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Study example to consider
A study wants to access the identifiable patient data from approximately 10,000 patients distributed between 30 practices in Norfolk. Assuming a response rate of 33.3% (which would be excellent!), then 30,000 patients in 30 practices (1000 per practice) would have to be approached for consent.
This would mean that:
- Someone would have to prepare and print 30,000 patient information sheets and 30,000 consent forms.
- Someone would have to buy and put stamps on 30,000 envelopes that will each contain: the GP cover letter, the patient information sheet, the consent form, the postage-paid reply envelope. (Consider the postage for the pack that you send, as it will inevitably be a large format envelope: minimum postage alone 61p per pack)
- Someone in each practice would have to go through their database to find the names and addresses of 1000 eligible patients.
- The practice would have to print out the name and address labels.
- Each practice would have to prepare 1000 cover letters to the patients
- At each practice, someone (researcher, admin worker on research team, someone from the practice) would have to collate all the paperwork put them in the envelopes, attach the labels and get all the envelopes to the post.
- If the response to the first mailing is low, you might also have to factor in sending out a reminder to some patients.
Just for this relatively simple, but not insignificant part of a study (getting the consented patients) you need to consider the time (and therefore cost) that it takes. For example, assuming that the time for each pack to be prepared (taking in to account printing, loading the printer with paper, replacing toner cartridges, clearing printer jams, collating the paperwork, filling, sealing and delivering the envelopes to the post) is approximately 5 minutes per pack, then:
1000 packs x 5 minutes per pack = 5000 minutes per practice
5000/60 = 83.33 hours = more than 2 full person-weeks’ work per practice, and therefore more than 60 person-weeks in total (more than a year’s solid work for one person).
How will you cost it and pay for it? What will you do? Practices may well not have the capacity to do it for you even if they want to!
