience in qualitative research and implementation research.
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 physicians of participating departments, field notes by the study team, and meeting minutes. Qualitative data analysis was based on the CFIR, a conceptual framework for implementation research. Major influencing factors on SDM implementation were found for all domains of the CFIR and amended by inductively derived influencing factors where necessary. Major themes regarded e.g., relative priority and relevance of SDM and its implementation, leadership support, coordination and communication, applicability and compatibility, and available resources. In addition, strong interrelations between different major influencing factors were identified.The influencing factors found in this trial align with previously reported influencing factors on SDM implementation [Furthermore, our comprehensive assessment of influencing factors guided by the CFIR as a theoretical foundation added to existing literature by highlighting the interrelations between influencing factors on different levels (i.e. regarding different CFIR domains) that likely need to be addressed simultaneously. A successful implementation program might need to take into account many if not all of the influencing factors in order to lead to a relevant change in SDM implementation. Barriers on different levels might stabilize the current lack of SDM uptake. Implementation efforts that manage to tackle some, but not enough of the influencing factors are likely not finding significant effects. This might explain, why the outcome evaluation of this trial did not show significant differences in patient-reported SDM uptake and most secondary outcomes before and after implementation of the multi-component SDM implementation program [In addition, the influencing factors differ in who has the power to modify them and how. Positive attitudes and motivation to change on the individual level, as found in this trial, did not suffice to foster SDM uptake on the department level. This aligns with recent literature that points to the necessity to consider barriers on the organizational and health system level in order to successfully implement SDM [Participatory research could be a way out of limited implementation success due to influencing factors on the individual, organizational, and intervention level [
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 the findings in other comprehensive cancer centers and countries is necessary. Furthermore, the sampling procedure could limit fair representation of the target population. Potential interview participants were contacted on the corridors of the inpatient wards and outpatient clinics. Nurses in leadership positions and senior physicians could be underrepresented, because they more often work in their offices compared to ward nurses or junior physicians. In terms of data saturation, a more targeted recruitment strategy might have been useful to ensure completeness. Additionally, it was not possible to conduct minutes for all meetings with clinical cooperation partners and SDM team trainings due to personnel resources. Nevertheless, we were able to collect rich data sets and identify influencing factors regarding all CFIR domains. The extensive coding system with a total of 79 codes and strong interdependency between individual codes made data analysis challenging. Quality of data analysis was safeguarded by extensive peer-review within the study team. Nevertheless, reducing the findings of this study to a sparser framework and corroborating the findings of this study with a quantitative design in the future would be valuable next steps. Furthermore, an in-depth analysis of potentially diverging views across professions and profession-specific needs could further enrich our understanding.
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 randomized design including such a thorough a priori planned process evaluation. Major influencing factors were found for all domains of the CFIR, and strong interrelations between those factors were evident. The identified influencing factors can be used for planning, conducting, and evaluating future SDM implementation. Further studies should investigate which of the influencing factors are predictors for implementation success, and how the interrelations can be taken into account successfully. This knowledge, in turn, may support the implementation of SDM in routine care in the future.
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, Teresa Greiter, Sophie Hachmeister, Hendrik Hagen, Stefanie Heger, Fatima Hussein, Anastasia Izotova, Joy Kukemüller, Finja Mäueler, Sophia Neumann, Nicolai Pergande, Martin Reemts, Greta Rose, Sophia Schulte, Cheyenne Topf, Marie-Luise Ude, Ayse Yilmaz, Stefan Zeh. Furthermore, we thank all non-author collaboration partners at the University Cancer Center Hamburg and the University Medical Center Hamburg, especially Carsten Bokemeyer, Anja Coym, Marcus Freytag, Barbara Schmalfeldt, Ralf Smeets, Tobias Vollkommer, and Isabell Witzel. We also thank Martin Härter and Levente Kriston for their involvement and advisory role throughout this trial. Last but not least, we are thankful to the members of the advisory board, Glyn Elwyn, Dominick Frosch, Mirjam Körner, Heather Shepherd, Monica Taljaard, and Michel Wensing.
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 of the study. PH, AL, and IS were involved in delivering the implementation program. WF and JZ were involved in the data collection of qualitative process interviews. PH, AL, WF, JZ, and IS were involved in collecting field notes. PH, AL, and IS were involved in writing meeting minutes for the process evaluation. HH, VM, and MP supported coordination of the study in the participating departments. PH and AL conducted the process evaluation analyses. IS contributed to these analyses. All authors were involved in the interpretation of the data. PH and AL wrote the first manuscript draft. All authors were engaged in critically revising the manuscript for important intellectual content. All authors read and approved the final manuscript.
