SANRA Tool for Assessing Narrative Review Articles
Categories Medical Writing

SANRA: Tool for Assessing Narrative Review Articles


SANRA is a tool for improving the quality of narrative articles. The tool was developed in 2010 and has been revised to make it simpler. The tool allows the editor to judge the quality of the manuscript and the readers to identify the relevance. It should be incorporated while authoring the narrative review articles.

Narrative Review Articles

Narrative reviews form an important part of medical literature. In medical literature, narrative reviews have the largest share of text. There are two types of literature reviews, i.e. systematic reviews and narrative or non-systematic reviews. While various guidelines have been proposed for systematic reviews, there are no standard guidelines for non-systematic or narrative reviews. The absence of these guidelines poses a question mark on the validity and authenticity of narrative reviews. However, narrative reviews are considered to be important when it comes to influencing the doctors in research as well as in clinical practice. The narrative reviews identify and summarize the already published articles in a particular research arena.

Advantages of Narrative Review Articles

There are various advantages of narrative review literature, especially in medical research. Following are some of the advantages:

Comprehensiveness: Narrative reviews provide more detailed and comprehensive information about a particular topic. They also include the debate and current lack of knowledge.

Avoid duplication: By including several primary studies, the narrative reviews avoid duplication of studies performed.

Guide future research: As they provide information about the lack of knowledge in a particular area, they act as guiding light for future researches.

New medical intervention: Through the analysis of primary studies, they sometimes propose a new medical intervention.

Assessing Narrative Review Articles: SANRA

Although narrative review articles or non-systematic reviews play an important role in the dissemination of medical information, they are generally considered as non-authentic and unreliable. This is probably the reason that the non-systematic reviews are placed lower in the hierarchy of evidence-based medicine relative to systematic reviews.

The systematic review articles are critically analyzed based on various tools. These analyses significantly improve the quality of systematic reviews. The tools for assessing systematic reviews include AMSTAR 2 which is a measurement tool for assessment. Thus, there is a need for developing a tool for assessing non-systematic review articles that helps to improve the quality of narrative reviews at all levels.

To fill this gap in the field of the review article, Christopher Baethge, Sandra Goldbeck-Wood, and Stephan Mertens developed SANRA, Scale for the Assessment of Narrative Review Articles. The main aim of developing SANRA was to help the editors to determine the quality of narrative reviews, the readers to evaluate what quality of review they are reading, and to improve the authors in writing the narrative review.

The seven-item version was quite satisfactory in testing the quality of narrative reviews. It was concluded that the seven-item version of SANRA ticked the boxes in terms of internal consistency and reliability.

The scale was then revised into a 6-item version. Each item has a score from 0 to 2, 0 being the low standard while 2 is a high standard score. 1 is considered as the intermediate score. The maximum score a narrative review can achieve can be 12. The 6 items that form the part of SANRA are:

  1. Important to readers: This item determines whether a proper justification is given to prove the importance of narrative reviews to readers. If the importance is not at all justified then a 0 score is given.
  2. Aims of the narrative reviews: If the aims of the review or questions are formulated concretely, scores are given to the article.
  3. Comprehensive literature search description: If the search strategy is not provided in the article, a 0 score is given. The maximum score, i.e. 2, is given when the author includes the inclusion criteria and search strategy along with a comprehensive description of the literature search.
  4. Referencing: If the key statements in the review are included without any appropriate references, the score given is 0, while for key statements with references, score 2 is allotted.
  5. Scientific reasoning: Scientific reasoning is an important part of the narrative review. Without reasoning, the readers may not have any interest in the article and may question reliability and authenticity. If there is no scientific evidence, the score allotted is 0, while 1 is given in case of incomplete evidence.
  6. Appropriate presentation of data: The author should present the data completely and in the most appropriate manner. It may include the confidence intervals, absolute and relative risk, and data that help in analyzing the outcome.

