scholarly journals Gastric Residual Volumes in the Adult Intensive Care Patient: a Systematic Review

2021 ◽  
Author(s):  
◽  
Rebecca Jane Jarden
Keyword(s):  
Systematic Review ◽  
At Risk ◽  
Intensive Care ◽  
Enteral Nutrition ◽  
Outcome Measures ◽  
Full Text ◽  
Primary Outcome ◽  
Risk Of Bias ◽  
Randomised Controlled ◽  
Patient At Risk

<p>Background: Enteral nutrition is one method of delivering nutrition to intubated patients. There are several issues that prevent optimal delivery of the prescribed enteral nutrition goal rates. The measurement of the patient's gastric residual volume (GRV) may demonstrate tolerability, or intolerability, of enteral nutrition. Identifying a safe GRV, at which to accept and continue enteral nutrition delivery, is essential to ensure the delivery of enteral nutrition adequately achieves the nutritional requirements of patients, and to mitigate the risks associated with the delivery of enteral nutrition. Objectives: This systematic review sought to answer the research question: what is the maximum GRV to accept in order to continue the delivery of enteral nutrition in the Intensive Care Unit (ICU) adult patient? This is specifically related to the primary outcome measures indicative of accepting a specified GRV that is too high or too low. Accepting a GRV that is too high would put the patient at risk of vomiting, regurgitation, aspiration of gastric contents and potentially aspiration pneumonia. Conversely, accepting a GRV that is too low would put the patient at risk of not achieving caloric needs, potentially placing the patient at risk of malnutrition and increased morbidity. Search methods: Databases searched included: CCTR, CLCMR, CLTA, CLEED, OVID MEDLINE (R) (Ovid SP), EMBASE, CINAHL Plus with Full Text (EBSCO host via helicon), AMED, Ovid Nursing Full Text plus, CDSR, ACP Journal Club, DARE, Proquest via helicon (advanced search), Pubmed via helicon (limits "all adult", "humans", "abstract", "title"), all EBM reviews, and the reference lists of articles. Selection criteria: The types of studies eligible for inclusion were published randomised controlled trials, case controlled studies, cohort studies and observational studies. Interventions considered were a comparison of two or more GRV measures. The participants eligible were adult ICU or critical care patients receiving enteral nutrition. The primary outcome measures for study inclusion were caloric requirement met, and specified potential adverse events including vomiting, regurgitation, or aspiration. Data collection and analysis: Data was extracted using a data extraction tool created by the researcher. Risk of bias was assessed by the author using two risk of bias assessment tools. Main results: Three studies met the inclusion criteria for the systematic review (McClave et al., 2005; Metheny, Schallom, Oliver, & Clouse, 2008; Pinilla, Samphire, Arnold, Liu, & Thiessen, 2001). Each of these studies contained methodological risks of bias and limitations related to their study designs. McClave et al.'s study was a prospective study (n = 40), Metheny et al.'s study was a prospective descriptive study (n = 206), and Pinilla et al.'s study was a randomised controlled trial (n = 80). No one study, or a combination of studies, provided conclusive evidence to support the use of one particular GRV over another. Author's conclusion: No recommendation for a definitive GRV was made in this systematic review due to the lack of strong evidentiary support for one GRV over another. There remain opportunities for enhancing practice through developing a consistent, multidisciplinary approach to managing GRVs. There are future research opportunities related to improving the management of GRVs in the enterally fed ICU patient, and achieving optimal volumes of nutrition delivered.</p>

scholarly journals Gastric Residual Volumes in the Adult Intensive Care Patient: a Systematic Review

2021 ◽  
Author(s):  
◽  
Rebecca Jane Jarden
Keyword(s):  
Systematic Review ◽  
At Risk ◽  
Intensive Care ◽  
Enteral Nutrition ◽  
Outcome Measures ◽  
Full Text ◽  
Primary Outcome ◽  
Risk Of Bias ◽  
Randomised Controlled ◽  
Patient At Risk

