Methodological Appraisal Research Articles

What are the holistic care impacts among individuals living through the COVID-19 pandemic in residential or community care settings? An integrative systematic review.

To critically synthesise evidence in relation to the holistic care impacts (physical, psychological, social, spiritual, and environmental well-being) among individuals living in residential aged care facilities (RACFs) with restrictions during the COVID-19 pandemic. An integrative systematic review followed a pre-registered protocol and has been reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) Guidelines. Electronic databases were searched from inception to June 2022. Qualitative, quantitative, and mixed methods studies were included. All articles were double screened according to a pre-determined eligibility criterion. The review process was managed using Covidence systematic review software. Data from the studies were extracted, methodological quality appraisal conducted, and a narrative synthesis conducted. 18 studies were included. The impact of restrictive practices and periods of lockdown impacted older people on all levels of individual quality-of-life. With or without COVID-19, residents experienced functional decline and many experienced malnutrition, increased incontinence, increased pain, and poorer general health and significant psychological distress. Depression increased with reduced social contact, as did anxiety and loneliness. Some residents spoke of suicidal ideation. It is highly plausible that further outbreaks may prompt knee-jerk reactions from public health departments and governing bodies to continue to restrict and lockdown facilities. Public health COVID-19 outbreak policy for aged care across the globe will need to consider the benefits verses risk debate given the findings uncovered in this review. These findings showed that it is vital that policy considers quality-of-life domains not solely survival rates.

Factors that influence the implementation of (inter)nationally endorsed health and social care standards: a systematic review and meta-summary

BackgroundHealth and social care standards have been widely adopted as a quality improvement intervention. Standards are typically made up of evidence-based statements that describe safe, high-quality, person-centred care as an...

Methodological Appraisal of Phase 3 Clinical Trials in Geographic Atrophy.

Geographic atrophy (GA) secondary to age-related macular degeneration is a common cause of blindness worldwide. Given the recent approval of the first therapy for GA, pegcetacoplan, we critically appraise methodological aspects of the phase 3 clinical trials published so far in this disease in relation to their design, analysis and interpretation. We reviewed some of the key attributes of all phase 3 clinical trials in GA available in the main public registry of clinical trials as of 20 May 2023. The topics discussed included types of endpoints, eligibility criteria, p-value and effect size, study power and sample size, the intention to treat principle, missing data, consistency of results, efficacy-safety balance and application of results. Five phase 3 clinical trials have reported results, either partially or completely: GATHER1, DERBY/OAKS, CHROMA/SPECTRI, SEATTLE and GATE. Although there are many similarities between these trials in terms of endpoints or broad eligibility criteria, they differ in several aspects (metric of the primary endpoint, sample size, type of adverse events, etc.) that can influence the results, which are discussed. Readers should understand key methodological aspects of clinical trials to improve their interpretation. On the other hand, authors should adhere to clinical trial reporting guidelines to communicate what was done and how it was done.

Activities to Promote Interprofessional Practice at Primary Healthcare Level: A Systematic Review

Currently, there is a trend towards interprofessional practice. Consequently, healthcare professionals must devise strategies to deal with the challenges faced in the public health sector. Investigating the ways in which healthcare professionals promote interprofessional care principles to manage patient care outcomes is crucial. Primary healthcare is a significant level of health service delivery, therefore, the implementation of interprofessional practice at this level is especially important. In this review, we aim to explore and describe the activities outlined in the literature, which are used to promote interprofessional practice at primary healthcare level. A systematic search of seven databases was conducted for articles published between 2008 and 2021. All articles with a quantitative, qualitative or mixed methodology, a primary healthcare facility study setting, and full-text availability were included. A methodological appraisal tool was adapted from the RE-AIM framework. Twelve studies were included in the final review. Interprofessional clinics, interprofessional collaborative practices, collaborative care processes, and interprofessional team training were the primary activities identified in the review. These studies aimed to promote interprofessional practice in healthcare settings through various activities. There was limited information regarding the efficiency of the activities. According to the findings, undertaking interprofessional collaborative practice models appears to be the most practicable strategy for implementing interprofessional activities. It is crucial that facility management support this endeavour for its implementation to be successful.

