Abstract of the thesis entitled. An evidence-based nurse-led fluid and dietary control program for haemodialysis patient. Submitted by.

Transcription

1 Abstract of the thesis entitled An evidence-based nurse-led fluid and dietary control program for haemodialysis patient Submitted by LAU, Wai Kwan For the degree of Master of Nursing at the University of Hong Kong in August 2013 End stage renal failure refers to an irreversible kidney dysfunction in which the kidneys fail to remove toxins from the blood stream. Haemodialysis is an effective treatment modality to sustain the lives of patients with end stage renal failure by removing waste products like urea, creatinine, and excess fluid. It involves a challenging regimen including dietary restrictions to ensure long-term survival. Failure to adhere with the regimen can result in fatal consequences. Renal patient discomfort related to non-adherence is commonly seen in clinical settings; however, there is currently no evidence-based fluid or dietary education program available to haemodialysis patients. This dissertation aims to identify and evaluate current evidence for the effectiveness of dietary and fluid control programs in the treatment of haemodialysis patients, to assess the transferability and feasibility of implementing a nurse-led education program regarding dietary and fluid control in haemodialysis patients, and to develop an evidence-based, nurse-led fluid and dietary control program for haemodialysis patients.

2 Four electronic bibliographical databases including PubMed, Cochrane library, PsycInfo and CINAHL and two searching engines including Google scholar and ProQuest were used to identify studies that examined the effectiveness of educational programs or interventions on fluid or dietary control for patients on haemodialysis. Forty-five unique studies were identified as potentially relevant. Eleven of those studies met the selection criteria and were evaluated in this dissertation. Appraisal instrument was used to evaluate the quality of the selected studies. Six studies and three studies showed statistically significant in reduction of serum phosphate level and interdialytic weight gain respectively after educational intervention. Critical evaluation of the available studies led to an evidence-based, nurse-led, fluid and dietary control program for haemodialysis patients that followed the guideline development process of the Scottish Intercollegiate Guideline Network. Comparison on the similarity of patient characteristics, staff competence, and organizational settings of the evaluated studies were similar to those of the target unit. Therefore, the proposed program may be transferable and feasible. Furthermore, a cost-benefit analysis showed that the benefit of the fluid and dietary control program to patients outweighs the cost needed to implement the program. This dissertation outlines a proposed twenty-week program including marketing of the program, training of staff in the targeted renal unit, pilot testing, and application of the proposed program. Evaluation of the program will focus on three categories: patient outcome, health care provider outcome, and organization outcome. Clinical effectiveness of the program is defined by an overall reduction in patients mean interdialytic weight gain and mean serum phosphate level, improvement in knowledge

3 test scores by patients, satisfactory nurses attendance rate in the renal training sessions, high nurse satisfaction with the educational program, and reduction of admission rate related to non-adherence.

4 An evidence-based nurse-led fluid and dietary control program for haemodialysis patient By LAU, Wai Kwan BN, RN A thesis submitted in partial fulfilment of the requirements for the Degree of Master of Nursing at the University of Hong Kong. August, 2013

5 Declaration I declare that this thesis represents my own work, except where due acknowledgement is made, and that it has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. LAU, Wai Kwan August, 2013 i

6 Acknowledgements I would like to express sincere gratitude to my supervisor, Professor Agnes Fung-Yee Tiwari, Head of School of Nursing, for her guidance and enlightenment. I am deeply grateful to my co-supervisor, Dr. Janet Wong Yuen Ha, Assistant Professor, for her encouragement and assistance. This dissertation could not have been completed without their generous support. I would like to thank Dr. Daniel Fong and Dr. William Li for giving tutorials of this dissertation. Finally, heartfelt thanks to my parents and brother for their understanding and support throughout my studies. ii

7 Contents Declaration... i Acknowledgement.... ii Table of Contents. iii Abbreviations iv Chapter 1 Introduction 1.1 Background Affirming the Need Global and Local Situation Current Practice Reason of Non-adherence and Role of Nurses Objectives and Significance Chapter 2 Critical Appraisal 2.1 Search and Appraisal Strategies Identification of Studies Inclusion Criteria Exclusion Criteria Data Extraction Appraisal Strategy Results Search Results Study Characteristics Methodological Issue of Studies Summary and Synthesis Summary of Data Synthesis of Data Conclusion Limitation of the Integrated Review Chapter 3 Translation and Application 3.1 Implementation Potential Transferability of Findings Feasibility Cost-benefit Ratio of the Innovation iii

8 3.2 Evidence-based Protocol Guideline Title The Objectives of this Guideline Intended Users Target Population Recommendations. 31 Chapter 4 - Implementation Plan 4.1 Communication Plan Identification and Involvement of Stakeholders Communication Strategies Pilot Study Plan Subject Recruitment Acceptability and Feasibility of the Proposed Innovation Intervention after Pilot Study Evaluation Plan Outcome Evaluation Nature and number of Clients Involved Time and Frequency of Taking Measurements Data Analysis Determining the Effectiveness of the Guideline Ethical Considerations Conclusion Appendices A. Search strategies and Search History B. Characteristics of excluded studies C. Tables of evidence D. Quality Assessment of Selected Studies E. Level of evidence hierarchy developed by the Scottish intercollegiate Guideline Network (SIGN) F. Comparison of the demographic characteristics of targeted patients between pediatric and adolescent renal unit and eleven selected studies G. Estimated operational cost for the fluid and dietary control program H. Grading recommendations developed by Scottish intercollegiate Guideline Network (SIGN) iii

9 I. Quality of the selected studies J. Summary of the proposed fluid and dietary education program K. Training Content by Renal advanced practice nurses (APNs) and Dietician L. Schedule for Implementing the Innovation M. Questionnaire to Patient on Feedback of Nurse-led Evidence-based Fluid and dietary control program References. 88 iii

10 Abbreviations APN COS DOM ESRF IDWG RCTs SIGN Advanced practice nurses Chief of Services Department Operations Manager End stage renal failure Interdialytic weight gain Randomized controlled trials Scottish intercollegiate Guideline Network iv

11 Chapter 1 Introduction 1.1. Background In 2011, over 121,000 persons in Hong Kong suffered from end stage renal failure (ESRF; Hospital Authority, 2011). ESRF refers an irreversible kidney dysfunction in which kidneys are not able to remove toxins from the blood stream. Dialysis and renal transplantation are the only available treatments for ESRF. Haemodialysis is an effective treatment modality to sustain the lives of patients with ESRF by removing the waste products like urea, creatinine, and excessive fluid. Patients usually have three to four sessions of 4-hour per session haemodialysis a week. Haemodialysis involves a challenging, complex, and long-term treatment regimen including adherence to fluid and dietary restrictions to ensure long-term survival (Mogan, 2000). Failure to adhere to the regimen can be fatal. Fluid restriction depends on the residual diuresis and can be as strict as a maximum of 500 ml intake daily (Denhaerynck et al., 2007). Fluid intake can be objectively measured by the interdialytic weight gain (IDWG), which is calculated by subtracting the post haemodialysis body weight of the previous session from the weight before the current haemodialysis session. The validity and reliability of IDWG measurement to indicate the fluid intake adherence has been evaluated in multiple 1

12 studies (Sharp, Wild, & Gumley, 2004; Tsay, 2003 & Kugler wt al., 2005). Non-adherence to fluid restriction may lead to poor health outcomes in patients undergoing haemodialysis. Hypertension, peripheral edema, pulmonary edema, muscle cramping, and dizziness can be caused by excessive fluid or sodium intake. Hypertension is the most common cause of death in patients receiving haemodialysis (Horl & Horl, 2003; Lopez-Gomez et al., 2005; Rahman, Sehgal, & Smith, 2000). Excessive IDWG between sessions of haemodialysis was associated with a 35% higher risk of death (Denhaerynck et al., 2007). In addition to reduced fluid intake, patients undergoing haemodialysis for ESRF must restrict phosphate and potassium intake. Serum phosphate levels monitor phosphate intake adherence. Non-adherence to phosphate limitation may also lead to health problems. Skin itchiness, bone pain, and even bone fractures may occur as a result of poor phosphate restrictions. Chronically elevated serum phosphate levels may lead to secondary hyperthyroidism and cause renal osteodystrophy (Malluche & Mawad, 2002). Increased serum phosphate level can also increase the risk of developing of coronary artery disease, even in young patients (Goodman, 2002). Excessive potassium intake can lead to hyperkalemia, which can cause alterations in skeletal, myocardial, and smooth muscle contractility, cardiac arrhythmias, cardiac arrest, and, in severe cases, paralysis of muscles that control 2

13 ventilation (Kugler et al., 2005). Interventions that promote fluid and dietary adherence in haemodialysis patients are crucial to the wellbeing and survival of patients. Adherence means more than just obeying instructions (Idier et al., 2011). Morgan (2000) said adherence implies more active and collaborative involvement of patients by working together with health care professionals in planning and implementing the treatment regimen. To promote adherence in haemodialysis patients, nurses play important roles in negotiating with patients on the treatment plan and assisting patients in achieving the treatment goals Affirming the Need Global and Local Situation Prevalence of fluid and dietary non-adherence in haemodialysis patients is high internationally. Denhaerynck et al. (2007) reviewed ten studies and summarized that self-reported prevalence of non-adherence with fluid restrictions ranged from 30% to 74% and from 19% to 57% for phosphorus intake. Furthermore, Leea and Molassiotis (2001) reported the rate of fluid and dietary compliance of Chinese patients on haemodialysis is only 40.3% and 35.5%, respectively. From observation in the clinical setting of a haemodialysis unit in Hong Kong, the phenomenon that patients frequently complain of discomforts like dizziness and 3

