The research question: the What, Why and How in hand surgery.

Identifying a good research question is one of the most important steps when laying the foundation of a research project. A good research question can aim to answer a hotly debated clinical issue, challenge a pre-existing dogma or make a contribution to specific aspects of a broader field of study. The difficulty in defining the question lies with pinpointing an important research topic or an area that is characterized by a lack of knowledge (the What), grasping the significance of how a precisely defined study can potentially impact on clinical practices (the Why) and determining the optimal study design tailored to answer the specific question (the How). These three domains constitute pivotal concepts in the process of shaping the research question.

Guidelines for Authors and Reviewers of Plastic Surgery.

Credible clinical research is a precondition of evidence-based surgery. If clinical research is not conducted and reported properly, such research can be unreliable, unclear, and misleading. Our journal, Plastic Surgery, aims to improve its quality and thus enhance interest, submissions, and readership. To do so, we must ensure that the articles published in our journal align with these goals. This article guides future clinical research contributors, how to design, conduct and report valuable and reliable research. Readers are informed how to choose a title and keywords that properly reflect the content of the article. The proper organization of a manuscript, and the information that goes into each section is described. Valuable tools like the EQUATOR Network Guidelines, the FINER Criteria and the PICOT Format are described for the reader. These resources help formulate a proper research question and ensure transparency in reporting. Commonly used study designs, and the research questions they answer are presented. This ensures that those engaged in research are choosing the right study design for their research. We outline the statistical information that should be presented in the Methods section and differentiate between the content that should be found in the Results and Discussion sections. As Plastic Surgery strives to publish high-quality, reliable research, it is by the standards presented in this article that we will judge all manuscripts submitted for publication.

Une recherche clinique crédible est une condition préalable à une chirurgie basée sur des données probantes. Si la recherche clinique n'est pas menée et rapportée correctement, cette recherche peut être non fiable, peu claire et trompeuse. Notre journal, Plastic Surgery a pour objectif d'améliorer sa qualité et par conséquent d'améliorer l'intérêt, les soumissions et le lectorat. Pour y parvenir, nous devons nous assurer que les articles qui y sont publiés sont conformes à ces objectifs. Le présent article vise à guider les futurs contributeurs à la recherche clinique sur la façon de concevoir, mener et rapporter une recherche de valeur et fiable. Les lecteurs sont informés sur comment choisir un titre et des mots-clés qui sont le reflet correct du contenu de l'article. La bonne organisation d'un manuscrit et l'information entrant dans chaque section sont décrites. Des outils intéressants tels que les lignes directrices du réseau EQUATOR, les critères FINER et le format PICOT sont décrits pour le lecteur. Ces ressources aident à formuler une question de recherche appropriée et à assurer la transparence dans la présentation des résultats. Les plans d'études souvent utilisés et les questions auxquelles la recherche répond sont présentés. Cela garantit à ceux qui s'engagent dans la recherche qu'ils choisissent le bon plan d'étude pour leur travail. Nous soulignons les renseignements statistiques qui devraient figurer dans la section Méthodes en les distinguant des résultats qui devraient se trouver dans les sections Résultats et Discussion. Alors que Plastic Surgery s'efforce de publier une recherche fiable et de grande qualité, c'est en fonction des normes présentées dans cet article que nous jugerons tous les manuscrits soumis pour publication.

[Research questions in participatory projects. Critical reflections from the project "Longing in later life"]. / Forschungsfragen in partizipativen Projekten. Kritische Reflexionen aus dem Projekt "Sehnsüchte im Alter".

BACKGROUND: A central component of participatory research is the collaborative, nonhierarchical work of co-researchers and academic researchers. The development of a research question has a special importance as it entails different meanings for those involved. For academic researchers the research question is focussed on gaining knowledge and is developed at an early stage of the project. For co-researchers the development and the finding of answers to a question are less important than the possibility of jointly changing their social reality. OBJECTIVE: This article investigates how these different interests influence the collaborative development of a research question and which factors can enhance the process. MATERIAL AND METHODS: Based on experiences from the participatory action research project "Longing in later life" and critical reflections, this article unpacks the different roles of the participants in the project and the process of co-creation. CONCLUSION: A joint development of a research question is time consuming and depends on the extent of shared experiences and the degree of marginalization among the group of co-researchers.

