CONSORT Checklist Research Articles

The effect of herbal medicine on neonatal jaundice: a systematic review

Background Herbal remedies have been implicated as adjunctive therapies in the treatment of neonatal jaundice over the years. The aim of this review was to investigate the therapeutic effects of herbal medicines on neonatal jaundice. Materials and Methods In this systematic review, a search process was performed in online databases of Scopus, Medline, Web of Science and Cochrane Library based on PRISMA guidelines. Components for searching were “neonatal jaundice” and “herbal medicine”. Relevant articles with language English published between January 1900 and October 2020 were extracted. The quality of the articles was assessed by the CONSORT checklist. Results Finally, according to including criteria, 9 studies with a total of 1323 neonates were selected. The herbal remedies used by researchers for treatment of neonatal jaundice included bilinester drop, alhagi pseudoalhagi, and zizyphus jujuba were used in 8 of 9 studies. In 5 of these 8 studies bilineaster significantly reduced serum bilirubin levels in infants compared to other groups. Conclusion: Based on the results, the herbal remedies (especially bilineaster) are probability effective as adjuvant therapies along with standard therapies in treatment of neonatal jaundice. These can reducing bilirubin level – hospitalization days and re hospitalization.

The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial.

Port needle insertions are painful and distressing for Pediatric Hematology-Oncology patients. Virtual Reality (VR) can be used during needle-related procedures in these patients. This study aimed to investigate the effect of VR distraction during access to the venous port with a Huber needle in reducing needle-related pain, fear, and anxiety of children and adolescents with cancer. This randomized controlled study used a parallel trial design guided by the CONSORT checklist. The sample of children (n=42) was allocated to the VR group (n=21) and the control group (n=21). Port needle-related pain was assessed using the Wong-Baker Faces Pain Rating Scale after the procedure. Before and after the port needle insertion procedure, anxiety and fear assessed using self- and parent-report using the Children's Anxiety Meter and Child Fear Scale. The primary outcome was the patient-reported pain scores after the procedure and fear and anxiety scores before and after the procedure. Pain, anxiety, and fear scores of the two groups and within groups were analyzed and also Spearman correlation analysis was used. Self-reported pain scores of patients in the VR and control group were 2.4±1.8 and 5.3±1.8, respectively. This study found a statistically significant difference between groups in pain scores (p<.001). A statistically significant difference was found between groups according to the self- and parent-reported fear and anxiety scores after the procedure. Self-reported fear scores in the VR and control group were 0.8±0.9, 2.0±1.0, self-reported anxiety scores were 2.9±2.0, 5.4±2.0, respectively (p<.001). Virtual reality is an effective distraction method in reducing port needle-related pain, fear, and anxiety in Pediatric Hematology-Oncology patients. ClinicalTrials.gov NCT04093154.

Prescribing laughter to ameliorate mental health, sleep, and wellbeing in university students: A protocol for a feasibility study of a randomised controlled trial

ObjectivesThis research is the first study to investigate the potential effects of a laughter prescription on both psychological health and objective sleep parameters in university students. The primary objective is to evaluate the feasibility of prescribing laughter to inform a larger randomised controlled trial. Secondary objectives are to assess if a two-week laughter prescription improves subjective and objective sleep outcomes, wellbeing, and/or psychological health outcomes. Trial designTo assess the feasibility of a randomised controlled trial for laughter prescription in relation to sleep, psychological health, and wellbeing. Forty university students will be recruited and randomised to one of two conditions (control/experimental). MethodsWrist actigraphy and sleep diaries will be used to estimate sleep outcomes during a one-week baseline testing phase and across the two-week intervention. The experimental group will be shown how to record a Laughie (a 1-min recording of their joyful laughter on their smartphone) and prescribed to laugh with it three times daily for 14 days (the control group will only track sleep). All participants will complete the WHO (Five) Well-being Index, and Hospital Anxiety and Depression Scale pre- and post-intervention. The CONSORT checklist, and the Feasibility, Reach-out, Acceptability, Maintenance, Efficacy, Implementation, and Tailorabilty (FRAME-IT) framework will guide intervention planning and evaluation. Participant interviews will be analysed using Differential Qualitative Analysis (DQA). ResultsThe feasibility of a two-week laughter prescription in university students and its impact on sleep, wellbeing, and/or psychological health outcomes will be assessed. ConclusionsZayed University Research Ethics Committee approved the study in July 2019. The research will be completed following protocol publication. Trial registrationClinicalTrials.gov. ID: NCT04171245. Date of registration: 18 October 2019.

Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial

BackgroundEarly rehabilitation has been proved very important for stroke patients. However, the effective model of transitioning from early in-hospital rehabilitation to discharge rehabilitation using the collaborative remote rehabilitation nursing model has not been thoroughly studied. ObjectiveTo explore the feasibility and effectiveness of collaborative care model based telerehabilitation exercise training for acute stroke patients. MethodsA randomized controlled clinical trial was conducted. Patients were recruited and randomly divided into intervention and control group. Both groups were given regular treatment and acute rehabilitation nursing instructions during hospitalization. The control group was followed by regular telephone follow-up after discharge. The intervention group received Internet-based remote rehabilitation project after discharge. Motor function, balance ability and quality of life were measured at the day of discharge, the 4th week, 8th week and 12th week after patients were discharged. The CONSORT checklist was used to check the procedure. ResultsA total of 61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group. Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78). Group-time interaction was significant in motor function and quality of life. ConclusionCollaborative care model based telerehabilitation exercise training program can safely and effectively improve the recovery of motor function and improve the quality of life in patients with stroke.

How can children be involved in developing oral health education interventions?

This review examined the oral health interventions that have been developed for elementary school age children and the involvement of children in these intervention studies. Eight randomised controlled trials involving 3,232 children were analysed using deductive content analysis by two authors. Child involvement was categorised using the Typology of Youth Participation and Empowerment TYPE model. In all eight studies, the interventions were designed by the researchers and adult-led without involvement of children. Further studies with participatory research methodology are recommended to better understand the role of involvement of children in oral health education.Data sources The data search was carried out in April 2018 using PubMed, CINAHL, Embase and Scopus databases. The search focused on elementary age school children (6-12 years) who were involved in oral health education intervention studies. Exclusion criteria were studies involving children with mental or physical impairment, undergoing hospital or orthodontic treatment, preventative treatments or solely targeted towards parents/caregivers or teachers.Study selection A systematic review method of randomised controlled trials (RCTs) was selected. Titles and abstracts were included or excluded before full text analysis for eligibility was carried out. Studies were assessed by two authors with a third author to be consulted in cases of disagreement.Data extraction and synthesis Study sample, intervention duration and content, selection, use of educational methods including use of a theoretical framework and outcomes were extracted from the data. Child involvement was categorised using the Typology of Youth Participation and Empowerment (TYPE) pyramid (Wong et al., 2010).1 The quality of studies was assessed using the CONSORT checklist and the Cochrane risk of bias tool. The methodological quality of the studies was relatively low with a score of 14-22 out of 36. Three studies were rated as being fair quality in terms of risk of bias. The remaining five were rated as either unclear or high risk of bias.Results Eight RCTs were selected for review. Sixty-five articles were assessed for eligibility and 57 articles were excluded due to non-RCT design, excluded/unreported ages and full text unavailability. Nine different methods of oral health education were identified: lecture; printed material; demonstration; toothbrushing diary; game; video; workshop; discussion; and oral hygiene training. None of the reported studies demonstrated a rationale for selecting their educational method. Four reports described a theoretical framework for development their intervention: social learning theory (Parcel and Baranowski, 1981) was used by Haleem et al. (2012); Health Belief Model (Becker, 1974) by Yekaninejad et al. (2012), Wolf's health learning capacity (2009) by Freeman et al. (2016) and Ajzen's theory of planned behaviour (1991) by Simpriano and Mialhe (2017). However, the use of these theories was limited and no attempts to introduce children's perspectives into the theoretical framework was identified.Five outcomes to measure effectiveness were found: clinical oral health status; oral health-related behaviour; oral health knowledge; attitudes towards oral health; and oral health related quality of life. Clinical oral health status was the most commonly used outcome (seven of the eight studies). Positive outcomes were found in all eight studies. None of the reports considered the potential for enhancing intervention effects by involving children more actively. The children's role in the interventions was mostly the Vessel type of participation from the TYPE pyramid model. Partially symbolic participation was detected in two studies - Haleem et al. (2012) trained children to conduct oral health education in the role of peer educators and Simpriano and Mialhe (2017) trained children to create their own plans for daily toothbrushing and how to overcome situations preventing that task. There were no reports of consultation or collaboration with children for their perspectives before or after the interventions. Interventions appear to have been created by the researchers alone.Conclusions In all of the included studies, children were only involved during the intervention implementation phase. The interventions were all adult designed and adult led. Lack of detail in the reports meant that reported positive outcomes could not be clearly attributed to the activities carried out by the children. Further studies with participatory research methodology are recommended to better understand the potential role of children in oral health education and research.

