METHODS: We used prospective data from the first 1,500 patients included in IGOS, aged ≥6 years and unable to walk independently. We evaluated whether the mEGOS at entry and week 1 could predict the inability to walk unaided at 4 and 26 weeks in the full cohort and in regional subgroups, using 2 measures for model performance: (1) discrimination: area under the receiver operating characteristic curve (AUC) and (2) calibration: observed vs predicted probability of being unable to walk independently. To improve the model predictions, we recalibrated the model containing the overall mEGOS score, without changing the individual predictive factors. Finally, we assessed the predictive ability of the individual factors.
RESULTS: For validation of mEGOS at entry, 809 patients were eligible (Europe/North America [n = 677], Asia [n = 76], other [n = 56]), and 671 for validation of mEGOS at week 1 (Europe/North America [n = 563], Asia [n = 65], other [n = 43]). AUC values were >0.7 in all regional subgroups. In the Europe/North America subgroup, observed outcomes were worse than predicted; in Asia, observed outcomes were better than predicted. Recalibration improved model accuracy and enabled the development of a region-specific version for Europe/North America (mEGOS-Eu/NA). Similar to the original mEGOS, severe limb weakness and higher age were the predominant predictors of poor outcome in the IGOS cohort.
DISCUSSION: mEGOS is a validated tool to predict the inability to walk unaided at 4 and 26 weeks in patients with GBS, also in countries outside the Netherlands. We developed a region-specific version of mEGOS for patients from Europe/North America.
CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that the mEGOS accurately predicts the inability to walk unaided at 4 and 26 weeks in patients with GBS.
TRIAL REGISTRATION INFORMATION: NCT01582763.
METHODS: We searched PubMed, Scopus, EMBASE, CINAHL, and Cochrane Library for relevant articles published from inception to 28th February 2021. All authors were involved in the screening and selection of studies. Original studies investigating the therapeutic, humanistic, safety, and economic impact of clinical pharmacists in Pakistani patients (hospitalised or outpatients) were selected. Two reviewers independently assessed the risk of bias in studies, and discrepancies were resolved through mutual consensus. All of the included studies were descriptively synthesised, and PRISMA reporting guidelines were followed.
RESULTS: The literature search found 751 articles from which nine studies were included; seven were randomized controlled trials (RCTs), and two were observational studies. Three RCTs included were having a low risk of bias (ROB), two RCTs were having an unclear ROB, while two RCTs were having a high ROB. The nature of clinical pharmacist interventions included one or more components such as disease-related education, lifestyle changes, medication adherence counselling, medication therapy management, and discussions with physicians about prescription modification if necessary. Clinical pharmacist interventions reduce medication-related errors, improve therapeutic outcomes such as blood pressure, glycemic control, lipid control, CD4 T lymphocytes, and renal functions, and improve humanistic outcomes such as patient knowledge, adherence, and health-related quality of life. However, no study reported the economic outcomes of interventions.
CONCLUSIONS: The findings of the studies included in this systematic review suggest that clinical pharmacists play important roles in improving patients' health outcomes in Pakistan; however, it should be noted that the majority of the studies have a high risk of bias, and more research with appropriate study designs is needed.
DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM).
METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice.
RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities.
CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.
AIM: This review aimed to explore the effects of psychoeducational interventions on improving outcome measures for patients diagnosed with schizophrenia.
METHODS: The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guideline was used in this systematic review. Two reviewers were involved in screening articles for inclusion and in the data extraction process. The selected studies were assessed for quality using the 'Consolidated Standards of Reporting Trial (CONSORT)' checklist. Out of the 441 records identified, 11 papers were considered for full review (from 2000 to 2018).
RESULTS: The psychoeducational interventions showed a consistent improvement in many outcome measures. Most of the reviewed studies focused on outpatients and the method of delivering the psychoeducational interventions was mostly in lecture format.
CONCLUSION: This systematic review of randomized controlled trial studies emphasizes the positive impact of psychoeducational interventions for patients diagnosed with schizophrenia concerning various outcome measures. The findings of this review have important implications for both nursing practice and research, as the information presented can be used by the administrators and stakeholders of mental health facilities to increase their understanding and awareness of the importance of integrating psychoeducational interventions in the routine care of patients diagnosed with schizophrenia.
METHODS: We conducted an observational crossover bench study to compare the cannula-to-Melker with the scalpel-bougie technique in a porcine tracheal model. Twenty-eight anesthetists participated. The primary outcome was time taken for device insertion. Secondary outcomes were first-pass success rate, incidence of tracheal trauma, and technique preference. We also compared the data on outcome measures with the data obtained in a similar workshop a year ago.
