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Abstract of the thesis entitled
An evidence-based dietary counseling to prevent secondary urolithiasis for
calcium-containing stone patient
Submitted by
YEUNG, Tsz Ying Crystal
For the degree of Master of Nursing
At the University of Hong Kong
in August 2015
Renal stones will complicate with haematuria, urinary tract obstruction, decreased
renal function and infection. There is a 50% recurrence risk within ten years for the
calcium-containing stone formers. Therapeutic nutrition recommendations are
adopted worldwide for the secondary prevention of urolithiasis.
However, there is no current evidence-based dietary counselling available to
stone patients. This dissertation aims to identify and evaluate current evidence of the
effectiveness of dietary control programmes in the treatment of first renal stones in
patients, to assess the transferability and feasibility of implementing a nurse-led
education programme regarding dietary control in patients with renal stones, and to
develop an evidence-based, nurse-led dietary control programme for patients with
renal stones.
Five electronic bibliographical databases including PubMed, Cochrane Library,
CINAHL, Embase, and Ovid Medline are used to identify studies that examined the
effectiveness or interventions of dietary control for patients with their first renal
stones to prevent secondary urolithiasis. Four studies met the selection criteria and are
evaluated in this dissertation. An appraisal instrument is used to evaluate the quality
of the selected studies. Critical evaluation of the available studies led to an
evidence-based, nurse-led, dietary control programme for patients with their first renal
stones that followed the guideline development process of the Scottish Intercollegiate
Guideline Network.
Comparison of the similarity of the patient characteristics, staff competence, and
organizational settings of the evaluated studies are similar to those of the target unit.
Thus, the proposed programme may be transferable and feasible. Moreover, a
cost-benefit analysis show that the benefit of dietary counselling to patients outweighs
the cost needed to implement the programme.
This dissertation outlines a proposed 78-month programme including marketing
of the programme, training of staff in the targeted urology unit, pilot testing, and
application of the proposed programme. Evaluation of the programme will focus on
three categories, patient outcome, healthcare provider outcome and system outcome.
Clinical effectiveness of the programme is defined by patients’ reduction rate of
recurrence, improvement in knowledge test scores, satisfactory nurse’s attendance rate
in the urology training sessions, high nurse satisfaction with the educational
programme and reduction of admission rates related to secondary urolithiasis.
An evidence-based dietary counseling to prevent secondary urolithiasis
for calcium-containing stone patient
By
Crystal T. Y. Yeung
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, 2015
i
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.
______________________________________
YEUNG, Tsz Ying Crystal
August, 2015
ii
Acknowledgements
I would like to express my sincere gratitude to my supervisor, Dr. Polly Chan, for her
guidance and enlightenment. This dissertation could not have been completed without
her generous support.
I would like to thank Dr. Ho and my ward manager Miss Yim for her understanding
and support throughout my studies.
iii
Content
Declaration P. i
Acknowledgement P. ii
Table of Contents P. iii
Abbreviation P. iv
Chapter 1 - Introduction
1.1 Background P. 1
1.2 Affirming needs P. 4
1.3 Objectives and significance P. 6
Chapter 2 - Critical Appraisal
2.1 Search and Appraisal strategies P. 9
2.2 Result P. 11
2.3 Summary and Synthesis P. 12
2.4 Diet recommendation P. 19
Chapter 3 - Translation and Application
3.1 Implementation Potential
3.1.1 Transferability of findings P. 23
3.1.2 Feasibility P. 25
3.1.3 Cost-benefit ratio of the innovation P. 28
3.2 Evidence-based protocol P. 31
Chapter 4 Implementation plan
4.1 Communication plan P. 41
4.1.1 Identification and involvement of
stakeholders
P. 41
4.1.2 Communication strategies P. 42
4.2 Pilot study plan P. 44
4.3 Evaluation plan P. 47
4.4 Ethical consideration P. 51
4.5 Conclusion P. 51
References P. 52
Appendixes
01 Local hospital data
02 Table of searching pathway
03 Table of evidence
04 Specific dietary regimen
05 Table of quality assessment and
Comparison of quality assessment
06 Baseline comparison
07 2L pitcher
08 Summary of recommendations
09 Flow chart of dietary counselling
10 Training detail of the training session from APN to RNs
11 Questionnaire to patient
12 Knowledge test
13 Questionnaire to staff
14 Face to face survey
15 Innovation schedule
16 Summary of evaluation plan
17 System outcome evaluation breakdown
18 PRISMA 2009 Checklist
19 PRISMA 2009 flow diagram
20 Cost
iv
Abbreviations
AC Associate consultant
APN Advanced practice nurse
COS Chief of services
DOM Department Operations Manager
ESWL Extracorporeal shock wave lithotripsy
KUB Kidney Ureters bladder x ray
PCNL Percutaneous nephrolithotomy
RCT Randomized Control Trial
RN Registered nurse
SIGN Scottish Intercollegiate Guideline Network
URSL Ureteroscopic Lithotripsy
USG or BS USG Ultrasonography / Bedside Ultrasonography
1
Chapter 1. Introduction
Introduction
With regard to urolithiaisis, which is a cosmopolitan disease, patients may have
one or more episodes in their lifetime. Stone may complicate with haematuria, urinary
tract obstruction, decreased renal function and infection (Tiselius, 2006). In the
various types of renal stones, calcium-containing stones make up to 75% of the total
(Sayer, 2008). Pure calcium oxalate stones rank the highest (33.9%), followed by pure
calcium phosphate stones (2.7%) and pure uric acid stones (0.8%), others are mixed
stones (62.6%) as reported in an Eastern Chinese studies in 2010 (Zhang et al, 2010).
The topic is “An evidence-based dietary counseling to prevent secondary
urolithiasis for calcium-containing stone patient”. The importance of translating the
best evidence into practice is illustrated by background, affirming needs and
significance.
1.1 Background
Stone recurrence is a common phenomenon worldwide. Once the first kidney
stone forms, there is approximately a 50% recurrence risk within ten years (Johri et al,
2010; Krieg 2005; Parmar 2004; Tiselius 2006). Regarding recurrence, about 18%
experience two episodes, 10% experience three episodes, 2% experience four
episodes, and 10% experience more than five episodes (Seitz & Fajkovic, 2013). In
2
my ward, stone formers are admitted repeatedly. From my experience, they have high
fever, or even urosepsis on admission due to the complications arising from renal
stones. Urgent fluid resuscitation, insertion of a double-J stent, insertion of
percutaneous nephrostomy, injection of broad spectrum antibiotics, or ICU care is
required for these patients. This costs a lot and consumes the scarce resources. Thus, it
is worth finding the most appropriate and effective strategy to prevent recurrence.
People aged 20-60 years are the main victims of secondary urolithiasis (Daudon
et al, 2004). The peak age of stone formation is different in men and women. Men
mostly suffer stones at 30 years old while women suffer within the range from 35 to
55 (Parmar, 2004). The prevalence of renal stones in men is between 7% and 15%
while the prevalence in women is between 3% and 6%. (Lewandowski & Rodgers,
2004). The male to female ratio is 2:1 but women with newly diagnosed
nephrolithiasis are rising dramatically. (Daudon et al, 2004).
Dietary management plays a pivotal role in both prevention and long-term
management (Ortiz-Alvarado et al, 2011). Therapeutic nutrition recommendations are
adopted worldwide for the secondary prevention of urolithiasis. Indeed, people from
different cultures and backgrounds absorb the same nutrients from various types of
food under different cooking methods. Specific strategies cannot be achieved to force
patients to strictly follow the recommendations. The main themes of prevention are
decreasing urine supersaturation and preventing calculus formation (Penniston &
3
Nakada, 2013).
Water intake
Increasing urine volume will reduce supersaturation to prevent stone formation
(Krieg, 2005). Job nature is a risk factor for secondary urolithiasis. Working in hot
environments such as chefs and drivers often restrict their fluid intake to avoid
toileting (Johri et al, 2010).
Oxalate food
Stone formers absorb about 50% more oxalates than non-stone formers for
no reason (Holmes & Assimos, 2004; Lewandowski & Rodgers, 2004). In reality,
oxalates are found in food with various concentrations. The highest level of oxalate
found in chocolate, spinach, rhubarb, nuts, beans etc.
Calcium level
Maintaining an adequate calcium level is important. If calcium intake is
restricted, a low calcium level will allow more free oxalates in the gut and to be
excreted in the urine, thus increasing the supersaturation of the salt, to form calcium
oxalate stones (Krieg, 2005; Lewandowski & Rodgers, 2004).
Protein diet
High protein consumption should be avoided. A study showed that an
4
increase of 34g/day of animal protein in the diet significantly increase urinary calcium
by 23% and urinary oxalates by 24% (Robertson et al, 1979). Nguyen et al (2001)
also reported that one third of calcium oxalate formers’ urinary oxalate increase after
the intake of animal protein.
1.2 Affirming needs
Permanent consequence
Kidney stones are a risk factor for chronic kidney disease. An 8-year study found
that stone formers have a higher risk for sustaining elevated serum creatinine and
reducing glomerular filtration rate. Also, renal scar will be formed by kidney stones
and the end stage is renal failure (Rule et al, 2009). To prevent end stage renal failure,
dietary management is crucial to prevent secondary urolithiasis.
Cost saving
The cost of urological intervention is around ₤2000 per episode per person while
the cost of preventive medication is around ₤300 per episode per person in the UK
(Robertson, 2006). However, diet regimen is a natural way to prevent secondary
urolithiasis and saves much cost. According to Borghi et al. (1996), the intake of 2L of
water per day is the golden rule for the prevention of stone recurrences. Water is
accessed easily and essential to humans. Prevention is better than cure. In a French
study, water assumption of 2L daily with 100% compliance among stone formers
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saved ₤49 million per year. If 25% of compliance is assumed, the cost still saved is
₤10 million per year (Lotan et al., 2012). To reduce the financial burden, there is a
strong need to persuade patients to undergo diet counselling to prevent recurrent
urolithiasis.
Medical prophylaxis
Pharmacological treatment is a kind of preventive measure (Tiselius, 2006).
Thiazide diuretics are used for recurrent calcium oxalate stones while allopurinal is
used for recurrent calcium oxalate stones with hyperuricaemia or hyperuricosuria
(Johri et al., 2010). However, lifelong drug preventive treatment may not be accepted
by patients (Tiselius, 2006). Compared with dietary management, every drug has its
documented side-effects. Thus, daily dietary and drinking recommendations are a
cost-effective strategy.
Current practice
In my workplace (one of the public hospitals under the hospital authority), there
is no diet intervention for stone formers. In addition, there is no study found in Hong
Kong to prevent secondary urolithiasis. However, there was a 47% recurrence rate in
stone formers who needed a secondary operation from July to October, 2014 in my
hospital (Appendix 01). Dietary management will be an innovation for these patients.
If patients are free from stones, it will reduce unnecessary readmission. So, there is a
strong need to launch this innovation to stop recurrent urolithiasis.
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Nurse role
The implications for nursing are also important. There is often a lack of nurse
involvement in preventing secondary urolithiasis in hospitals. As nurses act as
educators, dietary counselling can be a tool to build up rapport between nurses and
patients. Compliance with the diet can be ensured with nurses’ supervision. To
conclude, dietary counselling is an advisable regimen.
1.3 Objectives and Significance
Research Question
Can the dietary counselling prevent recurrent urolithiasis among calcium-containing
stone formers?
Objectives
To systematically review the current evidence of the effectiveness of dietary
management in urolithiasis patients,
To extract data from the sampled studies and compile a table of evidence,
To perform a quality assessment of the studies,
To determine the feasibility and transferability of dietary management to the
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target patients,
To develop an implementation and evaluation plan for the proposed intervention,
To set up the evidence-based protocol for delivering dietary management to
patients who need to prevent the recurrence of renal stones.
Significance
The majority of patients with recurrent urolithiasis are Asians aged 30-50 years
old. It totally affects working-age adults (Saigal et al, 2005; Wu et al, 2014). Stones
cause pain, obstruction, haematuria or even infection and reduce renal function.