Developmental language disorder in Chinese children: A systematic review of research from 1997 to 2022

Developmental language disorder (DLD) is one of the most common neurodevelopmental disorders. The influences of DLD on language development have been delineated in detail in English. The same is not true for Chinese, a group of Sinitic languages with distinct typological features that may modify the profile of DLD crosslinguistically. We conducted a systematic search of English and Chinese journal databases and reviewed 59 studies on the manifestations of DLD in Chinese. Methodological quality appraisal of the literature revealed several areas of improvement to enhance transparency and replicability. A bibliometric analysis indicated a steep growth trajectory of this literature. Examination of the participant selection and diagnostic criteria revealed limitations and calls for the development of assessment tools and increased knowledge of evidenced-based diagnostic practice. Areas of deficits demonstrated by Chinese children with DLD were synthesized qualitatively and discussed in light of the literature on clinical markers of DLD in English.

Change analysis of All India and regional rainfall data series at annual and monsoon scales

AbstractRainfall characteristics are changing due to several reasons and change/trend detection is required. Literature survey reveals many relevant studies whose outcomes are divergent, possibly because different data series and different methodologies have been applied. This paper presents a critical appraisal of past studies and methodologies for trend analysis. Results of trend analysis of Indian rainfall data are presented. Data for all of India and for five homogenous regions (North-West, Central North-East, North-East, West Central, and Peninsular India) for 1871–2016 were used. The Pettitt change point test, regression, Mann-Kendall (MK), and Wavelet Decomposition were used to study different aspects of changes. Results of the change point test showed that most rainfall series had change points around 1957–65, possibly due to large-scale land use, cultivation, irrigation, and industrial changes in this period. Generally, rainfall for most homogenous regions and sub-divisions show falling trends; some are statistically significant. Series was also decomposed by the wavelet method. Approximate and detailed components of some decomposed series showed a significant declining trend. This work has focused on the magnitude of rainfalls; trends in rainfall intensities are also important. It is necessary to establish denser observation networks to collect short-term data and analyze.

Comparing the Safety and Effectiveness of Ketamine Versus Benzodiazepine/Opioid Combination for Procedural Sedation in Emergency Medicine: A Comprehensive Review and Meta-Analysis.

Procedural sedation is essential in the ED to conduct painful procedures effectively. Ketamine and benzodiazepines/opioids are commonly used, with ketamine providing adequate analgesia and preserving airway muscle tone. However, ketamine is associated with adverse effectswhile benzodiazepines/opioids can lead to respiratory depression. This study compares the safety and efficacy of ketamine and midazolam/fentanyl. Two search methods were used to identify studies related to our topic, including a database search and a manual search involving screening reference lists of articles retrieved by the database search. A methodological quality appraisal was conducted on the articles suitable for inclusion using Cochrane's risk of bias tool in the Review Manager software (Review Manager (RevMan) (Computer program). Version 5.4, The Cochrane Collaboration, 2020). Moreover, pooled analysis was performed using the Review manager software. The study analyzed 1366 articles, of which seven were included for analysis. Pooled data showed that ketamine and midazolam/fentanyl had similar effects on pain scores during procedures and sedation depth measured by the University of Michigan sedation scale. However, the Modified Ramsay Sedation Score showed significantly more profound sedation in the ketamine group. The only significant adverse events were vomiting and nausea, which had a higher incidence in the ketamine group. Our data suggest that ketamine is as effective as the midazolam/fentanyl combination for procedural sedation but is associated with higher incidences of adverse events. Therefore, midazolam/fentanyl can be recommended for procedural sedation in the ED.However, it should be provided in the presence of a physician comfortable with airway management due to high incidences of oxygen desaturation.

