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Objectives To compare efficacy of aloe vera and probiotic mouthwashes vs fluoride mouthwash on Streptococcus mutans (S. mutans) in the plaque of orthodontic patients and to assess patient-reported outcomes and compliance. Materials and Methods This prospective randomized clinical trial included 90 patients aged 12–35 years and in permanent dentition, who were randomly allocated in a 1:1:1 ratio to three mouthwash groups: aloe vera, probiotic, or fluoride. Smartphone-based applications were used to improve patient compliance. The primary outcome was the change in S. mutans levels in plaque between two times: pre-intervention and after 30 days using real-time polymerase chain reaction (Q-PCR). Secondary outcomes were the evaluation of patient-reported outcomes and compliance. Results Mean differences between aloe vera vs probiotic: −0.53 (95% CI: −3.57 to 2.51), aloe vera vs fluoride: −1.99 (95% CI, −4.8 to 0.82), and probiotic vs fluoride: −1.46 (95% CI: −4.74 to 1.82) were not significant, P = .467. Intragroup comparison demonstrated a significant mean difference in all three groups of −0.67 (95% CI: −0.79 to −0.55), −1.27 (95% CI: −1.57 to −0.97), and −2.23 (95% CI: −2.44 to −2.00) respectively, P < .001. Adherence was above 95% in all groups. No significant differences in frequency of responses to patient-reported outcomes were found among groups. Conclusions No significant difference in efficacy among the three mouthwashes in reducing S. mutans level in plaque was found. Patient-reported assessments concerning burning sensation, taste, and tooth staining found no significant differences among mouthwashes. Smartphone-based applications can help improve patient compliance.

Background Studies have pointed to a complicated and mutual relationship between attention deficit hyperactivity disorder (ADHD) and attachment. In an observational follow-up study conducted in 2015 60 children from 7 years to 12 years recently diagnosed with ADHD were included and assessed according to attachment representation showing 85% of the children to be insecurely attached. Aim The aim of this study was to investigate the stability of this remarkably high frequency of insecure attachment in the same cohort of children. Methods Children previously assessed using the child attachment interview (CAI) when diagnosed with ADHD were contacted three years later for a follow-up CAI assessment. Results At follow-up, 31 children participated in the CAI-interviews. Since their diagnosis with ADHD, the children had received treatment as usual. The CAI-interviews showed a continued high rate of insecure attachment with 90% of the children classifying as insecurely attached compared to expected 38% in the normal population. Of these, the majority of children (77%) were classified as dismissing. Conclusion Our findings suggest that targeting ADHD-symptoms with our current treatment strategies does not in itself improve attachment security. Attachment security may in turn be a factor of importance when evaluating general functioning and prognosis.

To summarise latent tuberculosis infection (LTBI) management strategies among household contacts of bacteriologically confirmed pulmonary tuberculosis (TB) patients in high-TB burden countries.PubMed/MEDLINE (NCBI) and Scopus were searched (January 2006 to December 2021) for studies reporting primary data on LTBI management. Study selection, data management and data synthesis were protocol-driven (PROSPERO-CRD42021208715). Primary outcomes were the proportions of LTBI, initiating and completing tuberculosis preventive treatment (TPT). Reported factors influencing the LTBI care cascade were qualitatively synthesised.From 3694 unique records retrieved, 58 studies from 23 countries were included. Most identified contacts were screened (median 99%, interquartile range [IQR] 82%-100%; 46 studies). Random-effects meta-analysis yielded pooled proportions for: LTBI 41% (95% confidence interval [CI] 33%-49%; 21,566 tested contacts); TPT initiation 91% (95% CI 79%-97%; 129,573 eligible contacts, 34 studies); TPT completion 65% (95% CI 54%-74%; 108,679 TPT-initiated contacts, 28 studies). Heterogeneity was significant (IThe proportions of household contacts screened, detected with LTBI and initiated on TPT, though variable was high, but the proportions completing TPT were lower indicating current strategies used for LTBI management in high TB burden countries are not sufficient.

