Sonia Journal club presentation (2).pptx

Title: Application of Checklist-Based Nursing Care Process in Patients Undergoing Intervention for Coronary Chronic Total Occlusion: A Quasi-Randomized Study

Presenter: Sonia Pal, M.Sc. Nursing 2nd Year

Journal: BMC Nursing (2023)

Authors: Xia Ge, Haiyang Wu, Zhe Zang, and Jiayi Xie

DOI: 10.1186/s12872-023-03627-8

Study Overview:
This presentation focuses on the effectiveness of a checklist-based nursing care process for patients undergoing interventions for coronary chronic total occlusion (CTO). The study employs a quasi-randomized design to assess improvements in patient care outcomes.

Key Points:

Background: CTO interventions are complex, and traditional nursing methods have not been highly effective, necessitating the exploration of new approaches.
Objective: To investigate the effectiveness of a checklist-based nursing care process in improving care quality, reducing patient anxiety, increasing patient satisfaction, and minimizing adverse events.
Methodology:
Design: Quasi-randomized study
Setting: Department of Cardiology, Shengjing Hospital, China Medical University, Shenyang, China
Participants: 120 patients undergoing CTO interventions
Groups: Intervention group (checklist-based care) and control group (standard care)
Tools: Preoperative and postoperative PCI nursing care checklists, Zung Self-Rating Anxiety Scale, satisfaction questionnaires for doctors and patients
Ethical Considerations: The study adhered to the Declaration of Helsinki, with informed consent obtained from all participants.
Results: The study aimed to demonstrate that checklist-based nursing care could enhance nursing efficiency and patient outcomes compared to conventional methods.
Quality Control: A quality control team ensured adherence to the checklist and study protocol, with regular training and supervision of nursing staff.
Conclusion:
The presentation concludes with findings supporting the effectiveness of checklist-based nursing care in CTO interventions, suggesting improvements in patient care processes and outcomes. The study highlights the importance of structured nursing protocols in complex medical procedures.

1. Journal Club Presentation ‹#› Presented B y Sonia Pal M.Sc. Nursing 2 nd year

2. Article 1: Quantitative Research ‹#›

3. ‹#› TITLE Application of checklist- based Nursing care process in patients undergoing intervention for coronary chronic total occlusion :A Quasi-randomized

4. Keywords ‹#› Coronary chronic total occlusions Checklist Percutaneous coronary intervention Nursing Quasi-Randomized Study

5. Article details Author : Xia Ge , Haiyang Wu, Zhe Zang and Jiayi Xie Journal: BMC Nursing Publishing year: 2023 DOI: https://doi.org/10.1186/s12872-023-03627-8 Trial registration: ChiCTR 2200056804 Impact factor: 3.18 ‹#›

6. Background ‹#› Compensated Stage Decompensated Stage

7. Cont.. ‹#› However, only a few nursing methods are specifically applied to patients undergoing CTO interventions. the conventional nursing effect is not ideal, urgent need to explore more effective nursing methods. Coronary chronic total occlusion (CTO) interventions are more complex than general percutaneous coronary intervention (PCI) procedures.

8. ‹#› The checklist is a simple and effective tool for error management and performance improvement that has been widely used in many fields. But there have been no reports of the checklist being used to improve care for CTO patients. Cont..

9. Objective ‹#› This study aimed to investigate the effectiveness of a checklist-based nursing care process in patients undergoing Coronary chronic total occlusion (CTO) interventions.

10. Aims This study aimed to investigate the effectiveness of a checklist-based nursing care process in patients undergoing Coronary chronic total occlusion (CTO) interventions, including duration of care, patient anxiety, improved patient satisfaction, and occurrence of adverse events. ‹#›

11. Methodology Approach: Quantitative Research Design: Quasi Randomized ( Chinese Clinical Trial Registry (registration number ChiCTR2200056804, reg date17/02/2022). Study setting : Department of Cardiology, Shengjing Hospital, China Medical University, in Shenyang, China, from December 2020 to July 2021 Population: Patients who underwent CTO intervention Sample Size: 120 patients ‹#›

12. ‹#› Two Groups are intervention group (n = 60, adopted the checklist-based nursing care process for patient care) and a control group (n = 60, adopted nursing care according to the existing workflow) according to different nursing interventions. Cont..

13. Inclusion criteria The clinical symptoms and coronary angiographic results were in accordance with the international diagnostic criteria for CTO Age ≥ 18 years and the disease was within the scope of indications for intervention Exclusion Criteria Patients with serious chronic diseases or major organ dysfunctions such as diseases of the liver and kidney Patients with unopened vessels requiring secondary surgery or bypass Criteria

14. Inclusion criteria physically able to receive cardiac treatment interventions No relevant contraindications Normal cognition, hearing and intelligence, and basic communication and understanding ability Exclusion Criteria Patients who are not undergoing PCI for the first time Patients who cannot communicate effectively Patients with psychiatric disorders, psychiatric history, visual and hearing impairment, or cognitive impairment Criteria

15. Inclusion criteria Complete data collection, voluntary participation, and good compliance in this study Exclusion Criteria Patients who develop serious mental or physical illnesses during hospitalization Patients who are breastfeeding or pregnant. Criteria

16. ETHICAL CONSIDERATIONS ‹#› This study followed the Declaration of Helsinki, and patients signed informed consent.The study was approved by the ethics committee of Shengjing Hospital of China Medical University (approval no. 2020PS795K).

