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. 2022 Oct 12;23:870. doi: 10.1186/s13063-022-06816-6

Table 1.

Results of mapping exercise (short-list of Behaviour Change Techniques (BCT) for potential inclusion in recruitment intervention)

Behavioural analysis using TDF: barriers and enablers to inviting all eligible women to participate in a clinical trial in maternity care
Subtheme TDF domain BCT (salient domain) Example/suggestions Intervention function(s) Decision/notes

Availability and accessibility of resources

Having access to resources is a key enabler for trial recruitment. Recruiters need reliable technology such as iPads to facilitate mobile recruitment as they often have ‘no fixed abode’. Recruiters also struggle to communicate effectively without the use of dedicated reliable mobile phone technology. There is rarely a dedicated space for recruiters to have a private conversation with potential participants. Recruiters frequently ‘lurk’ in corridors and waiting rooms to meet potential participants. While the majority of recruiters identified the lack of space as a barrier, some felt that recruiting participants from the waiting area was an efficient use of the woman’s time. Having a sufficient number of staff, both clinical and research, allows recruiters the capacity to approach all eligible women and take the time needed to present and discuss the trial thoroughly with them. Recruiters frequently report that being understaffed limits their ability to reach all eligible women and as a result many recruitment opportunities are missed. Trial funding also plays a role in influencing recruitment efforts, as some recruiters report placing a greater emphasis on offering the trial to all eligible women, when the trial secures funding for the department

ECR

3.2. Social support (practical)

Advise on, arrange, or provide practical help (e.g. from friends, relatives, colleagues, ‘buddies’ or staff) for performance of the behaviour

Set up an online peer support group for recruiters

Develop a trial recruiter network with regular meetings providing peer support

Enablement ExcludeAPEASE (effectiveness) existing practice

7.1. Prompts/cues

Introduce or define environmental or social stimulus with the purpose of prompting or cueing the behaviour. The prompt or cue would normally occur at the time or place of performance

Provide recruiters with lanyard cards listing trials and inclusion criteria Environmental restructuring ExcludeAPEASE (effectiveness) existing practice

12.1. Restructuring the physical environment

Change, or advise to change the physical environment in order to facilitate performance of the wanted behaviour or create barriers to the unwanted behaviour (other than prompts/cues, rewards and punishments)

Have designated space (or folder) where trial materials are convenient and easy to access Environmental restructuring ExcludeAPEASE (effectiveness) existing practice

12.2. Restructuring the social environment

Change, or advise to change the social environment in order to facilitate performance of the wanted behaviour or create barriers to the unwanted behaviour (other than prompts/cues, rewards and punishments)

Assign roles (“champions”) responsible for trial recruitment in the area. Champions would take the lead to ensuring all women were approached with trial information Environmental restructuring ExcludeAPEASE (effectiveness) existing practice

12.5 Adding objects to the environment

Add objects to the environment in order to facilitate performance of the behaviour

Display trial information posters in the clinical area and staff break room (content maybe additional multiple BCTs on poster) Environmental restructuring

Exclude

APEASE (effectiveness) not reaching target (AACTTa)

Planning and preparation

The importance of planning and preparing for trial recruitment was emphasised. This involves screening ward and clinic lists and accessing women’s charts to gain background knowledge on potential participants. Recruiter’s favour strategies such as using a ‘two stage’ recruitment process because it allows women more time to assimilate trial information and make an informed decision as to whether they take part or not. Recruiters differentiate between non-CTIMP and CTIMP, highlighting that the latter requires extra planning and preparation on their behalf

Behavioural regulation

Less salient domains:

Knowledge

Memory, attention, decision-making processes

1.2. Problem solving

Analyse, or prompt the person to analyse, factors influencing the behaviour and generate or select strategies that include overcoming barriers and/or increasing facilitators (includes ‘Relapse Prevention’ and ‘Coping Planning’)

Provide recruiters with an opportunity to role play the recruitment encounter during trial training. Recruiters could role play with clinical colleagues to anticipate any environmental or emotional barriers and generate strategies to overcome these Enablement ExcludeAPEASE (effectiveness) existing practice

2.3. Self-monitoring of behaviour

Establish a method for the person to monitor and record their behaviour(s) as part of a behaviour change strategy

Ask recruiters to keep a record of each recruitment encounter or potential encounter and the outcomerecruiters could then reflect on diary and share learning with peers Enablement Include

