Advertising and general dental practice: how compliant are practice websites in Australia with legal requirements?

BACKGROUND: The Australian Health Practitioner Regulation Agency (AHPRA) requires general dental practitioners (GDPs) to agree to regulatory advertising guidelines on initial registration and annual renewal. The aim of this study was to determine the compliance of GDPs websites to these requirements. METHODS: A representative sample of GDPs websites from each state and territory in Australia was based on the total AHPRA registrant distribution. Assessment of compliance was used across five domains consisting of 17 criteria related to AHPRA's advertising of regulated health services guidelines, as well as section 133 of the National Law. Inter-rater reliability was estimated using Fleiss's Kappa. RESULTS: One hundred and ninety-two GDPs websites were reviewed with 85% non-compliant with at least one of the legal and regulatory requirements relating to advertising. Of these websites, 52% displayed false and misleading information, 12.8% had offers and inducement without clear terms and conditions, 11.5% used written testimonials, 33.9% created unrealistic expectation of benefit and 39.6% encouraged indiscriminate and unnecessary use of health services. CONCLUSIONS: More than 85% of GDP websites in Australia did not comply with legal and regulatory requirements related to advertising. A multi-stakeholder approach involving AHPRA, professional dental bodies and dental registrants is necessary to improve compliance.

Eruption disturbances in the mixed dentition: orthodontic considerations for primary dental care.

The primary dental care clinician is in a prime position to identify deviations from normal dental development. Disturbances can affect any new erupting tooth. The objective of this narrative review is to describe several situations in which eruption disturbances can arise during the mixed dentition. It will provide an overview of the orthodontic considerations of these disturbances in addition to key summary points on interceptive management, based on the best available evidence.

Effectiveness of tongue-tie assessment tools in diagnosing and fulfilling lingual frenectomy criteria: a systematic review.

It is unclear how effective tongue-tie classification assessment tools are in diagnosing symptomatic tongue-tie and fulfilling lingual frenectomy criteria. The purpose of this systematic review is to determine and evaluate any association between tongue-tie severity, as measured by pre-treatment assessment tools, and post-operative outcome following tongue-tie division. PubMed, EMBASE, and the Cochrane search engines were used to retrieve articles published between 1947 and 2021. Included studies consisted of patients with symptomatic tongue-tie, assessment by either the Coryllos, Kotlow, or Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF) classification tool, and tongue-tie division. A total of 205 abstracts were identified; 31 studies met the criteria for a full-text review, of which, only 14 studies met the criteria for data extraction and analysis. Six studies used the HATLFF, 2 studies used the Kotlow, 5 studies used the Coryllos, and 1 study used a combination of both Kotlow and Coryllos methods. Significant heterogeneity was evident across all studies. No statistical correlation between the two variables could be determined. Although tongue-tie division procedures appear to provide benefits in breastfeeding and speech, there are no data to suggest a statistically significant association between the severity of tongue-tie, and the correct identification of patients who would benefit from tongue-tie division. © 2022 Australian Dental Association.

The quality and readability of online molar incisor hypomineralization patient education materials: a systematic analysis.

BACKGROUND: Molar incisor hypomineralization (MIH) is estimated to affect 14% of children worldwide. It is crucial that patients and their families have access to easily comprehensible and reliable MIH-relevant information. This study aims to determine the quality, reliability and readability of online patient education materials about MIH. METHODS: A systematic search strategy was adopted. Five validated tools were used to assess the content of the 21 websites that satisfied inclusion/exclusion criteria. Data analyses were applied via GraphPad Prism software version 9 (GraphPad Software, San Diego, CA, USA). RESULTS: Five (23.8%) websites only satisfied the criteria for understandability and two (9.5%) websites satisfied the criteria for actionability using the Patient Education Materials Assessment Tool (PEMAT). No website contained the Health on the Net (HON)Code Seal and the mean (SD) Journal of the American Medical Association number of benchmarks per website was 1.33/4 (1.02). All websites failed to reach recommended minimum readability levels. Higher PEMAT scores were associated with 'easier' readability. CONCLUSIONS: Online patient education materials related to MIH are lacking in quality and reliability, and are too difficult for most to read easily. The authors of MIH-related online content should consider reference to quality of information tools when developing patient education materials.

