Selby - PRECIS assessment

Selby - PRECIS assessment

by Kevin -
Please go through each of the PRECIS-2 domains and give it an suggested or approximate score, and a few sentences on yours justification. 1 (very explanatory) – 5 (very pragmatic) 1. Amanyire et al: a. Eligibility criteria: All HIV-infected, treatment-naïve patients with CD4 counts 350 cells per uL, with increase to 500. 5 – very pragmatic b. Recruitment: 22 clinics supported by MJAP, with 2 clinics declining. No individual consent. 5- very pragmatic c. Setting: Clinics of MJAP – 3 Equally pragmatic and explanatory d. Organization: Several statements that resources similar to baseline in these clinics. 5 – very pragmatic e. Flexibility (delivery): Coaching visits and biannual feedback. Non-blinded. 4 – rather pragmatic f. Flexibility (adherence): Not well described, but appears that there was minimal additional adherence support for patients. 5- very pragmatic g. Follow-up: Baseline electronic health record used, then assessment of a random sample of patients for viral load and mortality. 5- very pragmatic h. Primary outcome: ART initiation at 14 days. Very short, intermediary outcome. 1- very explanatory i. Primary analysis: Patients with less than 14 days of observation not included. Unclear repercussions, though follow-up appears to be very good. 4- rather pragmatic 2. Rosen et al: a. Eligibility criteria: Quite broad. Though patients previously ART eligible or intending to shift care, as well as though deemed “clinically or emotionally unstable” were excluded. 3-Equally pragmatic and explanatory b. Recruitment: Unclear recruitment. c. Setting: 2 sites – primary health clinic and hospital. Affiliated with Boston University? 4 – fairly pragmatic d. Organization: Services performed by study nurses and staff, though with same level of training as local staff. e. Flexibility (delivery): Appears to be a very protocolized one-day visit. However, with machines and skills available in SA. 3- equally pragmatic and explanatory f. Flexibility (adherence): Adherence counselling given vs ‘adherence visit’. Seems very similar to national standard. 5- very pragmatic g. Follow-up: Same follow-up in both arms. Passive data collection. 5- very pragmatic h. Primary outcome: viral suppression within 10 months. Important to patients and longer follow-up (though not survival or lack of hospitalization).. 4. Fairly pragmatic i. Primary analysis: Post-randomization exclusions, though appear to be balanced and justified. 4- fairly pragmatic

Re: Selby - PRECIS assessment

by Kadiatou -

Hi Kevin,

 

You conducted a really thorough and detailed analysis, taking into account almost all the elements in the study designs. Our scores are close, but we seem to take different approach in the scoring. For example, for the Organization in the Amanyire et al., we both have a score of 3, but our arguments are different.

I noticed in Christine analysis that our arguments were similar, but the scores are different.

I am curious about the inter rater reliability of this instrument this tool is. A very useful tool, though.

Re: Selby - PRECIS assessment

by Sanithia -

Kadiatou raises a really good point about the inter-rater reliability. (I'm actually wondering if the intra-rater reliability is very good either.)

In reading everyone's responses, it reminds me how much your context and understanding can influence how you rate the studies, especially for the outcome. 

Re: Selby - PRECIS assessment

by A. Clemenzi-Allen -

Hey Kevin, Thanks for your thoughts. I had a different take on the outcome measurement, mostly that the Aminyire outcome was very practical (I think I gave it a 5). They were evaluating a tool to streamline implementation, not to measure virologic suppression (which was the outcome that was evaluated in the Rosen study). The impact of early ART initiation on virologic outcomes and mortality has already been evaluated in prior studies.