Publications by authors named "Lukman Thalib"

132 Publications

Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set.

Obes Sci Pract 2021 Jun 3;7(3):251-259. Epub 2021 Feb 3.

Department of Population Medicine College of Medicine QU Health Qatar University Doha Qatar.

Aims: With the rising number of outcomes being reported following gestational diabetes (GDM), the outcomes in existing studies vary widely making it challenging to compare and contrast the effectiveness of different interventions for GDM. The purpose of this study was to develop a core outcome and measurement set (COS) for GDM treatment trials.

Materials & Methods: A Delphi study with structured consultation with stakeholders and discussion within a specialist Gestational Metabolic Group (GEM) were combined with a comprehensive systematic search across different databases (PubMed, Cochrane Library, and Embase). Several Delphi rounds over 2 years were conducted culminating in this report.

Results: The process resulted in a targeted set of outcomes constituting a "GEM treatment set" aligned with expert opinion. The final COS also included a measurement set for the 11 important clinical outcomes from three major domains: maternal metabolic, fetal, and pregnancy related.

Conclusions: Based on the results of this study, it is recommended that future clinical trials on GDM report outcomes uniformly keeping to the recommended COS outcomes.
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http://dx.doi.org/10.1002/osp4.480DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170585PMC
June 2021

Repositioning for pressure injury prevention in adults: An abridged Cochrane systematic review and meta-analysis.

Int J Nurs Stud 2021 May 18;120:103976. Epub 2021 May 18.

NHMRC Centre of Research Excellence in Wiser Wound Care, Menzies Health Institute Queensland, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Brisbane and Gold Coast, Australia.

Background: A pressure injury is an area of localised damage to the skin and underlying tissues. Patient repositioning is an important prevention strategy, as those with limited mobility are at increased risk of developing pressure injury.

Objectives: To assess the clinical and cost-effectiveness of repositioning schedules on the prevention of pressure injury in adults.

Design: Systematic review and meta-analysis.

Data Sources: The Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials; MEDLINE (Ovid); Embase (Ovid) and Cumulative Index of Nursing and Allied Health Literature Plus (EBSCO) were searched in February 2019. No restrictions were applied to language or date of publication.

Review Methods: Studies were eligible if they were randomised controlled trials including cluster trials, published or unpublished, and undertaken in any healthcare setting that assessed the clinical and/or cost effectiveness of repositioning schedules for prevention of pressure injury in adults. Methodological quality of the studies was independently assessed by three authors. Heterogeneity between studies was assessed using the I statistic, and the pooled risk ratios along with their 95% confidence intervals were estimated using either fixed and random effects models, as indicated. Grading of Recommendations Assessment, Development and Evaluation was used to appraise the certainty of evidence.

Results: Eight eligible trials involving 3,941 participants published between 2004 and 2018 were identified. Trials compared either different repositioning frequencies or positioning regimens. Three trials (1074 participants) compared 2-hourly with 4-hourly repositioning (risk ratio 1.06, 95% confidence interval 0.80 to 1.41; I = 45%). Two other trials (252 participants) compared a 30-degree tilt with a 90-degree tilt (risk ratio0.62, 95% confidence interval 0.10 to 3.97; I =69%). Only two trials included economic analyses, both amongst nursing home residents. One study estimated the costs of repositioning to be Canadian dollars $11.05 and Canadian dollars $16.74 less per resident per day for the 3-hourly or 4-hourly regimens, respectively, when compared to 2-hourly regimen. The second study reported 3-hourly repositioning using a 30-degree tilt to cost €46.50 (95% confidence interval €1.25 to €74.60) less per patient in nursing time compared with 6-hourly repositioning with a 90-degree lateral rotation.

Conclusion: It remains unclear which repositioning frequencies or positions are most effective in preventing pressure injury in adults. There is limited evidence to support the cost effectiveness of repositioning frequencies and positions. Registration: Cochrane protocol published in 2012.
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http://dx.doi.org/10.1016/j.ijnurstu.2021.103976DOI Listing
May 2021

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial.

BMJ 2021 05 5;373:n893. Epub 2021 May 5.

National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care, Menzies Health Institute, Griffith University, Gold Coast, Qld, Australia.

Objective: To determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section.

Design: Multicentre, pragmatic, randomised, controlled, parallel group, superiority trial.

Setting: Four Australian tertiary hospitals between October 2015 and November 2019.

Participants: Eligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section.

Intervention: 2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure.

Main Outcome Measures: The primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis.

Results: In the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03).

Conclusion: Prophylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients.

Trial Registration: ANZCTR identifier 12615000286549.
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http://dx.doi.org/10.1136/bmj.n893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097312PMC
May 2021

Metformin is comparable to insulin for pharmacotherapy in gestational diabetes mellitus: A network meta-analysis evaluating 6046 women.

Pharmacol Res 2021 May 12;167:105546. Epub 2021 Mar 12.

Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar. Electronic address:

Context: The comparative efficacy of gestational diabetes (GDM) treatments lack conclusive evidence for choice of first-line treatment.

Objectives: The aim of this study was to compare the efficacy of metformin and glibenclamide to insulin using a core outcome set (COS) to unify outcomes across trials investigating the treatment of gestational diabetes mellitus.

Study Design: A network meta-analysis (NMA) was conducted.

Data-source: PubMed, Embase, and Cochrane Controlled Register of Trials were searched from inception to January 2020.

Study Selection: RCTs that enrolled pregnant women who were diagnosed with GDM and that compared the efficacy of different pharmacological interventions for the treatment of GDM were included.

Meta-analysis: A generalized pairwise modelling framework was employed.

Results: A total of 38 RCTs with 6046 participants were included in the network meta-analysis. Compared to insulin, the estimated effect of metformin indicated improvements for weight gain (WMD -2·39 kg; 95% CI -3·31 to -1·46), maternal hypoglycemia (OR 0.34; 95% CI 0.12 to 0·97) and LGA (OR 0.61; 95% CI 0.38 to 0·98). There were also improvements in estimated effects for neonatal hypoglycemia (OR 0.48; 95% CI 0.19 to 1·25), pregnancy induced hypertension (OR 0.63; 95% CI 0.37 to 1·06), and preeclampsia (OR 0.74; 95% CI 0.538 to 1·04), though with limited evidence against our model hypothesis of equivalence with insulin for these outcomes.

