Framework For Critical Appraisal Research Articles

A systematic review of cardiac surgery clinical prediction models that include intra-operative variables.

Most cardiac surgery clinical prediction models (CPMs) are developed using pre-operative variables to predict post-operative outcomes. Some CPMs are developed with intra-operative variables, but none are widely used. The objective of this systematic review was to identify CPMs with intra-operative variables that predict short-term outcomes following adult cardiac surgery. Ovid MEDLINE and EMBASE databases were searched from inception to December 2022, for studies developing a CPM with at least one intra-operative variable. Data were extracted using a critical appraisal framework and bias assessment tool. Model performance was analysed using discrimination and calibration measures. A total of 24 models were identified. Frequent predicted outcomes were acute kidney injury (9/24 studies) and peri-operative mortality (6/24 studies). Frequent pre-operative variables were age (18/24 studies) and creatinine/eGFR (18/24 studies). Common intra-operative variables were cardiopulmonary bypass time (16/24 studies) and transfusion (13/24 studies). Model discrimination was acceptable for all internally validated models (AUC 0.69-0.91). Calibration was poor (15/24 studies) or unreported (8/24 studies). Most CPMs were at a high or indeterminate risk of bias (23/24 models). The added value of intra-operative variables was assessed in six studies with statistically significantly improved discrimination demonstrated in two. Weak reporting and methodological limitations may restrict wider applicability and adoption of existing CPMs that include intra-operative variables. There is some evidence that CPM discrimination is improved with the addition of intra-operative variables. Further work is required to understand the role of intra-operative CPMs in the management of cardiac surgery patients.

CN83 Interventions to alleviate depression and anxiety in women with ovarian cancer to improve mental health and health-related quality of life

Patients with ovarian cancer, who also deal with depression and/or anxiety, are at a significantly greater risk of higher mortality rates, increased hospital stays, poorer mental health and, reduced health-related quality of life (HRQoL). This structured review aims to critically appraise and synthesise up to date evidence on the effectiveness of psychosocial interventions to combat anxiety and depression, to improve mental health and HRQoL in women with ovarian cancer at any point in the cancer trajectory. We explored the effectiveness of diverse interventions to combat depression and/or anxiety in adult women with a confirmed ovarian cancer diagnosis, offered at any point in the cancer trajectory. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines, peer reviewed publications of true and quasi-experimental studies were identified through a search of the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Excerpta Medica Online (Embase), and medical Literature Online (MEDLINE) databases from 2008 to 2021. The Critical Appraisal Framework for Original Research (CAFFOR) was used to to assess methodological rigour. Findings were synthesised using quantitative grouping and a narrative critical analysis. Seven studies were selected for the analysis of the findings and methodology of each paper and the discussion. The interventions were grouped into three different types: nurse-led, CBT-based, and exercise. Irrespective of type, the reviewed supportive care interventions seem to be beneficial in reducing patients' distress and enhancing HRQoL among ovarian cancer survivors. Focusing on people living with ovarian cancer, particularly at the early stages of development, may help improve the mortality rate of the patient group. To improve mental health and HRQoL in this group of patients, more rigorous development of existing interventions is necessary, as well as early screening for mental health deficits. Nurses play an essential role in improving mental health and HRQoL for women with ovarian cancer by leading and/or supporting delivery of complex supportive care interventions.

Synthetic and External Controls in Clinical Trials - A Primer for Researchers.

There has been a rapid expansion in the use of non-randomized evidence in the regulatory approval of treatments globally. An emerging set of methodologies have been utilized to provide greater insight into external control data used for these purposes, collectively known as synthetic control methods. Through this paper, we provide the reader with a set of key questions to help assess the quality of literature publications utilizing synthetic control methodologies. Common challenges and real-life examples of synthetic controls are provided throughout, alongside a critical appraisal framework with which to assess future publications.

Peak Oxygen Uptake in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Meta-Analysis.

