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• Volume 22, Issue 1
• How to appraise qualitative research
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• Calvin Moorley 1 ,
• Xabi Cathala 2
• 1 Nursing Research and Diversity in Care, School of Health and Social Care , London South Bank University , London , UK
• 2 Institute of Vocational Learning , School of Health and Social Care, London South Bank University , London , UK
• Correspondence to Dr Calvin Moorley, Nursing Research and Diversity in Care, School of Health and Social Care, London South Bank University, London SE1 0AA, UK; Moorleyc{at}lsbu.ac.uk

https://doi.org/10.1136/ebnurs-2018-103044

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Introduction

In order to make a decision about implementing evidence into practice, nurses need to be able to critically appraise research. Nurses also have a professional responsibility to maintain up-to-date practice. 1 This paper provides a guide on how to critically appraise a qualitative research paper.

What is qualitative research?

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Useful terms

Some of the qualitative approaches used in nursing research include grounded theory, phenomenology, ethnography, case study (can lend itself to mixed methods) and narrative analysis. The data collection methods used in qualitative research include in depth interviews, focus groups, observations and stories in the form of diaries or other documents. 3

Authenticity

Title, keywords, authors and abstract.

In a previous paper, we discussed how the title, keywords, authors’ positions and affiliations and abstract can influence the authenticity and readability of quantitative research papers, 4 the same applies to qualitative research. However, other areas such as the purpose of the study and the research question, theoretical and conceptual frameworks, sampling and methodology also need consideration when appraising a qualitative paper.

Purpose and question

The topic under investigation in the study should be guided by a clear research question or a statement of the problem or purpose. An example of a statement can be seen in table 2 . Unlike most quantitative studies, qualitative research does not seek to test a hypothesis. The research statement should be specific to the problem and should be reflected in the design. This will inform the reader of what will be studied and justify the purpose of the study. 5

Example of research question and problem statement

An appropriate literature review should have been conducted and summarised in the paper. It should be linked to the subject, using peer-reviewed primary research which is up to date. We suggest papers with a age limit of 5–8 years excluding original work. The literature review should give the reader a balanced view on what has been written on the subject. It is worth noting that for some qualitative approaches some literature reviews are conducted after the data collection to minimise bias, for example, in grounded theory studies. In phenomenological studies, the review sometimes occurs after the data analysis. If this is the case, the author(s) should make this clear.

Theoretical and conceptual frameworks

Most authors use the terms theoretical and conceptual frameworks interchangeably. Usually, a theoretical framework is used when research is underpinned by one theory that aims to help predict, explain and understand the topic investigated. A theoretical framework is the blueprint that can hold or scaffold a study’s theory. Conceptual frameworks are based on concepts from various theories and findings which help to guide the research. 6 It is the researcher’s understanding of how different variables are connected in the study, for example, the literature review and research question. Theoretical and conceptual frameworks connect the researcher to existing knowledge and these are used in a study to help to explain and understand what is being investigated. A framework is the design or map for a study. When you are appraising a qualitative paper, you should be able to see how the framework helped with (1) providing a rationale and (2) the development of research questions or statements. 7 You should be able to identify how the framework, research question, purpose and literature review all complement each other.

There remains an ongoing debate in relation to what an appropriate sample size should be for a qualitative study. We hold the view that qualitative research does not seek to power and a sample size can be as small as one (eg, a single case study) or any number above one (a grounded theory study) providing that it is appropriate and answers the research problem. Shorten and Moorley 8 explain that three main types of sampling exist in qualitative research: (1) convenience (2) judgement or (3) theoretical. In the paper , the sample size should be stated and a rationale for how it was decided should be clear.

Methodology

Qualitative research encompasses a variety of methods and designs. Based on the chosen method or design, the findings may be reported in a variety of different formats. Table 3 provides the main qualitative approaches used in nursing with a short description.

Different qualitative approaches

The authors should make it clear why they are using a qualitative methodology and the chosen theoretical approach or framework. The paper should provide details of participant inclusion and exclusion criteria as well as recruitment sites where the sample was drawn from, for example, urban, rural, hospital inpatient or community. Methods of data collection should be identified and be appropriate for the research statement/question.

Data collection

Overall there should be a clear trail of data collection. The paper should explain when and how the study was advertised, participants were recruited and consented. it should also state when and where the data collection took place. Data collection methods include interviews, this can be structured or unstructured and in depth one to one or group. 9 Group interviews are often referred to as focus group interviews these are often voice recorded and transcribed verbatim. It should be clear if these were conducted face to face, telephone or any other type of media used. Table 3 includes some data collection methods. Other collection methods not included in table 3 examples are observation, diaries, video recording, photographs, documents or objects (artefacts). The schedule of questions for interview or the protocol for non-interview data collection should be provided, available or discussed in the paper. Some authors may use the term ‘recruitment ended once data saturation was reached’. This simply mean that the researchers were not gaining any new information at subsequent interviews, so they stopped data collection.

The data collection section should include details of the ethical approval gained to carry out the study. For example, the strategies used to gain participants’ consent to take part in the study. The authors should make clear if any ethical issues arose and how these were resolved or managed.

