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Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom
Journal Pre-proof Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom Bethell GS, Chhabra S, M.S. Shalaby, H. Corbett, Kenny SE, and BAPS NOAH Contributors PII:
S1477-5131(20)30007-3
DOI:
https://doi.org/10.1016/j.jpurol.2020.01.005
Reference:
JPUROL 3361
To appear in:
Journal of Pediatric Urology
Received Date: 30 August 2019 Accepted Date: 11 January 2020
Please cite this article as: GS B, S C, Shalaby M, Corbett H, SE K, and BAPS NOAH Contributors, Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2020.01.005. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom Bethell GS1,2,, Chhabra S1,2, MS Shalaby3, H Corbett1, Kenny SE1,2 and BAPS NOAH Contributors 1. Alder Hey Children’s Hospital, East Prescot Rd, Liverpool, UK, L14 5AB 2. University of Liverpool, Crown Street, Liverpool, Merseyside, UK, L69 3BX 3. Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol, UK, BS2 8BJ
All correspondence to Professor S E Kenny, Department of Paediatric Urology, Alder Hey Children’s Hospital, East Prescot Rd, Liverpool, UK, L14 5AB Email: [email protected]
Tel: +44 151 282 4587
Contributors: Alok Godse, Royal Victoria Infirmary, Newcastle; Anupam Lall, Royal Victoria Infirmary, Newcastle; Arash Taghizadeh, Evelina London Children's Hospital, London; Boma Lee, Royal Hospital for Sick Children, Glasgow; Chris Driver, Royal Aberdeen Children's Hospital, Aberdeen; David Keene, Manchester Children's Hospital, Manchester; David Marshall, Royal Belfast Hospital for Sick Children, Belfast; Feilim Murphy, St George's Hospital, London; Fiona McAndrew, Alder Hey Children's NHS Foundation Trust, Liverpool; Guy Nicholls, Bristol Royal Hospital for Children, Bristol; Harish Chandran, Birmingham Children's Hospital, Birmingham; Henrik Steinbrecher, Southampton General Hospital, Southampton; Kathryn Evans, St George's Hospital, London; Liam McCarthy, Birmingham Children's Hospital, Birmingham; Mairi Steven, Royal Hospital for Sick Children, Glasgow; Manoj Shenoy, Queen's Medical Centre, Nottingham; Marie-Klaire Farrugia, Chelsea & Westminster Hospital, London; Mark Woodward, Bristol Royal Hospital for Children, Bristol; Martyn Flett, Royal Hospital for Sick Children, Glasgow; Milan Gopal, Royal Victoria Infirmary, Newcastle; Prasad Godbole, Sheffield Children's Hospital, Sheffield; Rejoo Daniel, Hull Royal Infirmary, Hull; Rosa M Romero, Oxford University Hospital, Oxford; Ruth Wragg, Birmingham Children's Hospital, Birmingham; Sengamalai Manoharan, Southampton General Hospital, Southampton; Stephen Griffin, Southampton General Hospital, Southampton; Stuart O'Toole, Royal Hospital for Sick Children, Glasgow; Tariq Abbas, Birmingham Children's Hospital, Birmingham; Varadarajan Kalidasan, Royal Alexandra Hospital, Brighton.
Key words Hypospadias, Surveys and Questionnaires, reconstructive surgical procedures, informed consent, decision making
Summary Background In hypospadias, the aim of surgical treatment is to achieve both desirable functional and cosmetic outcomes however complications following surgery are common and 18% of boys require reoperation. In mild degrees of hypospadias repair may be offered entirely to improve cosmesis meaning parents should be fully informed of this, and the potential for complications, during the consent process. Parents decision making may be aided by knowing how others in a similar position have felt about the decision that they made for their child. One method of measuring parental satisfaction is decisional regret (DR). Objectives To assess parental satisfaction following hypospadias surgery in the United Kingdom by assessing DR. Also, to determine the feasibility of obtaining meaningful data via mobile phone survey. Study design The National Outcomes Audit in Hypospadias database was commissioned by the British Association of Paediatric Surgeons to capture clinical information from hypospadias repairs. Following ethical approval (16/NW/0819) a text message was sent to mobile numbers in the database inviting participation in a questionnaire incorporating the validated DR scale (DRS). The primary outcome measure was mean DRS score which was correlated with clinical information, a score of zero indicated no regret and 100 was maximum regret. Results There were 340 (37%) responses. Median age at primary procedure was 16 (IQR 13-20) months. No DR (score=0) was detected in 186 (55%[95%CI49-60]) respondents however moderate-to-severe decisional regret (score = 26-100) was seen in 21(6.2%[95%CI3.6-8.7]) respondents. On multivariate analysis a distal meatus, a small glans and developing complications requiring repeat surgery were all associated with increased levels of regret (table). There was no association between DR and cases performed per surgeon. Discussion
1
Around half of respondents demonstrated no DR and post-operative complications requiring surgery were associated with the highest levels of DR which is similar to a Canadian study. Lorenzo et al. however found that DR was associated with circumcision which was undertaken in all boys however in this UK study around a third of boys were circumcised and regret levels between those circumcised or not were similar. This work is limited by surgeons submitting their own data on complications and there is also potential of selection bias between respondents and nonrespondents as with any survey. Conclusions Data from this study can be used to improve pre-operative counselling during the consent process. Smart mobile phone technology can be used successfully to distribute and collect parent reported outcomes.