An assessment of the treatment information contained within the websites of direct-to-consumer orthodontic aligner providers.

BACKGROUND: The use of direct-to-consumer (DTC) orthodontic aligners is growing. The purpose of this study was to evaluate the quality of information contained within the websites of DTC orthodontic aligner providers. METHODS: Websites that satisfied inclusion criteria were assessed for the presence of specific treatment-related features. Four validated quality of information instruments and readability tools were used to evaluate the content of the websites. Descriptive statistical analyses and intra-examiner reliability tests were performed. RESULTS: Twenty-one websites were evaluated. Few websites referred to the need for pre-treatment dental health (38.1%) and indefinite post-treatment retention (23.8%). Most websites (95.2%) were categorized as either 'poor' or 'very poor' according to their DISCERN scores. DISCERN items regarding information bias and treatment risks scored particularly poorly. Cohen's kappa intra-examiner reliability testing for DISCERN scores was 0.81-0.89. Three websites honoured two out of the four Journal of the American Medical Association benchmarks and 18 honoured one benchmark only. The readability scores indicated 'difficult to read' content. CONCLUSIONS: The quality of information contained within the websites of DTC orthodontic aligner providers is poor. Patient consent for DTC aligner treatment based solely on the information contained within the websites is likely to be invalid.

Web-based information on orthodontic clear aligners: a qualitative and readability assessment.

BACKGROUND: Data regarding the quality of information (QOI) related to orthodontic clear aligners (OCAs) on the internet are lacking. The aim of the present investigation was to assess the quality and readability of websites providing information regarding OCAs to prospective patients. METHODS: Three search terms were entered separately into three search engines. Four validated QOI instruments were used to determine the QOI and readability of the content contained within the websites that satisfied predetermined criteria. Descriptive statistical analyses and intrarater testing for DISCERN scores were calculated. RESULTS: Forty-nine websites satisfied inclusion/exclusion criteria. General dentists (44.9%) and specialist orthodontists (26.5%) authored the majority of websites. One website contained the Health on the Net (HON) code seal. Cohen's kappa for DISCERN scores was good (0.87). The overall mean (SD) DISCERN score was 38.55 (8.00)/80, range 26-60. The websites authored by 'Direct-to-consumer' OCA providers recorded the lowest DISCERN mean score (33/80). One website contained all four Journal of the American Medical Association (JAMA) benchmarks. The mean (SD) Flesch Reading Ease score was 53.92 (9.08), range 36-82.5. CONCLUSIONS: The QOI of the website content related to OCAs is poor and is 'fairly difficult' to read. Website authors should consider using QOI instruments and readability tools to enable the delivery of evidence-based and easily readable information regarding OCAs to prospective patients.

Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

BACKGROUND: The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. DISCUSSION: Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. CONCLUSIONS: In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult Critically Ill Patient

