hypothesis testing examples in healthcare

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Hypothesis testing, p values, confidence intervals, and significance.

Jacob Shreffler ; Martin R. Huecker .

Affiliations

Last Update: March 13, 2023 .

Definition/Introduction

Medical providers often rely on evidence-based medicine to guide decision-making in practice. Often a research hypothesis is tested with results provided, typically with p values, confidence intervals, or both. Additionally, statistical or research significance is estimated or determined by the investigators. Unfortunately, healthcare providers may have different comfort levels in interpreting these findings, which may affect the adequate application of the data.

Issues of Concern

Without a foundational understanding of hypothesis testing, p values, confidence intervals, and the difference between statistical and clinical significance, it may affect healthcare providers' ability to make clinical decisions without relying purely on the research investigators deemed level of significance. Therefore, an overview of these concepts is provided to allow medical professionals to use their expertise to determine if results are reported sufficiently and if the study outcomes are clinically appropriate to be applied in healthcare practice.

Hypothesis Testing

Investigators conducting studies need research questions and hypotheses to guide analyses. Starting with broad research questions (RQs), investigators then identify a gap in current clinical practice or research. Any research problem or statement is grounded in a better understanding of relationships between two or more variables. For this article, we will use the following research question example:

Research Question: Is Drug 23 an effective treatment for Disease A?

Research questions do not directly imply specific guesses or predictions; we must formulate research hypotheses. A hypothesis is a predetermined declaration regarding the research question in which the investigator(s) makes a precise, educated guess about a study outcome. This is sometimes called the alternative hypothesis and ultimately allows the researcher to take a stance based on experience or insight from medical literature. An example of a hypothesis is below.

Research Hypothesis: Drug 23 will significantly reduce symptoms associated with Disease A compared to Drug 22.

The null hypothesis states that there is no statistical difference between groups based on the stated research hypothesis.

Researchers should be aware of journal recommendations when considering how to report p values, and manuscripts should remain internally consistent.

Regarding p values, as the number of individuals enrolled in a study (the sample size) increases, the likelihood of finding a statistically significant effect increases. With very large sample sizes, the p-value can be very low significant differences in the reduction of symptoms for Disease A between Drug 23 and Drug 22. The null hypothesis is deemed true until a study presents significant data to support rejecting the null hypothesis. Based on the results, the investigators will either reject the null hypothesis (if they found significant differences or associations) or fail to reject the null hypothesis (they could not provide proof that there were significant differences or associations).

To test a hypothesis, researchers obtain data on a representative sample to determine whether to reject or fail to reject a null hypothesis. In most research studies, it is not feasible to obtain data for an entire population. Using a sampling procedure allows for statistical inference, though this involves a certain possibility of error. [1] When determining whether to reject or fail to reject the null hypothesis, mistakes can be made: Type I and Type II errors. Though it is impossible to ensure that these errors have not occurred, researchers should limit the possibilities of these faults. [2]

Significance

Significance is a term to describe the substantive importance of medical research. Statistical significance is the likelihood of results due to chance. [3] Healthcare providers should always delineate statistical significance from clinical significance, a common error when reviewing biomedical research. [4] When conceptualizing findings reported as either significant or not significant, healthcare providers should not simply accept researchers' results or conclusions without considering the clinical significance. Healthcare professionals should consider the clinical importance of findings and understand both p values and confidence intervals so they do not have to rely on the researchers to determine the level of significance. [5] One criterion often used to determine statistical significance is the utilization of p values.

P values are used in research to determine whether the sample estimate is significantly different from a hypothesized value. The p-value is the probability that the observed effect within the study would have occurred by chance if, in reality, there was no true effect. Conventionally, data yielding a p<0.05 or p<0.01 is considered statistically significant. While some have debated that the 0.05 level should be lowered, it is still universally practiced. [6] Hypothesis testing allows us to determine the size of the effect.

An example of findings reported with p values are below:

Statement: Drug 23 reduced patients' symptoms compared to Drug 22. Patients who received Drug 23 (n=100) were 2.1 times less likely than patients who received Drug 22 (n = 100) to experience symptoms of Disease A, p<0.05.

Statement:Individuals who were prescribed Drug 23 experienced fewer symptoms (M = 1.3, SD = 0.7) compared to individuals who were prescribed Drug 22 (M = 5.3, SD = 1.9). This finding was statistically significant, p= 0.02.

For either statement, if the threshold had been set at 0.05, the null hypothesis (that there was no relationship) should be rejected, and we should conclude significant differences. Noticeably, as can be seen in the two statements above, some researchers will report findings with < or > and others will provide an exact p-value (0.000001) but never zero [6] . When examining research, readers should understand how p values are reported. The best practice is to report all p values for all variables within a study design, rather than only providing p values for variables with significant findings. [7] The inclusion of all p values provides evidence for study validity and limits suspicion for selective reporting/data mining.

While researchers have historically used p values, experts who find p values problematic encourage the use of confidence intervals. [8] . P-values alone do not allow us to understand the size or the extent of the differences or associations. [3] In March 2016, the American Statistical Association (ASA) released a statement on p values, noting that scientific decision-making and conclusions should not be based on a fixed p-value threshold (e.g., 0.05). They recommend focusing on the significance of results in the context of study design, quality of measurements, and validity of data. Ultimately, the ASA statement noted that in isolation, a p-value does not provide strong evidence. [9]

When conceptualizing clinical work, healthcare professionals should consider p values with a concurrent appraisal study design validity. For example, a p-value from a double-blinded randomized clinical trial (designed to minimize bias) should be weighted higher than one from a retrospective observational study [7] . The p-value debate has smoldered since the 1950s [10] , and replacement with confidence intervals has been suggested since the 1980s. [11]

Confidence Intervals

A confidence interval provides a range of values within given confidence (e.g., 95%), including the accurate value of the statistical constraint within a targeted population. [12] Most research uses a 95% CI, but investigators can set any level (e.g., 90% CI, 99% CI). [13] A CI provides a range with the lower bound and upper bound limits of a difference or association that would be plausible for a population. [14] Therefore, a CI of 95% indicates that if a study were to be carried out 100 times, the range would contain the true value in 95, [15] confidence intervals provide more evidence regarding the precision of an estimate compared to p-values. [6]

In consideration of the similar research example provided above, one could make the following statement with 95% CI:

Statement: Individuals who were prescribed Drug 23 had no symptoms after three days, which was significantly faster than those prescribed Drug 22; there was a mean difference between the two groups of days to the recovery of 4.2 days (95% CI: 1.9 – 7.8).