The approach to data analysis (see ref  10 ) needs to be clearly articulated, for example, was there more than one person responsible for analysing the data? How were any discrepancies in findings resolved? An audit trail of how the data were analysed including its management should be documented. If member checking was used this should also be reported. This level of transparency contributes to the trustworthiness and credibility of qualitative research. Some researchers provide a diagram of how they approached data analysis to demonstrate the rigour applied ( figure 1 ).

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Example of data analysis diagram.

Validity and rigour

The study’s validity is reliant on the statement of the question/problem, theoretical/conceptual framework, design, method, sample and data analysis. When critiquing qualitative research, these elements will help you to determine the study’s reliability. Noble and Smith 11 explain that validity is the integrity of data methods applied and that findings should accurately reflect the data. Rigour should acknowledge the researcher’s role and involvement as well as any biases. Essentially it should focus on truth value, consistency and neutrality and applicability. 11 The authors should discuss if they used triangulation (see table 2 ) to develop the best possible understanding of the phenomena.

Themes and interpretations and implications for practice

In qualitative research no hypothesis is tested, therefore, there is no specific result. Instead, qualitative findings are often reported in themes based on the data analysed. The findings should be clearly linked to, and reflect, the data. This contributes to the soundness of the research. 11 The researchers should make it clear how they arrived at the interpretations of the findings. The theoretical or conceptual framework used should be discussed aiding the rigour of the study. The implications of the findings need to be made clear and where appropriate their applicability or transferability should be identified. 12

Discussions, recommendations and conclusions

The discussion should relate to the research findings as the authors seek to make connections with the literature reviewed earlier in the paper to contextualise their work. A strong discussion will connect the research aims and objectives to the findings and will be supported with literature if possible. A paper that seeks to influence nursing practice will have a recommendations section for clinical practice and research. A good conclusion will focus on the findings and discussion of the phenomena investigated.

Qualitative research has much to offer nursing and healthcare, in terms of understanding patients’ experience of illness, treatment and recovery, it can also help to understand better areas of healthcare practice. However, it must be done with rigour and this paper provides some guidance for appraising such research. To help you critique a qualitative research paper some guidance is provided in table 4 .

Some guidance for critiquing qualitative research

• ↵ Nursing and Midwifery Council . The code: Standard of conduct, performance and ethics for nurses and midwives . 2015 https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf ( accessed 21 Aug 18 ).
• Barrett D ,
• Cathala X ,
• Shorten A ,

Patient consent for publication Not required.

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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Academic writing: using literature to demonstrate critical analysis, kathleen duffy senior lecturer, school of nursing, midwifery and community health, glasgow caledonian university, glasgow, elizabeth hastie senior lecturer, school of nursing, midwifery and community health, glasgow caledonian university, glasgow, jacqueline mccallum senior lecturer, school of nursing, midwifery and community health, glasgow caledonian university, glasgow, valerie ness lecturer, school of nursing, midwifery and community health, glasgow caledonian university, glasgow, lesley price lecturer, school of nursing, midwifery and community health, glasgow caledonian university, glasgow.

When writing at degree level, nurses need to demonstrate an understanding of evidence by summarising its key elements and comparing and contrasting authors’ views. Critical analysis is an important nursing skill in writing and in practice. With the advent of an all-degree profession, understanding how to develop this skill is crucial. This article examines how students can develop critical analysis skills to write at undergraduate degree level. It highlights some of the common errors when writing at this academic level and provides advice on how to avoid such mistakes.

Nursing Standard . 23, 47, 35-40. doi: 10.7748/ns2009.07.23.47.35.c7201

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This article has been subject to double blind peer review

Critical appraisal - Education: methods - Literature and writing - Student nurses - Study skills

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Postgraduate Nursing: Critical appraisal and Evaluation of research

• EndNote & Referencing
• Academic Writing
• Research & Research Methods
• Introduction to Evidence-Informed Practice
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• Types of Research & Levels of Evidence
• Searching for the Evidence
• Critical appraisal and Evaluation of research
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Introduction to critical appraisal and evaluation

The information you use in your research and study must all be credible, reliable and relevant. Part of the Evidence-Based Practice process is to critically appraise scientific papers, but in general, all the resources you refer to should be evaluated carefully to ensure their credibility.

How can you tell whether the resources you've found are credible and suitable for you to reference? To evaluate Information you have found on websites, see the video below and the box on using Internet sites. Journal articles and academic texts should at least have gone through a process of peer review (see the video about peer review on the Journals page of this guide).

Critical appraisal of scientific papers takes the evaluation to another level. Once you have asked the clinical question and searched for evidence, it's often not enough that you've checked for peer review if you want to find the very best evidence - it will ensure that studies with scientific flaws are disregarded, and the ones you include are relevant to your question.

In the Evidence-Based Practice process, and especially in the process of evaluating primary research (which hasn't be pre-appraised or filtered by others), we need to go beyond the usual general information evaluation and make sure the evidence we are using is scientifically rigorous. The main questions to address are:

• Is the study relevant to your clinical question?
• How well (scientifically) was the study done, especially taking care to eliminate bias?
• What do the results mean and are they statistically valid (and not just due to chance)?