"OBJECTIVE: To update the 2002 version of ""Clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient."" DESIGN: A Task Force comprising 17 members of the Society of Critical Medicine with particular expertise in the use of neuromuscular-blocking agents; a Grading of Recommendations Assessment, Development, and Evaluation expert; and a medical writer met via teleconference and three face-to-face meetings and communicated via e-mail to examine the evidence and develop these practice guidelines. Annually, all members completed conflict of interest statements; no conflicts were identified. This activity was funded by the Society for Critical Care Medicine, and no industry support was provided. METHODS: Using the Grading of Recommendations Assessment, Development, and Evaluation system, the Grading of Recommendations Assessment, Development, and Evaluation expert on the Task Force created profiles for the evidence related to six of the 21 questions and assigned quality-of-evidence scores to these and the additional 15 questions for which insufficient evidence was available to create a profile. Task Force members reviewed this material and all available evidence and provided recommendations, suggestions, or good practice statements for these 21 questions. RESULTS: The Task Force developed a single strong recommendation: we recommend scheduled eye care that includes lubricating drops or gel and eyelid closure for patients receiving continuous infusions of neuromuscular-blocking agents. The Task Force developed 10 weak recommendations. 1) We suggest that a neuromuscular-blocking agent be administered by continuous intravenous infusion early in the course of acute respiratory distress syndrome for patients with a PaO2/FIO2 less than 150. 2) We suggest against the routine administration of an neuromuscular-blocking agents to mechanically ventilated patients with status asthmaticus. 3) We suggest a trial of a neuromuscular-blocking agents in life-threatening situations associated with profound hypoxemia, respiratory acidosis, or hemodynamic compromise. 4) We suggest that neuromuscular-blocking agents may be used to manage overt shivering in therapeutic hypothermia. 5) We suggest that peripheral nerve stimulation with train-of-four monitoring may be a useful tool for monitoring the depth of neuromuscular blockade but only if it is incorporated into a more inclusive assessment of the patient that includes clinical assessment. 6) We suggest against the use of peripheral nerve stimulation with train of four alone for monitoring the depth of neuromuscular blockade in patients receiving continuous infusion of neuromuscular-blocking agents. 7) We suggest that patients receiving a continuous infusion of neuromuscular-blocking agent receive a structured physiotherapy regimen. 8) We suggest that clinicians target a blood glucose level of less than 180 mg/dL in patients receiving neuromuscular-blocking agents. 9) We suggest that clinicians not use actual body weight and instead use a consistent weight (ideal body weight or adjusted body weight) when calculating neuromuscular-blocking agents doses for obese patients. 10) We suggest that neuromuscular-blocking agents be discontinued at the end of life or when life support is withdrawn. In situations in which evidence was lacking or insufficient and the study results were equivocal or optimal clinical practice varies, the Task Force made no recommendations for nine of the topics. 1) We make no recommendation as to whether neuromuscular blockade is beneficial or harmful when used in patients with acute brain injury and raised intracranial pressure. 2) We make no recommendation on the routine use of neuromuscular-blocking agents for patients undergoing therapeutic hypothermia following cardiac arrest. 3) We make no recommendation on the use of peripheral nerve stimulation to monitor degree of block in patients undergoing therapeutic hypothermia. 4) We make no recommendation on the use of neuromuscular blockade to improve the accuracy of intravascular-volume assessment in mechanically ventilated patients. 5) We make no recommendation concerning the use of electroencephalogram-derived parameters as a measure of sedation during continuous administration of neuromuscular-blocking agents. 6) We make no recommendation regarding nutritional requirements specific to patients receiving infusions of neuromuscular-blocking agents. 7) We make no recommendation concerning the use of one measure of consistent weight over another when calculating neuromuscular-blocking agent doses in obese patients. 8) We make no recommendation on the use of neuromuscular-blocking agents in pregnant patients. 9) We make no recommendation on which muscle group should be monitored in patients with myasthenia gravis receiving neuromuscular-blocking agents. Finally, in situations in which evidence was lacking or insufficient but expert consensus was unanimous, the Task Force developed six good practice statements. 1) If peripheral nerve stimulation is used, optimal clinical practice suggests that it should be done in conjunction with assessment of other clinical findings (e.g., triggering of the ventilator and degree of shivering) to assess the degree of neuromuscular blockade in patients undergoing therapeutic hypothermia. 2) Optimal clinical practice suggests that a protocol should include guidance on neuromuscular-blocking agent administration in patients undergoing therapeutic hypothermia. 3) Optimal clinical practice suggests that analgesic and sedative drugs should be used prior to and during neuromuscular blockade, with the goal of achieving deep sedation. 4) Optimal clinical practice suggests that clinicians at the bedside implement measure to attenuate the risk of unintended extubation in patients receiving neuromuscular-blocking agents. 5) Optimal clinical practice suggests that a reduced dose of an neuromuscular-blocking agent be used for patients with myasthenia gravis and that the dose should be based on peripheral nerve stimulation with train-of-four monitoring. 6) Optimal clinical practice suggests that neuromuscular-blocking agents be discontinued prior to the clinical determination of brain death."

Exploring attitudes toward eating disorders among elite athlete support personnel.