Conclusion: Metformin is, at least, comparable to insulin for the treatment of GDM. Glibenclamide appears less favorable, in comparison to insulin, than metformin.
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http://dx.doi.org/10.1016/j.phrs.2021.105546DOI Listing
May 2021

Questionable utility of the relative risk in clinical research: a call for change to practice.

J Clin Epidemiol 2020 Nov 7. Epub 2020 Nov 7.

Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.

Background And Objectives: In clinical trials, the relative risk or risk ratio (RR) is a mainstay of reporting of the effect magnitude for an intervention. The RR is the ratio of the probability of an outcome in an intervention group to its probability in a control group. Thus, the RR provides a measure of change in the likelihood of an event linked to a given intervention. This measure has been widely used because it is today considered a measure with "portability" across varying outcome prevalence, especially when the outcome is rare. It turns out, however, that there is a much more important problem with this ratio, and this paper aims to demonstrate this problem.

Methods: We used mathematical derivation to determine if the RR is a measure of effect magnitude alone (i.e., a larger absolute value always indicating a stronger effect) or not. We also used the same derivation to determine its relationship to the prevalence of an outcome. We confirm the derivation results with a follow-up analysis of 140,620 trials scraped from the Cochrane.

Results: We demonstrate that the RR varies for reasons other than the magnitude of the effect because it is a ratio of two posterior probabilities, both of which are dependent on baseline prevalence of an outcome. In addition, we demonstrate that the RR shifts toward its null value with increasing outcome prevalence. The shift toward the null happens regardless of the strength of the association between intervention and outcome. The odds ratio (OR), the other commonly used ratio, measures solely the effect magnitude and has no relationship to the prevalence of an outcome in a study nor does it overestimate the RR as is commonly thought.

Conclusions: The results demonstrate the need to (1) end the primary use of the RR in clinical trials and meta-analyses as its direct interpretation is not meaningful, (2) replace the RR by the OR, and (3) only use the postintervention risk recalculated from the OR for any expected level of baseline risk in absolute terms for purposes of interpretation such as the number needed to treat. These results will have far-reaching implications such as reducing misleading results from clinical trials and meta-analyses and ushering in a new era in the reporting of such trials or meta-analyses in practice.
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http://dx.doi.org/10.1016/j.jclinepi.2020.08.019DOI Listing
November 2020

Association of corticosteroids use and outcomes in COVID-19 patients: A systematic review and meta-analysis.

J Infect Public Health 2020 Nov 29;13(11):1652-1663. Epub 2020 Sep 29.

College of Medicine, Al Faisal University, Riyadh, Saudi Arabia; Infectious Diseases Section, Department of Medical Specialties, King Fahad Medical City, Riyadh, Saudi Arabia; Division of Infectious Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN, USA; Division of Epidemiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA. Electronic address:

Background: To systematically review the literature about the association between systemic corticosteroid therapy (CST) and outcomes of COVID-19 patients.

Methods: We searched Medline, Embase, EBM Reviews, Scopus, Web of Science, and preprints up to July 20, 2020. We included observational studies and randomized controlled trials (RCT) that assessed COVID-19 patients treated with CST. We pooled adjusted effect estimates of mortality and other outcomes using a random effect model, among studies at low or moderate risk for bias. We assessed the certainty of evidence for each outcome using the GRADE approach.

Results: Out of 1067 citations screened for eligibility, one RCT and 19 cohort studies were included (16,977 hospitalized patients). Ten studies (1 RCT and 9 cohorts) with 10,278 patients examined the effect of CST on short term mortality. The pooled adjusted RR was 0.92 (95% CI 0.69-1.22, I = 81.94%). This effect was observed across all stages of disease severity. Four cohort studies examined the effect of CST on composite outcome of death, ICU admission and mechanical ventilation need. The pooled adjusted RR was 0.41(0.23-0.73, I = 78.69%). Six cohort studies examined the effect of CST on delayed viral clearance. The pooled adjusted RR was 1.47(95% CI 1.11-1.93, I = 43.38%).

Conclusion: In this systematic review, as of July 2020, heterogeneous and low certainty cumulative evidence based on observational studies and one RCT suggests that CST was not associated with reduction in short-term mortality but possibly with a delay in viral clearance in patients hospitalized with COVID-19 of different severities. However, the discordant results between the single RCT and observational studies as well as the heterogeneity observed across observational studies, call for caution in using observational data and suggests the need for more RCTs to identify the clinical and biochemical characteristics of patients' population that could benefit from CST.
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http://dx.doi.org/10.1016/j.jiph.2020.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7522674PMC
November 2020

Physical activity in pregnancy prevents gestational diabetes: A meta-analysis.

Diabetes Res Clin Pract 2020 Oct 20;168:108371. Epub 2020 Aug 20.

Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.

Aims: The effectiveness of physical activity (PA) programs for prevention of gestational diabetes (GDM) lacks conclusive evidence. The aim of this study was to generate clear evidence regarding the effectiveness of physical activity programs in GDM prevention to guide clinical practice.

Methods: PubMed/Medline, ISI Web of Science, Scopus, and EMBASE were searched to identify the randomized trials (RCTs) published until June 2019. Randomised controlled trials enrolling women at high risk before the 20th week of gestation comparing the effect of PA interventions with usual care for prevention of GDM were retrieved. Data obtained were synthesised using a bias-adjusted model of meta-analysis.

Results: A total of 1467 adult women in 11 eligible trials were included. The risk of GDM was significantly lower with PA, but only when it was delivered in the healthcare facility (RR 0.53; 95% CI 0.38-0.74). The number needed to treat with PA in pregnancy (compared to usual care) to prevent one GDM event was 18 (95% CI 14 - 29). The overall effect of PA interventions regardless of location of the intervention was RR 0.69 (95% CI 0.51 - 0.94).

Conclusions: This study provides evidence that in-facility physical activity programs started before the 20th week of gestation can significantly decrease the incidence of GDM among women at high risk.
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http://dx.doi.org/10.1016/j.diabres.2020.108371DOI Listing
October 2020

Short-term improvements in diet quality in people newly diagnosed with type 2 diabetes are associated with smoking status, physical activity and body mass index: the 3D case series study.