Review article: The need for more efficient and patient‐oriented drug development pathways in NASH—setting the scene for platform trials

Non-alcoholic steatohepatitis (NASH) constitutes a significant unmet medical need with a burgeoning field of clinical research and drug development. Platform trials (PT) might help accelerate drug development while lowering overall costs and creating a more patient-centric environment. This review provides a comprehensive and nuanced assessment of the NASH clinical development landscape. Narrative review and expert opinion with insight gained during the EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. Although NASH represents an opportunity to use adaptive trial designs, including master protocols for PT, there are barriers that might be encountered owing to distinct and sometimes opposing priorities held by these stakeholders and potential ways to overcome them. The following aspects are critical for the feasibility of a future PT in NASH: readiness of the drug pipeline, mainly from large drug companies, while there is not yet an FDA/EMA-approved treatment; the most suitable design (trial Phase and type of population, e.g., Phase 2b for non-cirrhotic NASH patients); the operational requirements such as the scope of the clinical network, the use of concurrent versus non-concurrent control arms, or the re-allocation of participants upon trial adaptations; the methodological appraisal (i.e. Bayesian vs. frequentist approach); patients' needs and patient-centred outcomes; main regulatory considerations and the funding and sustainability scenarios. PT represent a promising avenue in NASH but there are a number of conundrums that need addressing. It is likely that before a global NASH PT becomes a reality, 'proof-of-platform' at a smaller scale needs to be provided.

Differences in the subgingival microbial composition associated with alcohol intake: A systematic review.

This study aimed to conduct a systematic evaluation of the literature on whether individuals exposed to alcohol intake present differences in the subgingival microbial composition compared to those unexposed. Five databases (MEDLINE, EMBASE, LILACS, SCOPUS and Web of Science) and one source of grey literature (Google Scholar) were searched by two independent reviewers up to December 2022 according to pre-specified eligibility criteria. No restrictions were imposed regarding the date and language of publication and the periodontal status of the participants. The Newcastle-Ottawa Scale was used for methodological quality appraisal and a narrative synthesis was performed. Eight cross-sectional studies and one cross-sectional analysis nested in a cohort were considered for qualitative analysis, including data of 4636 individuals. Overall, the studies exhibited considerable heterogeneity in terms of characteristics of the participants and microbiological methods. Four studies have high methodological quality. Exposed individuals have higher overall quantity of periodontal pathogens in shallow and moderate to deep pockets. Findings on richness, relative abundance, alpha- and beta-diversity were limited and inconclusive. The subgingival microbiota of individuals exposed to alcohol intake has higher overall quantity of red (i.e., P. gingivalis) and orange-complex (i.e., F. nucleatum) bacteria when compared to those unexposed.

A commentary on "Methodological appraisal of the evidence about efficacy of metabolic surgery in adults with nonmorbid obesity and hypertension: an overview of systematic reviews".

A commentary on "Methodological appraisal of the evidence about efficacy of metabolic surgery in adults with nonmorbid obesity and hypertension: an overview of systematic reviews".

Telemedicine and medical education: a mixed-methods systematic review protocol.

The objective of this review is to synthesize and appraise the available research on educational strategies required to prepare medical learners for engaging in telemedicine and virtual care. The COVID-19 pandemic has resulted in significant uptake of virtual care and telemedicine, highlighting the growing need for health care organizations and medical institutions to support physicians and learners navigating this new model of health care delivery, clinical learning, and assessment. Developing a better understanding of how best to prepare medical trainees across the continuum of undergraduate, postgraduate, and continuing professional development to engage in virtual care is critical to ensuring our continued ability to meet educational mandates and provide ambulatory care that is safe, efficient, and timely. Studies focused on teaching or learning telemedicine/virtual care that include an assessment of competencies, knowledge, or behaviors of learners will be considered for inclusion in the review. Embase, MEDLINE, Cochrane CENTRAL, Web of Science Core Collection, EbscoHost Education Source, and ProQuest Dissertations and Theses Global will be searched to identify published and unpublished studies. No date or language restrictions will be applied. This systematic review will be conducted in accordance with the JBI methodology for mixed methods systematic reviews using a convergent segregated approach. Titles and abstracts of potential studies will be screened and potentially relevant studies will undergo full-text review for eligibility and critical appraisal of the study methodology. Data will be extracted from those studies selected for inclusion. Findings will be described relating to the effectiveness of educational curricula, initiatives, and best practices in trainee engagement in telemedicine and virtual care. PROSPERO (CRD42021264332).