For a more detailed look at Critical Appraisal, head to the Systematic Review Guide - Critical Appraisal and the Evidence-Based Practic Guide - Appraise.

Critical appraisal tools

Fortunately, there have been some great checklist tools developed for different types of studies. Here are some examples:

• The Joanna Briggs Institute (JBI) provides access to critical appraisal tools, a collection of checklists that you can use to help you appraise or evaluate research.
• Critical Appraisal Skills Programme (CASP) is part of Better Value Healthcare based in Oxford, UK. It includes a series of checklists , suitable for different types of studies and designed to be used when reading research.
• The Equator Network is devoted to Enhancing the QUAlity and Transparency Of health Research. Among other functions, they include a  Toolkit for Peer Reviewing Health Research   which is very useful as a guide for critically appraising studies.
• Critical Appraisal Tools (CEBM)  - This site from the Centre of Evidence Based Medicine includes tools and worksheets for the critical appraisal of different types of medical evidence.
• Critical Appraisal Tools (iCAHE) - This site from the International Centre of Allied Health Evidence (at the University of South Australia) has a range of tools for various types of studies.
• Understanding Health Research - is from the Medical Research Council in the UK. It's a very handy all-purpose tool which takes you through a series of questions about a particular article, highlighting the good points and possible problem areas. You can print off a summary at the end of your checklist

Critical appraisal tools from the NHS in Scotland links interactively to all sorts of resources on how to identify the study type and build your critical appraisal skills, as well as to tools themselves.

Critical reading and understanding research

A useful series of articles for nurses about critiquing and understanding types of research has been published in the Australian Journal of Advanced Nursing by Rebecca Ingham-Broomfield, from the University of New South Wales:

Ingham-Broomfield, R. (2014). A nurses' guide to the critical reading of research . Australian Journal of Advanced Nursing , 32 (1), 37-44. [Updated from 2008.]

Ingham-Broomfield, R. (2014). A nurses' guide to quantitative research . Australian Journal of Advanced Nursing, 32 (2), 32-38. 

Ingham-Broomfield, R. (2015). A nurses' guide to qualitative research . Australian Journal of Advanced Nursing, 32 (3), 34-40. 

Ingham-Broomfield, R. (2016). A nurses' guide to mixed methods research . Australian Journal of Advanced Nursing, 33 (4), 46-52. 

Ingham-Broomfield, R. (2016). A nurses' guide to the hierarchy of research designs and evidence . The Australian Journal of Advanced Nursing, 33 (3), 38-43. 

Evaluate internet resources

The website domain gives you an idea of the reliability of a website:

Critical appraisal resources

Introduction to Critical Appraisal -  This short video from the library at the University of Sheffield in the UK looks at the background to critical appraisal, what it is, and why we do it. A very useful introduction to the topic.

Evaluating information

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Nursing Research and Its Critical Appraisal Essay (Critical Writing)

Process of critiquing an article, importance of critique for a nurse, critique of a published article.

Any note regarding critical analysis of an article starts with a summary of the point of view discussed in that paper. This summary highlights the thesis or the problem statement of the article under analysis. In this section, the author’s viewpoint is explored, based on the arguments and explanations provided by the author, and described. Here, some points may be given regarding the author’s experience in the subject, any previous work or other supporting evidence.

The way article has been organized; which facts have been chosen by the author to describe or support his/her article. How much focused is the author bout his/her article? How the author provides his/her theoretical knowledgebase to support his own write up? Moreover, based on the presented theoretical explanation, what is the evidence utilized by the author for further supporting his/her work? Does the evidence provided is suitable for the current article?

Do all the contents of the article are coherent? How much continuity is there in the main body of the article? Does the language of the article and the thought process go in unison? Any point where contradictions exist in the article?

In the critical analysis of the whole article, addressing all the above mentioned issues is very important. This process is efficiently completed when all the sections of an article are thoroughly reviewed following the above mentioned guidelines. This can be achieved by taking all the sections as one article at the first instance and completing the whole process. Afterwards, the whole article is critiqued. This also needs to look at the linking process of all the sections contained in the article.

Nursing research has been defined by Hunt (1991) as a planned systematic search for information within or about nursing, for the purpose of increasing the body of knowledge of nursing. Nurses should be research aware and be able to apply it to practise and therefore have an influence on health care (Henderson, 1987). However, in order to fully appreciate and fully utilize research, the nurse needs to know that it is credible and reliable. Nurses can learn to distinguish between good and bad research and be critical of other individual research. Therefore, the aim of this assignment is to explore the strengths and weaknesses of a research study define the term critique as a judgment about the merits and/or value of a piece of research. He suggests that because research is never perfect all research may be critically evaluated.

Critiquing research is essential for developing and refining nursing knowledge. However the word critique is often linked with the word criticize, which is frequently viewed as negative. Research is critiqued to broaden understanding, improve practice and provide a background for conducting a study. All nurses, including students, practicing nurses, administrators and researchers need to critique research. (Burns & Grove, 1995) 0gier (1992) argues that nurses have a responsibility to themselves, colleagues and clients to maintain and update their knowledge in relation to care without the ability to critique research this would be difficult.