To date, little is known about the beliefs, attitudes, and experiences of athlete support personnel (ASP) working in elite sport toward disordered eating (DE) and eating disorders (EDs). This study seeks to explore this area of mental health, employing an attribution model of stigma as a conceptual lens. Interviews were undertaken with 14 service providers (seven males and seven females) working in high-performance sport in Ireland. In contrast to previous research in the general population, findings revealed that sport-based personnel, in the main, did not hold the individual responsible for the development of their eating disorder. The predominant emotional response of those who had worked with an athlete with a known or suspected eating disorder was anxiety and worry. In line with the findings of previous studies with other health professionals, negative views on the prognosis of those with EDs were expressed by the ASP. Furthermore, confidentiality was found to be a significant barrier to bringing athletes' disclosure of problematic eating or exercise behavior to the fore. The findings of this study add to the limited research exploring attitudes toward EDs in sport and highlights the importance of greater education and openness toward this particular mental health problem.

Overcoming the barriers experienced in conducting a medication trial in adults with aggressive challenging behaviour and intellectual disabilities.

BACKGROUND: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. METHOD: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and haloperidol) and placebo. RESULTS: The trial faced significant problems in recruitment. The intent was to recruit 120 patients over 2 years in three centres and to use a validated aggression scale (Modified Overt Aggression Scale) score as the primary outcome. Despite doubling the period of recruitment, only 86 patients were ultimately recruited. CONCLUSIONS: Variation in beliefs over the efficacy of drug treatment, difficulties within multidisciplinary teams and perceived ethical concerns over medication trials in this population all contributed to poor recruitment. Where appropriate to the research question cluster randomised trials represent an ethically and logistically feasible alternative to individually randomised trials.

Neuroleptics in the treatment of aggressive challenging behaviour for people with intellectual disabilities: a randomised controlled trial (NACHBID).

OBJECTIVE(S): To assess the effects and cost-effectiveness of haloperidol, risperidone and placebo on aggressive challenging behaviour in adults with intellectual disability. DESIGN: A double-blind randomised controlled trial of two drugs and placebo administered in flexible dosage, with full, independent assessments of aggressive and aberrant behaviour, global improvement, carer burden, quality of life and adverse drug effects at baseline, 4, 12 and 26 weeks, and comparison of total care costs in the 6 months before and after randomisation. At 12 weeks, patients were given the option of leaving the trial or continuing until 26 weeks. Assessments of observed aggression were also carried out with key workers at weekly intervals throughout the trial. SETTING: Patients were recruited from all those being treated by intellectual disability services in eight sites in England, one in Wales and one in Queensland, Australia. PARTICIPANTS: Patients from all severity levels of intellectual disability; recruitment was extended to include those who may have been treated with neuroleptic drugs in the past. EXCLUSION CRITERIA: treatment with depot neuroleptics/another form of injected neuroleptic medication within the last 3 months; continuous oral neuroleptic medication within the last week; those under a section of the Mental Health Act 1983 or Queensland Mental Health Act 2000. INTERVENTIONS: Randomisation to treatment with haloperidol (a typical neuroleptic drug), risperidone (an atypical neuroleptic drug) or placebo using a permuted blocks procedure. Dosages were: haloperidol 1.25-5.0 mg daily; risperidone 0.5-2.0 mg daily. MAIN OUTCOME MEASURES: Primary: reduction in aggressive episodes between baseline and 4 weeks using Modified Overt Aggression Scale. Secondary: Aberrant Behaviour Checklist; Uplift/Burden Scale; 40-item Quality of Life Questionnaire; Udvalg for Kliniske Undersøgelser scale; Clinical Global Impressions scale. Economic costs recorded using a modified version of Client Service Receipt Inventory for 6 months before and after randomisation. RESULTS: There were considerable difficulties in recruitment because of ethical and consent doubts. Twenty-two clinicians recruited a total of 86 patients. Mean daily dosages were 1.07 mg rising to 1.78 mg for risperidone and 2.54 mg rising to 2.94 mg for haloperidol. Aggression declined dramatically with all three treatments by 4 weeks, with placebo showing the greatest reduction (79%, versus 57% for combined drugs) (p = 0.06). Placebo-treated patients showed no evidence of inferior response in comparison to patients receiving neuroleptic drugs. An additional study found that clinicians who had not participated in clinical trials before were less likely to recruit. Mean total cost of accommodation, services, informal care and treatment over the 6 months of the trial was 16,336 pounds for placebo, 17,626 pounds for haloperidol and 18,954 pounds for risperidone. CONCLUSIONS: There were no significant important benefits conferred by treatment with risperidone or haloperidol, and treatment with these drugs was not cost-effective. While neuroleptic drugs may be of value in the treatment of aggressive behaviour in some patients with intellectual disability, the underlying pathology needs to be evaluated before these are given. The specific diagnostic indications for such treatment require further investigation. Prescription of low doses of neuroleptic drugs in intellectual disability on the grounds of greater responsiveness and greater liability to adverse effects also needs to be re-examined.

Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis.

BACKGROUND: The objective of this report is to describe the roles, responsibilities and recommendations of a 3-member Event Adjudication Committee (EAC) and a 5-member data monitoring committee (DMC) for a prospective multicenter observational study of critically ill patients with renal insufficiency examining the bioaccumulation and bleeding risk associated with dalteparin thromboprophylaxis. METHODS: The EAC reviewed bleeding events to adjudicate whether they were major or minor and whether they were related to dalteparin (uncertain, unlikely, or likely). The DMC reviewed all bleeds deemed by the EAC as uncertain or likely due to dalteparin then recommended either to continue or suspend enrolment pending review by the steering committee, or requested more information. RESULTS: Consensus on bleeding severity was achieved for all cases. At the second planned interim analysis, the EAC recommended to the DMC and steering committee that the EAC should stop adjudicating whether bleeding was related to dalteparin since attribution was challenging in this population with numerous bleeding risk factors; moreover, no bleeding rates were available from prior studies or historical or concurrent controls. CONCLUSIONS: Adjudication of whether an outcome can be attributed to an intervention in an open-label, uncontrolled observational study gives a potentially misleading impression of research oversight without methodological face validity. In this study, the EAC recommended modification of the adjudication process, and the DMC recommended continuing enrolment to achieve the target sample size.

An evaluation of the conservative dual-criterion method for teaching university students to visually inspect AB-design graphs.

The present study evaluated the effects of both a traditional lecture and the conservative dual-criterion (CDC) judgment aid on the ability of 6 university students to visually inspect AB-design line graphs. The traditional lecture reliably failed to improve visual inspection accuracy, whereas the CDC method substantially improved the performance of each participant.

Dalteparin thromboprophylaxis for critically ill medical-surgical patients with renal insufficiency.

PURPOSE: Thromboprophylaxis with low-molecular-weight heparin (LMWH) may be more effective than unfractionated heparin but also more likely to bioaccumulate and potentially cause bleeding in patients with renal insufficiency. The objectives of this study were to assess, among medical-surgical patients in the intensive care unit receiving dalteparin 5,000 IU daily for thromboprophylaxis, (1) the relationship between renal dysfunction and LMWH bioaccumulation as measured by trough anti-Xa levels, (2) the relationship between renal dysfunction and risk of bleeding as measured by a surrogate marker (peak anti-Xa levels), and (3) the relationship between anti-Xa levels, bleeding events, and thrombotic events. MATERIALS AND METHODS: In this prospective single-center cohort study, we enrolled patients 18 years or older, expected to stay 72 hours or longer, and with a creatinine clearance 30 mL/min or higher at intensive care unit admission. We administered 5,000 IU dalteparin subcutaneously each day. The main phase 1 objective was to detect bioaccumulation of dalteparin by measuring trough anti-Xa levels (22-23 hours post dalteparin). The main phase 2 objective was to examine the relationship between renal dysfunction and peak anti-Xa levels (4 hours post dalteparin). We recorded creatinine clearance daily and bleeding and thrombotic events, blinded to anti-Xa levels. RESULTS: We enrolled 19 patients aged 62.7 (13.2) years with an APACHE II score of 23.5 (9.4). We measured trough anti-Xa levels on 185 occasions in 19 patients; we measured peak anti-Xa levels on 113 occasions in 11 patients. We identified no bioaccumulation of LMWH in this study, as detected by trough anti-Xa levels. Most peak anti-Xa levels were in the conventional prophylactic range. CONCLUSIONS: When administered in prophylactic doses to critically ill patients with a wide range of calculated creatinine clearances, we found no evidence of bioaccumulation of dalteparin. If dalteparin does not bioaccumulate, it may be an attractive alternative agent for thromboprophylaxis.