It is important to note that the width of the CI is affected by the standard error and the sample size; reducing a study sample number will result in less precision of the CI (increase the width). [14] A larger width indicates a smaller sample size or a larger variability. [16] A researcher would want to increase the precision of the CI. For example, a 95% CI of 1.43 – 1.47 is much more precise than the one provided in the example above. In research and clinical practice, CIs provide valuable information on whether the interval includes or excludes any clinically significant values. [14]

Null values are sometimes used for differences with CI (zero for differential comparisons and 1 for ratios). However, CIs provide more information than that. [15] Consider this example: A hospital implements a new protocol that reduced wait time for patients in the emergency department by an average of 25 minutes (95% CI: -2.5 – 41 minutes). Because the range crosses zero, implementing this protocol in different populations could result in longer wait times; however, the range is much higher on the positive side. Thus, while the p-value used to detect statistical significance for this may result in "not significant" findings, individuals should examine this range, consider the study design, and weigh whether or not it is still worth piloting in their workplace.

Similarly to p-values, 95% CIs cannot control for researchers' errors (e.g., study bias or improper data analysis). [14] In consideration of whether to report p-values or CIs, researchers should examine journal preferences. When in doubt, reporting both may be beneficial. [13] An example is below:

Reporting both: Individuals who were prescribed Drug 23 had no symptoms after three days, which was significantly faster than those prescribed Drug 22, p = 0.009. There was a mean difference between the two groups of days to the recovery of 4.2 days (95% CI: 1.9 – 7.8).

Clinical Significance

Recall that clinical significance and statistical significance are two different concepts. Healthcare providers should remember that a study with statistically significant differences and large sample size may be of no interest to clinicians, whereas a study with smaller sample size and statistically non-significant results could impact clinical practice. [14] Additionally, as previously mentioned, a non-significant finding may reflect the study design itself rather than relationships between variables.

Healthcare providers using evidence-based medicine to inform practice should use clinical judgment to determine the practical importance of studies through careful evaluation of the design, sample size, power, likelihood of type I and type II errors, data analysis, and reporting of statistical findings (p values, 95% CI or both). [4] Interestingly, some experts have called for "statistically significant" or "not significant" to be excluded from work as statistical significance never has and will never be equivalent to clinical significance. [17]

The decision on what is clinically significant can be challenging, depending on the providers' experience and especially the severity of the disease. Providers should use their knowledge and experiences to determine the meaningfulness of study results and make inferences based not only on significant or insignificant results by researchers but through their understanding of study limitations and practical implications.

Nursing, Allied Health, and Interprofessional Team Interventions

All physicians, nurses, pharmacists, and other healthcare professionals should strive to understand the concepts in this chapter. These individuals should maintain the ability to review and incorporate new literature for evidence-based and safe care.

Review Questions
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Disclosure: Jacob Shreffler declares no relevant financial relationships with ineligible companies.

Disclosure: Martin Huecker declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

Cite this Page Shreffler J, Huecker MR. Hypothesis Testing, P Values, Confidence Intervals, and Significance. [Updated 2023 Mar 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Research article
Open access
Published: 19 May 2010

The null hypothesis significance test in health sciences research (1995-2006): statistical analysis and interpretation

Luis Carlos Silva-Ayçaguer 1 ,
Patricio Suárez-Gil 2 &
Ana Fernández-Somoano 3

BMC Medical Research Methodology volume 10 , Article number: 44 ( 2010 ) Cite this article

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The null hypothesis significance test (NHST) is the most frequently used statistical method, although its inferential validity has been widely criticized since its introduction. In 1988, the International Committee of Medical Journal Editors (ICMJE) warned against sole reliance on NHST to substantiate study conclusions and suggested supplementary use of confidence intervals (CI). Our objective was to evaluate the extent and quality in the use of NHST and CI, both in English and Spanish language biomedical publications between 1995 and 2006, taking into account the International Committee of Medical Journal Editors recommendations, with particular focus on the accuracy of the interpretation of statistical significance and the validity of conclusions.

Original articles published in three English and three Spanish biomedical journals in three fields (General Medicine, Clinical Specialties and Epidemiology - Public Health) were considered for this study. Papers published in 1995-1996, 2000-2001, and 2005-2006 were selected through a systematic sampling method. After excluding the purely descriptive and theoretical articles, analytic studies were evaluated for their use of NHST with P-values and/or CI for interpretation of statistical "significance" and "relevance" in study conclusions.

Among 1,043 original papers, 874 were selected for detailed review. The exclusive use of P-values was less frequent in English language publications as well as in Public Health journals; overall such use decreased from 41% in 1995-1996 to 21% in 2005-2006. While the use of CI increased over time, the "significance fallacy" (to equate statistical and substantive significance) appeared very often, mainly in journals devoted to clinical specialties (81%). In papers originally written in English and Spanish, 15% and 10%, respectively, mentioned statistical significance in their conclusions.

Conclusions

Overall, results of our review show some improvements in statistical management of statistical results, but further efforts by scholars and journal editors are clearly required to move the communication toward ICMJE advices, especially in the clinical setting, which seems to be imperative among publications in Spanish.

Peer Review reports

The null hypothesis statistical testing (NHST) has been the most widely used statistical approach in health research over the past 80 years. Its origins dates back to 1279 [ 1 ] although it was in the second decade of the twentieth century when the statistician Ronald Fisher formally introduced the concept of "null hypothesis" H 0 - which, generally speaking, establishes that certain parameters do not differ from each other. He was the inventor of the "P-value" through which it could be assessed [ 2 ]. Fisher's P-value is defined as a conditional probability calculated using the results of a study. Specifically, the P-value is the probability of obtaining a result at least as extreme as the one that was actually observed, assuming that the null hypothesis is true. The Fisherian significance testing theory considered the p-value as an index to measure the strength of evidence against the null hypothesis in a single experiment. The father of NHST never endorsed, however, the inflexible application of the ultimately subjective threshold levels almost universally adopted later on (although the introduction of the 0.05 has his paternity also).