Owing to the pain, patients require frequent visits to the emergency department or a
period of hospitalization. After the acute period, patients may need to undergo
extracorporeal shock wave lithotripsy (ESWL), or ureteroscopy or percutaneous
surgery (Tiselius, 2006). So, stones impose a significant economic burden due to the
lost working days and medical care cost (Johri et al, 2010). It totally impairs the
quality of life of each patient. Thus, preventive measures are essential for patients
with recurrent urolithiasis.
For nurses, there is often a lack of nurse involvement in preventing stone
recurrence. Nurses always offer post-operative care for recurrent patients. However,
prevention is better than cure. Nurses would build up rapport during the dietary
counselling and advise patients to adhere to the diet modification. Therapeutic
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nurse-client relationships would be enhanced (Nursing Point, 2006).
For the entire health care system, stone management costs a lot. About 60% of
episodes receive intervention including either ESWL, ureteroscopy or percutaneous
surgery (Tiselius, 2006). The estimated average cost was ₤3.34 billion in the UK
(Robertson, 2006). The estimated total cost for treating stones in 2002 was $1.83
billion in the US and ₤111.3 million in the UK, ₤54.38 million in Germany
(Lewandowski & Rodgers, 2004). In a Netherlands’ study, 25% of patients with full
compliance of 2 L of water intake daily would eliminate 2,893 stones and save ₤10
million per year (Lotan et al, 2012). However, there is no study conducted in Hong
Kong. It is not possible to compare the cost saved in the Netherlands and Hong Kong.
In reality, due to the high rate of recurrence, dietary intervention should be
implemented in order to reduce the treatment cost. If dietary intervention prevents
20% of patients from suffering from secondary urolithiasis, it will greatly alleviate the
cost of drugs and operation. Thus, diet counselling should be adopted in the local
setting.
9
Chapter 2: Critical Appraisal
2.1 Search and Appraisal strategies
Selection criteria
The inclusion criteria:
The inclusion criteria are based on study design, population, intervention, and the
outcome measures:
1．All patients must understand dietary instructions
2．Adults diagnosed with at least one calcium oxalate kidney stone
3．Age >= 18
4．All patients must be ambulatory
5．Both male and female
6．Randomized Control Trial
7．Dietary management to prevent secondary urolithiasis except supplements
8．Outcome measured by number of recurrences after the dietary management
9．Study conducted over more than 36 months
The exclusion criteria:
1. Mentally impaired patients
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2. Known diseases which cause renal stone formation such as renal tubular
acidosis, hyperparathyroidism, Acromegaly, Cushing’s syndrome, primary
hyperparathyroidism, renal tubular acidosis, sarcoidosis, sponge kidney,
diabetes, inflammatory bowel disease, ileal or colonic resection, bariatric
surgery, immunologic disease, Primary hyperoxaluria treated with potassium
citrate, cholestyramine, or calcium supplements
Keywords
The keywords used were “dietary intake”, “dietary pattern”, “diet”, “dietary
intervention”, “nutrition”, “dietary management”, “kidney stones”, “urinary calculi”,
“urolithiasis”, “urinary tract stones”, and “nephrolithiasis”.
Search methodology
Quality Assessment
The Scottish Intercollegiate Guidelines Network (SIGN) methodology Checklist
2: Randomised controlled trials appraisal tool was used. All four individual checklist
were used according to the SIGN appraisal tool (Appendix 05). The internal validity
of the selected studies was evaluated according to the checklist. The level of evidence
is rated in accordance with the overall quality of the studies. Comparison of quality
11
assessment is listed.
2.2 Results
Between 7th July, 2014 and 9th September, 2014, a literature review was
conducted. Relevant keywords in the title, abstract and medical subject heading
(MeSH) were identified. A search was conducted through three electronic engines
PubMed, CINAHL, Embase, and Ovid Medline, and the Cochrane Library. The
abstracts were reviewed and full texts were retrieved for selection according to the
criteria. Some of the studies overlapped. Four studies were selected for critical
appraisal finally. The other studies could not meet the inclusion criteria or were
irrelevant. Two reviews were searched under the Cochrane Library. However, the
review included studies covering both primary urolithiasis and recurrent urolithiasis.
In this thesis, preventing recurrent renal stones is my main focus. Borghi et al. (2002)
was extracted from one of the review papers in the Cochrane Library. However, other
articles in the review paper were irrelevant to the topic, thus, no review paper was
suitable for my innovation. Moreover, a reference list of all relevant studies retrieved
was manually searched but with no result. (Appendix 02)
Detailed data are listed in the table of evidence in the form of patient
characteristics, intervention, comparison, length of follow up, outcome measures and
effect size. (Appendix 03)
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High quality (++), acceptable (+), and low quality / unacceptable (0) were used to
rank the study’s risk of bias. High quality (++) was given to Hiatt et al.’s (1996) study.
Randomization was used from a list of random numbers, ITT was adopted and sample
size recruitment was clearly stated (α = 0.05, β = 0.20, two-tailed test, 54 subjects
each group). Little risk of bias was noted and the results are unlikely to be changed.
In Borghi et al. (2002), high quality was ranked. Randomization was done using
sealed numbered envelopes, ITT was adopted and a precise drop out diagram drawn.
Little risk of bias is noted. In Borghi et al. (1996), acceptable (+) was graded. It has
the largest sample size among four studies, small drop out rate but ITT is abandoned.
Some flaws will be associated with the risk of bias. In Kocvara et al. (1999),
acceptable (+) is rated. No detailed randomization method is stated, ITT is ignored but
the study is conducted in three centres. Some flaws are associated with the risk of
bias.
2.3 Summary and synthesis
Summary
All four studies state the research question clearly. The participants are first-time
calcium-containing stone formers, interventions are the specified diet set by each
study, the control is another diet or no treatment, and the outcome measure includes
the rate of recurrence and urine composition. In this thesis, the reduction rate of
13
urolithiasis recurrence (%) is the main outcome measure.
Randomization eliminates selection bias, facilitate the blinding of investigators
and assessors and ensures the changes are due to the independent variables rather than
the confounding variables (Armijo-Olivo et al., 2009). With regard to the
randomization method, only two studies state the method used. Hiatt et al. (1996)
report that the randomized method is from a list of random numbers. Borghi et al.
(2002) distribute participants randomly by odd and even numbers. Borghi et al. (1996)
and Kocvara et al. (1999) assign patients into two groups randomly but no method is
supported. All four studies allocated patients randomly.
Concealment will minimize the risk of allocation bias (Attia, 2005). One of the
researchers in Borghi et al. (2002) generated a sequence, enclosing the numbers in
sealed and numbered envelopes. There is no concealment method mentioned in the
other three studies.
Blinding will minimize the risk of subject bias in that participants are kept
unaware of the treatment throughout the study (Attia, 2005). In dietary adjustment, all
participants cannot be blinded as they need to follow the diet regimen. Hiatt et al.
(1996) and Borghi et al. (2002) keep blinding the outcome assessors while the other
two studies do not mention this. The investigators in all four studies are not blinded.
14
The baseline characteristics of patients are allocated between treatment groups so
that any difference in outcome can be assumed to be due to the intervention. Similar
baselines demonstrate that the randomization process worked (Roberts and Torgerson,
1999). Baseline characteristics were similar in all four studies. There is no significant
difference between intervention and comparison groups.
The intervention themes of the four studies are similar. Firstly, increasing water
intake to around 2L per day is one of the parameters. Water is the vital component in
the four studies. Secondly, avoiding oxalate-rich food is proposed in two studies. Both
intervention and comparison groups avoided oxalate food in Borghi et al. (2002)
while the comparison group’s intake of oxalate food was restricted in Kocvara et al.
(1999). Thirdly, low or moderate protein diet is experimented with in three studies.
Both Kocvara et al. (1999) and Borghi et al. (2002) allocate a low-protein diet to the
comparison group while Hiatt et al. (1996) distribute it as an intervention group.
Finally, calcium intake is investigated in three studies. Both Kocvara et al. (1999) and
Borghi et al. (2002) compare low calcium levels and normal calcium levels in
intervention and comparison groups. In Hiatt et al. (1996), as calcium is contained in
dairy products, both intervention and control groups are instructed to consume the
same serving of dairy products.
All outcome measures are in a standardized way and stated clearly. The outcomes,
time of first recurrence and stone risk profile, are stated clearly in the four studies.
15
The measurement tools include a full physical examination, urine sample, a flat plain
abdominal x-ray and renal echography yearly. Urine samples are analysed using a
standard method. X-ray and USG are the valid and reliable machines to determine any
stone (Borghi et al, 1996; Hiatt et al, 1996; Kocvara et al, 1999; Borghi et al, 2002)
Drop out affects the power of a study. A high drop-out rate will hinder researchers
drawing a clear conclusion (Armijo-Olivo et al., 2009). The drop-out rate in the four
studies varied from 9.5% to 21.2%. Overall, such drop-out rate is regarded as
acceptable. In Borghi et al. (1996), 21 out of 220 subjects (9.5%) dropped out from
the study for reasons such as recurrence of renal stones and being excluded from the
study. In Hiatt et al. (1996), 21 out of 99 subjects (21.2%) did not complete the full
study. In Kocvara et al. (1999), 35 out of 242 subjects (14%) dropped out. In Borghi
et al. (2002), 17 out of 120 subjects (14%) withdrew from the study. The CONSORT
diagram is shown in the journal.
Intention to treat preserves the comparability of intervention and control groups,
generates more effective estimates of the treatment, eliminates the inferential basis of
statistical analysis, and provides greater accountability (Armijo-Olivo et al., 2009).
The intention to treat (ITT) principle is adopted in Hiatt et al. (1996) and Borghi et al.
(2002). In Hiatt et al. (1996), 17 out of 220 people withdrew from the study. Finally,
17 subjects turned up for the follow-up. In Borghi et al. (2002), 17 out of 120 subjects
dropped out. The researchers counted 120 subjects as the total sample size. The
16
researchers in the studies included the withdrawn cases in the analysis.
Multisite randomized clinical trials which include larger sample sizes have
greater power and more precise estimations are obtained. Also, higher generalizability
is ensured (Armijo-Olivo et al., 2009; Kraemer, 2000). Two studies were carried out
at multi-sites. In Hiatt et al. (1996), subjects were recruited from San Francisco,
Walnut Creek and Martinez, California. In Kocvara et al. (1999), the study was
carried out at Prague, Ostrava, Ceske Budejovice.
After the appraisal, these studies were applied to the target groups worldwide.
There are white, Asian, Hispanic and blacks in the study of Hiatt et al. (1996). The
Czech people are the study population in Kocvara et al. (1999). Italians are the target
group in the studies of Borghi et al (1996, 2002), including various occupations such
as civil servants, tradesmen, artisans, farmers, entrepreneurs, managers, practitioners,
retirees and housewives.
All four studies recruited more than 50 patients in each group. Patients’
characteristics are first calcium containing renal stones, received no other dietary
counselling before the study and all adults aged over 18 years old. Excluded patients
are those with some metabolic diseases or parathyroid disease. (Borghi et al, 1996;
Hiatt et al, 1996; Kocvara et al, 1999; Borghi et al, 2002).
17
All four studies use diet as an intervention and deliver the diet instructions after
comprehensive baseline examination and randomization.
All four studies provide urine analysis, renal echography and abdominal flat-plate
X-ray yearly for both intervention and control groups (Borghi et al, 1996; Hiatt et al,
1996; Kocvara et al, 1999; Borghi et al, 2002). Length of follow up ranges from 36
months to 60 months. Two studies conducted follow up every 6 months (Hiatt et al,
1996; Kocvara et al, 1999) while two studies did it yearly (Borghi et al, 1996; Borghi
et al, 2002).