Burns and Grove (1997) suggest The root meaning of the word ‘research’ is to search again or examine carefully. Research is a diligent systematic inquiry or investigation to validate and refine existing knowledge and generate new knowledge.

The primary goal of nursing research is to improve the quality of care given to clients. Research plays a key role in providing evidence on the value and limitations of clinical interventions and on their cost-effectiveness. The Royal College of Nursings secretary, Christine Hanncock states Central to our endeavours is to work to promote the value of nursing and it goes without saying that efforts to demonstrate the value of nursing can only succeed if they are founded on a solid research base. Securing an adequate research base for nursing is fundamental to its future. (Hanncock 1993).

The authors of the article have tried to state their objectives very well. They have been able to prove testing their hypothesis and answered the research questions. In a comprehensive way, the whole of the article has been presented reviewing the existing body of evidence available. Through the review of literature, a strong rational is built on which helped in justifying this research activity. Study design and methodology have been described in detail to make things understandable. Presentation of results followed by discussion and conclusion further improved the organization of the article and strengthened the evidence.

Title of this article could have been further improved because it looked into the compliance beyond fluid intake; treatment regimen and other diets also, although fluid played an important role. The abstract of the article gave a comprehensive summary of the research carried out along with its findings and conclusions. To introduce and provide key information about a research article, a well written, brief and comprehensive abstract becomes an essential section. It also gave an idea about the detailed contents and the presentation of the material in the main body of the article.

Before reviewing the available evidence on the issue of hemodialysis, fluids, compliance and health education the authors briefly described the renal failure and its complication. This description helped in understanding the topic in a better way; it also linked the next section in a smooth pattern. Reader does not find any gap left in between. An appropriate collection of evidence has been placed in the background section. This body of existing information is very much helpful in moving towards building a strong rational for the research carried out and eventually this article. A strong rationale is always based on thorough review of literature. Either there is dearth of information or a lot of information but some new hypotheses are generated which require their testing. So a comprehensive and interrelated section on background strengthened this article.

At times objectives are developed by the researcher but their presentation may not be appropriate. A good objective should be a SMART (specific, measurable, achievable, relevant and time-bound) one. The authors of this article have not been able to describe the objectives properly and clearly. Although, aim of the article/study has been stated but there is difference between the two terms in real research terminology.

The aim and the design of the study have been described very well with further elaborating the quasi experimental design options. The authors have provided information on study setting. But they have not informed about the time period of study. Fluid intake and requirements vary in different weather conditions. It is always a quest of a reader to know such things to answer the questions which arise in his or her mind. Sample size calculation has also been provided but the reference is very old; published almost 20 years back. It would have been better if a recent reference or discussion on sample size calculation was used.

A detailed description of the study participants, their inclusion and exclusion characteristics have been stated. Ethical considerations are hallmark of any research; its importance increases even further when there is any external factor is introduced to human (Rothman & Greenland, 1998).The authors also mentioned about the ethical approval which was obtained for carrying out this research. This is an important component of any research which is carried out on human beings. This is the right of every human to know about the research and decide without any coercion to take part in any research study or not! Ethical review takes care of these rights and requirements.

The authors have not only described the intervention in the text but also provided various tables to further improve the understanding of the intervention package. The study design has also been described diagrammatically. Utilizing different sets of presenting data helps gaining the attention of the reader. This also elaborates the whole process of activities conducted very well presentable. Description of education intervention which was implemented and the outcome measures looked for to assess any change or improvement in the compliance of the patients is an important opponent. In fact, this is the crux of the whole research activity because the assessment will be carried out and validated by estimating these indicators.

The process and the contents of data collection activity have been very well described. The authors shared the measurement and capturing of all the important variables at the time of data collection. The study has been divided in three phases: baseline, intervention and endline. Each phase continued for a period of two months. Assessment of knowledge and change of behavior after two months of health education seems to be a short interval. As patients of renal failure pass a life with chronic morbidity; this short interval assessment may not give any idea about the persistence of the behavior with good compliance. Therefore, either assessment should have been after a gap of sometime of health education activity or there should be a series of such assessment after intervention to look for persistence of complaint behavior.

Data management is a group of activities conducted right from the time of the data collection instruments are developed and it continues through the stages of data collection, validation, editing to entry and analysis. For any valid research study, the role of data management process is vital. If there is any breakage in this chain or disturbance of quality then whole of the study is out on stake. The authors of this study did not mention anything related to data management except information on analysis.

They have described analysis in some detail. Explanation for using a specific test is important and it also agrees to the requirement of this type of analysis (Machi, Campbell & Walters, 2007). The authors have mentioned applying various statistical tests at different situations to get the analysis which they wanted.

The results of the study have been elaborated in reasonable detail. Authors address all the main areas which required analysis. Various relationships have been explored as well as any level of significance testing has also been utilized. These analyses are important to make a point clear and defend or accept any hypothesis which has been tested. This section reflects a strong hold on the authors on the statistical issues. They have dealt this issue very efficiently. This is important quality of a researcher to convey or make the reader understand what he or she wants to present. However, with additional tables or graphs this section could have been made more understandable.

