DISEÑOS DE INVESTIGACION (ESTUDIOS ANALITICOS) · PDF filediseÑos de...

DISEOS DE INVESTIGACION
(ESTUDIOS ANALITICOS)

Que significan estas lneas descendentesen cuanto a los diseos de investigacin ?

Es la jerarqua de la evidenciaque nos brinda cada estudio

DISEO EXPERIMENTAL O ENSAYO CLINICO ALEATORIZADO
ASIGNACION AL AZAR
Grupo A
Grupo B

DISEO EXPERIMENTAL O ENSAYO CLINICO ALEATORIZADO (doble ciego)

ENSAYO CLINICO
ALEATORIZADO
( ciego o
enmascaramiento)

ENSAYO CLINICO
ALEATORIZADO
( ciego o
enmascaramiento)
Ciego simple Doble ciego Triple ciegoSujeto de estudio (paciente)Observador o evaluadorAnalista de datos
Tipo de enmascaramiento

ENSAYO CLINICO ALEATORIZADO
Compliance o como asegurarse que el paciente sigue al pie de la letra las indicaciones del mdico respecto de su tratamiento

Table 1: Checklist of items to include when reporting a randomized trialPAPER SECTION Item Descriptor Reported And topic # on page # TITLE & ABSTRACT 1 How participants were allocated to interventions (e.g., random allocation", "randomized", or "randomly assigned"). INTRODUCTION Background 2 Scientific background and explanation of rationale. METHODS Participants 3 Eligibility criteria for participants and the settings and locations where the data were collected. Interventions 4 Precise details of the interventions intended for each group and how and when they were actually administered. Objectives 5 Specific objectives and hypotheses. Outcomes 6 Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). Sample size 7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules. Randomization: Sequence generation 8 Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification). Allocation concealment 9 Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned. Implementation 10 Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups. Blinding (Masking) 11 Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated. Statistical methods 12 Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses. RESULTS Participant flow 13 Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons. Recruitment 14 Dates defining the periods of recruitment and follow-up. Baseline data 15 Baseline demographic and clinical characteristics of each group. Numbers analyzed 16 Number of participants (denominator) in each group included in each analysis and whether the analysis was by intention-to-treat". State the results in absolute numbers when feasible (e.g., 10/20, not 50%). Outcomes and Estimation 17 For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., 95% confidence interval). Ancillary analyses 18 Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory. Adverse events 19 All important adverse events or side effects in each intervention group. DISCUSSION Interpretation 20 Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. Generalizability 21 Generalizability (external validity) of the trial findings. Overall evidence 22 General interpretation of the results in the context of current evidence.
CONSORT

CONSORT
CONsolidated STandards Of Reporting Trials

ASIGNACION AL AZAR
Grupo A
Grupo B

Aleatorizacin
Grupo A
Grupo B

Aleatorizacin
Grupo A
Grupo B
Criterios de egreso
Criterios de ingreso al estudio

COHORTE O ESTUDIO PROSPECTIVO
Expuestos
No expuestos

Primera etapa
de un estudio de cohorte

Segunda etapa

Tercera etapa

Cuarta etapa

Criterios de ingreso tienen que ver con validez externa del estudio
Grupo A
Grupo B
Aleatorizacin
F
No-F
G
No-G
F= fumar y no-F= no fumar
G = hombres y no-G= mujeres

Criterios de ingreso tienen que ver con validez externa del estudio
Este estudio tiene mayor validez externa que el anterior estudio.
Fuman- Hombres
No Fuman- Hombres
Fuman- Mujeres
No Fuman- Mujeres

CASOS Y CONTROLES O RETROSPECTIVO

CASOS Y CONTROLES O ESTUDIO RETROSPECTIVO
Primera etapa
de un estudio de casos y controles

Segunda etapa

Tercera etapa

CASOS
Controles
PresentacinPower Point

CASOS
Controles
Comparacin

CASOS Y
CONTROLES
Casos
Causa hipotetizada
Controles
Causa hipotetizada
Criterios de ingreso
Criterios de ingreso

CASOS Y CONTROLES
Control de factores de confusin mediante pareamiento o matching

CASOS Y CONTROLESLista de cotejo para un protocolo de un estudio de casos y controles
(tomado de James J. Schlesselman: Case-Control Studies. Design, Conduct, Analysis)
Diseo de Investigacin
1. Es el estudio de casos y controles la estrategia investigativa a escoger ?
2. Es posible obtener el nmero de casos y controles necesarios para poder contestar la pregunta de la investigacin ? cul es el riesgo ms pequeo que puede detectar el estudio ?
3. El estudio incorpora enmascaramiento donde esto es necesario ?

Definicin de casos y seleccin de casos
1. Se han definido los casos de forma precisa? Son claros los criterios definidos para inclusin y exclusin ?
2. Los casos representan incidencia o prevalencia de la enfermedad? Puede justificarse el empleo de casos prevalentes ?
3. Los casos sern escogidos a partir de una poblacin definida ya sea geogrficamente o temporalmente?
4. Que tcnica se usar para determinar quien es un caso y para obtener una muestra? Es la forma de determinacin de los casos y de la seleccin de una muestra independiente del status de exposicin de los casos ?

Definicin de los controles y seleccin de los controles
1. Los controles sern hospitalarios o comunitarios o ambos ? Cuantos controles se seleccionarn por caso? Puede usted como investigador justificar la razn de casos/controles ?
2. Si los controles son hospitalarios: sern elegidos de una variedad de diagnosticos de admisin o solamente de algunos ? Que tipo de pacientes sern excluidos de ser controles y por qu ?
3. Los criterios de exclusin de los

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