14 headaches during haemodialysis is commonly seen. Some patients even experience a sudden loss of consciousness when receiving haemodialysis. Of these patients, most of them are related to excessive IDWG. It is not uncommon to see patients requiring hospitalization or even admission to the intensive care unit because of fluid overload. Sometimes, extra sessions of haemodialysis may have to be arranged to save lives of non-adherent patients. Besides, with review of their laboratory findings of their blood tests, hyperphosphatemia and hyperkalemia are expected in most of patients which would seriously affect patient s calcium metabolism in bone as a result of secondary hyperparathyroidism as mentioned and cardiac emergency respectively Current Practice In the haemodialysis unit of Hong Kong, fluid restriction is usually recommended by the physician in charge and reviewed by nurses with the patient. A dietician gives the dietary recommendation for patients when they are diagnosed with ESRF prior to or at the beginning of long-term haemodialysis. Dietary recommendations are reviewed only if there is any problem regarding the diets upon the request sent by physician. There is no standard schedule to review patient adherence to fluid and dietary restrictions and no standard fluid or dietary education program provided to patients. The nurses in the renal team provide haemodialysis to the patients with ESRF 3 to 4 times a week. They do not provide regular education 4

15 regarding diet restrictions or fluid limitation. The current practices of haemodialysis patient education are inadequate to promote patient wellbeing. Interventions targeted to improve fluid and dietary adherence should be implemented for the sake of patients safety and welfare Reason of Non-adherence and Role of Nurses Haemodialysis patients do not adhere to recommended fluid and dietary restrictions for a wide variety of reasons. Lack of information (Baraz et al., 2009), lower self-efficacy (Tsay, 2003), younger age (Kugler et al., 2005; Kugler et al., 2011; Leggat et al., 1998), and perceived barriers are all related to non-adherence (Lee & Molassiotis, 2001). To improve fluid and dietary adherence, it is essential to develop an evidence-based fluid and dietary control program. Nurses are in an excellent position to assess and enhance adherence and to subsequently improve clinical outcomes (Denhaerynck et al., 2007; Tsay, 2003). They have more face-to-face interactive time to reinforce the importance of adherence compared to other health care professionals (Barnett et al., 2007; Denhaerynck et al., 2007). They can engage in communication with patients during the haemodialysis sessions and use active listening and talking skills to educate the importance of adherence and what they have to comply with, listen to patient difficulties with the restrictions, and suggest solutions to the difficulties when adhering to the treatment 5

16 regimen. The role that nurses play in educating and supporting patients with chronic diseases is now well established (Denhaerynck et al., 2007). However, there is no such intervention that promotes fluid and dietary adherence led by nurses in a renal setting in Hong Kong. If an evidence-based, nurse-led fluid and dietary control program is provided to haemodialysis patients, the adherence rate of dietary and fluid control of the patients should increase Objectives and Significance The objectives of this dissertation are: i. To identify and evaluate the current evidence of the effectiveness of using dietary and fluid control programs with haemodialysis patients ii. To assess the transferability and feasibility of implementing a nurse-led education program regarding dietary and fluid control for haemodialysis patients iii. To develop an evidence-based, nurse-led fluid and dietary control program for haemodialysis patients A successful evidence-based, nurse-led fluid and dietary control program for patient on haemodialysis should increase a patient s knowledge of the importance of 6

17 fluid and dietary adherence and the complications that may arise due to non-adherence. Knowledge is a precondition of change (Mason, 2008). If patients lack knowledge about how their fluid intake and dietary habit affect their health, the reason for change is little. With the successful implementation of the program, mortality and morbidity of patients on haemodialysis related to non-adherence can be decreased and the wellbeing of them can be promoted. Although nurses have to implement the program, their overall workload is still decreased since extra haemodialysis sessions, unexpected hospitalization, and admission to intensive care units due to non-adherence can be minimized. Moreover, patients complaints of discomfort during haemodialysis can be decreased so as to lower the uncertainty faced by nurses when caring of patients undergoing haemodialysis. Additionally, society as a whole may benefit from haemodialysis patient education by a reduction in medical costs through the elimination of extra haemodialysis sessions and unexpected hospitalizations. 7

18 Chapter 2 Critical Appraisal 2.1 Search and Appraisal Strategies Identification of Studies Studies were first identified as potential publications of interest by using four electronic bibliographical databases (PubMed, Cochrane library, PsycInfo and CINAHL) and two search engines (Google Scholar and ProQuest) that were available in the Yu Chun Keung Medical Library of The University of Hong Kong and Electronic Knowledge Gate (ekg) of the Hospital Authority. The keywords used included hemodialysis, haemodialysis, education, teaching, intervention, dietary adherence, fluid adherence, interdialytic weight gain, hyperphosphatemia, potassium, and hyperkalemia. Detailed searching strategies and other keywords used were described in Appendix A. No restrictions were set on date or language of publications to avoid missing of potential publication selected or language bias. The titles and abstracts of all potential publications were carefully screened and full text papers related to the review topic were retrieved. Studies with relevant titles and abstracts but without available full text were then manually searched in other databases and search engines. In addition, manual search of the citation list of the selected studies was done to further screen for other potential 8

19 studies Inclusion Criteria All studies, including systematic reviews, meta-analysis, randomized controlled trials, and quasi-experimental trials, about education or teaching program or interventions addressing fluid or dietary control for patients on haemodialysis were included Exclusion Criteria Studies were excluded if they were conducted on patients on home haemodialysis, focused on psychological intervention without an educational or teaching element, or used measures of psychological outcomes only Data Extraction Data related to study type, level of evidence, subject characteristics, sample size, intervention, comparison, outcome measures, length of follow up, and effect size were extracted. Outcome measures included in the review were IDWG, serum phosphate level, dietary knowledge test score, and serum potassium level. 9

20 2.1.5 Appraisal Strategy The methodological quality of the included studies was evaluated with the checklist developed by Scottish Intercollegiate Guideline Network (SIGN, 2011). The following methodological areas were assessed: Appropriate and clearly focused question Random assignment Concealment method Blinding on subjects and investigators Comparison of similarity of experimental and control group The treatment under investigation Outcome measurement Dropout rate Intention to treat analysis Results between different sites The overall assessment was done by coding to indicate the study s effort on minimizing bias, and to evaluate on the study methodology, power analysis and generalizability. 10

21 2.2 Results Search Results A total of 664 citations were retrieved on 28 June, After reviewing the title and the abstract, 45 of the citations were potentially relevant to the study of fluid and dietary control programs. Of these, 21 of studies met the selection criteria. After elimination of duplicated publications, eleven publications were evaluated in this dissertation. The characteristics of the excluded studies are listed in Appendix B. All of studies were published in English. No studies published in other language were found Study Characteristics The eleven articles included were all primary studies that were published from 1998 to Among the studies, six of them were randomized controlled studies (RCTs), one was non-randomized controlled trial, and four were quasi-experimental studies. Four studies were conducted in USA, two in England, two in Taiwan, one in Malaysia, one in Iran, and one in Spain. No local studies were identified. Five studies were conducted in a single haemodialysis center and six studies were multi-center studies that included between two to fourteen haemodialysis units. The outline of study characteristics were stated in the appendix C, table of evidence. The quality of 11

22 the selected studies from critical appraisal was ranked from 2+ to 1+. Details of the critique were listed in appendix D, quality assessment of selected studies Methodological Issue of Studies The qualities of the selected studies varied. All studies addressed a clear and appropriate research questions or examined the effect of educational programs on fluid adherence or dietary adherence. Among the six RCTs, Baraz et al. (2009) used random allocation by using computer-generated numbers; Sullivan et al. (2009) used cluster randomization with utilization of random number generator. Tsay, (2003) only briefly mentioned that blind randomization was used in the published study. Group randomization was used in Lou et al. (2011). Ford et al. (2004) used a random number table to allocate the subjects to either a control or an experimental group. Random alternate allocation was used in Ashurst and Dobbie (2003), which was not an appropriate randomization, and therefore resulted in the study being downgraded to a controlled clinical trial instead of a RCT. Concealment was considered as well achieved in four studies (Baraz et al., 2009, Ford et al., 2004, Lou et al., 2011, Sullivan et al., 2009) according to the randomization method stated, and fairly achieved in Tsay (2003). Ashurst and Dobbie (2003) did not report the concealment method. Another controlled trial without randomization was Shaw-Stuart and Stuart 12

23 (2002), in which the experimental group and the controlled group were separated in two different private dialysis units. The four remaining studies consisted of three quasi-experimental designs including Schlatter and& Ferrans (1998), Sun et al. (2008), and Barnett et al. (2007), and one pilot study, Casey, Johney, and MsClelland (2002). All four studies used the same group pretest and posttest design to compare the subject before and after the intervention. Using the same group pretest and posttest design allowed the researcher to monitor the effect of the intervention while reducing the possibility of individual difference. However, selection bias and Hawthorn effect may exist under this design. A general limitation of all the selected studies is absence of blinding of experimenters and subjects. All the studies addressed that participants were required to sign consents before entering the studies, therefore blinding of subjects was impossible. The possible Hawthorn effect is shared in both experimental group and control group in all studies. Several studies addressed the blinding of researchers and other health care providers who were not involved in the research process. Sullivan et al. (2009) stated that because a study coordinator had to carry out the intervention, blinding was not possible. Blinding of the researchers was not achieved in Lou et al. (2011), Tsay (2003), and Ashurst and Dobbie (2003) but physicians, nurses, dieticians, and social workers were blinded in Tsay (2003). Haemodialysis dieticians and 13

