Primary Clinical Research Research Articles

Systematic Review of Gender and Sex Terminology Use in Arthroplasty Research: There Is Room for Improvement

BackgroundThere is increasing appreciation of the distinction between gender and sex as well as the importance of accurately reporting these constructs. Given recent attention regarding transgender and gender nonconforming (TGNC) and intersex identities, it is more necessary than ever to understand how to describe these identities in research. This study sought to investigate the use of gender- and sex-based terminology in arthroplasty research. MethodsThe 5 leading orthopaedic journals publishing arthroplasty research were reviewed to identify the first twenty primary clinical research articles on an arthroplasty topic published after January 1, 2022. Use of gender- or sex-based terminology, whether use was discriminate, and whether stratification or adjustment based on gender or sex was performed, were recorded. ResultsThere were 98 of 100 articles that measured a construct of gender or sex. Of these, 15 articles used gender-based terminology, 45 used sex-based terminology, and 38 used a combination of gender- and sex-based terminology. Of the 38 articles using a combination of terminology, none did so discriminately. All articles presented gender and sex as binary variables, and 2 attempted to explicitly define how gender or sex were defined. Of the 98 articles, 31 used these variables for statistical adjustments, though only 6 reported stratified results. ConclusionsArthroplasty articles infrequently describe how gender or sex was measured, and frequently use this terminology interchangeably. Additionally, these articles rarely offer more than 2 options for capturing variation in sex and gender. Future research should be more precise in the treatment of these variables to improve the quality of results and ensure findings are patient-centered and inclusive.

Research themes of family and community physicians in Brazil

Introduction: Research capacity in primary care varies worldwide, and bibliographic databases such as MEDLINE, Scopus and Web of Science do not index most primary care research coming from Latin America. Our objective was to investigate the research themes of family and community physicians in Brazil, and to correlate the articles’ research themes with their authors’ trajectories in postgraduate education. Methods: we compiled a national list of family and community physicians, retrieved their curricula from the Lattes Platform, compiled a list of journal articles, and obtained their keywords from LILACS and MEDLINE. Treating journal articles and their keywords as the two node types in a bipartite network, we derived research themes using the dual-projection algorithm, combining the Leiden algorithm with hierarchical clustering. Results: We found two research themes to be the largest, most developed, and most central ones: human health and primary care. Authors with a master’s or PhD in collective health (public health, epidemiology, and social sciences and humanities in health) were as likely as those with no postgraduate degree to publish articles on primary care. On the other hand, authors with a postgraduate degree in medicine were more likely to publish articles on human health. Conclusions: After discussing the findings in light of previous research and methodological aspects, we conclude there’s a relative divide between primary care and clinical research, and the highlight policy implications.

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model.

In the United States, osteopathic manipulative treatment (OMT), is a popular complementary physical health approach for the treatment of neuromusculoskeletal disorders. However, post-OMT adverse events (AEs) are poorly defined in terms of frequency, severity, and temporal evolution. To date, no benchmark for patient safety exists. To improve understanding in this field, we set out to model the landscape of patient harm after OMT. We conducted a comprehensive search of all available primary clinical research studies reporting on the occurrence of post-OMT AEs in nonpregnant, adult outpatients treated by an osteopathic physician in the United States. The methodology of eligible studies was then reviewed to select those containing the minimum required dataset to model the post-OMT AEs. The minimum required dataset consisted of four model parameters: 'post-OMT interval', 'OMT encounters with post-OMT interval assessment', 'AEs preceded by an OMT encounter', and 'AE severity.' We used the dataset extracted from selected studies to calculate a patient safety benchmark defined as the incidence rate of AEs per 100 post-OMT interval-days. From 212 manuscripts that we identified, 118 primary clinical research studies were assessed for eligibility. A total of 23 studies met inclusion criteria for methodological review, of which 13 studies passed and were selected for modeling. Mild AEs were the most frequent, accounting for n = 161/165 (98%) of total AEs observed in the literature. The cumulative incidence of mild AEs was also significantly greater (P = 0.01) than both moderate and severe grades. The benchmark incidence rate was 1.0 AEs per 100 post-OMT interval-days. The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs allowed for the derivation of a patient safety benchmark that, to date, has not been established in the field of osteopathic manipulative medicine. Additional research is needed to improve model resolution during the post-OMT period. This work conceptualized a model for identifying and grading post-OMT AEs, which should facilitate future comparisons between institutions in order to continually improve patient safety standards in the field of osteopathic manipulative medicine.