To evaluate the magnitude of the difference in VO2peak between patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME) and apparently healthy controls, 7 databases (Cochrane, PubMed, PsycINFO, Web of Knowledge, Embase, Scopus, Medline) were searched for articles published up to March 2018. Search terms included "chronic fatigue syndrom*"AND ("peak" OR "maxim*" OR "max") AND ("oxygen uptake" OR "oxygen consumption" OR "VO2peak" or "VO2max". Eligibility criteria were adults>18 y with clinically diagnosed CFS/ME, with VO2peak measured in a maximal test and compared against an apparently healthy control group. The methodological quality of included studies was assessed using a modified Systematic Appraisal of Quality for Observational Research critical appraisal framework. A random effects meta-analysis was conducted on 32 cross-sectional studies (effects). Pooled mean VO2peak was 5.2 (95% CI: 3.8-6.6) ml.kg-1min-1 lower in CFS/ME patients vs. healthy controls. Between-study variability (Tau) was 3.4 (1.5-4.5) ml.kg-1min-1 indicating substantial heterogeneity. The 95% prediction interval was -1.9 to 12.2 ml.kg-1min-1. The probability that the effect in a future study would be>the minimum clinically important difference of 1.1 ml.kg-1min-1 (in favour of controls) was 0.88 - likely to be clinically relevant. Synthesis of the available evidence indicates that CFS/ME patients have a substantially reduced VO2peak compared to controls.

The future for diagnostic tests of acute kidney injury in critical care: evidence synthesis, care pathway analysis and research prioritisation.

Acute kidney injury (AKI) is highly prevalent in hospital inpatient populations, leading to significant mortality and morbidity, reduced quality of life and high short- and long-term health-care costs for the NHS. New diagnostic tests may offer an earlier diagnosis or improved care, but evidence of benefit to patients and of value to the NHS is required before national adoption. To evaluate the potential for AKI in vitro diagnostic tests to enhance the NHS care of patients admitted to the intensive care unit (ICU) and identify an efficient supporting research strategy. We searched ClinicalTrials.gov, The Cochrane Library databases, Embase, Health Management Information Consortium, International Clinical Trials Registry Platform, MEDLINE, metaRegister of Current Controlled Trials, PubMed and Web of Science databases from their inception dates until September 2014 (review 1), November 2015 (review 2) and July 2015 (economic model). Details of databases used for each review and coverage dates are listed in the main report. The AKI-Diagnostics project included horizon scanning, systematic reviewing, meta-analysis of sensitivity and specificity, appraisal of analytical validity, care pathway analysis, model-based lifetime economic evaluation from a UK NHS perspective and value of information (VOI) analysis. The horizon-scanning search identified 152 potential tests and biomarkers. Three tests, Nephrocheck® (Astute Medical, Inc., San Diego, CA, USA), NGAL and cystatin C, were subjected to detailed review. The meta-analysis was limited by variable reporting standards, study quality and heterogeneity, but sensitivity was between 0.54 and 0.92 and specificity was between 0.49 and 0.95 depending on the test. A bespoke critical appraisal framework demonstrated that analytical validity was also poorly reported in many instances. In the economic model the incremental cost-effectiveness ratios ranged from £11,476 to £19,324 per quality-adjusted life-year (QALY), with a probability of cost-effectiveness between 48% and 54% when tests were compared with current standard care. The major limitation in the evidence on tests was the heterogeneity between studies in the definitions of AKI and the timing of testing. Diagnostic tests for AKI in the ICU offer the potential to improve patient care and add value to the NHS, but cost-effectiveness remains highly uncertain. Further research should focus on the mechanisms by which a new test might change current care processes in the ICU and the subsequent cost and QALY implications. The VOI analysis suggested that further observational research to better define the prevalence of AKI developing in the ICU would be worthwhile. A formal randomised controlled trial of biomarker use linked to a standardised AKI care pathway is necessary to provide definitive evidence on whether or not adoption of tests by the NHS would be of value. The systematic review within this study is registered as PROSPERO CRD42014013919. The National Institute for Health Research Health Technology Assessment programme.

A Conceptual Framework for Critical Appraisal in Systematic Mixed Studies Reviews

The past decade has been rich with methodological advancements in systematic reviews, several of which were inspired by the literature on mixed methods research. Systematic mixed studies reviews—that is, reviews combining qualitative and quantitative evidence—are increasingly popular as they can provide a better understanding of complex phenomena and interventions. However, they raise new challenges, especially regarding how to perform critical appraisal of the included studies that vary regarding the methodologies used. To address this challenge, conceptually clarifying critical appraisal is necessary. To this end, this article provides a framework for critical appraisal in systematic mixed studies reviews. This framework is an essential first step toward providing clear guidance on how to perform critical appraisal.

Factors associated with the uptake of seasonal influenza vaccination in adults: a systematic review.

