Exceeding the recruitment target in a primary care paediatric trial:an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

BACKGROUND: Recruiting to target in randomised controlled trials of investigational medicinal products (CTIMPs) in primary care and paediatric populations is notoriously difficult. More evidence is needed for effective recruitment strategies in these settings. We report on the impact of different recruitment strategies used in the Choice of Moisturiser in Eczema Treatment (COMET) study – a feasibility trial comparing the effectiveness of four emollients for the treatment of childhood eczema – recruiting via general practitioner (GP) surgeries. METHODS: Initially, 16 GP practices invited potentially eligible children to take part in the trial by sending an invitation letter (self-referral pathway) or by consenting and randomising them into the study during a visit to the practice (in-consultation referral). Measures implemented during the study to maximise accrual included signing up six additional GP practices, increasing the upper age limit eligibility criterion from 3 to 5 years, and permitting healthcare professionals other than doctors to confirm participant eligibility. We used descriptive statistics and univariate linear regression models to explore associations with practice recruitment rates. RESULTS: A total of 197 participants were recruited, exceeding the target of 160. Of these, 107 children entered via self-referral and 90 by in-consultation pathways. Of the recruited population, 12.6 % were aged between 3 and 5 years (the raised upper age limit). The six additional practices contributed 37.4 % (40 of 107) of participants recruited by self-referral. Only almost one-third (18 of 56 [32.1 %]) of potential recruiting clinicians recruited one or more participants in-consultation, which was a more problematic pathway because of data verification issues. Three research nurses and a pharmacist from four practices recruited 48.9 % (44 of 90) of participants via this pathway. Univariate linear regression models showed no evidence of association between the number of children recruited via the self-referral pathway by practice and practice list size (p = 0.092) or practice deprivation decile (p = 0.270), but practice deprivation was associated with a higher number of children recruited in-consultation (p = 0.020) by practice. CONCLUSIONS: Self-referral and in-consultation recruitment yielded similar numbers, but the in-consultation pathway was more problematic. Future trials of this type should consider the condition, normal care pathway and number of potentially eligible children and be prepared to use multiple recruitment strategies to achieve recruitment targets. TRIAL REGISTRATION: ISRCTN21828118. Registered on 1 May 2014. EudraCT2013-003001-26. Registered on 23 Dec 2013

Facilitating access to health research through a participatory research register:a feasibility study in outpatient clinics

Abstract Background A research register (Reach West) has been established to facilitate recruitment of people and patients to health-related research. We conducted a prospective feasibility study to investigate the practicality of recruiting through outpatient clinics. Methods Patients over 18 years of age attending dental, eye or oncology outpatient clinics in an acute hospital in the West of England were provided with the opportunity to participate in Reach West. In Phase I, recruitment packs were handed to clinic attendees who could place completed consent forms in secure drop-box or return them later on-line or by post. In Phase II, recruitment packs were posted directly to patients with consent forms to be returned by post or on-line. Response rates by age, sex, postcode (for level of deprivation), and clinic type were recorded for those agreeing to participate on paper or on-line. Results In Phase I, 2,314 of 4,500 (51.4%) of recruitment packs were handed out to clinic attendees, and 114 (5%) consented to join Reach West. In Phase II, 7,173 of 9000 packs were posted (79.7%), and 387 (5.4%) consented to participate. The overall consent rate was 6% (580), with the majority doing so on paper (87%) rather than on-line. The sample was balanced by sex, but mostly comprised people over 50 years located in less deprived postcodes. Non-staff costs for postal recruitment were lower than hand-outs in clinic (£6.84 compared with £8.05 per participant). Conclusions Recruiting participants to the Reach West register was feasible among those with oncology, dental or eye outpatient appointments by post or with packs given out in the clinic. Response rates were similar to those achieved for other registers. Recruitment of participants can be achieved through outpatient clinics but other strategies will also be required to attract large numbers of participants and more diverse populations

Facilitating access to health research through a participatory research register:a feasibility study in outpatient clinics