A 2023 Update on Managing Insomnia in Primary Care: Insights From an Expert Consensus Group.

Objective: To evaluate the status of management of insomnia disorder, describe gaps in current recognition and treatment, identify current guidance for optimal management, and develop up-to-date educational recommendations for primary care providers.Participants: Four insomnia experts representing primary care, psychiatry, and clinical research were selected based on clinical expertise, educational qualifications, and research experience. A patient with insomnia was also included.Consensus Process: The Insomnia Working Group met in March 2022 to review data on available therapies (including medications approved since publication of current guidelines) and share current best practices for evidence-based multimodal treatment of insomnia disorder.Conclusions: Insomnia is highly prevalent but underdiagnosed and undertreated. It is increasingly recognized as a distinct disorder, not merely a symptom arising secondary to another medical or psychiatric illness. The subtypes of sleep disturbance-reports of difficulty falling or staying asleep, insufficient sleep duration, early waking-and the presence of next-day impairment and common comorbid conditions require a targeted, individualized approach to therapy. Challenges exist in treating insomnia with commonly used on- and off-label drugs, including low-dose antidepressants, benzodiazepines, and benzodiazepine receptor agonists because of the risk of adverse effects, including impaired next-day functioning. The dual orexin receptor antagonists have a novel mechanistic target and offer an alternative pharmacologic choice. Optimal outcomes for insomnia require a comprehensive approach that includes lifestyle and behavioral strategies to mitigate maladaptive thoughts and behaviors related to sleep and selection of pharmacotherapy based on individual patient complaints and characteristics.

Impact of infusion frequency on quality of life in patients receiving home parenteral nutrition.

Home parenteral nutrition (HPN) may be needed as a long-term therapy for patients with chronic intestinal failure whose clinical condition does not allow complete weaning of the parenteral nutrition (PN) solution. HPN is a time-consuming and clinically complex therapy and can negatively affect quality of life (QOL). The level of dependency on HPN, specifically, infusion frequency, has been proposed as a factor that may have an effect on QOL in patients receiving HPN. The primary aim of this qualitative review is to identify the impact of HPN frequency (days per week of HPN infusion) on QOL measurements in adult patients receiving HPN. A comprehensive literature search was completed in PubMed and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. Primary clinical research studies were included if they were conducted in adult patients receiving HPN and included the assessment of the associations between the frequency of HPN infusion and QOL measurements. Six articles ultimately met the criteria for this review. There was variability among the studies, including use of different tools to measure QOL. However, all six studies suggest that a reduction in HPN frequency may be associated with an improvement in QOL. Whenever patients' clinical situation allows, a reduction in HPN frequency should be considered to improve QOL in patients receiving HPN.

Enrolment in clinical research at UCLH and geographically distributed indices of deprivation

Healthcare should be judged by its equity as well as its quality. Both aspects depend not only on the characteristics of service delivery but also on the research and innovation that ultimately shape them. Conducting a fully-inclusive evaluation of the relationship between enrolment in primary research studies at University College London Hospitals NHS Trust and indices of deprivation, here we demonstrate a quantitative approach to evaluating equity in healthcare research and innovation. We surveyed the geographical locations, aggregated into Lower Layer Super Output Areas (LSOAs), of all England-resident UCLH patients registered as enrolled in primary clinical research studies. We compared the distributions of ten established indices of deprivation across enrolled and non-enrolled areas within Greater London and within a distance-matched subset across England. Bayesian Poisson regression models were used to examine the relation between deprivation and the volume of enrolment standardized by population density and local disease prevalence. A total of 54593 enrolments covered 4401 LSOAs in Greater London and 10150 in England, revealing wide geographical reach. The distributions of deprivation indices were similar between enrolled and non-enrolled areas, exhibiting median differences from 0.26% to 8.73%. Across Greater London, enrolled areas were significantly more deprived on most indices, including the Index of Multiple Deprivation; across England, a more balanced relationship to deprivation emerged. Regression analyses of enrolment volumes yielded weak biases, in favour of greater deprivation for most indices, with little modulation by local disease prevalence. Primary clinical research at UCLH has wide geographical reach. Areas with enrolled patients show similar distributions of established indices of deprivation to those without, both within Greater London, and across distance-matched areas of England. We illustrate a robust approach to quantifying an important aspect of equity in clinical research and provide a flexible set of tools for replicating it across other institutions.

