Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

Abstract

Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence‐generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial‐related practices to routinise trial‐related activities in Melbourne‐located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face‐to‐face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double‐blinded, placebo‐controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven‐step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre‐trial clinical site assessment, (2) optimising pre‐recruitment arrangements, (3) developing and updating trial‐related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial‐related collaboration, (6) addressing trial‐related financial issues, and (7) communicating trial results to clinicians.

Key Messages.

• clinical practice may generate evidence only if evidence‐generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings

• there is a paucity of literature published to date on routinisation of RCTs in wound care

• we developed a seven‐step Routinisation of Trials in Clinical Care Framework to optimise wound care outcomes

• the seven‐step framework includes pre‐trial clinical site assessment, pre‐recruitment arrangements, updating trial‐related skills, RCT recruitment as part of routine clinical care, teamwork and trial‐related collaboration, trial‐related financial issues, and communicating trial results to clinicians

1. INTRODUCTION

The need for evidence‐based practice in wound care in Australia was identified in 2010.1, 2 Evidence‐based practice in wound care optimises wound‐healing outcomes and is cost‐effective.3, 4 However, findings from the latest available studies indicate that more Australians who suffer with chronic wounds do not receive evidence‐based wound care, and there are considerable knowledge‐practice gaps in this field, which need to be addressed as a matter of priority.5, 6

The need improved for evidence translation7, 8, 9 and evidence generation6 requires a change in paradigm to ensure that the evidence cycle contributes to “evidence‐generating” practice.10 Technological advances and innovations in wound management have increased the demand for randomised controlled trials (RCTs).11 RCT recruitment issues are common,12 and there is little evidence to guide researchers about how to recruit effectively into RCTs in clinical practice.13 Clinical practice will generate evidence only if evidence‐generating research projects, such as RCTs, became routinised in clinical settings. Routinisation of RCTs in clinical practice was identified as the main priority in a recent UK‐based Prioritising Recruitment in Randomised Trials (the PRioRiTy) study that included 790 stakeholders, including principal investigators, researchers, funders, clinicians, nurses, and members of the public.13 One of the identified 10 top priority questions by participating stakeholders was How can randomised trials become part of routine care and best utilise current clinical care pathways? 13

RCTs are reported as the gold standard to provide rigorous evidence of clinical intervention effectiveness. However, poorly designed and conducted RCTs may lead researchers to inaccurate conclusions that do not provide the best evidence to inform clinical practice.14, 15 RCTs are particularly important in the field of venous leg ulcer (VLU) management, where there is minimal or no evidence of effectiveness of adjuvant treatments to compression therapy.16, 17 For example, the results of many systematic reviews18, 19, 20, 21, 22 conducted in the field of VLU management report that much of the evidence of effectiveness of adjuvant therapies is limited or inconclusive. The researchers who conducted these systematic reviews linked their conclusion to the lack of RCTs in wound care and low quality of the available RCTs included in their review. Low‐quality findings were related to small sample size because of inadequate recruitment rate and the loss to follow‐up, which increase the probability of making a type II error.23 In addition to reduced statistical power, inadequate and slow‐progressing recruitment may increase the duration of the RCT, incur additional costs, and lead to premature discontinuation of clinical trials.23, 24 The quality of RCTs could be improved by addressing recruitment‐related issues. A recent systematic review12 indicates that there are various barriers and enablers to participant recruitment in RCTs. Some of these barriers, including ethics‐related, practitioner‐related, and collaboration‐related barriers, could be dealt with25 if RCTs became part of routine care in wound clinics.

Publications on strategies to improve recruitment rates,26, 27 to retain participants in clinical research,27, 28, 29 and to facilitate researcher‐clinician collaboration30, 31 reported difficulties in combining clinical and research roles, where the main reasons were the lack of time, ethical concerns,32 and absence of leadership, particularly in the field of nursing.33 The discussed models of combining clinical and research activities in various health fields were collaboration, partnership, and integration.34, 35, 36, 37 However, the process of routinisation of RCTs in clinical practice has not been discussed as a holistic process and as a separate model, including in the field of wound management. In this article, we have developed the Routinisation of Trials Framework, analysing practical suggestions offered by clinical and research nurses from the Australian wound clinics.

2. METHODS

We conducted a qualitative observational study nested within a larger RCT—ASPirin in Venous Leg Ulcer healing (ASPiVLU) trial—which is investigating the efficacy and safety of a daily dose of 300 mg of aspirin as an adjunct to compression therapy to treat VLUs.38 Details on aims, objectives, and primary outcomes of the ASPiVLU trial are provided in Table 1.

Table 1.

ASPiVLU background

Aim	The aim of the ASPiVLU trial is to investigate the efficacy and safety of a daily dose of 300 mg of aspirin as an adjunct to compression therapy to treat venous leg ulcers.
Objectives	The primary objective is to determine whether daily aspirin (300 mg) as an adjunct to compression improves the time to healing of the target ulcer in a 12‐week treatment period.
	The secondary objective is to determine the effects of aspirin on ulcer recurrence, wound pain, quality of life and well‐being, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.
Primary outcomes	Primary outcome was to determine the time to healing of the target ulcer at 12 weeks after randomisation. Healing was defined as 100% epithelialisation.
Secondary outcomes	There were several secondary outcomes including ulcer recurrence, wound pain, quality of life and well‐being, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.
Inclusion criteria	Participants are eligible if: They are aged 18 years and older;
	Have one or more leg ulcers in the presence of chronic venous insufficiency (CVI) as confirmed by clinical assessment and/or duplex ultrasound;
	The target ulcer (largest ulcer if more than one) is separated from the other ulcers by at least 1 cm;
	The target ulcer has been present for at least 6 weeks or the patient has a prior history of venous ulceration;
	The target ulcer area is ≥1 to ≤20 cm2 as measured by digital planimetry techniques;
	Ankle brachial pressure index (ABPI) measure of ≥0.7 mm Hg or systolic toe pressure ≥50 mm Hg to exclude arterial insufficiency; and
	If the potential participant is capable of providing informed consent (as per clinicians' judgement).
Exclusion criteria	Participants are excluded if: They are currently using aspirin;
	Have aspirin intolerance;
	Have a contraindication to taking aspirin or to participating;
	In the trial (as per clinicians' judgement);
	Are concurrently using any other antiplatelet or anticoagulation therapy, or
	Are pregnant or breastfeeding;
Eligibility assessment	The wound clinic medical practitioner and/or wound clinic nurse assesses the eligibility of patients according to the inclusion and exclusion criteria.
	At the subsequent visit, the wound clinic or research nurse confirms eligibility, obtains consent, and performs the baseline assessment including: sociodemographic details (age, ethnicity, smoking status, and employment status), physical examination, medical history including current medication use, and target ulcer assessment (general features, wound size, and duration).
Randomisation and data capture	Patients were randomly assigned to either control or experimental group through an electronic data capture system (EDC).
	The results from the clinical trial were recorded in an electronic case report form (CRF).
Training	Pre‐trial workshop was conducted for potential recruiters with the aim to inform about the trial and develop trial‐related skills.
	As part of this workshop, ASPiVLU recruiters were also trained to use Samsung tablets to enter the data for the study.
Rewards to clinicians	Clinical consultants were paid per recruit.

The main aim of this qualitative study was to identify barriers and enablers to the ASPiVLU participant recruitment and included wound clinic nurses, research nurses, general practitioners, and wound clinic specialists from four clinical sites in Victoria, Australia. We used semi‐structured face‐to‐face and telephone interviews depending on the health professionals' preference and availability. The researcher invited participants to share their experiences of participant recruitment for the ASPiVLU study with a focus on recruitment barriers and enablers and to provide suggestions on how to optimise future recruitment success. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, focusing on enablers and suggestions provided by the participants.

2.1. Participants

We conducted interviews with wound clinic nurses (9), research nurses (4), wound clinic consultants (4), general practitioners (3) and research officers (2) who were involved with the recruitment to the ASPiVLU trial. The participant characteristics are presented in Table 2.

Table 2.

Participant characteristics

Occupation	Wound clinic nurses—9;
	Research nurses—4;
	Wound clinic consultants—4;
	General practitioners—3; and
	Research officers—2.
Gender	Male—3
	Female—19
Clinical site	Clinical site 1—1 participant
	Clinical site 2—7 participants
	Clinical site 3—8 participants
	Clinical site 4—3 participants
	Clinical sites 1‐3—1 participant
	Clinical sites 1‐4—2 participants
Period of work in this clinical site (years)	Mean—8 years
	Range—<1‐25 years
Frequency of work with people with venous leg ulcers	Weekly basis—14
	Daily basis—1
	2–3 days/week—5 N/A—2
Number of patients with venous leg ulcers per day	Mean number—8.5 patients
	Range—0‐20 patients
	N/A—2
Duration of recruitment for the ASPiVLU (years)	2 years—18 participants
	1 year—3 participants
	Less than 1 year—1 participant
Number of participants	Mean number—9 participants
Recruited/facilitated recruitment	Range—0‐36 participants N/A—1

2.2. Data collection

Data were collected from August 2017 until November 2017, during which time we conducted 22 interviews, including 10 face‐to‐face and 12 telephone interviews. Seven face‐to‐face interviews were conducted in a clinical setting, and three interviews were conducted in the [Name withdrawn for a review purpose] University offices. Interviews with health professionals were scheduled at convenient times for participants, during the lunch break or out of their scheduled working hours. The interview time ranged from 20 to 45 minutes, subject to health professionals' availability; the mean interview time was 35 minutes. Participants were offered a $50 gift card for their participation. All interviews were audio recorded, and the audio files were transcribed by professional transcriptionists employed by the authorised transcription services. The first author compared the transcripts with the voice files to ensure data quality.

2.3. Ethical considerations

This study was approved by the [removed for peer‐review purpose] Ethics Committee. The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki. After reading the information statement, the participants were encouraged to ask study‐related questions, which were answered by the researcher. The researcher also reminded the participants about the voluntary nature of participation, their withdrawal rights, and confidentiality issues. All potential participants either signed a consent form prior to the face‐to‐face interview or provided verbal agreement prior to the telephone interview, which was audio recorded. Participants' permission to audio record the interview was sought before commencing the interview.

2.4. Data analysis

The aim of our initial thematic analysis of data obtained from qualitative face‐to‐face interviews with clinicians and researchers was to identify barriers and enablers to recruitment for the ASPiVLU25. Findings from this analysis were used to develop the theoretical framework of factors—barriers and enablers—that influenced the recruitment process25.

To identify themes related to routinisation of trials in clinical care, we conducted an additional analysis of the available data, focusing mostly on enablers and suggestions discussed by the participants. Secondary analysis allows maximisation of the value of existing data to reduce costs related to data collection, to focus on policy or process‐related targeted analysis, and to reduce burdening over‐researched groups.39 However, this approach has two main limitations: available data were collected to address a different question, and researchers conducting secondary analysis may not be the researchers who collected primary‐source data and conducted primary analysis.40 In our case, the original question regarding the RCT‐related barriers, enablers, and suggestions for improvements in wound clinics is very relevant to the additional question of how RCTs could be routinised in the same settings. The researchers who conducted secondary analysis were the researchers who collected primary‐source data and conducted primary analysis. To ensure inter‐rater reliability,41 data was re‐analysed by two researchers (VT and CW).

Secondary analysis was conducted using NVivo 11 software for qualitative data management. We used a data‐driven approach, which is one of the two approaches for analysing existing data, when researchers decide what particular questions could be answered using the available data set.40 Grounded Theory was used as a method of data analysis as our goal was to develop a theory that explains the circumstances in which RCTs can be routinised in wound care settings and how and why clinicians and researchers contribute to this process. Grounded Theory42 comprises the process of examination of various concepts grounded in the collected qualitative data and is a method of qualitative data analysis.43 This method allows us to generate explanatory theories of basic social processes, including those related to health and health care.43

There are four key steps of the qualitative data analysis process, including 1) immersion in the data, 2) coding, 3) creating categories, and 4) the identification of themes.44 These four steps are not linear and require ongoing transitions between them in order to make sense of the whole data set.44 Given that we already had the NVivo data set with codes developed during primary data analysis, we developed RCTs routinisation‐related categories and identified relevant themes. Seven themes were identified, comprising the steps in the Routinisation of Trials in Clinical Care Framework (Figure 1). These steps include: 1) conducting pre‐trial assessment of clinical site, 2) optimising pre‐recruitment arrangements, 3) developing and updating trial‐related skills, 4) embedding RCT recruitment as part of routine clinical care, 5) promoting teamwork and trial‐related collaboration, 6) addressing trial‐related financial issues, and 7) communicating trial results to clinicians (Table 3).

Figure 1.

The Seven‐step Routinization of Trials in Clinical Care Framework

Table 3.

The routinization of RCTs in clinical care: themes and sub‐themes

Themes	Sub‐themes	No of participants identified an issue	No of references
Pre‐trial assessment of clinical site	Careful selection of the clinical trial site	12	21
	Pre‐trial screening	9	13
	Eliciting pre‐trial information on other studies run by the clinic	9	14
Pre‐recruitment arrangements	Routinisation of pre‐screening logs	12	29
	Planning recruitment‐related visits	10	17
Embedding recruitment as part of routine clinical care	RCT recruitment as part of a consultation	9	13
	Ensuring that all new patients were considered for RCTs	11	19
	Recruitment pathways	6	14
	Allocating time for information provision and recruitment	12	34
	Arranging physical environment	12	16
	Addressing gatekeeping issuesa	18	39
	Considering benefits of participation	4	7
	Preventing dropouts	4	5
Promoting teamwork and trial‐related collaboration	Promoting intra‐professional collaboration	14	26
	Promoting clinician‐researcher collaboration	19	76
	Promoting inter‐professional collaboration	6	11
Addressing trial‐related financial issues	Considering trial‐related upfront expenses	1	2
	Considering site‐specific policies on reporting gifts	2	2
	Considering incentives for recruiter and participants	11	23
Developing and updating trial‐related skills	Developing skills in the beginning of the project	16	26
	Organising regular updates	8	11
	Planning research training courses for clinicians	4	5
Communicating trial results to cliniciansb	Communicating preliminary findings	N/A	N/A
	Sharing published works	N/A	N/A

^aWe combined two sub‐themes, (1) do no harm and (2) prioritise clinical over research activities.

^bThis theme came up as a matter of regular conversations of the ASPiVLU project staff with clinicians that occurred during field work and their regular visits to clinical sites, but did not arise at the time of interviews.

3. RESULTS

3.1. Conducting pre‐trial assessment of clinical site

3.1.1. Careful selection of the clinical trial site

The need for careful selection of the clinical trial site was frequently discussed by participants, and various options were offered. The clinicians participating in this study discussed advantages and disadvantages of different trial recruitment sites.

I think in a wound clinic, where they specialise in wound care, I think that you're going to get your best information about how a daily aspirin helps wound healing, because you're using cutting edge technology for wound management. Whereas, in a GP clinic, they're fantastic, but… they don't do that all the time, every day, the whole time. They do all sorts of different things. And, so I think that the most ideal environment to recruit patients for a venous leg ulcer study would be a venous leg ulcer clinic, or a wound clinic where you know that all the treatments going to be top and the same. [P18]

I did District Nursing before. I very successfully recruited a lot of patients for different studies. So yeah, that's not a bad place to get some more patients. They only thing with District Nursing is that their patient group is elderly as well, about 65… So, you might run into the same problem with the District Nursing in terms of the comorbidities. But you know, you might—there's a lot of patients in the community with venous leg ulcers. [P15]

3.1.2. Pre‐trial screening

Pre‐trial screening has been identified as an important step in the routinisation of the clinical trial process. It allows us to realistically estimate the number of potential patients that could be recruited per site and per period of time and to consider their eligibility.

The realistic identification of the potential patients is a well‐known phenomenon. Every investigator thinks that they've got hundreds of potential patients but as soon as you put the study criteria on top of those patients, they just disappear… [P03]

Looking at the patient population before starting the study to see what proportion of patients would be able to be recruited I think probably would have been a useful thing to do. Or doing a pilot study or something like that. Yeah a pilot study or yeah, pre‐screen—like looking at the patient population coming through the clinics to determine how many of them are already on anticoagulation, how many would have been eligible to participate probably would have been a useful thing to do. [P05]

3.1.3. Pre‐trial information on other studies run by the clinical site

Pre‐trial information on other studies run by the clinical site is vital given that multiple trails in one clinical site might interfere with the dynamics of the clinical environment.

I think [consultant's name] wants another two studies to start… I think that would be really difficult to manage… I might try and make that quite clear, and I am all for research, don't get me wrong, but it really interferes with the dynamics of the clinic, when you've got two researchers from [one University], and two from [another University], and one from somewhere else. And, they all want to see the patients, and they all want to read the notes, and they all want to take up the patients' time… I definitely have an issue with that, and I think that can become a problem. [P12]

3.2. Optimising pre‐recruitment arrangements

3.2.1. Routinisation of pre‐screening logs

One of the common suggestions on how to facilitate and routinise recruitment was the routinisation of pre‐screening logs; as one of the study participants suggested, “always bear in mind” to check the logs to determine if any of the patients meet the eligibility criteria for the trials.

I suppose when we have a new patient coming to the clinic, we always bear the study in mind when we're looking at their medical history and doing their initial assessment. And, generally the first visit is done between a nurse and a doctor, of the assessment, and we would talk together maybe before the patient comes about them possibly being a candidate for the study. [P10]

In terms of on a week by week basis, I would definitely allocate probably at least half an hour to do a quick screening, and then if there's anyone of interest, then I'll do a bit more of a deep dive on those patients. It might be between half an hour and an hour and a half per week on a Monday, to see who might be eligible. And that's just general screening. [P04]

3.2.2. Planning recruitment‐related visits

Planning a recruitment‐related visit was one of the most common suggestions on how to improve recruitment. Clinicians said that they would usually set up their own and patients' priorities. On busy clinical days and if the first appointment was a bit overwhelming for the patient, clinicians said that they would usually consider extending information provision about the RCTs and potential recruitment to their next visit.

There might be a time where we're just short of time and we have to ask them to come back again in a week's time or in three or four days' time to continue with the recruitment. [P06]

Because so many things go on sometimes at the first appointment; and it can be very overwhelming for the patients because they're doing lots of tests and lots of new information's given out, they might say to them we might consider for you this for the trial. So then they come in and see us [next visit], they might say, “They're thinking about for me to go on a trial or I might see it in their previous record that at the last appointment they're considering having them put on the trial.” [P11]

3.2.3. Allowing time for the potential participants to make a decision

Allowing time for the potential participants to consider if they want to participate and setting extra time for questions during the next appointment was also helpful. Some clinicians said that they would usually book a double appointment, which allowed them to incorporate research‐related activities in busy clinical practice.

