Guidelines Translation for Distress Management in Cancer Patients Based on CAN-IMPLEMENT: Implementation Part

Background: Stomach cancer patients receiving chemotherapy suffered severe distress. This study aimed to align the Cancer-related Distress Management Guidelines into clinical practice among stomach cancer patients receiving chemotherapy, and to monitor the implementation process of Cancer-related Distress Management Guidelines, evaluate the effects of guidelines implementation, and maintain the guidelines implementation in clinical practice. Methods: A Guideline Adaptation and Implementation Planning Resource (CAN-IMPLEMENT) was used as the research framework, which include three phases. Here the Implementation Part (Phase 2 and Phase 3) was reported: alignment of Cancer-related Distress Management Guidelines in clinical practice among stomach cancer patients receiving chemotherapy, and process monitoring and outcome evaluation of Cancer-related Distress Management Guidelines. Results: After the guidelines implementation, the formal audit criteria, working pathways, assessment tools, multidisciplinary panels, training manual for healthcare professionals, education and handbook for patients and their caregivers of distress management were developed on institutional level, as well as the related assessment tools and record forms. The completion rate of distress management record was increased from 0.0% to 97.9% (P<0.001). The compliance of most items in the audit checklist for medical staff's distress management were improved, from 57.1% to 100.0% (P<0.001). The distress positive rate of stomach cancer patients receiving chemotherapy was decreased from 22.7% to 9.3% (P<0.05), and the distress scores were declined from 2 (0-9) to 0 (0-7) (P<0.001). Conclusions: The completion rate of distress management records increased signicantly after guidelines implementation, revealing the process quality control of the distress management practice was good. At the institutional level, this guidelines implementation promoted the establishment of distress management system. To healthcare professionals, the guidelines implementation improved the distress management compliance. For stomach cancer patients receiving chemotherapy, distress management practices can effectively improve the distress of stomach cancer patients receiving chemotherapy.


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The guidelines implementation was feasible in low and middle income countries based on CAN-IMPLEMENT and guided by the Knowledge-to-Action Framework.

Background
Stomach cancer is one of the top 10 cancer types worldwide. The new cases of stomach cancer was over 1,000,000 and the deaths was about 783,000 in 2018, making it the fth most frequently diagnosed cancer and the third leading cause of cancer death [1]. In China, there were approximately 679,100 new cases and 498,000 deaths of stomach cancer in 2015, ranking second after lung cancer among all cancer types [2]. Hong et al. reported that the prevalence of clinically signi cant preoperative psychological distress was 76.97% in Chinese patients with newly diagnosed stomach cancer 3 . In addition, patients with clinically psychological distress were more likely to have poor quality of life and to demonstrate negative coping styles [3]. In the research site, the research team found that most stomach cancer patients have a low education level and a high age [4]. These patients are not good at expressing emotions, and their psychological care needs are easily overlooked. At the same time, all stomach cancer patients in the research site were undergoing chemotherapy or preparing for chemotherapy. Therefore, it was decided to recruit stomach cancer patients receiving chemotherapy as the research object of the guideline implementation after group discussion.
The guidelines implementation is a process of changing practice in health care while utilizing the best level of evidence that is available in the published literature [5]. As the critical link to put evidence into practice successfully, guidelines implementation is usually full of di cult challenges [6,7]. Fischer et al. indicated that the barriers to guideline implementation can be differentiated into personal factors, guideline-related factors, and external factors [8]. Accordingly, the corresponding strategies were identi ed, including dissemination, education and training, social interaction, decision support systems and standing orders [8]. Cheng et al. demonstrated the main barriers to evidence-based nursing implementation in China were lack of knowledge and skills for nurses, following by lack of protocol and heavy workload for system [9]. Lack of knowledge Another study conducted in China showed higher frequency and higher ranking of barriers for the guidelines implementation all converged on 'lack of access', 'less convenient', 'lack of applicability' and 'lack of evidence from Chinese sample', and higher frequency and higher ranking of enablers converged on 'Short formats presentation', 'Utilisation of various media', 'Information visualisation' and 'Linking to patient electronic medical records' [10].
This guidelines implementation project was closely collaborated among university and hospitals. To ensure the authority and resources required for the guidelines implementation, a multidisciplinary panel of guidelines implementation was developed. The members of the panel included hospital decision makers, department managers, guidelines adaptors, frontline medical staff, cancer patients, university researchers, etc., and can provide support in policies, resources, practice, management, etc. The participation of some core members of the guidelines adaptation panel can better ensure the consistency and continuity of guidelines adaptation and guidelines implementation. In addition, professionals in clinical practice situations are always faced with complex and heavy health care work. Researchers need to monitor the guidelines application process to understand the practice of guidelines' users following the recommendations, carry out the guidelines evaluation to clarify the effectiveness of the guidelines application, and maintain the guidelines application to regularize the guidelines' recommendations in the current practice situation.

