Traditional medical practice has been for clinical research specialists to study an issue and the evidence around it, determine the best practices to reach the desired medical outcome and make recommendations, which are published in journals, for practitioners in the field to follow. However, it is estimated that more than 7000 primary care journal articles are published monthly and that it would take a clinician over 625 hours per month to evaluate these articles (Alper et al, 2004).
MIT professor Edgar H Schein (2013) calls this the ‘culture of do and tell’. Best practice guidance ‘is nothing if it is not used’ (Patton, 1997), a statement that is reinforced by the many examples of evidence-based medical practice changes that fail to be implemented and therefore do not result in improved patient outcomes (Grol et al, 2005). Evidence suggests involving clinicians in the development of an innovation or proposal of change promotes implementation (Grol et al, 2005).
This research was designed to determine if a more collaborative approach to developing best practice guidelines for stoma care nurses would lead to faster acceptance and implementation and, ultimately, better patient outcomes. The study involved large numbers of nurses directly in the guidelines' development and in the dissemination of this information to speed up acceptance and implementation of the best practices.
According to Ostomy UK, more than 102 000 people in the UK have a stoma. Estimates of the global population of people living with a stoma range from 1 million to 2.5 million. Various studies have reported that as many as 76% of people with a stoma experience leakages (Porrett et al, 2011; Claessens et al, 2015; Maydick-Youngberg, 2017) and that this results in a loss of confidence in their stoma and a significantly decreased quality of life (Richbourg et al, 2007; Welser et al, 2009; Erwin-Toth et al, 2012; Colwell et al, 2017; Maydick-Youngberg, 2017). When surveyed, more than 75% of stoma care nurses reported that they sometimes or often encounter patients who have reduced their participation in hobbies, socialisation, leisure and physical activities because of their stoma, and almost 40% of nurse respondents reported having stoma patients who do not leave their homes because of their worry about leakages (based on Delphi surveys carried out during stages 2 and 3 of this project). Evidence shows that, with the right treatment and appliance, patients can resume their normal activities with confidence, but clinical practice guidelines for product selection are lacking (Hoeflok et al, 2017).
This project created a global consensus on medical practice guidelines between close to 2000 stoma care nurses, which is designed to significantly increase the quality of life of people with a stoma by using appliances that match their body profile to ensure the best fit and confidence.
Methods
A modified Delphi process was used for this project, which combined the scientific rigour of the traditional Delphi and RAND Nominal Group Technique (NGT-R), with virtual and face-to-face professionally facilitated dialogues. The methodology was designed by an International Association of Facilitators-certified professional facilitator, who had received specialised training in evaluative sciences.
The modified Delphi process included elements of traditional Delphi survey methodology (Dalkey and Helmer, 1963), NGT-R (Murphy et al, 1998) and process facilitation (Schuman, 2001). The hermeneutic approach used in this study included both the top-down and bottom-up approaches recommended in Grol et al's (2005) theory of change.
Stage 1 of the process started with a group of international stoma care nurse experts gathering for a combined face-to-face and virtual meeting to determine the study questions and objectives and to approve the overall study methodology and design. This included an advisory group, who led the research study, and an expert panel, who provided expert advice throughout the research process (Table 1).
| Advisory group | Canada (facilitator) Denmark (two members, one from Coloplast), Germany, UK, USA |
| Expert panel | Australia, Belgium, Canada (two), Czechia, Denmark, France (two), Germany, UK (two), USA |
A detailed literature review was conducted, which was reviewed by the advisory group and expert panel members at the beginning of and periodically throughout the research process, using the Stetler model of research utilisation (Stetler, 2001). An independent facilitator led all group dialogues, using structured group-facilitation processes to ensure outcome-based and balanced conversations were conducted, where all group members had an equal say in the decision-making and where all ideas were heard and thoughtfully considered. The advisory group continued interactions through a series of virtual dialogues that occurred at each stage of the research process. Through these discussions, they informed the Delphi survey process by contributing to question design, determining survey dissemination methods and interpreting results. The expert panel was consulted at stages 1, 4 and 5 of the process.
In Stage 2, the first Delphi survey was created and sent out in 11 languages to stoma care nurses around the world, via regional and nursing-association mailing lists. Survey responses were anonymous, which allowed respondents to be confident in sharing their experience and expertise without being concerned tat they would be identified.
The first Delphi survey collected information that included: each respondent's experience as a stoma care nurse; the factors they considered in assessing patients; if and how they assessed stoma patients' quality of life; assessment tools they regularly used; the most common issues and complications they saw with their stoma patients; how often they saw patients; how they educated stoma patients; and their opinions about optimal best practices in stoma care. In total, 926 responses were received from nurses, who provided specialised stoma care in 11 languages. Responses from clinicians who were not nurses or did not provide specialised stoma care were not included in the results or analysis. Another series of virtual dialogues were conducted with the advisory group to analyse the results of the first survey and develop a follow-up survey.
For stage 3, the second Delphi survey was disseminated in the same manner as the first survey. The second survey, built on the responses from the first survey, was used to confirm the results of the first and solicit the opinion of respondents on specific best practices in stoma care. The second survey was answered by 285 stoma care nurses in 10 languages. Since all surveys were anonymous, researchers were unable to track whether respondents to the second survey had also completed the first survey. Language preference cannot be linked to country of origin, as invitations included links to the survey in all languages, so respondents could choose their language regardless of where they lived.