11.2. Reduce negative emotions

Advise on ways of reducing negative emotions to facilitate performance of the behaviour (includes ‘Stress Management’)

To overcome ‘feeling the vibe’ remind recruiters that it’s OK just to invite women to the trial by giving them the information Enablement Include

11.3. Conserving mental resources

Advise on ways of minimising demands on mental resources to facilitate behaviour change

Recruiters to carry with them trial information packs/lanyards cards with eligibility criteria Enablement ExcludeAPEASE (effectiveness) existing practice

Being visible

The visibility of the trial and also the recruiter is important. Recruiter’s discussed ways in which they promote the trial, using methods such as posters to raise awareness of the trial amongst clinical staff and potential participants, both internally and externally at the site. Recruiters use creative means to maintain visibility of the trial and in doing so extend their reach in accessing potential participants that might otherwise have been missed. Recruiters being visible and having a presence in the clinical area also raises awareness about the trial and gives clinical colleagues a point of contact where they can signpost potential participants to

Behavioural regulation

Domain was only identified as an enabler (not a barrier)

Less salient domains:

Intentions

Environmental Context and resources

1.2. Problem solving

Analyse, or prompt the person to analyse, factors influencing the behaviour and generate or select strategies that include overcoming barriers and/or increasing facilitators (includes ‘Relapse Prevention’ and ‘Coping Planning’)

Encourage recruiters to plan

Give recruiters time to plan and develop design recruitment strategies tailored to each trial and each site

Enablement Excludedomain was only identified as an enabler (not a barrier)

2.3. Self-monitoring of behaviour

Establish a method for the person to monitor and record their behaviour(s) as part of a behaviour change strategy

Ask recruiters to record where they placed posters etc. to monitor what works. Ask women and clinical if they have noticed these posters referring to the trial Enablement

8.2. Behaviour substitution

Prompt substitution of the unwanted behaviour with a wanted or neutral behaviour

Recruiters approach all eligible women about trial the rather than making an assessment beforehand

Promote visibility of the trial and the recruiter by regular visits to the clinical area

Recruiters hand out ‘business’ card with photo and contact details to colleagues and women

Restriction

11.2. Reduce negative emotions

Advise on ways of reducing negative emotions to facilitate performance of the behaviour (includes ‘Stress Management’)

Reduce feelings of ‘being in the way’ by trial teams/clinical seniors reiterating the value of what they are doing and their contribution to clinical advancement Enablement

11.3. Conserving mental resources

Advise on ways of minimising demands on mental resources to facilitate behaviour change

Recruiters wear ID badges with trial name and recruiter role clearly visible

Recruiters wear lanyards with trial name and their role clearly visible

Advertise trials and brief inclusion criteria using hospital website/app

Enablement

Approach to recruiting

Recruiters describe how the actual approach to recruitment needs to be sensitive and appropriate to the woman’s situation. There was a common feeling that the approach should be quiet and gentle. Recruiters talk about the importance of timing when recruiting, choosing the ‘right’ time to approach was seen as key in successfully recruiting into a trial. Recruiters also discuss how their intuition plays a part in whether or not they approach a woman, describing how having a ‘feeling’ or getting a ‘vibe’ may deter them from offering a trial to a women despite her meeting eligibility criteria. Recruiters highlight that communicating the trial in a concise understandable way is key, and many describe having rehearsed a recruitment ‘spiel’ for each trial

Emotion

Less salient domains:

Skills

Beliefs about Consequences

Environmental context and resources

11.2. Reduce negative emotions

Advise on ways of reducing negative emotions to facilitate performance of the behaviour (includes ‘Stress Management’)

Reduce feelings of apprehension (burdensome to women) by using a ‘two-stage’ recruitment strategy to introduce the trial

To overcome ‘feeling the vibe’ remind recruiters that it’s OK just to invite women to the trial by giving them the information

Reduce negative emotions through building peer network—discuss the balance between protecting women’s interests while supporting them to benefit from evidence-based care

Enablement

ExcludeAPEASE (effectiveness) existing practice

Include

ExcludeAPEASE (effectiveness) existing practice

5.5. Anticipated regret

Induce or raise awareness of expectations of future regret about performance of the unwanted behaviour

Ask recruiters to assess the degree of regret they will feel if they do not invite all eligible women to participate in a trial (ask them how they would feel if potential participants are overlooked) Coercion ExcludeAPEASE (not appropriate)