Understanding how the research question impacts trial design: Examples from discectomy trials.

BACKGROUND: Formulating a pertinent research question is of the utmost importance in clinical research. An ill-conceived question may lead to an erroneous trial design, which may adversely affect the care of patients and provide uninformative or even misleading results. METHODS: We review the research question of a randomized trial on the timing of lumbar discectomy. We compare the resulting design with other trials, real or hypothetical, that would have been more appropriate. RESULTS: The RCT we examine randomly allocated patients to early or delayed surgery to answer a theoretical question of the effect of time on the efficacy of surgery. The trial was interpreted to have shown that early surgery was associated with better clinical and functional outcomes as compared to delayed surgery. This conclusion is clinically misleading. Valid comparisons between groups should be performed on intent-to-treat analyses and at the same time points after randomization (and not at a fixed follow-up period after surgery). The clinically pertinent comparison is not between the theoretical efficacy of surgery performed at various times, but between surgery and conservative management in patients presenting at various times. Better-designed trials on the clinical benefits of lumbar discectomy, including the treatment of chronic sciatica, have been published. CONCLUSION: Theoretical research questions inspired from observational data can lead to erroneous trial design. Prospective randomized trials impact practice immediately: they are unique occasions to address clinical problems and optimize care under uncertainty in real time. However, they require the research question to be formulated with great care.

An Overview of Survey Research.

Surveys provide evidence for the social sciences for knowledge, attitudes, and other behaviors, and, in health care, to quantify qualitative research and to assist in policymaking. A survey-designed research project is about asking questions of individuals, and, from the answers, the researcher can generalize the findings from a sample of respondents to a population. Therefore, this overview can serve as a guide to conducting survey research that can provide answers for practitioners, educators, and leaders, but only if the right questions and methods are used. The main advantage of using surveys is their economical access to participants online. A major disadvantage of survey research is the low response rates in most situations. Online surveys have many limitations that should be expected before conducting a search, and then described after the survey is complete. Any conclusions and recommendations are to be supported by evidence in a clear and objective manner. Presenting evidence in a structured format is crucial but well-developed reporting guidelines are needed for researchers who conduct survey research.

Formulating the Research Question and Framing the Hypothesis.

An understanding of the research process is an essential skill for designing a study and developing the research protocol. Poor study design can lead to fatal flaws in research methodology, ultimately resulting in rejection for publication or limiting the reliability of the results. Following the steps of the research process and devising the research question and hypothesis prior to study initiation can avoid common problems encountered with research questions and study design. Formulating the research question is the first step in the research process and provides the foundation for framing the hypothesis. Research questions should be feasible, interesting, novel, ethical, and relevant (FINER). Application of the FINER criteria can assist with ensuring the question is valid and will generate new knowledge that has clinical impact. Utilization of the population, intervention, comparison, and outcome (PICO) format helps to structure the question as well as refine and narrow the focus from a broad topic. The hypothesis is derived from the research question and is used to determine the experiments or interventions that will answer the question. This aim of this paper is to provide guidance for developing research questions and forming a testable hypothesis through application of the FINER criteria and the PICO process.

Tying research question and analytical strategy when variables are affected by medication use.

Ill-defined research questions could be particularly problematic in an epidemiological setting where measurements fluctuate over time due to intercurrent events, such as medication use. When a research question fails to specify how medication use should be handled methodologically, arbitrary decisions may be made during the analysis phase, which likely leads to a mismatch between the intended question and the performed analysis. The mismatch can result in vastly different or meaningless interpretations of estimated effects. Thus, a research question such as "what is the effect of X on Y?" requires further elaboration, and it should consider whether and how medication use has affected the measurements of interest. In our study, we will discuss how well-defined questions can be formulated when medication use is involved in observational studies. We will distinguish between a situation where an exposure is affected by medication use and where the outcome of interest is affected by medication use. For each setting, we will give examples of different research questions that could be asked depending on how medication use is considered in the estimand and discuss methodological considerations under each question.