<p>Background: Enteral nutrition is one method of delivering nutrition to intubated patients. There are several issues that prevent optimal delivery of the prescribed enteral nutrition goal rates. The measurement of the patient's gastric residual volume (GRV) may demonstrate tolerability, or intolerability, of enteral nutrition. Identifying a safe GRV, at which to accept and continue enteral nutrition delivery, is essential to ensure the delivery of enteral nutrition adequately achieves the nutritional requirements of patients, and to mitigate the risks associated with the delivery of enteral nutrition. Objectives: This systematic review sought to answer the research question: what is the maximum GRV to accept in order to continue the delivery of enteral nutrition in the Intensive Care Unit (ICU) adult patient? This is specifically related to the primary outcome measures indicative of accepting a specified GRV that is too high or too low. Accepting a GRV that is too high would put the patient at risk of vomiting, regurgitation, aspiration of gastric contents and potentially aspiration pneumonia. Conversely, accepting a GRV that is too low would put the patient at risk of not achieving caloric needs, potentially placing the patient at risk of malnutrition and increased morbidity. Search methods: Databases searched included: CCTR, CLCMR, CLTA, CLEED, OVID MEDLINE (R) (Ovid SP), EMBASE, CINAHL Plus with Full Text (EBSCO host via helicon), AMED, Ovid Nursing Full Text plus, CDSR, ACP Journal Club, DARE, Proquest via helicon (advanced search), Pubmed via helicon (limits "all adult", "humans", "abstract", "title"), all EBM reviews, and the reference lists of articles. Selection criteria: The types of studies eligible for inclusion were published randomised controlled trials, case controlled studies, cohort studies and observational studies. Interventions considered were a comparison of two or more GRV measures. The participants eligible were adult ICU or critical care patients receiving enteral nutrition. The primary outcome measures for study inclusion were caloric requirement met, and specified potential adverse events including vomiting, regurgitation, or aspiration. Data collection and analysis: Data was extracted using a data extraction tool created by the researcher. Risk of bias was assessed by the author using two risk of bias assessment tools. Main results: Three studies met the inclusion criteria for the systematic review (McClave et al., 2005; Metheny, Schallom, Oliver, & Clouse, 2008; Pinilla, Samphire, Arnold, Liu, & Thiessen, 2001). Each of these studies contained methodological risks of bias and limitations related to their study designs. McClave et al.'s study was a prospective study (n = 40), Metheny et al.'s study was a prospective descriptive study (n = 206), and Pinilla et al.'s study was a randomised controlled trial (n = 80). No one study, or a combination of studies, provided conclusive evidence to support the use of one particular GRV over another. Author's conclusion: No recommendation for a definitive GRV was made in this systematic review due to the lack of strong evidentiary support for one GRV over another. There remain opportunities for enhancing practice through developing a consistent, multidisciplinary approach to managing GRVs. There are future research opportunities related to improving the management of GRVs in the enterally fed ICU patient, and achieving optimal volumes of nutrition delivered.</p>

scholarly journals Increased fluid intake to prevent urinary tract infections: systematic review and meta-analysis

2020 ◽  
Vol 70 (692) ◽  
pp. e200-e207 ◽  
Author(s):  
Anna Mae Scott ◽  
Justin Clark ◽  
Chris Del Mar ◽  
Paul Glasziou
Keyword(s):  
Systematic Review ◽  
At Risk ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Primary Outcome ◽  
Fluid Intake ◽  
Risk Of Bias ◽  
Antimicrobial Use ◽  
Recurrent Utis ◽  
Tract Infections