Nutr Diabetes 2020 07 13;10(1):25. Epub 2020 Jul 13.

Menzies Health Institute Queensland, Griffith University, Gold Coast, 4215, Australia.

Background: Dietary intake impacts glycaemic control through its effect on weight and glucose-insulin homeostasis. Early glycaemic control is associated with improved outcomes and reduced mortality for people with type 2 diabetes (T2D). To date, the diet quality of people with T2D has only been studied cross-sectionally. The objective of this paper is to quantify short-term improvements in diet quality and to identify factors associated with improvements after T2D diagnosis among participants in the 3D study.

Methods: This paper presents data from the 3D study of 225 Australian adults, newly diagnosed with T2D. Telephone interviews collected demographic, diet, physical and health data at baseline and 3 months. Diet quality was assessed using the Dietary Approaches to Stop Hypertension (DASH) tool to examine short-term changes in diet quality after diagnosis. Participants were categorised into two groups: those who improved their diet quality by 3 months (increase in DASH score of 3 or more) and those who did not. Factors associated with change in DASH scores were clinically and statistically evaluated.

Results: The 3D cohort was comparable to Australian cohorts with diabetes by gender and body mass index (BMI) but differed by age, remoteness and socioeconomic status. Mean (SD) baseline DASH score was 24.4 (4.7), in the midrange of possible scores between 8 and 40. One third of participants improved their DASH score by 3-months. This group had lower diet quality (p < 0.001), lower BMI (p = 0.045), higher physical activity levels (p = 0.028) and were less likely to smoke (p = 0.018) at baseline.

Conclusions: Diet quality changes after diagnosis do not appear to be associated with demographic characteristics but were associated with lifestyle behaviours. Strategies targeted at better supporting smokers, those with low physical activity and higher BMI are required. Future research should investigate how the diet quality changes people make around time of diagnosis are related to long-term health outcomes.
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http://dx.doi.org/10.1038/s41387-020-0128-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359342PMC
July 2020

Global incidence of Necrotizing Enterocolitis: a systematic review and Meta-analysis.

BMC Pediatr 2020 07 13;20(1):344. Epub 2020 Jul 13.

Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.

Background: Necrotizing Enterocolitis (NEC) is a major cause of morbidity and mortality in the Neonatal Intensive Care Unit (NICU), yet the global incidence of NEC has not been systematically evaluated. We conducted a systematic review and meta-analysis of cohort studies reporting the incidence of NEC in infants with Very Low Birth Weight (VLBW).

Methods: The databases searched included PubMed, MEDLINE, the Cochrane Library, EMBASE and grey literature. Eligible studies were cohort or population-based studies of newborns including registry data reporting incidence of NEC. Incidence were pooled using Random Effect Models (REM), in the presence of substantial heterogeneity. Additional, bias adjusted Quality Effect Models (QEM) were used to get sensitivity estimates. Subgroup analysis and meta-regression were used to explore the sources of heterogeneity. Funnel plots as appropriate for ratio measures were used to assess publication bias.

Results: A systematic and comprehensive search of databases identified 27 cohort studies reporting the incidence of NEC. The number of neonate included in these studies was 574,692. Of this 39,965 developed NEC. There were substantial heterogeneity between studies (I = 100%). The pooled estimate of NEC based on REM was 7.0% (95% CI: 6.0-8.0%). QEM based estimate (6.0%; 95% CI: 4.0-9.0%) were also similar. Funnel plots showed no evidence of publication bias. Although, NEC estimates are similar across various regions, some variation between high and low income countries were noted. Meta regression findings showed a statistically significant increase of NEC over time, quantified by the publication year.

Conclusion: Seven out of 100 of all VLBW infants in NICU are likely to develop NEC. However, there were considerable heterogeneity between studies. High quality studies assessing incidence of NEC along with associated risk factors are warranted.
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http://dx.doi.org/10.1186/s12887-020-02231-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359006PMC
July 2020

Repositioning for pressure injury prevention in adults.

Cochrane Database Syst Rev 2020 06 2;6:CD009958. Epub 2020 Jun 2.

School of Nursing and Midwifery, Griffith University, Brisbane, Australia.

Background: A pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.

Objectives: To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.

Search Methods: We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.

Selection Criteria: Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.

Data Collection And Analysis: Three review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.

Main Results: We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials. Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision. One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision. In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision. Positioning regimens: four trials compared different tilt positions We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision. One trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence. Secondary outcomes No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction. Cost analysis Two included trials also performed economic analyses. A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed. A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR -46.50, 95% CI EUR -1.25 to EUR -74.60).

Authors' Conclusions: Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base. Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus "usual care" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.
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http://dx.doi.org/10.1002/14651858.CD009958.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265629PMC
June 2020

Risk of wheezing and asthma exacerbation in children treated with paracetamol versus ibuprofen: a systematic review and meta-analysis of randomised controlled trials.

BMC Pulm Med 2020 Mar 23;20(1):72. Epub 2020 Mar 23.

Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.

Background: Paracetamol and ibuprofen are the most commonly used medications for fever and pain management in children. While the efficacy appears similar with both drugs, there are contradictory findings related to adverse events. In particular, incidence of wheezing and asthma among children taking paracetamol compared to ibuprofen, remain unsettled.

Methods: We conducted a meta-analysis of randomized controlled trials (RCTs) that compared wheezing and asthma exacerbations in children taking paracetamol versus ibuprofen. A comprehensive search was conducted in five databases. RCTs reporting on cases of wheezing or asthma exacerbations in infants or children after the administration of paracetamol or ibuprofen were included. The pooled effect size was estimated using the Peto's odds ratio.

Results: Five RCTs with 85,095 children were included in the analysis. The pooled estimate (OR 1.05; 95%CI 0.76-1.46) revealed no difference in the odds of developing asthma or presenting an exacerbation of asthma in children who received paracetamol compared to ibuprofen. When the analysis was restricted to RCTs that examined the incidence of asthma exacerbation or wheezing, the pooled estimate remained similar (OR 1.01; 95%CI 0.63-1.64). Additional bias adjusted quality effect sensitivity model yielded similar results (RR 1.03; 95%CI 0.84-1.28).