Discussion section of any scientific article makes the article acceptable or not! It is this section where results of the current study are compared to the previous ones and thus a detail debate is carried out. The authors try to bring their study in the line of existing evidence if the results are alike; at times the results are against what had been presented in earlier studies then a plausible explanation is required by the authors to state his or her view point. If the results take an absolutely new turn then the authors also suggest further research in the area. This article has been very well supported by a wealth of discussion points. The authors have argues to explain what they have found in this study.

Narrating the limitations of a research study explicitly reflect the hold and neutral position of the authors. It also suggest about the careful nature of the authors who could identify the shortcomings of their study. No study can be carried out with 100 percent accuracy and without any deficiency but sharing any limitations are very important and professional characteristics. The authors of this article have shared the limitations of this study.

Drawing some important conclusions is also a key task which should not be overlooked. It determines the accomplishment of the objectives set at the beginning of the research study. It also reflects the ability of the authors to extract what have been important findings other than the set objectives.

Machin D., Campbell MJ., & Walters SJ. (2007). Medical Statistics: A textbook for the health sciences. 4 th edition, pp. 129-132. John Wiley & Sons Ltd.

Rothman KJ., & Greenland S. (1998). Modern Epidemiology. 2 nd edition, pp. 67-70. Lippincott – Raven, Philadelphia. The Practice of leadership,Web.

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Fowler J From staff nurse to nurse consultant: Academic essays part 7: demonstrating depth of writing. Br J Nurs. 2021; 30:(2) https://doi.org/10.12968/bjon.2021.30.2.132

Academic essays part 9: Use of your own experience

John Fowler

Educational Consultant, explores how to survive your nursing career

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One of the hardest aspects of essay writing for many students is when and how they should use their own clinical experience in an assignment. Junior students who are excited by their first clinical placements are often eager to describe their experience and senior nurses on master's courses may feel that their wealth of clinical experience should form the focus of essays.

Is clinical practice relevant?

As discussed in previous articles in this series (Fowler, 2020), the foundation of an assignment should be the critical appraisal of relevant evidence-based literature. This is something that the junior nursing student has to grapple with in their initial assignments because the temptation can be to simply describe what happened to a single patient they have nursed.

Lecturers guiding the student often have to repeat and reinforce the need to ‘come from the literature’ not from opinions. Such is the emphasis given to this perspective that many students, and even some lecturers, are left with the ‘rule’ that you should not use clinical experience at all in an academic essay. But nursing is a practice-based profession and we must learn how to incorporate our experience into evidence-based practice.

How not to use clinical experience in an academic essay

A common mistake made by junior nursing students is to write an assignment based on their own opinions, some random clinical observations and a superficial reference to a few articles. This is a formula for failure. A mistake that some qualified nurses make on master's assignments is that they want to use a particular perspective, gained from their experience, as the basis of the assignment, using selected literature to support their opinions—again, a formula for failure. Consider the following example that typifies numerous examples that I have read in assignments. ‘In my experience, post-operative pain can be reduced if the patients are given a good understanding of what is going to happen to them on return from surgery. Smith (2019) agrees with this, as does Jones (2017).’

The student is using their experience to form an opinion and then finding some literature to support their view. The lecturer marking this essay will know that the general sentiments expressed in this sentence have a degree of truth, but that the academic foundation on which they are built is faulty. The student is first expressing an opinion and then finding a couple of pieces of literature to support their view. Consider the more extreme example: ‘Postoperative pain can be reduced if the patients are given a pink crystal to hold for 30 minutes prior to surgery. Smith (2017) agrees with this as does Jones (2019).’

Using clinical experience to comment on the literature

Nursing is a practice-based profession and one of the marks of the developing specialist is the appropriate use of previous experience to inform evidence-based practice. It is important to understand and be able to demonstrate this both in our clinical practice and in our academic writing. The way to do so is to use clinical experience to comment on evidence extracted from the literature.

Consider the following example. The first two sentences were written in part 7 of this series to demonstrate comparative analysis, the final sentence illustrates how you can use your clinical experience to comment on the published evidence.

‘Smith (2015), in a controlled study of 2000 patients and Brown (2016) in a qualitative study interviewing 15 postoperative patients both identified written information as an important factor in their conclusion that preoperative information reduces the experience of pain postoperatively. Interestingly, both of these studies focused on women, whereas a similar, smaller controlled study by Taylor (2016) focusing on male surgical patients found little significant effect on pain reduction. The author's experience of having worked as a charge nurse for the past 5 years on surgical wards for both male and female patients is that both male and female patients who are given appropriate preoperative information appear to have a reduced need for higher doses of analgesia, suggesting that this is a complex multifactorial area requiring further controlled studies.’

You can see from the last sentence above that the student's experience is being used in a similar way to an additional piece of literature. The credibility of the experience is demonstrated, ie 5 years' experience as a charge nurse in surgical wards, followed by the clinical observations, followed by a discussion point. Note that it does not say: ‘Based on my experience, Smith and Brown are right and Taylor is wrong.’ A junior student might add a sentence, saying: ‘In the author's experience during their first student clinical placement on a male surgical ward, I observed that patients were routinely given verbal and written preoperative information relating to postoperative pain experience and several, but not all, patients appeared to find it useful when I subsequently discussed their experience of pain with them.’