A field testing was carried out to determine the internal consistency, item-total correlation, feasibility, validity, and reliability. All the three developers of SANRA rated the 30 manuscripts without systematic literature searches. These manuscripts were submitted to Deutsches Ärzteblatt in 2015. These ratings were given blindly and independently of each other. The SANRA should be incorporated while authoring and reviewing the narrative reviews, which are widespread in the medical literature. It will help in improving the quality of the article.


Baethge C, Goldbeck-Wood S, Mertens S. SANRA-a scale for the quality assessment of narrative review articles. Res Integr Peer Rev 2019; 4: 5

Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med. 2010;7(9):e1000326.

Antiseptic Mouthwash Kills Beneficial Bacteria and Increased the Risk of CVD
Categories Medical Writing

Antiseptic Mouthwash Kills Beneficial Bacteria and Increased the Risk of CVD

At the American Naturopathic Medical Association 36th Annual Convention and Educational Seminar, Nathan Bryan, delivered a lecture on the critical importance of nitric oxide for the health of vital organs and system of physiological functions. Nitric oxide is naturally produced in our body and plays a vital role in various functions such as inflammation, and regulation of blood pressure which is a prime factor in the prevention of cardiovascular diseases.

He added that, lack of nitric oxide can be considered as the early event in the onset and progression of cardiovascular disease. While explaining the various sources of natural production of nitric oxide, he brought out the importance of oral commensal bacteria and continual supply of nitric oxide by them. In order to maintain oral hygiene, there is a usual practice of applying antiseptic mouthwash / antibiotics which can kill these commensal bacteria resulting in eradication of one of the prime sources of nitric oxide production. This in turn keeps patient at increased risk for cardiovascular disease.

A study demonstrated that, though antiseptic mouthwashes eliminate bad breath / odour they will end up in killing good bacteria resulting increased blood pressure. The observed rise in blood pressure is around 26 mm Hg, which is an indication of essential hypertension in healthy individuals.

While concluding the lecture, Nathan Bryan added that one must choose evidence based therapeutic and nutritional strategy to restore nitric oxide production which is helpful to overcome the body’s own inefficiencies.

Narrative Writing in Clinical Research
Categories Medical Writing

Narrative Writing in Clinical Research: Guidelines for a Medical Writer

Narrative writing or writing patient safety narratives is an integral part of any clinical study report writing. Before dwelling into its guidelines, let us first understand what it is and what importance it carries in clinical research.

In simple terms, a narrative is a brief summary of the adverse events experienced by the patients during a clinical trial of a drug. It is submitted along with the clinical study report to establish any causal relationship between the events experienced by the patient and the drug under investigation. This also helps in establishing the drug safety profile.

Patient narratives are generally written for deaths, serious adverse events, any adverse event of special clinical interest, and events leading to permanent discontinuation of the patient from the trial.

Components of a patient narrative

As per International Conference on Harmonisation (ICH) E3 guidelines, a patient narrative must contain the following:

  • Nature, intensity, and outcome of the event
  • Clinical course of the event
  • Timing of study drug administration
  • Relevant laboratory measures
  • How the event was treated
  • Action taken with respect to the study drug
  • Post mortem findings (in case of death of the patient)
  • Investigator’s and sponsor’s (one who sponsors the clinical study) opinion on causality
  • Patient identifier
  • His age, sex, and general clinical condition
  • Disease being treated
  • Medical history of the patient
  • Medications taken in the past or taking currently
  • Any ongoing medical condition

What do you need to know before drafting a patient narrative?

1.Thorough knowledge and understanding of the therapeutic area of the drug under investigation

2.Knowledge of the regulatory requirements

Patient narratives are usually submitted to the regulatory authorities along with the clinical study report, included either as a text in Section 12.3.2 if the number of narratives is less (6–10) or provided in Section 14.3.3 as an appendix.

