Predicting Long-term Risk of Reoperations Following Abdominal and Pelvic Surgery: a Nationwide Retrospective Cohort Study
Conditions: Surgery, Abdominal Adhesion
Sponsor: Radboud University Medical Center

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 1 
 
Public Benefit and Privacy Panel for Health and Social Care 
Application Form 
 
Application Control 
Applicants should not fill out this section 
Application Coordinator 
Dionysis Vragkos 
Application Number 
1516-0370 
Submitted Date 
07/09/2016 
Applicant Name 
Richard Peter Gerardus ten Broek 
Proposal Name 
Adhesion-related hospital readmissions after abdominal and 
pelvic surgery: An update of the SCAR studies 
 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 2 
 
 
Contents 
 
Note to Applicants 
2 
Section 1 – People 
3 
Section 2 – Organisations & Bodies 
7 
Section 3 – Overview 
10 
Section 4 – Data & Data Subjects 
18 
Section 5 – Methodology & Data Processing 
23 
Section 6 – Declaration 
29 
Section 7 - Supporting Evidence 
30 
Appendix A – Reference lists for applicants 
31 
Appendix B –The Caldicott Principles & the Data Protection Principles (& Schedules) 
33 
 
Note to Applicants 
 
Prior to completing your application form you should: 
• Contact the eDRIS Team, who will assist you - Nss.edris@nhs.net or by phone on 0131 
275 7333 
• Read and understand the separate Guidance for Applicants 
 
Your application should be typed, not handwritten. Your eDRIS application coordinator will 
inform you how to submit your application form and any supporting evidence. Before 
submitting your completed application, you should ensure that: 
• All relevant sections of the application are complete 
• Relevant supporting evidence is attached 
• Individuals named on the form have read and approved its submission 
 
Please note that submitted applications may be circulated to panel members, administrative 
colleagues, NHSScotland information governance and information security colleagues, 
Caldicott Guardians, the CHI Advisory Group and, where appropriate, non-NHS Scotland 
colleagues from a variety of participating partner bodies, in the course of processing. You 
must make your eDRIS application coordinator aware of any confidential or sensitive 
information contained in your application which you would consider inappropriate for 
circulation in such a manner. Your application could be subject to disclosure or partial 
disclosure under the Freedom of Information (Scotland) Act, and will be retained in line with 
NHSScotland information policy. 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 3 
 
 
Section 1 – People 
1.1 
Applicant Please read section 1.1 of the guidance 
1.1.01 Full Name:  
Richard Peter Gerardus ten Broek 
1.1.02 Title: 
MD, PhD 
1.1.03 Position: 
Post-doctoral researcher, Project coordinator 
1.1.04 Professional Registration No.: 
If applicable 
1.1.05 Organisation Name: 
Radboud University Medical Center, Nijmegen, the 
Netherlands - department of Surgery 
1.1.06 Address: 
PO box 9101 
1.1.07 Postcode: 
6500 HB, Nijmegen, the Netherlands 
1.1.08 Telephone Number: 
+31636304310 
1.1.09 Email: 
Richard.tenBroek@radboudumc.nl 
1.1.10 Do you have an NHS 
contract/honorary contract? 
No 
1.1.11 Provide details of the most recent information governance training undertaken - a list of 
training courses is included at Appendix A, and you should particularly indicate if you 
have undertaken any of those listed 
 
Name of course: 
MRC Research Data and Confidentiality online module 
 
Link to course content: 
MRC Research Data and Confidentiality online module 
 
Institution: 
Medical research Council 
 
Date completed: 
May 12 2016 
 
1.2 
Clinical Sponsor/Lead Please read section 1.2 of the guidance  
1.2.01 Full Name:  
Ewen A Griffiths MD, FRCS  
1.2.02 Title: 
Consultant Upper GI and General Surgeon,  
1.2.03 Position: 
Clinical sponsor 
1.2.04 Professional Registration No.: 
GMC 4732039 
1.2.05 Organisation Name: 
Queen Elizabeth Hospital, Birmingham 
1.2.06 Address: 
University Hospitals NHS Foundation Trust 
Edgbaston, Birmingham, UK 
1.2.07 Postcode: 
B15 2TH 
1.2.08 Telephone Number: 
0121 3715883 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 4 
 
1.2.09 Email: 
Ewen.griffiths@uhb.nhs.uk 
1.2.10 Does this person have an NHS 
contract/honorary contract? 
Yes 
1.2.11 Provide details of the most recent information governance training undertaken - a list of 
training courses is included at Appendix A, and you should particularly indicate if this 
person has undertaken any of those listed 
 
Name of course: 
MRC Research Data and Confidentiality online module 
 
Link to course content: 
MRC Research Data and Confidentiality online module 
 
Institution: 
Medical research Council 
 
Date completed: 
1st Aug 2016 
 
1.3 
Information/Data Custodian Please read section 1.3 of the guidance 
1.3.01 
Full Name: 
Same as applicant 
1.3.02 
Title: 
 