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the efficacy and harms or adverse events of immunomodulatory therapies in people with ALS compared with a placebo, no additional treatment, or a standard-of-care protocol (with or without riluzole, edaravone, or both).

To assess the systematic reviews and meta-analyses investigating the dental caries experience in children with cleft lip and/or palate (CL/P).A systematic search was carried out from MEDLINE Via PubMed, JBI Database of Systematic Reviews and Implementation Reports, EMBASE, OVID, Cochrane Database of Systematic Review, and Epistemonikos databases. Two independent reviewers carried out the collection and analysis of the study data. Methodological quality was assessed by ROBIS (Risk of bias assessment in systematic review) tool.An initial search of electronic databases yielded a total of 25 relevant reviews, of which only three systematic reviews were taken into consideration for qualitative synthesis. The total number of unique primary studies among the three included systematic reviews were 25, of which overlap of the studies was calculated using citation matrix. The corrected covered area (CCA) was estimated to be 0.26. Based on the ROBIS tool, only one systematic review reported with low risk of bias.Individuals with CL/P report more decayed, missing, or filled teeth/surfaces than those without CL/P in primary, mixed, and permanent dentition. Future studies should focus on the factors which could modify the caries risk of an individual with CL/P.This umbrella review offers a more reliable and balanced view regarding the dental caries experience among individuals with cleft lip and/or palate. This paper also highlights the important role of pediatric dentist in multidisciplinary health care team in implementing first dental visit and anticipatory guidance to consider early diagnosis and specific preventive interventions for Early Childhood Caries (ECC) in individuals with CL/P.Abirami S, Panchanadikar NT, Muthu MS

OBJECTIVE To assess the effect of different frequencies of ventilator circuit changes in neonates and children through a systematic review and meta-analysis. INTERVENTIONS (1) "No routine change of ventilator circuit (unless visibly soiled)" versus "routine change at any fixed interval"; (2) routine change of circuit at "less frequent" versus "more frequent" intervals. OUTCOMES Primary outcomes were VAP rate (number of VAP episodes per 1000 ventilator-days) and all-cause mortality before discharge. METHODS MEDLINE, CENTRAL, EMBASE, and CINAHL were systematically searched from inception till November 3, 2020. Two authors assessed trial eligibility and risk of bias, and independently extracted data. Data were synthesized using fixed effects model. GRADE was used to assess certainty of evidence (CoE). RESULTS We identified six studies enrolling 768 participants evaluating circuit changes at two fixed intervals. Meta-analysis of studies on circuit changes "once in less than 7 days" versus "once weekly" showed no difference in VAP rate (risk ratio: 0.83 [0.38-1.81]; one randomized controlled trial (RCT) and 0.94 [0.49-1.81]; two before-after studies) or mortality before discharge (0.67 [0.34-1.3]; one RCT and 1.01 [0.63-1.64]; two before-after studies). CoE was very low. Less frequent circuit changes reduced health-care costs. No study evaluating "circuit changes only when visibly soiled" versus "circuit changes at a fixed interval" was identified. CONCLUSION There is no evidence to suggest that ventilator circuits can be safely left unchanged until visibly soiled in neonates and children. Extending circuit changes interval to "once weekly" may not increase VAP rate (CoE-very low) and reduces healthcare costs.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To determine the efficacy and safety of favipiravir in patients with COVID‐19 as compared to standard of care without favipiravir.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: This review aims to look at the benefits and harms of antibiotics used in the treatment of acute pyelonephritis in adults. The aspects of treatment that will be evaluated are: 1. Different routes of administration; 2. Different durations of the same antibiotic; and 3. Comparison of different antibiotic agents in the same population.