Abstract Background A research register (Reach West) has been established to facilitate recruitment of people and patients to health-related research. We conducted a prospective feasibility study to investigate the practicality of recruiting through outpatient clinics. Methods Patients over 18 years of age attending dental, eye or oncology outpatient clinics in an acute hospital in the West of England were provided with the opportunity to participate in Reach West. In Phase I, recruitment packs were handed to clinic attendees who could place completed consent forms in secure drop-box or return them later on-line or by post. In Phase II, recruitment packs were posted directly to patients with consent forms to be returned by post or on-line. Response rates by age, sex, postcode (for level of deprivation), and clinic type were recorded for those agreeing to participate on paper or on-line. Results In Phase I, 2,314 of 4,500 (51.4%) of recruitment packs were handed out to clinic attendees, and 114 (5%) consented to join Reach West. In Phase II, 7,173 of 9000 packs were posted (79.7%), and 387 (5.4%) consented to participate. The overall consent rate was 6% (580), with the majority doing so on paper (87%) rather than on-line. The sample was balanced by sex, but mostly comprised people over 50 years located in less deprived postcodes. Non-staff costs for postal recruitment were lower than hand-outs in clinic (£6.84 compared with £8.05 per participant). Conclusions Recruiting participants to the Reach West register was feasible among those with oncology, dental or eye outpatient appointments by post or with packs given out in the clinic. Response rates were similar to those achieved for other registers. Recruitment of participants can be achieved through outpatient clinics but other strategies will also be required to attract large numbers of participants and more diverse populations

Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial

Objective To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen

Medicine dosing by weight in the home: Can parents accurately weigh preschool children? A method comparison study

Objective: To determine the accuracy with which parents can estimate preschool children's weight using home scales in order to calculate antipyretic dose. Design: Cross-sectional, method comparison study. Setting and participants: 156 preschool children aged 6 months to 6 years recruited from primary care and the community to an antipyretic strategies trial and managed at home. Comparison and outcome measures: Research nurse weight estimate using Seca 835-2 digital paediatric scales compared with parental weight estimate using usual home scales. Results: Parents of 62 (40%) preschool children had home scales. Research scale estimated weights were heavier than home scale weight estimates, with a mean difference of 0.41 kg (95% CI -0.24 to 0.74 kg), with 95% limits of agreement of -2.44 to 1.47 kg. Conclusion: Weight can be estimated accurately enough to calculate antipyretic medicine doses by the minority of parents having scales that can be used to estimate their child's weight

The influence of clinical communication on parents’ antibiotic expectations for children with Respiratory Tract Infections

PURPOSE: The purpose of this study was to understand clinicians’ and parents’ perceptions of communication within consultations for respiratory tract infections (RTI) in children and what influence clinician communication had on parents’ understanding of antibiotic treatment. METHODS: We video recorded 60 primary care consultations for children aged 3 months to 12 years who presented with RTI and cough in 6 primary care practices in England. We then used purposive sampling to select 27 parents and 13 clinicians for semistructured video-elicitation interviews. The videos were used as prompts to investigate participants’ understanding and views of communication within the consultations. We analyzed the interview data thematically. RESULTS: While clinicians commonly told parents that antibiotics are not effective against viruses, this did not have much impact on parents’ beliefs about the need to consult or on their expectations concerning antibiotics. Parents believed that antibiotics were needed to treat more severe illnesses, a belief that was supported by the way clinicians accompanied viral diagnoses with problem-minimizing language and antibiotic prescriptions with more problem-oriented language. Antibiotic prescriptions tended to confirm parents’ beliefs about what indicated illness severity, which often took into account the wider impact on a child’s life. While parents understood antimicrobial resistance poorly, most held beliefs that supported reduced antibiotic prescribing. A minority attributed it to resource rationing, however. CONCLUSIONS: Clinician communication and prescribing behavior confirm parents’ beliefs that antibiotics are needed to treat more severe illnesses. Interventions to reduce antibiotic expectations need to address communication within the consultation, prescribing behavior, and lay beliefs

Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial

Objective To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home