24 clinicians who were not the researcher were kept blinded in Ashurst and Dobbie (2003) and Lou et al. (2011), respectively. Ashurst and Dobbie (2003) mentioned that the researcher did not contact the control group to avoid contamination. Blinding of the researcher was not stated in Shaw-Stuart and Stuart (2002) and Fort et al. (2004). Since blinding to experimenter was not done in all studies, possible experimenter bias may exist. In the eleven studies included in this analysis, sample size ranged from 21 to 288 patients. Power analysis was performed in four studies (Barnett et al., 2007; Lou et al., 2002; Sullivan et al., 2009; Tsay, 2003). Among these, only Sullivan et al. (2009) included a rigorous power analysis with a detailed description of how the required sample size was calculated. All studies included reported the study participation dropout rate (0% to 13.3%). An intention to treat principal was noted in three studies (Baraz et al., 2009; Lou et al., 2002; Sullivan et al., 2009). From the above quality assessment, three out of eleven studies were considered less rigorous because of the weak methodological designs that may lead to higher chances of bias. In the study of Shaw-Stuart and Stuart (2000), the concealment method was not addressed, dropout rate was not reported, and the authors did not report if there was significant difference in demographic data between the two groups. In Schlatter and Ferrans (1998), a high dropout rate, small sample size, 14

25 and a failure to consistently comply with intention-to-treat principal were noted. Lastly, Casey, Johney, and MsClelland (2002) was a pilot study that included a small sample size. Studies that were labeled as not rigorous were less important during the summary and synthesis of findings. 2.3 Summary and Synthesis Summary of Data Form the eight studies included in the summary, five were RCTs and three were quasi-experimental design. Two of them measured IDWG only (Barnett et al., 2007; Tsay, 2003), five measured serum phosphate level (Ashurst & Dobbie, 2003; Ford et al., 2004; Lou et al., 2002; Sullivan et al., 2009; Sun et al., 2008) and one (Baraz et al., 2009) measured IDWG, serum phosphate level, and serum potassium level. Baraz et al. (2009), Tsay (2003), and Barnett et al. (2007) showed a decrease of IDWG from 0.43kg to 0.9kg. Baraz et al. (2009) reported the highest decrease in mean of IDWG (p<0.000). Rate of fluid compliance was measured in Baraz et al. (2009) and Barnett et al. (2007). Barnett et al. (2007) defined rate of fluid adherence by the number of times subjects presented with an IDWG equal to or less than 2.5kg over a study period consisting of 26 hemodialysis sessions. The reported rate of fluid 15

26 adherence increased from 47% to 71.5% after intervention. However, Baraz et al. (2009) did not clearly define the fluid compliance rate. Blood pressure, a variable related to fluid adherence, was monitored only in Barnett et al. (2007), and was found not showing significant change after intervention. Serum phosphate level was measured in six studies. Ashurst and Dobbie (2003) defined hyperphosphatmia is a serum phosphate level greater than 1.7mmol/L. Lou et al. (2002) and Sullivan et al. (2009) defined it as a serum phosphate level greater than 5.5 mg/dl. Another two studies (Ford et al., 2004; Sun et al, 2008) defined it as a serum phosphate level greater than 6.0 mg/dl. The unit mg/dl was used for serum phosphate level in five studies except Ashurst & Dobbie (2003) used mmol/l for the measuring unit. Units were standardized to mmol/l by multiplying the value in mg/dl by as corresponded to the laboratory test in local setting. The change of the serum level among the six studies ranged from mmol/L to mmol/L. Lou et al. (2012) recorded the greatest decrease in serum phosphate level among the subjects from 2.293mmol/L to 1.777mmol/L (p = 0.002). In addition to treatment, one factor that might affect the serum phosphate level is medication. Medication related to phosphate binder was noted in Sullivan et al. (2009), Ashurst and Dobbie (2003), and Lou et al. (2012). Sullivan et al. (2009) recorded patients drug history during baseline data collection but did not change 16

27 medication or adjust its dosage during the intervention period. In contrast, Lou et al. (2012) allowed patients to change medications during the treatment under the advice of blinded clinicians. And Ashurst and Dobbie (2003) distributed a medication diary to both the intervention group and control group for them to record dosage and time of taking phosphate blinder. A secondary outcome measured in Sullivan et al. (2009) and Ford et al. (2004) was knowledge test score related to dietary adherence. Sullivan et al. (2009) conducted a test of nutritional knowledge related to reading ingredient labels and fact labels when choosing food, while Ford et al. (2004) conducted a knowledge test that only addressed phosphorous intake. Sullivan et al. (2009) had the highest change in knowledge score from 67% to 74% (p < 0.001). Serum potassium level was measured in only Baraz et al. (2009). However, the result is not statistically significant. The measured serum potassium level decreased from 5.46 meq/l to 5.1 meq/l (p = 0.184) and from 5.25mEq/L to 4.98 meq/l (p = 0.420) in the verbal education group and the video education group, respectively. Therefore, the only examination of the effect of intervention in patient potassium levels showed that intervention does not have a significant impact on serum potassium levels. Among the studies, three studies were conducted by nurses (Baraz et al., 2009; Barnett et al., 2007; Tsay, 2003), four studies were conducted by dieticians (Ashurst 17

28 and Dobbie, 2003; Ford et al., 2004; Lou et al., 2012; Sun et al., 2008) and one was carried out by a trained study coordinator (Sullivan et al., 2009) Synthesis of Data Subjects. From the eight included studies, the interventions were all applied to patients on chronic haemodialysis. All of the patients in the studies suffered from ESRF and required haemodialysis to sustain their lives, which is similar to the local setting. Most of the patients included in the studies were over the age of 18, probably because the sample in paediatric and adolescent renal units is limited and not sufficient to conduct a quality study. However, the age of all the population in the selected haemodialysis unit locally is 5 to 24, and the proposed evidence-based program will target patients 12 or above. The age range of the included studies is slightly different from the targeted patients, however it is unavoidable as it is the only population in the selected renal unit. Transferability of the evidence from the included studies is still applied to this group of patients because adolescents aged 12 and older are deemed cognitively mature (Kozier et al., 2004). They are able to use new information and communicate with adults on most subjects (Kozier et al., 2004). Therefore, the adolescent patients are able to understand the knowledge and the concept of proposed educational program. 18

29 Fluid and Dietary Control Program. Regarding to the fluid and dietary program, evidence from seven out of the eight studies included suggested that individual education sessions are effective to improve adherence (Ashurst & Dobbie, 2003; Barnett et al., 2007; Ford et al., 2004; Lou et al., 2012; Sun et al., 2008; Sullivan et al., 2009 Tsay, 2003). Only Baraz et al. (2009) did not mention the size of the group when demonstrating that group education was effective. All selected studies indicated that at least 30 minutes per session was effective to meet treatment goals (Ashurst & Dobbie, 2003; Barnett et al., 2007; Baraz et al., 2009; Ford et al., 2004; Lou et al., 2012; Sun et al., 2008; Sullivan et al., 2009; Tsay, 2003). Tsay (2003) had the longest teaching session of 60 minutes per session. It may be because the study of Tsay (2003) included more psychological elements apart from the educational part, such as setting goals and stressing emotional adjustment. Moreover, the number of sessions of education provided in the studies varied from one to twelve sessions. Ashurst and Dobbie (2003) and Sullivan et al. (2009) suggested one session, Baraz et al. (2009) suggested two, Lou et al. (2012) and Ford et al. (2004) suggested six, Barnett et al. (2007) suggested eight, and Sullivan et al. (2009) suggested twelve. A teaching booklet or handouts provided to patients as reference was shown to be effective to improve adherence in five of the included studies (Ashurst & Dobbie, 2003; Baraz et al., 2009; Ford et al., 2004; Sun et al., 19

30 2008; Sullivan et al., 2009). Effective education content common among the studies included knowledge related to ESRF, fluid limitations, dietary management for haemodialysis, restriction on food choices reasons for compliance, possible adverse consequences of non-compliance, and medications. Specific knowledge-like content of phosphorus in food additives included in the education program confirmed to be useful in reducing the serum phosphate level of haemodialysis patients (Sullivan et al., 2009). Patient adherence was enhanced through the inclusion of counseling and supportive measures in the education program (Barnett et al., 2007; Tsay 2003). Outcome Measures. From all the included studies, evidence showed IDWG is the standard measurement of adherence to fluid limitation (Baraz et al., 2009; Barnett et al., 2007; Tsay, 2003) and monitoring the level of serum phosphate is the indicator of phosphorus intake restriction (Ashurst & Dobbie, 2003; Baraz et al., 2009; Ford et al. 2004; Lou et al. 2012; Sullivan et al., 2009; Sun et al., 2008). Interventionist. Among all the included studies, three of them (Barnett et al., 2007; Sun et al.,2008; Tsay, 2003) stated nurses have an important role in educating, monitoring, reinforcing, and encouraging patients on haemodialysis and providing assistance whenever necessary, as they had a long term relationship with patients. 20

31 Although dieticians performed other studies, they did not suggest that dieticians should perform the educational program (Ashurst & Dobbie, 2003; Ford et al., 2004; Lou et al., 2012; Sun et al. 2008). Nurses may have the advantages to be the interventionist in the fluid and dietary control program from the evidence of the selected studies as they can collaborate with patients to achieve the adherence to the treatment regimen Conclusion No available studies provide the most effective guidelines for fluid and dietary control programs for patients on haemodialysis. However, this literature review has identified some essential elements that should be included in fluid and dietary control programs for haemodialysis patients. The target group of the guidelines is patients on chronic hemodialysis without mental incapability. Published data suggest that the intervention should be a one on one education session or group teaching session with at least 30 minutes per session for at least one session with teaching booklets or handouts provided to patients. A telephone follow up may be useful to improve adherence. The primary outcomes would be IDWG and serum phosphate level. Secondary outcome can be knowledge test score. 21

32 2.5 Limitations of the Integrated Review In this integrated review, a single reviewer selected and assessed the studies. Risk of study selection bias and bias on quality assessment may exist. To minimize the risk of bias, extensive and systematic searches were done with various databases to reduce chance of missed publications. Furthermore, quality assessment was performed systematically with a validated tool to minimize the variation of reviewing the quality of the studies (SIGN, 2011). 22