Studies on different populations have shown that a variety of factors influence attitudes and decision in the general population on vaccine uptake. This study explores factors associated with the uptake of influenza vaccination among adults. A systematic literature review was performed on literature searched in databases EMBASE, MEDLINE, Cochrane Library and Electronic Theses Online Service up until November 2013. A critical appraisal framework was designed to assess the methodological quality of the studies. Twenty-three articles met the inclusion criteria and were selected for outcome analysis and 21 were quantitative observational studies. Advancement in age (OR 1.06-23.7) and having chronic diseases (OR 1.38-13.7) were strongly indicative of vaccine uptake. Perceptions on vaccine efficacy (OR 2.7-10.55) and vaccine safety and adverse events (OR 10.5) were more influential than the level of knowledge on influenza and its vaccination. Advice from doctors/health professionals/family and/or close friends and free vaccination were also key factors in association with uptake of vaccination. This review highlighted the finding that perception on vaccine efficacy, perception on vaccine safety and adverse events, advice from doctors/health professionals/family/close friends and free vaccination are changeable factors that are strongly associated with influenza vaccination in adults aged 18-64.

Creating Australia's National Landscapes: Issues of collaborative destination management

Innovative and holistic approaches to destination marketing and management are needed to ensure that protected areas are managed, marketed and governed effectively alongside adjacent lands. This paper discusses Australia's National Landscapes Program, a collaborative nationwide initiative between parks and tourism agencies, local and state governments, and the private and non-profit sectors. A critical appraisal framework is presented for the various elements of the Program: geographical, ecological, socio-economic, cultural and visitor information. This paper argues that the approach adopted may be applicable for other collaborative destination management initiatives. It demonstrates the importance of adopting a geographical perspective in assessing nation-wide initiatives that takes full account of spatial challenges. Dimensions such as the scale, distances and accessibility compound the implementation challenges facing initiatives such as Australia’s National Landscapes Program. These challenges include ecological and socio-economic diversity, the number and variety of constituent organizations and understanding the current visitors, both domestic and international. The paper provides a potentially useful reference for jurisdictions that intend to implement large-scale collaborative destination management frameworks. It is noted that the challenges of identifying a common vision, objectives and measures of success, and of managing the politics of collaborations between different government levels and industry sectors, are magnified for larger-scale initiatives.

Measure of the Rate at which Mortality in Type 2 Diabetes Mellitus Occurs: Protocol for a Systematic Review

Introduction: Type 2 diabetes is the third largest cause of mortality in the United Kingdom, with about 50% of patients' having developed complications at time of diagnosis. We consider that the evidence which explores the actual hazard ratios of mortality has not been consistent. n this paper we discuss methodology and review the most recent accurate data on mortality in type 2 diabetes. Methods: A systematic review will be undertaken aimed at synthesis of evidence of relative risk of mortality in type 2 diabetes, using the Centre for Reviews and Dissemination guidelines. We will explore conflicting and unanswered questions in relation to mortality. The primary outcome is all-cause, overall-cause or total mortality expressed as hazard ratios. Sub-groups will also be explored; age, gender, socio-economic factors and causes of death. We will review abstracts published after 1990 in the English language. Our data source will include electronic databases; the Cochrane library, the Centre for Reviews and Dissemination, Medline/PubMed, and other grey literature. The study populations are type 2 diabetes patients whose mortality outcome, expressed as hazard ratio, has been evaluated. Data extraction will be undertaken by one reviewer and triangulated by the second and third reviewer. The quality of the included studies will be evaluated in accordance with the inclusion/exclusion criteria; methodological quality that meets the critical appraisal framework and the relevance to the research questions. Evidence from data will be synthesised through a descriptive epidemiological review from included studies; meta-analysis will be used if appropriate. Result & Conclusion: We expect to pool homogenous studies of large population cohorts which explore the hazard ratio of mortality, and to summarise the evidence of the actual mortality risk in type 2 diabetes, with limited bias. This will help direct future research in areas of unanswered questions and may influence healthcare policy decisions.

Accreditation of Australian urban planners: building knowledge and competence

There is an ongoing need to assess the relevance of current models of planning education. In light of changes to the accreditation of planners in Australia made in 2010, this paper critically examines whether the modifications are more suited to developing professional competence in graduates. We present a framework for critical appraisal of accredited professional degrees. This framework is based on theory that asserts the need for professionals to have both declarative (knowledge) and functional (competency) skills. Planning education accreditation standards for Australia, the United States and the United Kingdom are analysed and compared against this framework. Our findings indicate significant differences between the accreditation documents in the three countries. Additionally, our results indicate that the changes made to the Australian accreditation standards in 2010 have significantly improved its ability to guide the professional education of planners. We identify that further research is needed to measure the actual competence of graduates to determine appropriate standards and to verify existing competence.

Economic evaluation for first-line anti-hypertensive medicines: applications for the Philippines.