17. Declaration of Helsinki Set of ethical principles regarding human experimentation developed by the World Medical Association (WMA). Goal -New knowledge Helsinki is a city name Started -1964 Amendment-1975,1983,1983,1989,1996,2000,2002,2008,2013 ‹#›

18. GENERAL PRINCIPLES Risks, Burdens and Benefits Vulnerable Groups and Individuals Scientific Requirements and Research Protocols Research Ethics Committees Privacy and Confidentiality Informed Consent Use of Placebo Post-Trial Provisions Research Registration and Publication and Dissemination of Results Unproven Interventions in Clinical Practice

19. Sample size ‹#› Group sample sizes of 43 and 43 achieve 90% power to reject the null hypothesis of equal means when the population mean difference of preoperative nursing care time is 5 min and - with a standard deviation for both groups of 7 min and with a significance level (alpha) of 0.050 Assuming a 20% potential dropout rate, the final sample size was increased to 120 subjects, with 60 subjects in each intervention group.

20. RANDOMIZATION Doctors use random sequence software to generate 1 to 120 random serial numbers. Random serial numbers and then in the order in which the patients were treated, from front to back. Odd-numbered patients were included in the intervention group, while even-numbered patients were included in the control group. the intervention group and the control group were arranged in wards A and B respectively. ‹#›

21. Blinding They are unaware whether the evaluated patients are in the experimental group or the control group; The nurses in the control group used a blind method, that is, they were unaware that the ward had become the control group and still used existing working Single blind trail use:

22. TOOL FOR DATA COLLECTION 1- Preoperative -PCI nursing care checklist for CTO Patients 2-Postoperative -PCI nursing care checklist for CTO Patients 3-Zung self -Rating Anxiety scale 4-Doctors and Patient Satisfaction Nursing Care Questionnaire 5-Doctors Satisfaction Nursing Care Questionnaire 6-Patient Satisfaction Nursing Care Questionnaire

23. Zung self -Rating Anxiety scale There were 20 items in total, and the 4-level scoring method was adopted, with 15 positive scores and 5 negative scores. <50 => no anxiety 60–69 => moderate anxiety >69 => severe anxiety.

24. Zung Self-Rating Anxiety Scale (SAS) 1 I feel more nervous and anxious than usual 2 I feel afraid for no reason at all. 3 I get upset easily or feel panicky. 4 I feel like I’m falling apart and going to pieces. 5 I feel that everything is alright and nothing bad will happen 6 My arms and legs shake and tremble. 7 I am bothered by headaches neck and back pain 8 I feel weak and get tired easily. 9 I feel calm and can sit still easily. 10 I can feel my heart beating fast.

25. 11 I am bothered by dizzy spells. 12 I have fainting spells or feel like it. 13 I can breathe in and out easily. 14 I get numbness and tingling in my fingers and toes. 15 I am bothered by stomach aches or indigestion. 16 I have to empty my bladder often. 17 My hands are usually dry and warm. 18 My face gets hot and blushes. 19 I fall asleep easily and get a good night’s rest. 20 I have nightmares.

26. Measurements Occurrence of Adverse effect Patient’s Anxiety D octor and Patient satisfaction Preoperative nursing care tim e

27. Interventions ‹#› The primary nurse will create a checklist for patient admitted in the hospital, fill in the complete patient information, and manage the admitted patient according to the checklist. Within 24 h of admission, the primary nurse will score the patient based on the Self-Rating Anxiety Scale (SAS) All contents of the preoperative nursing care checklist for patients with CTO should be completed 1 day before surgery to 1 h before surgery . The checklist-based nursing care process was used to provide care and education to patients with CTO before and after PCI

28. Cont… ‹#› The members of the quality control team should check quality of all the activity and reports to the primary nurse in case any issue. The primary nurse provided care to the patient following the“CTO patient postoperative nursing care list,” The primary nurse completed the postoperative nursing care checklist for patients with CTO within 24 h after surgery Members of the quality control team checked the completion of the checklist before the patients were discharged and checked the completion of various questionnaires

29. Preoperative-PCI nursing care checklist for CTO patients Item Content Implementation Status Yes No Not Applicable Dietary guidance Low-salt and low-fat diet before surgery. ⬵ ⬵ ⬵ Diabetic diet for Diabetic patients. ⬵ ⬵ ⬵ Patient Preparation Left arm preferred for indwelling needle left foot for special cases. ⬵ ⬵ ⬵ Skin preparation: assess whether the patient needs skin presentation ⬵ ⬵ ⬵ Dress code: wear wristbands on left hand female patients take off underwear with steel ring. ⬵ ⬵ ⬵ Practice urination and defecation in bed. ⬵ ⬵ ⬵

30. Item Content Implementation Status Yes No Not Applicable Patient Preparation Get enough sleep the night before surgery. ⬵ ⬵ ⬵ History of allergy to contrast media. ⬵ ⬵ ⬵ Fasting or eating less before surgery. ⬵ ⬵ ⬵ Emptying the bladder before entering the operating room. ⬵ ⬵ ⬵ Need for catheterization. ⬵ ⬵ ⬵