33 Chapter 3 Translation and Application 3.1 Implementation Potential The integrated review discussed in the previous chapters demonstrated the fluid and dietary control program is effective in improving the health outcomes for patients on haemodialysis. The benefits of haemodialysis educational programs may be successfully transferred to other haemodialysis units, such as a selected renal unit in a public hospital of Hong Kong, to improve patients adherence to fluid and dietary restrictions. However, before adopting a new fluid and dietary control program, the transferability of the proposed educational program in the unit and the selected populations, the feasibility of implementing the program, and the cost-benefit ratio of the program in the proposed setting should all be carefully considered Transferability of Findings To assess if the proposed educational program would work well with the existing structures in the local haemodialysis unit, it is essential to compare the similarity of the target setting and that of the studies selected (Appendix F). The settings in the selected studies are either outpatient haemodialysis units or renal centers of hospitals are similar to the targeted renal unit in the local setting, a 23

34 paediatric and adolescent renal unit, which is a haemodialysis center. Both settings provide haemodialysis services to patients. Because ages and backgrounds of patients may impact the effectiveness of educational programs, the demographics and clinical background of populations in the selected studies and the targeted population of patients were compared. The published literature and the targeted population both served patients with ESRF on haemodialysis. However, there is a difference in the range of patient ages. Selected studies included mostly adult patients, but the targeted populations are adolescents aged 12 to 23 Although there is a difference in the age range, the proposed educational program is still transferable to the targeted renal unit. Since there are no established evidences or studies only focus on adolescents, to improve the dietary and fluid control in adolescent patients, it is necessary to search the best available evidence. Base on the principle, the concept of the fluid and dietary adherence are same in adult and adolescent patients. There is no reason to believe that educational programs based on the best available evidence could not be transferred to the local setting. Most patients in the target population are secondary school students, and therefore possess similar levels of literacy to patients included in published studies (Barnett et al., 2007; Schlatter & Ferrans, 1998; Sun et al., 2008). Moreover, most of the selected studies 24

35 were done in developed countries like USA and England, which share similar economic conditions and medical development with Hong Kong, thereby the transferability of the studies is not violated. Another factor concerning the success of transferability of findings is the philosophy of care. Patients with ESRF on haemodialysis require a more specialized care. The target setting and the reviewed studies employed a similar philosophy of care. The studies actively supported evidence-based practices that deliver cost-effective and high quality patient care to improve patients health outcomes. The studies findings also indicated that nurses are in a unique position to enhance the quality of care in patients with kidney disease and to collaborate with patients in adherence. The nurses in the local setting provide holistic care to patients and strive for the best quality of care to patients by supporting evidence-based practices and patient-centered care. It is estimated that the proposed educational program would benefit a large proportion of patients in the targeted setting. The targeted paediatric and adolescent renal unit is the largest haemodialysis center in Hong Kong, providing haemodialysis to paediatric and adolescent patients under Hospital Authority. Most paediatric and adolescent renal patients requiring dialysis in other Hong Kong hospitals are referred to the unit. The average number of patients requiring regular haemodialysis in this 25

36 center is around 20 per month. Among these patients, 85% of them are aged above 12 which are the targeted age range. It is estimated the proportion of patients benefit from the educational program is around 85% in the targeted setting which covered a large portion of adolescent patients requiring regular haemodialysis in Hong Kong. According to the length of follow up of the studies, length of implementation and evaluation is around twenty weeks Feasibility Administrative Support and Nursing Autonomy. To consider the feasibility of the proposed innovation, there are several factors that should be taken into account. Nursing autonomy on proposing evidence-based program and administrative support toward continuous quality improvement are granted in the selected renal unit of a public hospital under Hospital Authority. Currently, there is a new educational program for haemodialysis patients, which is well supported by the administrative stakeholders including the Chief of Services (COS), consultants, Department of Operation (DOM), ward manager, and nurses of the department. The program uses evidence-based practices to promote a better transition for adolescent patients transferring to the adult unit. Besides, there is an evidence-based group formed in our department led by DOM encouraged nurses to conduct quality improvement projects 26

37 based on the literatures. These showed that the organization climate is conducive to research utilization and that nursing staff and administrators are open to using evidence-based practices. Therefore, it is believed that the proposed program will be supported by administrative staff and can be carried out or terminated by nurses with autonomy. Anticipated Resistance. As with any new program, there may exist some internal resistance to change. The existing staff function would not be seriously affected, as education is the usual practice of the nurses in the proposed setting. However, as the new educational program would require more structured educational sessions, rearrangement of manpower and increased workload could be the source for potential resistance from staff members. A pilot study could be used to estimate the potential change in workload. This could provide a clear expectation of what might be changed under the new program, thus reducing resistance to the new program.. Staff Training and Resources. A new educational program will require staff knowledge and skills, time, equipment, and reorganization. Nursing staff in the target setting are mostly trained with renal specialty, possess knowledge relating to renal diet and fluid restriction, and are trained with skills for educating patients. To equip 27

38 the nurses involved with more detailed knowledge about diet control for haemodialysis patients, an experienced dietician will be invited to teach the nurses before implementation of the new program. Equipment like computer and stationary are available in the selected unit. Teaching booklets, handouts, and knowledge tests for the patients maybe designed by the nurses. Lecture rooms or activity rooms for education and training are available in the targeted setting. In addition, tools for evaluation of the program like blood tests and weight measurements are available. Overall, the facilities and equipment needed are easily assessable Cost-Benefit Ratio of the Proposed Program Potential Risks and Benefits. The new educational program presents no risk or harm to the participating patients, but it does require extra patient time. To ensure that the program is offered during a convenient time, the education sessions will be arranged right before or following their haemodialysis sessions for minutes. If the educational program is successful, patients would become more knowledgeable about their disease management and gain control over diet and fluid intake, eventually leading to better health outcomes. On the contrary, if the educational program is not carried out, patients health may be jeopardized. Poor fluid control could lead to dizziness, hypertension, and even pulmonary congestion (Baraz et al., 2009; Tsay, 28

39 2003). Also, poor dietary control may cause hyperphosphatemia and result in bone diseases (Sullivan et al., 2009). Estimated Cost. The new educational program would require minimal resources and manpower. The major material expenditure would include printing educational material like knowledge tests and teaching booklets. Most of the other resources including interview rooms and stationary are available in the selected setting. The setting up cost including the equipment, training expenses, and the running cost involves the printing of the educational materials in the long run. The overall cost estimated for the program is HKD $11200 (Appendix G). Non-material expenditure includes nursing staff and training for the nurses. Nurses will have to spend extra hours for the training and implementation of the program. Failure to implement the educational program could result in financial losses for the patients and the hospital. Extra haemodialysis sessions or intensive care unit admission may have to be arranged for patients who do not comply with fluid restriction (Baraz et al., 2009; Barnett et al., 2007; Casey, Johnson, & McClellan, 2002 & Tasy, 2003). It is estimated that an extra haemodialysis session costs HKD $6000 per patient. If the patient is admitted to an intensive care unit, it will cost HKD $3300 per night. Increased dosage or switching of medications to a more expensive 29

40 phosphate binder may be required for hyperphosphatemia. The benefits of the fluid and dietary control educational program outweigh the costs needed. 3.2 Evidence-Based Practice Guideline Guideline Title: An evidence-based nurse-led fluid and dietary control program for haemodialysis patient The Objectives The objectives of this guideline are: i. to summarize the clinical evidences for fluid and dietary control in haemodialysis patients; ii. to formulate clinical practice recommendations for a nurse-led fluid and dietary control program for haemodialysis patients based on the best evidence available; and iii. to promote diet and fluid adherence in haemodialysis patients in order to reduce the health risks of poor adherence. 30

41 3.2.3 Intended Users This guideline is intended to support the nurses in the selected setting, which is a paediatric and adolescent renal unit of a public hospital in Hong Kong Target Population The proposed educational program will target patients aged 12 or above requiring regular haemodialysis in a selected renal unit of a public hospital Recommendations This guideline is developed according to the previous systematic review and synthesized from the SIGN methodology in the SIGN 50: A guideline developer's handbook revised edition (2011). The guide for rating the quality of the selected studies and determining the level of evidence is attached in appendix E & H and the summary of level of evidence for the selected studies and summary of recommendation are attached in appendix D and appendix J respectively. Recommendation 1.0: The educational program. Recommendation 1.1. A structured educational intervention focusing on fluid and dietary adherence, with follow up and monitoring is effective in enhancing the 31

42 fluid and dietary control in haemodialysis patients. (Grading of Recommendation: A) Evidence. The typical approach to fluid and dietary education that includes a brief education session on dietary adherence is inadequate (Lou et al., 2002[1+]; Tsay, 2003[1+]). Lack of information is the most important factor contributing to non-compliance (Baraz et al., 2009[1+]). A structured educational intervention improves knowledge and at the same time promotes better adherence (Sun et al., 2008[2+]). Nine studies in the existing literature showed significant evidence that fluid and dietary education for haemodialysis patients is effective to improve adherence. Of these, three of them measured fluid adherence by comparing the IDWG. These three studies showed significant reduction in IDWG after the educational program on fluid adherence (Baraz et al., 2009[1+]; Tsay, 2003 [1+]; Barnett et al., 2007 [2+]). Seven of the studies showed significant improvement in the serum phosphate level of haemodialysis patients after receiving the education intervention regarding to dietary control (Baraz et al., 2009[1+]; Ford et al., 2004[1+]; Lou et al., 2002[1+]; Sullivan et al., 2009 [1+]; Ashurst & Dobbie, 2003[2+]; Sun et al., 2008 [2+]; Schlatter & Ferrans, 1998 [2-]). 32