Real price of health-experiences of out-of-pocket costs in Australia: protocol for a systematic review

IntroductionAustralians have substantial out-of-pocket (OOP) health costs compared with other developed nations, even with universal health insurance coverage. This can significantly affect access to care and subsequent well-being, especially for...

Critical appraisal of simulated patient methodology to assess the practice of community pharmacist in the Middle East and North Africa region: A systematic review.

The use of simulated patient (SP) methodology in pharmacy practice settings has increased recently. However, its applications can vary significantly within a region, hence affecting the quality of the SP methodology. The purpose of this systematic review is to critically assess the use of the SP methodology for assessing the practice of community pharmacists (CP) in the Middle East and North Africa (MENA) region. A comprehensive literature search was conducted using EMBASE, MEDLINE, ProQuest, and SCOPUS to identify articles published from 2011 to 2022. The selection of relevant studies for inclusion in the systematic review was based on the pre-determined inclusion criteria. The Mixed Method Appraisal Tool (MMAT) was used to assess the methodological quality of the included studies. Electronic search yielded 478 publications. A total of 45 studies were reviewed. The studies were conducted in 12 countries of the MENA region. The sample size between the reviewed articles ranged from 20 to 1000 (median= 129). A greater number of the included studies measured the adequacy of skill (pre-dispensing and/or post-dispensing) 38 (84.4%). The vast majority of the studies reported unsatisfactory results regarding the competencies of CP. The number of the SP ranged from 1 to 37 (median= 2). Most of the studies recruited only one SP per pharmacy 35 (77.8%). The most common data collection method was written data collection form 42 (93.3%). Few studies only had a detection system for SP visits 11 (24.4%), and only six studies incorporated performance feedback (13.3%). More than two-thirds of the studies provided a training session for SP 37 (82.2%). There was variation in the symptoms and drugs used in the SP scenarios in the studies. Although the results demonstrate the growth in the use of the SP method in MENA region countries, studies showed high variability in the level of reporting the study methodology. Consequently, we argue the need for standardized reporting of these studies.

Parents'/caregivers' fears and concerns about their child's epilepsy: A scoping review.

BackgroundChildhood epilepsy is a serious and common neurological condition and can have life-long consequences and its impact can pervade all aspects of family life. Whilst the medical management of seizures is important, much of the day-to-day home management of epilepsy is invisible to people external to the family, including health care professionals, and parents’/caregivers’ fears and concerns can go unacknowledged and unaddressed by health care professionals.ObjectiveThis objective of this review was to examine parents’/caregivers’ fears and concerns regarding their child’s epilepsy, the impact of these fears and concerns on family life, the social and emotional well-being of parents/caregivers and any factors which mitigate these fears and concerns.DesignScoping review using a modified version of Arksey and O’Malley’s framework.Data sourcesRelevant studies were identified using key search terms in Scopus, Medline, CINAHL and PsychInfo databases in March 2021 with hand checking of reference lists. Search terms were developed using population (parents/caregivers of children aged ≤ 18 years with epilepsy, families); concept (parents’/caregivers’ fears, concerns, anxiety about their child’s epilepsy); and context (any setting). A further search was run in April 2022. Other inclusion criteria: English language empirical studies, 2010–2021.Study appraisal methodsA minimum of two reviewers independently screened articles and undertook data extraction and decisions were consensually made.Methodological quality appraisal was undertaken using the Mixed Methods Appraisal Tool v2018. A data extraction table was created to chart all studies. The conduct and reporting of this study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) (S1 Table). There is no published copy of the review protocol.Main findingsThe search identified a total of 4077 papers (after duplicates were removed) of which 110 were assessed for eligibility. Twenty-four papers published between 2010–2021 were included in the review and each paper was treated as a separate study. The review findings indicate that parents’/caregivers’ fears and concerns stem from more than their child’s seizures and relate to many wider aspects of family life. These fears and concerns had far-reaching influences on their parenting/caregiving, and on the lifestyle and activities of their child and their family. What was less evident was what parents/caregivers wanted in terms of support or how they thought health professionals could acknowledge and/or allay their fears and concerns. The discussion is framed within the compassion-focused therapy model as a basis for generating new thinking about the impact of these fears and concerns and the need for a new agenda for clinical consultations in childhood epilepsy.ConclusionsThe review concludes with a proposal that a more compassionate agenda underpins the dialogue between parents/caregivers and clinicians to encompass and mitigate the wider emotional, psychosocial, and societal threats that impact on the parent/caregivers of children with epilepsy.