Conclusion: Although, Ibuprofen and paracetamol appear to have similar tolerance and safety profiles in terms of incidence of asthma exacerbations in children, we suggest high quality trials with clear definition of asthma outcomes after receiving ibuprofen or paracetamol at varying doses with longer follow-up are warranted for any conclusive finding.
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http://dx.doi.org/10.1186/s12890-020-1102-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7087361PMC
March 2020

Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis.

Int J Nurs Stud 2020 May 31;105:103546. Epub 2020 Jan 31.

School of Nursing and Midwifery, Menzies Health Institute Queensland (MHIQ), Griffith University, Gold Coast Campus, Queensland 4222, Australia. Electronic address:

Background: Pressure injuries are frequently occurred adverse events in hospitals, affecting the well-being of patients and causing considerable financial burden to healthcare systems. However, the estimates of prevalence, incidence and hospital-acquired rate of pressure injury in hospitalised patients vary considerably in relevant published studies.

Objectives: To systematically quantify the prevalence and incidence of pressure injuries and the hospital-acquired pressure injuries rate in hospitalised adult patients and identify the most frequently occurring pressure injury stage(s) and affected anatomical location(s).

Design: Systematic review and meta-analysis.

Data Sources: Medline, PubMed, Embase, Cochrane Library, CINAHL and ProQuest databases from January 2008 to December 2018.

Review Methods: We included studies with observational, cross-sectional or longitudinal designs, reporting pressure injury among hospitalised adults (≥16 years) and published in English. Outcomes were point prevalence, incidence of pressure injuries and the hospital-acquired pressure injuries rate reported as percentages. Two reviewers independently appraised the methodological quality of included studies. Heterogeneity was assessed by using the I² statistic and random effects models were employed. Sources of heterogeneity were investigated by subgroup analysis and meta-regression.

Results: Of 7,489 studies identified, 42 were included in the systematic review and 39 of them were eligible for meta-analysis, with a total sample of 2,579,049 patients. The pooled prevalence of 1,366,848 patients was 12.8% (95% CI 11.8-13.9%); pooled incidence rate of 681,885 patients was 5.4 per 10,000 patient-days (95% CI 3.4-7.8) and pooled hospital-acquired pressure injuries rate of 1,893,593 was 8.4% (95% CI 7.6-9.3%). Stages were reported in 16 studies (132,530 patients with 12,041 pressure injuries). The most frequently occurred stages were Stage I (43.5%) and Stage II (28.0%). The most affected body sites were sacrum, heels and hip. Significant heterogeneity was noted across some geographic regions. Meta-regression showed that the year of data collection, mean age and gender were independent predictors, explaining 67% variability in the prevalence of pressure injuries. The year of data collection and age alone explained 93% of variability in hospital-acquired pressure injuries rate.

Conclusion: This study suggested that the burden of pressure injuries remains substantial with over one in ten adult patients admitted to hospitals affected. Superficial pressure injuries, such as Stage I and II, are most common stages and are preventable. Our results highlight healthcare institutions' focus on pressure injuries globally and supports the need to dedicate resources to prevention and treatment on pressure injuries. Registration number: PROSPERO CRD42019118774.
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http://dx.doi.org/10.1016/j.ijnurstu.2020.103546DOI Listing
May 2020

Meta-Analysis of the Diagnostic Accuracy of Primary Bone and Soft Tissue Sarcomas by 18F-FDG-PET.

Med Princ Pract 2020 31;29(5):465-472. Epub 2019 Dec 31.

Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar,

Objectives: The goal of this meta-analysis was to assess the use of FDG-PET in the diagnosis of primary bone and soft tissue sarcomas.

Subjects And Methods: Several databases, including PubMed, Embase, Cochrane Library, and Web of Science, were searched. In addition to sensitivity and specificity, the diagnostic accuracy region for detecting and grading sarcomas were pooled using bivariate and hierarchical summary receiver-operating characteristic (HSROC) models. Subgroup analysis included pooling soft tissue and bone sarcomas separately, and sensitivity analysis included high-quality studies. The quality of eligible studies was assessed using QUADAS-2.

Results: Of the 1,258 papers screened, 21 studies satisfied the inclusion criteria. The pooled sensitivity and specificity of FDG-PET combined with CT for the detection of sarcomas were 89.2 and 76.3%, respectively. These diagnostic accuracy measures were higher when combined with CT than those of PDG-PET alone. Diagnostic accuracy for bone and soft tissue lesions were comparable but slightly better for soft tissue tumors. Pooling only the high-quality studies with low risk of bias yielded a sensitivity of 88.5% and specificity reduced to 65.6%. There was no evidence for publication bias, but significant heterogeneity among the studies was apparent. This study also showed that FDG-PET can efficiently differentiate between benign and malignant tumors, with a mean standard uptake value of maximally 2.52 units in benign and 6.81 units in malignant tumors (89.2% sensitivity and 75.1% specificity).

Conclusion: Our findings indicate FDG-PET can efficiently differentiate between benign and malignant bone and soft tissue tumors. We also found that FDG-PET improves accuracy in diagnosing soft tissue sarcomas when combined with CT.
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http://dx.doi.org/10.1159/000505651DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511687PMC
December 2019

P value-driven methods were underpowered to detect publication bias: analysis of Cochrane review meta-analyses.

J Clin Epidemiol 2020 02 16;118:86-92. Epub 2019 Nov 16.

Department of Population Medicine, College of Medicine, Qatar University, Doha, Qatar.

Objectives: The aim of the study was to investigate the effect of number of studies in a meta-analysis on the detection of publication bias using P value-driven methods.

Methods: The proportion of meta-analyses detected by Egger's, Harbord's, Peters', and Begg's tests to have asymmetry suggestive of publication bias were examined in 5,014 meta-analyses from Cochrane reviews. P values were also assessed in meta-analyses with varying number of studies, whereas symmetry was held constant. A simulation study was conducted to investigate if the above tests underestimate or overestimate the presence of publication bias.

Results: The proportion of meta-analyses detected as asymmetrical via Egger's, Harbord's, Peters', and Begg's tests decreased by 42.6%, 41.1%, 29.3%, and 28.3%, respectively, when the median number of studies in the meta-analysis decreased from 87 to 14. P values decreased as the number of studies increased in the meta-analysis, despite the level of symmetry remaining constant. The simulation study confirmed that when publication bias is present, P value tests underestimate the presence of publication bias, particularly when study numbers are small.