43 Recommendation 2.0: Time for the educational program. Recommendation 2.1. Education should be conducted right before or after haemodialysis sessions. (Grading of Recommendation: B) Evidence. Although two studies mentioned the intervention could be carried out when the patient s condition is stable during haemodialysis, this recommendation is not appropriate for a variety of reasons. During haemodialysis, patients may experience sudden discomfort and require nurse assistance. Because patient safety is the first priority, it is recommended to conduct the education right before or after haemodialysis (Baraz et al., 2009 [1+]). Furthermore, it is more convenient for patients to receive the education on the same day of their scheduled haemodialysis session to facilitate the participation rate (Baraz et al., 2009 [1+]). Recommendation 2.2. The education should last for minutes and at least two sessions should be provided. (Grading of Recommendation: A) Evidence. The studies reviewed in this dissertation showed that at least two, minute education sessions are effective to improve adherence to fluid and dietary recommendations in haemodialysis patients (Baraz et al., 2009[1+]; Ford et al., 2004[1+]; Lou et al., 2002[1+]; Sullivan et al., 2009[1+]; Tsay, 2003 [1+]; Ashurst & Dobbie, 2003[2+]; Barnett et al., 2007[2+]; Sun et al., 2008 [2+]; Schlatter & Ferrans, 33

44 1998[2-]). Recommendation 3.0: Mode and content of the educational program. Recommendation 3.1. Trained nurses should lead the fluid and dietary control program. (Grading of Recommendation: B) Evidence. Nurses are in a good position to encourage patients to adopt fluid and dietary adherence. They assist patients by setting goals, monitoring performance in each visit, clarifying symptoms and management, and responding to questions (Tsay, 2003 [1+]). Nurses in renal units are responsible for ongoing teaching and encouragement of haemodialysis patients for better fluid and dietary adherence (Schlatter & Ferrans, 1998[2-]). Training for nurses prior to implementation of the program is essential to provide structured and standard education to patients (Ford et al., 2004[1+]; Sullivan et al., 2009[1+]; Tsay, 2003[1+]). Recommendation 3.2. The innovation may include individual and group sessions. (Grading of Recommendation: A) Evidence. Studies in both individual education and group education are successful. Since there are at least two sessions, education may include both group and individual sessions. Group education allows teaching the general knowledge of 34

45 haemodialysis, which is more cost-effective (Sullivan et al., 2009[ 1+]). Also, it allows mutual support between patients for better adherence (Baraz et al., 2009[1+]; Tsay, 2003 [1+]; Barnett et al, 2007 [2+]). Individual sessions allow patients to express their difficulties to adherence and stress management can be offered. (Tsay, 2003[1+]). Recommendation 3.3. The content of the education should include simple knowledge appropriate for the patient s understanding. It includes the pathophysiology of renal failure and haemodialysis, food and fluid restriction, medication, reason for adherence, possible consequence of non-adherence, control of thirst, and stress management. (Grading of Recommendation: A) Evidence. Knowledge of renal failure and haemodialysis should be taught to enhance patients basic knowledge of the disease and treatment. Haemodialysis patients often comply better to potassium control, as excessive potassium intake can lead to immediate and life-threatening cardiac consequences like cardiac arrest. However, excessive phosphate intake can result in delayed and insidious adverse effects, such as renal bone disease, that dampen patient concern (Baraz et al., 2009). Therefore, food restriction should focus more on restricting food containing phosphate like soft drinks, milk, and dairy products (Baraz et al., 2009[1+]; Ford et al., 35

46 2004[1+]; Lou et al, 2002[1+]; Sullivan et al., 2009 [1+]; Ashurst & Dobbie, 2003[2+]; Sun et al., 2008 [2+]; Schlatter & Ferrans, 1998 [2-]. Education to avoid phosphorus containing food and phosphate additive significantly improves patient serum phosphate level (Sullivan et al., 2009[1+]). Advising fluid limitation and encourage patient to control the urge to drink showed positive improvement in fluid adherence (Baraz et al, 2009[1+]; Tsay, 2003[1+]). Recommendation 3.4. Teaching booklets or educational handouts are effective to reinforce learning and enhance patient adherence to fluid and dietary control. (Grading of Recommendation: A) Evidence. Teaching booklets should be provided to patients for reviewing the knowledge at home (Baraz et al [1+]). Providing handouts to patients related to food choices would serve to remind patients what to avoid when choosing food in restaurants. Foods that commonly include phosphate additives should be included to assist patients in identifying high phosphate-containing foods (Sullivan et al., 2009 [1+]). Recommendation 3.5. Attainable goals setting is suggested to the patient and recognition should be given when the goals are attained. (Grading of 36

47 Recommendation: B) Evidence. Participants are encouraged to set achievable goals, such as reducing a cup of drink per day. Praise and encouragement should be given when the goals are achieved (Tsay, 2003[1+]). Recommendation 4.0: Evaluation. Recommendation 4.1. The dietary and fluid compliance is determined by measuring the serum electrolytes and IDWG, respectively. (Grading of Recommendation: A) Evidence. Compliance parameters should be easily measurable, verifiable, reproducible, and clearly interpretable (Baraz et al., 2009[1+]). Also, the parameters should be meaningful to patients and related to their pathophysiological origin (Baraz et al., 2009[1+]). IDWG measuring by weight gain between sessions is considered to be most reliable and valid measure of fluid intake compliance (Tsay, 2003 [1+]) and serum phosphate level is the standard measurement for monitoring phosphate intake adherence (Baraz et al., 2009[1+]; Sullivan et al, 2009[1+]). 37

48 Recommendation 4.2. Knowledge tests should be included to assess the improvement in patient knowledge following education. (Grading of Recommendation: B) Evidence. Knowledge tests related to phosphate content are useful to assess patient knowledge and improvement after education. The assessment should be given before and after the educational program (Ford et al., 2004; Sullivan et al., 2009 [1+]; Schlatter & Ferrans, 1998 [2-]). Recommendation 5.0. Telephone follow up should be conducted during the second month after the education sessions to reinforce learning and answer any questions raised by patients. (Grading of Recommendation: B) Evidence. Placing a phone call to patients during the second month of the study with the intention of reinforcing the instructions of adherence and to answer the questions from patients could improve the adherence rate (Sullivan et al., 2009[1+]). 38

49 4.1 Communication Plan Chapter 4 Implementation Plan A well-planned communication strategy is essential to the successful implementation of the proposed innovation. The communication plan starts with identifying the stakeholders involved and determining the ways of communication to gain supports for the proposed innovation Identification and Involvement of Stakeholders Successful adoption of an evidence-based innovation requires support from a variety of stakeholders. A stakeholder is an individual or groups who will be affected directly or indirectly as a result of implementation of the proposed innovation. A review of the stakeholders is necessary to maximize congruence between stakeholders interests and the goals of the project (Registered Nurses Association of Ontario, 2002). Regarding to the proposed innovation, a nurse-led fluid and dietary control program for haemodialysis patient in a renal ward setting, the stakeholders include the administrators, renal consultants, advanced practice nurses (APNs), registered nurses working in the renal unit, the adolescent patients on haemodialysis participating in the program, and the parents of the participants. Stakeholders can be categorized into 39

50 internal stakeholders and external stakeholders. The internal key stakeholders who operate within the haemodialysis unit included the Department Operations Manager (DOM), ward manager, the renal consultants. They are important for supporting and approving the proposed innovation and enhancing the positive attitude of staff towards the proposed innovation. APNs and frontline nurses are other internal stakeholders who are the users of the guideline responsible for initiating the proposed innovation. The APNs who are of renal specialty were selected because they are more knowledgeable in management of renal failure and experienced in handling adolescent patients with poor compliance problem. They will be involved in training the staff and act as program coordinators. External stakeholder working outside the renal unit includes an experienced dietician who will be responsible for providing higher level of training on dietary control in haemodialysis patients to the frontline staff Communication Strategies Since administrators including DOM, the ward manager, renal consultants play important roles in promoting adoption of a new evidence-based guideline, approaching them would be the first step of the program. Formal meetings with them will be made by making appointment in advance. The significance of latest evidence 40

51 of the innovation, preliminary plan of the manpower and resource allocation would be presented in the meeting in order to convince the needs of implementing the innovation. Besides, information like feasibility and cost-benefit analysis of the program will also be presented to provide a clearer understanding of the implementation plan of proposed program. After gaining the approval of the administrators, the proposed innovation would be presented to approximately twenty staff including all APNs and registered nurses who work in the renal unit. Information disseminated including objectives, plan, and benefits of the proposed evidence-based guideline will be prepared. APNs will be recruited to be the program coordinators and provide training to frontline staff on the part of fluid control education. Another training session schedule on dietary control with an experienced dietician will be discussed (Appendix K). Moreover, nurses who are eager to join will be identified and recruited to assist the preparation of the education materials such as pamphlets and knowledge tests. 41

52 4.2 Pilot Study Plan Before fully implementing the proposed innovation, undertaking a pilot study which is a small-scale preliminary trial to test the feasibility is crucial. A pilot study determines the feasibility of the proposed innovation in different aspects, for instance, the acceptability and satisfaction of the staff carrying out the program and the targeted patients. Besides, it assesses the effectiveness of the innovation clinically. More importantly, any unexpected difficulties encountered in the pilot study can be identified to rectify the proposed program (Grove, 2013). It is estimated that the pilot study will last for one month and will be conducted by the pilot testing team including the innovation proposer, two program coordinators in the selected renal unit Subject Recruitment The inclusion criteria for the subject recruitment in pilot testing will be the same as in the proposed fluid and dietary control program for haemodialysis patient in order to make an accurate assessment of the feasibility of the full-scale program. Convenience sampling method will be adopted to recruit a group of adolescent patients on haemodialysis. Sample size of the pilot study is ten adolescent patients. Based on the statistic of the selected renal unit, the subject recruitment time is 42