Appraisal of seismic design methodologies for suspended non-structural elements in Europe

Appraisal of seismic design methodologies for suspended non-structural elements in Europe

Stress among Parents of Children with Hearing Loss and How They Deal with It: A Systematic Review.

Introduction Parenting a child with hearing loss may be accompanied by high stress levels and several challenges. Objectives The present systematic review was performed to compile the existing literature pertaining to parental stress in parents of children with hearing loss and coping strategies. Data synthesis The databases searched include PubMed/Medline, Scopus, Cochrane Library and Cumulative Index to Nursing, and Allied Health Literature. The systematic review was designed and performed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement guidelines. The screening for studies was performed independently by two researchers. Methodological quality appraisal was done using the Mixed methods appraisal tool. Twenty-eight studies were identified and included in the present review, which discussed the stress factors and coping mechanism associated with having child with hearing loss reported by parents. The factors leading to stress were thematically classified into parent/family-related factors, child-related factors, and professionals/service-related factors. The coping strategies were thematically classified into improved support systems and better professional resources. Conclusion The present systematic review was an attempt at exploring the various stress causing factors among parents of children with hearing loss. The various coping strategies would help in better planning services for these parents and helping to lessen the stress.

Windswept Deformity a Disease or a Symptom? A Systematic Review on the Aetiologies and Hypotheses of Simultaneous Genu Valgum and Varum in Children.

Objective: The objective of this study is to create an overview of the possible aetiologies of windswept deformity and to emphasize the points of attention when presented with a case. Methods: A systematic search according to the PRISMA statement was conducted using PubMed, African Journals Online, Cochrane, Embase, Google Scholar, and Web of Science. Articles investigating the aetiology of windswept deformity at the knee in children, and articles with windswept deformity as an ancillary finding were included. The bibliographic search was limited to English-language articles only. The level of evidence and methodological appraisal were assessed. Results: Forty-five articles discussing the aetiology of windswept deformity were included. A variety of aetiologies can be brought forward. These can be divided into the following groups: ‘Rickets and other metabolic disorders’, ‘skeletal dysplasias and other genetic disorders’, ‘trauma’ and ‘descriptive articles without specific underlying disorder’. With rickets being the largest group. Interestingly, in the group without a specific underlying disorder, all patients were from African descent, being otherwise healthy and presented with windswept deformity between two and three years of age. Conclusion: We have presented an overview that may help identify the underlying disorder in children with windswept deformity. A step-by-step guide for clinicians who see a child with windswept deformity is provided. Even though, according to the Oxford level of evidence, most articles have a low level of evidence.