A few years later, Jerzy Neyman and Egon Pearson considered the Fisherian approach inefficient, and in 1928 they published an article [ 3 ] that would provide the theoretical basis of what they called hypothesis statistical testing . The Neyman-Pearson approach is based on the notion that one out of two choices has to be taken: accept the null hypothesis taking the information as a reference based on the information provided, or reject it in favor of an alternative one. Thus, one can incur one of two types of errors: a Type I error, if the null hypothesis is rejected when it is actually true, and a Type II error, if the null hypothesis is accepted when it is actually false. They established a rule to optimize the decision process, using the p-value introduced by Fisher, by setting the maximum frequency of errors that would be admissible.

The null hypothesis statistical testing, as applied today, is a hybrid coming from the amalgamation of the two methods [ 4 ]. As a matter of fact, some 15 years later, both procedures were combined to give rise to the nowadays widespread use of an inferential tool that would satisfy none of the statisticians involved in the original controversy. The present method essentially goes as follows: given a null hypothesis, an estimate of the parameter (or parameters) is obtained and used to create statistics whose distribution, under H 0 , is known. With these data the P-value is computed. Finally, the null hypothesis is rejected when the obtained P-value is smaller than a certain comparative threshold (usually 0.05) and it is not rejected if P is larger than the threshold.

The first reservations about the validity of the method began to appear around 1940, when some statisticians censured the logical roots and practical convenience of Fisher's P-value [ 5 ]. Significance tests and P-values have repeatedly drawn the attention and criticism of many authors over the past 70 years, who have kept questioning its epistemological legitimacy as well as its practical value. What remains in spite of these criticisms is the lasting legacy of researchers' unwillingness to eradicate or reform these methods.

Although there are very comprehensive works on the topic [ 6 ], we list below some of the criticisms most universally accepted by specialists.

The P-values are used as a tool to make decisions in favor of or against a hypothesis. What really may be relevant, however, is to get an effect size estimate (often the difference between two values) rather than rendering dichotomous true/false verdicts [ 7 – 11 ].

The P-value is a conditional probability of the data, provided that some assumptions are met, but what really interests the investigator is the inverse probability: what degree of validity can be attributed to each of several competing hypotheses, once that certain data have been observed [ 12 ].

The two elements that affect the results, namely the sample size and the magnitude of the effect, are inextricably linked in the value of p and we can always get a lower P-value by increasing the sample size. Thus, the conclusions depend on a factor completely unrelated to the reality studied (i.e. the available resources, which in turn determine the sample size) [ 13 , 14 ].

Those who defend the NHST often assert the objective nature of that test, but the process is actually far from being so. NHST does not ensure objectivity. This is reflected in the fact that we generally operate with thresholds that are ultimately no more than conventions, such as 0.01 or 0.05. What is more, for many years their use has unequivocally demonstrated the inherent subjectivity that goes with the concept of P, regardless of how it will be used later [ 15 – 17 ].

In practice, the NHST is limited to a binary response sorting hypotheses into "true" and "false" or declaring "rejection" or "no rejection", without demanding a reasonable interpretation of the results, as has been noted time and again for decades. This binary orthodoxy validates categorical thinking, which results in a very simplistic view of scientific activity that induces researchers not to test theories about the magnitude of effect sizes [ 18 – 20 ].

Despite the weakness and shortcomings of the NHST, they are frequently taught as if they were the key inferential statistical method or the most appropriate, or even the sole unquestioned one. The statistical textbooks, with only some exceptions, do not even mention the NHST controversy. Instead, the myth is spread that NHST is the "natural" final action of scientific inference and the only procedure for testing hypotheses. However, relevant specialists and important regulators of the scientific world advocate avoiding them.

Taking especially into account that NHST does not offer the most important information (i.e. the magnitude of an effect of interest, and the precision of the estimate of the magnitude of that effect), many experts recommend the reporting of point estimates of effect sizes with confidence intervals as the appropriate representation of the inherent uncertainty linked to empirical studies [ 21 – 25 ]. Since 1988, the International Committee of Medical Journal Editors (ICMJE, known as the Vancouver Group ) incorporates the following recommendation to authors of manuscripts submitted to medical journals: "When possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty (such as confidence intervals). Avoid relying solely on statistical hypothesis testing, such as P-values, which fail to convey important information about effect size" [ 26 ].

As will be shown, the use of confidence intervals (CI), occasionally accompanied by P-values, is recommended as a more appropriate method for reporting results. Some authors have noted several shortcomings of CI long ago [ 27 ]. In spite of the fact that calculating CI could be complicated indeed, and that their interpretation is far from simple [ 28 , 29 ], authors are urged to use them because they provide much more information than the NHST and do not merit most of its criticisms of NHST [ 30 ]. While some have proposed different options (for instance, likelihood-based information theoretic methods [ 31 ], and the Bayesian inferential paradigm [ 32 ]), confidence interval estimation of effect sizes is clearly the most widespread alternative approach.

Although twenty years have passed since the ICMJE began to disseminate such recommendations, systematically ignored by the vast majority of textbooks and hardly incorporated in medical publications [ 33 ], it is interesting to examine the extent to which the NHST is used in articles published in medical journals during recent years, in order to identify what is still lacking in the process of eradicating the widespread ceremonial use that is made of statistics in health research [ 34 ]. Furthermore, it is enlightening in this context to examine whether these patterns differ between English- and Spanish-speaking worlds and, if so, to see if the changes in paradigms are occurring more slowly in Spanish-language publications. In such a case we would offer various suggestions.

In addition to assessing the adherence to the above cited statistical recommendation proposed by ICMJE relative to the use of P-values, we consider it of particular interest to estimate the extent to which the significance fallacy is present, an inertial deficiency that consists of attributing -- explicitly or not -- qualitative importance or practical relevance to the found differences simply because statistical significance was obtained.

Many authors produce misleading statements such as "a significant effect was (or was not) found" when it should be said that "a statistically significant difference was (or was not) found". A detrimental consequence of this equivalence is that some authors believe that finding out whether there is "statistical significance" or not is the aim, so that this term is then mentioned in the conclusions [ 35 ]. This means virtually nothing, except that it indicates that the author is letting a computer do the thinking. Since the real research questions are never statistical ones, the answers cannot be statistical either. Accordingly, the conversion of the dichotomous outcome produced by a NHST into a conclusion is another manifestation of the mentioned fallacy.