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 Foundation.
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 Germany and in the country of the investigator who proposes to use the data must be complied with. Due to the data being closely connected with the participating departments, it might not be possible to sufficiently anonymize all persons in all documents within this data set. Thus, some documents might have to be excluded from sharing. Preparing the data set for use by other investigators requires substantial work and is thus linked to available or provided resources. The data sets used in this study are in German language.
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 met. Study participation was voluntary. We obtained written informed consent from all patients participating in the trial. We obtained a waiver of consent for HCPs from the Ethics Committee. Nevertheless, study participation was voluntary and HCPs gave verbal consent before participating in the process interviews.
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 interests.
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 previously confirmed risk factors. The primary endpoint was the incidence of si-SSI. Considered secondary endpoints were major postoperative morbidity in both groups, additional wound complications, median hospital length of stay and need for re-hospitalisation.
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 endpoint, no significant differences in si-SSI rate were found: 17 (9.82%) staples group vs. 8 (4.62%) in subcuticular suture group (p = 0.062). Subset analysis confirmed absence of significant differences. As for secondary endpoints, overall wound complications did not differ significantly between two procedures: 19 (10.98%) vs. 10 (6.35%) (p = 0.127). There were no treatment related adverse events. However, occurrence of si-SSI contributed to major postoperative morbidity in both groups (p < 0.001 and p = 0.018) and to a substantially prolonged postoperative hospitalization (p = 0.015).
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 after elective hepatobiliary and pancreatic (HBP) procedures range from 8.0% to 15.5% [Numerous clinical interventions with varying levels of supporting evidence have been implemented to reduce si-SSI after elective abdominal surgery, including HBP surgery. A strategy to reduce the risk of SSI is the implementation of preventive care bundles. The concept of care bundle for prevention of SSIs was adopted from evidence documenting that structured approach to performing 3–5 evidence-based collective interventions could lead to an improved patient outcome regarding SSIs [Several studies have compared outcomes of subcuticular suture and skin staples for the prevention of si-SSI in different surgical scenarios. Various randomized clinical trials have reported a significantly lower incidence of si-SSI after subcuticular suture skin closure in clean surgery (i.e., caesarean delivery [The aim of this randomized clinical trial was to assess whether subcuticular suture skin closure in contrast to regular staples, reduces si-SSI rate in patients undergoing elective HBP surgery under conditions commonly encountered in general surgical practice.
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 indication, and they agreed to participate voluntarily in the study and therefore signed the provided written informed consent. All patients accepted to comply with the study protocol postoperative follow-up in outpatients’ clinics. There were no restrictions regarding surgical procedures. Exclusion criteria included: urgent or emergent surgery, class IV wounds according to the CDC classification (i.e. dirty or infected surgical site)15 and the presence of an active uncontrolled intraabdominal infectious foci prior to the intervention. Additional exclusion criteria were intraoperative uncontrolled faecal contamination of the surgical site and patients requiring reintervention due to major postoperative complications during follow-up, considering the potential confounding factor with the primary endpoint. Furthermore, all patients not complying with the specific study perioperative SSI prevention bundle or if they refused to participate, either verbal or in writing, were also excluded.All eligible patients provided written informed consent before undergoing study related procedures. The study was approved by the local Ethics Committee for Clinical Research of Donostia University Hospital and was conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013). This trial was designed and reported according to the CONSORT guidelines16 and was prospectively registered at ISRCTN registry, with the number ISRCTN 37315612 on the 14/01/2020.
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 relevant alcohol abuse, American Society of Anaesthesiologists (ASA) physical status classification ≥ 3, Body Mass Index (BMI) ≥ 25 kg/m
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 other hand, in the experimental group subcuticular suture was used, performing a continuous intradermal suture with 4/0 long-term absorbable monofilament material. In both groups abdominal fascia closure was performed with a continuous uninterrupted long-term absorbable suture (i.e., polydioxanone or polyglyconate) using “small-bites” technique. Subdermal layer (subcutaneous tissue) was closed when a depth ≥ 3 cm was found. For standardisation of all the procedures, both perioperative SSI prevention measures and incision closure procedure; staff surgeons were requested to learn the described interventions by means of specific lectures and reading a particular study protocol document provided by the investigators team. Furthermore, all participating surgeons were instructed to identify si-SSI according to CDC criteria [
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 study secondary endpoints were overall major postoperative morbidity in both groups, defined as Clavien-Dindo classification class ≥ IIIa [All patients were followed-up for the first 30 postoperative days, for both primary and secondary outcomes. During immediate postoperative period daily physical examination of the patient was performed by attending surgeons of the study team. After hospital discharge, all patients were followed-up in outpatients’ clinic for the second and fourth postoperative weeks to ensure post-discharge si-SSI detection. Complementary tests included aseptically obtained wound exudate cultures. All diagnosed si-SSI were confirmed by the reference HBP staff surgeons of the study team. The study protocol was published and is available online at
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 (IQR). Qualitative data is presented as absolute numbers and proportions. We used an intention-to-treat (ITT) analysis for all outcomes, and per-protocol (PP) analysis was performed for the primary endpoint. Differences among both groups were evaluated using parametric and non-parametric tests, as corresponded. We assessed the primary endpoint using χ
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 manuscript submitted for publication.