Conclusion: P value-based tests used for the detection of publication bias-related asymmetry in meta-analysis require careful examination, as they underestimate asymmetry. Alternative methods not dependent on the number of studies are preferable.
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http://dx.doi.org/10.1016/j.jclinepi.2019.11.011DOI Listing
February 2020

Metformin in pregnancy to avert gestational diabetes in women at high risk: Meta-analysis of randomized controlled trials.

Obes Rev 2020 01 31;21(1):e12964. Epub 2019 Oct 31.

Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar.

Previous randomized and observational studies on the efficacy of metformin in pregnancy to reduce incident gestational diabetes mellitus (GDM) in women at high risk (obesity, polycystic ovary syndrome [PCOS], or pregestational insulin resistance) have been conflicting and several groups are planning further randomized controlled trials (RCTs) to answer this question conclusively. This work assesses the efficacy of metformin in pregnancy to avert one outcome-incident GDM in women at high risk. We included RCTs comparing metformin with usual care or placebo controls in terms of incident GDM and recruiting women at high risk during early pregnancy. Eleven eligible trials enrolled 2370 adult women whose intervention arm consisted of metformin started at conception or before 20 weeks of gestation. Risk of GDM was similar in intervention compared with controls (risk ratio [RR] 1.03; 95% confidence interval [CI], 0.85-1.24). The data were of sufficient quality meeting the criteria for consistency and directness. We conclude that metformin does not contribute to averting the GDM outcome in women at high risk when initiated in pregnancy. The evidence provided by this synthesis affirms that further broad clinical trials investigating this question are no longer needed.
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http://dx.doi.org/10.1111/obr.12964DOI Listing
January 2020

Obesity and maternal perception: a cross-sectional study of children aged 6 to 8 years in Kuwait.

East Mediterr Health J 2019 Oct 4;25(7):465-472. Epub 2019 Oct 4.

Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar.

Background: Childhood obesity is on the increase in the Middle East.

Aims: This study aimed to determine the prevalence of obesity in those aged six to eight years and to investigate maternal perception of child weight.

Methods: A nation-wide study of data on height and weight were obtained from nurses' records, and maternal perceptions were assessed through a self-administered questionnaire. Sample size comprised 2208 individuals with BMI measurements and 1002 with BMI and maternal perception data.

Results: The prevalence of overweight and obese children combined was 40.9% as per WHO cut-off values and 39.7% as per Centres for Disease Control and Prevention categorizations. We also found that 77.9% of overweight and 45.4% of obese children were perceived by their mothers to have healthy body weights. Additionally, 39.8% of children with normal weight were also judged by their mothers to be underweight.

Conclusions: An alarmingly high prevalence of childhood obesity among Kuwaiti children, coupled with mothers distorted perception of their child's actual weight status is a serious concern that requires urgent public health intervention.
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http://dx.doi.org/10.26719/emhj.18.060DOI Listing
October 2019

The impact of obesity on the gestational diabetes differential between pregnant women with and without polycystic ovary syndrome.

Obes Rev 2019 11 22;20(11):1665-1666. Epub 2019 Jul 22.

Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar.

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http://dx.doi.org/10.1111/obr.12913DOI Listing
November 2019

Pressure injury prevalence and predictors among older adults in the first 36 hours of hospitalisation.

J Clin Nurs 2019 Nov 8;28(21-22):4119-4127. Epub 2019 Aug 8.

Menzies Health Institute Queensland, The School of Nursing and Midwifery, Griffith University, Southport, Queensland, Australia.

Aims And Objective: To describe the prevalence and predictors of pressure injuries among older adults with limited mobility, within the first 36 hr of their hospital admission in Australia.

Background: Pressure injuries are significant health, safety and quality of care issues for patients and healthcare organisations. The early implementation of the recommended pressure injury prevention international clinical practice guidelines is a way to reduce hospital-acquired pressure injuries. There is a paucity of evidence on the number of older persons who are admitted hospital with a pre-existing pressure injury.

Design: Prospective correlational study conducted in eight tertiary referral hospitals across Australia. Our sample comprised of 1,047 participants aged ≥65 years with limited mobility, drawn from a larger Australian pragmatic cluster randomised trial.

Methods: Using the STROBE statement, observational data were collected on participants' age, gender, presence of a pressure injury, Body Mass Index score, number of comorbidities and place of residence. These variables were analysed as potential predictors for pressure injuries within the first 36 hr of hospitalisation.

Results: From our sample, 113/1047 (10.8%) participants were observed to have a pressure injury within the first 36 hr of hospital admission. Age, multiple comorbidities and living in an aged care facility predicted the prevalence of pressure injury among older people within the first 36 hr of hospitalisation.

Conclusions: Our findings confirm that older adults, those with multiple comorbidities and individuals living in aged care facilities are more likely to come to hospital with a pre-existing pressure injury or develop one soon after admission.

Relevance To Clinical Practice: Many older patients come to hospital with a community-acquired pressure injury or develop a pressure injury soon after admission. This highlights the importance of the early detection of pressure injuries among older persons so that timely management strategies can be implemented along with the potential to reduce unnecessary financial penalties.
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http://dx.doi.org/10.1111/jocn.14967DOI Listing
November 2019

Prevalence of BRCA mutations among hereditary breast and/or ovarian cancer patients in Arab countries: systematic review and meta-analysis.

BMC Cancer 2019 Mar 21;19(1):256. Epub 2019 Mar 21.

Department of Public Health, College of Health Sciences, Qatar University, PO Box 2713, Doha, Qatar.

Background: To systematically assess the prevalence of BRCA1 and BRCA2 gene mutations in women with Hereditary Breast and/or Ovarian Cancer (HBOC) in Arab countries and to describe the variability in the BRCA gene mutations in different regions of the Arab world.

Methods: Observational studies reporting prevalence of BRCA mutations from 22 Arab countries were systematically searched in databases including PUBMED, EMBASE, Web of Science, and Google Scholar. Two reviewers independently screened the studies and extracted data and assessed the risk of bias. Hoy's risk of Bias tool was used to assess the biases in individual studies. Due to substantial heterogeneity, pooled weighted estimates were calculated using Quality Effect Models (QEM) that adjust for bias, while the Random Effect Models (REM) estimates served as the sensitivity estimates.