BackgroundMedicines to control hypertension, a leading cause of morbidity and mortality, are a major component of health expenditures in the Philippines. This study aims to review economic studies for first line anti-hypertensive medical treatment without co-morbidities; and discuss practical, informational and policy implications on the use of economic evaluation in the Philippines.MethodsA systematic literature review was performed using the following databases: MEDLINE, EMBASE, BIOSIS, PubMed, The Cochrane Library, Health Economics Evaluations Database (HEED) and the Centre for Reviews and Dissemination – NHS NICE. Six existing economic analytical frameworks were reviewed and one framework for critical appraisal was developed.ResultsOut of 1336 searched articles, 12 fulfilled the inclusion criteria. The studies were summarized according to their background characteristics (year, journal, intervention and comparators, objective/study question, target audience, economic study type, study population, setting and country and source of funding/conflict of interest) and technical characteristics (perspective, time horizon, methodology/modeling, search strategy for parameters, costs, effectiveness measures, discounting, assumptions and biases, results, cost-effectiveness ratio, endpoints, sensitivity analysis, generalizability, strengths and limitations, conclusions, implications and feasibility and recommendations). The studies represented different countries, perspectives and stakeholders.ConclusionsDiuretics were the most cost-effective drug class for first-line treatment of hypertension without co-morbidities. Although the Philippine Health Insurance Corporation may apply the recommendations given in previous studies (i.e. to subsidize diuretics, ACE inhibitors and calcium channel blockers), it is uncertain how much public funding is justified. There is an information gap on clinical data (transition probabilities, relative risks and risk reduction) and utility values on hypertension and related diseases from middle- and low- income countries. Considering the national relevance of the disease, a study on the costs of hypertension in the Philippines including in-patient, out-patient, out-of-pocket, local government and national government expenditure must be made. Economic evaluation may be incorporated in health technology assessment, planning, proposal development, research, prioritization and evaluation of health programmes. The approaches will vary depending on the policy questions. The information gap calls for building strong economic evaluative capacity in growing economies.

How to appraise the effectiveness of treatment

Introduction:Advances in treatment and disease prevention occur frequently in urology. Urologists must identify a framework within which to evaluate these therapeutic innovations.Materials and Methods:The evidence-based approach to critical appraisal is described using an example from the urological literature. A three-part assessment of the trial validity, treatment effect, and applicability of results will permit the urologist to critically incorporate medical and surgical advances into practice.Results:Validity of clinical trials hinges upon balancing patient prognosis at the initiation, execution, and conclusion of the trial. Readers should be aware of not only the magnitude of the estimated treatment effect, but also its precision. Finally, urologists should consider all patient-important outcomes as well as the balance of potential benefits, harms, and costs, and patient values and preferences when making treatment decisions.Conclusion:Use of this framework for critical appraisal will lead to a more evidence-based application of new therapies for patients. Incorporation of a more evidence-based practice within urology will lead to an increase in the quality of patient care.

Making sense of research: an introduction for health and social care practitioners

The Role of Research in the Health and Social Care Professions The Nature of Knowledge in Health and Social Care Overview of the Research Process Ethical Issues Searching and Reviewing the Literature Approaches to and Design of Research in Health and Social Care Research Problems, Aims, Questions and Hypotheses Sampling Understanding Data Collection Techniques Making Sense of Data Analysis Critical Appraisal of Health and Social Care Research Disseminating and Implementing Research Appendix 1. Critical appraisal framework Appendix 2. Literature searching Appendix 3. Four stages in critical appraisal

A graphic framework for teaching critical appraisal of randomised controlled trials

Students of evidence-based medicine often try unsuccessfully to commit to memory a particular critical appraisal framework (often lengthy), or they have to depend on pocket cards and are lost without them. We have described a pedagogic aid: a flow diagram of an RCT, which has been developed over years of teaching residents. This diagram focuses on the steps in an RCT, and by drawing arrows, it highlights the biases possible at each step. This diagram serves as a framework on which the list of critical appraisal questions can be hung and is easy to remember.

