How Do Urinary Calculi Influence Health-Related Quality of Life and Patient Treatment Preference: A Systematic Review

Abstract

Introduction:

Urinary stone disease is a common and often recurrent condition that can affect kidney function and requires a range of medical and surgical treatments, all of which can have a significant impact on patients' health-related quality of life (HRQoL) and treatment preferences.

Objective:

To review the literature systematically for all studies that include HRQoL measurement or patient preferences in the context of urinary stone disease.

Methods:

Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process, EMBASE, SCOPUS, EconLit, and Web of Science were searched from inception to January 2016. All study designs with adult participants were included. Narrative synthesis was performed.

Results:

Thirty-five studies met the inclusion criteria (six randomized controlled trials and 29 observational studies) from 15 countries, including 5472 patients. Eleven studies showed that stone formers had worse HRQoL than the general population; it was noted that stone formers were more likely to suffer from depression. Women have significantly lower HRQoL than men. Twenty-six studies used a generic HRQoL measure and six were nonvalidated disease specific. Studies concerning patient preference were heterogeneous and showed that extracorporeal shock wave lithotripsy is still favored above other interventions and that a large number of patients would prefer the treatment pathway to be decided upon by their clinician.

Conclusion:

Urinary calculi and its treatment can have significant negative patient impact and influence patient preferences. Patients with stone disease tend to have worse physical and mental HRQoL, quantified using generic measures. Structured research with disease-specific measures underpinned by sound methodology would be beneficial and aid in development of patient-centric management.

Systematic Review Registration:

This review was prospectively registered with the international prospective register of systematic reviews–PROSPERO 2013:CRD42013006084.

Introduction

Disease and treatment

Urinary stone disease has a high prevalence (2%–3%) among the general population with a significant risk of recurrence. The peak age of incidence is 35 years in men and there is a bimodal distribution in women.¹ Patients with urinary stone disease are often working productive members of society and their absence from the workplace may represent a genuine loss of national productivity. The disease is a common cause for emergency hospital admissions with over 30,800 hospital admissions reported in England annually and 550,000 emergency room visits in the United States in 2009.^2,3

When presentation is with acute colic, treatment of urinary stone disease involves control of pain, infection, and, if present, obstruction on an emergency basis. After the acute phase, further hospital visits/admissions for definitive medical treatments and therapeutic interventions are often needed. The overall patient journey can be long, multistep, and varies depending on treatment options and choices. Stone disease and its treatment affect patients' health and may have a significant negative impact on their health-related quality of life (HRQoL).

The European Association of Urology (EAU) and American Urological Association (AUA) guidelines state that patients with large stones or significant obstruction and those who fail to respond to expectant treatment require interventional treatment. Extracorporeal shock wave lithotripsy (SWL) and ureteroscopy (URS) are two most common competing interventional treatment options for ureteral or renal stones. Percutaneous nephrolithotomy (PCNL) and additional treatments are generally reserved for large renal stones.⁴ The treatments can offer equivalent clinical outcomes, but involve different pathways and risks. When considering patient preferences, outcomes, and resource efficiency, it is unclear if the current pathway of care is optimal. It is possible that some aspects of treatment could be changed and traded if patient impact and perspectives could be better understood.

Patient-reported outcome measures

The goals of modern surgery have been to treat pathology and restore normal anatomy and physiology, and therefore the goal of the stone surgeon has been to render the patient stone free. In recent years, it has become apparent that this is not always possible or necessarily the only important consideration.⁵ Similarly, assessment of disease impact on patients is likely to be important and can guide treatment decisions. All treatments have their inherent risk and complications, and quality of life may be more important to many patients than achieving a radiological stone-free status alone.⁶

Patient-reported outcome measures aim to measure patient's perspective of illness, health, and interventions in a valid reproducible way. Generic HRQoL measures have been developed and validated, such as the short-form 36 questionnaire (SF-36) and EuroQol 5 dimension (EQ-5D), and are used widely. Many specialty, disease, and procedure-specific measures have also been developed and validated, such as the EORTC QLQ-C30 and the Oxford Hip Score, and have been taken up into general use with varied effects.^7
–9 Attempts have been made to measure the disease and intervention impact in the field of urinary calculi as part of clinical studies.^6,10

Worldwide practices across different hospitals that incorporate patient preference vary significantly. Similarly, the impact of various treatments on patients' HRQoL, utilities, and preferences has not been examined and this is important in the context of clinical equipoise between treatment modalities.^11,12 Patients' expectations of treatment and the impact of disease on HRQoL, as well as changes to it due to treatments, would be important outcome parameters.

The aim of this study was to review systematically the available evidence regarding quality of life of adult patients with urolithiasis and how that might have influenced their treatment choice.

Methods

Design

A systematic review of the evidence regarding quality of life and patient preferences in urinary stone disease was conducted in accordance with the principles outlined in the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and the Cochrane Handbook of Systematic Reviews. The review was prospectively registered with the international prospective register of systematic reviews (PROSPERO 2013:CRD42013006084) to increase transparency and to avoid duplication of work.

Search strategy

A search strategy was developed in Ovid Medline, using Medical Subjecting Headings as well as free text and controlled vocabulary built around the research question (Table 1). The Medline search strategy was modified to use in the rest of the databases. The databases searched were Ovid MEDLINE(R) 1946 to present, Ovid MEDLINE(R), In-Process, and Other Nonindexed Citations, EMBASE 1947 to present, SCOPUS, EconLit, and Web of Science 1900 to present with no language restriction. All databases were searched up until January 2016. Autoalerts were set up for databases that allowed them. The records were imported into Endnote X7 and duplicates were removed. Two independent reviewers examined the titles/abstracts and irrelevant articles were discarded.

Table 1.