Neither baseline tests of molecular hypercoagulability nor D-dimer levels predict deep venous thrombosis in critically ill medical-surgical patients.

OBJECTIVE: Predicting patients who are harboring asymptomatic deep venous thrombosis (DVT), or who are at particular risk of developing DVT, is a desirable clinical goal since prevention or early treatment of DVT might reduce the risk of fatal pulmonary embolism. Thus validation of simple laboratory tests that reliably predict venous thromboembolism (VTE) would be clinically very important. Tests that might be useful for these applications include markers of hypercoagulability (predicting patients at risk of DVT) and D-dimer (predicting which patients may have acute DVT). METHODS: In a prospective cohort study we measured a panel of hypercoagulability markers at the time of ICU admission, and six commercial D-dimer assays were performed serially during the ICU stay in medical-surgical ICU patients who were screened for DVT with biweekly lower limb compression ultrasonography. Ultrasonography was also performed at the time of any clinically suspected DVT events. We matched cases with DVT with controls without DVT for length of stay in the ICU to generate receiver operating characteristics (ROC) curves. RESULTS: One hundred ninety-seven patients were enrolled. Blood was collected on a total of 763 occasions (median number of occasions per patient: 3, range 1-21). None of the assays predicted DVT, as indicated by the areas under the ROC curves, that did not differ significantly from 50%. CONCLUSION: In critically ill patients, neither tests of hypercoagulability nor D-dimer levels predict patients at risk of DVT and thus they should not be used to guide diagnostic testing for DVT.

Pharmacologic therapies for adults with acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Multiple pharmacologic treatments have been studied for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). OBJECTIVES: Our objective was to determine the effects of pharmacologic treatments on clinical outcomes in adults with ALI or ARDS. SEARCH STRATEGY: We searched OVID versions of CENTRAL (The Cochrane Library Issue 3, 2003), MEDLINE (1966 to week 2, January 2004), EMBASE (1980 to week 4, 2004), CINAHL (1982 to week 2, January 2004), and HEALTHSTAR (1995 to December 2003); proceedings from four conferences (1994 to 2003); and bibliographies of review articles and included studies. SELECTION CRITERIA: Randomized controlled trials of pharmacologic treatments compared to no therapy or placebo for established ALI or ARDS in adults admitted to an intensive care unit, with measurement of early mortality (primary outcome), late mortality, duration of mechanical ventilation, ventilator-free days to day 28, or adverse events. We excluded trials of nitric oxide, partial liquid ventilation, fluid and nutritional interventions, oxygen, and trials in other populations reporting outcomes in subgroups of patients with ALI or ARDS. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened titles and abstracts, rated studies for inclusion, extracted data and assessed methodologic quality of included studies. Disagreements were resolved by consensus in consultation with a third reviewer. For each pharmacologic therapy, we quantitatively pooled the results of studies using random effects models where permitted by the available data. We contacted study authors when clarification of the primary outcome was required. MAIN RESULTS: Thirty three trials randomizing 3272 patients met our inclusion criteria. Pooling of results showed no effect on early mortality of prostaglandin E1 (seven trials randomizing 697 patients; relative risk [RR] 0.95, 95% confidence interval [CI] 0.77 to 1.17), N-acetylcysteine (five trials randomizing 239 patients; RR 0.89, 95% CI 0.65 to 1.21), early high-dose corticosteroids (two trials randomizing 187 patients; RR 1.12, 95% CI 0.72 to 1.74), or surfactant (nine trials randomizing 1441 patients; RR 0.93, 95% CI 0.77 to 1.12). Two interventions were beneficial in single small trials; corticosteroids given for late phase ARDS reduced hospital mortality (24 patients; RR 0.20, 95% CI 0.05 to 0.81), and pentoxifylline reduced one-month mortality (RR 0.67, 95% CI 0.47 to 0.95) in 30 patients with metastatic cancer and ARDS. Individual trials of nine additional interventions failed to show a beneficial effect on prespecified outcomes. REVIEWERS' CONCLUSIONS: Effective pharmacotherapy for ALI and ARDS is extremely limited, with insufficient evidence to support any specific intervention.

Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure.

BACKGROUND: Noninvasive positive pressure ventilation (NPPV) provides ventilatory support without the need for an invasive airway. Interest has emerged in using NPPV to facilitate earlier removal of the endotracheal tube and decrease complications associated with prolonged intubation. OBJECTIVES: To summarize the evidence comparing NPPV and invasive positive pressure ventilation (IPPV) weaning on clinical outcomes in intubated adults with respiratory failure. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 2, 2003), MEDLINE (January 1966 to July 2003) and EMBASE (January 1980 to July 2003) for randomized controlled trials comparing NPPV and IPPV weaning. Additional data sources included personal files, conference proceedings and author contact. SELECTION CRITERIA: Randomized and quasi-randomized studies comparing early extubation with immediate application of NPPV to IPPV weaning in intubated adults with respiratory failure. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and abstracted data according to prespecified criteria. Sensitivity and subgroup analyses were planned to assess the impact of (i) excluding quasi-randomized trials and (ii) the etiology of respiratory failure on outcomes. MAIN RESULTS: We identified eleven trials, of which five were included, involving 171 participants with predominantly chronic obstructive pulmonary disease. Overall, the included studies were of moderate to good quality. Compared to the IPPV strategy, the NPPV strategy decreased mortality (RR 0.41, 95% CI 0.22 to 0.76), the incidence of ventilator associated pneumonia (RR 0.28, 95% CI 0.09 to 0.85), intensive care unit length of stay (WMD -6.88 days, 95% CI -12.60 to -1.15), hospital length of stay (WMD -7.33 days, 95%CI -14.05 to -0.61), total duration of mechanical support (WMD -7.33 days, 95% CI -11.45 to -3.22) and the duration of endotracheal mechanical ventilation (WMD -6.79 days, 95% CI -11.70 to -1.87). There was no effect of NPPV on weaning failures or the duration of mechanical support related to weaning and insufficient data to pool adverse events or quality of life. Excluding a single quasi-randomized trial maintained the significant reduction in mortality and ventilator associated pneumonia. Subgroup analyses suggested that the mortality benefit of the NPPV approach is greater in patients with chronic obstructive pulmonary disease. REVIEWER'S CONCLUSIONS: Summary estimates from five studies of moderate to good quality demonstrated a consistent positive effect on overall mortality. At present, use of NPPV to facilitate weaning in mechanically ventilated patients, with predominantly chronic obstructive lung disease, is associated with promising, although insufficient, evidence of net clinical benefit.

Clinical estimation of trunk position among mechanically ventilated patients.

OBJECTIVES: Trunk position at 45 degrees from the horizontal is associated with a decreased risk of gastroesophageal aspiration. The objectives of this study were to determine the accuracy of trunk flexion estimates compared to a reference standard measurement, and to determine agreement about trunk flexion among ICU clinicians. DESIGN: Prospective observational study. SETTING: Two university-affiliated medical-surgical ICUs. PATIENTS AND PARTICIPANTS: Thirty-three mechanically ventilated ICU patients, seven residents, two fellows, three intensivists, and twenty-eight bedside nurses. INTERVENTIONS: Prospectively, concurrently, and independently during rounds, one bedside nurse, one resident, one fellow, and one intensivist clinically estimated the trunk flexion of mechanically ventilated patients. To record the reference standard, a trained investigator measured trunk position in the vertical plane using a goniometer. MEASUREMENTS AND RESULTS: We made 438 clinical assessments on 33 patients aged 57.2+/-19.4 (SD) years with an APACHE II score of 27.3+/-9.4. Mean trunk flexion estimates were: nurses 24.3+/-12.3 degrees from the horizontal, residents 20.2+/-13.7, fellows 20.3+/-10.8, and intensivists 21.1+/-13.1 compared to the reference standard measurement 16.2+/-9.0 degrees. The accuracy of trunk flexion estimates was fair to moderate [intraclass correlation for reference standard versus nurses (ICC 0.42), residents (ICC 0.52), fellows (ICC 0.36), and intensivists (ICC 0.55)]. The agreement among different groups of clinicians was moderate. CONCLUSIONS: In mechanically ventilated patients, we found that clinical estimates of trunk position were moderately good, agreement amongst caregivers was moderately good, but that all clinicians tended to overestimate the angle of semirecumbency.