Table - Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001
2
Introduction Hypospadias is a common congenital abnormality characterised by displacement of the urethral meatus a variable distance along the ventral surface of the penis. It is associated with increased penile curvature and a hooded foreskin. Most commonly the urethral meatus is situated distally within the glans, coronal or sub-coronal in position. In the most severe variants of the disease the meatus can be in a perineal position.(1) The aim of surgical treatment is to achieve both desirable functional and cosmetic outcomes. Despite advances in surgical technique and post-operative care the complication rate reported by a large Australian population-based study was 9.4% for distal repairs and 33.3% for proximal repairs.(2) In the United Kingdom (UK), 18.1% of boys require a repeat procedure due to complications.(3) In mild degrees of hypospadias, surgical repair may not be required to correct function, including urinary flow, and instead reconstructive surgery may be offered to restore normal anatomy. Given this and the potential for complications following surgery, parents should be fully informed and involved during the consent process. Alternatively, it has been suggested that in distal hypospadias, consideration of surgical repair should be postponed until the boy is old enough to take part in the consent process.(4) One factor which may aid parents in decision making is to give feedback on how parents whose children have undergone surgery feel about the decision that they made. One method of measuring parental satisfaction is decisional regret (DR). DR is a validated measure of the medical decision making process that is not disease specific.(5) In distal hypospadias DR has been studied previously in single institution outside of the UK. Lorenzo et al initially surveyed parents using the DR scale (DRS) following pre-operative counselling for distal hypospadias repair and then followed these parents up at one year after repair. An element of decisional conflict preprocedure was experienced in 28% of participants, with 50% of parents experiencing an element of DR after the operation. Factors associated with DR were a high pre-procedure decisional conflict score and post-operative complications. A desire for circumcision was associated with a lower DRS score.(6, 7) Ghidini et al also studied DR in distal hypospadias and found that only 8.1% of respondents demonstrated no regret. Factors associated with DR include an initial desire to avoid surgery, younger age at follow-up, presence of lower urinary tract symptoms following surgery and a lower pediatric penile perception score (PPPS).(8) The PPPS was developed to assess patient and parent perceived outcomes of hypospadias surgery focusing on the appearance of the penis including shape of the penis and position of urethral meatus.(9)
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There is large variability in questionnaire response rate depending on study methodology. Postal delivery of patient surveys in the past has been effective and responses can also be increased with telephone follow up or mailed reminders. However, this method requires personnel and money to undertake, especially at population level.(10) Short message service (SMS), otherwise known as text message, has been successfully used to collect patient reported outcomes.[11] The aim of this study was to assess parental satisfaction following hypospadias surgery in the UK and to identify associated factors with the hypothesis that higher levels of DR would be associated with lesser severity of disease and a complicated treatment course. The secondary aim was to evaluate distribution and collection of patient reported outcomes via text message and internet enabled smart phones by comparison with published literature.
Patients and methods National Outcomes Audit in Hypospadias The National Outcomes Audit in Hypospadias (NOAH) was commenced in 2014 to collect data on hypospadias surgery taking place in the UK. Data is uploaded by surgeons undertaking hypospadias repair to a secure central database which is held by the British Association of Paediatric Surgeons (BAPS) and supplied by Dendrite Clinical Systems Ltd (Oxfordshire, UK), a specialist supplier of clinical databases. The data includes patient details, the extent of hypospadias, operative technique, complications identified at follow-up and whether re-operation was undertaken for complications. Written consent is also obtained from parents of patients to store National Health Service (NHS) numbers and a mobile telephone number in the database for the purpose of medium and long-term follow-up, such as this study. An NHS number is unique to an individual patient regardless of where they receive NHS healthcare in the UK allowing follow up even if patients relocate or seek care from a different center. Patients in the database were included in the study if they had a valid parental mobile number, had undergone a one stage repair or the second procedure of a planned two-stage repair and at least 3 months had elapsed since the procedure.
4
Decisional regret scale score The DRS allows quantification of parent satisfaction and is an open access, validated scale designed to assess the medical decision making process.(5) As per developer recommendations, users score statements on a Likert scale from strongly agree to strongly disagree (figure 1). These answers are then converted to a score where 0 indicates no regret and a score of 100 indicates high regret. A questionnaire was produced using pre-defined questions for distribution as per the DRS. A score of 0 was taken as no regret, 1-25 was mild regret and a score of 26 or more was interpreted as moderate to severe DR in accordance with previous studies.(6, 7)
Distribution of survey Following NHS Health Research Authority ethical approval (16/NW/0819) a text message was sent to all mobile numbers in the database inviting participation in and providing a link to a Survey Monkey (California, United States of America) questionnaire incorporating the DRS. A parent information sheet was included on the first page of the survey once the link was followed.
Statistical analysis A mean DRS score was calculated for each respondent and then linked to the demographic and clinical information from the NOAH database. Statistical analysis took place using StataSE v15 (StataCorp LLC, Texas, USA). For univariate analysis Chi squared test was used for categorical data, non-paired T test for parametric continuous data with two groups, ANOVA for parametric continuous data with more than two groups and Mann Whitney U for non-parametric continuous data. Multivariate analysis took place using linear regression analysis with the DRS score as the dependent variable with calculation of 95% confidence intervals (CI). P<0.05 was considered significant.