Research Question, Objectives, and Endpoints in Clinical and Oncological Research: A Comprehensive Review.

Clinical research is a systematic process of conducting research work to find solutions for human health-related problems. It is applied to understand the disease process and assist in the diagnosis, treatment, and prevention. Currently, we are experiencing global unrest caused by the coronavirus disease (COVID-19) pandemic. The novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been responsible for the deaths of more than 50 million people worldwide. Also, it has resulted in severe morbidity among the affected population. The cause of such a huge amount of influence on human health by the pandemic was the unavailability of drugs and therapeutic interventions to treat and manage the disease. Cancer is a disease condition wherein the normal cell function is deranged, and the cells multiply in an uncontrolled manner. Based on recent reports by the World Health Organization (WHO), cancer is the second leading cause of death globally. Moreover, the rates of cancers have shown an increasing trend in the past decade. Therefore, it is essential to improve the understanding concerning clinical research to address the health concerns of humans. In this review, we comprehensively discuss critical aspects of clinical research that include the research question, research objectives, patient-reported outcome measures (PROMs), intention-to-treat and per-protocol analysis, and endpoints in clinical and oncological research.

Developing research questions in conversation with the literature: operationalization & tool support.

Empirical Software Engineering rests on the understanding of practical problems and their solution counterparts. Frequently, solutions are not absolute but relative to the context where the problem is observed. This tends to imply that the solution and the problem unveil gradually together, and hence, researchers are not always in the position to state the research question (RQ) at the onset. Like software engineers when facing blurred requirements, researchers might not be familiar enough with the problem in the early phases of a research to properly scope their RQs (hereafter referred to as RQ Scoping). Here, the literature may play the role of the stakeholders in Agile methods: keeping the focus on the aspects that are essential (vs. accidental) of the RQ. Informed by Inductive Top-Down Theorizing, this article acknowledges RQ Scoping as iterative and incremental, entailing a conversation between the experimental work and literature reviewing. Yet, for literature reviewing to become "Agile" it is not only required to be driven by the RQ but also to have tool support. Tools might bring transparency and traceability, both factors especially welcome in a scenario characterized by testing (is my RQ relevant?) and adjustment (how can I make my RQ relevant?). Specifically, the advent of the RQ in close relationship with the literature advises for "Agile" literature reviewing to be conducted at the place where the literature is naturally kept: the Reference Management System (e.g., Mendeley). This article introduces the theoretical underpinnings, design principles, proof of concept and evaluation for FRAMEndeley, a Mendeley-integrated utility for RQ Scoping.

Formulación de preguntas clínicas estructuradas / Formulation of structured clinical questions

La rehabilitación clínica nos enfrenta constantemente a situaciones de dudas que pueden ser resueltas a través de la practica basada en evidencia. En esta guía metodológica aprenderemos sobre cómo formular este primer importante elemento. De este modo, se podrá consultar a la literatura científica disponible a través de una pregunta clínica estructurada que permita buscar, con la mayor eficiencia posible, las publicaciones relacionadas para responder la pregunta clínica realizada, evaluar y aplicar los resultados encontrados y finalmente valorar su impacto. La pregunta clínica se organiza en el formato PICoR (paciente, intervención, comparación y resultados) para identificar sus componentes y estructurar la búsqueda sistemática de información científica. También tiene utilidad en la metodología de estudios clínicos, define el diseño de la investigación y forma parte importante de la construcción de guías de práctica clínica.

Clinical rehabilitation constantly confronts us with situations of doubt that can be resolved through evidence-based practice. In this methodological guide, we are going to learn about how formulate this first relevant issue. Thereby, it could be possible consulting the available scientific literature through a structured clinical question that allows search for, with the greatest possible efficiency, related publications to answer the clinical question asked, evaluate, and apply the results found, to finally assess their impact. The clinical question is organized in the PICO format (patient, intervention, comparison, and outcome) to identify its components and structure the systematic search for scientific information. It is also useful in the methodology of clinical studies, defines the research design and forms an important part of the construction of clinical practice guidelines.