31. Item Content Implementation Status Yes No Not Applicable Goods Preparation Inform family members to prepare water cups straws and urinal pad. ⬵ ⬵ ⬵ Air mattress for patients undergoing lower limbs PCI. ⬵ ⬵ ⬵ Prepare resuscitation items and drugs. ⬵ ⬵ ⬵ Drug Instruction Give anticoagulants anti-anginal drugs and other drugs correctly as prescribed by the doctor and observe the efficacy and adverse effects of the drugs. ⬵ ⬵ ⬵ Give sedation if necessary as prescribed by the doctor. ⬵ ⬵ ⬵ Inform patients of oral drug usage and precautions. ⬵ ⬵ ⬵

32. Item Content Implementation Status Yes No Not Applicable Mental Nursing Explain to patients about the surgery and inform them about precautions. ⬵ ⬵ ⬵ Explain to family members to relieve their tension and anxiety. ⬵ ⬵ ⬵ Assess the patient's psychological state. ⬵ ⬵ ⬵ Adequate psychological nursing care for nervous anxious and fearful patients. ⬵ ⬵ ⬵

33. Postoperative -PCI nursing care checklist for CTO Item Content Implementation Status Yes No Not Applicable Clinical Observation 24 h postoperative ECG monitoring and vital signs monitoring. ⬵ ⬵ ⬵ Observation of blood flow and arterial pulsation in the operated limb. ⬵ ⬵ ⬵ Observe whether the patient has low back pain abdominal pain chest tightness and chest pain. ⬵ ⬵ ⬵ Monitor blood routine kidney function and coagulation function. ⬵ ⬵ ⬵ Prepare resuscitation items and drugs. ⬵ ⬵ ⬵

34. Item Content Implementation Status Yes No Not Applicable Wound Care Bandage the puncture site with pressure for 24 h and decompress and exhaust pressure every 3 h for a total of 2 times. ⬵ ⬵ ⬵ Observe the puncture wound for bleeding and hematoma ⬵ ⬵ ⬵ Patients with femoral artery puncture are placed on hover bed and given lower limb restraint brakes if necessary ⬵ ⬵ ⬵ Dietary guidance Patients without heart failure should drink more water to promote the excretion of contrast media. ⬵ ⬵ ⬵ Low-salt and low-fat diet more crude fiber food to prevent. ⬵ ⬵ ⬵

35. Item Content Implementation Status Yes No Not Applicable Health Education Patients with femoral artery puncture are advised to stay in bed absolutely for 12 h and the limb on the operated side can be turned axially after 12 h to prevent pressure sores. ⬵ ⬵ ⬵ Defecate in bed defecate without using too much force. ⬵ ⬵ ⬵ Do not over-flex the operated limb move the fingertips appropriately and do not lift more than 5 kg of weight for 3 months. ⬵ ⬵ ⬵ Drugs instruction: Long-term oral anticoagulants are required watch for nosebleeds bleeding gums black stools etc. ⬵ ⬵ ⬵ Regular blood tests. Femoral artery puncture patients should not do deep squats. ⬵ ⬵ ⬵

36. Item Content Implementation Status Yes No Not Applicable Mental nursing Listen to the patient's chief complaint ⬵ ⬵ ⬵ Assess the patient's psychological state. ⬵ ⬵ ⬵ Adequate psychological nursing care for anxious patients. ⬵ ⬵ ⬵

37. Cont… ‹#› The patient’s clinical observation, wound care, postoperative education etc were conducted regularly according to the doctor’s postoperative advice. The preoperative and postoperative SAS scoring was performed within 24 h of admission and before discharge, respectively. The doctor satisfaction survey and the patient satisfaction survey was conducted after surgery and the occurrence of adverse events was recorded.

38. Quality control ‹#› A checklist for quality control team was also established. The head nurse served as the team leader, and the team members were the head nurse assistant and two senior primary nurses with more than 5 years of experience. The team members were trained with the contents of the checklist, overall process of the study, and when to conduct checks to ensure the implementation of the checklist. The quality team measuring the occurrence of adverse events was blinded to the study allocation groups for the patient outcomes they were assessing Training organization. The head nurse organizes trainings for all nurses in the department to study the content of the checklist, understand the overall process of scientific research, and ensure complete data collection

39. Implementation of supervision and inspection . Members of the quality control team strictly check whether the study content is implemented on time before and after the surgery, and in any case of omission, the primary nurse is required to further complete the tasks to ensure appropriate implementation.

40. Validity and reliability

41. Validity 0.82 Nursing care checklist for CTO SAS SCALE Doctor nursing care questionnaire patient nursing care questionnaire 0.85 0.83

42. Reliability Tool Method Reliability Nursing care checklist for CTO Internal Consensus reliability Cronbach’s alpha 0.859 SAS SCALE Cronbach’s alpha 0.932 Doctor nursing care questionnaire patient nursing care questionnaire Internal Consensus Cronbach’s alpha Internal Consensus Cronbach’s alpha 0.893 0.898

43. Statistical analysis SPSS 26.0 software was used for statistical analysis. Measurement data were expressed as (‾x ± s), and the t test was used for comparison between groups. Count data were expressed as number of cases or percentage, and the χ2 test was used for comparison between groups. The difference was considered significant at P < 0.05

