Monthly Archives: August 2017

Clinical practice guidelines (CPGs)

Medical Writing

Healthcare professionals are expected to provide the best evidence based care to the patients. However, due to continuous medical advancements, it becomes challenging for the clinicians to keep abreast with the new developments and implement them in everyday practice.

Clinical practice guidelines (CPGs) have become increasingly important in the healthcare practice. They are evidence-based recommendations, intended to standardize treatment and provide high quality care to patients. These guidelines are a tool for translating research findings into clinical practice, thus, bridging the gap between what clinicians do and what scientific evidence supports. There is growing evidence that developing and adhering to CPG, can reduce practice variation, and improve outcomes and cost effectiveness of healthcare.

World over, physicians, healthcare organizations, professional societies, disease advocacy groups, government appointed workgroups etc. have been involved in developing CPG to standardize clinical practices.

Greater adherence to CPG is critical to improving healthcare processes and achieving the best patient outcomes. Now, the question arises, why these guidelines need to be followed? They are designed to:

  • Improveclinical outcomes
  • Provide easy access to quality information, so that clinicians have a wide range of options for patient care, improving efficiency and consistency of care
  • Helping clinicians stayapprised of the new developments, by use of up-to-date guidelines
  • Improve patient safety and quality of life by facilitating the treatment of patients based on the summary of benefits and limitations of interventions and procedures
  • By finding gaps in current knowledge, research activities can be prioritized

Some of the practitioners believe that guidelines are cookbook medicines, not allowing them to make their own independent decisions. The other reasons for non-adherence to these guidelines could be lack of awareness, lack of transparency in guideline development, lack of relevance to clinical practice, complex and conflicting guidelines, and lack of insufficient access to guidelines at point of care.

The development of a good guideline, includes, healthy participation of key stakeholders, access to accurate, credible, up-to-date,relevant scientific information, correct interpretation of the available evidence, clinical flexibility, and use of proper tools for implementation and monitoring in day to day practice. The guidelines must be clearly expressed in a user-friendly, logically organized format,written in anunambiguous, easy to follow language, and with clear links of recommendations to the available evidence.

To ensure improved care outcomes, emphasis should be placed on effective guideline implementation and evaluating their effectiveness in real world clinical settings. The guidelines should be evaluated for practicality and significance, projected benefits and harm,quality and strength of the scientific evidence and should be periodically updated to keep pace with latest advancements in the field of medicine.

Given the large number of guidelines, following are the key questions, one should keep in mind while reviewing any guideline:

  • Who developed the guideline?
  • Was systematic review of the literature carried out?
  • Were the recommendations valid?
  • Were all relevant outcomes (overall survival, impact on quality of life, absence of complications etc.) considered?
  • Does it report conflict of interest and how was it managed?
  • When was the guideline last updated and assessed for validity?

Turacoz Healthcare Solutions, understands the importance of clinical practice guidelines in improving healthcare standards and patient outcomes and recommends strict adherence to them.

Summing up Results of Research with Meta-Analysis: How it is Done and Why is it Important?

Awareness Day/Month, ,

We all are aware of the different types of publication documents, and meta-analysis is one of those documents with the highest level of evidence (Figure). Meta-analysis is a statistical analysis that combines or integrates the results of several independent clinical trials considered by the analyst to be combinable. It usually aims to resolve controversy over true effect, when results of individual studies are variable; and validate a statistically non-significant but clinically important result of small studies.

A meta-analysis usually considers the main outcome of the overall magnitude of the effect. The process of conducting a meta-analysis is often rigorous and well defined which leaves very less opportunities for bias to distort the results. While systematic reviews summarize the medical literature textually, meta-analyses statistically summarize results to obtain overall estimate of treatment effect.

Conducting a Meta-analysis

Over the years, the methodologies involved in conducting meta-analyses have changed. The Cochrane Collaboration has been the most important contributor to streamline and validate the procedures involved in conducting a meta-analysis. Major contributions of the Cochrane Handbook include development of protocols which describe literature search, and analytic and diagnostic methods for evaluating the output of meta-analyses. Additionally, the PreferredReporting Items for Systematic reviews and Meta-analyses(PRISMA) statement provides a more robust procedure in which meta-analyses can be conducted. Steps involved in a meta-analysis include:

A sound literature search is the key to achieving robust results. A clear definition of the hypotheses to be investigated can provide the framework for the overall process to be followed in a meta-analysis. The PRISMA statement recommends inclusion of PICOS (Participants, Interventions, Comparators, Outcomes, and Study Designs) explicitly in the research question. Inclusion of PICOS incorporates all aspects being considered for the selection of studies which further helps in searching for studies with specific information/results. Searching most electronic databases with relevant search terms is important to identify articles. However; identifying appropriate search terms is the first step to achieving this. According to the PRISMA statement, complete search strategy used for at least one electronic database must be reported.

The quality assessment of studies to be included is done by evaluating each study for the eligibility for inclusion, study bias, study quality, and reported findings. Often, two independent reviewers are involved in assessing the study quality of the included studies. This assessment basically provides insights to the degree to which the trial design, conduct, analysis, and presentation have minimized or avoided systematic biases.Several tools are available to assess the study quality of which JADAD, and QUADAS are a few to name.

Data extraction decides the result of the meta-analysis. Important data which requires to be collected includes study design, description of study groups, diagnostic information, treatments, length of follow-up evaluations, and outcome measures. Sometimes, data extraction may pose a challenge when studies use different outcome metrics. In these cases, the data must be converted to a uniform metric for easy pooling.

Measuring inter-study heterogeneity is very important to understand whether the data of the meta‑analysis has addressed the two most important questions:

  1. What is the overall relationship between the treatment/intervention/ exposure and the health outcomes?
  2. Is this association consistent across the studies that constitute the systematic review and meta-analysis?

Heterogeneity can be addressed by checking if the data is correct, analyzing variation in results of the study, further exploring heterogeneity by conducting sub-group analysis/ meta‑regression, using analysis procedures which ignore heterogeneity, change the effect measure, and finally exclude the studies which may create conflict.

The data analysis is very complex and involves several analysis techniques. This is usually done using the random effects model or the fixed effect model. The random effects model is used when there is considerable heterogeneity in the studies included while fixed effects model is used when the overall outcome is similar in all studies included. Meta-analyses may also include sensitivity analysis which is a repeat meta-analysis substituting alternative decisions and a meta-regression in which the outcome variable is predicted according to the values of one or more explanatory variables.

Interpretation of the analyzed results must provide answers which are relevant to the context of the current healthcare, state the methodological limitations of studies, consider size of effect in studies and review, their consistency and presence of dose-response relationship, consider interpreting results in context of temporal cumulative meta-analysis, make recommendations that are clear and practical, and finally propose future research age.

In conclusion, conducting a meta-analysis can prove beneficial as it summarizes the overall results in an area of research. However; it must be noted that a single study cannot provide definitive conclusions. In addition, larger randomized controlled trials may sometimes contradict to the results of a meta-analysis. Meta-analysis can summarize the results of studies with varying sample size, diverse populations across different ages which provide an opportunity to explore newer hypotheses. Having said that, meta-analysisstill remains the most important and efficient tool in adding value to the already available evidence. Turacoz Healthcare Solutions (THS) provides guidance in understanding the different attributes of a meta-analysis and its finer details.