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• J Clin Diagn Res
• v.11(5); 2017 May

Critical Appraisal of Clinical Research

Azzam al-jundi.

1 Professor, Department of Orthodontics, King Saud bin Abdul Aziz University for Health Sciences-College of Dentistry, Riyadh, Kingdom of Saudi Arabia.

Salah Sakka

2 Associate Professor, Department of Oral and Maxillofacial Surgery, Al Farabi Dental College, Riyadh, KSA.

Evidence-based practice is the integration of individual clinical expertise with the best available external clinical evidence from systematic research and patient’s values and expectations into the decision making process for patient care. It is a fundamental skill to be able to identify and appraise the best available evidence in order to integrate it with your own clinical experience and patients values. The aim of this article is to provide a robust and simple process for assessing the credibility of articles and their value to your clinical practice.

Introduction

Decisions related to patient value and care is carefully made following an essential process of integration of the best existing evidence, clinical experience and patient preference. Critical appraisal is the course of action for watchfully and systematically examining research to assess its reliability, value and relevance in order to direct professionals in their vital clinical decision making [ 1 ].

Critical appraisal is essential to:

• Combat information overload;
• Identify papers that are clinically relevant;
• Continuing Professional Development (CPD).

Carrying out Critical Appraisal:

Assessing the research methods used in the study is a prime step in its critical appraisal. This is done using checklists which are specific to the study design.

Standard Common Questions:

• What is the research question?
• What is the study type (design)?
• Selection issues.
• What are the outcome factors and how are they measured?
• What are the study factors and how are they measured?
• What important potential confounders are considered?
• What is the statistical method used in the study?
• Statistical results.
• What conclusions did the authors reach about the research question?
• Are ethical issues considered?

The Critical Appraisal starts by double checking the following main sections:

I. Overview of the paper:

• The publishing journal and the year
• The article title: Does it state key trial objectives?
• The author (s) and their institution (s)

The presence of a peer review process in journal acceptance protocols also adds robustness to the assessment criteria for research papers and hence would indicate a reduced likelihood of publication of poor quality research. Other areas to consider may include authors’ declarations of interest and potential market bias. Attention should be paid to any declared funding or the issue of a research grant, in order to check for a conflict of interest [ 2 ].

II. ABSTRACT: Reading the abstract is a quick way of getting to know the article and its purpose, major procedures and methods, main findings, and conclusions.

• Aim of the study: It should be well and clearly written.
• Materials and Methods: The study design and type of groups, type of randomization process, sample size, gender, age, and procedure rendered to each group and measuring tool(s) should be evidently mentioned.
• Results: The measured variables with their statistical analysis and significance.
• Conclusion: It must clearly answer the question of interest.

III. Introduction/Background section:

An excellent introduction will thoroughly include references to earlier work related to the area under discussion and express the importance and limitations of what is previously acknowledged [ 2 ].

-Why this study is considered necessary? What is the purpose of this study? Was the purpose identified before the study or a chance result revealed as part of ‘data searching?’

-What has been already achieved and how does this study be at variance?

-Does the scientific approach outline the advantages along with possible drawbacks associated with the intervention or observations?

IV. Methods and Materials section : Full details on how the study was actually carried out should be mentioned. Precise information is given on the study design, the population, the sample size and the interventions presented. All measurements approaches should be clearly stated [ 3 ].

V. Results section : This section should clearly reveal what actually occur to the subjects. The results might contain raw data and explain the statistical analysis. These can be shown in related tables, diagrams and graphs.

VI. Discussion section : This section should include an absolute comparison of what is already identified in the topic of interest and the clinical relevance of what has been newly established. A discussion on a possible related limitations and necessitation for further studies should also be indicated.

Does it summarize the main findings of the study and relate them to any deficiencies in the study design or problems in the conduct of the study? (This is called intention to treat analysis).

• Does it address any source of potential bias?
• Are interpretations consistent with the results?
• How are null findings interpreted?
• Does it mention how do the findings of this study relate to previous work in the area?
• Can they be generalized (external validity)?
• Does it mention their clinical implications/applicability?
• What are the results/outcomes/findings applicable to and will they affect a clinical practice?
• Does the conclusion answer the study question?
• -Is the conclusion convincing?
• -Does the paper indicate ethics approval?
• -Can you identify potential ethical issues?
• -Do the results apply to the population in which you are interested?
• -Will you use the results of the study?

Once you have answered the preliminary and key questions and identified the research method used, you can incorporate specific questions related to each method into your appraisal process or checklist.

1-What is the research question?

For a study to gain value, it should address a significant problem within the healthcare and provide new or meaningful results. Useful structure for assessing the problem addressed in the article is the Problem Intervention Comparison Outcome (PICO) method [ 3 ].

P = Patient or problem: Patient/Problem/Population:

It involves identifying if the research has a focused question. What is the chief complaint?

E.g.,: Disease status, previous ailments, current medications etc.,

I = Intervention: Appropriately and clearly stated management strategy e.g.,: new diagnostic test, treatment, adjunctive therapy etc.,

C= Comparison: A suitable control or alternative

E.g.,: specific and limited to one alternative choice.