44. Statistical Tests Use Statistical Tests Example Use Case t-Test Compare means of 2 group Compare test score of two teaching methods Anova Compare means of more than 2 group Compare test score among three teaching methods Chi-Square-Test Test Independence between categorical variable Test if there’s an association between gender and preferences for tea or coffee

45. Pearson Correlation Measure Linear association between 2 continuous variable Examine The Relationship age and income Regression Analysis Predict a continuous dependent variable based on 1 or more independent variable Predicting House prices based on square footage Mann-Whitney U Test Compare Distribution of 2 independent group Compare test scores between 2 different school Kruskal-Wallis Test Compare Distribution of more than 2 independent group Compare performance of different teaching methods across multiple school

46. Wilcoxon Signed-Rank Test Compare distributions of 2 related group Compare pre-test and post-test scores within a group McNemar’s Test Compare paired proportions or frequencies in a 2*2 contingency table Compare the effectiveness of two treatments on a binary outcomes Fisher’s Exact Test Compare proportions in a 2*2 contingency table Access the information between gender and smoking status in a small sample

47. The basic information between the two groups Among the 120 patients, 109 completed the study, and 11 patients did not complete the questionnaire due to early discharge from the hospital. The final intervention group included 56 patients with mean age of (65.05 ± 10.14) years, and the control group included 53 patients with mean age of (65.02 ± 10.73) years.

48. Table 1 The basic information between the two groups Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Age( x̄ ± s , years) 65.05 ± 10.14 65.02 ± 10.73 0.017 0.371 0.986 0.542 Male 39 34 Female 17 19 Ethnicity (cases) 0.000 1.000 Han 55 52 Other 1 1 Marriage status (cases) 0.320 0.572 (Married) 55 50 (Single) 1 3

49. Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Profession(cases) 0.966 0.326 Retired 41 43 On-the-job 15 10 Medical Insurance Type(cases) 2.810 0.094 In the city 50 41 Out of the city 6 12 Days of hospitalization ( x̄ ± s, days) 6.18 ± 2.39 6.85 ± 3.18 -1.260 0.210

50. Table 2 Comparison of preoperative care time between two groups of patients Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Preoperative nursing care time (x ± s,mins) 37.61 ± 5.15 50.98 ± 5.61 -12.965 <0.001 Preoperative nursing care time grouping 79.971 <0.001 < 40 min 40(71.0%) 2(3.8%) 40–50 min 16(28.6%) 20(37.7%) > 50 min 31(58.5%)

51. Table 3 Comparison of the incidence of nursing-related adverse events in the two groups [n(%)] Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Preoperat iv e Intravenous Access Related 2(3.57) 7(13.21) 2.187 0.139 Skin preparation in the operating area related 1(1.79) 6(11.32) 2.686 0.101 Omission goods 1(1.79) 8 (15.09) 4.731 0.030 Vomiting 35 2 0.001 0.978

52. Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P I ntraoperative Postoperative Defecation 16 20 0.567 0.451 Puncture site related 1(1.79) 3 (5.66) 0.320 0.572 Difficulty in urination 2 (3.77) 0.567 0.451 Skin Related 1 (1.89) 0.001 0.978 Total occurrence 5(8.93) 30(56.60) 28.391 < 0.001

53. Table 4 Comparison of SAS scores in the two groups Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Preoperative score (x ± s, scores) 65.58 ± 8.20 66.27 ± 9.73 -0.403 0.688 Preoperative score grouping 2.892 0.409 < 50 1 3 50–59 12 11 60–69 26 18 > 69 17 21

54. Item Intervention group (n = 56) Control group (n = 53) χ 2 or t P Postoperative score (x ± s, scores) 53.03 ± 10.24 60.87 ± 8.97 -4.236 < 0.001 Postoperative score grouping 20.471 < 0.001 < 50 21 4 50–59 20 18 60–69 13 18 > 69 2 13 t 11.624 4.782 P < 0.001 < 0.001

55. Table 5 Comparison of doctor and patient satisfaction in the two groups (‾x ± s, scores) Groups Cases Doctor satisfaction Patient satisfaction Intervention group 56 112.89 ± 12.11 93.64 ± 6.89 Control group 53 100.09 ± 8.34 84.32 ± 7.46 t 16 6.392 6.780 P < 0.001 < 0.001

56. Discussion Similarly study Previous studies have shown that nursing intervention in the interventional treatment of chronic complete occlusion of coronary artery disease has a very significant clinical effect, not only can improve the success rate of surgery, but also can reduce complications, so as to make patients satisfied Dissimilarly study NOT MENTIONED

57. Similarly study This study showed that the nurses in the intervention group spent significantly less time on preoperative nursing care than those in the control group.The nurses in the intervention group used a preoperative nursing care checklist and completed the checklist item by item to ensure the continuity of nursing care. Dissimilarly study NOT MENTIONED

58. Similarly study This study also showed that the patients in both groups had different anxiety levels before surgery and that their anxiety scores decreased after surgery. However, compared with the scores of the control group, the scores of the intervention group decreased more significantly. Dissimilarly study NOT MENTIONED

59. Clinical implementation The nursing checklist used in this study can be applied to the perioperative care of clinical CTO patients undergoing PCI. Nurses refer to the checklist to implement nursing measures for patients one by one, and mark the completed items before completion to avoid omissions and confusion. And it is concluded that using checklists to care for CTO patients can improve work efficiency and reduce the occurrence of adverse events .