53 estimated to be around 2 weeks Acceptability and Feasibility of the Proposed Innovation Acceptability of the targeted patients and the staff involved in the program should not be neglected. A questionnaire designed by the program proposer will be distributed to the participating patients to evaluate their satisfaction levels, obtain their opinions, and assess if they accept the new innovation after the pilot study (Appendix M). In addition, nurses will be surveyed via a pretest and posttest questionnaire and a face-to face interview after the pilot test to evaluate their perception, satisfaction, perceived workload, difficulties, and attitude towards the proposed program. For the feasibility of the innovation, various aspects will be considered to avoid unexpected difficulties in the full-scale program. Training is one of the crucial components. As mentioned, an experienced dietician and renal APNs will be invited to train the frontline nurses. A total of two sessions will be provided and the training sessions will be arranged to fit the working schedule of the nurses. Assessment of whether the duration and content of training are sufficient and appropriate can be done through the pilot study. Resources are another important part to be planned. For instance, pamphlets, knowledge test, and blood taking materials have to be prepared before implementation. Assessment of the prepared pamphlets and knowledge test is 43

54 necessary. Modification in the content may be made if needed. The outcomes measurement will also be tested. For example, the primary outcome is the IDWG of the patients. Patients are required to take their body weight before and after each haemodialysis session for comparison. It is important to standardize the method of obtaining body weight by, for example, only allowing patients to wear a light shirt or patient uniform when taking body weight to assure the accuracy of the measurement. Another outcome is the serum phosphate level, which has to be checked by taking a blood specimen before the start of haemodialysis and send to laboratory for testing. Because a more frequent blood taking is needed, the consent of the patients and their parents and opinions from physician are necessary. Time frame and cost expenditure of the full-scale program can be estimated through the pilot study. Information regarding unexpected time or cost needed will be considered and discussed after the pilot study so as to make further refinement in the proposed innovation Intervention After Pilot Study All data collected from the pilot study will be analyzed and compared with baseline data obtained before the pilot study. Meetings with administers including DOM, the ward manager, and renal consultants will be held to discuss the result of the 44

55 pilot study. Comments from patients and frontline staff will not be ignored. The evidence-based nurse-led fluid and dietary control program will be finalized after the pilot study. 4.3 Evaluation Plan A clear evaluation plan is an essential component to be made before the implementation (Grove, 2013; Registered Nurses Association of Ontario, 2002). It is a thoughtful process focusing on the topic concerned, collecting appropriate information, and making analysis and interpretation for determining the effectiveness and worthiness of the innovation (Grove, 2013) Outcome Evaluation Evaluation can be classified into three categories: patient outcome, health care provider outcome, and organization outcome. Examining the patient outcome is aimed at testing the clinical effectiveness of the proposed program. In the proposed fluid and dietary control program, the primary outcome is the IDWG of the patients. It is selected as the primary patient outcome because it is the standard and direct measurement of the adherence of fluid limitation in haemodialysis patients. It is measured by the weight gain between dialysis sessions (i.e. subtracting the post 45

56 hemodialysis weight from the weight preceding the next hemodialysis session) (Baraz et al., 2009, Barnett et al., 2007 & Tsay, 2003). The secondary patient outcomes for the proposed program are the serum phosphate level and scores on a knowledge test. Monitoring the change in serum phosphate level shows the patient s compliance with phosphorus intake restriction. The two renal physicians and two renal nurses will review the knowledge test to assure the content validity. The score obtained before and after the programs will indicate the effectiveness of the program in improving the patient s knowledge in fluid and dietary control. Another important consideration is the healthcare provider outcomes, which directly determine the success of the proposed program, since staff knowledge and skills affect the quality of education delivered to the targeted patients. Attendance rate of the training session will be measured. Assessment of their knowledge and teaching skills to adolescent patients will be made after training sessions. Additionally, a staff satisfaction score will be evaluated to determine their acceptability of the proposed innovation. For the organizational outcomes, haemodialysis patients requiring extra hospitalization including admission to intensive care units related to non-adherence to fluid or dietary control will be monitored. Also, the costs spent in the innovation and 46

57 the time required for implementing the innovation will be counted for organizational planning Nature and Number of Clients Involved Characteristics of the patients recruited are based on the evidence reviewed for the fluid and dietary control program and the local setting. Patients aged equal to or above 12 on regular haemodialysis in the selected renal unit will be evaluated. An on-line computer program (Lenth, 2009) is used for calculation of the sample size required in evaluations of the proposed program. A sample size of 30 was estimated by using a one-sample t test with a power of 0.8, a standard deviation of 1.5kg of IDWG reduction, and significance level of With estimation of 10% drop out rate, the minimum sample size is Time and Frequency of Taking Measurements The proposed program will last for about 20 weeks (Appendix L). Time and frequency of taking measurements may vary since different parameters are obtained from different stakeholders. For patient outcomes, IDWG will be taken at each haemodialysis sessions (i.e. around three times per week) and serum phosphate levels will be measured once per week before start haemodialysis. This will limit the number 47

58 of blood draws but obtain enough samples to monitor the phosphate level. The knowledge test will be assessed before and after the implementation of the innovation. Concerning the health care provider outcomes, knowledge tests will be delivered before and after the training session. Satisfaction survey and comments will also be collected immediately after training and on a monthly basis to monitor and solve the difficulties encountered immediately during the implementation period. Regarding to the organizational outcomes, hospitalization rate related to non-adherence is measured continuously during the implementation period. Expenses and manpower contributed to the program will be evaluated monthly to assess if there are any extra resources or staff needed Data Analysis There are total of three patient outcomes including one primary outcome and two secondary outcomes to be evaluated in response to the proposed educational program. The quantitative variables will be described by means and standard deviations and compared with one-sample t tests to detect any statistically significant differences before and after the proposed innovation. No formal subgroups analyses will be made. However, the impacts of patient characteristics like gender, ethnicity and time on dialysis will be explored. 48

59 Determining the Effectiveness of the Guideline To determine the effectiveness of the proposed innovation, the mean percentage of reduction of the patient outcomes and improvement in knowledge test scores will be calculated from the selected studies. Among the studies, the consensus of the effectiveness of reduction on IDWG and serum phosphate level, and improvement in knowledge test scores does not exist. Considering the studies selected in the literature review, the objective of reduction in IDWG is set at 15%, targeted reduction in serum phosphate level is set at 13.8%, and increase in score of knowledge test is set at 14% (Ashurst & Dobbie, 2003;Sullivan et. al., 2009 & Tsay, 2003). For the health care provider outcomes, the aims are 90% attendance rate in the renal training sessions and 60% satisfaction rate. Regarding to the organization outcome, the program aims to reduce 50% admission rate of patients on haemodialysis due to non- adherence to fluid and dietary control. 49

60 4.4. Ethical Considerations Ethical considerations should not be ignored in the proposed educational program. Approval from the Hospital Authority committee will be obtained. Moreover, as the targeted patients aged equal to or above 12, obtaining consents from the patients and the parents or guardians of patients under 18 is necessary prior implementing the program. Confidentiality should not be breached and all data from the patients should only be accessible by the staff organizing the program Conclusion The implementation and the evaluation of the proposed program contain several components. With smooth communication with the administrators and frontline staff, a pilot test for testing the feasibility, making improvements to the proposed innovation and the comprehensive evaluation plan, the proposed evidence-based guideline can be implemented successfully. 50

61 Appendix A Appendix A. Search strategies and Search History Databases Search Engine Search keywords CINAHL PubMed Cochrane Google PsycINFO ProQuest Library Scholar 1 Haemodialysis or Hemodialysis Education or Teaching or Intervention Dietary compliance or dietary adherence Fluid compliance or fluid adherence or fluid intake compliance or fluid intake adherence Interdialytic weight gain Phosphate or hyperphosphatemia hyperkalemia or potassium End stage renal failure or End stage renal disease (#1 or #8) and # (#1 or #8) and # 2 and # (#1 or #8)and #2 and # (#1 or #8) and #2 and # (#1 or #8) and #2 and # (#1 or #8) and #2 and # Number of citations meet the inclusion criteria

62 Appendix B Appendix B. Characteristics of excluded studies Studies Reason(s) for exclusion Nozaki, Oka & Chaboyer, 2005 Interventions on psychotherapy only Sharp et al, 2005 Outcome measurement on Depression scale Tsay & Hung et al, 2004 Interventions focus on quality of life Konstantinidou et al, 2002 Study focus on exercise training Cabness et al, 2007 Study focus on hemodialysis compliance Chen et al, 2008 Magrab & Oaoadopoulou, 1977 Welch & Thomas-Hawkins, 2005 Tsay, 2004 Sagawa et al, 2001 Bratley et al, 1990 Mathers, 1999 Outcome measurement on physical symptoms and psychological quality of life Study focused on compliance to hemodialysis sessions Study focus on psycho-education Study focus on psychological outcomes Study focus on psychological intervention Patient education focus on vascular cleansing compliance Outcome measurement on psychological outcomes 52

63 Appendix C. Table of evidence 53

64 Appendix C. Table of evidence 54

65 Appendix C. Table of evidence 55

66 Appendix C. Table of evidence 56

67 Appendix C. Table of evidence 57

68 Appendix C. Table of evidence 58

69 Appendix D. Quality assessment Quality assessment of the selected study Bibliographic citation: 1.Baraz et al Study type: Randomized trial SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the Background and Aim part of the study. 1.2 The assignment of subjects to treatment groups is randomised Well covered. All patients met the criteria were randomly assigned into verbal education group and video education group 1.3 An adequate concealment method is used Adequately addressed. Participants were allocated randomly by generating numbers from 0 to 99 using computer randomly. Odd numbers to indicate verbal education group. Even numbers to indicate video education group 1.4 Subjects and investigators are kept blind about treatment allocation 1.5 The treatment and control groups are similar at the start of the trial 1.6 The only difference between groups is the treatment under investigation Not addressed. Because consent was required before the intervention, the subjects knew they were under the research project. However, the researcher did not mention if they know which group the patients are in. Not addressed. Author did not clearly state the comparison of demographic data and health status between two groups but did mentioned about the overall characteristic of the participants. Not addressed. The author did not clearly state the comparison of demographic data and health status between two groups 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome was clearly stated including IDWG and biochemical parameters. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of Video group=0 Oral education group=0 59