Background: Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobiological disorders in childhood. Maternal resilience has been linked to treatment outcome in child ADHD. However, not much is known about factors that may facilitate maternal resilience. Aim: The aim of this study was to explore factors potentially facilitating resilience in mothers to children with ADHD. Method: The current study was part of a naturalistic observational study. 64 mothers to children diagnosed with ADHD completed a set of questionnaires and a short protocol including demographic and psychosocial items. Correlation matrix were estimated for each of the scores to establish the relationship between them. Results: We found significant negative correlations between maternal self-reported attachment style and self-reported resilience and between self-reported ADHD-symptoms and resilience-score. Conclusion: The findings indicate that selected factors in maternal functioning may contribute to development of resilience, which may in turn be a factor of importance in parenting.

The literature on the efficacy of erbium lasers for nonsurgical periodontal therapy is inconsistent. The objective of the umbrella review was to collate the information available in the systematic reviews to provide a comprehensive synthesis of clinical and patient reported outcomes following the use of erbium lasers for non-surgical periodontal therapy. An electronic database search was carried out, and systematic reviews/meta-analyses which assessed the efficacy of erbium lasers as monotherapy or as an adjunct to scaling and root planing were included. The methodological quality and reporting quality of the included studies were assessed. 15 Systematic reviews/meta-analyses were obtained after title, abstract, and full text search. The meta-analyses data revealed a clinical attachment level gain, reduction in probing pocket depth at 1 and 3-month follow-up, and no additional benefit at ≥ 6-month follow-up in the erbium laser group. The evidence gap map revealed lack of clinical outcome data at6-month follow-up and dearth in studies assessing patient reported outcome measures and adverse events. Erbium lasers may provide short-term clinical benefits, and further studies with standardized laser parameters evaluating long-term follow-up, patient-reported outcome measures, and adverse events are needed.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the efficacy and safety of plastic stents and metal stents in individuals undergoing endoscopic ultrasound‐guided transmural drainage of pancreatic fluid collections.

Technology-assisted parent-mediated interventions improve accessibility and are acceptable but not proven to be effective. We conducted a systematic search of 6 databases. We included and analysed results from studies on social and communication outcomes. Sixteen Randomised-Controlled-Trials (RCTs) with 748 participants were included. Most studies were rated as of good quality. Meta-analysis suggested that interventions were probably effective in improving emotion recognition. No significant differences were found in social communication, social functioning or language outcomes. At present, isolated tech interventions do not fulfil criteria for promising or established evidence-based interventions for ASD. Future research needs to focus on improving the effectiveness of technology-assisted parent-mediated interventions for ASD. Prospero Registration Number: CRD42020162825.

IntroductionThe heterogeneity in people with borderline personality disorder (BPD) and the range of specialised psychotherapies means that people with certain BPD characteristics might benefit more or less from different types of psychotherapy. Identifying moderating characteristics of individuals is a key to refine and tailor standard treatments so they match the specificities of the individual participant. The objective of this is to improve the quality of care and the individual outcomes. We will do so by performing three systematic reviews with meta-analyses of individual participant data (IPD). The aim of these reviews is to investigate potential predictors and moderating patient characteristics on treatment outcomes for patients with BPD.Methods and analysisWe performed comprehensive searches in 22 databases and trial registries up to October 6th 2020. These will be updated with a top-up search up until June 2021. Our primary meta-analytic method will be the one-stage random-effects approach. To identify predictors, we will use the one-stage model that accounts for interaction between covariates and treatment allocation. Heterogeneity in case-mix will be assessed with a membership model based on a multinomial logistic regression where study membership is the outcome. A random-effects meta-analysis is chosen to account for expected levels of heterogeneity.Ethics and disseminationThe statistical analyses will be conducted on anonymised data that have already been approved by the respective ethical committees that originally assessed the included trials. The three IPD reviews will be published in high-impact factor journals and their results will be presented at international conferences and national seminars.PROSPERO registration numberCRD42021210688.