The outcome measure is the number of people that have recurrence of renal
stones in %. In Borghi et al. (1996), effect size is -15%, p=0.008. It is statistically
significant. It implies that subjects in the intervention group, who increase their water
intake to 2 L per day, have less chance of recurrent renal stones than that of control
groups who receive no treatment. To prevent recurrence of renal stones, drinking at
least 2 L of water per day is proven to be effective. In Hiatt et al. (1996), the effect
size is +20%, p=0.006. It is statistically significant. It implies that participants in the
intervention group who receive low animal protein, high fruit and fibre, normal
calcium intake, and eight glasses of water, develop a higher chance of recurrent renal
stones than that of comparison group, normal calcium intake and 8 glasses of water. In
Kocvara et al. (1999), the effect size is -13%, p<0.01. It is statistically significant. It
implies that patients in the intervention group who receive low calcium and a specific
18
dietary regimen (Appendix 04) have less chance of recurrent renal stones than those
in the comparison group who consume moderate animal protein, restricted oxalate
food, adequate calcium, and regular fluid intake. In Borghi et al. (2002), the effect
size is +18%, p=0.03. It is statistically significant. It implies that patients in the
intervention group who receive low calcium, avoid oxalate food and drink 2 L of
water per day have a higher chance of recurrent renal stones than those in the
comparison group who receive low protein, low salt, normal calcium, avoid oxalates
and drink 2 L of water per day. Overall, those subjects who drink 2 L of water per day,
consume low protein, normal calcium and avoid oxalate food will have less chance of
developing recurrent urolithiasis.
The main theme of the regimen is concluded in four aspects. Firstly, increasing
water intake to 2L per day can be deduced from all four studies. The positive result of
each study is that 2 L of water intake is the vital regimen. Secondly, Borghi et al.
(2002) and Kocvara et al. (1999) show a positive result in avoiding oxalate food.
Thirdly, low or moderate protein diet is proved effective by Hiatt et al. (1996), Borghi
et al. (2002) and Kocvara et al. (1999). Finally, adequate calcium in the diet is also
proved effective by Hiatt et al. (1996), Borghi et al. (2002) and Kocvara et al. (1999).
Synthesis
Some dietary suggestions can be made based on the critical appraisal.
19
Conclusions can be summarized from the table of evidence and the diet protocol can
be proposed for the local setting.
2.4 Diet Recommendation
After the review of the four studies, a diet protocol can be concluded from the
summary. First of all, increasing water intake reaches 2 L per day is the golden rule to
prevent secondary urolithiasis. Moreover, avoiding oxalate food is another measure.
Also, a low or moderate protein diet is recommended. Finally, a moderate amount of
calcium is required in the dietary counselling.
Compliance
Dietary management is a huge challenge to patients. Hiatt et al. (1996) point out
that the researchers had no interaction with the subjects for 6 months. The dietary
interview was held every 6 months. Outside these periods, researchers cannot monitor
participants’ adherence to the specified diet. Moreover, Kocvara et al. (1999)
discovered that patients are not eager to obey the allocated diet. To solve it, several
dietary counselling and regular follow-up sessions every 3 months would be offered.
Study design
To implement the innovation, some considerations from the four studies should
be adopted, such as increasing water intake as the main intervention of the study. On
20
the other hand, regular follow up and simliar patients’ characteristics (comparable
demographic background) will be recommended. In addition, increasing the
frequency of interviews is a way to motivate patients. Thus, the proposed study
setting is to follow up the participants regularly every 3 months and set up a hotline
for enquiries.
Diet consideration
Four main themes in the diet counselling weigh equally in the innovation.
Patients are recommended to adhere to four criteria strictly and should not neglect the
importance of water intake. In Hiatt et al. (1996), the result contradicted the
hypothesis and was statistically significant. The researcher explained that the
intervention group focused on the complex dietary intervention and might not adhere
to the water intake. In contrast, the control group mainly focused on the fluid
recommendation. After the study, the researchers concluded that increasing fluid
intake instead of a high fibre and low protein diet has advantages in preventing
secondary urolithiasis.
In Kocvara et al. (1999), a specific diet yielded a lower recurrence rate related to
higher fluid intake and the enhanced effect of metabolic factors. The metabolic value
should be normal in each follow up, otherwise, a specific diet is recommended for
those with hyperoxaluria, hyperuricaemia, hypomagnesuria, hypocitraturia, and
21
hypercalciuria. However, a specific diet is not the main stream of the innovation.
General advice will be given to patients in order to sustain the uniqueness of the
innovation. Thus, a specific diet cannot be applied in the innovation.
After the summary and synthesis, the intervention diet includes increased water
intake, adequate calcium, avoiding high oxalate food, and a moderate protein diet. It
is proposed as an innovation for patients who have recurrent urolithiasis in my local
setting.
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Chapter 3 Implementation potential
The review demonstrates that the fluid and dietary control programme is effective
in preventing secondary urolithiasis. The benefits of dietary counselling may be
successfully transferred to other urology units, such as a selected urology unit in a
public hospital of Hong Kong, to improve patients’ adherence with regard to fluid and
dietary intake. Before adopting new dietary counselling, the transferability, feasibility
and cost-benefit ratio of the innovation should be carefully considered.
Target audience
The target audience of the innovation should meet the inclusion criteria and
exclusion criteria. Inclusion criteria are hospitalized patients aged older than 18, first
time diagnosised wih first calcium oxlate stone, admitted for elective URSL or PCNL
or ESWL. They must be mentally fit, capable of independent daily-living activities
and understand the dietary instructions. Exclusion criteria are patient having known
diseases related to urolithiasis.
Target setting
The target setting is a local public hospital in Hong Kong. It is a urology centre.
Urology nurses have an important role in the care of patients after discharge. Nurses
in the urology ward and centres will mainly be responsible for dietary counselling of
23
patients under this innovation.
In order to minimize the potential risk to patients from dietary counselling,
agreement from all the urological doctors must be obtained. All of them will be
invited to participate in the innovation.
3.1.1 Transferability of the findings
Four studies were selected which concluded that dietary counselling is effective
in preventing secondary urolithiasis.
The findings are transferable as they fit the target setting and audience. From the
research studies, the type and characteristics of patients were diagnosed first with
calcium oxalate stones and surgery or ESWL was done. The mean age was around
41-45 years old. The largest proportion of participants were male patients. The mean
age and ratio of sexes were similar to the data in the ward. The setting in the studies
was the urology centre while the setting in the innovation is the urology ward and the
urology centre. Education was initiated in the urology ward and the follow up was
held in the urology ward. Both settings provide urology care to patients. Recruitment
of patients in the innovation will be conducted in the post-operative period in our
programme while participants will be referred to the urology centre for recruitment
for the selected studies. During the post-operative phase, patients may have better
24
acceptance for the prevention of secondary urolithiasis after removal of their first
renal stone. Moreover, patients are taken care of by nurses 24 hours a day and have
much more contact time with them than other professionals. Rapport may be built up
easily through daily bedside care. Thus, it is more appropriate that nurses conduct the
dietary counselling. However, in the reviewed studies it was dietitians or doctors
(medical doctors) who did so while nurses will be the chief actors in the proposed
innovation. Moreover, most of the selected studies took place in developed countries
like the USA and Italy, which share similar economic conditions and medical
development with Hong Kong, thus the transferability of the studies is not reduced
(Appendix 06).
Another factor concerning the successful transferability of findings is the
philosophy of care. The innovation causes no conflict of philosophy of care in the
practice setting. The mission of that setting is to provide the best-possible care with a
caring heart, and empower people to regain their health and stay healthy by offering
them support in the form of information, encouragement and motivation. In fact, the
innovation was developed according to this principle of providing holistic care to
patients after surgery, and the ultimate goal of the programme is to improve patients’
quality of life by preventing secondary urolithiasis.
It is estimated that the proposed innovation will favour a large proportion of
patients in the targeted setting. According to the ward’s statistical profile, about eight
25
patients per month are admitted for elective stone surgery.
The pilot will take 6 months. From the table of evidence, the length of follow up
is usually 12 months but with low compliance. In the innovation, the length of follow
up is 3 months to increase the adherence. In addition, the studies conducted ranged
from 3 years to 5 years. If the pilot programme is successful, the implementation
period will be extended to 5 years.
3.1.2 Feasibility
Nurses will have the freedom to carry out or stop the innovation. Nurses will
introduce the details of the innovation and obtain consent for enrolment in the
programme if patients agree to the diet counselling. Ward Nurses and urology centre
nurses can conduct training with the guidance of the protocol and assess patients to
see whether they meet the inclusion criteria of the target population.
The current staff functions will not be interfered with by the proposed innovation.
The diet counselling will be conducted within 30 minutes on an individual basis.
From clinical experience, the most available time is usually after visiting hours. The
innovation can be conducted during that period.
Administrative and organizational support is important for communicating with
26
doctors and gaining their support for the programme. Ward manager and all urology
surgeons totally support this evidenced-based innovation. In fact, the local hospital is
keen on conducting research and welcomes innovation. There is no reason for the
hospital not to support the innovation because of its low cost and high impact and the
minimal risk to the patients. In addition, the philosophy of care in the proposed
innovation meets the mission of the hospital. Since 2009, all ward nurses should
remind or reinforce patients to perform pelvic floor exercises after robotic assisted
radical prostatectomy. All surgeons delegate the pelvic floor muscle training to senior
nurses and praise the performance of urology nurses. With the previous experience,
doctors and ward manager have been supporting this new innovation.
To launch this programme, conflict may occur among staff. Some colleagues
support the innovation in the long run. By providing some dietary advice, patients will
have a chance to modify their behaviour in order to prevent secondary urolithiasis. If
patients commit to the dietary control and prevent stone recurrence successfully,
those patients will not need to be readmitted because of renal stones again. It totally
decreases the admission rate and the recurrence rate. In contrast, some colleagues
oppose the programme due to heavy their workload. They claim that dietary advice
should be implemented by dietitians, but not by RN. In addition, 30-minute
counselling is very valuable in a busy ward. In the short run, a heavy workload can be
estimated under this programme. In fact, education is the usual practice of the nurses
in the urology setting. The new programme will require more structured educational
27
sessions, rearrangement of manpower and increased workload can be the source for
potential resistance from staff members. A pilot study should be employed to estimate
the potential change in workload. It can provide a clear expectation of what might be
changed under the new programme and reduce the resistance to the new programe.
According to the dietitian department, there is no guideline on preventing
secondary urolithiasis and dietitians will not provide any service regarding it. The
dietitian department and urology surgeons are committed to launching this dietary
advice to be conducted by urology nurses. Dietitians will give advice on preparing an
information pamphlet about food’s nutrients, but will not provide consultation to the
patients. Moreover, the X-ray department agrees to provide KUB services for the
patients during follow-up.
The protocol will be approved by the Chief of Services (COS), consultants, all
urology surgeons, Department Operations Manager (DOM), and ward manager. The
APN in the programme will train all nominated nurses. The APN will conduct all
follow up and assessment of KUB and BS USG. A training course is provided by an
associate consultant in USG imaging. If the APN finds any abnormalities, patients are
directly referred to the associate consultant immediately.
In addition, all pamphlets are prepared by the APN. BS USG is also performed
by the APN as the APN is well trained by the associate consultant. The USG machine
28
is one of the pieces of equipment which belongs to the urology centre. Dietitians will
suggest nutrient value information for the pamphlet. The X-ray department has agreed
to provide KUB service for the participants. The only purchased item is the 2 L
pitcher. With others’ support, the innovation is feasible.
The chief in-charge of the pilot programme is the Advanced Practice Nurse (APN)
of the urology centre. The APN trains the Registered Nurse in the urology centre first,
and then nominated nurses in the urology ward. The training will be conducted 1 hour
each session on two Saturdays and Sundays in the ward. The gift set includes the 2 L
pitcher and the pamphlets and a consent form will be explained in detail in the
training session. Role playing and Q&A will be launched to assess staff’s knowledge.
The aim of the training is to introduce the details of the innovation so that the training
provided by each nurse is standardized. The intervention protocol will be standardized
by systematic training for the nominated nurses with a standardized training protocol
before implementation. The content of the training protocol includes the importance
of preventing secondary urolithiasis, advantages of dietary modification over
medicine, the detail of the dietary regimen, usage of the pamphlet and the 2L water
pitcher.
Measuring tools are KUB and BS USG that are reliable to evaluate any renal
stone formed. Patients will have KUB and BS USG quarterly in each follow up. BS
USG is operated by the APN in the urology centre and the maintenance fee of the
29
USG is supported by the urology department. KUB service is supported by the X-ray
department.