Search Strategy

Ovid MEDLINE search strategy (adapted to individual databases):
1	ureteric calcul^*.tw. (338)
2	Ureteral Calculi/or ureteric calculi.mp. (5292)
3	Ureteral Calculi/or Kidney Calculi/or ureteric stone^*.mp. (18680)
4	ureteric stone^*.tw. (408)
5	ureteral stone^*.tw. (1672)
6	kidney stone^*.tw. (2717)
7	kidney calculi.mp. or Kidney Calculi/(15086)
8	renal stone^*.tw. (3024)
9	renal calcu^*.tw. (2511)
10	renal calcu^*.tw. (2511)
11	staghorn stone^*.mp. (238)
12	nephroliathiasis.mp. or Urinary Calculi/(9547)
13	ureterolithiasis.mp. or Ureterolithiasis/(276)
14	lithotrispy.mp. or Lithotripsy/(8345)
15	eswl.tw. (2467)
16	Kidney Calculi/or Lithotripsy/or shockwave lithotripsy.mp. or Ureteral Calculi/(23370)
17	lithotripsy.tw. (7649)
18	ureteroscop^*.tw. (2590)
19	ureteroscopy.mp. or Ureteroscopy/or Ureteral Calculi/(7228)
20	Ureteroscopy/or lithotripsy/or kidney calculi/or ureteral calculi/or retrograde intrarenal surgery.mp. (24390)
21	retrograde intrarenal surgery.tw. (56)
22	pcnl.mp. (721)
23	Percutaneous Nephrolithotomy.mp. or Nephrostomy, Percutaneous/(3854)
24	Percutaneous Nephrolith^*.tw. (1967)
25	Nephrolithotomy.mp. (1932)
26	1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 (37590)
27	“Quality of Life”.mp. or “Quality of Life”/(185106)
28	Health-related quality of life.tw. (20965)
29	Health Status.mp. or Health Status/(106559)
30	Patient participation/or patient preference/or “Patient Acceptance of Health Care”/(51876)
31	Patient treatment acceptability^*.mp. or “Patient Acceptance of Health Care”/(31879)
32	((patient or client) adj (prefer^* or focused or particp^*)).tw. (5609)
33	27 or 28 or 29 or 30 or 31 or 32 (321405)
34	26 and 33 (242)
35	limit 34 to all adult (19 plus years) (165)

Throughout the process, any disagreement was resolved by discussion and, if needed, a third impartial reviewer. The articles that remained were subject to a citation search and a hand search of references was performed.

Inclusion and exclusion criteria

Types of study designs included all relevant, published, randomized controlled trials (RCTs) and nonrandomized studies, as well as prospective observational studies with controls, retrospective studies, and comparative studies. Study populations were limited to adults (18 years old and above) with urinary stones or history of urinary calculi in primary, secondary, and tertiary care. Studies that examined patients with stones in the kidney, ureter, or both and that examined patients with stones of all sizes were included. Studies that made reference to ureteral stents without urinary stone disease were excluded.

Critical appraisal of the evidence

Two independent authors assessed all studies that met the inclusion criteria for quality. Observational studies were classified as being at a high, low, or of unclear quality, using the strengthening the reporting of observational studies in epidemiology (STROBE) checklist as guidance.¹³ RCTs were assessed for quality using the Critical Appraisal Skills Program (CASP) RCT checklist and Jadad scale.¹⁴ Measures of quality included appropriateness of study design, quality of reporting, and generalizability. Any disagreements were resolved by consensus or, if needed, adjudicated by a third impartial reviewer.

Data extraction and synthesis

Copies of all articles identified as being of potential importance were obtained and authors were contacted if necessary. Data extraction was performed by two independent reviewers using a bespoke data extraction form, designed specifically for this task. Data from articles were extracted into a Microsoft Excel spreadsheet.

Results

Evidence synthesis

A total of 3946 records were identified through database searching. Checking the reference lists of the articles identified four additional records. Duplicates were removed and finally 55 abstracts were assessed (16 poster abstracts and 39 full-text articles). Four articles were found to be without demographic data and requests for this information were sent to lead authors. No replies were received and they were therefore excluded. Of these 51 articles, 35 fulfilled the inclusion criteria after they were assessed for eligibility (six RCTs and 29 observational studies). The 16 articles that were not analyzed were excluded due to lack of appropriate data, article not being in English, or inclusion of pediatric patients with the adult population (see Figure 1). The studies included originated from 15 countries and involved 5472 patients.

FIG. 1.

Standard flow diagram (adapted from PRISMA): summary of evidence search and collection. PRISMA, preferred reporting items for systematic reviews and meta-analyses.

Six RCTs were included, but their data could not be collated for meta-analysis due to their heterogeneity of both variables and outcomes. Dellabella and colleagues described tamsulosin vs tamsulosin plus steroid with regard to stone expulsion time and HRQoL. Pearle and colleagues compared SWL with URS for lower pole caliceal stones with regard to stone clearance rate and HRQoL. Eryildirim and colleagues in 2015 compared patients taking analgesia alone with patients taking analgesia and tamsulosin. In 2001, Keely and colleagues compared the HRQoL of patients undergoing SWL with those being observed only for renal stones. Lee and colleagues compared medical expulsive therapy (tamsulosin) with no treatment for proximal ureteral stones. Stone passage time and HRQoL were compared.^15

–20 Finally, in a large, multicenter double-blind RCT, Pickard and colleagues compared tamsulosin, nifedipine, and a placebo. They found no difference in HRQoL between any of the groups at 4 or 12 weeks and no difference between rates of stone passage at 4 weeks.²¹ Due to the heterogeneity of the methods employed, process or intervention being measured, and lack of raw figures, domain data from these studies could not be pooled.

Summary of studies

Thirty-five studies were included in the narrative synthesis. The studies were split into two groups; those concerning HRQoL and those relating to patient preference. The HRQoL groups were divided into studies that include interventions (medical/surgical) and those that did not. The intervention group was further subdivided into groups based on stone site—ureteral, renal, or both (Tables 2 –5).

Table 2.