Describing deprescribing trials better: an elaboration of the CONSORT statement

ObjectiveThe objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elaborate and explain CONSORT items in this regard. Study Design and SettingAs a first step in a multistage process and based on a systematic review of deprescribing trials, we elaborated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials. ResultsWe identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants. ConclusionThis article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices.

A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life

BackgroundPersons with dementia with mild to moderate cognitive impairment are at risk for developing impairments with activities of daily living such as the ability to feed oneself, that negatively influence health. Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home.MethodsA cluster randomized controlled trial with a parallel mixed methods evaluation processes will be conducted to examine the efficacy of a train-the-trainer program using non-paid volunteers in respite care centers to deliver a telehealth mealtime intervention guided by the theory-based C3P Model—Change the Person, Change the People, Change the Place (C3P). In this six-month study, dyads of caregivers and persons with mild to moderate dementia receiving respite care services will be randomized to receive either the telehealth intervention or enhanced usual care. Within the intervention group, dyads will be partnered with a C3P trained volunteer who will work with caregivers via videoconference to devise and implement mealtime plans. Under usual care, dyads will receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer’s disease. The primary outcomes include weight maintenance or gain of the person with dementia and quality of life of the caregiver. A multi-level evaluation process utilizing respite center administrators and directors, volunteers, and caregivers will explore intervention fidelity, acceptability and sustainability. Using both the CONSORT and SPIRIT checklists as guidance, the comprehensive study design is more fully described in this manuscript.DiscussionIn this trial, we will lay the groundwork to examine the efficacy and sustainability of a train-the-trainer telehealth program that could be widely disseminated by national Alzheimer’s organizations and readily adopted by community agencies to provide additional resources to assist families in managing mealtimes at home, while promoting the quality of life of both the caregiver and the person with dementia.Trial registrationThis study was registered with clinicaltrials.gov: NCT03622814 on August 9, 2018..

Effect of Dexamethasone on Mortality in Adult and Elderly Patients with Sepsis: a Systematic Review

Sepsis is a serious disease that affects many people worldwide, and many therapies are used, including corticosteroids such as dexamethasone. However, there is no conclusion as yet, concerning the use of dexamethasone in patients with sepsis or septic shock. The aim of this study was to perform a literature review to assess the mortality of patients with sepsis or septic shock using dexamethasone, answering the following question: What is the effect of dexamethasone on mortality in adult and elderly patients with sepsis compared with mortality in patients who do not use anti-inflammatory therapy? The protocol of this study was registered in the PROSPERO database. The systematic literature search was performed in four electronic databases. Bias risk assessments were performed using the Cochrane Collaboration tool, and notification quality was assessed using the CONSORT-based checklist. The literature search initially identified 13,999 records. The three selected studies included eighty adult patients with sepsis or septic shock who had received dexamethasone as an intervention. Of the three articles, two concluded that the use of dexamethasone significantly reduces the mortality in patients with sepsis or septic shock. The Cochrane Collaboration tool bias risk results showed that none of the studies was completely bias-free and through the CONSORT checklist, it was found that none of the studies met 50% or more of the applicable requirements. Thus, it is clear from this review that further randomized clinical trials comparing the use of dexamethasone to placebo in adjunctive therapy for sepsis patients are needed. The registration number in the PROSPERO database is CRD42018088150.

Factors affecting moral distress in nurses working in intensive care units: A systematic review

Background Moral distress is a major issue in intensive care units that requires immediate attention since it can cause nurses to burnout. Given the special conditions of patients in intensive care units and the importance of the mental health of nurses, the present study was designed to systematically review the factors affecting moral distress in nurses working in intensive care units. Methods PubMed, EMBASE, Web of Science, Scopus, and Science Direct were systematically searched for papers published between 2009 and 2019. Original articles from quantitative and qualitative studies were reviewed. The CONSORT and STROBE checklists were used to assess the quality of the quantitative papers. The JBI checklist was applied for qualitative studies. Results Factors affecting moral distress in nurses include lack of nursing staff, nurses with inadequate experience, lack of support from organizations and colleagues, inadequate education and lack of knowledge of nurses, poor collaboration of physicians with nurses, ethical insensitivity and lack of teamwork, heavy workload, poor quality of care and moral violence and they are considered as risk factors for moral distress. Conclusion Many of the related causes are due to the nature of nurses’ work and it is necessary to manage the underlying conditions of this phenomenon so that it can be effectively prevented from spreading. Levels of moral distress require more attention of authorities in the use of prevention strategies and the reduction of effective factors in distress.