3.1.3 Cost-benefit ratio of the innovation
There is no potential physical risk to the patients. All patients will be enrolled
through the assessment of the surgeons and nurses in order to minimize the potential
risk. For example, some patients cannot drink 2 L of water daily due to congestive
heart failure and fluid restriction. Thus, enrolment screening will take place prior to
the innovation.
The potential benefit to patients is that the innovation can reduce the risk of
secondary urolithiasis. No recurrence can lead to a better social life for patients. The
potential benefit to nurses is that the readmission rate will be decreased as patients are
free from stones.
Under current practice, patients do not take measures to prevent secondary
urolithiasis. They have the risk of recurrence within five years according to the
selected studies. Finally, renal scars will be formed and destroy renal function.
Chronic renal failure will be one of the consequences. A large financial burden will be
caused by these patients.
30
The short-term material cost includes the pamphlet fees, 2 L pitchers fees and the
printing fees. The pamphlet is being prepared outside and the cost is around $500. The
2 L pitchers will be purchased from the contractor and the cost is around $19,000
(Appendix 07). The printing cost of the written material such as the invitation letter,
consent form, other administrative paper is $500 which is ad-hoc by the department,
as a printing service is already available in the department of limited cost. The
long-term maintenance fee of bedside ultrasonography is supported by the urology
centre. No extra fee should be paid.
If the innovation is not implemented, the cost for the health care expenditure will
be heavy. From the selected studies, the recurrence rate after the first kidney stone is
50% within 5 years. According to the previous surgery statistics, patients develop
their secondary urolithiasis and receive surgery afterwards. On average eight patients
receive the secondary urolithiasis surgery each month. According to Borghi et al.,
1996, there is 20% patients got relapse of renal stone in the intervention group.
The proposed innovation will enrol 40 patients in six months. Assuming that 32
patients will prevent secondary urolithiasis through the dietary counselling, there will
still be 8 patients after the innovation suffering from secondary urolithiasis in 5
years. Thus, the net expenditure is the subtraction of the expenditure saved for 5 years
and the set up and material cost of the proposed innovation for 5 years of around
ninety-seven thousand and three thousand. The average net expenditure saved is
31
around nineteen thousand each year (Appendix 20).
The potential non-material costs of implementing the proposed innovation
involve increase nurses’ stress and anxiety or impaired overall morale. Good
communication plans with adequate information provided to nurses before the
implementation are important for reducing this stress and anxiety. In addition, the
overall morale among staff will be motivated by the innovation’s positive benefit to
patients. It will bring increased commitment, recognition and appreciation of nurses
themselves.
In conclusion, the innovation can be implemented because of its transferability,
feasibility and cost-effectiveness.
32
3.2 Developing an evidenced-based practice guideline
Background
The innovation of the programme is evidence-based dietary counselling to
prevent secondary urolithiasis for patients with calcium-containing stones. Evidence
from different studies supports the claim that some dietary control can help patients to
prevent stone recurrence. Nowadays, there is a lack of nurse involvement in
preventing secondary urolithiasis so that an innovation with an evidence-based
guideline is important in helping nurses to provide high-quality care.
Development process
According to SIGN (2011), clinical practice guidelines have been defined by
Field and Lohr (1990) as systematically developed statements to assist decisions
about appropriate healthcare for specific clinical circumstances. SIGN (2011)
demonstrates that a strong base which provides evidence of effective practice
guidelines can assist nurses in making decisions about appropriate and effective care
for patients.
Before developing the new guideline, relevant studies were searched and a
systematic review of the four identified studies was carried out to find the most
up-to-date evidence on dietary counselling to prevent secondary urolithiasis. A
methodological quality appraisal is conducted on these studies using a tool from
SIGN (2011). This tool is to assess the methodological quality of studies and
facilitates the decision-making process. The results of the evaluation of the studies are
also of assistance in comparing studies and determining the relative strengths and
weaknesses. According to this systematic evaluation, all four studies were identified
as relevant and worthy of the methodological qualified ranking of ‘++’ and ‘+’ by the
overall assessment of SIGN (2011), and appropriate for the development of the best
possible guideline.
33
Name of the guideline
An evidence-based dietary counseling to prevent secondary urolithiasis for
calcium-containing stone patient.
Purpose
To reduce the rate of recurrence of calcium-containing stone among urological
patients who had their first renal stone removed with the use of dietary counselling
conducted by nurses.
Objective
Summarize the clinical evidence for patients with their first calcium-containing
stone with dietary regimen
Formulate clinical practice instructions for patients to prevent from secondary
urolithiasis
Reduce the risk of secondary urolithiasis in patients
Target users
Nurses in the urology centre
Nurses in the urology ward
Target population
Hospitalized urological patients, without limitation of age, with the inclusion
criteria:
Mentally fit
Independence in daily living activities
After treatment with the first-calcium containing stone, surgery such as URSL or
PCNL, or ESWL
34
No known diseases which cause renal stone formation
Target setting
The programme will be held in a local public hospital. A urological ward with 34
beds, and the urology centre will be chosen for the innovation programme.
Length of follow-up
In the pilot programme, the length of follow up will be six months. From the
statistical records of local hospitals, the average number of patients who undergo first
renal stone surgery are eight cases per month. In the pilot study, four patients will be
recruited. After the pilot study, 40 patients over six months will be recruited in the full
strength study. The full strength study will be conducted for 5 years. No matter
whether the pilot study or full strength study, every patient needs to attend follow up
every three months. If patients withdraw from the study, intention-to-treat will be
adopted.
Patient education tools
A patient gift set will be designed for the programme. There are two main items
in the set, an information leaflet and a 2 L pitcher.
In the leaflet, all the information will be described in detail. The process and
potential causes of secondary urolithiasis, and the importance and benefit of dietary
instructions will be included in the leaflet.
A 2 L pitcher will be given to patients in the gift set. Each participant should
drink 2 L of water per day, which is one of the golden rules to prevent secondary
urolithiasis. Another aim of the pitcher is to increase compliance with drinking the 2 L
of water daily. A 2 L pitcher provides a standard measurement of water intake daily.
Activities schedule
35
In the pilot programme, the innovation will be conducted post-operatively. If the
patients receive URSL or PCNL post-operatively and agree to receive the dietary
counselling, a gift set will be given to them by the ward. If the patients receive ESWL
and agree to receive the dietary counselling, a gift set will be given to them by the
urology centre. Consent will be obtained from patients before enrolling them in the
innovation.
The nurses will introduce the details and benefit of the pilot programme to the
patients. The importance, detail and advantages of dietary counselling will be
discussed together with the details and possible relapse of renal stones. Under the
guidance of the information leaflet, verbal instruction on the four domains of the
dietary regimen will be reminded to the patients. Patients are recommended to take
adequate calcium, avoid high oxalate food, drink 2 L of water per day and have a
moderate protein diet. Most of the common foods rich in calcium, protein and high
oxalate food will be listed in the leaflet, and a 2 L pitcher will be given to patients.
In the follow-up phase, the nurses in the urology centre of the hospital are mainly
responsible. Patients will attend the first dietary counselling post-operatively on day
14 and then every three months. Bedside ultrasound imaging (BS USG) will be
performed by nurses in the urology centre to screen any relapse of renal stones in each
follow up. Also, kidney-ureter-bladder radiography (KUB) will be performed on
patients in the X-ray department. If patients find relapse of renal stones, cases will be
directly referred to the associate consultant promptly for further management.
After a six-month pilot programme, participants will be encouraged to follow the
life-long dietary regimen in order to prevent secondary urolithiasis.
Recommendations
This guideline is developed according to the previous systematic review and
36
synthesized from the SIGN methodology in the SIGN 50: A guideline developer’s
handbook revised edition (2011). A summary of the recommendations is attached
(Appendix 08).
1 Recommendation: The innovation
Structured dietary counseling is recommended
Grade : A
Evidence:
Study Level of
evidence
Content
Borghi et
al., 1996
1++ However, when hypercalciuria is present, it is necessary to
introduce dietary measures to reduce the excretion of
urinary calcium.
Hiatt et al.,
1996
1++ To improve our understanding of the influence of diet on
kidney stones, we used a randomized controlled trial to test
the hypothesis that instructions on a low protein, high fibre
diet among persons who have had calcium oxalate stones
for the first time is an effective method to reduce the
frequency of recurrent stone events.
Kocvara et
al., 1999
1+ The formation of a kidney stone is closely related to dietary
habits, but despite this, no prospective studies of dietary
therapy in urinary stone disease have been reported until
recently.
It is obvious that to be widely accepted, this regimen must
be therapeutically effective, convenient for the patient and
inexpensive.
Despite major advances in modern stone therapy, these data
suggest an urgent need for an efficient prophylactic regimen
even in patients experiencing their first kidney stone.
2 Recommendation: Time for the dietary counselling
Dietary counselling should be conducted after renal stone removal.
Grade : A
Evidence:
Study Level of Content
37
evidence
Borghi et
al., 1996
1++ Once the lithiasic episode has been resolved (through
spontaneous expulsion of the calculus, shock wave
lithotripsy, percutaneous techniques or other procedures),
each patient was then thoroughly encouraged to resume their
normal diet and high water intake as before the lithiasic
episode.
Kocvara et
al.,1999
1+ The study comprised 242 patients treated for their first
idiopathic calcium kidney stone in three departments of
urology in 1991-4.
3 Recommendation: content of education
Dietary counselling includes increasing water intake, adequate calcium, avoiding high
oxalate food and having a moderate protein diet.
Grade : A
Evidence:
Study Level of
evidence
Content
Borghi et
al., 2002
1++
The other important result of a normal-calcium, low-protein,
low-salt diet is the consistent reduction in urinary oxalate
excretion. With a normal calcium diet, more calcium is
available in the intestinal lumen to form a complex with
oxalates, thus reducing its adsorption. In addition, the
reduced intake of protein may lower the endogenous
synthesis of oxalates. A normal-calcium, low-protein,
low-salt diet decreases urinary excretion of both calcium and
oxalate, which in combination with an increase in urinary
volume causes a marked reduction in the calcium oxalate
molar product and in the relative calcium oxalate saturation.
Hiatt et al.,
1996
1++
First, increased fluid intake effectively reduces the urinary
activity product ratio (saturation) and is one possible
explanation. We conclude that advice to reduce dietary
protein and to increase fibre and fluid intake does not reduce
the recurrence rate of calcium oxalate kidney stones
compared with simple advice to increase fluid intake. Low
protein diets are not harmful and have salutary effects on
patients who have cardiovascular disease or some cancers.
Kocvara et 1+ The prophylactic regimen is usually based on an increased
38
al., 1999 fluid intake. The lower recurrence rate in patients in group 1
may be related to both the higher fluid intake and the
enhanced effect on some metabolic risk factors (especially
uric acid disorders and possibly magnesium deficit). About
80% of the present patients admitted a lower calcium intake
at entry into the study, and regular and appropriate calcium
intake (mostly in dairy products) was recommended to these
patients, despite the high incidence of hypercalciuria.
Borghi et
al., 1996
1+ In this study we have shown that patients with idiopathic
calcium nephrolithiasis have a urine volume at the first
episode that is lower than the volume of healthy control
subjects, and that a simple but adequate increase in water
intake, without any changes in diet, can prevent recurrences
in a large number of subjects.
4 Recommendation: content of education
Educational handouts should be given.
Grade : A
Evidence:
Study Level of
evidence
Content
Hiatt et al.,
1996
1++
Persons in the intervention group were instructed to decrease
their intake of animal flesh proteins and other
purine-containing foods by avoiding a list of nine meats and
three legumes and limiting their intake to three 1-ounce
servings daily from a list of seven meat and dried legumes
groups.
Borghi et
al., 2002
1++
The men assigned to this regimen were given written
explanations and detailed information designed to help them
comply with the regimen.
5 Recommendation: content of education
A 2L water pitcher should be provided.
Grade: A
Evidence:
Study Level of Content
39
evidence
Hiatt et al.,
1996
1++
Finally, both intervention and control subjects were
instructed to drink six to eight glasses of liquid daily,
including one at bedtime, to keep the urine dilute.
However, the intervention subjects, who were following a
more complex dietary intervention, might not have followed
the fluid recommendations as closely. Reported fluid intake
levels were greater among the control subjects in the early
part of the trial when most of the stone events occurred.