The general objective of the present study is to evaluate the extent and quality of use of NHST and CI, both in English- and in Spanish-language biomedical publications, between 1995 and 2006 taking into account the International Committee of Medical Journal Editors recommendations, with particular focus on accuracy regarding interpretation of statistical significance and the validity of conclusions.

We reviewed the original articles from six journals, three in English and three in Spanish, over three disjoint periods sufficiently separated from each other (1995-1996, 2000-2001, 2005-2006) as to properly describe the evolution in prevalence of the target features along the selected periods.

The selection of journals was intended to get representation for each of the following three thematic areas: clinical specialties ( Obstetrics & Gynecology and Revista Española de Cardiología) ; Public Health and Epidemiology ( International Journal of Epidemiology and Atención Primaria) and the area of general and internal medicine ( British Medical Journal and Medicina Clínica ). Five of the selected journals formally endorsed ICMJE guidelines; the remaining one ( Revista Española de Cardiología ) suggests observing ICMJE demands in relation with specific issues. We attempted to capture journal diversity in the sample by selecting general and specialty journals with different degrees of influence, resulting from their impact factors in 2007, which oscillated between 1.337 (MC) and 9.723 (BMJ). No special reasons guided us to choose these specific journals, but we opted for journals with rather large paid circulations. For instance, the Spanish Cardiology Journal is the one with the largest impact factor among the fourteen Spanish Journals devoted to clinical specialties that have impact factor and Obstetrics & Gynecology has an outstanding impact factor among the huge number of journals available for selection.

It was decided to take around 60 papers for each biennium and journal, which means a total of around 1,000 papers. As recently suggested [ 36 , 37 ], this number was not established using a conventional method, but by means of a purposive and pragmatic approach in choosing the maximum sample size that was feasible.

Systematic sampling in phases [ 38 ] was used in applying a sampling fraction equal to 60/N, where N is the number of articles, in each of the 18 subgroups defined by crossing the six journals and the three time periods. Table 1 lists the population size and the sample size for each subgroup. While the sample within each subgroup was selected with equal probability, estimates based on other subsets of articles (defined across time periods, areas, or languages) are based on samples with various selection probabilities. Proper weights were used to take into account the stratified nature of the sampling in these cases.

Forty-nine of the 1,092 selected papers were eliminated because, although the section of the article in which they were assigned could suggest they were originals, detailed scrutiny revealed that in some cases they were not. The sample, therefore, consisted of 1,043 papers. Each of them was classified into one of three categories: (1) purely descriptive papers, those designed to review or characterize the state of affairs as it exists at present, (2) analytical papers, or (3) articles that address theoretical, methodological or conceptual issues. An article was regarded as analytical if it seeks to explain the reasons behind a particular occurrence by discovering causal relationships or, even if self-classified as descriptive, it was carried out to assess cause-effect associations among variables. We classify as theoretical or methodological those articles that do not handle empirical data as such, and focus instead on proposing or assessing research methods. We identified 169 papers as purely descriptive or theoretical, which were therefore excluded from the sample. Figure 1 presents a flow chart showing the process for determining eligibility for inclusion in the sample.

Flow chart of the selection process for eligible papers .

To estimate the adherence to ICMJE recommendations, we considered whether the papers used P-values, confidence intervals, and both simultaneously. By "the use of P-values" we mean that the article contains at least one P-value, explicitly mentioned in the text or at the bottom of a table, or that it reports that an effect was considered as statistically significant . It was deemed that an article uses CI if it explicitly contained at least one confidence interval, but not when it only provides information that could allow its computation (usually by presenting both the estimate and the standard error). Probability intervals provided in Bayesian analysis were classified as confidence intervals (although conceptually they are not the same) since what is really of interest here is whether or not the authors quantify the findings and present them with appropriate indicators of the margin of error or uncertainty.

In addition we determined whether the "Results" section of each article attributed the status of "significant" to an effect on the sole basis of the outcome of a NHST (i.e., without clarifying that it is strictly statistical significance). Similarly, we examined whether the term "significant" (applied to a test) was mistakenly used as synonymous with substantive , relevant or important . The use of the term "significant effect" when it is only appropriate as a reference to a "statistically significant difference," can be considered a direct expression of the significance fallacy [ 39 ] and, as such, constitutes one way to detect the problem in a specific paper.

We also assessed whether the "Conclusions," which sometimes appear as a separate section in the paper or otherwise in the last paragraphs of the "Discussion" section mentioned statistical significance and, if so, whether any of such mentions were no more than an allusion to results.

To perform these analyses we considered both the abstract and the body of the article. To assess the handling of the significance issue, however, only the body of the manuscript was taken into account.

The information was collected by four trained observers. Every paper was assigned to two reviewers. Disagreements were discussed and, if no agreement was reached, a third reviewer was consulted to break the tie and so moderate the effect of subjectivity in the assessment.

In order to assess the reliability of the criteria used for the evaluation of articles and to effect a convergence of criteria among the reviewers, a pilot study of 20 papers from each of three journals ( Clinical Medicine , Primary Care , and International Journal of Epidemiology) was performed. The results of this pilot study were satisfactory. Our results are reported using percentages together with their corresponding confidence intervals. For sampling errors estimations, used to obtain confidence intervals, we weighted the data using the inverse of the probability of selection of each paper, and we took into account the complex nature of the sample design. These analyses were carried out with EPIDAT [ 40 ], a specialized computer program that is readily available.

A total of 1,043 articles were reviewed, of which 874 (84%) were found to be analytic, while the remainders were purely descriptive or of a theoretical and methodological nature. Five of them did not employ either P-values or CI. Consequently, the analysis was made using the remaining 869 articles.

Use of NHST and confidence intervals

The percentage of articles that use only P-values, without even mentioning confidence intervals, to report their results has declined steadily throughout the period analyzed (Table 2 ). The percentage decreased from approximately 41% in 1995-1996 to 21% in 2005-2006. However, it does not differ notably among journals of different languages, as shown by the estimates and confidence intervals of the respective percentages. Concerning thematic areas, it is highly surprising that most of the clinical articles ignore the recommendations of ICMJE, while for general and internal medicine papers such a problem is only present in one in five papers, and in the area of Public Health and Epidemiology it occurs only in one out of six. The use of CI alone (without P-values) has increased slightly across the studied periods (from 9% to 13%), but it is five times more prevalent in Public Health and Epidemiology journals than in Clinical ones, where it reached a scanty 3%.