60. Research recommendation and future considerations This study is the first time that Checklist-based Nursing has been applied to the care of patients undergoing CTO interventional operation. Therefore, more randomized controlled trials should be conducted using other feasible nursing methods to identify the best and most effective nursing methods for CTO interventional operation.

61. strength According to author According to Presentar 1- This studies on improving nurses’ work efficiency before and after PCI 2-This study is the first to apply the checklist to patient nursing for CTO interventional procedures to explore effective working methods that can reduce the nursing staff’s preparation time and reduce nursing errors. Approval for this study was mentioned. Aims were mentioned cleary Study Design was mentioned clearly Intervention well designed and well explained. Sample selection well explained Inclusion and exclusion criteria mentioned Validity and reliability were mentioned

62. Conclusion The application of a checklist-based standard nursing care process in patients undergoing CTO interventions can significantly reduce the preoperative nursing care time, alleviate patient anxiety, improve patient and doctor satisfaction with the nursing care, and effectively reduce the occurrence of adverse events caused by nurses’ omissions or inadequate instructions. The proposed checklist based standard nursing care process is worthy of clinical promotion and application.

63. limitation According to author The main limitation of this study is that it was a single-center experiment, which reduces generalizability The selected patients were patients with standard condition of CTO interventional operation. According to Presentar Use of term quasi randomized Table not well explain

64. Consolidated Standards of Reporting Trail

65. Article 2: Qualitative Research ‹#›

66. ‹#› TITLE Home care experience and nursing needs of caregivers of children undergoing congenital heart disease operations: A qualitative descriptive study

67. Article details ‹#› Author : Zhi Hong Ni, Hai Tao Lv, Sheng Ding, Wen Ying Yao Journal: PLoS ONE Editor: Felipe Hada Sanders, University of São Paulo, BRAZIL Published: March 14, 2019 DOI: https://doi.org/10.1371/journal.pone.0213154 Impact factor: 2.7

68. Introduction

69. Cont… Congenital heart disease (CHD) is defined as having defect(s) (present since birth)in the structure of the heart. CHD includes several types of structural heart defects that develop prenatally, including ventricular septal defect (VSD), atrial septal defect (ASD), patent ductus arteriosus(PDA), and Tetralogy of Fallot (TOF). The worldwide prevalence of CHD is estimated at 1.35 million annually, and the incidence of children born with CHD is 1%, with over 100,000 new cases in China each year. With the development of medicine, when women are 18–20 weeks pregnant, fetuses can be screened for congenital heart disease under cardiac ultrasound. ‹#›

70. Cont… If a fetus has complex congenital heart disease, pregnant women can choose to terminate pregnancy at this stage. The detection rate of complex congenital heart disease by prenatal ultrasound screening is less than 50% T o provide better care for CHD children, parents need certain levels of postoperative knowledge, including how to understand children’s medical information, reduce anxiety, help children, and get support and comfort I n addition,health care professionals need to provide parents with disease management and treatment informatio n ‹#›

71. Aims & Objectives To explore the home care experiences of caregivers taking care of CHD children before and after cardiac surgery. ‹#›

72. Methodology Approach: Qualitative descriptive study Design- Phenomenological study Sampling technique: Purposive Sampling Population: CHD Childs Setting: University Children hospital of soochow, Suzhou China Sample size: 22 caregivers, CHD Childrens ‹#›

73. ‹#› P articipants Age - 23 and 40 years caregiver including 17 mother 5 father

74. Ethical considerations ‹#› This study was approved by the Ethics Committee of Children’s Hospital of Soochow University in Suzhou City, Jiangsu Province, China (Approval #2011002). The interviewees were informed of the purpose, methodology, content, and significance of this study.

75. Why Ethics matters in research ?

76. Criteria Inclusion criteria Children who accepted cardiac surgery for CHD treatment Children older than 1 month but less than 60 months Caregivers who were the children’s parents Caregivers who had normal cognition and expression ability Exclusion Criteria Caregivers who had a mental illness Children who had heart, lung, or brain functional failure or other serious complications

77. Data collection semi-structured interview Consulting six pediatric cardiac nurse Referring to systematic literature reviews modified interview outline on the basis of the outcome conducted a preliminary interview of five caregivers

78. F inal Interview Outline 1-W hat the caregivers knew about the CHD operation procedures 2-H ow they knew about the CHD operation procedures 6-What was the most difficult problem they encountered during the home care process 3-H ow they felt when they learned that their children had to undergo operations 4-whether the nurses told them everything they needed to know and did they want to know anything else about the operation 5-H ow they felt during the home care proces s

79. Cont… 10-W hether their relatives supported them 9-How they arranged their daily lives 8-what was the most significant help they needed 7- How they solved those difficulties they encountered

80. Data saturation Study data were continuously collected until no new events emerged. Thus, data saturation was achieved

81. In this study, we took measures to ensure the credibility, transferability, consistency, and confirmability Rigor Credibility To increase credibility, we included all possible considerations and representations of study subjects who were chosen according to their age, sex, and level of education.

82. Transferability To increase transferability, all caregivers were interviewed by the same interviewers who remained neutral and encouraged the interviewees to clearly express their feelings. . Consistency Consistency was demonstrated by providing detailed descriptions of all phases of the analysis process. The interview duration and the number of interviews were extended after considering the actual situation

83. C onfirmability To increase the confirmability of data obtained from the actual content of interview, we included two investigators who had either very limited or no clinical experience with CHD children.