Included Studies—No Intervention

Author (year)^reference	Demographics	Intervention and study type	Sampling	QoL instrument	Data collection	Results
Angell and colleagues (2012)²⁵	115 patients (386 asked, 271 said no). Mean age 52.8, 54.4% males, 76.9% white, 13% depressed.	None	Nonconsecutive/randomized patients recruited in clinic or mailed.	CUES-D depression questionnaire.	Self-directed questionnaire.	Patients with stones in the last 12 months or had one or more complications after surgery were more likely to be depressed. Those with greater than one visit to the ER were more likely to be depressed, but this was not statistically significant.
		Observational study
Bensalah and colleagues (2009)⁵³	159 patients. Mean age 51. 55% women. 55% ASA 1 or 2. 76% CaOx stones. 72% had previous stones and average of seven stone episodes per patient.	None	Consecutive patients from a single physician's service during a 4-month period.	Nonvalidated questionnaire created by researcher.	Interviewer-directed questionnaire for patients.	81.4% would rather take medications than experience a single stone passage event at home (urologists = 26% and 38% thought their patients would tolerate one and two stone passages a year, respectively).
	61 urologists from all over the world were surveyed.	Observational Study			Self-directed questionnaire for physicians (email).	91.6% would rather take medication than undergo a surgical procedure; urologists thought 33% and 31% would tolerate surgery every 3 years and every 2 years, respectively).
Bryant and colleagues (2012)²³	115 recruited. Mean age 53.3. 54.4% males.	All patients with urinary stone disease.	Consecutive patients with urinary stone disease.	SF-36	Self-directed questionnaires.	Stone formers had significantly decreased QOL across six of the eight domains compared with a random collection of healthy American adults. Female stone formers reported statistically lower QOL. These scores were statistically significant in the bodily pain, vitality, and emotional role health limitation domains.
	Mean BMI 29.3, 76.9% white, 19.9% black 6.97% other.	Observational study		Emory urology stone questionnaire used to gather clinical and demographic data.
Diniz and colleagues (2007)³³	194 patients (97 cases, 97 controls). Demographics of cases and controls were not significantly different.	None	Patients with at least two episodes of renal tract colic.	SF-36	Interviewer-directed questionnaire and interview.	In every domain of the SF-36, patients scored lower (mean) than the controls (with 95% confidence). Overall, mental and physical components of the SF-36 showed lower mean scores for the cases vs controls.
	Cases males 34%, mean age 44.	Observational study	Controls patients matched for age, sex.
	Controls males 34%, mean age 44.		Seven patients dropped out as they could not wait for the interview.
			Five controls dropped out. Large proportion of cohort is female, unlike the general stone population.
Donnally and colleagues (2011)²⁴	96 completed 2nd questionnaire. (155 recruited).	NA	152 patients enrolled from urology clinic. 96 completed the trial.	SF-36	Self-directed questionnaire.	Of the 96, 75 did not experience a stone in the previous month (which is the time period that the SF-36 asks about) in either questionnaire and therefore no significant differences were seen in any of the domains for this group.
	Of 152 recruited, 46% were men, 54% were women. Mean age 53.	Observational study	56 patients dropped out. Reasons unknown.		Interview (for medical history).	18 experienced a stone event in the month before the 1st, but not the second, and no significant difference in scores.
Margalith and colleagues (1997)	96 patients. Mean age 44.4. Males were 83.3%. Both groups have statistically similar demographics.	All stones	From those patients from urology clinic, two refused to take part due to religious reasons and two because of severe renal colic.	Spielberger's State-Trait Inventory test, Shannan's sentence completion test.	Interviewer-directed questionnaires.	The anxiety of patients is likely to decline when they perceive that they have been given relevant information. Patients' educational level and coping style were related to the level of anxiety.
		Observational study			Semistructured interviews
Moderitski and colleagues (2014)	295 participants. 128 men and 162 women—two groups.	None	Online recruitment through email and cystinuria website.	SF-36v2 online tool.	Online survey.	SWL in both groups was similar. More URS and PCNL in the cystinuria group. Combined men scored higher in all domains except physical functioning.
	Cystinuria group (214). Mean age 39, males 39% females 61%.	Observational study	Anonymous internet tool administration—no idea if these patients actually had the disease. Self-reporting means information may have not been clinically true.			Cystinuria women showed worse scores in vitality, social functions, and MCS in general. Noncystinuria women had lower scores for social functioning and role—emotional.
	Noncystinuria group: mean age 54, males 61% females 39%.		Self-selecting population.
			Computer literate and those with computer access only.
Parr (2015)⁵⁴	14 patients with cystinuria (16 patients on surgeon's list).	Patients with cystinuria.	All patients with cystinuria on surgeon's list—16 in total, of which 14 responded.	SF-36	Self-directed questionnaire (postal).	13 patients using medicines to control disease. Eight penicillamine D, seven sodium bicarb, and two captopril.
	64% males, 36% females. Median age 48. Average length of treatment at author's center = 7.2 years.	Observational study				12 patients reported adverse effects of drugs that interfered with continuation of drugs—nausea, lethargy, and headaches.
						Mean number of procedures per person = 10.6—uretero/pyeloscopy and lithotripsy±stent insertion (n = 98). Other procedures included PCNL (n = 22); SWL (n = 14), and ureteral stent insertion without lithotripsy (n = 15).
						In 7/8 domains (“Physical Functioning”; “Physical Role”; “Bodily Pain”; “General Health”; “Vitality”; “Social Functioning”; “Emotional Role”), patients with cystinuria scored lower than the general population (comparator = Australian National Health Survey 1995). Patients scored better than comparators in the emotional well-being domain.
						Physical and mental scores were lower for patients than patients from a normalized American study using SF 36 in 1998.
Penniston and Nakada (2007)	Respondents: 189 patients, 152.9% males and 47.1% females.	None	All patients on stone MDT clinic mailing database were invited to participate. Response rate 36.4%.	SF-36v2	Self-directed questionnaire.	Compared with U.S. healthy norms: lower HRQoL for general health (64.9 vs 72.0) and body pain (69.4 vs 75.2) only.
	Mean age 50.8. Mean age males 52.3. Mean age females 49.3.	Observational study
Penniston and colleagues (2013)	34 patients, mean age 51, female: male 1:1.6.	None	Item generation—not mentioned how or where they were recruited from.	New PROM instrument created (Wisconsin StoneQoL).	Item generation—Face-to-face interviews and small groups.	New disease-specific HRQoL measure created.
						Not available to scrutinize.
	Validation—248 patients male: female 1:1.5, mean age 54 (18–82).	Observational Study	Validation—not mentioned how patients were recruited—just states from urology clinic.	LifeScale, Perceived Stress Scale.	Validation–Self-directed questionnaire.	Weak correlation with existing tools—good as valid, but significantly different from those tools.
Tiselius (2006)⁴⁴	100 patients. Males = 74%, females 26%.	Long-term treatment preferences for stone formers pre-SWL.	100 consecutive patients before SWL (first-line intervention in that unit).	Bespoke unvalidated checklist.	Self-directed questionnaire.	99% of patients wanted to understand their stone disease better.
	No further demographic details given.	Observational study				95% were motivated to modify their diet.
						99% were motivated to change their drinking habits.
						81% felt a regular follow-up program was useful.
						71% were motivated to engage with pharmacological treatment.
						76% of patients were interested in stone prevention at extra cost to themselves (males = 73%, females 85%).