Effects of mental practice strategies associated to physiotherapy on gait and risk of falls in Parkinson’s disease: a pilot study of a randomized clinical trial

Abstract Introduction Parkinson’s Disease (PD) is a degenerative disorder that interferes with the voluntary movements due to dysfunction of the basal ganglia and presenting with motor signals, such as the reduction of gait speed. This contributes to an increased risk of falls. In rehabilitation, mental practice (MP) has been shown to promote plastic modulation of neural circuits and improve motor learning, but the results of research with MP in PD are still ambiguous due to the diversity of intervention strategies. Objectives To compare the effects of MP strategies associated to physiotherapy in gait and risk of falls in PD patients. Methodology We performed a pilot study of a clinical randomized, single blind, trial, conducted in accordance with the consort checklist. Patients with idiopathic PD were included and allocated to four groups: Control group (CG); Group with mental practice guided by images (MPI); Group with mental practice guided by audio (MPA); group with mental practice without a guide (MPWG). The subjects of the experimental groups were submitted to 15 sessions of physiotherapy and mental practice, while the CG received only physiotherapy. The sessions were held 2 times per week, 40 minutes for physiotherapy and approximately 5-10 minutes for the corresponding mental practice protocol. Spatial-temporal parameters of gait were assessed with the 10 meters Walking Test (TC10m), and the risk of falls was evaluated with the Timed Up and Go (TUG) test. Results The MPI group showed significant results for the parameters time (p = 0.027) and speed (p = 0.025) when compared with the results of the CG. No main effects for the group were observed concerning cadence and risk of falls had. Groups MPWG and MPA showed no significant results for the TC10m and TUG when compared with the CG. Conclusion The results of this pilot study suggest that MP guided by images associated to physical therapy was more effective to increase the gait speed than the alternative strategies.

147-LB: The Effects of Berberine, Cinnamon, or Fenugreek Seeds on Glucose and Lipid Metabolism in Prediabetes and Diabetes: An Assessment of the Quality of the Clinical Trials

The prevalence of diabetes is increasing. Several antidiabetic drugs are available to treat the disease, however, none has been effective in halting the progression decline in β-cell function and insulin sensitivity. Plant-derived nutraceuticals provide therapeutic potential and are widely used in integrative medicine. However, clinical trials that evaluated the efficacy of antidiabetic nutraceuticals have been inconsistent in their findings. This study assessed the quality of the clinical trials that investigated the effects of berberine, cinnamon, or fenugreek seeds on glucose and lipid metabolism. Five databases (UB Wahlstrom, PubMed, Cochrane Library, CINAHL, and Science Direct) were systematically searched for randomized controlled studies that investigated the effects of berberine, cinnamon, or fenugreek seeds on glucose and lipid metabolism in prediabetes and diabetes. Forty-three studies (11, 20, 12 on berberine, cinnamon, and fenugreek, respectively), involving 3, 459 study participants were retrieved. The studies were appraised for trial quality using the Jadad scale and the CONSORT checklist. The included berberine, cinnamon, and fenugreek studies had a Jadad score of 3.2, 3.4, and 2.4, respectively. The studies, combined, had a Jadad score of 2.98 and only 62.7% had a score ≥3. Appraisal for reporting quality showed that 33% of the trials were identified in the title or abstract as randomized. Allocation concealment, random sequence generation, and baseline demographics and clinical characteristics were reported in 35, 44 and 74% of the trials, respectively. The included studies had suboptimal methodological and reporting qualities. The studies were not efficacious enough to support their use in clinical decision making. Further RTCs with emphasis on methodological and reporting quality and comparative effectiveness need to be conducted to determine efficacious conclusions. Disclosure I. Abdi: None.

Low-power laser and potassium oxalate gel in the treatment of cervical dentin hypersensitivity-a randomized clinical trial.