Aim
Aims of this study was to carry out guidelines adaptation and implementation for distress management in cancer patients, which was based on CAN-IMPLEMENT and guided by the Knowledge-to-Action Framework. The adaptation part was reported in another paper. This section focused on implementation process. The Implementation Part (Phase 2 and Phase 3) was to align the Cancer-related Distress Management Guidelines into clinical practice among stomach cancer patients receiving chemotherapy, and to monitor the implementation process of Cancer-related Distress Management Guidelines, evaluate the effects of guidelines implementation, and maintain the guidelines implementation in clinical practice. The speci c objectives in Implementation Part were as follows: (1) To explore the gap between the current distress management and recommendations in the adapted guidelines; (2) To analyzing gaps, assessing barriers and supports of guidelines implementation from guidelines, users and practice context, and developing appropriate solutions; (3) To monitor the process and evaluate the outcome of this guidelines implementation; (4) To regularize the distress management among stomach cancer patients receiving chemotherapy.

Methods
Ethics approval for this study was obtained from School of Nursing XX University (IRB#2017-9-3) and XX Step 6 Align Knowledge to Local Context: A multidisciplinary panel of guidelines implementation was set up. The recommendations in the adapted guidelines were translated to practical audit criteria considering the local practice contexts and the speci c responsibilities of the professionals. A guidelines implementation work plan was developed by the multidisciplinary panel of guidelines implementation.
From September 2017 to June 2018, a cross-sectional study was conducted to describe and analyze the stomach cancer patients' distress and the gap between the current distress management and guidelines' recommendations. The self-designed distress management record in cancer patients, the self-designed audit checklist for medical institution's distress management, the self-designed audit checklist for medical staff's distress management, the Distress Thermometer (DT) [11] and the Hospital Anxiety and Depression Scale (HADS) [12] were used as instruments. The participants were a medical oncology unit, eight doctors, 20 nurses, eight mental health professionals, two social workers, four palliative care staff and 141 stomach cancer patients receiving chemotherapy.
Step 7 Assess Barriers and Facilitators to Knowledge Use / Step 8 Select and Tailor Implementation Interventions: Eight experts (two supervisor nurses and two nurse practitioners of oncology nursing, a supervisor nurse of palliative care, a physician of psychological medicine, a social worker, a nurse of psychological care) were invited to assess the barriers and supports of guidelines implementation, and develop feasible solutions by using the expert meeting method from innovation, adopters and practice environment.

Phase 3 Implementation, Evaluation and Sustainability: Guidelines Application and Evaluation
Step 9 Monitor Knowledge Use / Step 10 Evaluate Outcomes: A historical controlled trial was conducted with the same instruments in Step 6 between July 2018 and December 2018. The subjects included a medical oncology unit, eight doctors, 20 nurses, eight mental health professionals, two social workers, four palliative care staff and 193 stomach cancer patients receiving chemotherapy. In addition to the stomach cancer patients, the subjects were same with the participants in the gap analyses.
Step 11 Nuture Change and Sustain Knowledge Use: From January to March 2019, the implementation of Cancer-related Distress Management Guidelines was sustained by assessing barriers and facilitators to knowledge use, selecting and tailoring implementation interventions, monitoring process and evaluating outcomes again. For monitoring process and evaluating outcomes, another historical controlled trial was performed including a medical oncology unit, eight doctors, 20 nurses, eight mental health professionals, two social workers, four palliative care staff and 30 stomach cancer patients receiving chemotherapy. In addition to the stomach cancer patients, the subjects were same with the participants in the gap analyses. The instruments were same with these used in Step 6.