84. Data analysis The investigators extracted sentences containing information about home care experiences after the operation. The process continued with the completion of coding sheets, data grouping, category creation, and finally abstraction of categories. The various descriptions were placed under corresponding codes. The investigators worked together several times categorizing data. Thereafter, they segregated the data into five main categories Finally, they went back to the caregivers of CHD children who participated in this study and validated their findings. All the interviewees agreed that the investigators had presented accurate results. ‹#›

85. Table 1 . Demographic data of the children with congenital heart disease. Variables n F (%) Gender Male 13 59.1 Female 9 40.9 Age (months) 2–20 13 59.1 21–40 5 22.7 41–60 4 18.2

86. Residence City 8 36.4 Country 14 63.6 Only child Yes 17 77.3 No 5 22.7 CHD type VSD 8 36.4 ASD 5 22.7 PDA 5 22.7 TOF 4 18.2

87. Table 2. Demographic data of the caregivers. Variables n F (%) Education Middle School 7 31.8 Junior College 9 40.9 University 6 Income (yuan) <4000 5 27.3 4000–6000 11 50.0 >6000 6 27.3

88. Occupation Unemployed 3 13.6 Company worker 8 36.4 Agricultural worker (poor) 6 27.3 Office clerk 5 22.7 Caregiver Mother 7 77.3 Father 15 22.7

89. Analysis of the data identified five main themes , and each theme was supported by verbatim quotes from the study participants. Excessive mental burden Adapting roles constantly Under pressure and agony The impact on personal life Self-fulfillment in caring activities

90. Theme 1 Remorse and guilt Excessive mental burden Fear of Disclosure Frightened and restless

91. Theme-2 Under Pressure and agony Physical strength overdraft Heavy economic burden Disharmony in family relation

92. Theme -3 The impact on personal life Social impact Breaking the good life Forgetting self Integrated care role Seeking knowledge and help Theme -4 Adapting roles constantly

93. Theme-5 Self -fullment in caring activities Self affirmation Get satisfaction

94. Theme -1 Excessive mental burden Frightened and restless At first, the ability of the caregivers of CHD children to withstand sudden life changes was poor, which affected their mental health to a great extent. Because of China’s one-child policy, most CHD children were the only child in the family, and 19 caregivers of these 22 believed that the child was significant to the family.

95. Cont… There is a CHD child in the family, just like a stone pressed in the heart, and it is difficult to relax. I’ve never had sound sleep since my baby underwent surgery. When I took a nap, I was often awakened by nightmares. (Caregiver #2) Sometimes I went out and bought something, I always worried about the child at home. I am afraid he will have sudden difficulty breathing, and be rushed to hospital for treatment. (Caregiver #6)

96. Remorse and guilt Some caregivers appeared to suffer from feelings of remorse and uneasiness due to their child having CHD. Five caregivers blamed themselves for their children’s illnesses. When I was pregnant at an early stage, I had very bad cold with a fever, and I took a lot of medications. My child obtained this disease because of that. The doctor said the some medications may cause congenital defects of embryos. (Caregiver#5)

97. Caregivers of CHD children were often reluctant to disclose their children’s condition to colleagues or friends for fear that their children and the entire family would receive discrimination thus affecting the children’s future growth, both psychologically and physiologically. Seven caregivers believed that information about cardiac surgery should be kept confidential. Fear of disclosure

98. Cont… I take the child to the hospital, and I do not want to let others know. Sometimes when I met acquaintances in the hospital, I said that the child is only having a cold, just a minor illness. (Caregiver #7) My child underwent heart surgery, but I didn’t even tell my closest relatives and friends. If the information spreads out, other people will look at my children in a different way, which will affect his psychological health. CHD children who go to school and hunt for jobs in the future may be discriminated against. (Caregiver #4)

99. Theme 2: Under pressure and agony Physical strength overdraft CHD children who underwent surgery sometimes had difficulty breathing and feeding, and cried uneasily. Caregivers had to perform a lot of manual labor, including feeding children, changing diapers, administering medicine, and bathing, and they often felt powerless. Seven caregivers felt physically and mentally exhausted and physically overdrawn.

100. Cont… I’m busy all day,no time to rest. Sometimes I only slept 2–3 hours each night, and I can’t stand it anymore, but I cannot break down, because my child is so small.What can he do if I break down? (Caregiver #9)

101. I am just like a machine, taking care of my child from morning till night, including feeding milk and helping taking medicine. It is difficult for him to drink 30 ml of milk at one time; he needs to spit some out; bedding and clothing are often wet, so I must change his clothes, otherwise he will catch a cold again, which will exacerbate his illness. I think I’m going to break down. (Caregiver #1)

102. For the family of a CHD child, the economic pressure is very great. Indeed, the cost of cardiac surgery is as high as 6000 yuan (US$10,000), and much money is spent on monthly visits to the hospital. In addition, dispensing and inspection expenses are also very large. Six caregivers believed that the children’s surgery had a strong impact on the family’s budget. Heavy economic burden

103. Cont… My family income is low, and we spent all our money on my son. I also feel embarrassed borrowing money from relatives and friends. Since the child’s illness, the family’s money has been used up. I hope our child could get better soon. (Caregiver #7) In order to provide the child with appropriate medical treatment and ensure his medical fees are paid, I save every penny. Since he became ill, I have not bought a new dress for myself, and never bought anything expensive. (Caregiver #8)

104. Disharmony in family relations Caregivers of CHD children often have friction with other family members because of the family chores and the heavy burden of home care. Moreover, the child is young, cannot communicate with parents, and cannot offer comfort. Caregivers lack emotional support and suffer great pain themselves. Five caregivers could not cope with family conflicts appropriately.