I'll give them an extensive explanation about what is the research for and through that, if they understand, I'll give them the paperwork, the consent form to read through. They will take it home to have a read first so they do not need to feel pressure to confirm it straight away or make a decision straight away. At [Teaching Hospital] I usually see them in a week's time… If they have any question in between, they can always call me. If not, we can discuss further at their next appointment… A quick medical screen will be done just by asking a few questions with the patient, make sure their understanding is established, they have good knowledge of what the study is all about, they have the right material to go home to have a read, have a think about it and they come back and let me know that their decision. [P06]

… At both of my wound clinics, we allocate 60 minutes to each consultation, so beside the usual wound care, we do have time to discuss about this. And we have the possibility to actually allocate a little bit more time if we need to, if we know that the initial recruitment process is going to take a while. So we do have the flexibility to change our appointment time from 60 to 90 minutes. Within the 60 minutes, we are able to ask the right questions and check the process if the patient has started it so, no, I haven't realised any problem with that. [P06]

3.3. Embedding RCT recruitment as part of routine clinical care

3.3.1. RCT recruitment as part of a consultation

Clinical and research nurses suggested that trial recruitment‐ and trial‐related activities should become part of routine clinical care. One of the participants, a clinical nurse, said that trial recruitment has already become part of a consultation process in their clinic.

We will basically start with the clinical care, but when you start with the clinical care, that's when you start prompting for [the trial‐related] questions. And sometimes, especially when the patients don't quite understand what they're saying yes to or what's asked of them [in relation to trial], you can help to simplify it and help them to understand it better. [P15]

In other clinics, recruitment‐ and trial‐related activities should become more organised and better planned; as one of the research nurses explained:

There are a lot of hoops to jump through to get to the participation in the study. I'm not sure if maybe it's because the way that we're getting people into the study is quite—I wouldn't say disorganised—but we kind of just pop into the rooms and talk to them while they're getting their dressings done. It might benefit more from actually having more of a set protocol where they get their dressings done; they see the podiatrist; they see the dietician; and then maybe get offered research after that as more of an official protocol because at the moment it seems a bit rushed, a little bit all over the place. [P02]

3.3.2. Ensuring that all new patients were considered for RCTs

Ensuring that all new patients were considered for the trials run by the clinical site was another important suggestion on how to routinise RCTs.

If we think this is a new person, I haven't met them before… I might say to the doctor, would they be appropriate for the study. And our doctor is involved in the study, so he will have a bit of an idea or he'll have an idea if he thinks yes or no. Or we could find one of the research nurses because they're at the clinic in the morning trying to recruit people. We can call them in and say, “Have you looked at this person?” because they may have already met them the weeks previously when they've come in and maybe seen one of the other nurses so then they can say, “We've already checked on them. They're not appropriate” [or] “We didn't know about this person.” And then they'll go through their history. Often they've already been through their history and they'll come in and have a talk with them if they think that the person might be appropriate or interested. [P11]

3.3.3. Recruitment pathways

We have identified two different pathways to participant recruitment: bottom‐up and top‐down. The bottom‐up pathway is when a clinical or a research nurse identifies the potential participant, assesses his or her eligibility, and asks the PI (either a GP or a Wound Consultant) to confirm the potential participant's eligibility. The top‐down pathway is when the PI identifies a potential participant and asks the research nurse to enrol him or her in the study. Utilising both recruitment pathways helped to ensure that all eligible patients were informed about the study and were considered for recruitment.

Usually, if I have a new patient come through, I'll investigate what sort of wound they have, how long they've had it and obviously the most important, look in their history to see if they're already taking any blood thinning medications. And if they're not and they seem to have a wound that might be appropriate [for the study], then I mention to the doctor when he comes around or to the research nurses and suggest for further investigations if this person's appropriate [for inclusion in the trial]… Sometimes, [PI] may have flagged them when he's seen them at their first appointment. [P11]

I think we have both models [bottom‐up and top‐down] in operation here but because we do have research staff here in the clinic and we only have a once a week clinic, they usually have gone through the patient's files, obviously respecting confidentiality to work out whether they'd be potentially suitable. They will alert me. I will then assess the patient, I'll say to the nurse, “Yes this patient could be suitable.” So it's kind of a joint system. But I think you're right, my experience with research is that when you leave it entirely to the doctor to identify patients, the doctor can be so busy with other issues, clinical issues and there might be other things going on at the time that patients might be missed. [P21]

3.3.4. Allocating time for information provision and recruitment

Allocating time for discussing trials with the patients in a busy clinical environment was found to be difficult, particularly in the absence of research nurses on site. In addition to time required for discussing the trial, extra time was required for trial‐related activities, such as photographing the wound, taking pathology, randomising, and arranging medicines. Knowing that recruitment and immediate post‐recruitment activities are time‐consuming, some clinicians booked a lengthier appointment for the potential participants if they planned to involve them in a study.

3.3.5. Arranging physical environment

A few clinicians considered the availability of a separate consulting room for recruitment purposes as an enabler, particularly on clinical sites, where recruitment was conducted by research nurses.

Afterwards, she [the research nurse] can take the patient—we only have four rooms, so if we're having to spend more time with a patient, not only does it take that time but it takes up a room as well that other patients been waiting to occupy. So she can then, whilst we finish our treatment, take them off to her office that's not a clinical room and have a chat with them about things as well. [P10]

However, there was a difference across sites, and in the absence of physical space for a recruitment process, the recruitment process became a bit problematic.

We don't have many consulting rooms; so it's hard for the researchers probably to have their own room to go through patients' histories and it's probably a bit hard if they just wanted to take the patient somewhere and have a bit of a talk to them outside. If they're waiting to come in and they just want to ask them a few questions, I don't think that they have a room that they could really take them to. I suppose a shortage of privacy due to the lack of consulting rooms is a problem… [P11]

3.3.6. Addressing gatekeeping issues

Gatekeeping issues and factors that may influence gatekeeping behaviour could be addressed as early as possible. For example, potential side effects of trial/routine medicines and exclusion criteria should be discussed and steps on how to conduct risk‐benefit assessment outlined. Potential controversies in disease management could also be discussed to avoid recruitment‐related misconceptions as discussed below:

So you add another medication. It is another potential to harm because you know that adherence of the medication drop, and the polypharmacy issue associated with it. So I agree that that is another consideration. Or if anyone has some reflux on the background, like how comfortable are the clinician to say, “I'm happy for this patient to be on aspirin”? And I guess that that is something to be considered as well. Again, it's the principle of first do no harm. And plus, at the moment, we don't know what's the efficacy or benefit of putting someone on aspirin for venous ulcer.” [P20]

3.3.7. Considering benefits of participation

Considering benefits of RCT participation for the patient motivated clinicians to inform their patients about RCTs.