1019 Quantified Learning Curves for Robotic Gastrointestinal Surgery

Abstract Aim Robotic techniques are increasingly being adopted by gastrointestinal surgeons. It is important to understand the learning curves (LCs) for robotic surgery, to protect patients from harm caused by surgeon inexperience. The aim of this study was to summarise reports of the LC for three robotic gastrointestinal procedures: cholecystectomy, oesophagectomy and Roux-en-Y gastric bypass (RYGB). Method Three systematic reviews were conducted by the trainee led RoboSurg Collaborative. Systematic searches identified reports of primary clinical research involving robotic cholecystectomy, oesophagectomy and RYGB. Articles were screened in duplicate by title, abstract and then full text. References to the LC were extracted and coded. Quantifications of the learning curve were summarised using descriptive statistics. Results 259 articles were identified: 56 measured the LC, with 23 (9%) of these calculating the number of cases required to complete the LC. The mean reported number of cases at which the LC plateaued was: 16 for oesophagectomy (N = 6, SD = 3.7), 18 for cholecystectomy (N = 5, SD = 15.1), 34 for RYGB (N = 12, SD = 24.6). The reported LCs often incorporated equipment setup times, and so represents learning of the team as well as the surgeon. These values represent points on the LC that authors deemed their surgeons to have ‘completed’ learning. Definitions for when these points occurred varied greatly but largely fell in to two categories: ‘plateau of operative time’ or ‘matching operating time of laparoscopic control procedure’. Conclusions The heterogeneity in how LCs are defined, measured, and reported highlights the need for a more standardised approach when evaluating novel techniques such as robotics.

1028 How Has the Learning Curve Been Measured in Robotic Gastrointestinal Surgery?

Abstract Aim Robotic surgery is increasingly being adopted by gastrointestinal surgeons. The IDEAL Collaboration has recommended evaluation of the learning curve (LC) for such surgical innovations. It is not known how learning curves have been reported for robotic gastrointestinal procedures. The aim of this study was to summarise how the LCs were measured for three robotic gastrointestinal procedures: cholecystectomy, oesophagectomy and Roux-en-Y gastric bypass (RYGB). Method Three systematic reviews conducted by the trainee led RoboSurg Collaborative identified primary clinical research involving robotic cholecystectomy, oesophagectomy and RYGB. Articles were screened in duplicate by title, abstract and then full text. References to the LC were extracted and coded. The techniques used to measure the LC were summarised using descriptive statistics. Results 259 articles were identified, of which 56 (22%) actively measured the LC. The commonest surrogate marker for performance was operative time (N = 34, 63%). Several evaluated performances using the cumulative sum of the operative times (N = 8, 14%). Complications (N = 5, 8%) and time to complete a specific surgical step (N = 4, 7%) were also used. Some authors used multiple markers (N = 4, 7%). Cases were reported individually in 48 (81%) of the LCs, whereas they were grouped in 11 (19%). 19 authors (34%) provided graphical representation of the LC. Conclusions The reporting of LCs for robotic gastrointestinal surgery was heterogeneous and lacked standardisation. There was variation in choice of surrogate markers for performance, individual versus grouped case reporting, and graphical representations. To improve the utility of LC reports, the recommendations of the IDEAL Collaboration should be implemented.

Primary Clinical Research of a Patient Specific Implant System for an Old Zygomaticomaxillary Complex Comminuted Fracture

Primary Clinical Research of a Patient Specific Implant System for an Old Zygomaticomaxillary Complex Comminuted Fracture

Therapeutic Inertia in Prescribing Biologics for Patients with Moderate-to-Severe Asthma: Workshop Summary.