To estimate the incremental yield of single nucleotide polymorphism (SNP) array over karyotype and to assess the diagnostic accuracy of SNP array as a stand-alone test versus SNP array with karyotype in detecting chromosomal abnormalities for prenatal diagnosis in women with an abnormal fetal ultrasound.Studies in which SNP array and karyotype had been used for diagnosing chromosomal aberrations in fetuses with abnormal ultrasound findings were included. A systematic search of relevant studies published in the English language in EMBASE, PubMed, CENTRAL, CDSR (Cochrane database of systematic reviews), SCOPUS and Web of science between 1996 and May 2020 was performed. Primary outcome was incremental yield of SNP array over karyotype (number of patients with abnormalities detected by SNP array over number of patients with normal karyotype). Other outcomes included diagnostic accuracy of SNP array alone versus SNP array and karyotype for prenatal diagnosis. Pooled sensitivities, specificities, and their 95% confidence intervals (CI) were presented.Seven studies were included. The incremental yield of SNP array over karyotype was 8% (95% Confidence interval, CI 4-12%) while incremental yield of karyotype over SNP array in foetus with abnormal ultrasound was 0% (95% CI 0-1%). The agreement between SNP array and karyotype was 92%. The variant of unknown significance rates ranged between 4 and 8 %. The pooled sensitivity and specificity of SNP array versus SNP array and karyotype was 0.97 (95% CI 0.92-0.99) and 1.00 (95% CI1.00-1.00), respectively.SNP array provides additional information on chromosomal abnormalities over and above conventional karyotype. When used as a stand-alone test, SNP array performs favourably as a diagnostic modality when compared against SNP array and karyotype for prenatal diagnosis with an abnormal fetal ultrasound.

Bronchoscopic lung volume reduction (BLVR) methods have emerged as a new treatment option for patients with severe emphysema. Endobronchial valves and coils have been extensively studied. This review assesses efficacy, safety, and cost effectiveness of the BLVR procedures (stent, valves, vapor ablation, endobronchial coils, lung sealant) in patients with severe emphysema. Databases were searched until October 2016, and randomized controlled trials (RCTs) comparing available BLVR procedures to standard medical care or sham bronchoscopy were included. Random effect model and generic inverse variance approach were used for meta-analysis. Out of 381 identified records, 16 RCTs were included. As compared to recommended medical care or sham bronchoscopy, the BLVR procedures are more effective in improving quality of life [SGRQ score (WMD=−6.38; −9.12 to −3.65)] and 6MWT (WMD=24.21; 9.68–38.74) and percentage FEV1 (WMD=10.48; 7.07–13.89). Increased risk of serious adverse events (RR=2.18; 1.63–2.93), specifically for chronic pulmonary obstructive disease exacerbations and lower respiratory tract infection combined (RR=1.37; 1.07–1.75), were observed with bronchoscopic interventions, while there was no difference in number of deaths (RR=1.25; 0.79–1.99) and respiratory failure (RR=1.13; 0.57–2.21). The BLVR procedures, especially endobronchial coils, were found to be effective in the management of patients with severe emphysema irrespective of collateral ventilation. However, characterization of patients who would be most benefited from these procedures is required, and effectiveness of these procedures in long run needs to be established.

Atomoxetine is prescribed to children with autism spectrum disorder having symptoms of attention deficit hyperactivity disorder. We sought to examine the efficacy and safety of atomoxetine in this population. After screening for inclusion criteria, we identified three randomized placebo controlled trials involving 241 children. We assessed internal validity using standard Cochrane Risk of bias tool for randomized controlled trials (RCTs). We used Revman 5.3 for meta‐analysis and GRADE approach to create summary of findings with grading of the quality of evidence. Atomoxetine had a benefit on improving parent‐rated hyperactivity (standardized mean difference [SMD] = −0.73, 95% Confidence Interval, CI = −1.15 to −0.34) and parent‐rated inattention (SMD = −0.53, 95% CI = −0.93 to −0.12) but the magnitude of effects is uncertain. However, atomoxetine was also associated with increased risk of non‐serious adverse effects like nausea and vomiting, decreased sleep, and decreased appetite. Atomoxetine may be effective in improving hyperactivity and inattention in children with autism spectrum disorder and attention deficit hyperactivity disorder. However, we are uncertain about the true effect of this intervention and need more RCTs trials designed to evaluate this. Autism Research 2019, 12: 542–552. © 2019 International Society for Autism Research, Wiley Periodicals, Inc.\ud \ud \ud \ud Lay Summary\ud \ud Atomoxetine is prescribed for Attention Deficit Hyperactivity Disorder (ADHD). About a third of children and adolescents with autism also suffer from ADHD. We carried out an analysis of data reported from a specific kind of medication trials which had examined the effectiveness and side effects of atomoxetine in this patient population. We could find only three such trials and analyzed the reported data. Our analysis revealed that atomoxetine is effective in improving symptoms of ADHD like hyperactivity and inattention and also causes side effects like nausea, vomiting, decreased sleep, and decreased appetite. However, the existing data are insufficient to provide a conclusive statement with certainty and more trials are needed for this.