Borghi et
al., 1996
1+
Programme 1 has as its only measure a high water intake,
which would give a urine volume that was equal to or
greater than 2L a day (all patients received water that was
not too mineralized and they were all instructed to measure
their urine volume at home every 2 to 3 months).
Kocvara et
al., 1999
1+
Instructions for an adequate and regular fluid intake were
given to both groups of patients, as was information about
the appropriate fluid composition.
6 Recommendation: evaluation
Recurrence of renal stones detected by KUB and ultrasound.
Grade: A
Evidence:
Study Level of
evidence
Content
Hiatt et al.,
1996
1++
In addition, the subjects had an annual abdominal radiograph
taken at 1, 2, 3, and 4 years. Stones that were passed,
surgically removed, or radiographically visible were counted
as recurrences if they were not present on the baseline
radiographs.
Borghi et
al., 2002
1++
Silent recurrences were diagnosed on the basis of renal
ultrasound and abdominal flat-plate examinations performed
at yearly intervals. The imaging studies were performed by a
central radiology service, and the radiologist had no
knowledge of the trial or the group assignments.
Borghi et
al., 1996
1+
Each year for the 5-year follow up period, a 24-hour urine
collection was brought to the stone centre to determine the
urine stone risk profile and patients received a complete
40
physical examination, a flat plain abdominal x-ray and renal
echography.
Kocvara et
al., 1999
1+
Radiography and ultrasonography were performed to assess
the formation of any new recurrent stones.
7 Recommendation: Follow up
Regular follow up quarterly (3 months) should be adopted to increase compliance.
Grade: A
Evidence:
Study Level of
evidence
Content
Hiatt et al.,
1996
1++
Subjects visited the medical centre research clinic every 6
months for up to 4 years after randomization and were
followed for 4.5 years.
Apart from these contacts, which occurred about every 6
months, we had no other interaction with the subjects.
Our study was limited because we could not follow subjects
closely to ensure compliance.
Borghi et
al., 2002
1++
Twenty-four-hour urine specimens were obtained at
baseline, one week after randomization, and at yearly
intervals during the five years of the study.
Borghi et
al., 1996
1++
Each year for the 5-year follow up period a 24-hour urine
collection was brought to the stone centre to determine the
urine stone risk profile and patients received a complete
physical examination, a flat plain abdominal x-ray and renal
echography.
Kocvara et
al., 1999
1++
Dietary measures were adjusted according to the metabolic
follow-up after 6, 18 and 36 months in group 1.
The patients in group 2 were evaluated after 36 months.
Repeated dietary counselling was also necessary because no
significant decrease in uricaemia and uricosuria was
detected until evaluation after 3 years.
8 Recommendation: Programme duration
Dietary counselling should last for 5 years
Grade: A
41
Evidence:
Study Level of
evidence
Content
Hiatt et al.,
1996
1++
Subjects visited the medical centre research clinic every 6
months for up to 4 years after randomization and were
followed for 4.5 years.
Borghi et
al., 2002
1++
Twenty-four-hour urine specimens were obtained at
baseline, one week after randomization, and at yearly
intervals during the five years of the study.
Borghi et
al., 1996
1++
After the basic urine collection, patients were randomly
placed in two different follow up programme lasting 5 years.
Each year for the 5-year follow up period a 24-hour urine
collection was brought to the stone centre to determine the
urine stone risk profile and patients received a complete
physical examination, a flat plain abdominal x-ray and renal
echography.
Kocvara et
al., 1999
1++
The study spanned a 3-year period because the risk of
recurrence is maximal during this period.
The flow chart of the dietary counselling is attached (Appendix 09).
Conclusion
As this new guideline is developed from relevant, updated, and highly qualified
studies, it is believed to be effective in preventing secondary urolithiasis of patients
with calcium-containing stones in the proposed setting.
42
Chapter 4 :Implementation Plan
4.1 Communication plan
A well-planned communication strategy is essential to the successful
implementation of the proposed innovation. A communication plan will begin to
identify stakeholders and describe the communication channels in order to get support
for the proposed innovation.
4.1.1 Identification and involvement of stakeholders
To adopt a successful evidence-based innovation, support from various
stakeholders is required. Dietary counselling to prevent secondary urolithiasis for
patients with calcium-containing stones in a urology ward is proposed while the
stakeholders include both internal and external parties.
Internal stakeholder include the patients who have received their first
calcium-containing stone treatment, registered nurses (RNs) working in the urology
unit, advanced practice nurses (APNs), ward manager, department operations
manager (DOM), associate consultant (AC) and the consultant. The internal key
stakeholders are DOM and consultant. They are important for supporting and
approving the proposed innovation and enhancing the positive attitude of staff
towards the proposed innovation. They have more power to distribute resources
among the department, and allocating manpower and financial assistance to the
innovation. APNs and front-line nurses are the users of the guideline to initiate the
proposed innovation. The APN in the urology centre is responsible for training the
staff and is the programme coordinator. Also, the APN is more knowledgeable and has
more experience to handle patients with poor compliance problems.
43
External stakeholders include an experienced dietician who will be responsible
for providing a higher level of training in dietary control for patients with
calcium-containing stones to the centre APN, and radiographer who will be
responsible for providing KUB service for the participants during each follow-up.
4.1.2 Communication strategies
Approaching the DOM, the ward manager, the consultant and associate
consultant who play important roles in promoting the new evidence-based innovation,
will be the first step of the programme. Formal meetings will be held by making
appointment in advance. The importance of innovation and human resource allocation
will be submitted to the meeting, in order to convince them. In addition, cost-benefit
analysis and the feasibility of the programme will be submitted to provide a clearer
understanding of the implementation plan. The affirming needs will also be
emphasized at the meeting. Reasons include permanent consequence, financial burden
and natural therapy. Kidney stones are risk factors for chronic kidney disease and may
deteriorate to end stage renal failure (Rule et al, 2009). Most medical expenditure will
be spent on the removal of recurrent renal stones. Until now, there is no dietary
intervention before stones appear. If a patient is free of stones, it reduces unnecessary
readmission. Thus, daily dietary and drinking recommendations are a cost-effective
strategy to reduce the recurrence of calcium-containing stones.
After gaining the approval of the DOM and consultant, the proposed dietary
recommendations will be presented to about 20 staff. The objectives, the plan and the
benefits of the proposed evidence-based guideline will be presented. The APN in the
urology centre is the programme coordinator responsible for the training of other staff.
Moreover, a communication team will be established to aid the proposed innovation.
The team includes ward manager, APN, associate consultant, and two registered
nurses (one in the centre and one in the ward). The APN will elaborate the detail of
the proposed innovation to all nursing staff during training sessions to alleviate the
44
resistance of some nurses. Role playing and Q&A sessions will further enhance the
understanding of the innovation by the nursing staff.
The new guideline will be established by the communication team. Other nursing
staff are welcome to give advice on the guideline. Also, the core members of the
communication team will answer the queries from users. A pocket guide will be
situated in the nursing station for easy access. All updated information will be kept in
the resource manual in the nursing station.
All successful patients with no recurrent kidney stones after the dietary
counselling, will be recorded in the programme in order to encourage other patients
and provide evidence to DOM and Consultant. Also, regular meetings will be held to
obtain various parties’ feedback, share success stories, make revisions to the new
guideline if necessary based on the evidence collected from the audit nursing charts.
To increase the compliance of patients, the successful patients will form a group with
the help of the communication team to share their experience of the dietary
counselling. The patient support group may be formed after the pilot study. Moreover,
successful patients can give advice on adhering to the dietary counselling (Appendix
10).
45
4.2 Pilot Study Plan
The pilot study is a milestone of the innovation. It is a preliminary version of the
full-scale innovation. It determines the feasibility of the innovation in terms of
potential technical errors, timing, safety, budget, influences of stakeholders and
budget. Significantly, any unexpected difficulties encountered in the pilot study can be
notified to rectify the proposed programme (Grove, 2013). The objective of the pilot
study is to determine the feasibility of the guideline, estimate time and budget of the
innovation, and to assess the acceptability by frontline colleagues and patients.
Design and data collection
The outcome measure is the recurrence of any calcium-containing stones among
the participants.
The duration of the pilot study will be six months as dietary control will be
effective in long run (Borghi et al., 1996). In the pilot phase, the centre APN will
become the project coordinator responsible for training the frontline staff, following
up participants every three months, supervising the usage of the guideline, data
collection and evaluation.
Preparation
Before the pilot study, all the urology centre and ward frontline staff are required
to attend the training. The training comprises a knowledge test (Appendix 12), 1-hour
tutorial, and demonstration. As the dietary control measure will be taught in the
training session, the teaching material and content will be discussed with the dietitian
beforehand. The centre APN will explain the importance of dietary control in
preventing secondary urolithiasis among stone-formers after the first stone surgery on
two consecutive Saturdays and Sundays in the ward. In addition, the pamphlets and a
46
2 L pitcher will be introduced during the 1-hour tutorial. Role-playing and Q&A
sessions will be prepared and all attending staff will return demonstration after the
tutorial. Then, all attending staff will take a knowledge test at the end of the training.
The knowledge test is to assess the understanding of the dietary counselling. Another
training session will be conducted by an associate consultant to the APN.As the APN
has undergone the basic training on USG during the post-registration core course, a
tutorial will be provided. The 4-hour tutorial includes a training part and assessment
part. An associate consultant will teach various types of USG images and examine the
USG knowledge of the APN. Mostly, the black and white area will be shown
significantly if patients suffer from recurrent calcium-containing stones. The associate
consultant is responsible for evaluating the standard of using USG by the APN when
viewing an image of calcium-containing stones.
Resources
The pamphlets, 2L pitchers, consent form, questionnaire, knowledge test and
evaluation forms will be stored in the store room in the urology ward. Assessment and
modification will be made if needed in the pilot study.
Subject Recruitment
The inclusive and exclusive criteria are the same as those in the proposed
guideline. By convenience sampling, all eligible participants admitted to the urology
ward and undergo the first calcium-containing stone surgery such as URSL or PCNL
or ESWL will be recruited. The ineligible participants such as mentally incapacitated
or pregnant will be screened out. If frontline staff face the difficulties, the centre APN
will solve the problem.
Intervention.
47
The pilot will be run after the eligible participants are available. Team nurses
need to conduct dietary counselling and distribute the gift set including the pamphlets
and 2 L pitcher to these patients. The centre APN will follow up the patients every
three months. The outcome measurement is standardized, by KUB image and USG
image. A KUB image of patients will be taken in the X-ray department and BS USG
by a nurse in the urology centre during each follow-up.
If there is any recurrence of stones or any doubt during BS USG, the centre APN
will refer the patient to the associate consultant immediately for further treatment. The
centre APN needs to distinguish the BS USG with hydronephrosis from normal USG
images, black images may refer to water areas and bright small images may refer to
stones. If hydronephrosis is present, the image is apparent obviously in black and
white areas. Other conditions such as cysts, AML, haematoma, or cancer should be
referred to the associate consultant promptly. With mutual agreement, there is no
obligation for the centre APN to mis-diagnose the recurrence of renal stones. During
the pilot phase, all difficulties or special events will be documented for further
analysis.
Review of guideline
After the pilot test, all data will be evaluated by the communication team. A
questionnaire will be distributed to frontline staff for modification of the guideline.
The pilot test report and the modified guideline will be presented to COS, DOM and
WM during meetings. The report and guideline will be sent to all urology nurses via
email.
48
4.3 Evaluation plan
Evaluation is a vital process of the implementation. The objective of evaluation is
to document the implementation.
Outcome measure
Evaluation can be divided into three categories: patient outcome, healthcare
provider outcome and system outcome.
Patient outcome
The main outcome is to prevent the recurrence of calcium oxalate stones. There
will be no stone by KUB in the X-ray department and no hypronephrosis by BS USG.
Patient’s compliance can be asked for by the APN and reported by patients themselves.
However, it is difficult to assess the compliance of patients. A regular phone call by
the centre APN will be a measure to assess the compliance of patients. The
components of the dietary counselling will be emphasized by phone call, The centre
APN will answer any problems that participants may encounter during the dietary
control. Another problem is the dropout rate, participants may want to end the
programme during the pilot study. Then, the drop-out rate will be estimated. However,
all participants will be followed up at the end of the pilot study in order to detect any
recurrence of calcium-containing stones.
