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Table 5 Facilitators, barriers and suggestions regarding the recruitment process (views of patients in "normal" typeface and views of health professionals in "bold")

From: Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

Facilitators

Barriers

Suggestions

(27) The process was straightforward, clear and professional

(1) well organised packs

(4) Patients did not fully understand the process (outcomes, confused if antibiotics were part of trial)

(3) Unclear how the results would indicate if Pelargonium is effective when patients are also taking other meds

(7) limited and confusing inclusion criteria (child-bearing age)

• Better explain the use of antibiotics in relation to the study medication

have inclusion / exclusion cards

(26) Clinicians’ approach: helpful, informative, reassuring & spent enough time to explain the trial

(2) quick recruitment session

(1) direct approach in waiting room

(4) Burden: time consuming for GP and patients, paperwork and repetition of consent

(6) time consuming for GPs and nurses

(2) time consuming for patients

(3) too much pressure for primary care

(3) recruitment takes too long

• consent patients to trial once and remind them that they agreed to be contacted, etc.

• warn participants about duration of recruitment appointment

• approach patients when feeling better

reduce paperwork for clinicians

research nurses to run the trial and give them protected time

condense and simplify process and documents

send member of HATRIC team/nurse to discuss with patients before they see the GP

run it outside primary care (e.g. A&E, walk-in centres)

separate the process (identification –recruitment) and bring back patients

remote consent and trial medicine

(22) Clear information on the PIS

(3) Fear of side-effects

(6) long diary considered as burden

(1) severe adverse event

• recruit patients earlier in their illness

• GPs to explain the new drug and if harmless in simple lay terms

translate PIS in different languages

make the font bigger

make the diary more user-friendly

bound it together better

simplify and make it less busy

(22) Patients took part to help with research, reduce Antibiotics use and try alternative ways

(2) patient willing to help with research

(3) Did not understand randomisation

(2) randomisation

• direct approach by the GP

(9) Wish/need to take something when Antibiotics not appropriate

(2) Prescription of Antibiotics enabled some patients to take part

(3) Offer of (delayed) Antibiotics

(2) If GP had not given them immediate Antibiotics, they would not have considered taking part

• use simple terms and consistently: infection, cough, bronchitis

(1) Vouchers were a good incentive

(1) Vouchers are good (but may not work in affluent areas)

(5) equipoise (e.g. if too ill, woman of childbearing age)

(2) Clinician’s lack of equipoise: (under) report side effects

(1) GP described the trial as a ‘secondary thing’

• use an app for busy people

(8) patients’ positive views on herbal meds

(2) staff’s positive views on herbal medicine

(4) patients’ negative views on herbal medicine

 

(5) number of GPs and nurses actively involved in the site

(1) not many staff involved

train nurses to check eligibility

(1) patients’ high demographics

(7) seasonal reasons (no eligible patients during summer)

(4) patients would not bother GP for viral infections

(1) patients were beyond 3-week period

open trial in winter, run full season

(2) prompts from the system

(3) triage system

(2) introducing trial on the phone

(2) research-clinical parallel sessions

(3) first few recruitments were difficult

(2) surgery’s system (MAC nurse, multi-site)

(1) not having NHS.netaccount to send the forms

(4) not enough payment for GPs

support the GPs and nurses for recruiting the first 1–2 patients

ensure 2nd recruit is soon after the 1st

run parallel research – clinical sessions

introduce trial when in reception

a boost of money to motivate sites monthly competition between sites