BMI = body mass index; ER = emergency room; HRQoL = health-related quality of life; MCS = mental component score; PCNL = percutaneous nephrolithotomy; PROM = patient-reported outcome measure; QoL = quality of life; SF-36 = short-form 36 questionnaire; SWL = extracorporeal shockwave lithotripsy; URS = ureteroscopy.

Table 3.

Included Studies—Intervention for Ureteral Stones

Author (year)^reference	Demographics	Intervention and study type	Sampling	QoL instrument	Data collection	Results
Dellabella and colleagues (2005)¹⁵	60 patients	MET	Randomized from emergency room or clinic.	EQ-5D	Self-directed questionnaire.	No difference in EQ-5D scores in both groups.
	Tamsulosin: age 43.2, males 20.	RCT (Jadad score = 2).				No difference in work days lost in each group.
	Tamsulosin+steroid: 45.8, males 23.
Eryildirim and colleagues (2015)²⁰	120 patients. 72% men, 28% women.	MET and analgesia vs Analgesia.	Consecutive patients, randomized.	EQ5D and EQ5D VAS.	Self-directed questionnaire.	MET = significantly effective in lowering the mean number of renal colics (p = 0. 0001). Therefore, lower need for analgesia and lower number of ED visits. MET did not lower the VAS score during colic attack (p = 0.11).
						EQ-5D index demonstrated a significantly higher mean index value in cases undergoing MET when compared with the others (p = 0.0006).
						EQ-5D VAS = higher mean values in patients undergoing MET (p = 0.0001).
	50% upper ureter and 50% lower.	RCT, not blinded (Jadad score = 2).
Fann and colleagues (2012)²⁹	89 patients. Mean age 43 (range 20–65). Males 75%.	Medical, SWL, URS, and surgery (lap/open).	267 patients who sought medical help for ureteral stones.	Standard gamble method to ascertain utility for each treatment.	Interviewer-directed questionnaires with clinical scenarios.	Medication, SWL, and URS were all similar, URS having the lowest utility of the three and SWL the highest.
	History of SWL 85%, history of URS 56%.	Observational study	201 patients in total.			In the chronic phase, maintenance with surveillance had highest utility and continued medication the lowest. All choices in the group had similar utility. Women and those with lower educational level had lower utilities than men throughout.
			52 selected randomly (to represent the 118), 96 being SWL and 53 URS.
			56% dropout rate. Reasons not known.
Izamin and colleagues (2009)³⁹	67 patients in total (30 SWL and 37 URS). Groups not significantly different.	SWL and URS	Nonrandomized universal sampling of patients. How groups were chosen was not explained. Those with radio-opaque stones, ureteral. Previous treatment greater than 6 months ago.	SF-36	Self-directed questionnaire.	SWL group had significantly larger stones.
						For <1 cm stones = 11 SWL and 26 URS.
						For >1 cm stones = 19 SWL and 11 URS.
	SWL: males 56.7% Malay 44.6%, age 52.7.	Observational study				Clinically similar outcomes.
	URS: males 43.3%, Malay 55.4%, age 48.7.					URS more cost-effective than SWL.
						No significant difference between SWL and URS with regard to mental score and physical scores before and after treatments.
Karlsen and colleagues (2007)³⁰	71 patients.	SWL vs URS.	Patients with ureteral stones between 5 and 10 mm who did not respond to MET were recruited.	Visual analog scale for bother symptoms score.	Unsure if written or interview. Clinical and demographic data collected from notes.	Stone-free rate seems to be higher; quicker with URS (but not statistically significant).
	SWL mean age 49 (range 27–77) males 82%.	Observational study	73% and 68% of SWL and URS patients accepted randomization.			Treatment for 5 to 10 mm upper ureteral stones should be a choice dependent on patient preference. Both treatments are acceptable and give similar results.
	URS mean age 49 (range 22–82) males 63%.		There was no difference between randomized and nonrandomized populations.			SWL is preferred by patients due to fewer symptoms post-treatment.
			Nine in total not included. Five patients passed stone spontaneously before treatment and four did not attend follow-up.
Lee and colleagues (2014)⁵⁵	79 patients (109 recruited, 54 in each group. Mean patient age 45.8. Mean stone size 3.53 mm) significant difference in demographics between groups.	MET	Inclusion: 18+, presented with colic, single, unilateral < or = 6 mm proximal ureteral stone.	EuroQOL	Self-directed questionnaire.	74.1% of treatment group passed stone compared with 46.3% in the nontreatment group and had faster stone passage time.
		RCT (Jadad score = 2)	73.2% completed the study (81.5% of the MET group and 64.8% of nontreatment groups completed study.	Visual pain score.		No difference in EuroQOL poststudy score and oral analgesic requirements. 90.9% of the treatment group was willing to undergo that pathway again compared with 74.3% of nontreatment group
Pickard and colleagues (2015)²¹	1136 patients.	MET: Tamsulosin vs nifedipine vs placebo.	Multicenter trial randomized over 24 sites in the United Kingdom. Aged 18–65, <0 mm ureteral stones.	SF-36	Self-directed questionnaire.	QoL was the secondary outcome in study.
	Males = 81%, females = 19%.	RCT (Jadad score = 2)		EQ5D Visual Analog score.		No difference in QoL between the 3 groups.
	Mean age placebo 42.8.					No difference in stone clearance at 4 weeks between groups.
	Mean age nifedipine 42.3.
	Mean age tamsulosin 43.1.
Rabah and colleagues (2011)³⁶	110 patients, 220 in comparator group (matched for age and sex)	SWL	Patients identified by hospital-wide census. All patients who underwent SWL for treatment of ureteral stones over 9 months were included and a comparator group with no renal disease.	SF-36	Interviewer-directed questionnaire.	Significant difference between groups for pain and social functioning subgroups.
	Age mean 41.5 (range 19–80). 66% males.	Observational study			Medical notes reviewed.	Patient's QoL affected significantly (statistically) by age (unsure if this is increased or decreased), presence of stent, and concomitant lower back pain and type 2 diabetes.
	Type 2 diabetes mellitus 6.4%, hypertension 4.5%, gout 9.1%, and low back pain 19.1%.

ED = emergency department; EQ-5D = EuroQol 5 dimension; MET = medical expulsive therapy; RCT = randomized controlled trial; VAS = visual analogue scale.

Table 4.

Included Studies—Intervention for Renal Stones

Author (year)^reference	Demographics	Intervention and study type	Sampling	QoL instrument	Data collection	Results
Deem and colleagues (2011)¹⁷	32 patients.	PCNL vs SWL	Ages between 18 and 80 years. Stones between 1 and 2 cm on CT. <12 cm skin to stone distance. Central region pole stones.	SF-8	Self-directed questionnaire (unknown if in person or mail).	20 underwent PCNL and 12 SWL.
	Ages between 18 and 80 years. PCNL mean age 47.2, 100% white, 55% males.	Randomized trial.	35 patients were recruited and 3 dropped out due to new onset pregnancy, loss of insurance, and failure to present to follow-up.			Stone-free rate at 1 week and 3 months: PCNL 95%, 85%, SWL 17%, 33% (67% required second procedure, and 17% required two or more).
						QoL = All patients had significantly higher scores at 3 months with regard to physical health. PCNL group QoL was better at 3 months with regard to physical health (ESWL not significant).
	SWL mean age 52.5, 100% white, and 50% males.		Small sample size—post hoc power calculations = need 40 for each arm.			Study closed after 26 months—retrospective power found to be 84% for 3-month outcome significantly in favor of PCNL.
	No statistical significance between groups.
Jura and colleagues (2013)²⁸	13 patients. Mean age 38 (range 23–72). 85% females. Mean stone diameter 3 mm (1.5–4 mm). Single stone 69%, multiple stones 31%.	URS	All patients undergoing URS in a 9-year period under a single surgeon.	Nonvalidated questionnaire created by study authors.	Interviewer-directed questionnaire (Telephone survey).	Stone free 60%, reduction in stone size 30%, unchanged 10%.
		Observational study	Small numbers. Not randomized.			85% reported complete resolution of pain, 15% reported partial resolution. 12 patients could describe pre and postop QoL and 67% reported improvement, 33% reported no change.
Keeley and colleagues (2001)¹⁸	228 patients recruited.	SWL vs Observation.	Any patient with renal stones with a combined diameter of <15 mm.	Nottingham Health Profile.	Self-directed questionnaire.	Complete stone fragmentation 34%, partial 52%, no response 15%. During treatment, 36% reported pain. 12% nausea. 3% hospitalized within a week, none requiring surgery. 12% failed to attend follow-up.
	113 in SWL group (80.5% men).	RCT	81 not eligible or declined (31). 15 withdrew before the trial started (malignancy, refused SWL, ineligible, and not specified).			No statistical difference between symptoms or QoL between groups.
	115 in observational group (85.2% men).	(Jadad score = 3)
	184 completed.
Mays and colleagues (1990)²⁷	632 patients (59 PCNL and 573 SWL).	PCNL and SWL.	All patients undergoing PCNL at one center and SWL at another center.	Nottingham Health Profile.	Self-directed questionnaire.	Pretreatment, SWL group had statistically significantly lower energy and emotional state scores than the PCNL group.
	SWL males 59%, mean age 49.	Observational study	All patients undergoing PCNL at one center and SWL at another center.	A nonvalidated questionnaire created by study group.	Patient notes reviewed.	Both groups said they would have their mode of treatment again and there was no statistical difference between the two groups.
	PCNL males 69%, mean age 47.		Nonrandomized.
Pearle and colleagues (2008)¹⁶	67 patients recruited and randomized.	URS vs SWL for lower pole stones in symptomatic patients, <1 cm.	Patients recruited from OP clinics. 67 randomized (SWL 32 URS 35).	SF-36 once pretreatment and once a month post-treatment.	Self-directed questionnaire.	SWL—Would choose again: 90%.
	SWL 32. (59.4% males, females 40.6%). Mean age 52.5.	RCT (Jadad score = 3).	Both arms matched for age, sex, BMI, stone size, treatment side, and ASA score.			URS—Would choose again: 63%.
	URS 35 (48.6% males, females 51.4%). Mean age 49.3.					Patients treated with SWL were able to drive, return to nonstrenuous activity and work, and achieve 100% recovery more rapidly than the URS group. SWL patients needed fewer pain pills postop.
						No statistical difference in stone-free rate between groups (pain free).
Pérez-Fentes and colleagues (2015)⁴³	40 patients. Mean age = 55.7. Males 40%, females 60%. Mean BMI 29.3.	PCNL	Consecutive patients undergoing PCNL at one center.	SF-36	Self-directed questionnaire.	PCNL rendered 70% of the cases completely stone free with a 35% complication rate (33% Clavien I + II).
		Observational study				The baseline scores of all SF-36 domains were worse than the reference population. Three months after PCNL, bodily pain was the only dimension whose change was relevant for patients (effect size [ES] = 0.71, minimal clinically important difference [MCID] = 0.56).
						A year after, this favorable effect of PCNL on body pain is still present, being also beneficial on both role physical (ES = 0.58, MCID = 0.52) and the physical component summary (ES = 0.56, MCID = 0.43). Social function was also close to reaching clinical relevance a year after the procedure (ES = 0.66, MCID = 0.72).
Proietti and colleagues (2014)⁵⁶	27 patients. 36% males, 64% females.	Medical therapy (Cystoman©) after PCNL.	All consecutive patients undergoing PCNL in time frame in one Italian center.	SF-36	Self-directed questionnaire.	High SF-36 scores after PCNL and cystoman© treatment in physical functioning and energy/fatigue domains.
	Mean age = 47.	Nonrandomized case–control trial.
	Mean BMI 22.3.
	Stone composition: Calcium oxalate 52%, uric acid 8%, struvite 40%.
Sahin and colleagues (2014)⁴⁰	71 patients. 21% males, 79% females.	SWL	Consecutive patients undergoing SWL at one center.	SF-36	Self-directed questionnaire.	Patients with fragments <4 mm = 79% passed in <5 weeks. 19% required emergency SWL and 2% needed URS. Average daily analgesia use = 138 mg. Fewer (0.07) number of ED visits.
	Average age = 41.3	Observational study				Patients with fragments >4 mm = 31% passed in <3 weeks. 38% required emergency SWL and 24% needed URS. Average daily analgesia use = 375 mg. Greater (0.5) number of ED visits.
						At 1 month, only the General Health domain was worse in the large (>4 mm) groups. At 3 months, all domains were worse for the larger stone group.
Sahin and colleagues (2014)⁴⁰	90 patients. 58.9% males, 41.1% females. Average age = 41.5.	SWL	Consecutive patients undergoing SWL at one center.	SF-36	Self-directed questionnaire.	At 1 month, all patients had globally lower scores. At 3 months, the 21 to 25 mm group had lower scores compared with the other two groups, which were back to pretreatment levels.
		Observational study
Sarkissian and colleagues (2013)³¹	No demographic details given.	Observation vs SWL vs URS.	Opportunistic nonrandomized sampling from stone clinic.	None	Thought experiment questionnaire.	OBS = 22.8%, SWL = 47.5%, URS 29.7%.
		Observational study.				Patients who had passed larger stones were less likely to choose OBS over intervention.
						Previous SWL were more likely to pick SWL and previous URS more likely to pick URS.
						Previous SWL, but not URS = 94.4%, chose SWL again, 5.6% URS.
						Previous URS, but not SWL = 47.8%, preferred URS, equal number chose OBS (26.1%) or SWL (26.1%).
						Patients with no previous intervention—100% chose SWL.
						56.4% of all patients would defer treatment choice to physician.
Staios and colleagues (2007)⁴²	22 patients. Median age 56.5 (range 21–72). Men (60.2%, females 39.8%).	PCNL for diverticular and deep lower pole stones.	22 consecutive patients with deep renal or diverticular stones.	SF-36	Self-directed questionnaire.	87% were stone free. Three patients have significantly better SF-36 score. Six patients were better, but not significant, four patients had reduced score. Nine patients were the same.
		Observational study

