What are Reporting Guidelines for Research?

Reporting guidelines are recommendations of what information authors should include in their manuscripts when writing about their research. These are imperative for ensuring ethical and valid research, especially in the health sciences.

Many reporting guidelines were written for health science research. The Equator Network lists 542. There are reporting guidelines for different types of manuscripts (for example, PRISMA was designed for systematic reviews), different types of study designs (CONSORT for randomized controlled trials), and for research on specific topics or fields (STROBE for epidemiology and REMARK for tumor marker prognostic studies).

Many journals also endorse or even require the use of these guidelines. The Journal of the American Medical Association, The Lancet, and the New England Journal of Medicine, for instance, require authors to follow the CONSORT guidelines in randomized controlled trials (RCTs).

This article will familiarize you with the main clinical guidelines and provide specific examples of how they’re reflected in published studies. These studies give good examples of what’s expected of you when you communicate the outcomes of these guidelines in your scientific manuscript.

What do reporting guidelines consist of?

Reporting guidelines can be in the form of structured text, a checklist, or a flow diagram.

These guidelines are meant to improve the quality, transparency, repeatability, comparability, and applicability of research in a field. The use of standardized guidelines allows research to be included in systematic reviews and meta-analyses and it assists scientists, especially health science researchers and professionals, to make research-based decisions.

The Equator Network lists reporting guidelines commonly used in the health sciences. It also offers a search engine to browse for guidelines by study type, clinical area, or using keywords. Equator is also a great resource when searching for keywords to include after your abstract.

The most-encountered reporting guidelines are listed below so you can see their various differences and specifics. You’ll also know what to do when encountering one of these guidelines as you seek to publish your research, systematic review, protocol, and so forth.

The main reporting guidelines for journal publication

PRISMA

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were designed to improve the reporting of systematic reviews. PRISMA consists of a 27-item checklist, an expanded checklist, a flow diagram, and an Explanation and Elaboration document.

Specifically, PRISMA requires you to report:

• which databases or websites you searched
• which search terms or criteria you used to find studies
• which criteria you used to include or exclude such studies in your review

For example, a systematic review on perioperative interventions to prevent postoperative pulmonary complications used search terms such as “postoperative care” and “postoperative complications” combined with “respiratory failure” and similar terms.

In this case, researchers used only studies published between 1990 and December 12, 2017, and only included those related to patients aged 18 and over.

CONSORT

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were designed to improve the reporting of randomized controlled trials (RCTs).

CONSORT consists of a 25-item checklist, a flow diagram, and an Explanation and Elaboration document. Specifically, it’s important to report:

• the trial design
• how participants were selected
• sample sizes obtained for each group
• how many participants were included and excluded, and for what reason
• how participants were randomized
• whether participants and care providers were blinded during the study

For example, a trial comparing fractional flow reserve- and angiography-guided percutaneous coronary intervention assessed 1,905 patients, but 900 were not eligible for various reasons. Therefore, 1,005 patients were randomly assigned to receive either angiography-guided percutaneous coronary intervention (496 patients) or fractional flow reserve-guided percutaneous coronary intervention (509 patients).

STROBE

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were designed to improve the reporting of observational studies in epidemiology, including cohort, case-control, and cross-sectional studies. STROBE consists of a 12-item checklist and an Explanation and Elaboration document.

Specifically, these guidelines require authors to describe the eligibility criteria of participants included in cohort and cross-sectional studies, as well as a rationale for assigning participants to case or control groups. This case-control study, for example, used 373 age and gender-matched colorectal cancer patients from the Iowa Cancer Registry as controls for 368 cutaneous melanoma cases to determine if arsenic exposure increased the risk of developing cutaneous melanoma.

COREQ

The Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines were designed to improve the reporting of qualitative research, including interviews and focus groups. COREQ consists of a 32-item checklist requiring a description of the person leading the interviews or focus groups. This should include their credentials, background, training, and gender, as well as their relationship with participants.

Researchers should also report:

• participants’ demographic information
• how participants were recruited and selected
• the setting in which the data were collected
• questions and prompts used to lead discussions

A good example of applying these guidelines is this study on nursing home staff’s perceptions of barriers toward implementing person-centered care for people living with dementia.

This study used convenience sampling to recruit 24 staff members from six nursing homes in South Korea for semi-structured interviews. The researchers included a table with all interview questions. This also comprised a detailed description of the authors who conducted the interviews, their qualifications, background, relationship with the nursing homes, and experience in nursing home care as well as in conducting qualitative research.

CARE

The Consensus-based Clinical Case Report Guidelines (CARE) were developed to improve the reporting of case reports. CARE consists of a 13-item checklist, a flow diagram, and an Explanation and Elaboration document. Specifically, it requires thorough reporting of patient information and symptoms, clinical findings, diagnostic assessment, therapeutic interventions, and outcomes.

In one example, this study reported a case of a 2-year-old who presented with a stiff and swollen knee without any other symptoms. The initial diagnosis was oligoarthritis, but treatment with steroid injections was ineffective. Further tests were conducted when a relative of the patient was diagnosed with pulmonary tuberculosis. The chest radiograph was normal, but an effusion from the swollen knee tested positive for *Mycobacterium tuberculosis*. Anti-tuberculous therapy resolved the joint swelling.