Again if we have got something that will help the patient, why not? You put yourself [in their place] when you are sick and you're really suffering. For me, I'm losing my hair, I'm talking to you about—you know, and I want anyone, anyone in the world and I want anyone to tell me to try something, I will try, because I want to get my hair back and I can't. The same thing is with leg ulcers. I want someone to take me to heal this, so I will be able to dance, I'll be able to go out, I'll be able to enjoy my life again, so I don't know, this is something really—it's a bit critical because of its benefit to the patient. The patient is everything. For me the patient is everything. [P16]

3.3.8. Preventing dropouts

Supporting the study participants and considering a potential dropout on a case‐by‐case basis is vital. Although some dropouts could be inevitable, others could be easily prevented. For example, taxi vouchers were provided to participants who could not drive themselves and use public transport because of health‐related issues, and an appointment was booked at a more convenient time.

I did have one patient; and she lived a fair way out… And so, she became quite unreliable in the end; and we ended up giving her taxi vouchers in order for her to attend her appointments, so that we could finish the study off. So that was about $60 each way… The younger people might be taking time off work in order to attend appointments during business hours, and that could be a struggle. So maybe supporting the option of doing it after hours or some sort of [covering] transport cost for the patient might have some value for that group as well. [P04]

3.4. Promoting teamwork and trial‐related collaboration

3.4.1. Promoting intra‐professional collaboration

Promoting teamwork and trial‐related collaboration, both intra‐ and inter‐professionally, as early as possible was a common suggestion. Effective principal investigator‐clinical nurse communication and collaboration start during the clinical trial planning process. Teamwork would be optimal if the trial‐related activities and roles were discussed as early as possible.

When you were talking about enablers before, I just thought then, when a study is initiated, and it's discussed with an investigator at a site, I think it would be really good, if possible, if the investigator also discusses it and has involved the unit manager as well; in this instance, of the wound clinic, to see just how… I know they talk about it later, but to actually have someone assigned and say, “If I take on this study, will you be willing—can we give you part of your day in a clinic, we'll give you half‐an‐hour or something where you're assigned to do research for me?” And they come up with an agreement before the study comes through and then they go, “Who's doing this?” and it just goes to the head of the unit who is full‐on and has maybe a little bit of inclusion or can you include one of the staff member in the study if there was something they might be interested in research and offer them the ability to maybe get a bit of research experience. [P01]

Teamwork and mutual support were discussed as invaluable in a busy clinical environment, where a few RCTs were conducted, particularly when clinical nurses were combining clinical and research activities.

I think a lot of time when there's a recruitment happening, if I'm aware that it's going to take a long time, I usually will try to continue with it. Then if it's affecting my next patient's appointment, if my next patient might be waiting for me, I might have to get another consultant to assist me with it, so that I can continue to proceed with the recruitment. [P06]

3.4.2. Promoting clinician‐researcher collaboration

Planning clinician‐researcher collaboration and introducing research staff to clinical staff members has facilitated better teamwork.

I think we're very familiar with the [research nurses] now, and they work well with us, and we work well with them, and I think we all work—they're almost working as part of our team. But, I think it's at that initial stage, we need to know what they're here for, what they're looking for, what's going on, which is what we do know now. But, at the start, I don't think we did. But, as I said, it's changing, I think now we've made a point of saying, "Well, we need to know what's going on with these studies. Who's coming? Why are they coming? What are they doing?" Whereas, we'd have never got that at the start, but now we know what's going on. [P12]

Availability of project nurses on site and clinical‐research staff collaboration were considered important factors by all participants in our study. The discussed benefits were reduced workload, support in the beginning of the trial, reminders about the trial, completing trial‐related documentation, and interaction with patients, all of which have contributed to the smoother running of RCTs.

Having [the project nurses] here makes an enormous difference because they can come, look at the histories and say: “This is a potential.” Then they can come in, talk to the patient, give them the instruction sheet and that improves the whole ability to attract people on the studies. I remember I was doing a study; and I was getting nowhere and then we put someone on and all of a sudden we started enrolling patients purely because there was someone there that was doing nothing else, but looking at potential patients. When you've got so many other things on your brain, your mind, that's not the first thing on your mind. [P19]

Honestly, it would be difficult for us working without them [project nurses]. As I said, they're lovely people; they cooperate with us; they even help us, honestly. If the patient is going through the project or the trial, and I am already doing something; and I will go and get the dressing material; they wouldn't leave the patients by themselves. They talk to the patient, so the patient doesn't feel lonely. Always interacting feels interesting to people, so it's good. [P16]

I mean it's been very helpful having the assistance of [the project nurses]. So, that's certainly been an advantage… it's certainly helpful in terms of the workload of the staff to have their assistance with the recruitment and the documentation. [P09]

3.4.3. Promoting inter‐professional collaboration

Inter‐professional collaboration with other sectors, including pathology and pharmacy, has helped to ensure faster RCT‐related procedures.

Very often there's an arrangement with pathology, whether it's a formalised relationship or an informal relationship, to take the blood sample. We don't seem to have had any problems with that. [P03]

And it was also a bit tricky because pharmacy were, involved but they weren't on the online system. So when I would randomise them and then I'd have to send a copy of the randomization to pharmacy via email and then they'd release the medication for that patient. Which was really good, but it was a bit of a challenge in making sure that it happens really fast so that the patient wasn't delayed going home, because we didn't want them to have to hang around for two hours to wait to get their medications. We needed to make sure that that happened quite promptly. [P04]

3.5. Addressing trial‐related financial issues

3.5.1. Considering trial‐related upfront expenses

Trial‐related financial issues, including upfront payment for setting up pharmacy accounts for the participants and financial disadvantages related to the participants' dropout rate, came up only in one of our interviews with a nurse manager:

And the other process issue was probably around liaising with pharmacy. So the way we do things at [this health care setting] is any kind of medications, pharmacy manages that process. So we have to pay a setup fee for pharmacy, and it's about $600. I mean it's only $50 a year to maintain but if you only recruit one patient, that's $650. If you recruit 35 patients, its $600 plus the $50 fee. It's a big upfront expense. So often what we were doing is we were paying for that out of our operating cost centre and then when those two patients were completed, we get a completion fee, but we still have the bear all the upfront costs at the beginning. So my manager was very supportive of that, there was no questions about it but I guess the point is, if the two patients hadn't completed their 24 weeks because they couldn't or they were ‘lost to follow up’, we wouldn't have got the completion fee but we would have still bore the cost of setting up for the research. So probably that was the other side of it. Yeah, so probably that's the main things. [P04]

3.5.2. Considering site‐specific policies on reporting gifts

Considering site‐specific policies on reporting gifts prior to offering incentives for recruitment or completion of study‐related procedures was suggested by one of the project nurses.