Results The NOAH database contained 908 valid mobile numbers and 340 (37%) responses were received which were linked to clinical data within the NOAH database and these form the study population. Non-responders were excluded; age at primary surgery (16 v 17 months, p=0.16), the severity of hypospadias (distal [71% v 66%], mid-shaft [17% v 22%], proximal [11% v 12%], p=0.13) and number of boys experiencing post-operative complications (9.4% v 11.8%, p=0.29) were similar between
5
those who did and did not respond. The median time from either primary surgical repair or the second stage of a two-stage approach to completion of survey was 15.5 (IQR 9.6-23.1) months. There was no correlation between this length of time and DRS score (p=0.88). The median age of the study population at initial surgery (primary surgical repair or first stage of a two stage repair) was 16 (interquartile range [IQR] 13-20) months. Overall, 243 (72%) boys had distal hypospadias (glans, coronal or sub-coronal), 58 (17%) had a mid-shaft defect and 39 (12%) had a proximal meatus. Chordee was documented in 208 (61%) cases and penile torsion in 41 (12%) boys. In total, 130 (38%) boys were circumcised at initial procedure and 40 (12%) underwent a two-stage approach. Thirty-two (9.4%) boys experienced post-operative complications including 18 complications in 14 (4.1%) boys that did not require surgery. Complications corrected with surgery were seen in 18 (5.3%) boys and required 20 surgical procedures, table 1. No DR was reported by 186 (55% [95% CI 49-60]) respondents, mild regret (DRS score=1-25) was reported by 133 (39% [95% CI 34-44]) parents and moderate-to-severe DR (DRS score=26-100) was encountered by 21 (6.2% [95% CI 3.6-8.7]) respondents. Pre-operative characteristics and operative technique used were similar between cases where moderate-to-severe DR was experienced to those where it was not (table 2). Parents of children who required repeat surgery for complications were more likely to demonstrate moderate-to-severe regret than those who did not (43% v 2.8%, p<0.001). However, this difference was not detected in those that developed complications that did not require surgery (table 2). On univariate analysis parents of boys who underwent their first surgical procedure aged less than 18 months, had a small glans and required repeat surgery for complications had a significantly higher DRS score (table 3). A multivariate linear regression model was then created to explore any possible confounding between pre-operative characteristics, management and clinical outcomes associated with differences in DRS score (table 4). Distal hypospadias was associated with a DRS score increase of 3.3 (95% CI 0.5-6.2, p=0.02), a small glans was associated with a DRS score increase of 3.4 (95% 0.7-6.2, p=0.02) and experiencing a post-operative complication requiring repeat surgery increased the DRS score by 17.8 (95% CI 13.0-22.6, p<0.001). Individual surgeon data were also analyzed to determine whether an association existed between mean DRS score and volume of cases entered in the NOAH database. On linear regression analysis there was no association between mean DRS score and overall cases undertaken per surgeon
6
(p=0.39) (figure 2) nor mean DRS score and cases undertaken per year per surgeon (over the last 2 years) (p=0.31). Free text responses In addition, parents were able to give free text responses that were a useful source of feedback to individual surgeons. Although most comments were positive, comments were made that give individual surgeons the opportunity to redesign their services, waiting times and ‘nil by mouth’ rules. One parent wrote that they hadn’t realized that there was a decision to be made which suggests that management options are not always made clear to families during the consent process.
Discussion There are various extents of hypospadias ranging from minimal ventral displacement of the urethral meatus to a perineal defect and marked chordee. Although some cases require surgical repair to achieve normal penile function, in most boys with minor degrees of hypospadias the issue is predominantly cosmetic. Taking this into account, it is important that parents consenting to elective hypospadias surgery are fully informed of the outcomes so that they feel that they are able to make the right decision. These outcomes include complication rate, functional outcomes and parental satisfaction following surgery. The main aim of this study was to assess parental satisfaction following hypospadias repair in the UK and to identify associated factors. In this study, 55% of respondents expressed no DR whilst moderate-to-severe DR was expressed by 6% of respondents. On multivariate analysis a distal meatus, a small glans and development of complications requiring repeat surgery were all associated with increased levels of regret. Lorenzo et al used the DRS to survey parents in a Canadian center following distal hypospadias repair and detected no DR in 50% of respondents, mild DR in 41.4% of respondents and moderate to severe DR in 8.6% of respondents which is similar to the findings of this study.(6) It was also found that increased parental DR at follow up was associated with post-operative complications, preoperative decisional conflict and a desire to avoid circumcision.(6) In the Canadian study no patients underwent foreskin reconstruction however, in our UK study only 38% of patients were circumcised as part of their hypospadias repair. Despite this there was no difference in DR in parents of boys who were circumcised to those who weren’t. It is not documented in the current study whether
7
circumcision took place through parental preference, for cultural reasons, or whether it was decided by the surgeon based on either the hypospadias anatomy or the surgeon’s preference. If it is the former two, circumcision would not be expected to increase DR. Of note, it has been reported that preputial reconstruction reduces complications in distal hypospadias(11) and additionally a metaanalysis looking at the same question has shown no difference in complication rate between those patients undergoing circumcision and those having a preputial reconstruction.(12) Ghidini et al undertook a similar study looking at DR in distal hypospadias at a single Italian institution. One association with a higher DRS score at follow-up was an initial desire to avoid surgical intervention. This is particularly relevant in the most distal forms of hypospadias where the predominant issue is a cosmetic one. Conversely, a study in the United States using social media to survey adult males determined that 7.1% of men do have untreated hypospadias of which 5% have ‘mild’ defects. Those with mild untreated hypospadias have lower Sexual Health Inventory scores, greater ventral curvature, more difficulty with sexual intercourse and less satisfaction with the position and shape of the meatus than those without hypospadias.(13) However, in the current study, on multivariate analysis, distal hypospadias was associated with a higher level of DR. This may be due to parents feeling that in the more severe variants of hypospadias, surgery is always necessary, and therefore they are more willing to tolerate some degree of complications. With these findings in mind, there is little evidence against offering surgical repair for all extents of hypospadias. Parents should be informed of potential complications during the consent process for surgery, outcomes of those who have not undergone surgery and how parents who have had to make a similar decision have felt in terms of DR. The current methodology allows surgeon and center specific outcomes to be available for surgeons to discuss with parents, in addition as evidence for revalidation. Obtaining an acceptable response rate is a challenge in any questionnaire based study, particularly at follow-up.(14) In this study we trialed use of text messaging to deliver a link to an online survey that can easily be accessed, viewed and completed using a smart mobile telephone. This method required significantly less resource than conventional methods and delivered an acceptable response rate (the overall cost was £135). A limitation is that those who receive a link who do not have a smart phone are unlikely to make the effort to copy the address into a computer internet browser. In the UK 91% of adults aged 25-34 own an internet enabled mobile phone.(15) Response rates for postal surveys has historically been around 60%.(10) In a recent study of adults with rheumatoid arthritis, text message was used to deliver a follow-up questionnaire at one-month intervals. It was found that the initial response was highest when a questionnaire consisting of six
8
instead of 23 questions (response rate = 80 v 67%) was used and response rate decreased with increased length of follow-up.(16) A challenge of survey studies is balancing increased follow-up versus decreasing response rate. Future work should look at methods to increase this such as telephone or text message reminders or voucher incentives. Limitations of the current study are case ascertainment – surgeons are responsible for entering their own data and at the time of this study only 1/3 of UK surgeons are participating. The findings from this study may not be generalizable to the rest of UK surgeons as there may be some characteristics of participating versus non-participating surgeons in terms of outcomes. There is also a risk of selection bias in the non-respondents, as with any questionnaire-based study, although it is likely that those who did not respond are satisfied with the hypospadias repair which may have skewed our results. This work also only uses one form of evaluating outcomes which is DR and this information should be correlated with surgical and non-surgical outcomes when relaying this information to parents. As the number of patients recorded in the NOAH database and the length of time since surgery increases it will be possible to re-distribute the DRS questionnaire allowing comparison of DR at short and long term follow-up for individual patients and collect further data such as patient’s penile perception and functional scores. As NOAH is an operative database, the DR of parents who declined hypospadias surgery for their child has not been collected. Indeed, there is little data on what proportion of boys whose parents have made this decision eventually opt for reconstructive surgery. Collection of this data and determining DR in the same way as this study would provide more important information as part of the consent process for parents considering surgical intervention.
