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ENCePP Guide on Methodological Standards in Pharmacoepidemiology

 

8. Dissemination and reporting

8.1. Principles of communication

 

Aspects of research communication and reporting include, but are not limited to, reports to health authorities, sponsors, presentations in scientific fora, scientific publications, patient focused communications and websites.

 

The Declaration of Helsinki provides guidance on the registration, publication and dissemination of research results. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. A means to achieve this with pharmacoepidemiology studies is through registration of protocols and reports of studies in the EU PAS Register.

 

8.2. Communication of study results

 

Important points that are emphasised by the guidelines cited below are:

  • Sources of research funding should always be disclosed whether in oral or written presentation.
  • A dissemination and communication strategy should be pre-defined as part of the funding contract.

 

  • All results with a scientific or public health impact must be made publicly available without undue delay.

 

  • Quantitative measures of association should be reported rather than just results of testing.

 

The ISPE GPP contain a section on communication (section V) which includes a statement that there is an ethical obligation to disseminate findings of potential scientific or public health importance and that research sponsors (government agencies, private sector, etc.) shall be informed of study results in a manner that complies with local regulatory requirements. The Guidance on the format and content of the final study report of non-interventional post-authorisation safety studies (PASS) provides a template for final study reports that may be applied to any non-interventional PASS, including meta-analyses and systematic reviews. The FDA’s Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Health Care Data Sets includes a description of all the elements that should be addressed and included in the final study report of such studies.

 

The Enhancing the Quality and Transparency of Health Research (EQUATOR) network is an international initiative that aims to enhance the reliability and value of the published health research literature. A catalogue of reporting guidelines for health research (Eur J Clin Invest 2010;40(1):35-53) presents a collection of tools and guidelines available on the EQUATOR website relating to resources, education and training to facilitate good research reporting and the development, dissemination and implementation of robust reporting guidelines to increase the accuracy and transparency of health research reporting.

 

The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) Statement Guidelines for reporting observational studies has established recommendations for improving the quality of reporting of observational studies and seeks to ensure a clear presentation of what was planned, done, and found. Of note, the aim of these guidelines was not to prescribe the reporting of observational research in a rigid format, but to address what should be the essential information contained by a publication on an observational study.

 

The STROBE statement is designed to apply to all observational studies. In addition, The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement (PLoS Med. 2015;12(10):e1001885) was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD makes additional recommendations on the reporting of methods of selection for study populations, exposures, outcomes and covariates (including codes or algorithms used), whether validation has been conducted, the level of access to databases used, and data linkages that were required to conduct the study.

 

The Meta-analysis of Observational Studies in Epidemiology (MOOSE) group has developed a consensus statement and recommendations for reporting meta-analyses of observational studies in epidemiology. It is equivalent to the STROBE Statement Guidelines for reporting observational studies and the Consolidated Standards of Reporting Trials Consolidated Standards for Reporting Trials (CONSORT) 2010 Statement for RCTs, in that they have communication as their primary objective and take the form of a list of minimum requirements for adequate reporting. The authors recommend a broad inclusion of studies and conduct of post-hoc sensitivity on the dependence of the results on factors, such as quality of underlying papers, design, accounting for confounders etc. The authors comment on the particular problems in merging observational studies with highly variable sets of confounders that were or were not controlled for, but they do not suggest any solution or give any references to possible ways to address it.

 

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses consisting of a 27-item checklist and a flow diagram. While focused on randomised trials, PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions. PRISMA may also be useful for critical appraisal of published systematic reviews, although it is not designed as a quality assessment instrument.

 

The Guidelines for Submitting Adverse Event Reports for Publication (Pharmacoepidemiol Drug Saf 2007;16(5): 581–7) lists the key elements that have to be included when publishing a report of one or more adverse events.  These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) andare available on their web sites.

 

Additional guidance is provided in the ENCePP Checklist for Study Protocols and Code of Conduct and the IEA GEP guideline that have been reviewed elsewhere in this Guide.

 

Authorship should conform to the guidelines established by the International Committee of Medical Journal Editors (ICJME)Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals.

 

 

Individual Chapters:

 

1. Introduction

2. Formulating the research question

3. Development of the study protocol

4. Approaches to data collection

4.1. Primary data collection

4.1.1. Surveys

4.1.2. Randomised clinical trials

4.2. Secondary data collection

4.3. Patient registries

4.3.1. Definition

4.3.2. Conceptual differences between a registry and a study

4.3.3. Methodological guidance

4.3.4. Registries which capture special populations

4.3.5. Disease registries in regulatory practice and health technology assessment

4.4. Spontaneous report database

4.5. Social media and electronic devices

4.6. Research networks

4.6.1. General considerations

4.6.2. Models of studies using multiple data sources

4.6.3. Challenges of different models

5. Study design and methods

5.1. Definition and validation of drug exposure, outcomes and covariates

5.1.1. Assessment of exposure

5.1.2. Assessment of outcomes

5.1.3. Assessment of covariates

5.1.4. Validation

5.2. Bias and confounding

5.2.1. Selection bias

5.2.2. Information bias

5.2.3. Confounding

5.3. Methods to handle bias and confounding

5.3.1. New-user designs

5.3.2. Case-only designs

5.3.3. Disease risk scores

5.3.4. Propensity scores

5.3.5. Instrumental variables

5.3.6. Prior event rate ratios

5.3.7. Handling time-dependent confounding in the analysis

5.4. Effect measure modification and interaction

5.5. Ecological analyses and case-population studies

5.6. Pragmatic trials and large simple trials

5.6.1. Pragmatic trials

5.6.2. Large simple trials

5.6.3. Randomised database studies

5.7. Systematic reviews and meta-analysis

5.8. Signal detection methodology and application

6. The statistical analysis plan

6.1. General considerations

6.2. Statistical analysis plan structure

6.3. Handling of missing data

7. Quality management

8. Dissemination and reporting

8.1. Principles of communication

8.2. Communication of study results

9. Data protection and ethical aspects

9.1. Patient and data protection

9.2. Scientific integrity and ethical conduct

10. Specific topics

10.1. Comparative effectiveness research

10.1.1. Introduction

10.1.2. General aspects

10.1.3. Prominent issues in CER

10.2. Vaccine safety and effectiveness

10.2.1. Vaccine safety

10.2.2. Vaccine effectiveness

10.3. Design and analysis of pharmacogenetic studies

10.3.1. Introduction

10.3.2. Identification of generic variants

10.3.3. Study designs

10.3.4. Data collection

10.3.5. Data analysis

10.3.6. Reporting

10.3.7. Clinical practice guidelines

10.3.8. Resources

Annex 1. Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes