A recruiting failure turned success

Research midwives were employed to approach potential recruits in the antenatal clinic of the John Hunter Hospital. All pregnant women who were up to 16 weeks gestation were eligible to participate in the Math Model of Pregnancy study. At this first encounter a brief verbal description of the study was provided and the recruiting materials were issues. Follow-up phone calls were usually made two or three days after first being approached, to determine willingness to participate. The same method of recruiting continued with the change over to the Women and Their Children's Health (WATCH) Study.

Just over 600 women who had previously participated in, or were currently enrolled in, the Math Model Study were to be invited to join the ABCD Obesity Study. It was estimated that with a response rate of 60 to 70%, between 360 and 430 mother-child (up to four years of age) pairs would be recruited into this study, in addition to 100 women who were currently pregnant. This estimate was thought to be conservative, given that these women had previously consented to research of a similar nature.

Due to the large sample size recruiting was to be staggered, with a sample of 50 women approached at a time. Potential participants were to be invited into the study from both ends of the Math Model timeframe, first approaching those who had been out of the study the longest (n = 25), as well as those who had most recently joined (n = 25). Of the 50 invitations to participate that were mailed out, a total of only five consents were received, even after a follow-up letter was distributed. Four of these consents came from women who were currently pregnant and were still actively involved in the Math Model study.

Prior to submitting the ethics application for committee review, advice was sought from the Professional Research Ethics Officer on the appropriateness of re-recruiting subjects that had previously participated in research. Concerns were raised regarding the manner in which potential participants would be contacted, and measures (for example the mode of contact) were written into the research protocol to avoid consent out of a sense of obligation. The original application for the ABCD Obesity Study was made to the Hunter Area Research Ethics Committee in May 2005 and approval was obtained in September 2005. Prior to commencing recruitment, a variation to the original application was submitted and approval for this was received in October 2005. Recruitment then commenced immediately and continued for the duration of the next six weeks. After this time it was evident that we were not going to be successful in meeting our sample size targets and subsequently our research objectives, due to the very poor rate of response (10%) to the invitation to participate.

Women who participated in the Math Model of Pregnancy Study consented to having three study ultrasound scans, at 18–20, 26 and 32 weeks gestation. At each of these study visits non-fasting blood and urine samples were collected. Umbilical cord blood was collected at birth. Participants had the option of donating one further blood sample while in labour and additionally, their placenta after delivery.

The information statement for the ABCD Obesity study documented the requirements of participation as attending two appointments at the John Hunter Hospital, at which physical measurements would be collected and questionnaires would be interview-administered for both mother and child. Dietary data recording for mother and child was a major component of the ABCD Obesity Study, including 3-day weighed food records and food frequency questionnaires. Maternal and child blood samples were also listed as optional components of the study.

The WATCH Study has combined the data that was planned for collection in both parent studies, using the prospective longitudinal study design that was already in place for the Math Model study, but with ongoing follow-up in infancy and early childhood. An extra ultrasound scan is performed at 36 weeks for the women in the WATCH Study who have not already delivered. Child follow-ups take place at 3, 6, 9, 12 and 24 months, with physical, medical and dietary data being collected at these study visits.

A review of the study design and all recruiting materials was undertaken in an effort to identify the shortcomings of the project. Evaluation and advice was sought from those with extensive expertise in recruiting, not only for research purposes but for large-scale public health interventions. Literature on recruiting participants was consulted [3‐9]. All feedback was considered in the redevelopment of the project and a complete overhaul of the method of recruitment and the materials provided to potential participants took place.

Feedback highlighted that from the outset the title ABCD Obesity may have been a deterrent. Initially there was consensus among the research team that having a strong term like 'obesity' in the study name would attract interest, in a similar fashion to its common use in public and popular press. In hindsight however, it was likely to be the opposite. The social interpretation from consumer literature tends to be pejorative in nature, and the study title was likely to be particularly discouraging to women who were above their healthy weight range [10, 11].

There are ethical considerations that need to be assessed before commencing research involving a population or group who are often targeted or who have previously participated in research. The National Statement on Ethical Conduct in Human Research [12] provides guidance on what is appropriate and emphasises the need to respect the rights of the participant to decline. In practise, this sensitivity translated into the way that we were able to approach potential participants, as further described below. The mode of contact proved to be so unsuccessful that during the study redesign we redirected the focus to the women who were currently pregnant and had not previously been approached.

Sending a letter of invitation through the mail was always going to be a less than ideal recruiting strategy for several reasons. Firstly, we could not be sure that the intended recipient actually received the invitation, unless of course we received a reply. Conversely, we could not be sure where the recipient did not receive the invitation as a result of a change of address, unless our mail-out was delivered 'return to sender' (only two were returned in this way). Registered mail would have been useful, however this option was not considered at the time of the mail out.