70 Appendix D. Quality assessment the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Well covered. All subjects were analyzed as in the allocated group Where the study is carried out at more than one site, results are comparable for all sites Not addressed. The study was carried out in 3general hospitals in Tehran. All results were analyzed. However, the researcher did not compare the result from each hospital. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Power analysis was not used to calculate the sample size. Yes. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. Both Video and Oral Educational program are effective in controlling dietary and fluid intake of hemodialysis patient. Nurses should emphasize sodium compliance in patients having hemodialysis and explain its adverse effects, such as excessive weight gain, hypertension and peripheral edema. 60

71 Appendix D. Quality assessment Quality assessment of the selected study Bibliographic citation: 2. Tsay, 2003 Study Type: Randomized controlled Trial Section 1: Internal validity 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the Background part of the study. 1.2 The assignment of subjects to treatment groups is randomised Well covered. All patients met the criteria were randomly assigned into self-efficacy training group and usual care group 1.3 An adequate concealment method is used Adequately addressed. Blind randomization was used. 1.4 Subjects and investigators are kept blind about treatment allocation Well covered. Only the researcher knew which treatment patients were receiving. Care providers including nurses, doctors were not informed of participants treatment group. 1.5 The treatment and control groups are similar at the start of the trial Adequately addressed. Demographical and clinical characteristics were similar between two groups. Power analysis was used to calculate the sample size. 1.6 The only difference between groups is the treatment under investigation Adequately addressed 1.7 All relevant outcomes are measured in a standard, valid and reliable way 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Well covered. Outcome was clearly stated. 1 patient /32 patients (3.125%) from each group dropped out because of hospitalization or relocation. Adequately addressed. Intention to treat was not used. 61

72 Appendix D. Quality assessment 1.10 Where the study is carried out at more than one site, results are comparable for all sites Not addressed. Section 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the Yes, power analysis was used to calculate the sample size. statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes, the target group, haemodialysis patient of the study and proposed guideline are similar except the age range. 2.4 Notes. Summarise the author s conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. This study supports the self-efficacy training is effective in controlling the mean body weight gains of ESRF patients receiving hemodialysis. Quality assessment of the selected study Bibliographic citation: 3.Sullivan et al Study Type: Randomized controlled Trial SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the first part of the study. 1.2 The assignment of subjects to treatment groups is randomised Well covered. All patients met the criteria were randomly assigned into intervention group and control group using a random number generator according to their facility or to their shift or hemodialysis. 1.3 An adequate concealment method is used Adequately addressed. 62

73 Appendix D. Quality assessment 1.4 Subjects and investigators are kept blind about treatment allocation Adequately addressed. The subjects and the study coordinators were not possible to be blinded. Subjects are required to sign consent for participation. The study coordinators are required to carry out the intervention. 1.5 The treatment and control groups are similar at the start of the trial Well covered. There is no significant difference of the demographical and clinical characteristics between two groups. Power analysis was used to calculate the sample size. 1.6 The only difference between groups is the treatment under investigation Well covered. 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcomes were clearly stated measured in a standard, valid, reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Intervention group: 14/145 (9.66%) dropped out Control group: 14/134 (10.45%) dropped out Adequately addressed. Intention to treat was used Where the study is carried out at more than one site, results are comparable for all sites Not addressed. The study carried out in 14 dialysis center. Result was not compared between facilities, SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that Yes. Power analysis was used to calculate the sample size and baseline data are similar between groups 63

74 Appendix D. Quality assessment the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. Educating patient with ESRF to avoid phosphorus containing food additives resulted in clinically significant improvements in serum phosphate level. Quality assessment of the selected study Bibliographic citation: 4. Ashurst & Dobbie, 2003 Study Type: Randomized controlled Trial SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The objective of the study is clearly addressed in the first part of the study. The hypothesis was clearly stated at the part of hypothesis 1.2 The assignment of subjects to treatment groups is randomised Adequately addressed. All patients met the criteria were randomly assigned into control group or intervention group 1.3 An adequate concealment method is used Adequately addressed. Random allocation was used. 1.4 Subjects and investigators are kept blind about treatment allocation Adequately addressed. The researchers were kept blind about the treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial Well addressed. Demographical and clinical characteristics were similar between two groups. Power analysis was not used to calculate the sample size. 64

75 Appendix D. Quality assessment 1.6 The only difference between groups is the treatment under investigation Adequately addressed. The only difference between groups if the intervention. 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome was clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Total two patients dropped out from the study but before intervention. Both were from control group. No drop out after intervention. Adequately addressed. Intention to treat was used. Patients who died or underwent transplantation after the intervention were included in all analysis Where the study is carried out at more than one site, results are comparable for all sites Not applicable. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes. However, power analysis was not used to calculate the sample size. Yes, the target group, haemodialysis patient of the study and proposed guideline are similar. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. An educational intervention is shown statically and clinically significant to decrease serum phosphate levels in dialysis patients 65

76 Appendix D. Quality assessment Quality assessment of the selected study Bibliographic citation: 5. Shaw-Stuart & Stuart, 2000 Study Type: Controlled Trial without randomization SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the first part of the study. 1.2 The assignment of subjects to treatment groups is randomised Not addressed. Study was carried out in two private freestanding dialysis units. One is experimental group, another one is control group 1.3 An adequate concealment method is used Not addressed. Concealment method was not reported. 1.4 Subjects and investigators are kept blind about treatment allocation Not addressed. 1.5 The treatment and control groups are similar at the start of the trial Adequately addressed. Demographical and clinical characteristics were similar between two groups. Power analysis was not used to calculate the sample size. 1.6 The only difference between groups is the treatment under investigation Adequately addressed 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome measures were clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Not Reported 66

77 Appendix D. Quality assessment 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Not Reported 1.10 Where the study is carried out at more than one site, results are comparable for all sites Not addressed. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? - Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? No. Given the above potential biases, study results could not be solely attributed to study intervention. Majority of the participants were African-American in their sixth decade, the generality is questionable 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. No differences found between 2 groups may suggest either form of the intervention is equally effective in reduction of serum phosphate levels among individuals receiving hemodialysis. Quality assessment of the selected study Bibliographic citation: 6.Lou et al, 2011 Study Type: Randomized controlled Trial SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim and the hypothesis of the study is clearly addressed in the introduction part of the study. 67

78 Appendix D. Quality assessment 1.2 The assignment of subjects to treatment groups is randomised Adequately addressed. Group randomization were used to assign the patients into experimental group and control group according to their hemodialysis unit 1.3 An adequate concealment method is used Adequately addressed. 1.4 Subjects and investigators are kept blind about treatment allocation 1.5 The treatment and control groups are similar at the start of the trial Well addressed. The participants are required to sign an informed consent to join the program; they would know they joined the research but not the treatment allocation. The study did not report if the investigators were kept blind. Adequately addressed. Demographical and clinical characteristics were similar between two groups. Power analysis was used to calculate the sample size. 1.6 The only difference between groups is the treatment under investigation Adequately addressed. 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome was clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) 11 patients were lost in total. 5 in experimental group. 6 in control group. Adequately addressed. Intention to treat was not used Where the study is carried out at more than one site, results are comparable for all sites Adequately addressed, the study was done in 5 hemodialysis units from 5 hospitals. Result was not compared between sites. The data analysis focused on individuals with multivariate adjustment for potential confounders. 68

79 Appendix D. Quality assessment SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes, power analysis was used to calculate the sample size. Yes, the target group, haemodialysis patient of the study and proposed guideline are similar except the age range. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. An intensive 6-month dietary intervention focusing on phosphorus intake reduction is able to obtain an adjusted decrease of 0.96 mg/dl in serum phosphate level. Quality assessment of the selected study Bibliographic citation: 7. Ford et al, 2004 Study Type: Randomized controlled Trial SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The purpose of the study is clearly addressed in the first part of the study, just before the part of method 1.2 The assignment of subjects to treatment groups is randomised Well covered. All patients met the criteria were randomly assigned into an experimental group or a control group using a random numbers table. 1.3 An adequate concealment method is used Adequately addressed. 69

80 Appendix D. Quality assessment 1.4 Subjects and investigators are kept blind about treatment allocation 1.5 The treatment and control groups are similar at the start of the trial Well covered. The participants cannot be blind as they have to sign consent before joining the study. Each patient was assigned a case study number to ensure confidentially about the treatment allocation. Well covered.no significant difference was found in patients demographical and clinical characteristics between two groups. However, there is a significant difference in the knowledge level between 2 groups in pretest. Power analysis was not used to calculate the sample size. 1.6 The only difference between groups is the treatment under investigation Adequately addressed. The difference between groups not only the intervention but also the pre-intervention knowledge test score. 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome was clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Intervention group: 3 out of 35; control group 4 out of 35 Adequately addressed. Intention to treat was not used. Only the participants completed the study were included in analysis Where the study is carried out at more than one site, results are comparable for all sites Not addressed. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? + Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the No, power analysis was not used to calculate the 70