To evaluate the effectiveness of different protocols for the treatment of cervical dentin hypersensitivity (CDH) in non-carious cervical lesions (NCCLs). The CONSORT checklist was used to design this study. The sample with n = 74 participants (389 NCCLs) was randomly allocated into three groups: G1, potassium oxalate (Oxa-Gel BF); G2, GaAlAs (gallium-aluminum-arsenate) low-power laser (100mW, 808nn, 60J/cm2); and G3, potassium oxalate (Oxa-Gel BF) associated with the GaAlAs low-power laser. The CDH was triggered by the evaporative stimulus test (EST) and by the tactile stimulus test (TST). The visual analog scale (VAS) was used to quantify the degree of CDH. Changes in sensitivity were assessed from baseline over 3weeks. Data were analyzed for NCCLs using mixed-effects models with unstructured direct product covariance structure (α = 0.05). After the first application, participants from G1 and G3 had a reduction in CDH (p < 0.05) compared with group G2 for TST. After the second application, G3 participants had a reduction in CDH (p < 0.05) in relation to G2 for both stimuli. Reduction in CDH (p < 0.05) occurred over 3weeks for EST and TST for all groups; however, there was no difference between groups at the end of the therapies. Potassium oxalate was more effective in reducing immediate CDH. After four applications, all groups showed similar results for the reduction of CDH. GaAlAS laser irradiation and oxalate potassium gel could reduce the symptoms of CDH; thus, they are viable alternatives for the treatment of this condition. Chemical occlusion of dental tubules showed effective results after a shorter time interval. Brazilian Clinical Trials Registration Platform under protocol number RBR-4ybjmt. http://www.braziliantrials.com/?keywords=RBR-4ybjmt&order=%7Eensaios.patrocinador_primario.

Improved quality of care by using the PRISMS form to support self‐management in patients with COPD: A Randomised Controlled Trial

To investigate the effects on the quality of care of the Patient Report Informing Self-Management Support (PRISMS) form compared with usual care among patients with chronic obstructive pulmonary disease (COPD) consulting a COPD nurse in primary health care. Patients with COPD experience symptoms affecting their everyday lives, and there is a need for interventions in self-management support. The delivery of chronic care in an organised, structured and planned manner can lead to more productive relationships between professionals and patients. A multicentre randomised controlled trial with a post-test design, according to the CONSORT checklist, in one intervention group (n=94) and one control group (n=108). In addition to usual care, the intervention group (n=94) completed the PRISMS form to indicate areas where they wanted self-management support before the consultation with the COPD nurse. This form comprises 17 items that patients with COPD commonly experience as problems. The control group received usual care (n=108). The primary outcome was patients' satisfaction with quality of care, assessed using the Quality from the Patient's Perspective (QPP) questionnaire. Means and (SD) are presented where applicable. Differences between the intervention and control group were analysed with Student's t test for independent groups for interval data, and the Mann-Whitney U test for ordinal data. Participants in the intervention group were more satisfied with the QPP domains "personal attention," regarding both "perceived reality" (p=.021) and "subjective importance" (p=.012). The PRISMS form revealed "shortness of breath" as the most commonly experienced problem and the issue most desired to discuss. The PRISMS form improved patient satisfaction with quality of care regarding personal attention, which is an important factor in patient participation and improving relationships and communication. The PRISMS form can be a useful tool in improving person-centred care when delivering self-management support. 192691 at http://www.researchweb.org/is/en/sverige/project/192691.

Adjuvant chemotherapy in curatively resected rectal cancer: How valid are the data?

BACKGROUNDAccording to the result of the Cochrane review published in 2012, postoperative adjuvant chemotherapy (CTx) is associated with a survival benefit for rectal cancer patients operated for cure in comparison to patients who underwent only the surgical resection.AIMTo analyze the quality of the data supporting the advantage of adjuvant CTx after surgery for rectal cancer. In the times of increasing health care costs, it is imperative to offer the patient an evidence-based therapy that justifies potential side effects as well as costs.METHODSOverall survival was selected as endpoint of interest. Among the 21 included papers which analyzed this endpoint, we identified those three publications which have the highest weights to influence the final result. The validity of these papers was analyzed using the CONSORT checklist for randomized controlled trials. We performed a second meta-analysis excluding the three analyzed studies (n = 18) in order to assess their impact on the overall result of the original meta-analysis. Finally, we performed a third meta-analysis excluding all studies (n = 16) which showed a statistically improved overall survival.RESULTSThe detailed analysis of the three most relevant RCTs according to the items of the CONSORT checklist showed several pitfalls. In up to 47% of the items, inappropriate answers were found. Generally, a lack of information regarding the randomization procedure as well as the absence of allocation concealment, blinded set-up, of intention-to-treat analysis and omission of sample size calculation were common problems of the analyzed studies. The exclusion of these three studies from the meta-analysis did not affect the general result of the meta-analysis, still confirming a survival advantage after adjuvant chemotherapy. After exclusion of single studies with a statistically significant outcome improvement, the meta-analysis of the remaining 16 studies again shows a statistically significant result due in part to a large remaining sample size.CONCLUSIONThe three most powerful publications show substantial deficits. We suggest a more critical appraisal regarding the validity of single studies because a meta-analysis cannot overcome the limitations of individual trials by pooling treatment effect estimates to generate a single best estimate.