Results: Fourteen studies reporting prevalence of BRCA were included. The pooled estimate of BRCA among HBOC was 20% (95% CI: 7-36%). Subgroup analysis including only those with low risk of bias provided an estimate of 11% (95% CI: 1-27%). Levant region had higher prevalence 28% (95% CI: 11-49%) compared to Arabian Gulf region and North Africa but differences are not statistically significant, when tested using Z-test for proportions.

Conclusion: Given the pooled estimates vary widely with substantial heterogeneity, larger, well-designed studies are warranted to better understand the frequency and the impact of BRCA gene mutations among Arab women.

Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42018095905 .
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http://dx.doi.org/10.1186/s12885-019-5463-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429759PMC
March 2019

The authors reply.

Crit Care Med 2019 02;47(2):e162-e163

School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, QLD, Australia; Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar; Menzies Health Institute Queensland, Griffith University, QLD, Australia; Intensive Care Services, Royal Brisbane and Women's Hospital and School of Nursing, Queensland University of Technology, Brisbane, QLD, Australia, and Institute for Skin Integrity and Infection Prevention, University of Huddersfield, Huddersfield, United Kingdom; Department of Internal Medicine, Ghent University, Ghent, Belgium, and Burns, Trauma and Critical Care Research Centre, University of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia; Menzies Health Institute Queensland, Griffith University, QLD, Australia; Department of Medical-Surgical Nursing, School of Nursing, University of Saõ Paulo, Saõ Paulo, Brazil; School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, QLD, Australia.

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http://dx.doi.org/10.1097/CCM.0000000000003565DOI Listing
February 2019

A Tailored, Bundle Care Intervention Strategy to Reduce Cardiac Mortality During the Hajj: A Population-Based, Before and After Study.

Angiology 2019 Jul 10;70(6):547-553. Epub 2019 Jan 10.

5 Cardiac Sciences Department, College of Medicine, King Saud University-Medical City, Riyadh, Saudi Arabia.

Background: Hajj is the largest human gathering with over 2 million people. We evaluated the effect of bundle care intervention on mortality.

Methods: A population-based, before and after study compared the effect of an intervention on mortality. The intervention included recruitment of cardiac team, introducing 24/7 catheterization service, cardiac coordination, standardized cardiac care pathways, and establishment of an effective transportation system.

Results: Cardiac mortality accounted for about 52% of all in-hospital deaths before intervention in 2009. This decreased significantly to 43.3%, 32.5%, and 19.7% in 2009, 2010, and 2011, respectively. In-hospital mortality of acute coronary syndromes was 4.7%, 4.6%, and 3.0%, in the years 2009, 2010, and 2011, respectively. Mortality due to other causes remained largely unaffected. There was no significant change in the national mortality due to cardiac causes over the same period provided a reassurance that the observed improvement in in-hospital acute coronary syndrome mortality was not due to overall improvement in health care. The numbers of cardiac catheterization procedures increased 3-fold and cardiac surgical procedures increased 5-fold between 2009 and 2011.

Conclusions: In this study, we found that an evidence-based intensive bundle care intervention substantially reduced the cardiac mortality among the pilgrims assembling for Hajj in Makkah.
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http://dx.doi.org/10.1177/0003319718822630DOI Listing
July 2019

Effectiveness of Different Topical Treatments in the Healing of Pressure Injuries: A Network Meta-analysis.

J Am Med Dir Assoc 2019 04 22;20(4):399-407. Epub 2018 Nov 22.

Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar.

Objectives: Pressure injuries (PIs) are one of the most common types of complex wounds and impose a huge economic burden on the healthcare system and the patients. A plethora of topical treatments is widely available for PI treatment, yet there is a paucity of evidence with regard to the most effective treatment. The objective of this study was to compare the effect of various topical treatments and identify the best treatment choice(s) for PI healing.

Design: Systematic review and network meta-analysis.

Setting And Participants: All published randomized controlled trials that compared the effectiveness of 2 or more of the following dressing groups: basic, foam, active, hydroactive, and other wound dressings.

Measures: The outcome was the relative risk (RR) of complete healing following treatment and the generalized pairwise modeling framework was used to generate mixed treatment effects against hydroactive wound dressing, currently the standard of treatment for PIs. All treatments were then ranked by their point estimates.

Results: 40 studies (1757 participants) comparing 5 dressing groups were included in the analysis. All dressings groups ranked better than basic (ie, saline gauze or similar inert dressing). The foam [RR 1.18; 95% confidence interval (CI) 0.95-1.48] and active wound dressing (RR 1.16; 95% CI 0.92-1.47) ranked better than hydroactive wound dressing in terms of healing of PIs when the latter was used as the reference group.

Conclusions/implications: There was substantial uncertainty around the point estimates; however, evidence from our analysis supports the use of hydroactive wound dressings to replace basic dressings. Foam and active wound dressing groups seem promising and therefore need further investigation. High-quality, rigorously conducted research about the clinical effectiveness of the topical treatments in these 2 groups developed in consultation with health professionals, patients, and their carers is needed to identify if indeed foam and active wound dressings provide advantages over hydroactive dressings.
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http://dx.doi.org/10.1016/j.jamda.2018.10.010DOI Listing
April 2019

Anaphylaxis triggers in a large tertiary care hospital in Qatar: a retrospective study.

World Allergy Organ J 2018 4;11(1):20. Epub 2018 Sep 4.

1Biomedical Science Department, College of Health Science, Qatar University, P.O. Box 2713, Doha, Qatar.

Background: Anaphylaxis is a serious allergic disease that may lead to death if not immediately recognized and treated. Triggers of anaphylaxis including food, drugs, and insect stings can vary widely. The incidence of anaphylaxis seems to be affected by age, sex, atopy, and geographic location. This study aims to examine the common triggers of anaphylaxis in Qatar.

Methods: A total of 1068 electronic medical records were audited using power chart system: 446 from the medical coding system of anaphylaxis and 622 from the epinephrine auto-injectors (EAIs) dispensed during January 2012-December 2017.