Ambivalent handling of the significance

While the percentage of articles referring implicitly or explicitly to significance in an ambiguous or incorrect way - that is, incurring the significance fallacy -- seems to decline steadily, the prevalence of this problem exceeds 69%, even in the most recent period. This percentage was almost the same for articles written in Spanish and in English, but it was notably higher in the Clinical journals (81%) compared to the other journals, where the problem occurs in approximately 7 out of 10 papers (Table 3 ). The kappa coefficient for measuring agreement between observers concerning the presence of the "significance fallacy" was 0.78 (CI95%: 0.62 to 0.93), which is considered acceptable in the scale of Landis and Koch [ 41 ].

Reference to numerical results or statistical significance in Conclusions

The percentage of papers mentioning a numerical finding as a conclusion is similar in the three periods analyzed (Table 4 ). Concerning languages, this percentage is nearly twice as large for Spanish journals as for those published in English (approximately 21% versus 12%). And, again, the highest percentage (16%) corresponded to clinical journals.

A similar pattern is observed, although with less pronounced differences, in references to the outcome of the NHST (significant or not) in the conclusions (Table 5 ). The percentage of articles that introduce the term in the "Conclusions" does not appreciably differ between articles written in Spanish and in English. Again, the area where this insufficiency is more often present (more than 15% of articles) is the Clinical area.

There are some previous studies addressing the degree to which researchers have moved beyond the ritualistic use of NHST to assess their hypotheses. This has been examined for areas such as biology [ 42 ], organizational research [ 43 ], or psychology [ 44 – 47 ]. However, to our knowledge, no recent research has explored the pattern of use P-values and CI in medical literature and, in any case, no efforts have been made to study this problem in a way that takes into account different languages and specialties.

At first glance it is puzzling that, after decades of questioning and technical warnings, and after twenty years since the inception of ICMJE recommendation to avoid NHST, they continue being applied ritualistically and mindlessly as the dominant doctrine. Not long ago, when researchers did not observe statistically significant effects, they were unlikely to write them up and to report "negative" findings, since they knew there was a high probability that the paper would be rejected. This has changed a bit: editors are more prone to judge all findings as potentially eloquent. This is probably the frequent denunciations of the tendency for those papers presenting a significant positive result to receive more favorable publication decisions than equally well-conducted ones that report a negative or null result, the so-called publication bias [ 48 – 50 ]. This new openness is consistent with the fact that if the substantive question addressed is really relevant, the answer (whether positive or negative) will also be relevant.

Consequently, even though it was not an aim of our study, we found many examples in which statistical significance was not obtained. However, many of those negative results were reported with a comment of this type: " The results did not show a significant difference between groups; however, with a larger sample size, this difference would have probably proved to be significant ". The problem with this statement is that it is true; more specifically, it will always be true and it is, therefore, sterile. It is not fortuitous that one never encounters the opposite, and equally tautological, statement: " A significant difference between groups has been detected; however, perhaps with a smaller sample size, this difference would have proved to be not significant" . Such a double standard is itself an unequivocal sign of the ritual application of NHST.

Although the declining rates of NHST usage show that, gradually, ICMJE and similar recommendations are having a positive impact, most of the articles in the clinical setting still considered NHST as the final arbiter of the research process. Moreover, it appears that the improvement in the situation is mostly formal, and the percentage of articles that fall into the significance fallacy is huge.

The contradiction between what has been conceptually recommended and the common practice is sensibly less acute in the area of Epidemiology and Public Health, but the same pattern was evident everywhere in the mechanical way of applying significance tests. Nevertheless, the clinical journals remain the most unmoved by the recommendations.

The ICMJE recommendations are not cosmetic statements but substantial ones, and the vigorous exhortations made by outstanding authorities [ 51 ] are not mere intellectual exercises due to ingenious and inopportune methodologists, but rather they are very serious epistemological warnings.

In some cases, the role of CI is not as clearly suitable (e.g. when estimating multiple regression coefficients or because effect sizes are not available for some research designs [ 43 , 52 ]), but when it comes to estimating, for example, an odds ratio or a rates difference, the advantage of using CI instead of P values is very clear, since in such cases it is obvious that the goal is to assess what has been called the "effect size."

The inherent resistance to change old paradigms and practices that have been entrenched for decades is always high. Old habits die hard. The estimates and trends outlined are entirely consistent with Alvan Feinstein's warning 25 years ago: "Because the history of medical research also shows a long tradition of maintaining loyalty to established doctrines long after the doctrines had been discredited, or shown to be valueless, we cannot expect a sudden change in this medical policy merely because it has been denounced by leading connoisseurs of statistics [ 53 ]".

It is possible, however, that the nature of the problem has an external explanation: it is likely that some editors prefer to "avoid troubles" with the authors and vice versa, thus resorting to the most conventional procedures. Many junior researchers believe that it is wise to avoid long back-and-forth discussions with reviewers and editors. In general, researchers who want to appear in print and survive in a publish-or-perish environment are motivated by force, fear, and expedience in their use of NHST [ 54 ]. Furthermore, it is relatively natural that simple researchers use NHST when they take into account that some theoretical objectors have used this statistical analysis in empirical studies, published after the appearance of their own critiques [ 55 ].

For example, Journal of the American Medical Association published a bibliometric study [ 56 ] discussing the impact of statisticians' co-authorship of medical papers on publication decisions by two major high-impact journals: British Medical Journal and Annals of Internal Medicine . The data analysis is characterized by methodological orthodoxy. The authors just use chi-square tests without any reference to CI, although the NHST had been repeatedly criticized over the years by two of the authors:

Douglas Altman, an early promoter of confidence intervals as an alternative [ 57 ], and Steve Goodman, a critic of NHST from a Bayesian perspective [ 58 ]. Individual authors, however, cannot be blamed for broader institutional problems and systemic forces opposed to change.

The present effort is certainly partial in at least two ways: it is limited to only six specific journals and to three biennia. It would be therefore highly desirable to improve it by studying the problem in a more detailed way (especially by reviewing more journals with different profiles), and continuing the review of prevailing patterns and trends.