ARRIVE

The Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were developed to improve the reporting of bioscience research using laboratory animals.

ARRIVE consists of an essential checklist of 10 items, a full checklist with a further set of 11 recommended items, and an Explanation & Elaboration document. The essential checklist in this case requires that you report the details of animals used (species, gender, age, etc.), the exact number in each group, if any animals were excluded from analysis, and why, as well as a detailed description of experimental procedures.

This recommended checklist also adds the name of the ethical review committee that approved the study, with relevant document numbers, animal housing conditions, steps taken to reduce their pain or suffering, and whether any adverse events occurred during the experiment.

In one example, this study investigating the influence of chronic L-DOPA treatment on immune response following allogeneic and xenogeneic graft in a rat model of Parkinson’s disease included a table summarizing the sample size of each treatment group. This research also disclosed that some of their animals had to be removed from the study because they developed tumors unrelated to the experiment.

STARD

The Standards for Reporting Diagnostic Accuracy (STARD) guidelines were developed to improve the reporting of diagnostic accuracy studies. STARD consists of a 30-item checklist, a flow diagram, and an Explanation and Elaboration document. Specifically, STARD requires authors to include the eligibility criteria used to include participants and how many patients underwent the index and reference standard test.

For example, this study investigating the diagnostic accuracy of fecal immunochemical testing for hemoglobin as a screening tool for colorectal cancer provides a flow diagram of participants throughout the study. In terms of the original 360 patients screened, only 255 were eligible and completed the immunochemical test for fecal hemoglobin (the index test) while only 229 received a colonoscopy (the reference test).

MOOSE

The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were designed to improve the reporting of meta-analyses of observational studies in epidemiology.

MOOSE consists of a six-item checklist that requires authors to report:

• the details of the search strategy they used
• how studies were assessed
• how data were classified, coded, and analyzed
• relevant descriptive information for each study included

For example, this study on peripheral fibroblast growth factor-2 levels in major depressive patients provides a flow diagram showing how many search results the researchers acquired from each database, which articles were included, and which were excluded. In this case, from an original 243 articles found, only seven were included in the meta-analysis.

These studies were summarized in a table, describing the sample size, age, and gender of participants, country where the study was conducted, and fibroblast growth factor levels found.

RATS

The Qualitative Research Review Guidelines or RATS is a checklist written to guide peer reviewers working on qualitative research manuscripts. The guidelines recommend reviewers think about the relevance of the study design (R), the appropriateness of the qualitative method used (A), the transparency of procedures used (T), and the soundness of the interpretive approach (S) to make up the acronym RATS.

For example, the checklist prompts the reviewer to ask if qualitative methodology was the best approach to achieve the study aims

TREND

The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) guideline was written to improve the reporting of intervention evaluation studies using nonrandomized designs. TREND consists of a 22-point checklist including requirements such as including eligibility criteria of participants and recruitment methods, how participants were assigned to different groups, and details of the study interventions. Results should include sample sizes for each analysis, and report estimated effect sizes and confidence intervals.

For example, in a study that investigated the efficiency of using infrared vein imaging to insert intravenous catheters in COVID-19 patients, patients were assigned to either the control or intervention group based on the ward they were admitted to due to logistical considerations in the COVID-19 isolation wards during the pandemic. The researchers had 62 patients in the intervention group and 60 in the control group. There was no statistical difference between the demographic details of the patients in the two groups.

MIAME

The Minimum Information About a Microarray Experiment (MIAME) guideline was written to improve the reporting of microarray experiments. The guideline document comprises six parts that describe what information should be included in manuscripts that used microarray experiments.

MIAME requires that authors describe the samples used, the experimental design, the assay design, hybridizations, measurements (including raw images of each assay, image analysis, and a summary of the final processed data), and normalization controls.

For example, a study on genes in developing mouse lungs extracted total RNA from lung tissue from 5- to 7-day old mice. RNA was subjected to synthesis, fragmentation, and hybridization using the CodeLink Expression Assay Kit. The raw data and details of the label protocol, hybridization protocol, scan protocol, and data processing were made available on NCBI´s Gene Expression Omnibus database accession number GSM5702660.

REMARK

The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) guideline was written to improve the reporting of tumor marker prognostic studies. REMARK consists of a 20-item checklist and an Explanation and Elaboration document. Specifically, they require authors to report patient characteristics and treatments, specimen characteristics, assay methods, study design, and statistical analysis.

For example, this study evaluating the prognostic value of cathepsin-D in primary breast cancer included 2,810 samples that had been stored in liquid nitrogen in a tumor bank from patients who were diagnosed with breast cancer between 1978 and 1992, had no metastatic disease at diagnosis, no previous diagnosis of carcinoma, and no evidence of disease within 1 month of surgery. Patients with inoperable T4 tumors and patients who received neoadjuvant therapy before surgery were excluded from the study.

Make sure you get your guidelines and journal requirements 100% right

We hope this article provides a quick and useful reference on the main reporting guidelines you may face as a (clinical) researcher, and how they’re represented in studies. To be sure you’ve met the research requirements and the other requirements of your target publication, we recommend an AJE edit. A publication professional will work with you to ensure you’ve satisfied the requirements, and they’ll get your scientific English in tip-top shape, ready for the world to see.