Effects of hospital-family holistic care model on the health outcome of patients with permanent enterostomy based on the theory of 'Timing It Right'.

To explore the effects of hospital-family holistic care model based on 'Timing It Right' on the health outcome of patients with permanent colostomy. Colorectal cancer is a common malignant tumour of digestive system, which seriously threatens human life and health. Colostomy is one of the main treatments for colorectal cancer, which effectively improves the 5-year survival rate of patients. However, the postoperative psychological and physiological rehabilitation nursing is still faced with great challenges due to the change of body image and defecation pathway caused by colostomy. A randomised controlled trial was conducted, and 119 patients with permanent enterostomy were randomly divided into two groups, with 60 cases in the intervention group and 59 cases in the control group. The intervention group received routine care follow-up and hospital-family holistic care intervention based on 'Timing It Right', while the control group received routine care and follow-up. The resilience, self-care ability, complications and life quality of patients with permanent enterostomy were compared between two groups before intervention, at discharge, 3months and 6months after discharge. CONSORT checklist was applied as the reporting guideline for this study (see Appendix S1). A total of 108 patients with permanent enterostomy completed the study (90.76%). At 3months and 6months after discharge, the resilience and quality of life in the intervention group were significantly better than those in the control group (t=4.158 vs. 7.406, t=4.933 vs. 8.611, p<.05), while the complications in the intervention group were significantly lower than that in the control group (25.5% vs. 41.51%, 14.45% vs. 30.19%; p<.05). The self-care ability of the intervention group was significantly better than that in the control group (t=1.543 vs. 3.656 vs. 6.273, p<.05) at discharge, 3months and 6months after discharge. The interaction between time and grouping showed that the effect of time factor varied with the grouping. After intervention, there were significant differences in psychological resilience, self-care ability, complications and quality of life between the two groups at different observation points (p<.01). The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35±4.25 vs. 60.45±8.42, p<.01). The hospital-family holistic care model based on 'Timing It Right' can effectively improve the psychological resilience, self-care ability and quality of life; reduce complications; and improve the health outcomes of patients with permanent enterostomy. Patients with permanent enterostomy have different needs for nursing care at different stages of the disease, and they are dynamically changing. The hospital-family holistic care model based on 'Timing It Right' can effectively improve the health outcomes of patients with permanent enterostomy, which is worthy of clinical application.

Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12years old: A randomised controlled study.

Virtual reality (VR) can be used during painful procedures in children. The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety of children aged 5-12years old during blood draw. This randomised controlled study used parallel trial design guided by the CONSORT checklist, see Supporting Information. The sample of children (n=136) was allocated to the VR-Rollercoaster (n=45), VR-Ocean Rift (n=45) and control group (n=46) using blocked randomisation. The primary outcome was pain scores after the blood draw and fear and anxiety scores before and after the blood draw. Before the blood draw, fear and anxiety scores were assessed using self-report and reports from the parents and the researcher using the Child Fear Scale and Children's Anxiety Meter. After the blood draw, level of pain experienced was assessed using the Wong-Baker Faces Pain Rating Scale and the fear and anxiety levels experienced by the children during the blood draw were re-evaluated. Pain scores were found to be lower in the VR-Rollercoaster group and the VR-Ocean Rift group. A statistical difference was found between groups according to self-, parent- and researcher-reported fear and anxiety scores after blood draw. While being in VR-Rollercoaster and VR-Ocean Rift group reduced children's fear and anxiety, being in the control group increased fear levels by 20% and anxiety levels by 34.1%. VR is an effective method in reducing procedure-related pain, fear and anxiety in children aged 5-12years old during blood draw. Evidence-based guidelines and protocols should be created for nonpharmacological methods such as VR for procedural pain and anxiety in children.