81 Appendix D. Quality assessment statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? sample size. Yes, the target group, haemodialysis patient of the study and proposed guideline are similar except the age range. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. This study proved that individualized and focused patient education targeting phosphorus control and compliance is beneficial. Quality assessment of the selected study Bibliographic citation: 8. Schlatter & Ferrans, 1998 Study Type: Quasi-experimental using one group, pretest-posttest design SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The purpose and hypothesis of the study are clearly addressed in the first part of the study, just before the part of literature Review 1.2 The assignment of subjects to treatment groups is randomised Not Applicable. 1.3 An adequate concealment method is used Not Applicable. 1.4 Subjects and investigators are kept blind about treatment allocation Well covered. The participants cannot be blind as they have to sign consent before joining the study. 1.5 The treatment and control groups are similar at the start of the trial Adequately addressed. The treatment group and the control group are the same group of patients. 1.6 The only difference between groups is the treatment under investigation Adequately addressed. The difference between groups not only the intervention but also the pre-intervention knowledge test score. 71

82 Appendix D. Quality assessment 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered. Outcome measurements were clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Adequately addressed. 7out of 36 patients (11.11%) were dropped out. Adequately addressed. Intention to treat was not used. Only the participants completed the study were included in analysis Where the study is carried out at more than one site, results are comparable for all sites Not applicable. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? -, the study do not have a control group, Hawthorne effect may have caused the changes No, power analysis was not used to calculate the sample size. Yes. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. One-on-one education session, with a register nurses, can have an effect on patients knowledge and compliance. There is a weak correlation between a decreased in phosphorus change score and an increased in phosphorus diet knowledge test(r=0.21). 72

83 Appendix D. Quality assessment Quality assessment of the selected study Bibliographic citation: 9. Sun et al, 2008 Study Type: prospective self-control study SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The purpose and hypothesis of the study are clearly addressed in the part of introduction 1.2 The assignment of subjects to treatment groups is randomised Not Applicable 1.3 An adequate concealment method is used Not Applicable. 1.4 Subjects and investigators are kept blind about treatment allocation Adequately addressed. The participants cannot be blind as they have to sign consent before joining the study. 1.5 The treatment and control groups are similar at the start of the trial Well covered. Same group before intervention was used as control. The study used pretest and posttest design. 1.6 The only difference between groups is the treatment under investigation 1.7 All relevant outcomes are measured in a standard, valid and reliable way Adequately addressed. Same group was used pretest and posttest. Power analysis was not used to calculate the sample size. Well covered. All outcome measures were well addressed in the analysis. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Adequately addressed. No patients dropped out in the study. 73

84 Appendix D. Quality assessment 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Adequately addressed. All participants result were analyzed 1.10 Where the study is carried out at more than one site, results are comparable for all sites Not applicable. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? +, Same group was used as control group, no blinding in the study. Yes. Regardless of the above potential limitations, the study was conducted in a scientifically rigorous manner Yes, the target group, chronic haemodialysis patient of the study and proposed guideline are similar except the age range. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. Patient education in the study could improve both knowledge and drive the same time and could successfully reduce phosphate level by 0.7mg/dL mg/dl in all studied patients. Quality assessment of the selected study Bibliographic citation: 10. Barnett et al Study Type: Quasi-experimental design SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the The study part of the journal. 74

85 Appendix D. Quality assessment 1.2 The assignment of subjects to treatment groups is randomised Not applicable. The study was conducted using quasi-experimental, one-group design. 1.3 An adequate concealment method is used Not applicable. 1.4 Subjects and investigators are kept blind about treatment allocation Adequately addressed. Participants were required to sign consent forms before joining the study. Blinding is not possible due to the study nature. 1.5 The treatment and control groups are similar at the start of the trial Adequately addressed. The same group was involved for pretest and posttest 1.6 The only difference between groups is the treatment under investigation 1.7 All relevant outcomes are measured in a standard, valid and reliable way Adequately addressed. Same group was involved for control group before intervention. Therefore, minimal difference between intervention group and control group. Well covered. Outcome was clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) 4/30 (13.333%) of subjects dropped out including 3 deaths and one pregnancy. Adequately addressed. Intention to treat was not used Where the study is carried out at more than one site, results are comparable for all sites Not applicable. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? Code ++, +, or +, Intention to treat was not used in the study. Power analysis was used to calculate the sample size. 75

86 Appendix D. Quality assessment 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Possible bias of the study resulted from lacking of a control group and small sample size. Yes, the target group, haemodialysis patient of the study and proposed guideline are similar. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. This study concluded that there is a need to educate patients on hemodialysis on the importance of adherence to fluid restriction, IDWG and the associated health risk. Quality assessment of the selected study Bibliographic citation: 11, Casey, Johnson & McClelland, 2002 Study Type: Pilot study SECTION 1: INTERNAL VALIDITY 1.1 The study addresses an appropriate and clearly focused question. Well covered. The aim of the study is clearly addressed in the Introduction part of the study. 1.2 The assignment of subjects to treatment groups is randomised Not applicable. The study was done on one group of participants. 1.3 An adequate concealment method is used Not applicable. 1.4 Subjects and investigators are kept blind about treatment allocation Not addressed. Blinding was not done in this study. 1.5 The treatment and control groups are similar at the start of the trial Not Applicable. Same group of participants were involved in pretest posttest. 76

87 Appendix D. Quality assessment 1.6 The only difference between groups is the treatment under investigation 1.7 All relevant outcomes are measured in a standard, valid and reliable way Adequately addressed. Same group of participants involved in pretest posttest. There are no change in this group of participants. Well covered. Outcome was clearly stated. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Adequately addressed. No drop out in the study. Adequately addressed. All data were accounted 1.10 Where the study is carried out at more than one site, results are comparable for all sites Not addressed. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? - Code ++, +, or 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? No, power analysis was not used to calculate the sample size. The sample size is small. Yes. Participants were patients with ESRF on chronic haemodialysis which is similar to the guideline except the age range. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. More research is needed to further analyse the outcomes of verbal and written information in hemodialysis unit due to the limitation of this study, small number of participants. 77

88 Appendix E Appendix E. Level of evidence hierarchy developed by the SIGN SIGN grading system: Level of evidence (Scottish Intercollegiate Guidelines Network, 2011) 78

89 Appendix F Appendix F. Comparison of the demographic characteristics of targeted patients between PMH pediatric and adolescent renal unit and eleven selected studies Patients demorgraphics Targeted patient in Renal unit of PMH Baraz et al Tsay,2003 Sullivan et al Ashurst & Dobbie, 2003 Shaw-stuart & Stuart, 2000 Lou et al Ford et al, 2004 Schlatter & Ferrans, 1998 Sun et al Barnett et al Casey Johnson & MsClelland, 2002 Age(years) Range: : 34.9% : 28.6% 40-50: 36.5% / /-13 Range:22-88 mean :53.6 mean :58.05 mean :62.15+/ :9.5% 36-50:15.9% 51-75: 60.3% 76+:14.3% Range:28-87 Mean: :6% % 41-50:16% 51-60:22% 61-70:40% >70:8% Range:27-80 Mean: 52.8+/-11.6 range:27-82 Male (n(%)) (52.4%) 30 (48.2%) 171(59.3%) 35(60.3%) 35(43.2%) 42(52.5%) 24(38.1%) 14(48.3%) 21(42%) 13(50%) 11(52.4%) Female (n(%) (47.6%) 32 (51.8%) 117 (40.7%) 23(39.7%) 46(56.8%) 38(47.5) 39(61.9%) 15(51.7%) 29(58%) 13(50%) 10(47.6%) Education level College(n(%)) 0 33 (52.4%) 14(48.3%) 2(4%) 4(3.8%) Graduated Secondary(n(%)) studying from 18 (28.6%) (100%) elementary N/A N/A N/A N/A N/A 15(51.7%) 18(36%) 22(84.2%) school (45.2%) Primary(n(%)) 0 12 (19.0%) 0 12 (24%) 0 Length of time on hemodialysis Setting: mean: 2 years hemodi alysis unit in PMH 4.6+/ / Renal units from 3 general hospital 3 out-patient hemodialysis centre 14 long term dialysis facilities N/A (more than 1 year) A hemodialysis unit in teaching hospital N/A A private freestandin g dialysis unit N/ A (at least 6 months) A dialysis unit <1: 12.7% 1-3: 42.9% 4-5: 17.5% 6+: 26.9% 3 outpatient dialysis centre range:6 months to 22 years Mean:2.9 years Suburban dialysis unit <1:12% 1-3:22% 3-5:14% 5-10:28% >10:24% Single dialysis unit in university hospital range: months 40months +/ A major teaching hospital N/A N/A A outpatient hemodialysis unit 79

90 Appendix G Appendix G. Estimated operational cost for the fluid and dietary control program Set-up cost i) Preparation and Training Description Cost (HK$) 2 Advanced Practice Nurses (APN) 5 hours 1100 ($220/hour) (training and prepare materials) 3 Registered Nurses (RN) 4 hours 720 ($180/hour) (prepare materials including phamlets and knowledge test) 10 Registered Nurses (RN) 2 hours ($180/hour) Experienced dietician 1 hour ($200/hour) (provide training) Total: HKD$ ii) Material Cost (for every 20 Patients) Venue and equipment for education session and training Computers and computer software Stationary Knowledge test N/A HKD $1 /set Available in hospital 20 Teaching booklets and handouts HKD $3/set 60 Total: HKD$ 80 Running Cost i) Staff 80

91 Appendix G Nursing staff Total: HKD$ Individual session for 20 patients (1hour each) ($180/hour) 1 group session (4 patients a group), total 5 sessions (1hour each) Telephone follow up (10mins each) for 20 patients ii) Material Cost (for every 20 Patients) Venue, equipment, stationary, N/A computers Knowledge test HKD $1 /set (100sets for a year) Teaching booklets and handouts HKD $3/set (100sets for a year) Total: HKD $400 Available Overall estimated cost of the program: HKD $

92 Appendix H Appendix H: Grading recommendations developed by SIGN SIGN 50: A guideline developer s handbook (2008) 82