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Acknowledgements

The authors would like to thank Tania Iglesias-Cabo and Vanesa Alvarez-González for their help with the collection of empirical data and their participation in an earlier version of the paper. The manuscript has benefited greatly from thoughtful, constructive feedback by Carlos Campillo-Artero, Tom Piazza and Ann Séror.

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LCSA designed the study, wrote the paper and supervised the whole process; PSG coordinated the data extraction and carried out statistical analysis, as well as participated in the editing process; AFS extracted the data and participated in the first stage of statistical analysis; all authors contributed to and revised the final manuscript.

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Silva-Ayçaguer, L.C., Suárez-Gil, P. & Fernández-Somoano, A. The null hypothesis significance test in health sciences research (1995-2006): statistical analysis and interpretation. BMC Med Res Methodol 10 , 44 (2010). https://doi.org/10.1186/1471-2288-10-44

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hypothesis testing examples in healthcare

Hypothesis Testing - Analysis of Variance (ANOVA)

Introduction

Learning objectives.

All Modules

Table of F-Statistic Values

Author

This module will continue the discussion of hypothesis testing, where a specific statement or hypothesis is generated about a population parameter, and sample statistics are used to assess the likelihood that the hypothesis is true. The hypothesis is based on available information and the investigator's belief about the population parameters. The specific test considered here is called analysis of variance (ANOVA) and is a test of hypothesis that is appropriate to compare means of a continuous variable in two or more independent comparison groups. For example, in some clinical trials there are more than two comparison groups. In a clinical trial to evaluate a new medication for asthma, investigators might compare an experimental medication to a placebo and to a standard treatment (i.e., a medication currently being used). In an observational study such as the Framingham Heart Study, it might be of interest to compare mean blood pressure or mean cholesterol levels in persons who are underweight, normal weight, overweight and obese.

The technique to test for a difference in more than two independent means is an extension of the two independent samples procedure discussed previously which applies when there are exactly two independent comparison groups. The ANOVA technique applies when there are two or more than two independent groups. The ANOVA procedure is used to compare the means of the comparison groups and is conducted using the same five step approach used in the scenarios discussed in previous sections. Because there are more than two groups, however, the computation of the test statistic is more involved. The test statistic must take into account the sample sizes, sample means and sample standard deviations in each of the comparison groups.

If one is examining the means observed among, say three groups, it might be tempting to perform three separate group to group comparisons, but this approach is incorrect because each of these comparisons fails to take into account the total data, and it increases the likelihood of incorrectly concluding that there are statistically significate differences, since each comparison adds to the probability of a type I error. Analysis of variance avoids these problemss by asking a more global question, i.e., whether there are significant differences among the groups, without addressing differences between any two groups in particular (although there are additional tests that can do this if the analysis of variance indicates that there are differences among the groups).

The fundamental strategy of ANOVA is to systematically examine variability within groups being compared and also examine variability among the groups being compared.

After completing this module, the student will be able to:

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Quick Guide to Biostatistics in Clinical Research: Hypothesis Testing

In this article series, we will be looking at some of the important concepts of biostatistics in clinical trials and clinical research. Statistics is frequently used to analyze quantitative research data. Clinical trials and clinical research both often rely on statistics. Clinical trials proceed through many phases . Contract Research Organizations (CRO) can be hired to conduct a clinical trial. Clinical trials are an important step in deciding if a treatment can be safely and effectively used in medical practice. Once the clinical trial phases are completed, biostatistics is used to analyze the results.

Research generally proceeds in an orderly fashion as shown below.

Once you have identified the research question you need to answer, it is time to frame a good hypothesis. The hypothesis is the starting point for biostatistics and is usually based on a theory. Experiments are then designed to test the hypothesis. What is a hypothesis ? A research hypothesis is a statement describing a relationship between two or more variables that can be tested. A good hypothesis will be clear, avoid moral judgments, specific, objective, and relevant to the research question. Above all, a hypothesis must be testable.

A simple hypothesis would contain one predictor and one outcome variable. For instance, if your hypothesis was, “Chocolate consumption is linked to type II diabetes” the predictor would be whether or not a person eats chocolate and the outcome would be developing type II diabetes. A good hypothesis would also be specific. This means that it should be clear which subjects and research methodology will be used to test the hypothesis. An example of a specific hypothesis would be, “Adults who consume more than 20 grams of milk chocolate per day, as measured by a questionnaire over the course of 12 months, are more likely to develop type II diabetes than adults who consume less than 10 grams of milk chocolate per day.”

Null and Alternative Hypothesis

In statistics, the null hypothesis (H 0 ) states that there is no relationship between the predictor and the outcome variable in the population being studied. For instance, “There is no relationship between a family history of depression and the probability that a person will attempt suicide.” The alternative hypothesis (H 1 ) states that there is a relationship between the predictor (a history of depression) and the outcome (attempted suicide). It is impossible to prove a statement by making several observations but it is possible to disprove a statement with a single observation. If you always saw red tulips, it is not proof that no other colors exist. However, seeing a single tulip that was not red would immediately prove that the statement, “All tulips are red” is false. This is why statistics tests the null hypothesis. It is also why the alternative hypothesis cannot be tested directly.

The alternative hypothesis proposed in medical research may be one-tailed or two-tailed. A one-tailed alternative hypothesis would predict the direction of the effect. Clinical studies may have an alternative hypothesis that patients taking the study drug will have a lower cholesterol level than those taking a placebo. This is an example of a one-tailed hypothesis. A two-tailed alternative hypothesis would only state that there is an association without specifying a direction. An example would be, “Patients who take the study drug will have a significantly different cholesterol level than those patients taking a placebo”. The alternative hypothesis does not state if that level will be higher or lower in those taking the placebo.

The P-Value Approach to Test Hypothesis

Once the hypothesis has been designed, statistical tests help you to decide if you should accept or reject the null hypothesis. Statistical tests determine the p-value associated with the research data. The p-value is the probability that one could have obtained the result by chance; assuming the null hypothesis (H 0 ) was true. You must reject the null hypothesis if the p-value of the data falls below the predetermined level of statistical significance. Usually, the level of statistical significance is set at 0.05. If the p- value is less than 0.05, then you would reject the null hypothesis stating that there is no relationship between the predictor and the outcome in the sample population.