BackgroundApproximately 15% of community-prescribed antibiotics are used in treating urinary tract infections (UTIs). Increase in antibiotic resistance necessitates considering alternatives.AimTo assess the impact of increased fluid intake in individuals at risk for UTIs, for impact on UTI recurrence (primary outcome), antimicrobial use, and UTI symptoms (secondary outcomes).Design and settingA systematic review.MethodThe authors searched PubMed, Cochrane CENTRAL, EMBASE, two trial registries, and conducted forward and backward citation searches of included studies in January 2019. Randomised controlled trials of individuals at risk for UTIs were included; comparisons with antimicrobials were excluded. Different time-points (≤6 months and 12 months) were compared for the primary outcome. Risk of bias was assessed using Cochrane Risk of Bias tool. Meta-analyses were undertaken where ≥3 studies reported the same outcome.ResultsEight studies were included; seven were meta-analysed. There was a statistically non-significant reduction in the number of patients with any UTI recurrence in the increased fluid intake group compared with control after 12 months (odds ratio [OR] 0.39, 95% confidence interval [CI] = 0.15 to 1.03, P = 0.06); reduction was significant at ≤6 months (OR 0.13, 95% CI = 0.07 to 0.25, P<0.001). Excluding studies with low volume of fluid (<200 ml) significantly favoured increased fluid intake (OR 0.25, 95% CI = 0.11 to 0.59, P = 0.001). Increased fluid intake reduced the overall rate of all recurrent UTIs (rate ratio [RR] 0.46, 95% CI = 0.40 to 0.54, P<0.001); there was no difference in antimicrobial use (OR 0.52, 95% CI = 0.25 to 1.07, P = 0.08). Paucity of data precluded meta-analysing symptoms.ConclusionGiven the minimal potential for harm, patients with recurrent UTIs could be advised to drink more fluids to reduce recurrent UTIs. Further research is warranted to establish the optimal volume and type of increased fluid.

scholarly journals Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e052598
Author(s):  
Karen L Barker ◽  
Jonathan Room ◽  
Ruth Knight ◽  
Susan Dutton ◽  
Francine Toye ◽  
...  
Keyword(s):  
At Risk ◽  
Usual Care ◽  
Outcome Measures ◽  
Knee Arthroplasty ◽  
Primary Outcome ◽  
Rehabilitation Programme ◽  
Poor Outcome ◽  
Home Based ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy.DesignA prospective, single-blind, two-arm randomised controlled superiority trial.Setting14 National Health Service physiotherapy departments in the UK.Participants621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool.InterventionsA multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy.Main outcome measuresThe primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance.Results621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4–7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2–6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI −0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions.ConclusionsThe CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group.Trial registration numberISRCTN13517704.

scholarly journals Alpha-2 agonists for sedation of mechanically ventilated adults in intensive care units: a systematic review

2016 ◽  
Vol 20 (25) ◽  
pp. 1-118 ◽  
Author(s):  
Moira Cruickshank ◽  
Lorna Henderson ◽  
Graeme MacLennan ◽  
Cynthia Fraser ◽  
Marion Campbell ◽  
...  
Keyword(s):  
Systematic Review ◽  
Intensive Care ◽  
Critically Ill ◽  
Outcome Measures ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Mechanically Ventilated ◽  
Length Of Icu Stay ◽  
Sedative Agents