Background Health behaviour can change outcomes in both healthy and diseased populations and are particularly useful in promoting compliance to treatment and maintain fidelity to care seeking and follow-up options in chronic diseases. Interventions to change health behaviour based on psychological theory more often successful than those without any underlying theory. The theory of planned behaviour (TPB) is one such psychological theory which had been found to predict human behaviour with respect to disease prevention and when applied to interventions can change the outcomes of diseases. Most of the research evidence of TPB based interventions have been from developed world. Evidence is required whether TPB based interventions can be applied and works in low resource, low health literacy settings of low and middle income countries (LMICs).Methods The protocol has been developed as per PRISMA-P guidelines and incorporates PICO (population, intervention, comparison, outcomes) framework for describing the methodology. Population above 18 years of age and having any chronic disease will be selected while any health or educational intervention based on constructs of TPB will be included. Comparison will be with non TPB based interventions or treatment as usual without any intervention and the primary outcome will be the behaviour change effected by the TPB based intervention. Intervention studies will be considered and relevant databases like MEDLINE, EMBASE, Cochrane Library and ProQuest will be explored. Data extraction will done in a standardised form and quality assessment will be done using the Cochrane Collaboration’s Tool for Assessing the Risk of Bias. Narrative synthesis of the selected studies will be done to draw the conclusions and meta-analysis will be done if the heterogeneity is less than 50% by I-2 statistics.Discussion This systematic review will provide new evidence on fidelity and effectiveness of the TPB based interventions among chronic disease patients in low health literacy population of LMIC settings. This will provide us with new knowledge of how to plan and use such interventions to change health behaviour in chronic disease patients.Systematic review registration this protocol has been registered in PROSPERO with registration no. CRD42018104890.

Background Health behaviour can change outcomes in both healthy and unhealthy populations and are particularly useful in promoting compliance to treatment and maintaining fidelity to care seeking and follow-up options in chronic diseases. Interventions to change health behaviour based on psychological theory are more often successful than those without any underlying theory. The theory of planned behaviour (TPB) is one such psychological theory which had been found to predict human behaviour with respect to disease prevention and when applied to interventions can change the outcomes of diseases. Most of the research evidence of TPB-based interventions have been from developed world. Evidence is required whether TPB-based interventions can be applied and works in low-resource, low health-literacy settings of low- and middle-income countries (LMICs). Methods The protocol has been developed as per PRISMA-P guidelines and incorporates PICO (population, intervention, comparison, outcomes) framework for describing the methodology. Population above 18 years of age and having any chronic disease (as defined for this systematic review) will be selected, while any health or educational intervention based on constructs of TPB will be included. Comparison will be with non-TPB-based interventions or treatment as usual without any intervention, and the primary outcome will be the behaviour change effected by the TPB-based intervention. Intervention studies will be considered, and relevant databases like MEDLINE, Embase, Cochrane Library and ProQuest will be explored. Data extraction will done in a standardised form, and risk-of-bias assessment will be done using the Cochrane Collaboration’s tools for such assessment. Narrative synthesis of the selected studies will be done to draw the conclusions, and meta-analysis will be done to calculate the effect estimates with I-squared statistics to describe the heterogeneity. Discussion This systematic review will provide new evidence on fidelity and effectiveness of the TPB-based interventions among chronic disease patients from low health literacy, resource-poor background. It will inform of how to plan and use such interventions to change health behaviour in chronic disease patients, particularly in LMIC settings. Systematic review registration PROSPERO CRD42018104890.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: PRIMARY OBJECTIVE: To assess the efficacy and safety of antibiotics in adults with irritable bowel syndrome compared to placebo or standard medical therapy alone. SECONDARY OBJECTIVE: To determine the duration of response or time of recurrence following antibiotics in adults with irritable bowel syndrome.