We've tried offering incentives for recruitment. This is because we felt that the investigator got the money but the nurses didn't necessarily see it and could feel that their work wasn't valued. So we decided that we would try giving them a gift card as part of the process of saying thank you. We've had negative responses from a couple of sites to that. One site has said, “We don't want the gift card,” and another site, the feedback that I got is, “Please don't send me another gift card. It was more trouble than it's worth.” [P03]

3.5.3. Considering incentives for recruiters

Some of the clinical nurses said that financial incentives would make no difference because most clinicians are willing to contribute to RCTs given that patients meet the recruitment criteria.

Some of the nurses told me about six months ago there was, or maybe 12 months ago, they were offered a voucher, like a voucher forI don't know, if they recruited patients I guess there's a reward. And I know that that didn't make a lot of difference because the issue wasn't people finding patients, the issue was patients being eligible and appropriate. So yeah, so I know that made no difference really to people's recruiting because I think it was more the appropriateness of the patients rather the willingness of the teams to participate. [P05]

3.5.4. Considering incentives for participants

Small incentives for patients for participating in RCTs were found to be helpful in facilitating recruitment and retaining.

As part of the study, there was a compression stocking available. I would definitely include an incentive like that, if I was going to start the study again, or possibly even increase the incentive, particularly if you were going to target a community group. So, give them a reason to actually become involved by offering them that extra, either extra visits, or extra equipment or wound dressings that might improve the recruitment. [P14]

I suppose the only thing is to advertise and then you can give them free dressings because they all complain about the price of dressings. Dressings is probably the one thing that will always get them to accept going in the trial, and I think at the moment they do get a pair of compression socks, so they get that. But when they're offered that, they actually haven't had to buy them and they don't realise how expensive they are, so it's almost like that comes later and then they go, “That's great, I didn't have to buy them.” [P17]

3.6. Developing and updating trial‐related skills

3.6.1. Developing and updating trial‐related skills

The importance of RCT‐related training and developing and updating trial‐related skills of clinicians involved in the project were discussed by all participants:

The training was good… I think it was fairly comprehensive. Like with most studies, and we participate in a few, it's a case of until you're actually doing the work, I don't believe you encounter the potential bits you've missed in the education. And I've always found that any query we asked about was always answered really promptly. But as an overall, the education was spot on. There was nothing missed. But, as I said, I had gaps between when I would be with one recruit to the next. And it could well just have been that I had lost track of exactly what I had to do. [P07]

Regular updates of trial‐related skills, or how the participants called them, “refreshers,” were essential, in addition to additional training sessions for new staff members who did not attend the initial training session for the RCTs run by the clinical site. These updates are equally important for clinicians who undertook the initial training but lost some of their skills because of insufficient/slow recruitment as a result of the lack of eligible participants.

I didn't really take on any training. I got showed through the recruitment. We had a sheet that we could look at saying the people that might be appropriate. We also get told when a new study's generally coming and what sort of things that they're looking for. And then because I'm in the room when they're recruiting, you get a bit of an idea what sort of questions they're asking and what sort of criteria they're looking for but no official training. [P11]

Maybe having refreshers on training for the staff involved in the study. I know that the staff members when this study started up, they all seem very interested—this is what I've heard from other staff members—but they all seemed very interested in being involved in the study and yes, yes, yes, we'll do this, but I think you need to have updates every year otherwise you lose a bit of that momentum and enthusiasm. Now, half the staff in the clinic don't really know anything about what the study is about because they've either forgotten or new staff have come into the clinic that weren't there for the original training. [P02]

3.6.2. Planning research training courses for clinicians

There were suggestions on raising nurses' awareness about the importance of evidence‐based practice and promoting their education and training, which would help to divert them from experience‐based practice to evidence‐based practice and eventually facilitate the routinisation of RCTs in clinical practice. Involvement of clinical nurses in RCTs as part of their postgraduate studies was one of the suggestions on how to increase nurses’ understanding of the nature and the importance of RCTs and their willingness to collaborate, which is essential in the routinisation of RCTs into clinical practice.

Many of them have never been directly involved in research. Research is a very specific area. Those of us who have been involved—you know, like a research profile like this—they're uncertain at times because they don't necessarily fully understand what research is all about. They understand that it's there but depending on the level, because we have both enrolled nurses and registered nurses. The enrolled nurse has done maybe 18 months, the registered nurse four years, so there's great difference in the general knowledge level. That certainly is an issue I think, but the more advanced ones, particularly the ones that have done postgrad work, then research has had to be part of their postgraduate studies. [P19]

3.7. Communicating trial results to clinicians

Communicating trial results theme came up as an ordinary conversation of the ASPiVLU project staff with clinicians during their regular visits to clinical sites, but did not arise at the time of interviews. All clinicians expressed their ongoing interest in the preliminary results of both studies the ASPiVLU RCT and the nested study on recruitment barriers and enables. They also expressed their interest to read published works based on findings from both projects.

4. DISCUSSION

The aim of this study was to identify and discuss best trial‐related practices that allowed us to routinise trial‐related activities in some clinical sites as reported by clinicians and researchers at the time of face‐to‐face and telephone interviews.

4.1. Pre‐trial assessment of clinical site

Pre‐trial visits to and assessment of the clinical site was identified as one of the major themes in our study. Clinical nurses and principal investigators compared and discussed advantages and disadvantages of various study sites, including the wound clinics, general practices, and the Royal District Nursing Service, and their potential for recruitment. Most of them agreed that wound clinics were the most appropriate site for selecting participants for ASPiVLU. Careful selection of the clinical site is frequently recommended and could be achieved through a feasibility study, which requires early site visits. During such visits, the researchers (a) assess site recruitment potential, including the numbers of eligible patients, their willingness to participate and to be randomised, clinicians' willingness to recruit, and time required for data collection, and (b) establish collaboration with clinicians and assess their training needs.45 In our study, some clinical nurses particularly suggested checking how many other trials and other studies are running in a clinical site or were planned to run. They stated that multiple concurrent trials may interfere with clinical work and reduce the recruitment rate. These and other points for pre‐trial assessment are usually included in the site assessment/feasibility checklist.46 Although there are limited publications on feasibility studies in wound care,47, 48, 49 there is no checklist developed for site assessment to date.