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 management protocol including a bundle of preventive interventions for si-SSI endorsed by Surgical Site Infection panel of the Spanish Surgical Association [The efficacy of subcuticular suture on reduction of si-SSI has been widely investigated. Subcuticular suturing is accepted as the procedure of choice for clean surgical procedures (wound class 1 according to the CDC criteria) [Several observational and some randomized studies have published a potential benefit of subcuticular suture in the prevention of si-SSI in patients undergoing elective clean-contaminated or contaminated surgery [When the present study was already registered and actively recruiting patients for one year, a meta-analysis of randomized studies [Elective surgery for HBP diseases is associated with prolonged operative time, blood loss, and frequent comorbidity due to patients’ baseline clinical characteristics, which may make the risk of si-SSI differ from other gastrointestinal surgeries [In 2018 two relevant observational propensity-matched cohort studies were published. Both evaluated effect of subcuticular suture on si-SSI in elective HBP surgery [Our study included a comprehensive population based on regular HBP elective procedures, considering all surgical approaches along with a broad spectrum of surgery indications. Furthermore, to our knowledge, this is the only randomized study evaluating si-SSI in HBP surgery that incorporated a specific perioperative protocol encompassing a bundle of validated preventive measures for si-SSI endorsed by leading scientific surgical expert panels. Therefore, the strength of this randomized controlled trial (CLOSKIN trial) is that it provides comprehensive pragmatic evidence on the prevention of si-SSI in relation to the method of wound closure in elective HBP surgery.The present study has several limitations. The research design did not consider the influence of surgical wound length on si-SSI as a possible risk factor, although it considered major open surgery and laparoscopic approach individually as reported in subset analysis. As expected, due to the pragmatic nature of the present randomized clinical trial, a minor group of patients required antibiotic therapy due to other indications besides si-SSI (i.e., urinary tract infection, hospital-acquired pneumonia, or central venous catheter related infections). Although systematic use of antibiotics has not proven to prevent si-SSI, it must be acknowledged that this could have influenced si-SSI incidence. In the same line raising awareness and compliance with hand wash by health care professionals during SARS-CoV-2 pandemic might have led in some point to a decrease in overall si-SSI rate. Nonetheless, it is expected that this would have affected equally to both study groups. Additionally, although the overall compliance with the preventive care bundle for si-SSI was recorded, no information regarding compliance of certain individual measures was obtained. The assessment of si-SSI was performed according to the CDC definition and criteria for si-SSI [
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 subcuticular suture or surgical staples can be considered routine method for wound closure in HBP elective surgery, albeit individual patient characteristics and particular preferences should also be considered. Considering all this clinical data and the pragmatic evidence of the present randomized controlled trial, the authors consider no further need for additional randomized studies to address this issue. Future studies should focus on aggregated data analysis comparing clean surgery against clean-contaminated and contaminated surgery.
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 by IAA, MAZ, XAM, RJA and JMEN. All authors commented on previous versions of the manuscript. All individuals designated as authors qualify for authorship, according to the ICMJE guidelines for authorship criteria, and all those who qualify for authorship are listed. All authors read and approved the final version of the manuscript to be published.
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 neither had access to study raw data. All authors had complete access to the study data that support the publication.
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 study are available from the corresponding author on reasonable request.
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 Helsinki (World Medical Association, 2013).
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 trial to assess the impact of introducing TyphiBEV® vaccine to those between 1 and 30 years of age in a high-burden setting.
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 as improved sanitation and clean water supplies. However, the development of such infrastructure is a long-term solution, and the WHO recommends the programmatic of typhoid conjugate vaccines (TCVs) to reduce the burden of this disease [Within India, data from the SEFI network and other studies have shown that TCV rollout is a cost-effective strategy to reduce the burden of typhoid in the country, and especially among children and young adults in urban areas who are disproportionally affected by it [
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