The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients.

OBJECTIVE: To estimate the mortality and length of stay in the intensive care unit (ICU) attributable to clinically important gastrointestinal bleeding in mechanically ventilated critically ill patients. DESIGN: Three strategies were used to estimate the mortality attributable to bleeding in two multicentre databases. The first method matched patients who bled with those who did not (matched cohort), using duration of ICU stay prior to the bleed, each of six domains of the Multiple Organ Dysfunction Score (MODS) measured 3 days prior to the bleed, APACHE II score, age, admitting diagnosis, and duration of mechanical ventilation. The second approach employed Cox proportional hazards regression to match bleeding and non-bleeding patients (model-based matched cohort). The third method, instead of matching, derived estimates based on regression modelling using the entire population (regression method). Three parallel analyses were conducted for the length of ICU stay attributable to clinically important bleeding. SETTING: Sixteen Canadian university-affiliated ICUs. PATIENTS: A total of 1666 critically ill patients receiving mechanical ventilation for at least 48 hours. MEASUREMENTS: We prospectively collected data on patient demographics, APACHE II score, admitting diagnosis, daily MODS, clinically important bleeding, length of ICU stay, and mortality. Independent adjudicators determined the occurrence of clinically important gastrointestinal bleeding, defined as overt bleeding in association with haemodynamic compromise or blood transfusion. RESULTS: Of 1666 patients, 59 developed clinically important gastrointestinal bleeding. The mean APACHE II score was 22.9 +/- 8.6 among bleeding patients and 23.3 +/- 7.7 among non-bleeding patients. The risk of death was increased in patients with bleeding using all three analytic approaches (matched cohort method: relative risk [RR]= 2.9, 95% confidence interval (CI)= 1.6-5.5; model-based matched cohort method: RR = 1.8, 95% CI = 1.1-2.9; and the regression method: RR = 4.1, 95% CI = 2.6-6.5). However, this was not significant for the adjusted regression method (RR = 1.0, 95% CI = 0.6-1.7). The median length of ICU stay attributable to clinically important bleeding for these three methods, respectively, was 3.8 days (95% CI = -0.01 to 7.6 days), 6.7 days (95% CI = 2.7-10.7 days), and 7.9 days (95% CI = 1.4-14.4 days). CONCLUSIONS: Clinically important upper gastrointestinal bleeding has an important attributable morbidity and mortality, associated with a RR of death of 1-4 and an excess length of ICU stay of approximately 4-8 days.

An evidence-based approach to acute respiratory distress syndrome.

We provide an evidence-based approach to managing patients with acute lung injury and acute respiratory distress syndrome (ARDS). We searched MEDLINE and the Cumulative Index to Nursing and Allied Health for randomized trials evaluating lung-protective ventilation strategies, inhaled nitric oxide, prone positioning, and late-phase corticosteroids for managing these patients, and for additional literature related to long-term follow-up of ARDS survivors. The results of our review suggest that pressure- and volume-limited ventilation, according to the ARDS Network protocol, can reduce mortality for patients with acute lung injury, and so may an "open lung" approach to mechanical ventilation. Those 2 strategies are currently being compared in 2 multicenter randomized trials. Although both inhaled nitric oxide therapy and prone positioning can produce dramatic acute improvements in oxygenation for some patients, there is no evidence that these interventions can benefit patients with respect to patient-important outcomes. Therefore it is unreasonable to be dogmatic about the role of inhaled nitric oxide and prone positioning in ARDS. The role of corticosteroids in the late phase of ARDS is unclear and remains a very important unanswered question. With respect to long-term follow-up, we found that pulmonary dysfunction is probably not a major source of morbidity for ARDS survivors, whereas neuropsychological dysfunction is prominent. Ongoing research may suggest interventions to improve the outcome of ARDS and of critical illness in general.