5.6. Information about emotional consequences

Provide information (e.g. written, verbal, visual) about emotional consequences of performing the behaviour

Provide recruiters with information about women’s autonomy and right to determine their own health choices. Remind recruiters that whether to offer trial participation is not their choice to make Education/Persuasion Include

12.6. Body changes

Alter body structure, functioning or support directly to facilitate behaviour change

Make recruiters aware of how they position themselves during a recruitment encounter. Encourage recruiters to be at the same eye level as the woman (i.e. both seated) when discussing the trial Enablement

Exclude—

APEASE (not practicable)

13.2. Framing/reframing

Suggest the deliberate adoption of a perspective or new perspective on behaviour (e.g. its purpose) in order to change cognitions or emotions about performing the behaviour (includes ‘Cognitive structuring’)

Recruiters focus on offering the ‘invitation’ to participate in a trial (rather than thinking about the number of women that agree to participate) Enablement Include

The ‘right’ participants

Despite believing that all pregnant women, if eligible, should be offered the opportunity to join a trial, and have the right to decide whether or not they participate, recruiters highlighted difficulties in identifying the ‘right’ participants. In the first instance, recruiters discuss assessing the suitability of potential trial participants based on their own judgement or beliefs on whether the woman could or would complete the trial. In the second instance, recruiters report the ambiguity relating to their own interpretation of the protocol criteria i.e. who was or was not eligible, proved problematic in finding the ‘right’ participant for the trial

Beliefs about consequences

Less salient domains:

Knowledge

Memory and decision processes

Intentions

5.1. Information about health consequences

Provide information (e.g. written, verbal, visual) about health consequences of performing the behaviour

Explain that not inviting all eligible women to participate in a trial could restrict and slow down evidence generation and treatment options for o women during pregnancy Education Include

5.2. Salience of consequences

Use methods specifically designed to emphasise the consequences of performing the behaviour with the aim of making them more memorable (goes beyond informing about consequences)

Show treatment options and advances in care now available to women as a result of earlier clinical trial. Show how lack of evidence limits choices and treatment options for women Education Include

5.3. Information about social and environmental consequences

Provide information (e.g. written, verbal, visual) about social and environmental consequences of performing the behaviour

Remind recruiters that women have the right to be asked if they would like to participate Persuasion Include

5.5. Anticipated regret

Induce or raise awareness of expectations of future regret about performance of the unwanted behaviour

Ask recruiters to assess the degree of regret they will feel if they do not invite all eligible women to participate in a trial (ask them how they would feel if potential participants are overlooked) Coercion ExcludeAPEASE (not appropriate)

5.6. Information about emotional consequences

Provide information (e.g. written, verbal, visual) about emotional consequences of performing the behaviour

Provide recruiters with information about women’s autonomy and right to determine their own health choices. Remind recruiters that whether to offer trial participation is not their choice to make Education/Persuasion Include

9.2. Pros and cons

Advise the person to identify and compare reasons for wanting (pros) and not wanting to (cons) change the behaviour (includes ‘Decisional balance’)

Ask recruiters to list and compare the advantages and disadvantages of inviting all eligible women to participate in a trial Enablement Include

10.10. Reward (outcome)

Arrange for the delivery of a reward if and only if there has been effort and/or progress in achieving the behavioural outcome (includes ‘Positive reinforcement’)

Arrange for recruiters to receive reward (i.e. box of chocs) if, and only if, there is an increase in the number of women are invited to take part in a trial Incentivisation ExcludeAPEASE (ethical)

4.1. Instruction on how to perform behaviour

Advise or agree on how to perform the behaviour (includes ‘Skills training’)

Provide step by step training to recruiters on how to invite all eligible women to participate in a trial Training ExcludeAPEASE (effectiveness) existing practice

4.2. Information about antecedents

Provide information about antecedents (e.g. social and environmental situations and events, emotions, cognitions) that reliably predict performance of the behaviour

Encourage recruiters to keep a record of situations or events occurring prior to approaching a woman about the trial and reflect on this (learning) with peers

Experienced recruiters to give lectures/talk discussing how to troubleshoot antecedents

Education Include

5.1. Information about health consequences

Provide information (e.g. written, verbal, visual) about health consequences of performing the behaviour

Explain that not inviting all eligible women to participate in a trial could restrict and slow down evidence generation and treatment options for o women during pregnancy. Specific tagline (easy for recruiters remember) about the health consequences of not inviting all eligible women to participate in a trial Education Include

5.3. Information about social and environmental consequences

Provide information (e.g. written, verbal, visual) about social and environmental consequences of performing the behaviour

Remind recruiters that not inviting all eligible women to participate in a trial could led to health inequality for women

Highlight the contribution to evidence that inviting all eligible women to trial makes

Education/Persuasion Include

Putting women’s clinical care and wellbeing first

Prioritising the clinical care and wellbeing of potential participants is a view shared by all recruiters in the study. Trial recruitment is a secondary consideration for recruiters as they attend to the immediate physical or emotional needs that women have. Recruiters discussed their professional responsibility and a duty of care towards women and seek to minimise any potential burden associated with participation

Intentions

Less salient domains:

Social/professional Role and identity

Goals

Goal setting (behaviour)

Set or agree on a goal defined in terms of the behaviour to be achieved

Ask recruiters to set an agreed daily/weekly goal for inviting all eligible women to participate in a trial Enablement Include

5.1. Information about health consequences

Provide information (e.g. written, verbal, visual) about health consequences of performing the behaviour

Explain that by not inviting all eligible women to participate in a trial reduces the evidence base and treatment options available to women during pregnancy.Reinforce research as part of clinical care and central to generating evidence to inform treatments. Emphasise the counter factual is to provide a treatment based on preference not evidence, i.e. care will not be evidence based, rather it will be based on the clinicians preference Education Include

10.8. Incentive (outcome)

Inform that a reward will be delivered if and only if there has been effort and/or progress in achieving the behavioural outcome (includes ‘Positive reinforcement’)

Inform recruiters that they will receive money if, and only if, there is an increase in the number of women are invited to take part in a trial

Acknowledge changes in behaviour (i.e. increased number of women invited to trial) by rewarding recruiters with co-authorship or other non-monetary incentives

Incentivisation

Exclude—

APEASE (not acceptable)

Acceptability of the intervention

Recruiter’s beliefs about the acceptability of the intervention directly influences whether or not they invite all eligible women to a trial. Recruiters were more comfortable and therefore more willing to recruit to trials where they believed the intervention was acceptable to women. Recruiting for trial interventions that did not align with their professional opinion was more challenging for recruiters. Furthermore, the recruiter’s perception of acceptability varies depending on their clinical background

Beliefs about consequences

Less salient domains:

Social and professional role and identity

5.1. Information about health consequences

Provide information (e.g. written, verbal, visual) about health consequences of performing the behaviour

Inform recruiters of the rationale for the trial intervention and how the trial results will help fill a gap in the evidence

Explain that approaching all eligible women has a potential to make trials happening more efficiently and generate evidence more quickly

Address concerns about the acceptability of the trial intervention with the early involvement of recruiters (from MDT background) in design

Education

Include

ExcludeAPEASE (effectiveness) existing practice

5.2. Salience of consequences

Use methods specifically designed to emphasise the consequences of performing the behaviour with the aim of making them more memorable (goes beyond informing about consequences)

Show recruiters treatment options and advances in care now available to women because of earlier clinical trials interventions

Invite past trial participants to discuss with recruiters their experiences of receiving an intervention that had been deemed ‘less acceptable’

Persuasion

Include

(would need to also give balance of different opinions)

5.3. Information about social and environmental consequences

Provide information (e.g. written, verbal, visual) about social and environmental consequences of performing the behaviour

Remind recruiters that not inviting all eligible women to participate in a trial could led to health inequality for women

Highlight the contribution to evidence that inviting all eligible women to trial makes

Persuasion Include

5.5. Anticipated regret

Induce or raise awareness of expectations of future regret about performance of the unwanted behaviour

Ask recruiters to assess the degree of regret they will feel if they do not invite all eligible women to participate in a trial with an intervention that later proves beneficial to women’s care, or standard care proved to be detrimental Coercion ExcludeAPEASE (not appropriate)

5.6. Information about emotional consequences

Provide information (e.g. written, verbal, visual) about emotional consequences of performing the behaviour

Recruiters share anecdotes of past emotionally sensitive situations where women were glad to be invited to participate in the trial and may have found inclusion helpful or comforting in their situation Education/Persuasion Include

Commitment to the research

Recruiters express a sense of ownership towards the trial and discuss feeling ‘invested’ in it. This sense of ownership and desire for success appears to encourage recruiters to extend the invitation to participate in the trial to all eligible women

Recruiters consider the research to be a worthwhile endeavour when it addresses a clinical need. Recruiters are also keen to show clinical colleagues that the research is worthwhile. Belief in the research enables recruitment, however, when doubts are raised so too are barriers

Intentions

Less salient domains:

Social and professional role and identity

Beliefs about consequences

1.1. Goal setting (behaviour)

Set or agree on a goal defined in terms of the behaviour to be achieved

Ask recruiters to set an agreed daily/weekly goal for inviting all eligible women to participate in a trial Enablement Include

5.1. Information about health consequences

Provide information (e.g. written, verbal, visual) about health consequences of performing the behaviour

Explain that not inviting all eligible women to participate in a trial reduces the potential evidence base and treatment options available to women during pregnancy Education Include

10.8. Incentive (outcome)

Inform that a reward will be delivered if and only if there has been effort and/or progress in achieving the behavioural outcome (includes ‘Positive reinforcement’)

Inform recruiters that they will receive a reward for increasing the number of eligible women invited to the trial (possible reward with co-authorship/public acknowledgement) Incentivisation ExcludeAPEASE (ethical)

Being supported

Support from peers across the trial setting is important to recruiters and enables them to offer the trial to all eligible women. Collaboration from clinical colleagues allows recruiters to gain access to potential participants, this support is valued by recruiters as they make efforts to build and nurture these relationships. Recruiters report that the absence of support from clinical colleagues passively blocks them from reaching all potential trial participants. Collaboration with other trial recruiters, both inside and outside the current trial, provides an additional source of support encouraging recruiters to offer the trial to all eligible women

Recruiters reported that regular communication with the trial team was helpful, while onsite support from the team was especially appreciated

Social Influences

Less salient domains:

Social and professional role and identity

Reinforcement

3.1. Social support (unspecified)

Advise on, arrange or provide social support (e.g. from friend, relatives, colleagues or staff or non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling, but only when it is directed at the behaviour

Encourage recruiters to call a ‘buddy’ when they are struggling to invite all eligible women to the trial (i.e. set up WhatsApp group)

Give recruiters protected time to engage in their peer support network

Enablement ExcludeAPEASE (effectiveness) existing practice

3.2. Social support (practical)

Advise on, arrange, or provide practical help (e.g. from friends, relatives, colleagues, ‘buddies’ or staff) for performance of the behaviour

Set up an online peer support group for recruiters

Develop a trial recruiter network with regular meetings providing peer support

Opportunities for peer learning both within and across sites, etc

Team meetings to discuss the trials (similar to MDT meeting) to get buy in from cross speciality

Enablement ExcludeAPEASE (effectiveness) existing practice

6.2. Social comparison

Draw attention to others’ performance to allow comparison with the person’s own performance

Show recruiters the proportion of women approached to participate in a trial by other trial recruiters/sites and compare with their own data

Site league tables (publish data on all trial sites including their level of resources) at set time points in the recruitment process, so that each site can see for themselves how they compare

Persuasion ExcludeAPEASE (effectiveness) existing practice

6.3. Information about others’ approval

Provide information about what other people think about the behaviour. The information clarifies whether others will like, approve or disapprove of what the person is doing or will do

Let recruiters know clinical colleagues are on board and approve of the trial invitation Persuasion ExcludeAPEASE (effectiveness) existing practice

10.4. Social reward

Arrange verbal or non-verbal reward if and only if there has been effort and/or progress in performing the behaviour (includes ‘Positive reinforcement’)

Congratulate and praise recruiters for each day/week they invite all eligible women to participate in a trial (not just for numbers recruited). Potential mode of deliveryTwitter/email/card to acknowledge effort Incentivisation ExcludeAPEASE (effectiveness) existing practice

Gatekeeping

Recruiter’s report experiencing some logistical and/or active clinician gatekeeping at trial sites. Much to the frustration of some recruiters, there appears to be a number of eligible women that are denied the invitation to participate in a trial because of logistical or clinician gatekeeping. While some recruiters are sympathetic and make an allowance for gatekeeping behaviour, others seek to address it by escalating the issue to senior colleagues

Social Influences

Less salient domains:

Intentions

3.1. Social support (unspecified)

Advise on, arrange or provide social support (e.g. from friends, relatives, colleagues, buddies or staff or non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling, but only when it is directed at the behaviour

Advise recruiters to call a ‘buddy’ when they are struggling (due to gatekeeping) to invite all eligible women to the trial

