Abstract Background People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed ‘Studies Within A Trial’ (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. Methods Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. Results Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p -value = 0.671, I 2 = 0%). There was no effect on any other outcomes. Conclusions Multimedia alongside written information did not improve trial recruitment rates. Trial registration ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.
Abstract Background Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates, by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by PPI contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised. Results 9.6% of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (OR = 0.844, 95% CI 0.58 to 1.22). We also found no effects on the proportion of people response to the invitation (odds ratio1.02 95% CI 0.79 to 1.33) or retention in the trial at 6 and 12 months after randomization (odds ratios 0.84, 95% CI 0.57 to 1.22 and 0.80, 95% CI 0.54 to 1.18 respectively.) Conclusions The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population. Trial Registration: Current controlled trials ISRCTN 06710391 (21/11/2013) SWAT registration SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START) (11/01/2012).
Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial.A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial.Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)).This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study.International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.
Stillbirths are devastating, cannot be predicted, and often occur without a clear cause. The recognition of fetal growth restriction (FGR) as one cause can lead to well-timed delivery and improved outcomes. This study was performed to investigate the role of demographic, social, and medical risk factors known at the beginning of pregnancy and those appearing as pregnancy progresses and their contributions to the incidence of stillbirths. Data included maternal demographic, medical, and social characteristics and fetal or neonatal characteristics. The presence of intrauterine growth restriction was established based on a birth weight below the 10th weight-for-gestational-age centile. Stillbirth was defined as a neonate born after the 24th week of pregnancy who did not breathe or show any signs of life. The independent and multiple variable effects of variables on stillbirths were assessed in Poisson regression models. From 92,218 singleton pregnancies, 389 were stillbirths, for a stillbirth rate of 4.2 per 1000 births. Stillbirth rates were increased in the first as well as third and later pregnancies compared with second pregnancies and those in mothers of African, African Caribbean, and South Asian ethnic origin. Social factors with significant associations included deprivation and unemployment of the mother or her partner. Obesity, active and passive smoking, lack of antenatal folic acid, initiation of prenatal care after 13 weeks, history of mental health problems, diabetes, and prior stillbirth increased the risk. In the current pregnancy, preeclampsia and antepartum hemorrhage were strongly associated, but gestational diabetes was not. The strongest factor was FGR, with a relative risk (RR) of 4.0 when FGR was detected antenatally, but 8.0 when FGR was undetected. The overall stillbirth rate of 4.2 per 1000 births was a composite of 2.4 per 1000 (185/76,356) in pregnancies without FGR and 16.7 per 1000 (195/11,697) in pregnancies with FGR. Of pregnancies with FGR, the stillbirth rate for cases detected antenatally was 9.7 (35/3601) compared with 19.8 (160/8096) for undetected cases. The overall stillbirth rate was higher in mothers who smoked (5.8 vs 3.8/1000 births), but this was only in pregnancies with FGR (13.0); the risk of stillbirth in pregnancies without FGR (3.7) was similar to that for nonsmoking mothers (3.8). Obesity, preexisting diabetes, history of mental health problems, and antepartum hemorrhage in the index pregnancy were associated with an increased risk of stillbirth. Active smoking was associated with an increased risk of stillbirth (adjusted RR, 2.5), but the RR was 5.7 for pregnancies with FGR. No association was found between passive smoking and stillbirth unless FGR was also present (RR, 10.0). The risk of stillbirth was increased for all pregnancies with FGR, but was highest when the mother did not smoke (RR, 7.8). The highest population-attributable risks were associated with FGR, primiparity, and antepartum hemorrhage. Although several risk factors for stillbirth can be ascertained early in pregnancy, the main factor is FGR, which is not usually predicted or recognized antenatally. The findings indicate the importance of improving current strategies and protocols for improved surveillance of fetal growth antenatally. Early detection of fetal growth problems can reduce the risk of stillbirth and must become a key indicator of safety and effectiveness in antenatal care.
Abstract Background: Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates, by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods: The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by PPI contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised . Results: 9.6% of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (OR = 0.844, 95% CI 0.58 to 1.22). We also found no effects on response to the invitation (pre-randomisation – odds ratio1.02 95% CI 0.79 to 1.33) or retention in the trial at 6 and 12 months after randomization (odds ratios 0.84, 95% CI 0.57 to 1.22 and 0.80, 95% CI 0.54 to 1.18 respectively.) Conclusions: The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population. Trial Registration: Current controlled trials ISRCTN 06710391 (21/11/2013). SWAT registration: SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START) (11/01/2012). Keywords: Recruitment; patient information; research methodology; randomized controlled trial.
NHS community pharmacies provide effective smoking cessation services; however, there is scope for increasing throughput and improving quit rates. This trial examines whether the Smoking Treatment Optimisation in Pharmacies (STOP) intervention can improve smoker engagement to increase service throughput, retention and quitting.
Background: Printed participant information about trials is often technical, long and difficult to navigate. Optimisation and user testing can improve information materials, and may improve participant understanding and rates of recruitment.Methods: A study within a trial (SWAT) was undertaken within the ISDR trial. Potential participants in the ISDR trial were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing.Results: A total of 3,169 patients were randomised in the SWAT. Recruitment rates to the ISDR trial were 25.3% in the optimised information group and 26.1% in the standard information group (odds ratio 0.951; 95% CI 0.752 to 1.201; p=0.672). Clinic attendance rates were 71.6% in the optimised information group and 69.3% in the standard information group (OR 1.145; 95% CI 0.885 to 1.480; p=0.304).Conclusions: Optimisation of participant information through information design and user testing did not affect rate of recruitment to the host ISDR trial.Registration: ISRCTN ID ISRCTN87561257; registered on 08 May 2014.
'%3e%3cpath fill='%23012169' d='M0 0v30h60V0z'/%3e%3cpath stroke='%23fff' stroke-width='6' d='m0 0 60 30m0-30L0 30'/%3e%3cpath stroke='%23C8102E' stroke-width='4' d='m0 0 60 30m0-30L0 30' clip-path='url(%23b)'/%3e%3cpath stroke='%23fff' stroke-width='10' d='M30 0v30M0 15h60'/%3e%3cpath stroke='%23C8102E' stroke-width='6' d='M30 0v30M0 15h60'/%3e%3c/g%3e%3c/svg%3e)