How measurements affected by medication use are reported and handled in observational research: A literature review.

PURPOSE: In epidemiological research, measurements affected by medication, for example, blood pressure lowered by antihypertensives, are common. Different ways of handling medication are required depending on the research questions and whether the affected measurement is the exposure, the outcome, or a confounder. This study aimed to review handling of medication use in observational research. METHODS: PubMed was searched for etiological studies published between 2015 and 2019 in 15 high-ranked journals from cardiology, diabetes, and epidemiology. We selected studies that analyzed blood pressure, glucose, or lipid measurements (whether exposure, outcome or confounder) by linear or logistic regression. Two reviewers independently recorded how medication use was handled and assessed whether the methods used were in accordance with the research aim. We reported the methods used per variable category (exposure, outcome, confounder). RESULTS: A total of 127 articles were included. Most studies did not perform any method to account for medication use (exposure 58%, outcome 53%, and confounder 45%). Restriction (exposure 22%, outcome 23%, and confounders 10%), or adjusting for medication use using a binary indicator were also used frequently (exposure: 18%, outcome: 19%, confounder: 45%). No advanced methods were applied. In 60% of studies, the methods' validity could not be judged due to ambiguous reporting of the research aim. Invalid approaches were used in 28% of the studies, mostly when the affected variable was the outcome (36%). CONCLUSION: Many studies ambiguously stated the research aim and used invalid methods to handle medication use. Researchers should consider a valid methodological approach based on their research question.

Reducing research wastage by starting off on the right foot: optimally framing the research question.

PURPOSE: Strongly framed research questions are clear as to the population (P), the exposures or interventions (E/I), comparison groups (C), outcomes (O), time when relevant (T), and what the investigator wants to know. A solid framework sets up the measurement model, analysis, and anticipated results. The purpose of this study was to estimate the extent to which research questions in journals that focused on patient-reported outcome measures (PROM) and quality of life (QOL) are clear. METHODS: All 440 research articles published in four PROM journals in 2020. excluding reviews, psychometric, and qualitative papers, were reviewed. Research questions were classified as: (i) adequately framed (ii) poorly framed; or (iii) unframed based on clarity criteria. Examples from each journal were presented and reframed to match results in the article. RESULTS: Of 440 articles, 195 (44.3%) were classified as adequately framed; 230 (52.2%) as poorly framed; and 15 (3.4%) as unframed. There was heterogeneity across journals (Chi-square: 20.8; 6 df; p = 0.002). Only 29% were framed according to what the investigators wanted to know; 72% were framed like a "to do" list; and 6% were framed as a research agenda. CONCLUSION: Almost half of the questions were poorly framed or unframed a practice that could contribute to research wastage. Even "adequately framed" questions rarely stated what they wanted to know a priori, increasing the risk of biased reporting. Researchers, reviewers, and editors should encourage the use established frameworks for research questions.

Supporting policy and practice in Ontario through ICES' Applied Health Research Question (AHRQ) program.

ICES upholds a strong reputation for generating high-quality evidence to inform policy and practice through its collaborations with a broad range of health system stakeholders including government policymakers and healthcare providers including clinicians. Supported by the Ontario Ministry of Health and Ministry of Long-Term Care, the ICES Applied Health Research Question (AHRQ) Program leverages the data holdings and, scientific and clinical expertise to generate evidence tailored to the information needs of requestors. This paper outlines the approach, process, strengths, challenges and the resulting influence and impact to the healthcare landscape in Ontario.

A Recommender System to Help Refining Clinical Research Studies.

The process of refining the research question in a medical study depends greatly on the current background of the investigated subject. The information found in prior works can directly impact several stages of the study, namely the cohort definition stage. Besides previous published methods, researchers could also leverage on other materials, such as the output of cohort selection tools, to enrich and to accelerate their own work. However, this kind of information is not always captured by search engines. In this paper, we present a methodology, based on a combination of content-based retrieval and text annotation techniques, to identify relevant scientific publications related to a research question and to the selected data sources.

Matching Variables With the Appropriate Statistical Tests in Counseling Research.