OBS = observation.

Table 5.

Included Studies—Interventions for Both Renal and Ureteral Stones Combined

Author (year)^reference	Demographics	Intervention and study type	Sampling	QoL instrument	Data collection	Results
Arafa and Rabah (2010)³²	275 patients. 19–90 years. Mean age 41.5.	SWL, URS, PCNL	All patients admitted over a 9-month period for stone treatment. Comparator group matched for age, sample size, and sex.	SF-36	Self-directed questionnaire.	PCNL patients had significantly worse scores than the other modes in all domains except body pain. Overall value was lower.
	67% male.	Observational study			Interview to collect medical and demographic data.	Advanced age decreased HRQoL in all domains.
	275 controls matched for age and sex.
Kartha and colleagues (2013)⁵⁷	Review article.	All	N/A	N/A	Review of literature.	Stone formers have more stressful life events and higher stress levels. Higher rates of depression in recurrent stone formers. Stone formers have lower overall QoL scores.
		Review Article.
Kouriefs and colleagues (2004)⁵⁸	208 patients (340 questionnaires were sent out. 64% response rate.	SWL	All patients who had SWL in 1 year	Nonvalidated questionnaire designed by researchers.	Self-directed questionnaire (postal).	Stone clearance most important to patients. (Staff attitude, with reference to friendliness and efficiency, scored highly (means of 8.985 [SD 1.285] and 9.186 [SD 1.057], respectively).
		Observational study				Pain control was ranked only 8th.
						At the other end of the spectrum, the need for sedation during treatment was statistically the least important factor.
Kurahashi and colleagues (2008)³⁷	76 pts.	SWL, URS, PCNL, Ureterolithotomy (open or laparoscopic).	Patients who had undergone lithotripsy (SWL 66, URS 25, PCNL 6, ureterolithotomy 3) greater than 3 months ago (range 3–78).	SF-36	Self-directed questionnaire	Those undergoing two or more lithotripsy sessions had statistically significantly lower scores in the bodily pain domain.
	Mean age 54.7.	Observational study				Those undergoing SWL had significantly better general health domain scores than those undergoing any other form of treatment
	Males 72.4%
Quatan and colleagues (2003)⁵⁹	162 patients (340 questionnaires sent out).	SWL	All patients who attended SWL.	Nonvalidated questionnaire.	Self-directed questionnaire.	All responses rated 1–5.
		Observational study	Those who did not return the survey were not included.			Overall, patients rated unit highly. Highest scores—patient friendliness and explanation, promptness of start, and smooth recovery. Lowest score—patient expectoration of stone clearance.

SD = standard deviation.

HRQoL studies

Most studies use radiological clearance of stones as the primary outcome for research into the treatment of urinary stones. Five studies state that in the modern era of patient-centered care, HRQoL must be considered as an important outcome.^6,22
–24 Generic HRQoL tools have been used for this purpose up until now. The SF-36 was used as a measure in 16 studies. Other validated measures of HRQoL used by researchers include SF8, EQ-5D, LifeScale, Perceived Stress Scale, CUES-D depression questionnaire, and the Nottingham Health Profile.^{6,15,17
–19,25

–30} Seven studies used nonvalidated measures or questionnaires either in isolation or in conjunction with validated generic questionnaires.^27
–29,31

Results from the studies using the SF-36 revealed that general health physical function, role limitations due to physical health problems, bodily pain, general health perception, and social function were main domains that were affected. Additional questionnaires revealed that trouble looking after the home, lower urinary tract symptoms, and sleep disturbance were also affected, but not evaluated by the SF-36. Six studies showed that stone formers had worse HRQoL than the general population or controls.^{22,23,25,32,33} Two studies showed this to be true for those without active stone disease and one showed that patients with stone disease were more likely to suffer from depression.^25,33