IntroductionThe heterogeneity in people with BPD and the range of specialised psychotherapies means that people with certain BPD characteristics might benefit more or less from different types of psychotherapy. Identifying moderating characteristics of individuals is a key to refine and tailor standard treatments so they match the specificities of the individual patient. The objective of this is to improve the quality of care and the individual outcomes. Thus, the aim of the current reviews is to investigate potential predictors and moderating patient characteristics on treatment outcomes for patients with BPD.Methods and analysisOur primary meta-analytic method will be the one-stage random-effects approach. To identify predictors, we will be using the one-stage model that accounts for interaction between covariates and treatment allocation. Heterogeneity in case-mix will be assessed using a membership model based on a multinomial logistic regression where study membership is the outcome. A random-effects meta-analysis is chosen to account for expected levels of heterogeneity.Ethics and disseminationThe statistical analyses will be conducted on anonymised data that have already been approved by the respective ethical committees that originally assessed the included trials. The three IPD reviews will be published in high impact factor journals and their results will be presented at international conferences and national seminars.Protocol registrationThe IPD reviews, described in this study protocol, are registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number: awaiting)Strengths and limitations of this protocolThese IPD-reviews are the first to systematically review and investigate psychotherapy for people with borderline personality disorder using individual participant data.The IPD-reviews will provide information on moderators and predictors in patients with borderline personality disorder that predict who may benefit most from which type of specialised psychotherapy.Individual participant data allows for a more precise risk of bias assessment and decreases the amount of unclear risk of bias in many of the included trials.A limitation to IPD-reviews in general is that data retrieval can be challenging.The IPD-reviews are limited to the outcomes and patient characteristics that have been assessed in the included trials.

Objectives: We sought to assess health literacy (HL) and its associated factors in the Bahraini community using a validated HL scale and address its deficient domains to inform policy. Methods: We carried out a conveniently sampled, cross-sectional survey using the All Aspects of Health Literacy Scale in the Bahraini community. The scale has three key aspects: basic or functional HL (FUN-4 items), which corresponds to basic reading and writing skills, and knowledge of health conditions and health systems; communicative or interactive HL (COM-3 items) on communicative and social skills to extract information from different forms of communication; and critical HL (CR-4 items), the advanced cognitive and social skills to critically analyze information and exert greater control over life events and situations relating to individual and community level wellbeing goals. We examined the association between sociodemographic and health information for the survey tool items using the chi-square test. The relationship between total scale score and subscale scores of the three domains of the survey tool to sociodemographic and health information was investigated using the t-test and ANOVA. Results: Of the 836 participants (mean age = 26.6 years), single (64.0%) and university students (76.6%) were predominant; 15.6% reported long-term sickness and visited the general physician often. The highest mean item scores were for empowerment (1.8) and lowest for functional HL (0.1). The significant domain-specific responses to the survey tool items were 12 for critical HL, 10 for functional HL, six for communicative HL, and five for empowerment. Participants aged < 30 years old, female, married, pursuing/completed Master’s program, employed, and whose self-rating of health was excellent had higher total HL scores. Conclusions: Older, less educated respondents with a poor self-rating of health had low HL scores. We recommend further studies to address the relative importance of functional, interactive, and critical HL in the community to promote health outcomes.