Conclusions Overall, most parents are content with the decision that they make for their son to have hypospadias surgery. Only 6.2% of parents experience moderate or severe decisional regret following hypospadias surgery. Data from this study can be used to counsel parents of boys with hypospadias when considering surgery as part of the consent process, in addition to providing evidence for surgeon revalidation. A key finding is that post-operative complications requiring repeat surgery are associated with higher levels of regret whereas complications not requiring surgery are not. Additionally, we have shown that delivery of an online survey link via text message to smart mobile phones is an effective way to delivery follow-up questionnaires in this population.
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Acknowledgements The authors would like to acknowledge the patients and their parents for participating in this study.
Conflict of interest statement No conflicts of interest.
Funding statement No external funding received.
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Figures legends Figure 1 – Questionnaire sent to parents designed using the decisional regret scale manual. Figure 2 - Funnel plot of individual surgeon’s mean decisional regret scale score versus volume of cases registered in the NOAH database. On linear regression analysis there was no association between mean decisional regret scale score and overall cases undertaken per surgeon (p=0.39). Short dashed line = one standard deviation. Long dashed line = two standard deviations.
Tables and legends
Table 1 – Post operative complications experienced in 32 [9.4%] patients Surgery undertaken for complication (18
Surgery not undertaken for complication (14
patients)
patients)
Urethro-cutaneous fistula (9)
Urethro-cutaneous fistula (5)
Foreskin issues (6)
Foreskin issues (4)
Wound dehiscence (3)
Cosmetic issues (4)
Cosmetic issues (2)
Penoscrotal web (3)
Urethral stricture (2)
Chordee (2)
Graft failure (1) Meatal retraction (1) Table 1 – Post operative complications experienced (in 32 [9.4%] patients) split by those where repeat surgery was undertaken and those where it wasn’t. Number shown in brackets is number of reported complications.
12
Table 2 – Univariate analysis comparing pre-operative characteristics, operative technique and outcomes for mild and no decisional regret (DRS score=0-25) to moderate to severe decisional regret (DRS score=26-100) None or mild DR
Moderate to severe
(score=0-25)
DR (score=26-100)
16 (13-20)
16 (14-17)
0.49
Distal
227 (71)
16 (76)
0.20
Mid-shaft
53 (17)
5 (24)
Proximal
39 (12)
0 (0)
Shallow glans groove
116 (36)
9 (43)
0.55
Small glans
70 (22)
7 (33)
0.23
Chordee
196 (61)
12 (57)
0.70
One stage
280 (88)
20 (95)
0.30
Two stage
39 (12)
1 (4.8)
125 (39)
5 (24)
0.16
13 (4.1)
1 (4.8)
0.88
9 (2.8)
9 (43)
<0.001
Age at primary procedure,
P
months (IQR) Meatal position
Surgical approach
Circumcision at initial procedure Complications not requiring surgery Repeat surgery for complications
Table 2 – Comparison of pre-operative characteristics, operative technique and outcomes with univariate statistical analysis of cases experiencing mild and no decisional regret (DRS score=0-25) to moderate to severe decisional regret (DRS score=26-100). DR = Decisional regret, IRQ = Interquartile range. Data are n (%).
13
Table 3 – Univariate analysis of decisional regret scale scores comparing pre-operative characteristics, operative technique and outcomes Mean DRS score +/-
P
SD Age at primary
<18 months (n=210)
8.1+/-11.9
procedure
>18 months (n=130)
5.7 +/-8.6
Meatal position
Distal (n=243)
7.7 +/-11.1
Mid-shaft (n=58)
6.7 +/-11.5
Proximal (n=39)
5.1 +/-7.1
Shallow (n=125)
7.9 +/-11.8
Normal (n=215)
6.8 +/-10.2
Small (n=77)
9.7 +/-13.2
Normal (n=263)
6.5 +/-9.9
Yes (n=208)
7.1 +/-11.0
No(n=132)
7.5 +/-10.6
One stage (n=300)
7.4 +/-10.9
Two stage (n=40)
6.3 +/-10.1
Circumcision at
Yes (n=130)
7.0 +/-9.7
initial procedure
No (n=210)
7.4 +/-11.5
Complications not
Yes (n=14)
10.4 +/-10.5
requiring surgery
No (n=308*)
6.1 +/-9.3
Repeat surgery for
Yes (n=18)
24.2 +/-18.5
Complications
No (n=322)
6.3 +/-9.4
Glans groove
Glans appearance
Chordee
Surgical approach
0.04
0.36
0.39
0.02
0.74
0.55
0.72
0.10
<0.001
Table 3 – Mean decisional regret scale scores comparing pre-operative characteristics, operative technique and outcomes with univariate statistical analysis. DRS = Decisional regret scale, SD = standard deviation. * = those with complications requiring reoperation excluded.
14
Table 4. Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001
Table 4 - Multivariate linear regression analysis of association of decisional regret scale score with pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders plus age at primary surgery. DRS = Decisional regret scale, CI = confidence interval.