Healthcare provider outcome
The satisfaction of healthcare provider outcome directly ascertains the success of
innovation. A questionnaire will be used as a tool to evaluate the satisfaction of the
innovation (Appendix 13). The survey has a 5-point Likert scale, from 1 (totally
disagree) to 5 (totally agree). The higher the score is, the higher the satisfaction of
49
frontline staff towards the dietary counselling.
System outcomes
There is no adverse effect if patients try the dietary counselling. As the USG
machine is already available in the urology centre, access to equipment is easy. Also,
the costs of the innovation will be calculated according to the account record for the
2L pitchers and the pamphlets, surgery fees, and hospitalization fees. The records will
be obtained from the account department of the hospital with approval. In addition,
turnover rate or sick leave rate will be evaluated to assess the availability of human
resources.
Nature and number of clients involved
Patient characteristics will be recruited based on a review of evidence dietary
advice and local settings. Patients aged above 18, both male and female, who
understand the dietary instructions, are ambulatory and have no other metabolic
disease, have undergone the first calcium oxalate stone surgery (URSL or PCNL) or
ESWL, and been hospitalized post-operatively will be evaluated. Mentally
incapacitated patients and pregnant women will be excluded from study.
Software (Lenth, 2009) was used for calculation of the sample size required for
evaluation of the proposed programme. A sample size of 33 was estimated by using a
one-sample t test with a power of 0.8, a standard deviation of 1 stone prevention per
patient, and significance level of 0.05. From the selected RCTs, it is found out that
number of recurrence is less in intervention group than the control group (Borghi et
al., 1996; Hiatt et al., 1996; Kocvara et al., 1999; Borghi et al., 2002). The aim of the
innovation is to prevent the recurrence of renal stones. If one stone is present on the
KUB, the innovation will fail. It implies that the dietary counselling will prevent the
formation of one stone per patient during the innovation.
With an estimated of 20% drop out rate from the selected RCTs, the minimum
50
sample size is 40 (Borghi et al., 1996; Hiatt et al., 1996; Kocvara et al., 1999; Borghi
et al., 2002). From the recent data, an average of eight eligible patients receive
surgery each month. The pilot study will recruit a total of four patients in one month
while the full scale study will recruit 40 patients over 6 months.
Time and frequency of taking measurements
The proposed innovation will last for about 78 months (Appendix 15). In the
selected RCT, the length of follow-up in the study ranges from 3 years to 5 years
(Borghi et al., 1996; Hiatt et al., 1996; Kocvara et al., 1999; Borghi et al., 2002). The
pilot study will last for 6 months and the full-scale study will last for 5 years
according to the selected RCTs. As the recurrence rate of calcium oxalate stones is
50% within 5 years, then a 5-year study is optimal to measure the condition of
participants (Borghi et al., 1996; Hiatt et al., 1996; Kocvara et al., 1999; Borghi et al.,
2002). The centre APN will collect data throughout the 5 years of study and follow up
patients every three months.
For patient outcome, KUB and USG will be taken at each 3-month follow-up.
The knowledge test will be delivered to patients to assess the adherence of patients to
the dietary control (Appendix 12). A questionnaire will be delivered to patients post
-study to assess the satisfaction level of patients towards the dietary counselling
(Appendix 11).
For healthcare provider outcomes, a knowledge test will also be delivered before
and after the training session. Moreover, a satisfaction survey and comments will be
conducted after the pilot testing and half-yearly in the full-scale innovation (Appendix
14). The aim is to tackle the difficulties encountered during the implementation period
(Appendix 16).
For system outcomes, hospitalization rates of recurrent urolithiasis during the
51
execution of continuous measurement will be evaluated. Cost and manpower
contributed to the plan will be evaluated semi-annually to assess any additional
resources or staff needed for the required innovation (Appendix 17). Regarding
expenses, the cost of URSL and PCNL surgery and the cost of ESWL for recurrent
calcium-containing stone participants will be evaluated. Also, the hospitalization rate
of less than 3 days, more than 3 days and any ICU admission will also be evaluated.
In manpower, the sick leave rate and resignation rate of staff will be evaluated. Data
will be collected each week and evaluated half-yearly.
Data analysis
A two-tailed paired t-test will be used to analyze if the recurrence of calcium
oxalate stones is reduced in the intervention group. The level of significance will be
0.05. The main outcome of the programme is to reduce the recurrence rate.
Paired t-test will be used to estimate the staff satisfaction survey towards the
dietary counseling and will be conducted in the 8th month, 33rd month, 39th month,
45th month, 51st month, 57th month, 63rd month, 69th month, and 76th month with 95%
confidence interval.
The cost of the whole innovation will be summed up in the76th month.
Determining the effectiveness of the guideline
In patient outcome, the result of the selected study on preventing secondary
urolithiasis is 15% by drinking 2L of water alone (Borghi et al., 1996). The aim of the
target prevention rate in the proposed innovation is 30%. As there is no data shown on
the knowledge test in the selected study, the mean score of the knowledge test in the
proposed innovation will show improvement in the post-test compared to the pre-test.
52
In healthcare provider outcome, the target attendance rate is over 95% in the
training session and the satisfaction rate is over 60% in the staff questionnaire.
In system outcome, the innovation aims to reduce the admission rate by 50% due
to secondary urolithiasis surgery expenditure by 20% and the manpower rate should
remain less than 10% of the resignation rate and less than 50% of the sick leave rate.
4.4 Ethical Consideration
Ethical consideration should be emphasized in the proposed innovation. Hospital
Authority Board approval should be obtained prior to the study. Also, consents form
should be signed. Confidential and personal data can only be accessed by the staff of
the organization programme. All nurses should follow the principle of Autonomy,
Beneficence, Non-maleficence and Justice throughout the programme.
4.5 Conclusion
The implementation and evaluation of the proposed innovation contain several
parts. With smooth communication with the administrators and frontline staff, a pilot
study to test the feasibility, is necessary to improve the programme. A comprehensive
evaluation plan, and the proposed guidelines will successfully promote the
programme.
53
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Novarini, A., (2002). Comparison of two diets for the prevention of recurrent
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Holmes, R. P. & Assimos, D. G., (2004). The impact of dietary oxalate on kidney
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Kocvara, R., Plasgura, P., Petrik, A., Louzensky, G., Bartonickova, K., & Dvoracek, J.,
(1999). A prospective study of nonmedical prophylaxis after a first kidney stone.
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Lotan, Y., Jimenez, I. B., Lenoir-Wijnkoop, I., Daudon, M., Molinier, L., Tack, I., &
Nuijten, M. J. C., (2012). Increased water intake as a prevention strategy for
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Appendix 1
July 2014
Primary Secondary Sex Age Diagnosis Operation
√ F 62 Left ureteric stone Left URSL
√ F 63 Left renal stone Left URSL
√ M 47 Right ureteric stone Right URSL
√ M 70 Left PUJ stone Left PCNL
√ M 58 Left ureteric stone Left URSL
√ M 49 Left PUJ stone Left URSL
√ M 47 Right ureteric stone Right URSL
√ F 55 Left ureteric stone Left URSL
√ F 49 Right ureteric stone Right URSL
√ M 46 Left ureteric stone Left URSL
√ F 48 Left ureteric stone Left URSL
√ F 48 Bil. staghorn stone Right PCNL
√ M 53 Bil renal stone Bil URSL
August 2014
√ M 49 Left ureteric stone Left URS
√ M 82 Bil renal stone Bil URSL
√ M 84 Left ureteric stone Left URSL
√ M 30 Left PUJ stone Left URSL
√ F 55 Right PUJ stone Right URSL
√ M 69 Left ureteric stone Left URSL
√ F 51 Right ureteric stone Right URSL
√ M 43 Left ureteric stone Left URSL
√ M 47 Right ureteric stone Right URSL
√ F 49 Right staghorn stone Right PCNL
√ M 42 Right ureteric stone Right URSL
√ F 49 Right renal stone Right URSL
Appendix 1
September 2014
√ F 31 Left staghorn stone Left PCNL
√ M 75 Left ureteric stone Left URSL
√ F 56 Right renal stone Right PCNL
√ M 60 Right VUJ stone Right URSL
√ M 49 Right ureteric stone Right URSL
√ M 39 Right renal stone Right URSL
√ F 22 Right renal stone Right PCNL
√ F 60 Right VUJ stone Right URSL
√ M 60 Left PUJ stone Left URSL
√ F 48 Right staghorn stone Right PCNL
√ F 57 Right ureteric stone Right URSL
√ F 59 Left ureteric stone Left URSL
√ M 75 Left renal stone Left URSL
√ M 46 Left ureteric stone Left URSL
√ M 29 Left VUJ stone Left URSL
√ F 29 Right renal stone Right URSL
√ M 65 Left staghorn stone Left PCNL
√ M 55 Right ureteric stone Right URSL
October 2014
√ M 59 Left staghorn stone Left PCNL
√ M 58 Left ureteric stone Left URSL
√ M 56 Right ureteric stone Right URSL
√ F 63 Right staghorn stone Right URSL
√ F 67 Left staghorn stone Left PCNL
√ M 76 Left ureteris stone Left URSL
√ M 73 Left ureteric stone Left URSL
√ M 55 Right ureteric stone Right URSL
√ F 45 Right PUJ stone Right PCNL
√ M 58 Left renal stone Left PCNL
√ M 74 Left ureteric stone Left URSL
√ M 36 Right PUJ stone Right URSL
Appendix 02 Table of searching pathway
Search engine Pubmed EBSCOEmbase1974 to 2014 week 44
Ovid Medline Cochrane
key words
dietary intake ordietary pattern ordiet ordietary intervention ornutrition ordietary management
dietary intake ordietary pattern ordiet ordietary intervention ornutrition ordietary management
diet dietdiet ordietary management
and and and and
kidney stones orurinary calculi orurolithiasis orurinary tract stones ornephrolithiasis
kidney stones orurinary calculi orurolithiasis orurinary tract stones ornephrolithiasis
urolithiasis(included relatedterms)
urolithiasisurolithiasis orrecurrent renal stone
Result 2497 23292 1382 483 50
Limit1 RCT2 Full text
1 RCT2 full text
1 Full text2 Human
1 Full text2 Human
3 all adults4 academic journal
3 English4 RCT
3 RCT4 all adult
Result 73 447 15 2
Review abstract 11 20 1 0 2
Review full paper 4 2 1 0 0
Borghi et al., 1996Hiatt et al., 1996
Kocvara et al., 1999Borghi et al., 2002
Borghi et al., 1996Hiatt et al., 1996
Kocvara et al., 1999
Excluded all excluded articles are not met the inclusion criteria, or irrelevnt to the topic
Appendix 03 Table of Evidence
Bibilographic
citation
Study
type
EV
levPatient Characteristics Intervention Comparison
Length of
follow up,
months
Outcome
measures,
%
Effect size
IG - CG
Borghi et al, 1996 RCT II 1 first and only one episode calcium stone high water intake no treatment 60 no. of (12/99 - 27/100)*100%
2 no arterial hypertension equal to or greater than recurrence =12%-27%
3 no dietary prevention 2L per day = -15%
4 live in Parma, Italy
5 mean age: 41 n=110 (drop out 11) n=110 (drop out 10) p= 0.008
Hiatt et al, 1996 RCT II 1 single proven calcium oxalate stone Low animal protein, purine 2 daily sevings 48 no. of (12 / 50 - 2/49)*100%
2 live in the USA high fruit, vegetables and dairy products recurrence =24% - 4%
3 mean age:43 whole grans 6 to 8 glasses of liquid = + 20%
increased bran
p=0.006
2 daily sevings dairy products n=51 (drop out 2)
6 to 8 glasses of liquid
n=51 (drop out 1)
Kocvara et al, 1999 RCT II 1 After 1st calcium kidney stone metabolic screening moderate animal protein 36 no. of (7/113 - 18/94)*100%
2 aged 18-72 specific dietary regimen restrict oxalate-rich food recurrence =6%-19%
3 live in Czech Republic adequate calcium intake = - 13%
increase fibre
n=121 (drop out 8) moderate sodium p<0.01
adequate fluid
n=121 (drop out 27)
Borghi et al, 2002 RCT II 1 idiopathic hypercalciuria Low calcium Normal calcium 60 no. of (23/60 - 12/60) *100%
2 recurrent renal stone avoid oxalate-rich foods low animal protein recurrence =38% - 20%
3 no previous diet counselling >2L water low salt = + 18%
4 live in Parma, Italy avoid oxalate-rich foods
5 mean age: 45 >2L water p=0.03
n=60 (drop out 9) n=60 (drop out 8)
Appendix 04 Specific dietary regimen
after a first kidney stone. BJU International, 84, 393-398.
