Dicas de palavras utilizadas para fazer "link" entre palavras/frases

CRITÉRIOS PARA ESTUDO DE VIABILIDADE (estudo piloto)

Em estudos de viabilidade, os critérios de viabilidade se tornam primários e os demais desfechos (estudo propriamente dito) passam a ser analisados como secundários). Assim, o foco é o entendimento da viabilidade de realização do estudo completo.

Feasibility outcomes

1.       Blinding of assessor - Assessor’s correct guess for group allocation

2.       Attrition rate (in both arms) - Acceptability of random allocation to a treatment group

3.       Contamination of intervention - Understanding possible contamination between the groups

a.       Have you talked to other participants in this study about the intervention they are receiving?

b.       Has your attitude towards the intervention changed after talking to the participant (s) in the other group?

c.       Are any of the participants in the other group aware of the type of intervention you are receiving in this study?

4.       Adherence to treatment - Adherence to treatment

a.       n

b.       Number of days (SD)

5.       Satisfaction (all the participants of the Intervention group will be asked to respond an adapted version of the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS)56 at 1 week following treatment). The question asked will be:

a.       Did my physiotherapist carefully explain the treatments I received?

b.       Did my physiotherapist treat me respectfully?

c.       Did my physiotherapist answer all my questions? Responses to this question are made on a five points categorical scale

                                                               i.      1= ‘completely disagree’

                                                             ii.      2= ‘Disagree’

                                                           iii.      3= ‘Neutral’

                                                           iv.      4= ‘Agree’

                                                             v.      5= ‘Completely agree’

6.       Difficulty scale - Difficulty in understanding the information provided by the physiotherapist. Responses to this question are made on a five points categorical scale

a.       Very easy

b.       Easy

c.       Neither easy nor difficult

d.       Difficult

e.       Very difficult

Referências importantes para estudos de viabilidade (estudo piloto):

Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi:10.1186/1471-2288-10-1.

Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi:10.1136/BMJ.E7586.

Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi:10.1136/BMJ.I5239.

Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013;13(1):104. doi:10.1186/1471-2288-13-104.

Fergusson D. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ. 2004;328(7437):432-0. doi:10.1136/bmj.37952.631667.EE.

Schulz KF, Grimes DA. Blinding in randomised trials: Hiding who got what. Lancet. 2002;359(9307):696-700. doi:10.1016/S0140-6736(02)07816-9.

McGrath JM. Not all studies with small samples are pilot studies. J Perinat Neonatal Nurs. 27(4):281-283. doi:10.1097/01.JPN.0000437186.01731.bc