Women tended to have statistically lower HRQoL than men.³⁴ Greater medical comorbidity (including being obese, increasing age, suffering from diabetes, hypertension, and musculoskeletal complaints) resulted in worse reported HRQoL than fitter patients.^22,23,29,35 Diniz and colleagues reported that stone patients in lower socioeconomic groups had lower HRQoL.³³

Bryant, Angell, and Penniston reported that stone formers and/or those undergoing treatment for stone disease were more likely to suffer from depression, have more stressful life events, and have lower emotional HRQoL. Angell also stated that those suffering with one or more complications after stone surgery were statistically more likely to be depressed.^{22,23,25,32,35,36} It was also noted that the greater the number of stone events requiring medical consultation, the lower the HRQoL score.^23,35

Three studies found problems with using generic HRQoL measures for patients with urinary stone disease and six concluded that a disease-specific HRQoL measure for patients with urinary stones is needed.^{22
–24,27,35}

Studies with no intervention

Modersitzki and colleagues reported lower HRQoL in American patients with cystinuria compared with noncystinuria patients in all domains except emotional role.³⁵ They found that temporal proximity to the last stone event and greater frequency of stone events per year decreased HRQoL. Diniz and colleagues described a Brazilian patient population with recurrent urinary stone disease in an intercrisis period.³³ These patients had lower HRQoL across all domains of the SF-36 compared with controls.

Donnally and colleagues reported that in an American patient population with urinary stone disease, patients who did not experience any stone episodes in the month before completing the SF-36, did not have any significant difference in HRQoL compared with controls.²⁴

Penniston and Nakada reported lower general health and bodily pain scores for American patients with urinary stone disease compared with the healthy American population. Women reported lower scores than men.³⁴ Bryant and colleagues reported that compared with the general American population, American stone formers suffered with lower SF-36 scores in six of the eight domains (including physical function, role limitations due to physical health problems, bodily pain, general health perception, vitality, and social function).^{16,22
–24,32,33,35
–37}

Studies with intervention for ureteral stones

Izamin and colleagues reported significant differences in mental component (MCS) and physical component (PCS) scores before and after treatment for ureteral stones in those undergoing treatment (SWL or URS) in a Malaysian patient group compared with the control population. However, there was no significant difference in scores between those undergoing either treatment.³⁸ Rabah showed that in their Saudi population, those undergoing SWL suffered with statistically significant lower SF-36 scores in the physical functioning, social functioning, and bodily pain domains.³⁹

Studies with intervention for renal stones

Deem and colleagues reported similar results to Rabah in an American cohort undergoing either SWL or PCNL for renal stones, with all patients reporting improved PCS, but no difference in MCS. This improvement was statistically significant in patients who had undergone PCNL at 3 months, whereas those who had undergone SWL showed no significant difference. Two articles by Sahin and colleagues in 2014 and 2015 showed that larger residual fragments after SWL caused worse HRQoL.^40,41 Staios and colleagues saw a statistically significant improvement after treatment in the mental health and emotional role domains in British patients who had undergone PCNL for lower pole stones.⁴² Pérez-Fentes and colleagues studied patients undergoing PCNL and compared preoperative HRQoL with HRQoL at 3 and 12 months.⁴³ They found that patients' HRQoL was better after 3 months and that perceived benefit continued up to a year.

Studies with interventions for both renal and ureteral stones combined

Arafa and Rabah described better HRQoL scores for Saudi patients after SWL compared with healthy controls a few months after treatment in all domains except bodily pain and general health.³² Interestingly, Kurahashi and colleagues reported that there was no significant difference in Japanese patients who had undergone SWL and healthy Japanese people.³⁷

Studies of patients with lower pole stones by Pearle and all urinary stones by Arafa showed that those undergoing SWL were more likely to get back to a normal routine more quickly (this included returning to work) than those undergoing other interventions; however, Mays and colleagues reported the converse and Karlsen and colleagues reported no significant difference in patients with proximal ureteral stones. Karlsen and colleagues also reported no difference in the number of patients who claimed that their social life was affected and no difference between patients' satisfaction with treatment, but SWL was generally preferred to URS due to fewer postoperative symptoms.^16,27,30,32

Studies evaluating patient preference

Studies regarding patient preference were heterogeneous in nature and were subdivided into those that asked patients about intervention and those that did not.

Noninterventional patient preference studies

Bensalah reported in 2009 that of the urologists questioned, most thought that patients would tolerate one or two stone episodes a year to avoid long-term medication; however, 81% of patients stated they would prefer long-term medication than suffer any more stone episodes.

One study showed that educating patients before treatment tended to decrease anxiety associated with the treatment.²⁶ Tiselius showed in 2006 that almost all patients were motivated (in theory) to change dietary and drinking habits to decrease the chance of a further stone episode, but only 81% felt that a regular follow-up program was useful. Interestingly, only 76% were interested in prevention of further episodes if it were to cost them money.⁴⁴

Interventional patient preference studies

In two studies, patients were asked to rank treatment options from most to least desirable and, in both studies, the order was SWL, URS, and PCNL.²⁹ Sarkissian and colleagues reported that 56.4% of patients would defer treatment choice to their urologist.³¹ It was also shown in two studies that those who have undergone a particular intervention would be most likely to choose that intervention again in the future and that past stone experience affects treatment.^27,31

Discussion

The primary goal of treatment for urinary stone disease has been to achieve the highest radiological stone-free rate. Better HRQoL has been a secondary outcome if considered at all. However, in the era of holistic medicine, greater patient-centric care has become the focus of treatment. As the importance of HRQoL grows, so does the desire to quantify it to measure something that was thought to be immeasurable in the past.⁴⁵

Until recently, HRQoL in urinary stone disease has been gauged by and large by generic measures such as the Nottingham Health Profile in the past and the SF-36 and EQ-5D EuroQol questionnaires in more recent years. Most studies showed that patients with urinary stone disease have lower HRQoL than the reference population. Studies have also shown a relationship between HRQoL and the burden of comorbidities, as well as socioeconomic status. The few studies that evaluated patient preference were heterogeneous. SWL seemed to be preferable to other interventional options when surgical treatments were considered. More than half of patients would choose to follow their surgeon's choice of treatment.