Moderate-to-severe asthma represents about a quarter of the nearly 10% of Americans diagnosed with asthma. Many patients with moderate-to-severe asthma have uncontrolled symptoms that lead to exacerbations requiring oral corticosteroids. There are many factors contributing to poor asthma control, including poor adherence to prescribed therapies, the under-prescribing of biologics and therapeutic inertia. We convened an eight-member panel from fields of primary care, pulmonology, immunology, health services and clinical research, behavioral science and pharmaceutical medical affairs, with the goal of identifying contributing factors and solutions to therapeutic inertia with asthma biologics. We used the Capability, Opportunity, and Motivation (COM-B) model to classify patient and provider behavior towards therapeutic inertia. The model incorporates existing behavior theories and is driven by the interaction of capability, opportunity, and motivation. We used a Delphi method to identify and develop six primary solutions: 1) integration of patient-centered outcomes into asthma management practice; 2) provider education about asthma treatment; 3) moderate-to-severe asthma care delivery redesign; 4) harmonized, evidence-based protocol for the management of moderate-to-severe asthma; 5) designated coordinator approach for optimal asthma management; and 6) a case coordination digital support tool. Integration of patient-centered outcomes into asthma management practice and provider education were identified as having the highest potential to impact therapeutic and clinical inertia. The COM-B model is effective in identifying improvement within therapeutic inertia targeting the capabilities, opportunities, and motivations of patients, providers, and payer systems.

COVID-19 Surveillance in a Primary Care Sentinel Network: In-Pandemic Development of an Application Ontology.

BackgroundCreating an ontology for COVID-19 surveillance should help ensure transparency and consistency. Ontologies formalize conceptualizations at either the domain or application level. Application ontologies cross domains and are specified through testable use cases. Our use case was an extension of the role of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) to monitor the current pandemic and become an in-pandemic research platform.ObjectiveThis study aimed to develop an application ontology for COVID-19 that can be deployed across the various use-case domains of the RCGP RSC research and surveillance activities.MethodsWe described our domain-specific use case. The actor was the RCGP RSC sentinel network, the system was the course of the COVID-19 pandemic, and the outcomes were the spread and effect of mitigation measures. We used our established 3-step method to develop the ontology, separating ontological concept development from code mapping and data extract validation. We developed a coding system–independent COVID-19 case identification algorithm. As there were no gold-standard pandemic surveillance ontologies, we conducted a rapid Delphi consensus exercise through the International Medical Informatics Association Primary Health Care Informatics working group and extended networks.ResultsOur use-case domains included primary care, public health, virology, clinical research, and clinical informatics. Our ontology supported (1) case identification, microbiological sampling, and health outcomes at an individual practice and at the national level; (2) feedback through a dashboard; (3) a national observatory; (4) regular updates for Public Health England; and (5) transformation of a sentinel network into a trial platform. We have identified a total of 19,115 people with a definite COVID-19 status, 5226 probable cases, and 74,293 people with possible COVID-19, within the RCGP RSC network (N=5,370,225).ConclusionsThe underpinning structure of our ontological approach has coped with multiple clinical coding challenges. At a time when there is uncertainty about international comparisons, clarity about the basis on which case definitions and outcomes are made from routine data is essential.

Ocular Demodex: a systematic review of the clinical literature.

There is increasing clinical and research interest in the potential contribution of Demodex to ocular surface disease. The aim of this systematic review was to summarise and synthesise current clinical evidence relating to the aetiology, diagnosis and treatment of ocular Demodex. A comprehensive literature search was performed in OVID Medline, OVID Embase, and clinical trial registries, for studies published between 1990 and August 2019, examining Demodex on the ocular surface. The review included primary clinical research studies and systematic reviews of primary clinical research studies, where Demodex was considered in the context of the ocular surface and/or adnexa. Studies were categorised using the National Health and Medical Research Council evidence hierarchy. Risk of bias assessment was performed using validated tools for studies categorised as providing Level I or II evidence. A total of 87 studies were eligible for inclusion, including two systematic reviews. Most studies (60%) were observational, describing the prevalence of ocular Demodex in different clinical populations. There was a high degree of variability in the epidemiological data derived from cross-sectional aetiology studies. There was mostly consistent evidence to support an association between ocular Demodex and chronic blepharitis. Seven diagnostic test-accuracy studies were identified, which considered a range of techniques, including slit lamp examination for cylindrical eyelash collarettes and/or eyelash manipulation techniques, light microscopic evaluation of epilated eyelashes and in vivo confocal microscopy. There is currently no accepted gold-standard diagnostic method for ocular Demodex. For intervention studies, there was one systematic review, 11 published randomised trials, six trial registry entries, and nine case series. Despite a number of recent trials, the appropriate treatment regimen for ocular Demodex (including the optimal criteria and timing of an intervention) is not clearly established. This comprehensive narrative synthesis has captured the landscape of clinical evidence relating to the prevalence, aetiology, diagnosis and treatment of ocular Demodex. There remain opportunities to enhance understanding of its role in ocular surface disease, best diagnostic approaches and optimal treatment protocols.

Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy.

Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy.

The Role of the Hand Surgeon in Microsurgery in Brazil.

Objective This study evaluates the conditions for microvascular procedures found by hand surgeons in Brazilian clinical practices. Methodology A prospective, observational, and analytical primary clinical research conducted during the 37 th Brazilian Congress of Hand Surgery, from March 30 th to April 1 st , 2017, in Belo Horizonte, in which physicians answered 12 closed, objective, multiple-choice questions regarding their geographic region, type of institution (public or private), microsurgical training, time of experience, technical conditions, the availability of a standby team for emergencies and compensation. Results The study analyzed 143 hand surgeons; among them, 65.7% participants were based at the Southeast region, 13.3% in the Northeast region, 11.9% in the South region, 6.3% in the Central-West region and 2.8% in the North region. Regarding the time of experience, 43.4% of the hand surgeons had less than 5 years, 16.8% had 5 to 10 years, 23.8% 10 to 20 years, and 23% had more than 20 years of practice in microvascular surgery. Seven percent of the surgeons had no training in microvascular surgery; for 63.6%, training occurred during medical residency, whereas 30.8% were trained in another institution, and 7.7% in another country. Among these surgeons, 76.9% worked at both private and public hospitals, 14.7% at private hospitals and 5.6% at public hospitals. Regarding compensation, 1.8% of the surgeons considered it adequate, and 98.2%, inadequate in public hospitals, whereas 5.0% considered it adequate, and 95.0%, inadequate in private hospitals. Conclusion This research shows that most surgeons were trained in microsurgery, had never performed reattachments, and considered that compensation is inadequate; moreover, standby teams were not available. There are few, unevenly distributed hand surgeons with microsurgical ability in emergency settings, and their compensation is low.

Perioperative Quality Initiative consensus statement on the physiology of arterial blood pressure control in perioperative medicine

BackgroundPerioperative arterial blood pressure management is a physiologically complex challenge influenced by multiple factors. MethodsA multidisciplinary, international working subgroup of the Third Perioperative Quality Initiative (POQI) consensus meeting reviewed the (patho)physiology and measurement of arterial pressure as applied to perioperative medicine. We addressed predefined questions by undertaking a modified Delphi analysis, in which primary clinical research and review articles were identified using MEDLINE. Strength of recommendations, where applicable, were graded by National Institute for Health and Care Excellence (NICE) guidelines. ResultsMultiple physiological factors contribute to the perioperative physiological importance of arterial pressure: (i) arterial pressure is the input pressure to organ blood flow, but is not the sole determinant of perfusion pressure; (ii) blood flow is often independent of changes in perfusion pressure because of autoregulatory changes in vascular resistance; (iii) microvascular dysfunction uncouples microvascular blood flow from arterial pressure (haemodynamic incoherence). From a practical clinical perspective, we identified that: (i) ambulatory measurement is the optimal method to establish baseline arterial pressure; (ii) automated and invasive arterial pressure measurements have inherent physiological and technical limitations; (iii) individualised arterial pressure targets may change over time, especially in the perioperative period. There remains a need for research in non-invasive, continuous arterial pressure measurements, macro- and micro-circulatory control, regional perfusion pressure measurement, and the development of sensitive, specific, and continuous measures of cellular function to evaluate blood pressure management in a physiologically coherent manner. ConclusionThe multivariable, complex physiology contributing to dynamic changes in perioperative arterial pressure may be underappreciated clinically. The frequently unrecognised dissociation between arterial pressure, organ blood flow, and microvascular and cellular function requires further research to develop a more refined, contextualised clinical approach to this routine perioperative measurement.

