Development of the Draft Clinical Guideline on How to Resuscitate Dying Patients in the Iranian Context: A Study Protocol

Set ≠ 1

After selecting the subject of this guideline, in accordance with what is stated above (Relevance of old age, the growing trend of chronic diseases, lack of financial and human resources, imposing huge costs to the patient and society, and diversity in decision-making), Iran is not an exception, and the need to develop a directive in this regard was made in consultation with the team members.

Set ≠ 2

In this study, the scope was primary and before the first session of consensus of “making a decision by the care team on how to resuscitate the dying patients.” In the first meeting of the team members of drafting the guideline, the guideline scope was changed to the decision-making of care and treatment team in specialized and subspecialized hospitals on how to do CPR in patients.

Set ≠ 3

In the development of proposal stage, the beneficiaries of the study were selected as the patient, family, caregivers, and policymakers in the field of the health system and all interdisciplinary and related guidelines.

The study had no time limitation in the literature review and focused on the study guidelines on DNR in the world, which were searched with an emphasis on Islamic and legal principles related to decision making on the DNR. To search for these studies, electronic bibliographic data sources and online databases such as Medline, EMBASE, Springer, Blackwell Synergy, Elsevier, Scopus, Cochran Library as well as databases, including SID, Iran Medex, and Magiran were used. In addition, a manual search was done on articles references. The books on fatāwā (In the Islamic faith is the word for the legal opinion or learned interpretation religious issues) and religious questions from respected Marja’ taqlīdī (Islamic experts in areas of jurisprudence (Fiqh) and Islamic law) – literally means “Source to Imitate/Follow” or “Religious Reference” – were studied trying to study legal issues regarding do not resuscitation of patients.

After preparing the papers, in the first stage, the titles and abstracts of the papers were reviewed, and related items were included in the study. The full text of relevant articles was evaluated and scored with the help of checklist and tables of evidence. To evaluate the quality of each of the articles, the Tool Review related to the design of that article was used. The studies were reviewed with the help of tools such as COREQ and CASP.

Furthermore, no guidelines were found regarding the use of such guidelines at the national level; only three review articles had been written on this subject. At the international level, the full texts of two guidelines were approved and entered in the interview using the Appraisal of Guidelines for Research and Evaluation Instrument.

In preparation for the interview, some questions in the same format were extracted after the review; questions such as:

• Have you ever had a case to consider DNR for?

• How did you perform? What challenging issues or dilemmas have you experienced? What strategies have you adopted?

• What credible rules and regulations are available in this regard?

• What were your standards for considering a DNR?

• Did you inform the patient and his family?

• What are the risks and benefits of the DNR?

• What elements are involved in resuscitation or nonresuscitation of dying patients? Should the consent be taken? Who should complete the consent? At what stage? With what conditions?

Set ≠ 4

Then, the set of texts, review was content analyzed, and seven aspects were extracted accordingly. In accordance with the relevant concept of each of the dimensions, the competent ones or process owners of responsible persons and decision-making were considered. These seven dimensions included the medical team (doctors, nurses), economists, religious, ethics professionals, lawyers, patients, and their families.

In the first phase of the work, as the aim was to draft the guidelines on a theoretical basis, therefore, the seven extracted dimensions were considered. A list of experts competent to meet the conditions (being a clinical specialist in the field, having scientific works such as articles and books on the subject) were considered. Based on priority in each dimension, ten people were selected (however, other than the patient and the family). First, we conducted a deep semi-structured interview with the person with priority (with the help of guiding questions obtained during literature review). If the person was not willing to continue the participation, according to the list, we would interview with the next subject. Furthermore, at the end of the interview, we talked about the extracted dimensions and asked the subjects’ opinions in this regard. Furthermore, at the end of the interviews of the specific dimension, the subjects might have agreed to go to a group or individual or objected the interview with the individuals of another dimension. For example, the social workers and sociologists were included in these dimensions that were added to the study dimensions in interviewing with the experts, while the majority of subjects, especially medical staff were opposed to the patient and family dimension. They suggested that the cultural context of our society is not now able to talk to the families in this regard. For now, this issue is better raised in the community at the beginning through the media, and decisions in this regard would be made in coming years. One of the main challenges in this stage was referring to the adoption of the charter of patients’ rights and the important issue of medical and nursing ethics codes and reports on the process of providing the possible solutions in the work trend. So far, a total of 20 interviews (8 interviews with nurses, 8 by physicians, and 4 interviews with social workers) were carried out. The duration of each interview was 45–60 min, and they were asked to allow audio recording of interviews. At the beginning of each interview, the objectives of the study, the right of individuals to participate or exit from the study at any time of the interview were explained to the participants and informed consent was obtained from them. They were also assured regarding data confidentiality. The author prepared a transcript of the interview text at the end of each interview session and read them several times to reach a deep and accurate understanding of them. Then, the text was analyzed to the smallest meaningful units (codes). The codes were placed in six major categories derived from the literature review.

The permanent and continuous involvement of the subject was used to ensure the credibility and acceptability of data. The codes assessment method by the participants was used. Thus, the initial codes were controlled by the interviewees before classifying in the classes. For coding the codes in the classes extracted, the observer review method (by advisor and consultant professors and two PhD Nursing candidates) was used [Figure 1].

Close

Figure 1

Diagram of set 3 and 4

Export to PPT

More than 1150 codes have been extracted so far from these twenty interviews that were included into each of the seven dimensions based on conducted content analysis, and the analysis continues until data saturation.

The interviews were conducted mostly in the interviewees’ offices. In three cases, the respondents were willing to refer the researcher's office at the School of Nursing and Midwifery. The respondents’ transportation costs were provided, and they were also given a gift.

Regarding the presence of the patient and family, as mentioned, the participants opposed to doing interviews with family members and patients due to cultural issues and Iranian society nonacceptance of such issues. They believed this would depend on the culture-making through by the media, preparation of brochures, banners, etc. However, for providing maximum variation in sampling and with respect to the fact the acceptance or rejection of the DNR order, the patients, and their families have a fundamental role, the team members of guidelines developing decided to do interviews with this group as well.

Set ≠ 5

The final stage of this study, which is ongoing while writing this article, is as follows:

After doing individual interviews and directed content analysis associated with reviewing the literature, the recommendations were extracted. Then, the final recommendations will be extracted with nominal group technique (NGT).

Nominal group technique

In qualitative research to explore the wide range of ideas or deeply examine a specific question among the target population, the group-based method such as NGT is used. In these methods, the depth and richness of the subject are discussed together. Participants in NGT participate in a structured face-to-face meeting lasting at least more than 2 h with a number of people between 5 and 9; however, some researchers may include more people in the group. The key issues used at an NGT meeting include the followings:

• The question or questions used in the focused group meeting must be clear and motivating so that will lead to a significant participation and presence

• Participants at the meeting must have expertise in the relevant field or have executive powers

• The facilitator must be an expert and familiar with the process of the group meetings.[20]

In this approach, we invite at least nine people from those interviewed, those with a more key role or the competent people associated with those having a higher executive capability (heterogeneous). Then, the recommendations extracted during the interviews are discussed. The person's statements are put on a flip chart and also recorded, which will be analyzed in three formats of acceptable, need to be further investigated and irrelevant, and at the end, the final recommendations will be extracted. Two qualitative and quantitative approaches can be used for data analysis. In the qualitative method, the quotations can help to explain individual and group thoughts of people.

In quantitative analysis, the two-stage scoring, Delbecq approach is used. Following voting on the recommendations, at the end of the same session, the final results will be shared.

Regarding the holding place for NGT meeting, we have currently made the requirements to hold the meetings in the corresponding author's office, at the School of Nursing and Midwifery in Tehran University of Medical Sciences. The transportation will be provided by them; a fee for them will be also considered. In this session, the article authors (the core members of the guidelines developers) will attend along with representatives of the interviewees. Furthermore, before entering the NGT meeting, the participants will be asked to declare any conflicts of their interest [Figure 2].

Close

Figure 2

Diagram of study

Export to PPT

Ensuring the reliability of the findings

To ensure the reliability of data derived from interviews with experts, in addition to control them during the meeting, the data will be checked through e-mail with the experts as well. During the development of guideline process, the Conference on Guideline Standardization checklist is also used. The mentioned checklist has 18 items that are particularly used to validate the clinical guidelines, which will be used after writing the drafts of the guideline recommendations.[21]

The participants were assured about the confidentiality of information discussed during the formal and informal interviews. Personal information, political and religious beliefs, and ethnic issues of participants will remain confidential by the researcher. The possibility to announce they are willing to discontinue in participation at any stage of the study is reminding the participants. Article and guideline inclusion criteria are listed in Table 2.

Table 2 Article and guideline inclusion criteria

In drafting guideline, at the beginning of the development program of the guideline, all those in the central core or are technical experts, professional members, and the beneficiaries, need to express any conflicts of their interest honestly.[22]

A NICE guide on ethical considerations in the formulation of guidelines believes that the guidelines should be developed in such a way that is bound by the following four basic principles:

• Respect for autonomy (everyone in the community meetings and focus groups has the right to freely express his opinion. During the facilitating sessions of the group, the issue that all the group members express their opinions and not being affected by one or more people who have a higher power should be considered. Furthermore, the guidelines should be developed in such a way that people can freely accept or reject the health care and providing services to improve the health. The concept of patient choice needs to be considered in the guidelines)

• Nonmaleficence (Lack of physical and mental harm must be met during the drafting of guidelines. The guideline recommendations should be developed in a way that the minimum harm affects the patient)

• Beneficence (It is closely related to the principle of nonmaleficence. The NICE Committee believes that the recommendations should be written in a way the patient is minimally hurt)

• Justice (Mismatch between demands and resources in providing health care can lead to injustice. NICE insists that the guidelines should be developed in such a way that justice is met in distribution of services based on the relevant guidelines).[14]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.