105. I take care of the child every day, and have no-one to discuss anything with. The child can- not talk and just cries. My husband works late every day, so he has no time to take care of our baby. I am so depressed! (Caregiver #3)

106. Theme 3:The impact on personal life Social Impact Caregivers of CHD children usually had no space and time for themselves, and did not participate in social activities. Five caregivers gave up their original responsibility and role in the work.

107. Cont… Ever since I heard that children had the disease, I have no mood to do my own thing. Originally, I planned to pursue postgraduate studies in 2 years and look for new career development opportunities, but the child is not well and I don’t have time and energy to learn. (Caregiver #7)

108. Breaking the good life Many young parents had an optimistic vision and plan for family and life, but when the child was diagnosed with CHD, all hope vanished like soap bubbles.

109. Cont… I had planned to save much money so that I may travel abroad with my family for a holiday. Now that my child underwent cardiac surgery, the plan was ruined. (Caregiver #4) I planned to buy a new house in 2 years, so that my retired parents may come and live in it. Now all the money has been spent on the child’s operation; I can’t afford to buy the house anymore. (Caregiver #8)

110. Forgetting self Caregivers of CHD children usually devoted all their energy and time to care for child and often neglected their own health needs. My friend said “you take care of the child every day except yourself. You didn’t do that before!” Sometimes I feel I’m really forgetting myself. (Caregiver #15)

111. Theme 4: Adapting roles constantly Seeking knowledge and help: When caregivers learned that their children had CHD, it came as a ‘bolt from the blue’ for many of them. However, over time, they gradually accepted the reality.

112. When I was in the hospital, I consulted the doctors and nurses about some of the knowledge of cardiac surgery, and the nurses were very patient with me. (Caregiver #3) I hope professionals will continue to help and care for us. I will do my best to take care of my child so that he can recover soon. (Caregiver #9)

113. Integrated care role While taking care of CHD children, caregivers gradually acquiesced to their roles.

114. Cont… I have to take good care of my child. He’s so weak. I want to protect him. I know I am the backbone and the hope of this family, and I can’t count on anyone else. It’s my duty. (Caregiver #13) When I was young, my parents doted on me and I never did any housework. My parents are old now, their health is not good, and they can’t help me anymore. Now I am the pillar of the family; I must be strong; I’m going to prop up my family. (Caregiver #21)

115. Theme 5: Self-fulfillment in caring activities Caregivers of CHD children often bore a heavy burden on their body and mind, but at the same time they gained similar happiness to other people. Self-affirmation :

116. Cont… I feel as a mother especially great; whether or not society needs me, whether or not my company needs me, my child definitely needs me. (Caregiver #20) I never felt the responsibility of being a mother like I do now. Now I think the most successful thing is that the baby smiles at me. I think it feels precious. (Caregiver #17)

117. Get satisfaction A very important reason that caregivers of CHD children try their best to take care of their children is to fulfill their responsibilities. Moreover, they achieved a sense of satisfaction when the children gradually recovered.

118. Cont… When the baby calls me ‘mum’, I feel so happy. When I saw him recovering gradually, I felt it was worthwhile to pay a lot more [money]. (Caregiver #22) I am the father of my child, and my child is the continuation of my life. Thus, it is my duty to take care of my child. I see the future in him. (Caregiver #14)

119. Discussion (Preoperative Period) Shock and Denial Present Study In the present study, we found that caregivers were most strongly aware of their emotional reactions and psychological distress (including shock, denial, and hopelessness) when they first learned that their children had CHD, which was consistent with other reports Similar Study Not Mentioned

120. Discussion (Operational Period) Inner fear & Suffering Present Study Lawoko et al investigated the anxiety level of parents of CHD children who underwent open chest surgery, and found that these parents were generally anxious. Cardiac surgery was associated with high risk and great trauma, and the efficiency of the cardiac operation as part of the CHD treatment as well as the risk of complications were the caregivers’ biggest concerns Similar Study . Cardiac surgery was associated with high risk and great trauma, and the efficiency of the cardiac operation as part of the CHD treatment as well as the risk of complications were the caregivers’ biggest concerns

121. Discussion (Convalescence Period) Postoperative period Worries about the future Present Study in the present study, we found that caregivers felt regretful and inferior for failing to have a healthy child, and almost all caregivers blamed themselves for their children’s suffering from CHD, and were extremely self-critical. Similar Study As well.Mahle et al believed that parents’ positive coping techniques can provide children with very good psychological support and promote their rehabilitation. Therefore, health care professionals should pay close attention to the mental health of caregivers and give them extra emotional support.