4.2. Pre‐recruitment arrangements

Routinising pre‐screening of eligible patients in order to increase enrolment in RCTs was one of the suggestions to increase the recruitment rate and routinise RCTs in clinical care.50, 51 The research and clinical nurses in our study said that they would routinely perform pre‐screening of patients' logs prior to the clinic. Routinised pre‐screening of patients' logs also allows better planning of the next appointment, for example, booking a longer appointment for patients who were pre‐selected for the RCT. This approach was found to be helpful in reducing the waiting time of the next patient and stabilising a busy clinical environment.

One study reported that the pre‐screening rate among clinical research assistants in their study was 29% and principal investigators 13%.50 The researchers highlighted that pre‐screening of eligible patients could be performed prospectively and retrospectively, and practicing both approaches helped to ensure that no eligible patients were missed. Some large centres use semi‐automated pre‐selection, which was found to be effective.50 There is evidence that the regular use of screening logs would optimise the recruitment.51

4.3. Developing and updating trial‐related skills

The findings of our study indicate that clinicians were satisfied with trial‐specific training at the beginning of the project. However, they said that refreshers during the course of recruitment could have been helpful. Clinicians' insufficient trial‐related skills were frequently reported as a barrier to recruitment.12 Clinicians' training, particularly related to recruitment and retention of participants, was reported as one of the potential strategies to improve the recruitment rate.52, 53, 54 However, the evidence that clinicians' generic and trial‐specific training increases recruitment rates is limited as there is only a systematic review of training programmes for recruiters of RCTs.55 Latest studies suggest that appropriate training and support have the potential to facilitate recruitment even to more complex RCTs.51 Pre‐trial training may, in part, address the urgent need for improvements in the education and training of clinicians to increase the uptake of evidence‐based practice in wound care in Australia.6

4.4. Embedding recruitment as part of routine clinical care

Routinisation of RCTs in clinical care may become possible if the RCT recruitment consultation becomes part of clinical consultation.56 Prolonged consultation time, clinical workload reduction, and reserving some time for trial‐related consultation were found to be beneficial.53, 57 However, the evidence of the effectiveness of interventions to increase or decrease the length of consultation, as reported in the recent systematic review, is still limited.58 A new six‐step model was developed to improve the recruitment practice in clinical settings, embedding it in a clinical consultation.59 The main steps of this model are as follows: (a) explain the condition, (b) reassure patients about receiving treatment, (c) clarify uncertainty, (d) explain the study purpose, (e) give a balanced view of treatments, and (f) explain study procedures.59

In our study, clinicians said that regular allocation of time for trial‐related information provision to their patients was found to be helpful in this process. However, this was not always possible in a busy practice, and some eligible patients may not have been informed. However, regular retrospective screening logs would ensure that all new patients were informed, as we have already discussed. Research nurses were focused more on setting up the physical environment where they were able to provide trial‐related information to the potential participants, ensuring privacy. This was of concern in some busy clinical sites, where all consulting rooms were occupied by clinicians, and sometimes, research nurses/assistants did not have a separate room to run the RCT recruitment consultation.

Although RCTs are designed to produce quality evidence about the safety and efficacy of interventions, often, there is uncertainty about the risks and benefits of a study population of trial participants compared with standard interventions.60 This becomes a concern when a clinician who provides care is also a trial investigator who recruits for the trial and assesses the safety and efficacy of the trialled intervention.60 Clinical and research roles are frequently considered conflicting, and health professionals would usually prioritise their clinical role.61 Gatekeeping was defined as “the process by which physicians choose not to participate in a clinical study, or not to recruit individual patients who would otherwise be eligible to participate in clinical research studies”.61 ^{, p.100} Findings from a recent systematic review62 indicate that health professionals' assumption of patient vulnerability and their focus on clinical role and the duty to protect patients were the main reasons for gatekeeping, particularly if clinical trials were perceived as treat and their benefits for patients were overlooked.62 Some researchers suggest that clinicians informed their patients selectively and did not necessarily approach all eligible patients, making their decisions based on various other factors derived from their long‐standing relationships with their patients.61 The effects of gatekeeping on patients' outcomes, however, were under‐researched.63

Clinical trials are an important option of care in wound management as they often provide the most up‐to‐date and effective treatment for various wounds, and participants should not be limited to this option. Nevertheless, patient enrolment in RCTs in wound clinics remains particularly low because of diverse wound aetiologies, multiple patient comorbidities, the plethora of management approaches, wide‐ranging outcome measures,12, 15 and the lack of patients' involvement in decision‐making6 given that patients lack an understanding of the processes of both wound healing and the study design. Shared decision‐making on participation in clinical trials is desirable.64 However, the evidence of effectiveness of individual interventions focused on improving shared decision‐making is limited.65

Considering patients' benefits of participation in a clinical trial was found to be an enabler to patient recruitment in our study. Findings from a qualitative study conducted by Gullemin and coauthors61 also suggest that physicians made recruitment decisions based on their assessment of patients' benefits of participation among other factors. Another gatekeeping‐related factor was individual clinician's perception that adding additional medicine, aspirin, to patients who already receive various other medicines would reduce their compliance given that the latest evidence suggests that polypharmacy would reduce patients' compliance with the treatment regimen. Early identification and addressing clinicians' concerns related to patients' risks and benefits of trial participation would help to ensure smooth running of the trial.

4.5. Importance of teamwork and trial‐related collaboration

The benefits of teamwork in running RCTs were previously acknowledged, particularly the potential to increase the recruitment rate.66 One of the practical suggestions on how to improve teamwork was to view different team members' professional expertise, opinions, and expectations as complementary and not as controversial and conflicting.67 In our study, effective teamwork was identified as one of the factors that improved recruitment rate. In addition, teamwork has allowed incorporation of immediate post‐recruitment activities in a busy clinical practice in the absence of research nurses on site. These activities included measuring the size of the wound and photographing it, taking blood samples, completing trial‐related paperwork, and entering patients' details in the electronic case report system.