15
Table - Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001
S1477-5131(20)30007-3
DOI:
https://doi.org/10.1016/j.jpurol.2020.01.005
Reference:
JPUROL 3361
To appear in:
Journal of Pediatric Urology
Received Date: 30 August 2019 Accepted Date: 11 January 2020
Please cite this article as: GS B, S C, Shalaby M, Corbett H, SE K, and BAPS NOAH Contributors, Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2020.01.005. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
Parental Decisional Satisfaction After Hypospadias Repair In The United Kingdom Bethell GS1,2,, Chhabra S1,2, MS Shalaby3, H Corbett1, Kenny SE1,2 and BAPS NOAH Contributors 1. Alder Hey Children’s Hospital, East Prescot Rd, Liverpool, UK, L14 5AB 2. University of Liverpool, Crown Street, Liverpool, Merseyside, UK, L69 3BX 3. Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol, UK, BS2 8BJ
All correspondence to Professor S E Kenny, Department of Paediatric Urology, Alder Hey Children’s Hospital, East Prescot Rd, Liverpool, UK, L14 5AB Email: [email protected]
Tel: +44 151 282 4587
Contributors: Alok Godse, Royal Victoria Infirmary, Newcastle; Anupam Lall, Royal Victoria Infirmary, Newcastle; Arash Taghizadeh, Evelina London Children's Hospital, London; Boma Lee, Royal Hospital for Sick Children, Glasgow; Chris Driver, Royal Aberdeen Children's Hospital, Aberdeen; David Keene, Manchester Children's Hospital, Manchester; David Marshall, Royal Belfast Hospital for Sick Children, Belfast; Feilim Murphy, St George's Hospital, London; Fiona McAndrew, Alder Hey Children's NHS Foundation Trust, Liverpool; Guy Nicholls, Bristol Royal Hospital for Children, Bristol; Harish Chandran, Birmingham Children's Hospital, Birmingham; Henrik Steinbrecher, Southampton General Hospital, Southampton; Kathryn Evans, St George's Hospital, London; Liam McCarthy, Birmingham Children's Hospital, Birmingham; Mairi Steven, Royal Hospital for Sick Children, Glasgow; Manoj Shenoy, Queen's Medical Centre, Nottingham; Marie-Klaire Farrugia, Chelsea & Westminster Hospital, London; Mark Woodward, Bristol Royal Hospital for Children, Bristol; Martyn Flett, Royal Hospital for Sick Children, Glasgow; Milan Gopal, Royal Victoria Infirmary, Newcastle; Prasad Godbole, Sheffield Children's Hospital, Sheffield; Rejoo Daniel, Hull Royal Infirmary, Hull; Rosa M Romero, Oxford University Hospital, Oxford; Ruth Wragg, Birmingham Children's Hospital, Birmingham; Sengamalai Manoharan, Southampton General Hospital, Southampton; Stephen Griffin, Southampton General Hospital, Southampton; Stuart O'Toole, Royal Hospital for Sick Children, Glasgow; Tariq Abbas, Birmingham Children's Hospital, Birmingham; Varadarajan Kalidasan, Royal Alexandra Hospital, Brighton.
Key words Hypospadias, Surveys and Questionnaires, reconstructive surgical procedures, informed consent, decision making
Summary Background In hypospadias, the aim of surgical treatment is to achieve both desirable functional and cosmetic outcomes however complications following surgery are common and 18% of boys require reoperation. In mild degrees of hypospadias repair may be offered entirely to improve cosmesis meaning parents should be fully informed of this, and the potential for complications, during the consent process. Parents decision making may be aided by knowing how others in a similar position have felt about the decision that they made for their child. One method of measuring parental satisfaction is decisional regret (DR). Objectives To assess parental satisfaction following hypospadias surgery in the United Kingdom by assessing DR. Also, to determine the feasibility of obtaining meaningful data via mobile phone survey. Study design The National Outcomes Audit in Hypospadias database was commissioned by the British Association of Paediatric Surgeons to capture clinical information from hypospadias repairs. Following ethical approval (16/NW/0819) a text message was sent to mobile numbers in the database inviting participation in a questionnaire incorporating the validated DR scale (DRS). The primary outcome measure was mean DRS score which was correlated with clinical information, a score of zero indicated no regret and 100 was maximum regret. Results There were 340 (37%) responses. Median age at primary procedure was 16 (IQR 13-20) months. No DR (score=0) was detected in 186 (55%[95%CI49-60]) respondents however moderate-to-severe decisional regret (score = 26-100) was seen in 21(6.2%[95%CI3.6-8.7]) respondents. On multivariate analysis a distal meatus, a small glans and developing complications requiring repeat surgery were all associated with increased levels of regret (table). There was no association between DR and cases performed per surgeon. Discussion
1
Around half of respondents demonstrated no DR and post-operative complications requiring surgery were associated with the highest levels of DR which is similar to a Canadian study. Lorenzo et al. however found that DR was associated with circumcision which was undertaken in all boys however in this UK study around a third of boys were circumcised and regret levels between those circumcised or not were similar. This work is limited by surgeons submitting their own data on complications and there is also potential of selection bias between respondents and nonrespondents as with any survey. Conclusions Data from this study can be used to improve pre-operative counselling during the consent process. Smart mobile phone technology can be used successfully to distribute and collect parent reported outcomes.