Process Optimization and Stability of Waste Orange Peel Polyphenols in Extracts Obtained with Organosolv Thermal Treatment Using Glycerol-Based Solvents

This study was focused on the simultaneous organosolv treatment/extraction of waste orange peels (WOP) for the effective recovery of polyphenolic antioxidants. The treatments were performed with aqueous glycerol mixtures, which were acidified either with citric acid or hydrochloric acid (HCl). Process optimization was carried out using response surface methodology and comparative appraisal of the different processes tested, based on both the extraction efficiency factor (FEE), severity factor (SF) or combined severity factor (CSF). Metabolite stability was also of major concern, and it was examined by deploying liquid chromatography-mass spectrometry. The results drawn suggested 90% (w/w) glycerol to be the highest-performing system, providing a yield in total polyphenols of 44.09 ± 5.46 mg GAE g−1 DM at 140 °C for 50 min, with a FEE of 2.20 and an SF of 2.88. Acidification with 1% citric acid was proven less efficient and equally severe, whereas acidification with 1% HCl was less severe but also less efficient. The major disadvantage associated with the use of HCl was its detrimental impact on the polyphenolic composition of WOP since major metabolites, such as narirutin, hesperidin and didymin, did not survive the process. By contrast, the formation of lower molecular weight compounds was observed. With regard to antioxidant properties, the extract obtained with aqueous glycerol displayed significantly higher antiradical activity and reducing power, which was in line with its higher concentration in total polyphenols. It was concluded that organosolv treatment with aqueous glycerol under the conditions employed may boost polyphenol recovery from WOP, thus giving extracts with powerful antioxidant characteristics.

A systematic review opens the black box of "usual care" in stroke rehabilitation control groups and finds a black hole.

In experimental trials, new methods are tested against the "best" or "usual" care. To appraise control group (CG) interventions provided as "usual care," we focused on stroke as a leading cause of disability demanding rehabilitation as a complex intervention. For this methodological appraisal, we conducted a systematic review of RCTs without timespan limitation. The PICO included stroke survivors, rehabilitation, control group intervention, lower limb function. To assess the risk of bias, we used the Cochrane risk of bias tool (RoB). We identified the terminology describing the CG Program (CGP), performed a knowledge synthesis and conducted a frequency analysis of provided interventions. We included 155 publications. 13.6% of the articles did not describe the CG, and 11.6% indicated only the professionals involved. In the remaining 116 studies, three studies provided an intervention according to specific guidelines, 106 different "usual care" CGPs were detected, with nine proposed twice and two between four and five times. The most adopted terminology to state "usual care" was "conventional physiotherapy." This study shows that usual care in CG does not actually exist, as both specific terminology and consistency within CGP contents are missing. Reporting guidelines should give better assistance on this issue. These results should be verified in other fields.

Effectiveness of Bacille Calmette-Guerin Vaccination Policies in Reducing Infection and Severity of COVID-19: a Systematic Review Protocol

Introduction: The bacille Calmette-Guerin (BCG) vaccine is used for the prevention of tuberculosis (TB) worldwide. Evidence reports a much lower incidence of COVID-19 in TB-endemic areas implying a possible protective mechanism of BCG in countries with mandated BCG policies. The objective of the study is to synthesize and critically evaluate the effectiveness of national BCG vaccination policies in reducing infection and severity of COVID-19 in their native population. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a comprehensive search using pre-identified keywords will be done in PubMed, Cochrane, HERDIN Plus, WPRIM, Web of Science and EBSCO databases. After the initial selection of studies based on eligibility criteria, methodological appraisal will be conducted using the Joanna Briggs Institute appraisal instruments and an adapted quality assessment checklist for ecologic studies. Relevant data will be extracted and synthesized including reporting descriptive and inferential statistics to interpret results. Results: The study will generate a systematic review synthesizing evidence regarding the effects of BCG in curtailing the spread of the COVID-19 pandemic. Discussion: The battle against the COVID-19 pandemic is far from over, and as such, further studies must be undertaken to verify the evidence behind initial strategies in battling it. This includes the use of BCG in decreasing COVID-19 incidence and mortality. The results of the review can ultimately guide health authorities and policy makers create evidence-based decisions regarding BCG vaccination policies and clinical trials related to COVID-19 control and prevention. Systematic Review Registration: PROSPERO, CRD42021244060