Background Virtual reality (VR) computer technology creates a simulated environment, perceived as comparable to the real world, with which users can actively interact. The effectiveness of VR distraction on acute pain intensity in children is uncertain. Objectives To assess the effectiveness and adverse effects of virtual reality (VR) distraction interventions for children (0 to 18 years) with acute pain in any healthcare setting. Search methods We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and four trial registries to October 2019. We also searched reference lists of eligible studies, handsearched relevant journals and contacted study authors. Selection criteria Randomised controlled trials (RCTs), including cross-over and cluster-RCTs, comparing VR distraction to no distraction, non-VR distraction or other VR distraction. Data collection and analysis We used standard Cochrane methodological processes. Two reviewers assessed risk of bias and extracted data independently. The primary outcome was acute pain intensity (during procedure, and up to one hour post-procedure). Secondary outcomes were adverse effects, child satisfaction with VR, pain-related distress, parent anxiety, rescue analgesia and cost. We used GRADE and created 'Summary of findings' tables. Main results We included 17 RCTs (1008 participants aged four to 18 years) undergoing various procedures in healthcare settings. We did not pool data because the heterogeneity in population (i.e. diverse ages and developmental stages of children and their different perceptions and reactions to pain) and variations in procedural conditions (e.g. phlebotomy, burn wound dressings, physical therapy sessions), and consequent level of pain experienced, made statistical pooling of data impossible. We narratively describe results. We judged most studies to be at unclear risk of selection bias, high risk of performance and detection bias, and high risk of bias for small sample sizes. Across all comparisons and outcomes, we downgraded the certainty of evidence to low or very low due to serious study limitations and serious or very serious indirectness. We also downgraded some of the evidence for very serious imprecision. 1: VR distraction versus no distraction Acute pain intensity: during procedure Self-report: one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence). Observer-report: no data. Behavioural measurements (observer-report): two studies, 62 participants; low-certainty evidence. One study (n = 42) found no beneficial effect of non-immersive VR. One study (n = 20) found a beneficial effect favouring immersive VR. Acute pain intensity: post-procedure Self-report: 10 studies, 461 participants; very low-certainty evidence. Four studies (n = 95) found no beneficial effect of immersive and semi-immersive or non-immersive VR. Five studies (n = 357) found a beneficial effect favouring immersive VR. Another study (n = 9) reported less pain in the VR group. Observer-report: two studies (216 participants; low-certainty evidence) found a beneficial effect of immersive VR, as reported by primary caregiver/parents or nurses. One study (n = 80) found a beneficial effect of immersive VR, as reported by researchers. Behavioural measurements (observer-report): one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence). Adverse effects: five studies, 154 participants; very low-certainty evidence. Three studies (n = 53) reported no adverse effects. Two studies (n = 101) reported mild adverse effects (e.g. nausea) in the VR group. 2: VR distraction versus other non-VR distraction Acute pain intensity: during procedure Self-report, observer-report and behavioural measurements (observer-report): two studies, 106 participants: Self-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (very low-certainty evidence). Observer-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (low-certainty evidence). Behavioural measurements (observer-report): one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) reported a difference in mean pain change scores with fewer pain behaviours in VR group (low-certainty evidence). Acute pain intensity: post-procedure Self-report: eight studies, 575 participants; very low-certainty evidence. Two studies (n = 146) found a beneficial effect favouring immersive VR. Two studies (n = 252) reported a between-group difference favouring immersive VR. One study (n = 59) found no beneficial effect of immersive VR versus television and Child Life non-VR distraction. One study (n = 18) found no beneficial effect of semi-immersive VR. Two studies (n = 100) reported no between-group difference. Observer-report: three studies, 187 participants; low-certainty evidence. One study (n = 81) found a beneficial effect favouring immersive VR for parent, nurse and researcher reports. One study (n = 65) found a beneficial effect favouring immersive VR for caregiver reports. Another study (n = 41) reported no evidence of a difference in mean pain change scores. Behavioural measurements (observer-report): two studies, 106 participants; low-certainty evidence. One study (n = 65) found a beneficial effect favouring immersive VR. Another study (n = 41) reported no evidence of a difference in mean pain change scores. Adverse effects: six studies, 429 participants; very low-certainty evidence. Three studies (n = 229) found no evidence of a difference between groups. Two studies (n = 141) reported no adverse effects in VR group. One study (n = 59) reported no beneficial effect in reducing estimated cyber-sickness before and after VR immersion. 3: VR distraction versus other VR distraction We did not identify any studies for this comparison. Authors' conclusions We found low-certainty and very low-certainty evidence of the effectiveness of VR distraction compared to no distraction or other non-VR distraction in reducing acute pain intensity in children in any healthcare setting. This level of uncertainty makes it difficult to interpret the benefits or lack of benefits of VR distraction for acute pain in children. Most of the review primary outcomes were assessed by only two or three small studies. We found limited data for adverse effects and other secondary outcomes. Future well-designed, large, high-quality trials may have an important impact on our confidence in the results.