Can systematic reviews contribute to regulatory decisions?

The new call on independent research on drugs issued in October 2016 by the Italian Medicines Agency (AIFA) explicitly reported that proposals based on systematic reviews were not admissible, and no justification or explanation for this choice was given. Prompted by this policy decision, here, we briefly discuss the potential usefulness of systematic reviews in responding to regulatory needs. First, systematic reviews, by collecting, analysing and critically appraising all relevant studies on a specific topic, may be used by different stakeholders as a basis for making clinical and policy recommendations, including regulatory recommendations. Second, systematic reviews may advance knowledge as primary clinical research does. Third, systematic reviews may be particularly useful to detect signals of unknown adverse effects. Fourth, systematic reviews may be used to identify knowledge gaps. Systematic reviews may simultaneously produce new findings and summarize existing knowledge, with the potential of informing regulatory decisions more pragmatically and more rapidly than other research designs. We suggest that national and international calls on independent research on drugs should not put primary clinical research against systematic reviews, as it implies a focus on the methods instead of on the questions being asked. As most calls only broadly define the research areas and the topics to be covered, we argue that it should be up to the applicant to make a proposal on which design provides the most valid and useful answer, and up to the assessors to carefully check the validity, feasibility and relevance of such a proposal.

유전자 편집에 근거한 유전자치료 연구의 윤리

The method of adding multiple copies of transgenes, which was adopted in early gene therapy, has had a variety of adverse effects as well as a problem of controlling experimental outcomes. The development of site-specific nucleases, specifically CRISPR-Cas9, has brought new promise to the field but has also given rise to ethical dilemmas. Pre-clinical research has been conducted to correct mutated genes by establishing induced pluripotent stem cells, and primary clinical research has been carried out on delivering gene editing tools and transplanting corrected cells to patients. Germline editing requires strict guidelines because it leads to permanent genetic change that will affect future generations. This article discusses how to avoid therapeutic misconceptions during translation from pre-clinical to primary clinical research, how to estimate the social risks and benefits often neglected in the risk/benefit analysis, and how to decide the specificity of gene targeting effects. In addition, this article addresses the status of embryos, a topic that is largely ignored in germline editing research. As gene editing technology advances, the legislation and regulations governing clinical practice based on conventional gene therapeutic research should be reconsidered.

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology.

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient’s own center, in which personal details are shown and the other for statistical purposes, where all center’s anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies.

Implementation of evidence-based practice in anaesthesia

### Key points Evidence-based medicine can be defined as ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’.1 It is a combination of individual clinical expertise with the best available evidence, aiming to improve patient outcomes whilst continually updating practice as new research becomes available. Evidence-based practice holds the patient at its core; it is ‘an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best’.2 The practice of evidence-based medicine can be thought of as a five-step process:3 1. Formulating a question 2. Obtaining the evidence through systematic searching 3. Critically appraising the evidence 4. Incorporating the evidence into your practice 5. Evaluating the process and identifying areas for improvement This article aims to guide the reader through the salient points of the first three steps, and touch briefly on the fourth. ### Question formulation Just as with primary clinical research, the outcome of critical appraisal hinges on asking the right initial question. Uncertainties arising from clinical practice should be ‘formatted’ into a …

Study Design Algorithm.

To aid authors in correctly naming their study design, to assist readers and reviewers who must decide what the design was for some published studies, and to provide consistency in evaluating the design of published studies, especially for those conducting systematic reviews and evidence synthesis. An annotated algorithm method is used to prompt serial questions and analysis to identify a single study design. The algorithm begins with a research article. Primary clinical research is divided into experimental and observational studies. Key determinants include identifying the study question and the population, intervention, comparison, and outcome. Experimental therapy and prognosis studies are subdivided into 4 design types. Observational therapy and prognosis studies are subdivided into 7 design types. Experimental diagnosis and screening studies are subdivided into 2 types. Observational diagnosis and screening studies are subdivided into 5 types. An annotated algorithm may be used by authors, readers, and reviewers to consistently determine the design of clinical research studies.