BackgroundCare of critically ill patients in intensive care units (ICUs) often requires potentially invasive or uncomfortable procedures, such as mechanical ventilation (MV). Sedation can alleviate pain and discomfort, provide protection from stressful or harmful events, prevent anxiety and promote sleep. Various sedative agents are available for use in ICUs. In the UK, the most commonly used sedatives are propofol (Diprivan®, AstraZeneca), benzodiazepines [e.g. midazolam (Hypnovel®, Roche) and lorazepam (Ativan®, Pfizer)] and alpha-2 adrenergic receptor agonists [e.g. dexmedetomidine (Dexdor®, Orion Corporation) and clonidine (Catapres®, Boehringer Ingelheim)]. Sedative agents vary in onset/duration of effects and in their side effects. The pattern of sedation of alpha-2 agonists is quite different from that of other sedatives in that patients can be aroused readily and their cognitive performance on psychometric tests is usually preserved. Moreover, respiratory depression is less frequent after alpha-2 agonists than after other sedative agents.ObjectivesTo conduct a systematic review to evaluate the comparative effects of alpha-2 agonists (dexmedetomidine and clonidine) and propofol or benzodiazepines (midazolam and lorazepam) in mechanically ventilated adults admitted to ICUs.Data sourcesWe searched major electronic databases (e.g. MEDLINE without revisions, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE and Cochrane Central Register of Controlled Trials) from 1999 to 2014.MethodsEvidence was considered from randomised controlled trials (RCTs) comparing dexmedetomidine with clonidine or dexmedetomidine or clonidine with propofol or benzodiazepines such as midazolam, lorazepam and diazepam (Diazemuls®, Actavis UK Limited). Primary outcomes included mortality, duration of MV, length of ICU stay and adverse events. One reviewer extracted data and assessed the risk of bias of included trials. A second reviewer cross-checked all the data extracted. Random-effects meta-analyses were used for data synthesis.ResultsEighteen RCTs (2489 adult patients) were included. One trial at unclear risk of bias compared dexmedetomidine with clonidine and found that target sedation was achieved in a higher number of patients treated with dexmedetomidine with lesser need for additional sedation. The remaining 17 trials compared dexmedetomidine with propofol or benzodiazepines (midazolam or lorazepam). Trials varied considerably with regard to clinical population, type of comparators, dose of sedative agents, outcome measures and length of follow-up. Overall, risk of bias was generally high or unclear. In particular, few trials blinded outcome assessors. Compared with propofol or benzodiazepines (midazolam or lorazepam), dexmedetomidine had no significant effects on mortality [risk ratio (RR) 1.03, 95% confidence interval (CI) 0.85 to 1.24,I2 = 0%;p = 0.78]. Length of ICU stay (mean difference –1.26 days, 95% CI –1.96 to –0.55 days,I2 = 31%;p = 0.0004) and time to extubation (mean difference –1.85 days, 95% CI –2.61 to –1.09 days,I2 = 0%;p < 0.00001) were significantly shorter among patients who received dexmedetomidine. No difference in time to target sedation range was observed between sedative interventions (I2 = 0%;p = 0.14). Dexmedetomidine was associated with a higher risk of bradycardia (RR 1.88, 95% CI 1.28 to 2.77,I2 = 46%;p = 0.001).LimitationsTrials varied considerably with regard to participants, type of comparators, dose of sedative agents, outcome measures and length of follow-up. Overall, risk of bias was generally high or unclear. In particular, few trials blinded assessors.ConclusionsEvidence on the use of clonidine in ICUs is very limited. Dexmedetomidine may be effective in reducing ICU length of stay and time to extubation in critically ill ICU patients. Risk of bradycardia but not of overall mortality is higher among patients treated with dexmedetomidine. Well-designed RCTs are needed to assess the use of clonidine in ICUs and identify subgroups of patients that are more likely to benefit from the use of dexmedetomidine.Study registrationThis study is registered as PROSPERO CRD42014014101.FundingThe National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.

scholarly journals Management of Peri-Implantitis Lesions without the Use of Systemic Antibiotics: A Systematic Review

2020 ◽  
Vol 8 (3) ◽  
pp. 106
Author(s):  
Ahsen Khan ◽  
Ankit Goyal ◽  
Scott D. Currell ◽  
Dileep Sharma
Keyword(s):  
Systematic Review ◽  
Full Text ◽  
English Language ◽  
Small Sample ◽  
Risk Of Bias ◽  
Surgical Debridement ◽  
Current Evidence ◽  
Assessment Development ◽  
Randomised Controlled ◽  
Meta Analyses