RESULTS: The scalpel-bougie technique was significantly faster than the cannula-to-Melker technique for cricothyroidotomy (median time of 45.2 s vs. 101.3 s; P = 0.001). Both techniques had 100% success rate within two attempts; there were no significant differences in the first-pass success rates and incidence of tracheal wall trauma (P > 0.999 and P = 0.727, respectively) between them. The relative risks of inflicting tracheal wall trauma after a failed cricothyroidotomy attempt were 6.9 (95% CI 1.5-31.1), 2.3 (95% CI 0.3-20.7) and 3.0 (95% CI 0.3-25.9) for the scalpel-bougie, cannula-cricothyroidotomy, and Melker-Seldinger airway, respectively. The insertion time and incidence of tracheal wall trauma were lower when the present data were compared with data from a similar workshop conducted the previous year.
CONCLUSIONS: This study supports the use of a scalpel-bougie technique for cricothyroidotomy by anesthetists and advocates a yearly training program for skill retention.
OBJECTIVE: With the growing body of evidence supporting the use of eHealth interventions, the intention is to conduct a meta-analysis on various health outcomes of eHealth interventions among ischaemic heart disease (IHD) patients.
METHODS: Based on PRISMA guidelines, eligible studies were searched through databases of Web of Science, Scopus, PubMed, EBSCOHost, and SAGE (PROSPERO registration CRD42021290091). Inclusion criteria were English language and randomised controlled trials published between 2011 to 2021 exploring health outcomes that empower IHD patients with eHealth interventions. RevMan 5.4 was utilised for meta-analysis, sensitivity analysis, and risk of bias (RoB) assessment while GRADE software for generating findings of physical health outcomes. Non-physical health outcomes were analysed using SWiM (synthesis without meta-analysis) method.
RESULTS: This review included 10 studies, whereby, six studies with 895 participants' data were pooled for physical health outcomes. Overall, the RoB varied significantly across domains, with the majority was low risks, a substantial proportion of high risks and a sizeable proportion of unclear. With GRADE evidence of moderate to high quality, eHealth interventions improved low density lipoprotien (LDL) levels in IHD patients when compared to usual care after 12 months of interventions (SMD -0.26, 95% CI [-0.45, -0.06], I2 = 0%, p = 0.01). Significance appraisal in each domain of the non-physical health outcomes found significant findings for medication adherence, physical activity and dietary behaviour, while half of the non-significant findings were found for other behavioural outcomes, psychological and quality of life.
CONCLUSIONS: Electronic Health interventions are found effective at lowering LDL cholesterol in long-term but benefits remain inconclusive for other physical and non-physical health outcomes for IHD patients. Integrating sustainable patient empowerment strategies with the advancement of eHealth interventions by utilising appropriate frameworks is recommended for future research.
OBJECTIVE: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.
EVIDENCE REVIEW: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.
FINDINGS: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]).
CONCLUSIONS AND RELEVANCE: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.
METHODS AND ANALYSIS: This mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.
ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.
REGISTRATION DETAILS: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1371.
METHODS: Traumatic cardiac arrest patients from 13 countries in the Pan-Asian Resuscitation Outcomes Study registry from 2009 to 2018 were analyzed. Multilevel logistic regression was performed to identify factors associated with the primary outcomes of survival to hospital discharge and favorable neurological outcome (Cerebral Performance Category (CPC) 1-2), and the secondary outcome of return of spontaneous circulation (ROSC).
RESULTS: There were 207,455 out-of-hospital cardiac arrest cases, of which 13,631 (6.6%) were trauma patients aged 18 years and above with resuscitation attempted and who had survival outcomes reported. The median age was 57 years (interquartile range 39-73), 23.0% received bystander cardiopulmonary resuscitation (CPR), 1750 (12.8%) had ROSC, 461 (3.4%) survived to discharge, and 131 (1.0%) had CPC 1-2. Factors associated with higher rates of survival to discharge and favorable neurological outcome were arrests witnessed by emergency medical services or private ambulances (survival to discharge adjusted odds ratio (aOR) = 2.95, 95% confidence interval (CI) = 1.99-4.38; CPC 1-2 aOR = 2.57, 95% CI = 1.25-5.27), bystander CPR (survival to discharge aOR = 2.16; 95% CI 1.71-2.72; CPC 1-2 aOR = 4.98, 95% CI = 3.27-7.57), and initial shockable rhythm (survival to discharge aOR = 12.00; 95% CI = 6.80-21.17; CPC 1-2 aOR = 33.28, 95% CI = 11.39-97.23) or initial pulseless electrical activity (survival to discharge aOR = 3.98; 95% CI = 2.99-5.30; CPC 1-2 aOR = 5.67, 95% CI = 3.05-10.53) relative to asystole.
CONCLUSIONS: In traumatic cardiac arrest, early aggressive resuscitation may not be futile and bystander CPR may improve outcomes.
METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted.
RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high.
CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness.
TRIAL REGISTRATION: PROSPERO (CRD42023438187). Registered 21/06/2023.