However, if the p-value is greater than the predetermined level of significance, then there is no statistically significant association between the predictor and the outcome variable. This does not mean that there is no association between the predictor and the outcome in the population. It only means that the difference between the relationship observed and the relationship that could have occurred by random chance is small.

For example, null hypothesis (H 0 ): The patients who take the study drug after a heart attack did not have a better chance of not having a second heart attack over the next 24 months.

Data suggests that those who did not take the study drug were twice as likely to have a second heart attack with a p-value of 0.08. This p-value would indicate that there was an 8% chance that you would see a similar result (people on the placebo being twice as likely to have a second heart attack) in the general population because of random chance.

The hypothesis is not a trivial part of the clinical research process. It is a key element in a good biostatistics plan regardless of the clinical trial phase. There are many other concepts that are important for analyzing data from clinical trials. In our next article in the series, we will examine hypothesis testing for one or many populations, as well as error types.

Thank you for this very informative article. You describe all the things very well. I am doing a fellowship in Clinical research training. This information really helps me a lot in my research studies. I have been connected with your site since a long time for such updates. Thank you once again

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Hypothesis Testing, P Values, Confidence Intervals, and Significance

Definition/introduction.

Issues of Concern

Hypothesis Testing

Research Question: Is Drug 23 an effective treatment for Disease A?

Research Hypothesis: Drug 23 will significantly reduce symptoms associated with Disease A compared to Drug 22.

The null hypothesis states that there is no statistical difference between groups based on the stated research hypothesis.

Researchers should be aware of journal recommendations when considering how to report p values, and manuscripts should remain internally consistent.

Significance

An example of findings reported with p values are below:

Confidence Intervals

In consideration of the similar research example provided above, one could make the following statement with 95% CI:

Clinical Significance

Nursing, Allied Health, and Interprofessional Team Interventions

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Understanding confidence intervals helps you make better clinical decisions

P ERHAPS YOU DIDN ’ T LEARN about the confidence interval (CI) in your formal education or you don’t hear the term in daily conversation. Confidence interval just doesn’t roll of the tongue of a staff nurse quite like blood pressure or urine output does.

But knowing the importance of the CI allows you to interpret research for its impact on your practice. Evidence-based decision making is central to healthcare transformation. To make good decisions, you must know how to interpret and use research and practice evidence. Evaluating research means determining its validity (were the researchers’ methods good ones?) and reliability (can clinicians get the same results the researchers got?).

CI and the degree of uncertainty

In a nutshell, the CI expresses the degree of uncertainty associated with a sample statistic (also called a study estimate). The CI allows clinicians to determine if they can realistically expect results similar to those in research studies when they implement those study results in their practice. Specifically, the CI helps clinicians identify a range within which they can expect their results to fall most of the time.

Used in quantitative research, the CI is part of the stories that studies tell in numbers. These numeric stories describe the characteristics, or parameters, of a population; populations can be made up of individuals, communities, or systems. Collecting information from the whole population to find answers to clinical questions is practically impossible. For instance, we can’t possibly collect information from all cancer patients. Instead, we collect information from smaller groups within the larger population, called samples. We learn about population characteristics from these samples through a process called inference.

To differentiate sample values from those of the population (parameters), the numeric characteristics of a sample most commonly are termed statistics, but also may be called parameter estimates because they’re estimates of the population. Inferring information from sample statistics to population parameters can lead to errors, mainly because statistics may differ from one sample to the next. Several other terms are related to this opportunity for error—probability, standard error (SE), and mean. (See What are probability, standard error, and mean?)

Calculating the CI

Used in the formula to calculate the upper and lower boundaries of the CI (within which the population parameter is expected to fall), the SE reveals how accurately the sample statistics reflect population parameters. Choosing a more stringent probability, such as 0.01 (meaning a CI of 99%), would offer more confidence that the lower and upper boundaries of the CI contain the true value of the population parameter.

Not all studies provide CIs. For example, when we prepared this article, our literature search found study after study with a probability ( p ) value) but no CI. However, studies usually report SEs and means. If the study you’re reading doesn’t provide a CI, here’s the formula for calculating it:

95% CI: X= X‾ ± (1.96 x SE), where X denotes the estimate and X‾ denotes the mean of the sample.

To find the upper boundary of the estimate, add 1.96 times the SE to X‾. To find the lower boundary of the estimate, subtract 1.96 times the SE fromX‾. Note: 1.96 is how many standard deviations from the mean are required for the range of values to contain 95% of the values.

Be aware that values found with this formula aren’t reliable with samples of less than 30. But don’t despair; you can still calculate the CI— although explaining that formula is beyond the scope of this article. Watch the video at https://goo.gl/AuQ7Re to learn about that formula.

Real-world decision-making: Where CIs really count

Now let’s apply your new statistical knowledge to clinical decision making. In everyday terms, a CI is the range of values around a sample statistic within which clinicians can expect to get results if they repeat the study protocol or intervention, including measuring the same outcomes the same ways. As you critically appraise the reliability of research (“Will I get the same results if I use this research?”), you must address the precision of study findings, which is determined by the CI. If the CI around the sample statistic is narrow, study findings are considered precise and you can be confident you’ll get close to the sample statistic if you implement the research in your practice. Also, if the CI does not contain the statistical value that indicates no effect (such as 0 for effect size or 1 for relative risk and odds ratio), the sample statistic has met the criteria to be statistically significant.

The following example can help make the CI concept come alive. In a systematic review synthesizing studies of the effect of tai chi exercise on sleep quality, Du and colleagues (2015) found tai chi affected sleep quality in older people as measured by the Pittsburgh Sleep Quality Index (mean difference of -0.87; 95% CI [-1.25, -0.49]). Here’s how clinicians caring for older adults in the community would interpret these results: Across the studies reviewed, older people reported better sleep if they engaged in tai chi exercise. The lower boundary of the CI is -1.25, the study statistic is -0.87, and the upper boundary is -0.49. Each limit is 0.38 from the sample statistic, which is a relatively narrow CI. Keep in mind that a mean difference of 0 indicates there’s no difference; this CI doesn’t contain that value. Therefore, the sample statistic is statistically significant and unlikely to occur by chance. Because this was a systematic review and tai chi exercise has been established as helping people sleep, based on the sample statistics and the CI, clinicians can confidently include tai chi exercises among possible recommendations for patients who have difficulty sleeping.