Table - Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001
2
Introduction Hypospadias is a common congenital abnormality characterised by displacement of the urethral meatus a variable distance along the ventral surface of the penis. It is associated with increased penile curvature and a hooded foreskin. Most commonly the urethral meatus is situated distally within the glans, coronal or sub-coronal in position. In the most severe variants of the disease the meatus can be in a perineal position.(1) The aim of surgical treatment is to achieve both desirable functional and cosmetic outcomes. Despite advances in surgical technique and post-operative care the complication rate reported by a large Australian population-based study was 9.4% for distal repairs and 33.3% for proximal repairs.(2) In the United Kingdom (UK), 18.1% of boys require a repeat procedure due to complications.(3) In mild degrees of hypospadias, surgical repair may not be required to correct function, including urinary flow, and instead reconstructive surgery may be offered to restore normal anatomy. Given this and the potential for complications following surgery, parents should be fully informed and involved during the consent process. Alternatively, it has been suggested that in distal hypospadias, consideration of surgical repair should be postponed until the boy is old enough to take part in the consent process.(4) One factor which may aid parents in decision making is to give feedback on how parents whose children have undergone surgery feel about the decision that they made. One method of measuring parental satisfaction is decisional regret (DR). DR is a validated measure of the medical decision making process that is not disease specific.(5) In distal hypospadias DR has been studied previously in single institution outside of the UK. Lorenzo et al initially surveyed parents using the DR scale (DRS) following pre-operative counselling for distal hypospadias repair and then followed these parents up at one year after repair. An element of decisional conflict preprocedure was experienced in 28% of participants, with 50% of parents experiencing an element of DR after the operation. Factors associated with DR were a high pre-procedure decisional conflict score and post-operative complications. A desire for circumcision was associated with a lower DRS score.(6, 7) Ghidini et al also studied DR in distal hypospadias and found that only 8.1% of respondents demonstrated no regret. Factors associated with DR include an initial desire to avoid surgery, younger age at follow-up, presence of lower urinary tract symptoms following surgery and a lower pediatric penile perception score (PPPS).(8) The PPPS was developed to assess patient and parent perceived outcomes of hypospadias surgery focusing on the appearance of the penis including shape of the penis and position of urethral meatus.(9)
3
There is large variability in questionnaire response rate depending on study methodology. Postal delivery of patient surveys in the past has been effective and responses can also be increased with telephone follow up or mailed reminders. However, this method requires personnel and money to undertake, especially at population level.(10) Short message service (SMS), otherwise known as text message, has been successfully used to collect patient reported outcomes.[11] The aim of this study was to assess parental satisfaction following hypospadias surgery in the UK and to identify associated factors with the hypothesis that higher levels of DR would be associated with lesser severity of disease and a complicated treatment course. The secondary aim was to evaluate distribution and collection of patient reported outcomes via text message and internet enabled smart phones by comparison with published literature.
Patients and methods National Outcomes Audit in Hypospadias The National Outcomes Audit in Hypospadias (NOAH) was commenced in 2014 to collect data on hypospadias surgery taking place in the UK. Data is uploaded by surgeons undertaking hypospadias repair to a secure central database which is held by the British Association of Paediatric Surgeons (BAPS) and supplied by Dendrite Clinical Systems Ltd (Oxfordshire, UK), a specialist supplier of clinical databases. The data includes patient details, the extent of hypospadias, operative technique, complications identified at follow-up and whether re-operation was undertaken for complications. Written consent is also obtained from parents of patients to store National Health Service (NHS) numbers and a mobile telephone number in the database for the purpose of medium and long-term follow-up, such as this study. An NHS number is unique to an individual patient regardless of where they receive NHS healthcare in the UK allowing follow up even if patients relocate or seek care from a different center. Patients in the database were included in the study if they had a valid parental mobile number, had undergone a one stage repair or the second procedure of a planned two-stage repair and at least 3 months had elapsed since the procedure.
4
Decisional regret scale score The DRS allows quantification of parent satisfaction and is an open access, validated scale designed to assess the medical decision making process.(5) As per developer recommendations, users score statements on a Likert scale from strongly agree to strongly disagree (figure 1). These answers are then converted to a score where 0 indicates no regret and a score of 100 indicates high regret. A questionnaire was produced using pre-defined questions for distribution as per the DRS. A score of 0 was taken as no regret, 1-25 was mild regret and a score of 26 or more was interpreted as moderate to severe DR in accordance with previous studies.(6, 7)
Distribution of survey Following NHS Health Research Authority ethical approval (16/NW/0819) a text message was sent to all mobile numbers in the database inviting participation in and providing a link to a Survey Monkey (California, United States of America) questionnaire incorporating the DRS. A parent information sheet was included on the first page of the survey once the link was followed.
Statistical analysis A mean DRS score was calculated for each respondent and then linked to the demographic and clinical information from the NOAH database. Statistical analysis took place using StataSE v15 (StataCorp LLC, Texas, USA). For univariate analysis Chi squared test was used for categorical data, non-paired T test for parametric continuous data with two groups, ANOVA for parametric continuous data with more than two groups and Mann Whitney U for non-parametric continuous data. Multivariate analysis took place using linear regression analysis with the DRS score as the dependent variable with calculation of 95% confidence intervals (CI). P<0.05 was considered significant.
Results The NOAH database contained 908 valid mobile numbers and 340 (37%) responses were received which were linked to clinical data within the NOAH database and these form the study population. Non-responders were excluded; age at primary surgery (16 v 17 months, p=0.16), the severity of hypospadias (distal [71% v 66%], mid-shaft [17% v 22%], proximal [11% v 12%], p=0.13) and number of boys experiencing post-operative complications (9.4% v 11.8%, p=0.29) were similar between
5
those who did and did not respond. The median time from either primary surgical repair or the second stage of a two-stage approach to completion of survey was 15.5 (IQR 9.6-23.1) months. There was no correlation between this length of time and DRS score (p=0.88). The median age of the study population at initial surgery (primary surgical repair or first stage of a two stage repair) was 16 (interquartile range [IQR] 13-20) months. Overall, 243 (72%) boys had distal hypospadias (glans, coronal or sub-coronal), 58 (17%) had a mid-shaft defect and 39 (12%) had a proximal meatus. Chordee was documented in 208 (61%) cases and penile torsion in 41 (12%) boys. In total, 130 (38%) boys were circumcised at initial procedure and 40 (12%) underwent a two-stage approach. Thirty-two (9.4%) boys experienced post-operative complications including 18 complications in 14 (4.1%) boys that did not require surgery. Complications corrected with surgery were seen in 18 (5.3%) boys and required 20 surgical procedures, table 1. No DR was reported by 186 (55% [95% CI 49-60]) respondents, mild regret (DRS score=1-25) was reported by 133 (39% [95% CI 34-44]) parents and moderate-to-severe DR (DRS score=26-100) was encountered by 21 (6.2% [95% CI 3.6-8.7]) respondents. Pre-operative characteristics and operative technique used were similar between cases where moderate-to-severe DR was experienced to those where it was not (table 2). Parents of children who required repeat surgery for complications were more likely to demonstrate moderate-to-severe regret than those who did not (43% v 2.8%, p<0.001). However, this difference was not detected in those that developed complications that did not require surgery (table 2). On univariate analysis parents of boys who underwent their first surgical procedure aged less than 18 months, had a small glans and required repeat surgery for complications had a significantly higher DRS score (table 3). A multivariate linear regression model was then created to explore any possible confounding between pre-operative characteristics, management and clinical outcomes associated with differences in DRS score (table 4). Distal hypospadias was associated with a DRS score increase of 3.3 (95% CI 0.5-6.2, p=0.02), a small glans was associated with a DRS score increase of 3.4 (95% 0.7-6.2, p=0.02) and experiencing a post-operative complication requiring repeat surgery increased the DRS score by 17.8 (95% CI 13.0-22.6, p<0.001). Individual surgeon data were also analyzed to determine whether an association existed between mean DRS score and volume of cases entered in the NOAH database. On linear regression analysis there was no association between mean DRS score and overall cases undertaken per surgeon
6
(p=0.39) (figure 2) nor mean DRS score and cases undertaken per year per surgeon (over the last 2 years) (p=0.31). Free text responses In addition, parents were able to give free text responses that were a useful source of feedback to individual surgeons. Although most comments were positive, comments were made that give individual surgeons the opportunity to redesign their services, waiting times and ‘nil by mouth’ rules. One parent wrote that they hadn’t realized that there was a decision to be made which suggests that management options are not always made clear to families during the consent process.