Arrange for trial team to support recruiters with regular site visits

Enablement ExcludeAPEASE (effectiveness) existing practice

3.2. Social support (practical)

Advise on, arrange, or provide practical help (e.g. from friends, relatives, colleagues, ‘buddies’ or staff for performance of the behaviour

Set up an online peer support group for recruiters

Develop a trial recruiter network with regular meetings providing peer support

Encourage research culture with recruiters giving clinical colleagues regular updates on the progress of the trial and potential contribution it will make to the clinical field

Enablement ExcludeAPEASE (effectiveness) existing practice

6.2. Social comparison

Draw attention to others’ performance to allow comparison with the person’s own performance

Recruiters show clinical colleagues the proportion of women approached at their site compared to other sites (produce a visual representation like a thermometer chart, showing climbing numbers Persuasion

Exclude

APEASE (effectiveness) only helpful if number of women approached does in fact lead to more recruitment

6.3. Information about others’ approval

Provide information about what other people think about the behaviour. The information clarifies whether others will like, approve or disapprove of what the person is doing or will do

Tell recruiters that clinical colleagues approve of all eligible women being invited to participate in a trial

Hold MDT trial meetings to discuss trials in the clinical area

Persuasion ExcludeAPEASE (effectiveness) existing practice

10.4. Social reward

Arrange verbal or non-verbal reward if and only if there has been effort and/or progress in performing the behaviour (includes ‘Positive reinforcement’)

Congratulate each clinical area for referring women to the trial (numbers could be identified by doing an audit asking women if they had been invited to participate in a trial during their care episoderesults could be displayed in public area of hospital Incentivisation ExcludeAPEASE (effectiveness) existing practice

Recruitment targets

Recruitment targets set by the trial teams can be a driver for recruiters and encourages them to invite all eligible women to join a trial. Targets can also create competition between trial sites, which is generally well received as recruiters appreciate the opportunity to benchmark their recruitment performance. However, the element of competition serves as a disincentive for some recruiters as they feel under pressure to measure up to what they often consider as unachievable recruitment targets

Goals

Less salient domains:

Reinforcement

Emotion

Social influences

1.1. Goal setting (behaviour)

Set or agree on a goal defined in terms of the behaviour to be achieved

Collaborative goal setting (considering resources) encouraging recruiters to set an agreed daily/weekly goal of inviting all eligible women to participate in a trial. Emphasis on SMART goals

Discuss with site teams to set realistic targets

Enablement

Include

(emphasis on this has to be a collaborative effort, given that unrealistic goals etc. can serve as a disincentive)

1.3. Goal setting (outcome)

Set or agree on a goal defined in terms of a positive outcome of wanted behaviour

Set a weekly goal (e.g. x number of eligible women invited to trial) as an outcome of changed recruitment behaviours Enablement Include

1.5. Review behaviour goal(s)

Review behaviour goal(s) jointly with the person and consider modifying goal(s) or behaviour change strategy in light of achievement. This may lead to re-setting the same goal, a small change in that goal or setting a new goal instead of (or in addition to) the first, or no change

Collaboratively review how well a recruiter’s/site’s performance corresponds to the previously agreed goals (e.g. whether they invited all eligible women to trial). Modifying future goals to ensure that they remain realistic given environmental constraints and adjust as required

Review and feedback on screening logs

Regular review of targets (and active support of trial teams to achieve them)

Enablement ExcludeAPEASE (effectiveness) existing practice

1.6. Discrepancy between current behaviour and goal

Draw attention to discrepancies between a person’s current behaviour (in terms of the form, frequency, duration, or intensity of that behaviour) and the person’s previously set outcome goals, behavioural goals or action plans (goes beyond self-monitoring of behaviour)

Trial team to do an audit and feedback on previously agreed site goals and highlight any discrepancies. The findings could be reported to recruiters and followed up with offers of practical assistance from the trial team Coercion

Exclude—

APEASE (acceptability)

1.7. Review outcome goal(s)

Review outcome goal(s) jointly with the person and consider modifying goal(s) in light of achievement. This may lead to re-setting the same goal, a small change in that goal or setting a new goal instead of, or in addition to the first

Review how many eligible women were invited to participate in a trial and consider modifying the recruitment goal accordingly, e.g. by increasing or decreasing subsequent recruitment targets Enablement Include

aAACTT Action Actor Context Target Time