122. Discussion (Convalescence Period) Postoperative period Worries about the future Present Study . In this study, since all the children were infants, caregivers had to live with a heavy burden of care, including night time feeding, and pacifying the crying children to enable them to sleep. Similar Study , caregivers spent nearly all of their time taking care of children, resulting in termination of work, lack of social roles, and fewer opportunities to participate in recreational activities

123. Discussion (Convalescence Period) Postoperative period Worries about the future Present Study In the present study, we found that caregivers were more concerned with the surgical arrangements before the operation, and how to take good care for children after the operation. Nurses should inform caregivers about the medical treatment, surgery, and nursing information, and promptly appease any anxiety and confusion Similar Study Recent research has shifted from an emphasis on the psychopathology of family to a focus on the resilience of families in coping with the challenges presented by a young child’s condition

124. Study limitations Only those caregivers recruited whose CHD children were aged between 1 month and 60 months Themes had some overlapping, which appeared to be inevitable in this study.

125. Relevance to clinical practice This study describes the home care experiences and needs of caregivers whose children underwent CHD operations. The experiences of caregivers providing care to CHD children are complex, Hence, we need to sufficiently train healthcare staff so that they identify the needs of caregivers and provide them with targeted intervention that meets their demands. The findings from this study highlight the need for more effective and individualized nursing intervention for CHD caregivers.

126. Conclusions The study demonstrated that caregivers of CHD children who underwent cardiac surgery are under great psychological pressure during the home care rehabilitation period post operation. To further strengthen the care and emotional support, health care professionals should develop care plans for both CHD children and their caregivers, and reduce the intensity of stress effectively so that caregivers can maintain their physical and mental health

127. CONSOLIDATED CRITERIA FOR REPORTING QUALITATIVE RESEARCH (COREQ) GUIDELINES

128. Item no. Topic Guide Questions/Description Reported Domain 1: Research team and reflexivity PERSONALITY CHARACTERISTICS 1. Interviewer/facilitator Which author/s conducted the interview or focus group? Mentioned 2. Credentials What were the researcher’s credentials? E.g. PhD, MD NOT Mentioned 3. Occupation What was their occupation at the time of the study? NOT Mentioned

129. Item No. Topic Guide Questions/Description Reported 4. Gender Was the researcher male or female? MALE 5. Experience and training What experience or training did the researcher have? NOT MENTION Relationship with participant 6. Relationship established Was a relationship established prior to study commencement? First author provided information about Study NOT Mentioned

130. Item No. Topic Guide Questions/Description Reported 7. Participant knowledge of the interviewer What did the participants know about the researcher? e.g. personal goals, reasons for doing the research Yes, First author provided information about her background 8. Interviewer characteristics What characteristics were reported about the interviewer /facilitator? e.g. Bias, assumptions, reasons and interests in the research topic caregiver

131. Item No. Topic Guide Questions/Description Reported Domain-2 Study Design Theoretical framework 9. Methodological orientation and Theory What methodological orientation was stated to underpin the study? e.g. grounded theory, discourse analysis, ethnography, phenomenology, content analysis Phenomenological- Participant selection 10. Sampling How were participants selected? e.g. purposive, convenience, consecutive, snowball Purposive Sampling

132. Item No. Topic Guide Questions/Description Reported 11. Method of approach How were participants approached? e.g. face-to-face, telephone, mail, email Face-to-face 12. Sample size How many participants were in the study? 22 caregiver 13. Non-participation How many people refused to participate or dropped out? Reasons? Not reported

133. Item No. Topic Guide Questions/Description Reported Setting 14. Setting of data collection Where was the data collected? e.g. home, clinic, workplace University children Hospital in china 15. Presence of non-participants Was anyone else present besides the participants and researchers? 16. Description of sample What are the important characteristics of the sample? e.g. demographic data, date Table 1 and Table 2

134. Item No Topic Guide Questions/Description Data collection 17. Interview guide Were questions, prompts, guides provided by the authors? Was it pilot tested? Prompts shared in supplementary data 18. Repeat interviews Were repeat interviews carried out? If yes, how many? Not repeat 19. Audio/visual recording Did the research use audio or visual recording to collect the data? Yes

135. Item no Topic Guide Questions/Description Reported 20. Field notes Were field notes made during and/or after the interview or focus group? Yes Page 5 21. Duration What was the duration of the interviews or focus group? Table 3 22. Data saturation Was data saturation discussed? Yes Page 3 23. Transcripts returned Were transcripts returned to participants for comment and/or Correction? Not reported

136. Item No. Topic Guide Questions/Description Reported Domain 3: Analysis and Findings Data analysis 24. Number of data coders How many data coders coded the data? Not mentioned 25. Description of the coding tree Did authors provide a description of the coding tree? Page 6 26. Derivation of themes Were themes identified in advance or derived from the data? Identified

137. Item no Topic Guide Questions/Description Reported 27. Software What software, if applicable, was used to manage the data? Not reported 28. Participant checking Did participants provide feedback on the findings? Not reported Reporting 29. Quotations presented Were participant quotations presented to illustrate the themes/findings? Was each quotation identified? e.g. participant number Quotations are marked “V” for video and “I” for interviews.

138. Item No Topic Guide Questions/Description Reported 30. Data and findings consistent Was there consistency between the data presented and the findings? Page 5,6,7 illustration of invitations to participants 31. Clarity of major themes s Were themes identified in advance or derived from the data? Page 6 32. Clarity of minor themes Is there a description of diverse cases or discussion of minor themes? Page 6