Resection or radiofrequency ablation for hepatocellular carcinoma? Assessment of validity of current studies, meta-analyses and their influence on guidelines

BackgroundTwo Cochrane reviews compared overall survival following liver resection (LR) or radiofrequency ablation (RFA) for patients with hepatocellular carcinoma. The first from 2013, found moderate evidence for a survival advantage for LR over RFA when limiting the analysis to trials at low risk of bias. The second (2017), found no evidence for a difference in all-cause mortality for LR versus RFA. Aim was to assess the validity of the randomized controlled trials included in both Cochrane reviews and to investigate their impact on current guidelines. MethodsThe validity of the studies was analyzed using the CONSORT checklist. Two meta-analyses were then performed with all eligible studies from both meta-analyses. Finally, the impact of the result of the original meta-analyses on eight international guidelines was assessed. ResultsThe four randomized controlled trials showed several inconsistencies (unclear or inadequate randomization, absence of sample-size calculation, missing blinded setup and/or conflicts of interest). All guidelines used recommendations based on the results of the meta-analyses or on studies included in the meta-analyses. ConclusionThe analyzed studies showed a substantial lack of overall validity. However the results of these studies and subsequent meta-analyses are used as the evidence base for the majority of current guidelines.

Validity of studies suggesting preoperative chemotherapy for resectable thoracic esophageal cancer: A critical appraisal of randomized trials.

BACKGROUNDIn 2015, Kidane published a Cochrane review and meta-analysis to summarise the impact of preoperative chemotherapy versus surgery alone on survival for resectable thoracic esophageal cancer. The authors concluded that preoperative chemotherapy improved overall survival (OS).AIMThe aim of this article was to assess the validity of the three most powerful studies included in the Cochrane review and the meta-analysis supporting the advantage of preoperative chemotherapy and to investigate the impact of an exclusion of these three studies on the result of the meta-analysis.METHODSOS was selected as the endpoint of interest. Among the ten included papers which analysed this endpoint, we identified the three publications with the highest weights influencing the final result. The validity of these papers was analysed using the CONSORT checklist for randomized controlled trials. We performed a new meta-analysis without the three studies to assess their impact on the general result of the original meta-analysis.RESULTSThe three analysed studies revealed several inconsistencies. Inappropriate answers were found in up to one third of the items of the CONSORT checklist. Missing information about sample-size calculation and power, unclear or inadequate randomisation, and missing blinded set-up were the most common findings. When the three criticized studies were excluded in the meta-analysis, preoperative chemotherapy showed no benefit in OS.CONCLUSIONThe three most powerful publications in the Cochrane review show substantial deficits. After the exclusion of these studies from the meta-analysis, preoperative chemotherapy does not seem to result in an advantage in survival. We suggest a more critical appraisal regarding the validity of single studies.

Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials.

BackgroundStandardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision‐making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent.MethodsRCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted.ResultsOf 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper.ConclusionDespite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.

The use of mentholated popsicle to reduce thirst during preoperative fasting: A randomised controlled trial.

To compare mentholated popsicle with usual care (absolute fasting) in the change of thirst intensity and discomfort of patients in the preoperative fasting. Thirst is defined as the desire to drink water, and it is considered to be a multifactorial symptom. In the preoperative fasting, the patient may experience intense thirst, often for a long time, that can lead to feelings of suffocation, desperation, fear and anxiety. A randomised controlled trial. Forty patients, aged between 18-60years, were randomised to mentholated popsicle group or absolute fasting group (twenty in each). The primary outcomes were thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale), both measured twice (baseline and after 20min of intervention). The CONSORT checklist was used to report this study. Mean age was similar in both groups (38years in the mentholated popsicle group and 39 in the absolute fasting group). At baseline, the mentholated popsicle group had higher median for the scales of intensity (6.5) and discomfort (7.5) from thirst than the absolute fasting group (5.0 and 5.0, respectively). At the end of 20min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively). The use of mentholated popsicle decreased the intensity and discomfort from thirst, and it is a viable strategy for the management of thirst in the preoperative fasting. In the preoperative fasting, making mentholated popsicles available to patients is an easy strategy to manage thirst, which might lead to better care.