Background Nutrition is an important aspect of management in severe acute pancreatitis. Enteral nutrition has advantages over parenteral nutrition and is the preferred method of feeding. Enteral feeding via nasojejunal tube is often recommended, but its benefits over nasogastric feeding are unclear. The placement of a nasogastric tube is technically simpler than the placement of a nasojejunal tube. Objectives To compare the mortality, morbidity, and nutritional status outcomes of people with severe acute pancreatitis fed via nasogastric tube versus nasojejunal tube. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS on 17 October 2019 without using any language restrictions. We also searched reference lists and conference proceedings for relevant studies and clinical trial registries for ongoing trials. We contacted authors for additional information. Selection criteria We included randomised controlled trials (RCTs) and quasi-RCTs comparing enteral feeding by nasogastric and nasojejunal tubes in participants with severe acute pancreatitis. Data collection and analysis Two review authors independently screened studies for inclusion, assessed risk of bias of the included studies, and extracted data. This information was independently verified by the other review authors. We used standard methods expected by Cochrane to assess the risk of bias and perform data synthesis. We rated the certainty of evidence according to GRADE. Main results We included five RCTs that randomised a total of 220 adult participants from India, Scotland, and the USA. Two of the trial reports were available only as abstracts. The trials differed in the criteria used to rate the severity of acute pancreatitis, and three trials excluded those who presented in severe shock. The duration of onset of symptoms before presentation in the trials ranged from within one week to four weeks. The trials also differed in the methods used to confirm the placement of the tubes and in what was considered to be nasojejunal placement. We assessed none of the trials as at high risk of bias, though reporting of methods in four trials was insufficient to judge the risk of bias for one or more of the domains assessed. There was no evdence of effect with nasogastric or nasojejunal placement on the primary outcome of mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.36 to 1.17; I2 = 0%; 5 trials, 220 participants; very low-certainty evidence due to indirectness and imprecision). Similarly, there was no evidence of effect on the secondary outcomes for which data were available. These included organ failure (3 trials, 145 participants), rate of infection (2 trials, 108 participants), success rate (3 trials, 159 participants), complications associated with the procedure (2 trials, 80 participants), need for surgical intervention (3 trials, 145 participants), requirement of parenteral nutrition (2 trials, 80 participants), complications associated with feeds (4 trials, 195 participants), and exacerbation of pain (4 trials, 195 participants). However, the certainty of the evidence for these secondary outcomes was also very low due to indirectness and imprecision. Three trials (117 participants) reported on length of hospital stay, but the data were not suitable for meta-analysis. None of the trials reported data suitable for meta-analysis for the other secondary outcomes of this review, which included days taken to achieve full nutrition requirement, duration of tube feeding, and duration of analgesic requirement after feeding tube placement. Authors' conclusions There is insufficient evidence to conclude that there is superiority, inferiority, or equivalence between the nasogastric and nasojejunal mode of enteral tube feeding in people with severe acute pancreatitis.