The idea that patients with active urinary stone disease tend to have worse HRQoL than those without makes sense, but all authors except Donnally found that even between episodes, HRQoL was worse in both the physical and mental health domains. This suggests two things. First, even between acute episodes, stone patients suffer with physical symptoms greater than that of the reference population. Second, stone patients always have their stone symptoms borne in mind either on a conscious or subconscious level and this in turn affects their emotional well-being. Decreased HRQoL has been noted in other chronic diseases such as diabetes and chronic renal failure.^46,47 Greater education empowers patients and allows them to feel more in control of their disease and this may help increase HRQoL in the long term.⁴⁸

Most patients surveyed appeared to have poorer HRQoL during and immediately after treatment, but at the time of follow-up (most often at 3 months), patient's HRQoL was improved. One study measured HRQoL at 12 months after the procedure and the improvement was maintained. It would be interesting to know whether that improvement was maintained at 3 or 4 years, when new stones may be appearing and need treatment. Better HRQoL following SWL, compared with controls, shown in the study by Arafa and colleagues could be due to SWL patients being more aware of their bodies and appreciation of good health or by virtue of a response shift, which involves a change in internal values and standards following illness.

With regard to return to work after interventional treatment, reports were varied and no consensus reached. This is an important point because patients tend to suffer with stone episodes in the most productive years of their life and may be the main breadwinners of the household. Decreasing the length and severity of stone episodes may help both the patient and the wider economy.

An interesting point raised by Bensalah and colleagues is the disparity between patients' and urologists' view of acceptability of treatment. A vast majority of patients did state that they would prefer long-term medication to experiencing any stone episode in the future, and a majority of urologists thought their patients would prefer to experience one or two stone episodes a year to avoid long-term medication. This may be explained, in part, by the fact that although patients would initially like long-term prophylactic treatment, long-term compliance tends to be poor and this can be predicted by the experienced clinician.⁴⁹

Studies regarding patient treatment preference were heterogeneous, and being such a small number of articles, it is difficult to draw firm conclusions from them. Patients tend to prefer SWL to other interventional treatments because it carries a lesser burden of postprocedural symptoms. More than half patients said they would follow their surgeon's advice with treatment choice. It was unclear if these patients were significantly different from the rest of the study population. These patients may represent an older more deferential subset of patients who feel that the doctor is the expert and they do not feel comfortable making a choice about their own healthcare.⁵⁰ Patients also seemed to prefer to have treatments they have already undergone in the past. Any procedure carries risk and risk of the unknown. A false sense of security may exist in the minds of patients who have undergone a certain treatment with no harm done to them. They may feel that the procedure is safer than the alternatives because no harm came to them last time, even though the true level of risk might be different. Greater patient education and empowerment may negate these effects.

The results of this review highlight the importance of HRQoL in patients with urinary stone disease and the need of good quality evidence to improve patient care. The journey experience of patients with stone disease has not been fully explored and these results highlight the lack of standardized and valid disease-specific HRQoL measures. The task of creating an HRQoL measure for urinary stone disease has been challenging due to wide variation of patient experience and symptoms, coupled with the HRQoL impact of the treatments offered.

Little work has been done with regard to patient preference of treatment. This is surprising as the current EAU and AUA Guidelines suggest that patients with ureteral or renal stones as much as 20 mm can be offered SWL or URS as first-line interventional treatment and SWL or URS as first- or second-line treatment for ureteral stones of any size.⁵¹ We found that a significant proportion of patients were likely to choose an intervention they had already received or to defer the decision to their urologist.

None of the studies evaluated the impact of patients' disease and management on patients' family members. Due to the chronic nature of the condition, this is an important aspect to consider in the wider psychosocial context as medical decision-making is often an amalgamation of the ideas, concerns, and expectations of the patients and their confidants, who are often close members of the family.⁵² Similarly, many other aspects of stone disease and its treatments that could alter current treatment pathways need to be studied. Detailed economic health service research in this area could aid in development of patient-centric treatments.

Our review has limitations. We excluded non-English language articles and studies published only as abstracts. We could not use graphical or statistical methods to assess for publication bias because of the paucity of evidence, and we did not identify any unpublished randomized trials that met our inclusion criteria.

Conclusion

Our study has shown that both urinary stone disease and its treatments have short- and long-term impacts on patient's HRQoL, affecting a wide variety of domains. This is likely to have influence on patients' treatment choices. This has been objectively demonstrated with the use of generic valid and unvalidated measures. The results highlight the importance of the creation of sound, standardized, patient-reported outcome measures as the currently used generic tools were found to be lacking. Further research in this area would aid in better patient-centric care.

Footnotes

Acknowledgments

The authors would like to thank Mala Mann (MCLIP) from Specialist Unit for Review Evidence (SURE), Cardiff University, for her advice on systematic review methodology and assistance with designing the search strategy and Prof. Sam Salek from Cardiff University for his support. No funding was sought to undertake this review.

Declarations

Copyright declaration:

The corresponding author has the right to grant on behalf of all authors and does grant on behalf of all authors a worldwide license to the Publishers and its licensees in perpetuity, in all forms, formats, and media (whether known now or created in the future), to i) publish, reproduce, distribute, display, and store the Contribution; ii) translate the Contribution into other languages, create adaptations, reprints, include within collections, and create summaries, extracts, and/or abstracts of the Contribution; iii) create any other derivative work(s) based on the Contribution; iv) to exploit all subsidiary rights in the Contribution; v) the inclusion of electronic links from the Contribution to third-party material wherever it may be located; and vi) license any third party to do any or all of the above.

Transparency declaration:

Hrishi Joshi affirms that this article is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

Authors' Contributions

A.R.—First reviewer, created search strategy and data extraction form, wrote first draft of manuscript, and created tables and figures. Z.H.—Second reviewer, helped write the first draft of manuscript and helped in creating tables. H.J.—Initial concept, referee, editor of manuscript, and guarantor.

Author Disclosure Statement

No competing financial interests exist.

Abbreviations Used

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