In our case we were working from hospital records which may or may not have contained the potential participant's most current postal address. To put this in context, between 1996 and 2001, 40.5% of people living in the Hunter region had changed their address [13]. While 28% of these remained living in the Hunter region, 12.5% had moved either elsewhere in NSW, interstate or overseas[13]. These figures do not take into consideration multiple changes in address that may have occurred. Lack of most current data may have been a major contributor to the very poor response rate in the sample of women who had completed their involvement in the Math Model project several years ago.

For those who did receive the information, from the outset the onus was on them to establish contact with the research team whether to agree to participate or to seek more information. A reply-paid, self-addressed envelope was provided with a response form asking potential participants to either opt-in or opt-out of the study. Nil opt-out responses were received. Furthermore, the mailed-out invitation to participate in research arriving was out of context when the research was to be based in a healthcare setting like the hospital.

It was important to weigh up the participant burden in relation to what they got back from their involvement in this research. The altruistic motive of helping others can be a behaviour driver, but if there are obstacles to doing so it may not be enough. Consider (if applicable): the time of available study appointments; the location of the research and ease of getting there; any cost incurred by participating including time off work, travel, and parking; the number of study visits and duration of appointments; and availability of child care. While it is unethical to provide incentives of a disproportional magnitude (financial or otherwise) that may coerce individuals to participate, especially those who are economically vulnerable, or where inducements are undue [14], it is unreasonable not to make participation as easy and rewarding as possible for those who do consent. Reimbursement for time and travel were not deemed feasible for WATCH Study participants. Parking permits were issued to cover all parking expenses associated with study visits and a light meal was provided on the occasions when fasting samples were collected.

The detail in the planning and development phase of the research project is often intertwined with the writing of the ethics application. However this can quickly lead to lapsed judgement about your priorities. In wanting to get started on the research the focus became obtaining approval by the ethics committee. While it is the ethics committee's responsibility is to represent participants and researchers alike, the nature of the application process can hamper achieving the most desirable outcomes for both. Take, for example, the recruiting materials which are described below. By focusing too heavily on the primary function of informing the participant prior to consent we produced a document that was unable to maintain the interest of the reader and may not have been well understood.

The written information provided to potential subjects should reflect the nature of the research, not only in terms of content but also visual presentation. In our case, pregnancy is generally regarded as a positive time in a woman's life, hence we wanted to reinforce this with the written materials we provided in the revised study (copy of WATCH Study Information pamphlet available from author AH on request). The use of images including a study logo, colour and using a pamphlet format has helped us to convey the information we need participants to be aware of in order for them to provide informed consent. While the ABCD recruiting material did include a study logo, it was not colour printed and was presented as formal document rather than pamphlet style.

The length of the text is another important factor that needs to be considered. With careful deliberation we were able to condense what had been two separate information statements totalling just over eight A4 pages in length, into one single double-sided A4 information pamphlet for the WATCH Study. This information pamphlet has been more favourably received by not only by potential participants but also by the other healthcare professionals who see our participants over the course of standard antenatal care.

The ease of readability of the information statement is too often neglected [15] despite the simplicity in considering this. Readability statistics are available as part of the Microsoft Word (Microsoft Office Word 2003) spelling and grammar functions and they provide an objective measure of how easy materials are to read. The Flesch Reading Ease score rates text on a 100-point scale; the higher the score, the easier it is to understand. Additionally you receive a grading for your text, known as the Flesch-Kincaid Grade Level, which ascribes the text a school grade (United States) level. For example, a score of 8.0 means that an eighth grader should be able to understand the document [16]. Both are calculated using formulas that consider the average sentence length and average number of syllables per word [16]. For most standard documents, the aim is for a Flesch Reading Ease score of approximately 60 to 70 and a Flesch-Kincaid Grade Level of 7.0 to 8.0 [16]. We were able to reduce our Flesch-Kincaid Grade Level from 10.9 for the ABCD Obesity Study and 11.3 for the Math Model recruiting materials, to 7.1 for the combined WATCH study information pamphlet.

This incorporates many of the factors previously described and will be defined by the level of detail put into developing the study design. Ultimately we had to put ourselves in the position of potential participants and write the study materials from this viewpoint. Ethics committees provide guidance on what information must be given. But it is ultimately the researchers responsibility to ensure that we communicate effectively with potential participants in a manner which aims to encourage participation. From our experience we would recommend seeking advice from those with expertise in recruiting who understand the common mistakes that researchers make when designing the recruitment protocol and materials. Additionally using materials that have proven to be successful as a template may also be advantageous.

Whist we believe that it was the multiple changes that resulted in our improved response rate, the empirical study design is such that we cannot provide direct evidence that all of the changes contributed to the observed improvement. It is possible that only some of the strategies were instrumental in improving the response rate, or even just one. Because all of the changes were made at once we cannot quantify the relative contributions of each. It is even possible that one or more of the changes may have had a negative impact on potential respondents, but that the positive changes compensated so that overall there was still a significant net improvement in our response rate. Future research studies will be required to determine which are the most efficient strategies for ensuring recruitment protocol success.