Condition Measure
Restriction of animal proteins
Regular intake of calcium-rich food (0.75 - 1.0g Ca)
(in absorptive hypercalciuria and in hypocalcaemia,
divided into small doses during the day)
Restriction of meat products to 80g/day
1-2 meatless days / week
low-purine diet
firm restriction of oxalate-rich diet
regular intake of dairy products in main meal
lemons and increased fibre intake
Increase in fibre intake, especially bran,
Regular intake of dairy products
Mineral water with a high content of magnesium
restriction of animal roteins
1-2 lemons / day (orange juice in normal oxaluria)
increase in fruit and vegetables (depending on oxaluria)
Hypocitraturia
Kocvara, R., Plasgura, P., Petrik, A., Louzensky, G., Bartonickova, K., & Dvoracek, J., (1999). A prospective study of nonmedical prophylaxis
Specific dietary measures adjusted according to the comprehensive metabolic evaluation in intervention group
Hypercalciuria
Hyperuricosuria,
hyperuricaemia
Mild hyperoxaluria
(up to 0.8mmol / day)
Magnesium deficiency
Appendix 05 Comparision of quality assessment
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 2.1
Bibilographic
citation
clear
focused
question
randomized
assignmentconcealment blinding
similar
treatment
and
control
trial
treatment
is the
only
difference
between
group
outcomes
measured
in valid
reliable
way
drop
out
%
ITTmulti
centre
minimise
bias
Borghi et al, 1996 √ Can't say X X √ √ √ 9.5 X 1 +
Hiatt et al, 1996 √ √ X X √ √ √ 21.2 √ 3 ++
Kocvara et al, 1999 √ Can't say X X √ √ √ 14 X 3 +
Borghi et al, 2002 √ √ √ X √ √ √ 14 √ 1 ++
Comparison of quality assessment
Appendix 05 Table of Quality assessment
Borghi, L., Meschi, T., Amato, F., Briganti, A., Novarini, A., & Giannini, A., (1996).
Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a
5-year randomized prospective study. J Urol, 155 (3), 839-843.
Section 1: Internal Validity In this study this criterion is
1.1 The study addresses an appropriate and
clearly focused question.
Yes Clear objective
stated
1.2 The assignment of subjects to treatment
groups is randomised.
Can’t say Method not
specified
1.3 An adequate concealment method is
used.
No No concealment
method reported
1.4 Subjects and investigators are kept
“blind” about treatment.
No Cannot blind
participants
1.5 The treatment and control groups are
similar at the start of the trial.
Yes Similar baseline
characteristics
1.6 The only difference between groups is
the treatment under investigation.
Yes No other differences
except water intake
1.7 All relevant outcomes are measured in a
standard, valid and reliable way.
Yes Outcome measure
described clearly
1.8 What percentage of the individuals or
clusters recruited into each treatment arm
of the study dropped out before the study
was completed?
9.5% 21/220 * 100%
1.9 All the subjects are analysed in the
groups to which they were randomly
allocated (often referred to as intention
to treat analysis).
No ITT is not
mentioned
1.10 Where the study is carried out at more
than one site, results are comparable for
all sites.
Not
applicable
Only one site
Borghi, L., Meschi, T., Amato, F., Briganti, A., Novarini, A., & Giannini, A., (1996).
Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a
5-year randomized prospective study. J Urol, 155 (3), 839-843.
Section 2: Overall assessment of the study
2.1 How well was the study done to
minimise bias?
Code as follow: ++, +, 0
+
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?
Yes
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 and
mention any areas of uncertainty raised above.
Statistically significant
Long period of follow up, sufficient control group
Increase in fluid intake would have a strong reduction against recurrences
Hiatt, R., A., Ettinger, B., Caan, B., Quesenberry, C. P., Duncan, D., & Citron, J. T.
(1996). Randomized controlled trial of a low animal protein, high fiber diet in the
prevention of recurrent calcium oxalate kidney stones. American Journal of
Epidemiology, 144(1), 25-33.
Section 1: Internal Validity In this study this criterion is
1.1 The study addresses an appropriate and
clearly focused question.
Yes Clear objective
stated
1.2 The assignment of subjects to treatment
groups is randomised.
Yes Poor method - a list
of random numbers
1.3 An adequate concealment method is
used.
No No concealment
method is reported
1.4 Subjects and investigators are kept
“blind” about treatment.
No Participant cannot
be blinded
1.5 The treatment and control groups are
similar at the start of the trial.
Yes No significance
difference in
baseline data
1.6 The only difference between groups is
the treatment under investigation.
Yes No other difference
between groups
1.7 All relevant outcomes are measured in a
standard, valid and reliable way.
Yes Recurrence of stone
as outcome measure
1.8 What percentage of the individuals or
clusters recruited into each treatment arm
of the study dropped out before the study
was completed?
21.2% Clearly stated
1.9 All the subjects are analysed in the
groups to which they were randomly
allocated (often referred to as intention
to treat analysis).
Yes 17 / 21 people no
evidence of
recurrence stone,
ITT is mentioned
1.10 Where the study is carried out at more
than one site, results are comparable for
all sites.
Yes Three centres
Hiatt, R., A., Ettinger, B., Caan, B., Quesenberry, C. P., Duncan, D., & Citron, J. T.
(1996). Randomized controlled trial of a low animal protein, high fiber diet in the
prevention of recurrent calcium oxalate kidney stones. American Journal of
Epidemiology, 144(1), 25-33.
Section 2: Overall assessment of the study
2.1 How well was the study done to
minimise bias?
Code as follow: ++, +, 0
++
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?
Yes
Intervention group 50 people,
Control group 49 people,
Power 0.8, two-tailed test
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 and
mention any areas of uncertainty raised above.
1. Statistically significant result.
2. Cannot prove low protein and high fiber diet would be beneficial on
preventing secondary urolithiasis
3. Cannot follow subjects diet compliance
4. Higher fluid intake in control group than intervention group
5. No measurement on calcium intake
6. Increase water intake have advantage on prevent secondary urolithiasis
Kocvara, R., Plasgura, P., Petrik, A., Louzensky, G., Bartonickova, K., & Dvoracek, J.,
(1999). A prospective study of nonmedical prophylaxis after a first kidney stone.
BJU International, 84, 393-398.
Section 1: Internal Validity In this study this criterion is
1.1 The study addresses an appropriate and
clearly focused question.
Yes Clear objective
stated
1.2 The assignment of subjects to treatment
groups is randomised.
Can’t say Not mention the
method
1.3 An adequate concealment method is
used.
No No concealment
method reported
1.4 Subjects and investigators are kept
“blind” about treatment.
No All parties know
their roles
1.5 The treatment and control groups are
similar at the start of the trial.
Yes No significant
difference in
baseline data
1.6 The only difference between groups is
the treatment under investigation.
Yes No other difference
between groups
1.7 All relevant outcomes are measured in a
standard, valid and reliable way.
Yes Recurrence of stone
as outcome measure
1.8 What percentage of the individuals or
clusters recruited into each treatment arm
of the study dropped out before the study
was completed?
14% 35 / 242 * 100%
1.9 All the subjects are analysed in the
groups to which they were randomly
allocated (often referred to as intention
to treat analysis).
No ITT not mention
1.10 Where the study is carried out at more
than one site, results are comparable for
all sites.
Yes 3 centres
Kocvara, R., Plasgura, P., Petrik, A., Louzensky, G., Bartonickova, K., & Dvoracek, J.,
(1999). A prospective study of nonmedical prophylaxis after a first kidney stone.
BJU International, 84, 393-398.
Section 2: Overall assessment of the study
2.1 How well was the study done to
minimise bias?
Code as follow: ++, +, 0
+
Some flaws on risk of bias
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?
Yes
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 and
mention any areas of uncertainty raised above.
1 higher fluid intake,
2 metabolic diet eliminate metabolic disorders,
3 higher dairy intake,
4 repeated dietary counseling and regular FU
Specific individualize metabolic diet may not cost-effective
Borghi, L., Schianchi, T., Meschi, T., Guerra, A., Allegri, F., Maggiore, U., &
Novarini, A., (2002). Comparison of two diets for the prevention of recurrent
stones in idiopathic hypercalciuria. N Engl J Med, 346 (2), 77-84.
Section 1: Internal Validity In this study this criterion is
1.1 The study addresses an appropriate and
clearly focused question.
Yes Clear objective
stated
1.2 The assignment of subjects to treatment
groups is randomised.
Yes Poor method - odd
and even numbers
1.3 An adequate concealment method is
used.
Yes Numbered
envelopes are sealed
1.4 Subjects and investigators are kept
“blind” about treatment.
No Cannot be blind on
diet intervention
1.5 The treatment and control groups are
similar at the start of the trial.
Yes Similar baseline
characteristics
1.6 The only difference between groups is
the treatment under investigation.
Yes No other differences
except the diet
1.7 All relevant outcomes are measured in a
standard, valid and reliable way.
Yes Outcome measures
described clearly
1.8 What percentage of the individuals or
clusters recruited into each treatment arm
of the study dropped out before the study
was completed?
14% 17 / 120 * 100%
1.9 All the subjects are analysed in the
groups to which they were randomly
allocated (often referred to as intention
to treat analysis).
Yes ITT mentioned
1.10 Where the study is carried out at more
than one site, results are comparable for
all sites.
Not
applicable
One site only
Borghi, L., Schianchi, T., Meschi, T., Guerra, A., Allegri, F., Maggiore, U., &
Novarini, A., (2002). Comparison of two diets for the prevention of recurrent
stones in idiopathic hypercalciuria. N Engl J Med, 346 (2), 77-84.
Section 2: Overall assessment of the study
2.1 How well was the study done to
minimise bias?
Code as follow: ++, +, 0
++
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?
Yes
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 and
mention any areas of uncertainty raised above.
1. No control group
2. Intervention diet decrease both calcium and oxalate, increase urinary volume
as well
3. Poor compliance on diets
4. Little control of calcium intake
Appendix 06. Baseline comparision
Patients
demographics
Targeted patient
in urology unit of PMHBorghi et al., 1996 Hiatt et al., 1996 Kocvara et al., 1999 Borghi et al., 2002
Age (years) 50 41 43 45 45
Male (n/%) 24 / 82% 70 /70% 36 / 72% 37/39% 54 / 100%
Female (n/%) 5/18% 29 /30% 14 / 28% 57/61% 0 / 0 %
Setting Urology Out patient clinic
Length of study
(year)5 5 4 3 5
Mode of stone
single renal stone
treated
and free from stone at
study
single renal stone treated
and free from stone at
study
single renal stone
treated
and free from stone at
study
single renal stone treated
and free from stone at
study
single renal stone
treated
and free from stone at
study
Recruitment
Start at post-op after the
first renal stone surgery
in ward or ESWL in
centre
Refer to urology
out patient
clinic
Refer to urology
out patient
clinic
Refer to urology
out patient
clinic
Refer to urology
out patient
clinic
Conductors Nurses Doctors / Professors Doctors / ProfessorsUrologists and
DieticianDoctors / Professors
Country Hong Kong Italy the USA the Czech Republic Italy
Urology Out patient clinic Urology Out patient clinic Urology Out patient clinic Urology Out patient clinic
Appendix 07. 2 L pitcher purchased from contractor
Appendix 08 Summary of recommendation
Dietary counseling to prevent secondary urolithiasis after first calcium-containing stone
Intended users: nurses working in urology ward and center
RecommendationGrading of
recommendation
The innovationA structured dietary counseling
is recommendedA
Time for the
dietary counseling
Dietary counseling should be conducted
after the renal stone removal.A
Dietary counseling included increasing
water intake, adequate calcium food,
avoid high oxalate food and moderate
protein diet.