Discussion There are various extents of hypospadias ranging from minimal ventral displacement of the urethral meatus to a perineal defect and marked chordee. Although some cases require surgical repair to achieve normal penile function, in most boys with minor degrees of hypospadias the issue is predominantly cosmetic. Taking this into account, it is important that parents consenting to elective hypospadias surgery are fully informed of the outcomes so that they feel that they are able to make the right decision. These outcomes include complication rate, functional outcomes and parental satisfaction following surgery. The main aim of this study was to assess parental satisfaction following hypospadias repair in the UK and to identify associated factors. In this study, 55% of respondents expressed no DR whilst moderate-to-severe DR was expressed by 6% of respondents. On multivariate analysis a distal meatus, a small glans and development of complications requiring repeat surgery were all associated with increased levels of regret. Lorenzo et al used the DRS to survey parents in a Canadian center following distal hypospadias repair and detected no DR in 50% of respondents, mild DR in 41.4% of respondents and moderate to severe DR in 8.6% of respondents which is similar to the findings of this study.(6) It was also found that increased parental DR at follow up was associated with post-operative complications, preoperative decisional conflict and a desire to avoid circumcision.(6) In the Canadian study no patients underwent foreskin reconstruction however, in our UK study only 38% of patients were circumcised as part of their hypospadias repair. Despite this there was no difference in DR in parents of boys who were circumcised to those who weren’t. It is not documented in the current study whether
7
circumcision took place through parental preference, for cultural reasons, or whether it was decided by the surgeon based on either the hypospadias anatomy or the surgeon’s preference. If it is the former two, circumcision would not be expected to increase DR. Of note, it has been reported that preputial reconstruction reduces complications in distal hypospadias(11) and additionally a metaanalysis looking at the same question has shown no difference in complication rate between those patients undergoing circumcision and those having a preputial reconstruction.(12) Ghidini et al undertook a similar study looking at DR in distal hypospadias at a single Italian institution. One association with a higher DRS score at follow-up was an initial desire to avoid surgical intervention. This is particularly relevant in the most distal forms of hypospadias where the predominant issue is a cosmetic one. Conversely, a study in the United States using social media to survey adult males determined that 7.1% of men do have untreated hypospadias of which 5% have ‘mild’ defects. Those with mild untreated hypospadias have lower Sexual Health Inventory scores, greater ventral curvature, more difficulty with sexual intercourse and less satisfaction with the position and shape of the meatus than those without hypospadias.(13) However, in the current study, on multivariate analysis, distal hypospadias was associated with a higher level of DR. This may be due to parents feeling that in the more severe variants of hypospadias, surgery is always necessary, and therefore they are more willing to tolerate some degree of complications. With these findings in mind, there is little evidence against offering surgical repair for all extents of hypospadias. Parents should be informed of potential complications during the consent process for surgery, outcomes of those who have not undergone surgery and how parents who have had to make a similar decision have felt in terms of DR. The current methodology allows surgeon and center specific outcomes to be available for surgeons to discuss with parents, in addition as evidence for revalidation. Obtaining an acceptable response rate is a challenge in any questionnaire based study, particularly at follow-up.(14) In this study we trialed use of text messaging to deliver a link to an online survey that can easily be accessed, viewed and completed using a smart mobile telephone. This method required significantly less resource than conventional methods and delivered an acceptable response rate (the overall cost was £135). A limitation is that those who receive a link who do not have a smart phone are unlikely to make the effort to copy the address into a computer internet browser. In the UK 91% of adults aged 25-34 own an internet enabled mobile phone.(15) Response rates for postal surveys has historically been around 60%.(10) In a recent study of adults with rheumatoid arthritis, text message was used to deliver a follow-up questionnaire at one-month intervals. It was found that the initial response was highest when a questionnaire consisting of six
8
instead of 23 questions (response rate = 80 v 67%) was used and response rate decreased with increased length of follow-up.(16) A challenge of survey studies is balancing increased follow-up versus decreasing response rate. Future work should look at methods to increase this such as telephone or text message reminders or voucher incentives. Limitations of the current study are case ascertainment – surgeons are responsible for entering their own data and at the time of this study only 1/3 of UK surgeons are participating. The findings from this study may not be generalizable to the rest of UK surgeons as there may be some characteristics of participating versus non-participating surgeons in terms of outcomes. There is also a risk of selection bias in the non-respondents, as with any questionnaire-based study, although it is likely that those who did not respond are satisfied with the hypospadias repair which may have skewed our results. This work also only uses one form of evaluating outcomes which is DR and this information should be correlated with surgical and non-surgical outcomes when relaying this information to parents. As the number of patients recorded in the NOAH database and the length of time since surgery increases it will be possible to re-distribute the DRS questionnaire allowing comparison of DR at short and long term follow-up for individual patients and collect further data such as patient’s penile perception and functional scores. As NOAH is an operative database, the DR of parents who declined hypospadias surgery for their child has not been collected. Indeed, there is little data on what proportion of boys whose parents have made this decision eventually opt for reconstructive surgery. Collection of this data and determining DR in the same way as this study would provide more important information as part of the consent process for parents considering surgical intervention.