Background: This systematic review aims to assess the current evidence on the efficacy of surgical and non-surgical debridement techniques in the treatment of peri-implantitis lesions without the use of any antimicrobials. Method: Five electronic databases (MEDLINE, Pubmed, Scopus, CINAHL and Cochrane) were used, alongside hand searches, to find relevant articles. Full-text articles that were randomised controlled trials, published in the English language from 2011 onwards without pre-operative, peri-operative and post-operative antibiotic usage were included. The study was conducted according to the latest Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-P protocols, the latest Cochrane Risk of Bias tool and each investigated intervention was evaluated using the grading of recommendation, assessment, development and evaluation (GRADE) system. Results: The search yielded 2718 results. After initial screening, 38 full-text articles were assessed for eligibility. From these, 11 studies satisfied all inclusion criteria. These 11 articles described six non-surgical and five surgical debridement therapies. Most articles were classified as having either a high risk of bias or presenting with some concerns. Small sample sizes, in combination with this risk of bias, meant that all interventions were adjudged to be of either low or very low quality of evidence. Conclusion: While all investigated modalities displayed some sort of efficacy, this review suggests that a surgical approach may be best suited to treating peri-implantitis lesions in the absence of antibiotic therapy. Despite this weak indication, further research is required in this field.

scholarly journals Simulation training in non-cancer palliative care for healthcare workers: a systematic review of controlled studies

2020 ◽  
pp. bmjstel-2019-000570
Author(s):  
Joanne Tropea ◽  
Ross Bicknell ◽  
Debra Nestel ◽  
Caroline A Brand ◽  
Christina E Johnson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Palliative Care ◽  
Outcome Measures ◽  
Healthcare Workers ◽  
Simulation Training ◽  
Opportunity To Learn ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Organisation Of Care ◽  
Randomised Controlled

BackgroundThe need for healthcare workers (HCWs) to have skills and knowledge in non-cancer palliative care has been recognised. Simulation is increasingly being used for palliative care training, offering participants the opportunity to learn in a realistic environment and fully interactive way.ObjectiveThe aim of this systematic review was to summarise and critically appraise controlled studies on simulation training in non-cancer palliative care for HCWs.SelectionMedline, CINAHL, PubMed and Cochrane Library databases were searched using palliative care and simulation terms. Randomised controlled trials (RCTs), non-randomised RCTs and controlled before-and-after (CBA) studies were included. Two reviewers independently screened titles and abstracts and undertook full article review using predefined selection criteria. Studies that met the inclusion criteria had data extracted and risk of bias assessed using the Cochrane Effective Practice and Organisation of Care risk of bias criteria.FindingsFive articles were included: three RCTs and two CBA studies. All studies assessed learners’ palliative care communication skills, most studies evaluated learners’ perception of change in skills and one study assessed impact on patient outcomes and learners’ change in behaviour when applied in practice. There was variation in intervention content, intensity and duration, outcome measures and study design, making it difficult to compare and synthesise results.ConclusionThere is a paucity of evidence to support simulation training to improve non-cancer palliative care. This review highlights the need for more robust research, including multicentre studies that use standardised outcome measures to assess clinician skills, changes in clinical practice and patient-related outcomes.

scholarly journals Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Grey Literature ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Head Lice ◽  
Efficacy And Safety ◽  
Randomised Controlled ◽  
Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

scholarly journals Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045343
Author(s):  
Ray Moynihan ◽  
Sharon Sanders ◽  
Zoe A Michaleff ◽  
Anna Mae Scott ◽  
Justin Clark ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Unmet Need ◽  
Healthcare Utilisation ◽  
Healthcare Services ◽  
Risk Of Bias ◽  
Secondary Outcome ◽  
Severe Illness ◽  
Service Utilisation ◽  
Registration Number