Results: Of 1068 patients, 574 (53.5%) had anaphylaxis; male to female ratio was 1.2, and 300 patients (77.9%) were less than 10 years old. The common triggers were food ( = 316, 55.0%), insect stings ( = 161, 28.0%), and drugs ( = 103, 17.9%). Common anaphylaxis food triggers were nuts ( = 173, 30.1%), eggs ( = 89, 15.5%), and seafood ( = 72, 12.5%), and common anaphylaxis medication triggers were antibiotics ( = 49, 8.5%) and nonsteroidal anti-inflammatory drugs ( = 30, 5.2%). Interestingly, 135 anaphylactic patients (23.5%) were due to black ant stings. The anaphylaxis triggers varied significantly between children and adults. Among children (less than 10 years), three quarters of the events were triggered by food (223, 74.3%) while among adults (20-55 years), insect stings ( = 59, 43.0%) and drugs ( = 44, 32.0%) were dominant.

Discussion: This is the first national study stratifying anaphylaxis triggers among different age groups in Qatar. This study will serve as a guide for clinical practice in allergy clinics in Qatar and will help to assess future trends of anaphylaxis in Qatar.
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http://dx.doi.org/10.1186/s40413-018-0200-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6122634PMC
September 2018

Foam dressings for treating pressure injuries in patients of any age in any care setting: An abridged Cochrane systematic review.

Int J Nurs Stud 2018 Nov 24;87:140-147. Epub 2018 Jul 24.

Health Economics Group, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.

Background: Pressure injuries are localised areas of injury to the skin and/or underlying tissues.

Objectives: To assess foam dressings compared to other dressings in healing pressure injuries.

Design: Systematic review and meta-analysis DATA SOURCES: The review team searched: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials; Ovid MEDLINE; Ovid Embase; EBSCO CINAHL Plus and the NHS Economic Evaluation Database. Authors also searched clinical trials registries and scanned reference lists for reviews, meta-analyses and health technology reports. No restrictions were applied to language, publication date or study setting.

Study Eligibility Criteria: Published or unpublished randomised controlled trials and cluster- randomised controlled trials that examined the clinical or cost effectiveness of foam dressings for healing pressure injuries.

Participants: Patients of any age with a pressure injury of Stage II or above in any care setting.

Interventions: Use of any foam wound dressing for treating Stage II pressure injuries or above.

Study Appraisal And Synthesis Methods: Full-text were assessed for eligibility using a priori criteria by two authors. Risk of bias was assessed using the Grading of Recommendations, Assessment, Development and Evaluation criteria, and Consolidated Health Economic Evaluation Reporting Standards. Risk ratio and mean difference with 95% confidence intervals were used to measure the effect. The review team used Review Manager 5 to enter narrative and qualitative data of included studies.

Results: Authors found nine studies published between 1994 and 2016 involving 483 participants with pressure injuries at Stage II or above. Included studies compared foam dressings with other types of dressings. However, it was unclear if the foam dressing affected healing (RR 1.00, 95% CI 0.78-1.28), time to complete healing (MD 5.67 days 95% CI-4.03-15.37), adverse events (RR 0.33, 95% CI 0.01-7.65), or reduction in pressure injury size (MD 0.30 cm per day, 95% CI -0.15 to 0.75), as the certainty of the evidence was very low.

Limitations: Using the Grading of Recommendations, Assessment, Development and Evaluation criteria, the certainty and completeness of evidence was low to very low, making it difficult to draw comparisons between foam and other dressings.

Conclusions And Implications: It is uncertain whether foam dressings are more clinically effective, more acceptable to users, or more cost effective compared to alternative dressings in treating pressure injuries.
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http://dx.doi.org/10.1016/j.ijnurstu.2018.07.012DOI Listing
November 2018

Incidence and Prevalence of Pressure Injuries in Adult Intensive Care Patients: A Systematic Review and Meta-Analysis.

Crit Care Med 2018 11;46(11):e1074-e1081

School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, QLD, Australia.

Objectives: To systematically assess the incidence and prevalence of pressure injuries in adult ICU patients and the most frequently occurring pressure injury sites.

Data Sources: MEDLINE, Embase, the Cochrane Library, and Cumulative Index to Nursing and Allied Health Literature.

Study Selection: Observational studies reporting incidence rates, cumulative incidence, and prevalence of pressure injuries.

Data Extraction: Two reviewers independently screened studies, extracted data, and assessed the risk of bias. Meta-analyses of pooled weighted estimates were calculated using random effect models with 95% CIs reported due to high heterogeneity. Sensitivity analyses included studies that used skin inspection to identify a pressure injury, studies at low risk of bias, studies that excluded stage 1 and each stage of pressure injury.

Data Synthesis: Twenty-two studies, 10 reporting cumulative incidence of pressure injury irrespective of stage, one reporting incidence rate (198/1,000 hospital-days), and 12 reporting prevalence were included. The 95% CI of cumulative incidence and prevalence were 10.0-25.9% and 16.9-23.8%. In studies that used skin inspection to identify pressure injuries, the 95% CI of cumulative incidence was 9.4-27.5%; all prevalence studies used skin inspection therefore the results were unchanged. In studies assessed as low risk of bias, the 95% CI of cumulative incidence and prevalence were 6.6-36.8% and 12.2-24.5%. Excluding stage 1, the 95% CI of cumulative incidence and prevalence were 0.0-23.8% and 12.4-15.5%. Five studies totalling 406 patients reported usable data on location; 95% CI of frequencies of PIs were as follows: sacrum 26.9-48.0%, buttocks 4.1-46.4%, heel 18.5-38.9%, hips 10.9-15.7%, ears 4.3-19.7%, and shoulders 0.0-40.2%.

Conclusions: Although well-designed studies are needed to ensure the scope of the problem of pressure injuries is better understood, it is clear prevention strategies are also required.
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http://dx.doi.org/10.1097/CCM.0000000000003366DOI Listing
November 2018

Performance evaluation of five commercial assays in assessing seroprevalence of HEV antibodies among blood donors.

J Med Microbiol 2018 Sep 27;67(9):1302-1309. Epub 2018 Jul 27.

1​Department of Biomedical Science, College of Health Sciences, Qatar University, Doha, Qatar.

Introduction: Although hepatitis E virus (HEV) is mainly transmitted via the faecal-oral route, the rate of HEV transmission via blood donation is on the rise. However, the seroprevalence of HEV among blood donors is not well established and is thought to be affected by the type of diagnostic assay used. We aimed to evaluate performance and correlation among widely used commercial diagnostic assays for the seroprevalence assessment of HEV-IgM/IgG among blood donors.