Conclusions Overall, most parents are content with the decision that they make for their son to have hypospadias surgery. Only 6.2% of parents experience moderate or severe decisional regret following hypospadias surgery. Data from this study can be used to counsel parents of boys with hypospadias when considering surgery as part of the consent process, in addition to providing evidence for surgeon revalidation. A key finding is that post-operative complications requiring repeat surgery are associated with higher levels of regret whereas complications not requiring surgery are not. Additionally, we have shown that delivery of an online survey link via text message to smart mobile phones is an effective way to delivery follow-up questionnaires in this population.
9
Acknowledgements The authors would like to acknowledge the patients and their parents for participating in this study.
Conflict of interest statement No conflicts of interest.
Funding statement No external funding received.
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Figures legends Figure 1 – Questionnaire sent to parents designed using the decisional regret scale manual. Figure 2 - Funnel plot of individual surgeon’s mean decisional regret scale score versus volume of cases registered in the NOAH database. On linear regression analysis there was no association between mean decisional regret scale score and overall cases undertaken per surgeon (p=0.39). Short dashed line = one standard deviation. Long dashed line = two standard deviations.
Tables and legends
Table 1 – Post operative complications experienced in 32 [9.4%] patients Surgery undertaken for complication (18
Surgery not undertaken for complication (14
patients)
patients)
Urethro-cutaneous fistula (9)
Urethro-cutaneous fistula (5)
Foreskin issues (6)
Foreskin issues (4)
Wound dehiscence (3)
Cosmetic issues (4)
Cosmetic issues (2)
Penoscrotal web (3)
Urethral stricture (2)
Chordee (2)
Graft failure (1) Meatal retraction (1) Table 1 – Post operative complications experienced (in 32 [9.4%] patients) split by those where repeat surgery was undertaken and those where it wasn’t. Number shown in brackets is number of reported complications.
12
Table 2 – Univariate analysis comparing pre-operative characteristics, operative technique and outcomes for mild and no decisional regret (DRS score=0-25) to moderate to severe decisional regret (DRS score=26-100) None or mild DR
Moderate to severe
(score=0-25)
DR (score=26-100)
16 (13-20)
16 (14-17)
0.49
Distal
227 (71)
16 (76)
0.20
Mid-shaft
53 (17)
5 (24)
Proximal
39 (12)
0 (0)
Shallow glans groove
116 (36)
9 (43)
0.55
Small glans
70 (22)
7 (33)
0.23
Chordee
196 (61)
12 (57)
0.70
One stage
280 (88)
20 (95)
0.30
Two stage
39 (12)
1 (4.8)
125 (39)
5 (24)
0.16
13 (4.1)
1 (4.8)
0.88
9 (2.8)
9 (43)
<0.001
Age at primary procedure,
P
months (IQR) Meatal position
Surgical approach
Circumcision at initial procedure Complications not requiring surgery Repeat surgery for complications
Table 2 – Comparison of pre-operative characteristics, operative technique and outcomes with univariate statistical analysis of cases experiencing mild and no decisional regret (DRS score=0-25) to moderate to severe decisional regret (DRS score=26-100). DR = Decisional regret, IRQ = Interquartile range. Data are n (%).
13
Table 3 – Univariate analysis of decisional regret scale scores comparing pre-operative characteristics, operative technique and outcomes Mean DRS score +/-
P
SD Age at primary
<18 months (n=210)
8.1+/-11.9
procedure
>18 months (n=130)
5.7 +/-8.6
Meatal position
Distal (n=243)
7.7 +/-11.1
Mid-shaft (n=58)
6.7 +/-11.5
Proximal (n=39)
5.1 +/-7.1
Shallow (n=125)
7.9 +/-11.8
Normal (n=215)
6.8 +/-10.2
Small (n=77)
9.7 +/-13.2
Normal (n=263)
6.5 +/-9.9
Yes (n=208)
7.1 +/-11.0
No(n=132)
7.5 +/-10.6
One stage (n=300)
7.4 +/-10.9
Two stage (n=40)
6.3 +/-10.1
Circumcision at
Yes (n=130)
7.0 +/-9.7
initial procedure
No (n=210)
7.4 +/-11.5
Complications not
Yes (n=14)
10.4 +/-10.5
requiring surgery
No (n=308*)
6.1 +/-9.3
Repeat surgery for
Yes (n=18)
24.2 +/-18.5
Complications
No (n=322)
6.3 +/-9.4
Glans groove
Glans appearance
Chordee
Surgical approach
0.04
0.36
0.39
0.02
0.74
0.55
0.72
0.10
<0.001
Table 3 – Mean decisional regret scale scores comparing pre-operative characteristics, operative technique and outcomes with univariate statistical analysis. DRS = Decisional regret scale, SD = standard deviation. * = those with complications requiring reoperation excluded.
14
Table 4. Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001
Table 4 - Multivariate linear regression analysis of association of decisional regret scale score with pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders plus age at primary surgery. DRS = Decisional regret scale, CI = confidence interval.
15
Table - Multivariate linear regression analysis of decisional regret scale score comparing pre-operative characteristics, operative technique and outcomes with adjustment for potential confounders Change in DRS score, (95% CI)
P
Increase in age at primary surgery, per month
-0.03 (-0.08-0.03)
0.34
Distal meatus
3.3 (0.5-6.2)
0.02
Small glans
3.4 (0.7-6.2)
0.02
Two stage repair
0.1 (-3.9-4.1)
0.96
Complication not requiring surgery
5.1 (-0.3-10.5)
0.06
Complication requiring further surgery
17.8 (13.0-22.6)
<0.001