Review of guidelines for good practice in decision-analytic modelling in health technology assessment

To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. Electronic databases. A systematic review of existing good practice guidelines was undertaken to identify and summarise guidelines currently available for assessing the quality of decision-analytic models that have been undertaken for health technology assessment. A synthesised good practice guidance and accompanying checklist was developed. Two specific methods areas in decision modelling were considered. The first method's topic is the identification of parameter estimates from published literature. Parameter searches were developed and piloted using a case-study model. The second topic relates to bias in parameter estimates; that is, how to adjust estimates of treatment effect from observational studies where there are risks of selection bias. A systematic literature review was conducted to identify those studies looking at quantification of bias in parameter estimates and the implication of this bias. Fifteen studies met the inclusion criteria and were reviewed and consolidated into a single set of brief statements of good practice. From this, a checklist was developed and applied to three independent decision-analytic models. Although the checklist provided excellent guidance on some key issues for model evaluation, it was too general to pick up on the specific nuances of each model. The searches that were developed helped to identify important data for inclusion in the model. However, the quality of life searches proved to be problematic: the published search filters did not focus on those measures specific to cost-effectiveness analysis and although the strategies developed as part of this project were more successful few data were found. Of the 11 studies meeting the criteria on the effect of selection bias, five concluded that a non-randomised trial design is associated with bias and six studies found 'similar' estimates of treatment effects from observational studies or non-randomised clinical trials and randomised controlled trials (RCTs). One purpose of developing the synthesised guideline and checklist was to provide a framework for critical appraisal by the various parties involved in the health technology assessment process. First, the guideline and checklist can be used by groups that are reviewing other analysts' models and, secondly, the guideline and checklist could be used by the various analysts as they develop their models (to use it as a check on how they are developing and reporting their analyses). The Expert Advisory Group (EAG) that was convened to discuss the potential role of the guidance and checklist felt that, in general, the guidance and checklist would be a useful tool, although the checklist is not meant to be used exclusively to determine a model's quality, and so should not be used as a substitute for critical appraisal. The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.

Critical appraisal checklist for qualitative research studies.

The ability to critically appraise literature is an essential skill for clinicians adopting a population perspective. Conventions exist for reporting and evaluating the quality of quantitative and epidemiological research. The same traditions do not exist in qualitative research for a number of reasons including the number of theories under which this type of research can be conducted and the subsequent incompatibility of indicators of quality. This paper presents a 10-point checklist for assessing the quality of qualitative research in clinical epidemiological studies. We aim to provide a framework for critical appraisal as well as offer direction for qualitative researchers in designing and publishing their work.

Pharmacologic treatment of geriatric depression: key issues in interpreting the evidence.

A framework for critical appraisal of antidepressant trial literature involving geriatric subjects is presented. Among older adults, treatment decisions are complicated by comorbid medical and cognitive illness, the variable course of recovery, and the overlap of depressive symptoms with other disease symptoms. Consumers of the literature on competing antidepressant therapies for older adults must consider disease and population-specific outcome assessment issues. An appraisal guide, adapted for geriatric depression, is developed from literature on methodological challenges of outcome assessment and published clinical trials comparing competing antidepressant therapies in older subjects. The clinical utility of pharmacologic treatment of depression can be difficult to assess because depression scales in current use provide an important but limited perspective on treatment outcome and because the scales vary in actual content and ability to detect change. The use of indicators of function, independence, and self-perceived well-being as outcomes offers additional patient relevance and should be included. Key considerations involve (1) general characteristics: whether the depression outcome measure is valid and reproducible for the aged population under study, whether the outcome measure is sensitive to treatment-related change, and whether the time-frame of outcome assessment is appropriate for the treatment goal; (2) cognitive impairment: how subjects with dementia are assessed, and whether the impact of the intervention on caregivers and healthcare systems is considered as a relevant outcome; (3) pharmacologic issues: whether the comparator agent is a reasonable usual-care standard in the older adult and whether ascertainment for adverse effects is similar for all agents under study; and (4) broader general health status issues: whether functional or quality of life measures are used as outcome indicators.

Exploratory Study of Residents' Conceptual Framework for Critical Appraisal of the Literature

Background: Limited success of efforts to improve residents' critical appraisal skills may be due to poor understanding of their preintervention conceptual framework. Description: To describe internal medicine residents' a priori conceptual approach to critical appraisal of intervention trials, we performed an exploratory content analysis of 41 residents' unprompted descriptions of strengths and weaknesses of a randomized trial of spa therapy for back pain. Evaluation: Eighty-eight percent of responses were assigned independently by 2 reviewers to 23 categories ( kappa. 65). Residents agreed on some important characteristics (e.g., blinding), disagreed on others (e.g., similarity of treatment and control groups), frequently mentioned some irrelevant characteristics (e.g., "objective" vs. "subjective" outcomes), and rarely mentioned some important criteria (e.g., intention to treat). Conclusions: An open-ended questionnaire reliably revealed both expected and unexpected conceptions and misconceptions among residents who had received minimal or no formal instruction in critical appraisal. We propose a classification model for residents' critical appraisal concepts that can be tested in future studies and used to identify areas for focusing interventions to improve resident physicians' critical appraisal skills.