Now you can apply your knowledge of CIs to make wise decisions about whether to base your patient care on a particular research finding. Just remember—when appraising research, consistently look for the CI. If the authors report the mean and SE but don’t report the CI, you can calculate the CI using the formula discussed earlier.

The authors work at the University of Texas at Tyler. Zhaomin He is an assistant professor and biostatistician of nursing. Ellen Fineout-Overholt is the Mary Coulter Dowdy Distinguished Professor of Nursing.

Selected references

Du S, Dong J, Zhang H, et al. Taichi exercise for self-rated sleep quality in older people: a systematic review and meta-analysis. Int J Nurs Stud . 2015;52(1):368-79.

Fineout-Overholt E. EBP, QI, and research: strange bedfellows or kindred spirits? In: Hedges C, Williams B, eds. Anatomy of Research for Nurses . Indianapolis, IN: Sigma Theta Tau International; 2014:23-44.

Fineout-Overholt E, Melnyk BM, Stillwell SB, Williamson KM. Evidence-based practice, step by step: critical appraisal of the evidence: part II: digging deeper—examining the “keeper” studies. Am J Nurs . 2010;110(9): 41-8.

Kahn Academy. Small sample size confidence intervals

Melnyk BM, Fineout-Overholt E. ARCC (Advancing Research and Clinical practice through close Collaboration): a model for system-wide implementation and sustainability of evidence-based practice. In: Rycroft-Malone J, Bucknall T, eds. Models and Frameworks for Implementing Evidence-Based Practice: Linking Evidence to Action . Indianapolis, IN: Wiley-Blackwell & Sigma Theta Tau International; 2010.

O’Mathúna DP, Fineout-Overholt E. Critically appraising quantitative evidence for clinical decision making. In: Melnyk BM, Fineout- Overholt E, eds. Evidence-Based Practice in Nursing and Healthcare: A Guide to Best Practice . 3rd ed. Philadelphia: Lippincott Williams and Wilkins; 2015:81-134.

Plichta, SB, Kelvin E. Munro’s Statistical Methods for Health Care Research . 6th ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2013.

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Statistics Made Easy

The Importance of Statistics in Healthcare (With Examples)

The field of statistics is concerned with collecting, analyzing, interpreting, and presenting data.

In the field of healthcare, statistics is important for the following reasons:

Reason 1 : Statistics allows healthcare professionals to monitor the health of individuals using descriptive statistics.

Reason 2 : Statistics allows healthcare professionals to quantify the relationship between variables using regression models.

Reason 3 : Statistics allows healthcare professionals to compare the effectiveness of different medical procedures using hypothesis tests.

Reason 4 : Statistics allows healthcare professionals to understand the effect of lifestyle choices on health using incidence rate ratio.

In the rest of this article, we elaborate on each of these reasons.

Reason 1: Monitor the Health of Individuals Using Descriptive Statistics

Descriptive statistics are used to describe data.

Healthcare professionals often calculate the following descriptive statistics for a given individual:

Mean resting heart rate.
Mean blood pressure.
Fluctuation in weight during a certain time period.

Using these metrics, healthcare professionals can gain a better understanding of the overall health of individuals.

They can then use these metrics to inform individuals on ways they can improve their health or even prescribe specific medications based on the health of the individual.

Reason 2: Quantify Relationship Between Variables Using Regression Models

Another way that statistics is used in healthcare is in the form of regression models .

These are models that allow healthcare professionals to quantify the relationship between one or more predictor variables and a response variable .

For example, a healthcare professional may have access to data on total hours spent exercising per day, total time spent sitting per day, and overall weight of individuals.

They might then build the following multiple linear regression model:

Weight = 124.33 – 15.33(hours spent exercising per day) + 1.04(hours spent sitting per day)

Here’s how to interpret the regression coefficients in this model:

For each additional hour spent exercising per day, total weight decreases by an average of 15.33 pounds (assuming hours spent sitting is held constant).
For each additional hour spent sitting per day, total weight increases by an average of 1.04 pounds (assuming hours spent exercising is held constant).

Using this model, a healthcare professional can quickly understand that more time spent exercising is associated with lower weight and more time spent sitting is associated with higher weight.

They can also quantify exactly how much exercise and sitting affect weight.

Reason 3: Compare Medical Procedures Using Hypothesis Tests

Another way that statistics is used in healthcare is in the form of hypothesis tests .

These are tests that healthcare professionals can use to determine if there is a statistical significance between different medical procedures or treatments.

For example, suppose a doctor believes that a new drug is able to reduce blood pressure in obese patients. To test this, he may measure the blood pressure of 40 patients before and after using the new drug for one month.

He then performs a paired samples t- test using the following hypotheses:

H 0 : μ after = μ before (the mean blood pressure is the same before and after using the drug)
H A : μ after < μ before (the mean blood pressure is less after using the drug)

If the p-value of the test is less than some significance level (e.g. α = .05), then he can reject the null hypothesis and conclude that the new drug leads to reduced blood pressure.

Note : This is just one example of a hypothesis test that is used in healthcare. Other common tests include a one sample t-test , two sample t-test , one-way ANOVA , and two-way ANOVA .

Reason 4: Understand Effects of Lifestyle Choices on Health Using Incidence Rate Ratio

An incidence rate ratio allows healthcare professionals to compare the incident rate between two different groups.

For example, suppose it’s known that people who smoke develop lung cancer at a rate of 7 per 100 person-years.

Conversely, suppose it’s known that people who do not smoke develop lung cancer at a rate of 1.5 per 100 person-years.

We would calculate the incidence rate ratio (often abbreviated IRR) as:

IRR = Incidence rate among smokers / Incidence rate among non-smokers
IRR = (7/100) / (1.5/100)

Here’s how a healthcare professional would interpret this value: The lung cancer rate among smokers is 4.67 times as high as the rate among non-smokers.

Using this simple calculation, healthcare professionals can gain a good understanding of how different lifestyle choices (like smoking) affect health in individuals.

Additional Resources

The following articles explain the importance of statistics in other fields:

Why is Statistics Important? (10 Reasons Statistics Matters!) The Importance of Statistics in Nursing The Importance of Statistics in Business The Importance of Statistics in Economics The Importance of Statistics in Education

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