In stage 4, the results were analysed by the advisory group in a second series of virtual dialogues, and a third survey was developed. The third Delphi survey was sent to the advisory group and the international expert panel. Sixteen personalised survey invitations were sent and 14 responses were received. The questions in the third survey focused on the practice guidance that had emerged from the earlier surveys and facilitated dialogues, narrowed the consensus and tested it against the literature.
Then, for stage 5, all the survey results were summarised and presented to the advisory group and expert panel at a 1-day face-to-face workshop run by the independent facilitator. The group analysed the consensus process results and refined the wording into best practice guidelines for stoma care nurses designed to ensure optimal quality of life for their patients. The resulting guidelines, the Consensus guidelines—standardising peristomal body profile assessment to enable quick and individualised solutions to improve quality of life, include best practices regarding: frequency of contact with patients; how to assess patients' body profile; the use of validated assessment tools; and how to engage and educate patients and encourage them to be proactive partners in their own care (Figure 2).
The final step in the process—stage 6—was conducted at Ostomy Days 2018 in Copenhagen, where 960 stoma care nurses were presented with and endorsed the best practice guidelines and then engaged in a facilitated dialogue on how to speed acceptance and implementation of the guidelines around the world. An interview matrix facilitation process was used, where every nurse present answered four questions (Box 1), in the language of their choice, in a series of one-to-one and many-to-many conversations. The themes of the conversations were summarised and documented by participants in their language groups then translated and thematically grouped by the facilitators. The results were then presented back to the participants at the close of the Ostomy Days congress and were later provided in writing to participants by the congress organisers.
Participants
More than 2000 nurses were involved in the consensus building process, covering 20 countries and 16 languages (Table 2), with a combined experience of over 16 million hours of specialised stoma care. An estimated 1200 nurses answered one or more of the Delphi surveys and more than 960 were involved in one or more face-to-face dialogues. Respondents were experienced stoma care nursing professionals, with 75% having more than 10 years of full-time stoma care experience (Figure 3).
| Survey 1 (n=926) | Survey 2 (n=285) | Ostomy Days dialogue (n=960) |
|---|---|---|
| English |
Dutch |
Italian |
Ethical considerations
Institutional review board approval was provided without qualifiers by Asentral IRB.
All surveys were 100% anonymous, with no way for survey responses to be linked to respondents. The demographic information collected focused solely on clinical credentials and type of clinical practice. No individual patient information was collected. The resulting guidelines do not refer to or recommend any products or brands, but instead focus on how to assess patients, identify their body profile requirements and determine the type of product best suited for that patient to provide the highest level of confidence.
Results
The results exceeded the expectations of the advisory group, who reached 100% agreement on the outcomes and reported that the large-scale collaborative process was effective and produced sound, evidence-informed best practice guidelines. All members of the expert panel endorsed the resulting guidelines as well. Participant evaluations at the end of the Ostomy Days congress assessed participants' overall satisfaction with the project process and the results. Participants rated the process and the results very highly, with a mean score of 8.8 on a scale of 1–10, with 10 being the highest satisfaction rating.
Results of the Delphi surveys also indicated that nurse respondents understood the need for best practice guidance focused on increasing patient outcomes and quality of life. Of respondents, 95% agreed that it was part of the stoma care nurse's job to ensure their patients are able to experience an optimal quality of life. However, they observed that the majority of their patients changed their lifestyles and decreased social and physical activities as a result of their stomas (Table 3). When asked why patients decreased socialisation, leisure and physical activities after stoma formation, nurses reported past experience of leakages as the most commonly given reason (Figure 4) and that having evidence-based, standardised practice guidelines could or would benefit them and their patients (Figure 5).
| Patient's behaviour change | Stoma nurses who see this sometimes or often in patients |
|---|---|
| Refusal to leave home | 40% |
| Only leaving home for short periods of time | 63% |
| Not staying away from home over night | 69% |
| Reduced socialisation | 76% |
| Decreased physical activity | 87% |
| Decreased physical intimacy | 81% |
| Significant reduction in hobbies and social activity | 76% |
The results also support the hypothesis that including large groups of clinicians in the development of practice guidelines leads to faster acceptance, accelerated implementation in patient care regimens and ultimately better patient outcomes. Close to 2000 nurses from more than 25 countries endorsed the guidelines, and they committed to disseminating and promoting them among colleagues in their home countries using implementation action plans that they developed (Figure 6).
The key themes that emerged during the Ostomy Days congress dialogue were:
Conclusions
The results of this study demonstrate that popular scientific theories about decision-making and implementation are applicable to the development of medical practice guidelines and can lead to better patient outcomes. The results support the idea that evidence-based best medical practice guidance can be developed using large-scale consensus processes, and that an inclusive approach to the process can lead to accelerated implementation and result in improvements in patient outcomes.
The research also provided practice guidelines designed to lead to better outcomes and quality of life for patients with a stoma. The guidelines are being championed by more than 2000 stoma care nurses in 25 countries, and they are leading to changes in care regimens for thousands of stoma patients around the world. Further research is recommended into the long-term effects of the practice guidelines on patient quality of life.
Replication of the large-scale consensus process used in this research is also recommended for the development of other types of medical practice guidelines. This would further demonstrate the effectiveness of a collaborative approach on the speed of acceptance and adoption of the best practices and ultimately on patient outcomes.