Collaboration on individual and institutional levels and creating clinical‐research partnerships were described as a key to successful clinical research.67, 68, 69, 70 In this article, we have discussed the importance of the trial‐related clinician‐researcher collaborations and their collaboration with the staff members from other departments involved in clinical trial, such as pathology and pharmacy. Clinician‐researcher collaboration fosters research expertise with clinical leadership. The benefits of clinician‐researcher collaboration includes improved estimation of the size of the population of interest and recruitment rate, selection of the outcome measures, and prediction of acceptability of RCTs in a clinical setting.71 Moreover, improved clinician‐researcher collaboration would help to address the disparity between ideal RCT evidence and real‐world clinical evidence.11 In our study, many clinicians said that they viewed research nurses as part of their team and acknowledged that the availability of research nurses on site has improved recruitment rate and reduced their workload. They also said that effective clinician‐researcher communication and collaboration in some clinical sites ensured that all patients who were eligible to participate in the ASPiVLU were well informed about this trial, their eligibility being assessed before they were invited to participate.

Development of clinical‐research partnerships is a longstanding tradition between the academic and clinical settings, also related to undergraduate and postgraduate teaching and research.72 This topic came up as a sub‐theme related to training and skill development of clinicians involved in the ASPiVLU. Consultants who we have interviewed proposed that, in order to embed RCTs in clinical practice, clinical nurses involved in RCTs could be concurrently enrolled in postgraduate studies and perform their RCTs‐related activities as part of their degree project.

4.6. Addressing trial‐related financial issues

Financial management of large multi‐site clinical trials is complex, and various cost reimbursement issues may arise.73 As our nested study has confirmed, there were no major financial issues reported except an issue by a nurse manager from one ASPiVLU site with regards to difficulties related to the upfront payment for setting up pharmacy accounts for the participants and related financial disadvantages because of the participants' dropout rate. Representation of financial managers from clinical sites in the trial committee would be able to address this issue and simplify budgeting and transactions, including predictable upfront payments.73 Other minor issues discussed by participants included financial incentives to clinicians and patients.

Financial incentives are frequently provided to clinicians recruiting to RCTs to compensate their time, which is deemed acceptable, and increase their interest in recruitment.53, 74, 75 However, it is unclear whether financial incentives increase the recruitment rate and represent an efficient use of project resources.74 It is also unclear if financial incentives to clinicians per recruited person would be a better approach than to use a clinical research assistant to facilitate recruitment.74 Financial incentives to physicians for patient recruitment were also criticised on an ethical basis.53 In our study, the interviewed clinicians said that financial incentives were not important, and they were willing to recruit because of their interest in the research topic and focus on the patients' benefits of participation. They also acknowledged that provided financial benefits may not influence the recruitment rate, particularly because of the lack of eligible patients, and refused to accept the gift cards as a result of complicated procedures on reporting gifts in some sites. Given that clinicians' involvement in RCTs could be considered one of their clinical roles, the eligible clinicians could be reimbursed through a central research reimbursement scheme at their site.

Financial incentives in the form of financial rewards on completion or paid participation provided to the potential participants tended to improve the recruitment rate.76 In our study, provision of compression stockings to participants once they had healed was considered a compensation of the costs participants would have incurred if they have purchased their own compression stockings. Similarly, provision of taxi vouchers for trial‐related appointments for the participants who were unable to drive was acknowledged by clinicians as an appropriate and a fair way to compensate the participants given that some elderly people are financially disadvantaged.77 Financial incentives to clinicians and participants are usually planned in the beginning of the study, and researcher‐clinician communication would be an effective way to finalise the researchers' decision on their use.

4.7. Communicating trial results to clinicians

Findings of clinical trials are usually published in peer‐reviewed journals, included in the training workshops, and presented at conferences for health professionals. However, not all health professionals from a particular clinical site would have an opportunity to attend these training sessions and conferences and to locate the published works. Based on the clinicians' repeated inquiries regarding the findings from the RCT and the nested qualitative study, we plan to provide, at the end of the project, short meetings in all clinical sites to discuss the main findings and distribute access to the study publications. This is not a novel approach to keep clinicians up to date with the latest available evidence in wound care. However, timely communication of trial results to clinicians has the potential to translate the latest evidence into their practice6, 78 given that knowledge of the best evidence is the first step in the implementation process.79

4.8. Limitations and suggestions for future research

One of the limitations of our qualitative study is that we conducted a secondary analysis of the data that were collected with the aim to identify barriers and enablers to participant recruitment in an RCT on wound management. Our project did not focus directly on routinisation or RCTs in clinical practice. However, addressing barriers and focusing on enablers of RCTs in clinical care have the potential to facilitate routinisation.

We limited our discussion to the trials at the wound management clinical sites that were included in our study. These suggestions to routinise trials in clinical care may be a useful guide to other researchers who plan to undertake RCTs. This is a new field of inquiry,13 and further research on evidence of the effectiveness of the individual approaches on routinising trials in wound care is warranted to add to this preliminary research. The need for international collaboration on evidence generation in wound care research and other health research is needed.80, 81 The RCT routinisation framework validated in wound care settings would be a valuable guide for international researchers to maximise future research efforts in this field.

Finally, this article is written from researchers' and clinicians' perspective, and thus, the patients' perspective about routinisation of trials in wound care would need to be considered to ensure consumer involvement in wound care research.6 Traditionally, consumers are not aware of the benefits of evidence‐based practice, including wound care, and do not actively seek this practice or lobby governments to generate evidence and adopt this practice.6

5. CONCLUSION

Routinisation of RCTs in clinical practice is a unique priority area within the RCT methodology. However, no evidence is available to guide this process.13 Following the recent calls for knowledge and evidence generation in health care,82 and in wound care6 in particular, we contribute to the scarce literature published to date on the routinisation of RCTs in wound care. Focus on routinizing clinical trials as part of clinical care has the capacity to optimise wound‐healing outcomes. By optimising communication between clinicians, researchers, and patients, we are more likely to address key recruitment barriers and facilitate greater public involvement in the research process.

CONFLICTS OF INTERESTS

The authors have no conflict of interest to declare.

Author contributions

All persons designated as authors qualify for authorship. Each author has participated sufficiently in the work to take public responsibility for the content.

Team V, Weller CD. Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal. Int Wound J. 2019;16:442–458. 10.1111/iwj.13053