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Recomendaciones para la preparación y presentación del Protocolo de Investigación
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Recomendaciones para la preparación y presentación del Protocolo de Investigación

  1. Definir claramente la pregunta de estudio. Ver apuntes de Métodos de Investigación.
  2. Asegurar que el diseño permite contestar la pregunta de estudio. Ver apuntes de Métodos de Investigación.
  3. El reporte en el protocolo debe incluir todos los ítemes del título, introducción y método de las pautas disponibles en Equator-Network (ver https://www.goodreports.org/) . Las usuales son

Diseño

Pauta a utilizar

Estudio de prevalencia

https://www.goodreports.org/strobe-cross-sectional/ 

Identificación de factores de riesgo mediante estudio de casos y controles

https://www.goodreports.org/strobe-case-control/ 

Revisión sistemática de intervenciones

https://www.goodreports.org/prisma-p/ 

Revisión sistemática de estudios observacionales

https://www.equator-network.org/reporting-guidelines/meta-analysis-of-observational-studies-in-epidemiology-a-proposal-for-reporting-meta-analysis-of-observational-studies-in-epidemiology-moose-group/ 

Estudio con encuestas

Online Eysenbach, G., 2004. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J. Med. Internet Res. 6, e34.

Otras Kelley, K., Clark, B., Brown, V., Sitzia, J., 2003. Good practice in the conduct and reporting of survey research. Int. J. Qual. Health Care 15, 261–266.

  1. El reporte de estadísticas debe seguir las recomendaciones de Harrington et al., 2019. New Guidelines for Statistical Reporting in the Journal. N. Engl. J. Med. 381, 285–286 o de Lang  T,  Altman  D. Statistical  Analyses  and  Methods  in  the  Published  Literature  the  SAMPL  Guidelines. (PDF)
  2. Todos los protocolos deben incluir un plan de manejo de datos. Se puede hacer uno con la plantilla de https://dmponline.dcc.ac.uk/ 
  3. Todos los datos originales generados durante la investigación junto con los scripts de análisis deben ser incluidos en la tesina y depositados en un repositorio. Se debe generar un DOI para el repositorio. Algunos repositorios sugeridos son http://figshare.com/, https://data.mendeley.com/ y http://osf.io/  

Formato de Tesis, eliminar todo lo que está en color rojo

Elementos mínimos según tipo de estudio

Estudios de corte transversal

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported

Objectives

3

State specific objectives, including any prespecified hypotheses

Methods

Study design

4

Present key elements of study design early in the paper

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

Participants

6

(a) Give the eligibility criteria, and the sources and methods of selection of participants

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

Data sources/ measurement

8*

For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group

Bias

9

Describe any efforts to address potential sources of bias

Study size

10

Explain how the study size was arrived at

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding

(b) Describe any methods used to examine subgroups and interactions

(c) Explain how missing data were addressed

(d) If applicable, describe analytical methods taking account of sampling strategy

(e) Describe any sensitivity analyses

Estudios de cohorte

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported

Objectives

3

State specific objectives, including any prespecified hypotheses

Methods

Study design

4

Present key elements of study design early in the paper

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

Participants

6

(a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up

(b) For matched studies, give matching criteria and number of exposed and unexposed

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

Data sources/ measurement

8*

For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group

Bias

9

Describe any efforts to address potential sources of bias

Study size

10

Explain how the study size was arrived at

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding

(b) Describe any methods used to examine subgroups and interactions

(c) Explain how missing data were addressed

(d) If applicable, explain how loss to follow-up was addressed

(e) Describe any sensitivity analyses

Estudios de casos y controles

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported

Objectives

3

State specific objectives, including any prespecified hypotheses

Methods

Study design

4

Present key elements of study design early in the paper

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

Participants

6

(a) Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls

(b) For matched studies, give matching criteria and the number of controls per case

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

Data sources/ measurement

8*

For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group

Bias

9

Describe any efforts to address potential sources of bias

Study size

10

Explain how the study size was arrived at

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding

(b) Describe any methods used to examine subgroups and interactions

(c) Explain how missing data were addressed

(d) If applicable, explain how matching of cases and controls was addressed

(e) Describe any sensitivity analyses

Estudios clínicos

Introduction

Background and objectives

2a

Scientific background and explanation of rationale

2b

Specific objectives or hypotheses

Methods

Trial design

3a

Description of trial design (such as parallel, factorial) including allocation ratio

3b

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Participants

4a

Eligibility criteria for participants

4b

Settings and locations where the data were collected

Interventions

5

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Outcomes

6a

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6b

Any changes to trial outcomes after the trial commenced, with reasons

Sample size

7a

How sample size was determined

7b

When applicable, explanation of any interim analyses and stopping guidelines

Randomisation:

 Sequence generation

8a

Method used to generate the random allocation sequence

8b

Type of randomisation; details of any restriction (such as blocking and block size)

 Allocation concealment mechanism

9

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

 Implementation

10

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

Blinding

11a

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

11b

If relevant, description of the similarity of interventions

Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes

12b

Methods for additional analyses, such as subgroup analyses and adjusted analyses

Revisiones sistemáticas

INTRODUCTION

Rationale

3

Describe the rationale for the review in the context of what is already known.

Objectives

4

Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).

METHODS

Protocol and registration

5

Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

Eligibility criteria

6

Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.

Information sources

7

Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

Search

8

Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.

Study selection

9

State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

Data collection process

10

Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

Data items

11

List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.

Risk of bias in individual studies

12

Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.

Summary measures

13

State the principal summary measures (e.g., risk ratio, difference in means).

Synthesis of results

14

Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis.

Risk of bias across studies

15

Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).

Additional analyses

16

Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.


Título

Autores

Afiliación

Dirección de contacto

Abstract (más 250 palabras)

Palabras clave (máximo 6)

Introducción

Material y Métodos

Resultados

Discusión

Conclusión

Referencias

Utilizar formato Harvard

Anexos