O= Outcomes: The desired results or patient related consequences have to be identified. e.g.,: eliminating symptoms, improving function, esthetics etc.,

The clinical question determines which study designs are appropriate. There are five broad categories of clinical questions, as shown in [ Table/Fig-1 ].

[Table/Fig-1]:

Categories of clinical questions and the related study designs.

2- What is the study type (design)?

The study design of the research is fundamental to the usefulness of the study.

In a clinical paper the methodology employed to generate the results is fully explained. In general, all questions about the related clinical query, the study design, the subjects and the correlated measures to reduce bias and confounding should be adequately and thoroughly explored and answered.

Participants/Sample Population:

Researchers identify the target population they are interested in. A sample population is therefore taken and results from this sample are then generalized to the target population.

The sample should be representative of the target population from which it came. Knowing the baseline characteristics of the sample population is important because this allows researchers to see how closely the subjects match their own patients [ 4 ].

Sample size calculation (Power calculation): A trial should be large enough to have a high chance of detecting a worthwhile effect if it exists. Statisticians can work out before the trial begins how large the sample size should be in order to have a good chance of detecting a true difference between the intervention and control groups [ 5 ].

• Is the sample defined? Human, Animals (type); what population does it represent?
• Does it mention eligibility criteria with reasons?
• Does it mention where and how the sample were recruited, selected and assessed?
• Does it mention where was the study carried out?
• Is the sample size justified? Rightly calculated? Is it adequate to detect statistical and clinical significant results?
• Does it mention a suitable study design/type?
• Is the study type appropriate to the research question?
• Is the study adequately controlled? Does it mention type of randomization process? Does it mention the presence of control group or explain lack of it?
• Are the samples similar at baseline? Is sample attrition mentioned?
• All studies report the number of participants/specimens at the start of a study, together with details of how many of them completed the study and reasons for incomplete follow up if there is any.
• Does it mention who was blinded? Are the assessors and participants blind to the interventions received?
• Is it mentioned how was the data analysed?
• Are any measurements taken likely to be valid?

Researchers use measuring techniques and instruments that have been shown to be valid and reliable.

Validity refers to the extent to which a test measures what it is supposed to measure.

(the extent to which the value obtained represents the object of interest.)

• -Soundness, effectiveness of the measuring instrument;
• -What does the test measure?
• -Does it measure, what it is supposed to be measured?
• -How well, how accurately does it measure?

Reliability: In research, the term reliability means “repeatability” or “consistency”

Reliability refers to how consistent a test is on repeated measurements. It is important especially if assessments are made on different occasions and or by different examiners. Studies should state the method for assessing the reliability of any measurements taken and what the intra –examiner reliability was [ 6 ].

3-Selection issues:

The following questions should be raised:

• - How were subjects chosen or recruited? If not random, are they representative of the population?
• - Types of Blinding (Masking) Single, Double, Triple?
• - Is there a control group? How was it chosen?
• - How are patients followed up? Who are the dropouts? Why and how many are there?
• - Are the independent (predictor) and dependent (outcome) variables in the study clearly identified, defined, and measured?
• - Is there a statement about sample size issues or statistical power (especially important in negative studies)?
• - If a multicenter study, what quality assurance measures were employed to obtain consistency across sites?
• - Are there selection biases?
• • In a case-control study, if exercise habits to be compared:
• - Are the controls appropriate?
• - Were records of cases and controls reviewed blindly?
• - How were possible selection biases controlled (Prevalence bias, Admission Rate bias, Volunteer bias, Recall bias, Lead Time bias, Detection bias, etc.,)?
• • Cross Sectional Studies:
• - Was the sample selected in an appropriate manner (random, convenience, etc.,)?
• - Were efforts made to ensure a good response rate or to minimize the occurrence of missing data?
• - Were reliability (reproducibility) and validity reported?
• • In an intervention study, how were subjects recruited and assigned to groups?
• • In a cohort study, how many reached final follow-up?
• - Are the subject’s representatives of the population to which the findings are applied?
• - Is there evidence of volunteer bias? Was there adequate follow-up time?
• - What was the drop-out rate?
• - Any shortcoming in the methodology can lead to results that do not reflect the truth. If clinical practice is changed on the basis of these results, patients could be harmed.

Researchers employ a variety of techniques to make the methodology more robust, such as matching, restriction, randomization, and blinding [ 7 ].

Bias is the term used to describe an error at any stage of the study that was not due to chance. Bias leads to results in which there are a systematic deviation from the truth. As bias cannot be measured, researchers need to rely on good research design to minimize bias [ 8 ]. To minimize any bias within a study the sample population should be representative of the population. It is also imperative to consider the sample size in the study and identify if the study is adequately powered to produce statistically significant results, i.e., p-values quoted are <0.05 [ 9 ].

4-What are the outcome factors and how are they measured?

• -Are all relevant outcomes assessed?
• -Is measurement error an important source of bias?

5-What are the study factors and how are they measured?

• -Are all the relevant study factors included in the study?
• -Have the factors been measured using appropriate tools?