Quantitative research literacy, including matching variables with the appropriate statistical tests, is a key element in counselor education and preparation. Counselor educators are tasked with teaching quantitative research and statistics, which counselors-in-training tend to find anxiety-producing. Authors aimed to provide a succinct overview of matching variables with appropriate statistical tests and provide strategies counselor educators can use to enhance their pedagogy.

Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes.

Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health records (EHR) and administrative insurance claims data are used extensively by both manufacturers and regulators to evaluate post-marketing safety of products in the real world. The feasibility of using these data for analysis in a research study depends on the specific research question and the availability, quality and relevance of the collected data to address the scientific question. It is unlikely that any specific database could be 'qualified' for use across all research questions, even within a specific therapeutic area, due to dependence of feasibility on the elements of the specific research question. This paper describes considerations for determining whether EHR or claims data can be used for specific research purposes. A new structured approach for assessing the feasibility of these data in research is proposed. The framework builds on and considers whether each element of the PICOTS framework for well-structured research questions is adequately captured to allow for viable reliance on EHR and claims data for that specific scientific question. Practical examples and discussion of the limitations of RWD for research are given along with approaches for interpretation of analyses using RWD.

Converging on Bladder Health through Design Thinking: From an Ecology of Influence to a Focused Set of Research Questions.

Lower urinary tract symptoms affect a substantial number of women in the United States (U.S.) and globally. In 2015, the Prevention of Lower Urinary tract Symptoms in women (PLUS) Research Consortium was funded to establish the scientific basis for prevention efforts by (1) understanding healthy bladder function and (2) identifying risk and protective factors for bladder health in women across the lifecourse. This transdisciplinary consortium generated a list of over 600 candidate risk and protective factors for bladder health in women and girls and refined and prioritized these into 29 focused research questions to inform a national longitudinal observational study in the U.S. This paper describes that process using design thinking, a human-centered set of principles and strategies by which innovations are developed, as a framework. Design thinking is an iterative process consisting of five stages: Empathizing with end-users of innovations, Defining core principles girding the work, Ideation of all possible solutions, and rapid-cycle Prototyping and Testing of solutions. Lessons learned are offered to inform future prevention science research endeavors that might benefit from such an approach.

El objeto de conocimiento en la investigación cualitativa: un asunto epistemológico / The object of knowledge in qualitative research: an epistemological matter / O objeto de conhecimento na pesquisa qualitativa: um assunto epistemológico

Resumen Introducción: Los procesos reflexivos e interrogativos necesarios para desarrollar preguntas de investigación cualitativas efectivas, pueden dar forma y dirección a un estudio, sin embargo; a menudo se subestiman. Las buenas preguntas de investigación no necesariamente producen una buena investigación, pero las preguntas mal concebidas o elaboradas probablemente crearán problemas que afectarán todas las etapas posteriores de un estudio. Objetivo: Este artículo aborda el desarrollo de preguntas de investigación y cómo los procesos de generación y refinación de preguntas son fundamentales para la conformación de un estudio cualitativo. Desarrollo: Generar preguntas de investigación relevantes y adecuadas requiere que el investigador preste atención no solo a las preguntas en sí mismas, sino a sus conexiones con todos los componentes del diseño; es decir, los objetivos a los que pueden responder las preguntas; las implicaciones para las preguntas relacionadas con su marco conceptual; los métodos que podría usar para responder las preguntas y las amenazas de validez que deberá abordar. Al igual que con los otros componentes del diseño, reflexionar sobre estos temas es una herramienta extremadamente útil para desarrollar sus preguntas. Conclusiones: En los estudios cualitativos, el proceso continuo de preguntas es una parte integral en la comprensión de las vidas y perspectivas de otros. Es importante enfatizar que este tipo de investigación requiere que el investigador asuma una postura epistemológica, seleccione un método y también elija ciertas técnicas que le permitan recopilar información en el trabajo de campo.