Phase 2 Solution Building: Guidelines Alignment
Step 6 Align Knowledge to Local Context The multidisciplinary panel of guidelines implementation included a professor and an associate professor skilled with evidence-based practice methodologies, a chief physician of psychological medicine, a chief physician of palliative care, a chief physician, an associate chief physician and an attending doctor of oncology, a professor, an associate professor, three supervisor nurses, two nurse practitioners and two nurses of oncology nursing, an associate professor of psychological care, two social workers, a doctoral candidate and a postgraduate student of nursing science.
Ten translated practical audit criteria were developed based on the extracted recommendations from the adapted guidelines. Table 1. The distress management clinical pathways were also developed based on the translated practical audit criteria. Figure 1. The work plan of guidelines implementation were presented as a protocol for a historical controlled trial. The contents of work plan included the following parts: design, participant, inclusion criteria, sample size, research site, intervention, instruments, data collection, analyses and so on. The interventions were the practical audit criteria based on the recommendations in the adapted guidelines.
Before the guidelines implementation, there was no formal audit criteria, working pathways, assessment tools, multidisciplinary panels, training manual for healthcare professionals, education and handbook for patients and their caregivers of distress management on institutional level, as well as the related assessment tools and record forms. Therefore, the completion rate of distress management record was 0.0% at baseline. The compliance of each item on the audit checklist for medical staff's distress management in cancer patients were all 0.0%. Table 2. The distress positive rate of stomach cancer patients receiving chemotherapy (DT≥4) was 22.7%, and the distress score was 2 (0-9). Table 3 and Table 4. The problem report rates of stomach cancer patients receiving chemotherapy with moderate to severe distress were 0.0% to 75.0%. The positive rates of anxiety and depression were both 40.0%.
Step 7 Assess Barriers and Facilitators to Knowledge Use / Step 8 Select and Tailor Implementation Interventions Six barriers and six supports of the guidelines implementation were identi ed from the guidelines, the adopters and the practice environment. Ten corresponding solutions were developed too. Figure 2.

Phase 3 Implementation, Evaluation and Sustainability: Guidelines Application and Evaluation
Step 9 Monitor Knowledge Use / Step 10 Evaluate Outcomes After the guidelines implementation, the formal audit criteria, working pathways, assessment tools, multidisciplinary panels, training manual for healthcare professionals, education and handbook for patients and their caregivers of distress management on institutional level were developed, as well as the related assessment tools and record forms. Except for the body mass index, there was no statistically signi cant difference on the general conditions of the two groups of patients before and after the guidelines implementation (P>0.05). Table 5. The completion rate of distress management record was increased from 0.0% to 97.9% (P<0.001). The compliance of most items on the audit checklist for medical staff's distress management were improved, from 57.1% to 100.0% (P<0.001). Table 2. The distress positive rate of stomach cancer patients receiving chemotherapy was decreased from 22.7% to 9.3% (P<0.05), and the distress scores were declined from 2 (0-9) to 0 (0-7) (P<0.001). Table 3 and Table  4. The problem reporting rates of stomach cancer patients receiving chemotherapy with moderate to severe distress were slightly lower, from 0.0% to 61.1% (P>0.05). The positive rates of anxiety and depression were both slightly increased to 64.7% (P>0.05).
Step 11 Nuture Change and Sustain Knowledge Use The results of the guidelines implementation maintenance were similar to those during the guidelines implementation period. The formal audit criteria, working pathways, assessment tools, multidisciplinary panels, training manual for healthcare professionals, education and handbook for patients and their caregivers of distress management on institutional level were maintained, as well as the distress management record. When compared to the results of gap analyses, the compliance of most items in the audit checklist for medical staff's distress management were improved to 89.7%-100.0% (P<0.001), the distress positive rate of stomach cancer patients receiving chemotherapy was decreased to 3.3% (P<0.001), and the distress scores were sustained at 0.5 (0-5) (P<0.001).