Data Analysis and Results:

- Were the tests appropriate for the data?

- Are confidence intervals or p-values given?

• How strong is the association between intervention and outcome?
• How precise is the estimate of the risk?
• Does it clearly mention the main finding(s) and does the data support them?
• Does it mention the clinical significance of the result?
• Is adverse event or lack of it mentioned?
• Are all relevant outcomes assessed?
• Was the sample size adequate to detect a clinically/socially significant result?
• Are the results presented in a way to help in health policy decisions?
• Is there measurement error?
• Is measurement error an important source of bias?

Confounding Factors:

A confounder has a triangular relationship with both the exposure and the outcome. However, it is not on the causal pathway. It makes it appear as if there is a direct relationship between the exposure and the outcome or it might even mask an association that would otherwise have been present [ 9 ].

6- What important potential confounders are considered?

• -Are potential confounders examined and controlled for?
• -Is confounding an important source of bias?

7- What is the statistical method in the study?

• -Are the statistical methods described appropriate to compare participants for primary and secondary outcomes?
• -Are statistical methods specified insufficient detail (If I had access to the raw data, could I reproduce the analysis)?
• -Were the tests appropriate for the data?
• -Are confidence intervals or p-values given?
• -Are results presented as absolute risk reduction as well as relative risk reduction?

Interpretation of p-value:

The p-value refers to the probability that any particular outcome would have arisen by chance. A p-value of less than 1 in 20 (p<0.05) is statistically significant.

• When p-value is less than significance level, which is usually 0.05, we often reject the null hypothesis and the result is considered to be statistically significant. Conversely, when p-value is greater than 0.05, we conclude that the result is not statistically significant and the null hypothesis is accepted.

Confidence interval:

Multiple repetition of the same trial would not yield the exact same results every time. However, on average the results would be within a certain range. A 95% confidence interval means that there is a 95% chance that the true size of effect will lie within this range.

8- Statistical results:

• -Do statistical tests answer the research question?

Are statistical tests performed and comparisons made (data searching)?

Correct statistical analysis of results is crucial to the reliability of the conclusions drawn from the research paper. Depending on the study design and sample selection method employed, observational or inferential statistical analysis may be carried out on the results of the study.

It is important to identify if this is appropriate for the study [ 9 ].

• -Was the sample size adequate to detect a clinically/socially significant result?
• -Are the results presented in a way to help in health policy decisions?

Clinical significance:

Statistical significance as shown by p-value is not the same as clinical significance. Statistical significance judges whether treatment effects are explicable as chance findings, whereas clinical significance assesses whether treatment effects are worthwhile in real life. Small improvements that are statistically significant might not result in any meaningful improvement clinically. The following questions should always be on mind:

• -If the results are statistically significant, do they also have clinical significance?
• -If the results are not statistically significant, was the sample size sufficiently large to detect a meaningful difference or effect?

9- What conclusions did the authors reach about the study question?

Conclusions should ensure that recommendations stated are suitable for the results attained within the capacity of the study. The authors should also concentrate on the limitations in the study and their effects on the outcomes and the proposed suggestions for future studies [ 10 ].

• -Are the questions posed in the study adequately addressed?
• -Are the conclusions justified by the data?
• -Do the authors extrapolate beyond the data?
• -Are shortcomings of the study addressed and constructive suggestions given for future research?
• -Bibliography/References:

Do the citations follow one of the Council of Biological Editors’ (CBE) standard formats?

10- Are ethical issues considered?

If a study involves human subjects, human tissues, or animals, was approval from appropriate institutional or governmental entities obtained? [ 10 , 11 ].

Critical appraisal of RCTs: Factors to look for:

• Allocation (randomization, stratification, confounders).
• Follow up of participants (intention to treat).
• Data collection (bias).
• Sample size (power calculation).
• Presentation of results (clear, precise).
• Applicability to local population.

[ Table/Fig-2 ] summarizes the guidelines for Consolidated Standards of Reporting Trials CONSORT [ 12 ].

[Table/Fig-2]:

Summary of the CONSORT guidelines.

Critical appraisal of systematic reviews: provide an overview of all primary studies on a topic and try to obtain an overall picture of the results.

In a systematic review, all the primary studies identified are critically appraised and only the best ones are selected. A meta-analysis (i.e., a statistical analysis) of the results from selected studies may be included. Factors to look for:

• Literature search (did it include published and unpublished materials as well as non-English language studies? Was personal contact with experts sought?).
• Quality-control of studies included (type of study; scoring system used to rate studies; analysis performed by at least two experts).
• Homogeneity of studies.

[ Table/Fig-3 ] summarizes the guidelines for Preferred Reporting Items for Systematic reviews and Meta-Analyses PRISMA [ 13 ].

[Table/Fig-3]:

Summary of PRISMA guidelines.

Critical appraisal is a fundamental skill in modern practice for assessing the value of clinical researches and providing an indication of their relevance to the profession. It is a skills-set developed throughout a professional career that facilitates this and, through integration with clinical experience and patient preference, permits the practice of evidence based medicine and dentistry. By following a systematic approach, such evidence can be considered and applied to clinical practice.

Financial or other Competing Interests