ObjectivesTo determine the extent and nature of changes in utilisation of healthcare services during COVID-19 pandemic.DesignSystematic review.EligibilityEligible studies compared utilisation of services during COVID-19 pandemic to at least one comparable period in prior years. Services included visits, admissions, diagnostics and therapeutics. Studies were excluded if from single centres or studied only patients with COVID-19.Data sourcesPubMed, Embase, Cochrane COVID-19 Study Register and preprints were searched, without language restrictions, until 10 August, using detailed searches with key concepts including COVID-19, health services and impact.Data analysisRisk of bias was assessed by adapting the Risk of Bias in Non-randomised Studies of Interventions tool, and a Cochrane Effective Practice and Organization of Care tool. Results were analysed using descriptive statistics, graphical figures and narrative synthesis.Outcome measuresPrimary outcome was change in service utilisation between prepandemic and pandemic periods. Secondary outcome was the change in proportions of users of healthcare services with milder or more severe illness (eg, triage scores).Results3097 unique references were identified, and 81 studies across 20 countries included, reporting on >11 million services prepandemic and 6.9 million during pandemic. For the primary outcome, there were 143 estimates of changes, with a median 37% reduction in services overall (IQR −51% to −20%), comprising median reductions for visits of 42% (−53% to −32%), admissions 28% (−40% to −17%), diagnostics 31% (−53% to −24%) and for therapeutics 30% (−57% to −19%). Among 35 studies reporting secondary outcomes, there were 60 estimates, with 27 (45%) reporting larger reductions in utilisation among people with a milder spectrum of illness, and 33 (55%) reporting no difference.ConclusionsHealthcare utilisation decreased by about a third during the pandemic, with considerable variation, and with greater reductions among people with less severe illness. While addressing unmet need remains a priority, studies of health impacts of reductions may help health systems reduce unnecessary care in the postpandemic recovery.PROSPERO registration numberCRD42020203729.

scholarly journals Testing for non-inferior mortality: a systematic review of non-inferiority margin sizes and trial characteristics

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044480
Author(s):  
Sandra Pong ◽  
Martin Urner ◽  
Robert A Fowler ◽  
Nicholas Mitsakakis ◽  
Winnie Seto ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Absolute Risk ◽  
Methodological Issue ◽  
Medical Specialty ◽  
Risk Difference ◽  
Baseline Risk ◽  
Industry Funding ◽  
Eligibility Criteria ◽  
Randomised Controlled

ObjectiveTo describe the size and variability of non-inferiority margins used in non-inferiority trials of medications with primary outcomes involving mortality, and to examine the association between trial characteristics and non-inferiority margin size.DesignSystematic review.Data sourcesMedline, Medline In Process, Medline Epub Ahead of Print and Embase Classic+Embase databases from January 1989 to December 2019.Eligibility criteriaProspective non-inferiority randomised controlled trials comparing pharmacological therapies, with primary analyses for non-inferiority and primary outcomes involving mortality alone or as part of a composite outcome. Trials had to prespecify non-inferiority margins as absolute risk differences or relative to risks of outcome and provide a baseline risk of primary outcome in the control intervention.Results3992 records were screened, 195 articles were selected for full text review and 111 articles were included for analyses. 82% of trials were conducted in thrombosis, infectious diseases or oncology. Mortality was the sole primary outcome in 23 (21%) trials, and part of a composite primary outcome in 88 (79%) trials. The overall median non-inferiority margin was an absolute risk difference of 9% (IQR 4.2%–10%). When non-inferiority margins were expressed relative to the baseline risk of primary outcome in control groups, the median relative non-inferiority margin was 1.5 (IQR 1.3–1.7). In multivariable regression analyses examining the association between trial characteristics (medical specialty, inclusion of paediatric patients, mortality as a sole or part of a composite primary outcome, presence of industry funding) and non-inferiority margin size, only medical specialty was significantly associated with non-inferiority margin size.ConclusionAbsolute and relative non-inferiority margins used in published trials comparing medications are large, allowing conclusions of non-inferiority in the context of large differences in mortality. Accepting the potential for large increases in outcomes involving mortality while declaring non-inferiority is a challenging methodological issue in the conduct of non-inferiority trials.

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