Discussion
The members in multidisciplinary panel of guidelines implementation included different roles, such as hospital decision makers, department managers, frontline medical staff, patients, and university researchers. They can provide support in terms of policies, resources, practice, and management. Some core members of the guidelines adaptation panel were also members of the guidelines implementation panel, which can better ensure the consistency and continuity of the guidelines translation, so as to smoothly advance the guidelines implementation. The work plan of guidelines implementation was formulated by coordinating resources related to nursing, psychological medicine, social work, and medical treatment under the leading of the guidelines implementation panel. In the gap analyses, the difference between distress management practice in the research site and recommendations in the adapted guidelines was quite big. There was no distress management system at institutional level before the guidelines implementation, and healthcare professionals almost do not provide any services on distress management for cancer patients. However, the distress status of stomach cancer patients receiving chemotherapy was not optimistic. Distress has large negative impact on patients' quality of life [3]. Therefore, it is necessary to carry out distress management [13,14,15]. The barriers and supports of this guidelines implementation were identi ed from the aspects of guidelines, the adopters and the practice environment [16]. Grifford and her colleagues reported that barriers included lack of evidence, inadequate knowledge in evidence-based practice, and patients' inability to understand new evidence, while leadership support and network information services were factors that promote evidence-based practice [17]. The results in this study were similar to results of her study. Meanwhile, the solutions corresponding to the above barriers and supports were formulated, including education and training, communication and exchange, review and feedback, patient-related measures, organization-level intervention and so on.
The completion rate of distress management records increased signi cantly during the guidelines implementation, revealing the process quality control of the distress management practice was good. At the institutional level, this guidelines implementation promoted the establishment of distress management system. The results of this study indicate that the research site approved the Cancer-related Distress Management Guidelines, formed the speci c and operable clinical pathways, and formulated related assessment tools and record forms. At the same time, a multidisciplinary team for distress management in cancer patients had been established, a standardized training and education project for medical staff and patients had been formed, training manual had been produced for medical staff training, and educational handbook had been sent to patients and their caregivers. To the healthcare professionals, the guidelines implementation improved the distress management compliance according to the recommendations in the adapted guidelines. The high compliance demonstrated the overall maturity of distress management in cancer patients and trouble-free operation of the multidisciplinary team. Patients who need distress management can receive distress management services in a timely, convenient and effective manner. In terms of stomach cancer patients receiving chemotherapy, the positive rate and score of distress decreased signi cantly after the guidelines implementation, indicating that distress management practices can effectively improve the distress of stomach cancer patients receiving chemotherapy. Previous studies also showed that distress management can reduce distress in cancer patients. Millegan et al. reported that the use of iPads during chemotherapy is a potentially effective way to introduce meditation as a stress management tool for people with cancer [18].
This study has the following limitations. First, barriers and facilitators to knowledge use were assessed using expert meeting method. The questionnaire survey may be more appropriate. Second, the study design of guidelines evaluation was a historical controlled trial. It is recommended to use stepped wedge trail design in future studies. Third, only stomach cancer patients receiving chemotherapy were included in the guidelines implementation. Thus, the results need to be further veri ed in patients with other types of tumors before being popularized.