Abstract Introduction: Although frequently underestimated, reflexive and interrogative processes needed to develop the research questions in qualitative research, can give shape and direction to a study. Good research questions do not necessarily produce a good research study, but badly conceived or elaborated research questions can create problems which will further have impacts on all stages of the study. Objective: This study addresses the development of research questions and how their generation and refinement processes are fundamental in the conformation of a qualitative study. Development: Generating relevant and adequate research questions requires the researchers to give attention to the questions and their relations to all the components of the design; in other words; to the objectives, the conceptual framework, the methods used, the possible implications involved, the validity, etcetera. Reflecting on these issues is a useful tool while developing research questions. Conclusions: In qualitative studies, the ongoing process of questioning is integral to the comprehension of the lives and perspectives of others. So, it is important to emphasize that qualitative research requires the researchers to adopt an epistemological posture by selecting methods and procedures which can support their field work information gathering.

Resumo Introdução: Os processos reflexivos e interrogativos necessários para desenvolver perguntas de pesquisa qualitativas efetivas podem dar forma e direção a um estudo, porém frequentemente são subestimados. As boas perguntas de pesquisa não necessariamente produzem uma boa pesquisa, mas as perguntas mal concebidas ou elaboradas provavelmente criarão problemas que afetarão todas as etapas posteriores de um estudo. Objetivo: Este artigo aborda o desenvolvimento de perguntas de pesquisa e como os processos de produção e refinamento de preguntas são fundamentais para a conformação de um estudo qualitativo. Desenvolvimento: Gerar perguntas de pesquisa relevantes e adequadas requer que o pesquisador preste atenção não só às preguntas em si mesmas, senão a suas conexões com todos os componentes do desenho: quer dizer, os objetivos aos que podem responder as preguntas; as implicações para as preguntas relacionadas com seu marco conceptual; os métodos que poderia usar para responder as perguntas e as ameaças de validade que deverá abordar. Ao igual que com os outros componentes do desenho, refletir sobre estes temas é uma ferramenta extremadamente útil para desenvolver suas perguntas. Conclusões: Nos estudos qualitativos, o processo contínuo de perguntas é uma parte integral na compreensão das vidas e perspectivas de outros. É importante enfatizar que este tipo de pesquisa, requer que o pesquisador assuma uma postura epistemológica, selecione um método e também eleja certas técnicas que lhe permitam recopilar informação no trabalho de campo.

De vuelta a la clínica: sin justificación no existe pregunta de investigación que valga.

A clinical research question requires the concurrence of clinical experience and knowledge on methodology and statistics in that who formulates it. Initially, a research question should have a structure that clearly establishes what is that which is being sought (consequence or outcome), in whom (baseline status), and by action of what (maneuver). Subsequently, its reasoning must explore four aspects: feasibility and reasonableness of the questioning, lack of a prior answer, relevance of the answer to be obtained, and applicability. Once these aspects are satisfactorily covered, the question can be regarded as being "clinically relevant", which is different from being statistically significant, which refers to the probability of the result being driven by chance, which does not reflect the relevance of the question or the outcome. One should never forget that every maneuver entails adverse events that, when serious, discredit good results. It is imperative to have the possible answer estimated from within the structure of the question. The function of clinical research is to corroborate or reject a hypothesis, rather than to empirically test to find out what the outcome is.

La formulación de una pregunta de investigación clínica requiere la concurrencia de experiencia clínica y conocimiento en metodología y estadística. Inicialmente, la pregunta de investigación debe contar con una estructura que deje claro qué se busca (consecuencia o desenlace), en quién (estado basal) y por acción de qué (maniobra). Posteriormente, su argumentación debe explorar cuatro aspectos: factibilidad y sensatez del cuestionamiento, ausencia de respuesta previa, relevancia de la respuesta a obtener y aplicabilidad. Una vez que estos aspectos han sido cubiertos en forma satisfactoria puede considerarse que la pregunta es "clínicamente relevante", que es diferente a significancia estadística (la probabilidad de que el resultado se deba al azar y que no refleja la relevancia de la pregunta ni de los resultados). Nunca se debe olvidar que toda maniobra conlleva eventos adversos, que cuando son graves demeritan los buenos resultados. Es imperativo estimar la posible respuesta desde la estructura de la pregunta; la función de la investigación clínica es corroborar o rechazar una hipótesis, no probar empíricamente para ver qué resulta.