3.Understanding of the role and expectations of the regulatory authorities

As narratives are reviewed by the regulatory authorities, their objectives must be borne in mind before drafting a narrative. These objectives are:

  • Identification and close examination of adverse events that require further monitoring
  • Identification of frequency and severity of unexpected adverse events
  • Identification of the factors affecting the occurrence of adverse drug reactions like patient’s age, gender, ethnicity, race, associated illness, abnormalities of renal or hepatic function, and genetic characteristics or drug-related factors such as dose, plasma concentration, duration of exposure, and concomitant medications.
  • Evaluating and analyzing the data for any limitations and safety analysis of the drug.

4.Sources of data

You can use various sources of information while preparing a patient narrative. These include:

  • Primary source which is the clinical database listings
  • Secondary source which include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, and Data Clarification Forms (DCFs)

5.The number of patient narratives to be prepared

Challenges in narrative writing process

The most common challenges observed while drafting a patient narrative are:

  • Large number of resources required for the project
  • Maintaining consistency in the narratives
  • Timely delivery of high quality narratives
  • Lack of standardized data sources or patient profiles
  • High variability in template finalization before and after sample narratives due to differences in opinion of reviewers
  • Change in reviewers in intermediate or later stages of the project
  • Delay in review cycles
  • Delay in receiving consensus on comments and queries from the clinical team

How to overcome these challenges?

    1. Hold a meeting with all the stakeholders of the project and finalize a template for the sample narrative, in consensus with the clinical team.
    2. Review your clinical database listings for all the necessary information as per the agreed narrative template.
    3. Use standardized data sources throughout the process. Also use a resource utilization tracker that lists down all the ongoing studies, percent utilization and free capacity of the resources in each project.
    4. Use a standardized narrative tracking sheet to record details like the list of patients requiring narrative, their criteria for narrative, author, reviews, and dates.
    5. Standardize the review process and have proactive communication with all the stakeholders including the clinical team for finalizing the sample narrative.
    6. Finalize the sample narrative before dispatching future batches.
    7. Use an automation tool for narrative writing. This is particularly helpful in case of large volumes of narratives to ensure consistency, quality, and timely delivery of narratives. However, medical and scientific review, data quality control, and quality calibration must be performed regularly even if the narratives are generated using an automation tool. Quality can be checked and maintained by using a quality tracker to calculate any major or minor errors in the narrative.

Tips for writing an effective patient narrative

    • Always use hard space and hard hyphens for days, dates, and laboratory values to avoid splitting on the next page or next line except at the beginning of a sentence (hard hyphen: ctrl + shift + hyphen; hard space: ctrl + shift + space)
    • Be consistent while using the patient throughout the narrative.
    • Tag the narrative template against the information available in data sources to help the reviewer track the information easily.
    • Always use generic names for the patient’s concomitant medications or treatment medications for adverse events. However, for combination drugs, generic drug name should be provided along with the trade name in brackets; for example, lisinopril-hydrochlorothiazide (Zestoretic)
    • For describing the adverse event and medical history or ongoing condition of the patient, always use the preferred terms like pain in extremity should be reported as pain in hands or pain in legs.
    • Quick check your narrative before submitting it to the scientific reviewer.

Quality control (QC) is an important step in the delivery of a narrative project. If time is not a constraint, QC must be performed during the review and final delivery stages. However, if that is not feasible, a thorough and independent final QC should suffice.

Cognibrain healthcare technologies are the best provider of medical writing and healthcare communication services. Our Medical writing services include clinical and regulatory writing which encompasses clinical study reports, clinical study protocol, investigator brochures and pharmacovigilance writing like patient safety narratives, periodic safety update reports. Our non clinical or non regulatory medical writing services include medical manuscript writing service for journal submission, publication support for medical journals, medical abstract writing and poster presentation for medical conference, systemic review and meta analysis. We also provide healthcare communication services like medico marketing writing, product monographs, medical content writing for therapeutic products, medical devices, nutraceutical products and treatment procedures and medical websites.