A
Education handouts should be given. A
A 2L water pitcher should be provided. A
EvaluationRecurrence of renal stone detected by
KUB and ultrasound.A
Follow-up
Regular follow-up quarterly (3 month)
should be adopted to increase
compliance
A
Program durationDietary counseling should be
lasted for 5 years.A
Target population: Patient received surgery or ESWL after first calcium stone
Content of education
Appendix 09 Flow chart of the dietary counseling
Urology ward Urology centre
Post operation
(URSL / PCNL)
after first calcium stone
orPost ESWL
afer first calcium stone
age >= 18
mentally fit
ADL independent
no knowen disease related to
urolithiasis
~ 8 cases / month
referred by surgeons
Dietary counseling
- 30 mins
1 importance of prevention
2 advantage of dietary modification
over medicine
3 Dietary regimen
4 Usage of Pamphlet + 2L pitcher
5 Regular follow up
Consent1 bring phamplet and 2L pitcher
2 FU appt
1 st FU Day 14
upon discharge
1 Q & A
2 FU appt
FU every 3 months
1 KUB
2 BS USG
Recurrence with stone No stone
Consult
Associate Consultant
immediately at the same day
for further management
FU every 3 months up to 5 years
Appendix 10
Training detail of the training session from APN to 20 RNs
Time Two consecutive Saturaday and Sunday
Duration 1 hour
Educator APN
Communication team Associate consultant, Ward manager,
APN,1 center RN and 1 ward RN
Preparation
Dietician advice on dietary counseling
to APN
Training to 20 RNs Conducted by APN
assess duration and skill
to deliver dietary counseling
Training to APN Conducted + evaluated by AC
4 hour tutorial
training + assessment
USG images + knowledge
if fail, re-training
Training
Content objectives , plan, benefits, importance
Method Role playing
Q&A
Recruitment 40 patients in 6 months
Resources pamphlets
2 L pitchers
consent forms store at store room in urology ward
Questionnaire
Knowledge test
Evaluation forms
pocket guide in nursing station
Evaluation
Increase adherence
Regular Meeting share success stories
obtain feedback
revise guideline
audit nursing charts
Patient group form after the pilot study
encourage other participants
provide evidence to higher management
Appendix 11
Questionnaire to Patient on Feedback of dietary counseling to prevent secondary
urolithiasis for calcium-containing stone program
Dear participants,
You are invited to participate in a survey to evaluate the satisfactory levels towards
the dietary counseling to prevent secondary urolithiasis for calcium-containing stone
program.
Please rate with the use of the following scale (√ the items selected)
(5 = totally agree, 4 = agree, 3 = neutral, 2 = disagree, 1 = totally disagree)
Items 1 2 3 4 5
1) I am satisfied with the education provided
Reason
2) The dietary counseling improves my knowledge in
dietary control.
3) After attending the program, I get better dietary
control
4) I would recommend this program to other patients
5) Other opinions
Appendix 12
Knowledge test
1 How much water consumed daily in order to acheive the minimum
requirement of the dietary counseling?
A 10L B 8L C 0.5L D 2L
2 What level of calcium should be taken daily?
A restricted B adequate C in excess D none
3 How much salt should be taken daily?
A 1g B 10g C 2g D 3g
4 Which food can be consumed according to the dietary counseling?
A Spinach B apple juice C Chocolate D Soy beans
5 What level of protein should be taken daily?
A moderate B low protein C in excess D none
Appendix 13
Questionnaire to Staff on Feedback of dietary counseling to prevent secondary
urolithiasis for calcium-containing stone program
Dear colleague,
You are invited to participate in a survey to evaluate the satisfactory levels towards
the dietary counseling to prevent secondary urolithiasis for calcium-containing stone
program.
Please rate with the use of the following scale (√ the items selected)
(5 = totally agree, 4 = agree, 3 = neutral, 2 = disagree, 1 = totally disagree)
Items 1 2 3 4 5
1) I am satisfied with the education provided
Reason
2) The dietary counseling improves my knowledge in
dietary control.
3) After attending the program, I get less work stress on
my duty.
4) I can manage the dietary counseling independently.
5) I can handle the dietary counseling with full
confidence.
6) I am eager to deliver education program to
urolithiasis patient
7) Other opinions
Appendix 14
Face to face survery
Conducted by the centre APN to other frontline staff
Perception
1 How do you feel about the dietary counseling on preventing secondary urolithiasis?
Satisfaction
2 Do you satisfacty with the logisticis of dietary counseling?
(Render dietary counseling during 1300 - 1400 on weekday if selected patient agreed)
If not satisfactory, pls specify
If satisfactory , describe how you balance the time of education and other nursing care
Workload
3 Describe the positive consequence after rending the dietary counseling.
4 How do you rate your stress level after rending the dietary counseling.
Difficulties
5 Describe the negative consequence after rending the dietary counseling.
6 Discuss the difficulties that you encounted
Attitude
7 Descirbe your role on the dietary counseling
8 Please vote for agree / against the dietary counseling
Appendix 15
Schedule for implementing the evidence-based dietary counseling to prevent secondary urolithiasis for calcium oxalate stone patients
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 27 39 51 63 75 76 77 78
Seeks approval from administrators
Gain support from APNs and frontime staff
Train the centre APN
Train other frontline staff
Recruit 4 patients in pilot study
Carry out pilot testing of the innovation (6 months)
Amend the full-scale program as indicated
Recruit 40 patients in 6 months
Implementation of dietary counseling (Full scale)
Evaluation : system outcomes
Evaluation : healthcare provider outcomes
Evaluation : patient outcomes
Month
5- year study
Tasks
Appendix 16 summary of evaluation plan
Pre Post
1 hour
dietary counseling KUB + BS USG KUB + BS USG
Post-knowledge test Post-knowledge test
Questionnaire Questionnaire
(every 3 month) (every 3 month)
5th month , 8th month 30th month, 33rd month,.......... to 76th month
1 hour
pre-knowledge test training session Post-knowledge test Questionnaire Questionnaire
Face to face survey Face to face survey
at 8th month (every 6 months)
33th, 39 th, 45th, 51st, 57th, 63rd, 69th, 76th month
Pilot (total six months)
Full scale ( 5 year study)
Patient
Staff
Evaluation
Pilot
Evaluation
Full-scale
Appendix 17
System outcome evaluation breakdown
Resources
URSL PCNL
week 1
week 2
week 3
week 4
week 5
week 6
week 7
week 8
week 9
week 10
week 11
week 12
week 13
week 14
week 15
week 16
week 17
week 18
week 19
week 20
week 21
week 22
Expenses Hospitalization rate Manpower
surgery ($)ESWL ($) < 3 days >= 3 days ?ICU admission
Sick leave
rate
resign
rate
PRISMA 2009 Checklist
Section/topic # Checklist item Reported on page #
TITLE
Title 1 Identify the report as a systematic review, meta-analysis, or both. 1 (Ch.1)
ABSTRACT
Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.
Frontpage
INTRODUCTION
Rationale 3 Describe the rationale for the review in the context of what is already known. 4-6 (Ch.1)
Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).
6 (Ch.1)
METHODS
Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.
10 (Ch.2)
Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered,
language, publication status) used as criteria for eligibility, giving rationale. 9-10 (Ch.2)
Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.
11 (Ch.2)
Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.
11 (Ch.2)
Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).
11 (Ch.2) Appendix 2
Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.
NA
Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.
11 (Ch.2) Appendix 3
Risk of bias in individual studies
12 Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.
13 (Ch.2)
PRISMA 2009 Checklist
Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means). 12 (Ch.2)
Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency
(e.g., I2) for each meta-analysis. 12-19
(Ch.2)
Section/topic # Checklist item Reported on page #
Risk of bias across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).
Appendix 5
Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.
NA
RESULTS
Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.
Appendix 2
Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.
Appendix 5 table
Risk of bias within studies 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). Appendix 5 Comparison
Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.
Appendix 3
TOE
Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. Appendix 3
TOE
Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). Appendix 5 Comparison
Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). NA
DISCUSSION
Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers).
Appendix 3
TOE
Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias).
19 – 21
(Ch. 2)
Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. 19 – 21
PRISMA 2009 Checklist
(Ch. 2)
FUNDING
Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review.
NA
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097
For more information, visit: www.prisma-statement.org.
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097
For more information, visit www.prisma-statement.org.
PRISMA 2009 Flow Diagram
Records identified through database searching
(n = 27,704 )
Scre
enin
g In
clu
ded
El
igib
ility
Id
enti
fica
tio
n
Additional records identified through other sources
(n =0 )
Records after duplicates removed (n = 0 )
Records screened (n = 537 )
Records excluded (n = 530 )
Full-text articles assessed for eligibility
(n = 7 )
Full-text articles excluded, with reasons
(n = 3 )
Studies included in qualitative synthesis
(n = 0 )
Studies included in quantitative synthesis
(meta-analysis) (n =4 )
Appendix 20 Cost
Estimated operational cost for the dietary counseling
Set-up cost
Preparation and Training Description Cost (HK$)
1 Advanced Practice
Nurses (APN)
Training and prepare materials 10 hours
($220/hour)
$2,200
2 Registered Nurses Held in working hours on two Sat
and Sun morning and afternoon
session
8 hours
($0)
$0
3 Dietitian Provide advice on Dietary
Pamphlet
1 hour
($220/ hour)
$220
Sub-total: $2,420
Material cost (for 5 years)
1 Venue Education session and training N/A Available in
hospital 2 Computers and
computer software
3 Stationary
4 Pamphlet Dietary information 100 books
5 years
$1/book
$500
5 2L pitcher Purchased online 100 bottles
5 years
$38/bottle
$19,000
Sub-total: $19,500
Total: $21,920
Operational cost for 5 years
1 BS USG Maintenance fee, supported by
centre
N/A Available in
hospital
Overall estimated cost of the program for 5 years : HK$21,920
Estimated cost of the program for 1 year: HK$4,384
Cost of hospitalization per patient per day
Hospitalization Description Cost (HK$)
1 Inpatient cost per day Average acute surgery bed include
I) direct cost : staff, drug, consumables
II) indirect cost : pathology, radiology, catering and
laundry
$4,605
Surgery
1 ESWL One side
$15,000
2 Surgery Major I URSL
$34,450
3 Surgery Major II PCNL $44,550
Average cost of the stone removal: $31,333
Estimated cost of 2 day hospitalization + 1 surgery( average cost) per
patient :
$40,543
Estimated cost of 2 day hospitalization + 1 surgery to remove stone (average cost) per patient:
HK$40,543
In present, 6 patients received treatment each month
Description Cost (HK$)
1 Estimated cost 6 patients $40,543 /
patient
$243,258
The estimated cost for 1 year
2 Estimated cost 12 months $243,258 /
month
$2,919,096
According to the PMH statistics, there are average 6 patients received secondary urolithiasis
surgery each month.
Under the proposed innovation, 40 patients recruited in six month, average 6-7 patient recruited
each month.
If 28 patients got benefit from the innovation, free of stone, there are still 12 patients may suffered
from secondary urolithiasis under the dietary counseling.
Under the proposed innovation, 32 patients got benefit from the innovation
Description Expenditure
saved (HK$)
1 Assume 32 patients are
free of stone
32 patients $40,543 /
patient
$1,297,376
Still 8 patients suffered from secondary urolithiasis
Description Cost (HK$)
1 Estimated cost 8 patients $40,543 /
patient
$324,344
Expenditure saved
1 $1,297,376 - $324,344 $973,032
Expenditure saved
=Save 32 patients from surgery - still 8 patients receive surgery
= saved 24 patients surgery expenditure
= $1,297,376 - $324,344
=$973,032
Net expenditure saved for 5 years
Description Expenditure
saved (HK$)
1 Expenditure saved on surgery fee for 5 years -
Set- up and material cost of the proposed innovation for 5 years
973,032 - 21,920
951,112
Net expenditure saved for 1 year
1 951,112 / 5
190,222.40
Net expenditure saved for 1 year is HK$ 190,222