Methodology: A total of 1049 blood donor samples were tested for HEV IgG and IgM using different enzyme immunoassays (Wantai, Eruoimmune, MP diagnostics, Mikrogen immunoblot, HEV-IgM rapid test). The performance of each assay was evaluated according to our established silver standard value based on three or more IgG concordant assay results.

Results: HEV seroprevalence varied considerably using these assays, ranging from 10.1 % (Euroimmune-ELISA) to 18.0 % (Wanti-ELISA) for HEV-IgG, and from 0.2 % (Wanti-ELISA) to 2.6 % (MP Rapid test) for HEV-IgM. A total of 155 of 216 (71.6%) samples tested positive for HEV-IgG by three or more concordant assays. On the other hand, IgM assays showed poor agreement as only 7.6 % (4/52) of the specimens were positive according to three or more concordant assay test results. All HEV-IgG assays revealed high sensitivity and specificity (ranging 96.5-100 %),and excellent Kappa concordance (0.88-0.95), except for Euroimmun ELISA (sensitivity=61.5 %, kappa=0.63). MP ELISA showed the highest levels of sensitivity (100 %) and specificity (98.5 %).

Conclusions: Due to discrepancies in the performance of various IgG and IgM assays, seroprevalence studies should be based on furher confirmatory testing for decisive conclusions to be reached.
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http://dx.doi.org/10.1099/jmm.0.000807DOI Listing
September 2018

Does Cognitive Impairment and Agitation in Dementia Influence Intervention Effectiveness? Findings From a Cluster-Randomized-Controlled Trial With the Therapeutic Robot, PARO.

J Am Med Dir Assoc 2018 07 13;19(7):623-626. Epub 2018 Apr 13.

Department of Public Health, College of Health Sciences, Qatar University, Qatar.

Objectives: To explore whether severity of cognitive impairment and agitation of older people with dementia predict outcomes in engagement, mood states, and agitation after a 10-week intervention with the robotic seal, PARO.

Design: Data from the PARO intervention-arm of a cluster-randomized controlled trial was used, which involved individual, nonfacilitated, 15-minute sessions with PARO 3 afternoons per week for 10 weeks.

Sample And Participants: One hundred thirty-eight residents-aged ≥60 years, with dementia-from 9 long-term care facilities.

Measures: A series of stepwise multiple linear regressions were conducted. Dependent variables were participants' levels of engagement, mood states, and agitation at week 10 [assessed by video observation and Cohen Mansfield Agitation Inventory-Short Form (CMAI-SF)]. Predictor variables were baseline levels of cognitive impairment [assessed by Rowland Universal Dementia Assessment Scale (RUDAS)] and agitation (CMAI-SF).

Results: Five models were produced. The strongest finding was that participants with more severe agitation at baseline had higher levels of agitation at week 10 (R = .82, P < .001). Predictors of positive response were less significant. Low levels of agitation at baseline predicted greater positive behavioral engagement with PARO (R = .054, P = .009) and fewer observed instances of agitation (R = .033, P = .045) at week 10, whereas greater visual engagement was predicted by both lower levels of agitation and cognitive impairment (R = .082, P = .006). Less severe cognitive impairment predicted greater pleasure at week 10 (R = .067, P = .004).

Conclusions/implications: Participants with severe agitation had poor response to PARO. Lower levels of agitation and higher cognitive functioning were associated with better responses. In clinical practice, we recommend PARO should be restricted to people with low-moderate severity of agitation. Further research is needed to determine the optimal participant characteristics for response to PARO.
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http://dx.doi.org/10.1016/j.jamda.2018.02.014DOI Listing
July 2018

Effect of a robotic seal on the motor activity and sleep patterns of older people with dementia, as measured by wearable technology: A cluster-randomised controlled trial.

Maturitas 2018 Apr 13;110:10-17. Epub 2018 Jan 13.

School of Psychiatry, University of New South Wales, Sydney, Australia. Electronic address:

Objectives: The robotic seal, PARO, has been used as an alternative to animal-assisted therapies with residents with dementia in long-term care, yet understanding of its efficacy is limited by a paucity of research. We explored the effects of PARO on motor activity and sleep patterns, as measured by a wearable triaxial accelerometer.

Study Design: Cluster-randomised controlled trial, involving 28 facilities in Queensland, Australia. Nine facilities were randomised to the PARO group (individual, non-facilitated, 15-min sessions three afternoons per week for 10 weeks), 10 to a plush toy (PARO with robotic features disabled) and nine to usual care.

Main Outcome Measures: Changes in day- and nighttime motor activity and sleep after the 10-week intervention, as measured by SenseWear armbands, worn by participants continuously for 24 h at baseline, during two single intervention days in weeks 5 and 10 respectively, and post-intervention (week 15). Analyses followed intention-to-treat, using repeated-measures mixed-effects models.

Results: After 10 weeks, the PARO group showed a greater reduction in daytime step count than usual care (p = 0.023), and in nighttime step count (p = 0.028) and daytime physical activity (p = 0.026) compared with the plush toy group. At post-intervention, the PARO group showed a greater reduction in daytime step count than the plush toy group (p = 0.028), and at nighttime compared with both the plush toy group (p = 0.019) and the usual-care group (p = 0.046). The PARO group also had a greater reduction in nighttime physical activity than the usual-care group (p = 0.015).

Conclusions: PARO may have some effect on motor activity of older people with dementia in long-term care, but not on sleep patterns. Australian New Zealand Clinical Trials Registry (ACTRN12614000508673).
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http://dx.doi.org/10.1016/j.maturitas.2018.01.007DOI Listing
April 2018

The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial.

J Am Med Dir Assoc 2018 07 9;19(7):619-622.e1. Epub 2018 Jan 9.

Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar.

Objectives: To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care.

Design: An economic evaluation, nested within a cluster-randomized controlled trial.

Setting: Twenty-eight facilities in South-East Queensland, Australia.

Participants: A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia.

Intervention: Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care.

Measurements: The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW).

Results: For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care.

Conclusion: The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation.
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http://dx.doi.org/10.1016/j.jamda.2017.10.008DOI Listing
July 2018