Conclusion
The gap between distress management practice in the research site and the guideline recommendations was quite different. Meanwhile, the guidelines implementation barriers and supports were identi ed, feasible solutions were developed. The process quality control of the distress management practice in cancer patients was good. The evidence translation project can facilitate the establishment of distress management system and resources, promote the medical staff to improve the distress management compliance, and reduce the level of distress in cancer patients. The maintenance of the guidelines implementation can sustain the clinical translation effects. Thus, guidelines implementation was feasible in low and middle income countries based on CAN-IMPLEMENT and guided by the Knowledge-to-Action Framework. Tables Table 1 The recommendations in the adapted guidelines and the corresponding practical criteria Recommendations Practical audit criteria Recommendation 1: All patients should be assessed prior to clinical visits using the Distress Thermometer, and immediate screenings should be provided during the vulnerable period.
Practical audit criterion 1: Charge nurses screen and record distress for every patient using the Distress Thermometer when they visit the hospital, and patients' distress is immediately screened and recorded in vulnerable period.
Recommendation 2: If the patient's distress is mild (thermometer score < 4), the primary oncology team should assess the possible distress related symptoms of the patient.
Practical audit criterion 2: If the patient's distress is mild (thermometer score < 4), the charge nurse should use the distress standardization management record table to assess and record the possible distress related symptoms of the patient. Recommendation 3: According to the assessment results of possible distress related symptoms, the primary oncology team manages the symptoms associated with the patient's distress.
Practical audit criterion 3: According to the results of possible distress related symptoms, the charge nurse manage and record the symptoms associated with the patient's distress based on the distress management training manual, and refer to the professionals if necessary. Recommendation 4: After the primary oncology team manages the symptoms associated with the patient's distress, the Distress Thermometer is used again for followup screening.
Practical audit criterion 4: After managing the symptoms associated with the patient's distress, the charge nurse should follow-up and record the patient's distress using the Distress Thermometer within 30 days on the patient's next admission or by telephone. Recommendation 5: If the patient's distress is moderate or severe (thermometer score ≥ 4), further clinical evaluations should be provided by oncology team, including clinical interviews, anxiety/depression assessment, etc.
Practical audit criterion 5: If the patient's distress is moderate or severe (thermometer score ≥ 4), the charge nurse should provide further clinical evaluation and records, including Problem List of the Distress Thermometer, the Hospital Anxiety and Depression Scale. Recommendation 6: According to the results of further clinical evaluations, it is recommended to refer patients, and mental health professionals provide psychoeducation for patients in need.
Practical audit criterion 6: According to the results of further clinical evaluations, the charge nurse advises the patient to refer, and the mental health professionals provide psychoeducation, supportive psychotherapy, cognitive behavioral therapy, family and couples therapy for patients in need. Recommendation 7: According to the results of further clinical evaluations, it is recommended to refer patients, and mental health professionals provide cognitive behavioral therapy for patients in need. Recommendation 8: According to the results of further clinical evaluations, it is recommended to refer patients, and mental health professionals provide supportive psychotherapy for patients in need. Recommendation 9: According to the results of further clinical evaluations, it is recommended to refer patients, and mental health professionals provide family and couples therapy for patients in need. Recommendation 10: According to the results of further clinical evaluations, it is recommended to refer patients, and social workers provide support and counseling to patients in need.
Practical audit criterion 7: According to the results of further clinical evaluations, the charge nurse advises the patient to refer, and social workers provide support and counseling to patients in need.
Recommendation 11: According to the results of further clinical evaluations, it is recommended to refer patients, and life meaning support staff provide life meaning care for patients in need.
Practical audit criterion 8: According to the results of further clinical evaluations, the charge nurse advises the patient to refer, and life meaning support staff provide life meaning care for patients in need.
Recommendation 12: According to the results of further clinical evaluations, it is recommended to refer patients, and medical staff provide palliative care for patients in need.
Practical audit criterion 9: According to the results of further clinical evaluations, the charge nurse advises the patient to refer, and medical staff provide palliative care for patients in need. Recommendation 13: Patients who were referred or not referred to mental health professionals, social workers, life meaning support staff, medical staff were further screened using the Distress Thermometer.
Practical audit criterion 10: For patients who were referred or not referred to a professional for further treatment, the charge nurse should follow-up and record the patient's distress using the Distress Thermometer within 30 days on the patient's next admission or by telephone. Table 2 The comparison on completion rate of distress management on the audit checklist for medical staff before and after the guidelines implementation Criteria n a Before n a After c 2 P n % n %   Table 5 The comparison on general conditions of stomach cancer patients receiving chemotherapy before and after the guidelines implementation Figure 1 The distress management clinical pathways