1.3.03 
Position: 
 
1.3.04 
Professional Registration No.: 
If applicable 
1.3.05 
Organisation Name: 
 
1.3.06 
Address: 
 
1.3.07 
Postcode: 
 
1.3.08 
Telephone Number: 
 
1.3.09 
Email: 
 
1.3.10 
Does this person have an NHS 
contract/honorary contract? 
Choose an item. 
1.3.11 
Provide details of the most recent information governance training undertaken - a list of 
training courses is included at Appendix A, and you should particularly indicate if this 
person has undertaken any of those listed 
 
Name of course: 
 
 
Link to course content: 
If applicable 
 
Institution: 
 
 
Date completed: 
 
 
1.4 Others with access to identifiable or potentially identifiable data Please read section 1.4 
of the guidance  

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 5 
 
Complete this section if applicable – for each additional person 
Full Name: 
Pepijn Krielen 
Telephone or Email: 
+31613218398 
Organisation: 
Radboud University Medical 
Center 
Position: 
PhD Student 
Professional 
Registration No: 
Z478129 
NHS contract/ 
honorary contract? 
No  
IG Training - Name of course: 
MRC Research Data and Confidentiality online module 
IG Training - Link to course: 
MRC Research Data and Confidentiality online module 
IG Training - Institution: 
Medical research Council 
Date completed: 8th AUG 2017 
 
Full Name: 
Janienke van Lier 
Telephone or Email: 
+31613218398 
Organisation: 
Radboud University Medical 
Center 
Position: 
PhD Student 
Professional 
Registration No: 
Z516230 
NHS contract/ 
honorary contract? 
No  
IG Training - Name of course: 
MRC Research Data and Confidentiality online module 
IG Training - Link to course: 
MRC Research Data and Confidentiality online module 
IG Training - Institution: 
Medical research Council 
Date completed:  
 
 
1.5 Others Please read section 1.5 of the guidance 
Complete this section if applicable – for each additional person 
Full Name: 
Michael Parker 
Involvement 
in 
Proposal: 
Principal investigator, Study 
design 
Organisation: Royal College of Surgeons Position: 
Emeritus Professor in Surgery, 
study steering group 
 
Complete this section if applicable – for each additional person 
Full Name: 
Harold Ellis 
Involvement 
in 
Proposal: 
Study design 
Organisation: Kings college London 
Position: 
Emeritus professor,  study 
steering group 
Complete this section if applicable – for each additional person 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 6 
 
Full Name: 
Harold Ellis 
Involvement 
in 
Proposal: 
Study design 
Organisation: Kings college London 
Position: 
Emeritus professor,  study 
steering group 
 
 

                                                                                                                        
 
 
 
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Section 2 – Organisations & Bodies 
2.1 
Organisation or Body Leading Proposal Please read section 2.1 of the guidance  
2.1.01 
Organisation or Body Name: 
Dutch Adhesion Group 
(Research workgroup linked to the Dutch college of 
gastro-intestinal surgeons and Dutch college of 
gynaecologists and obstetricians) 
If the organisation here is an 
NHSScotland board, note this 
and go directly to question 
2.1.4 
2.1.02 
Is this organisation or body a registered data 
controller? If ‘Yes’, provide Data Protection Registration 
Number: 
No 
2.1.03 
Is this a commercial organisation or body?  
No  
2.1.03a If ‘Yes’, please provide a full explanation of the 
organisation or body’s activity and industry sector, 
including any previous experience of using 
NHSScotland data  - append supporting documentation 
as appropriate 
If applicable 
2.1.04 
Is this organisation or body wholly funding or paying for 
the costs of conducting the proposal? 
Yes  
 
2.2 
Organisation or Body Funding Proposal Please read section 2.2 of the guidance  
Complete the following section if you answered ‘No’ to question 2.1.4 
2.2.01 
Organisation or Body Name: 
 
If the organisation here is an 
NHSScotland board note this 
and, go directly to section 2.3 
2.2.02 
Is this organisation or body a registered data 
controller? If ‘Yes’, provide Data Protection Registration 
Number: 
No 
2.2.03 
Is this organisation or body a commercial organisation? 
No  
2.2.03a If ‘Yes’, please provide a full explanation of the 
organisation or body’s activity and industry sector, 
including any previous experience of using 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 8 
 
NHSScotland data - append supporting documentation 
as appropriate 
 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 9 
 
 
2.3 Other Relevant Organisations or Bodies Please read section 2.3 of the guidance  
Complete this section if applicable 
Organisation Name 
Nature of Business/Sector 
Nature of interest in proposal 
Radboud University Medical 
Center, Nijmegen, the 
Netherlands 
University Medical Center 
University supporting proposal 
and facilitating the applicant 
 
 
 
 
 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 10 
 
  
Section 3 – Overview 
3.1 
Proposal Essentials Please read section 3.1 of the guidance  
3.1.01 Proposal title/name: 
Adhesion-related hospital 
readmissions after abdominal and 
pelvic surgery: An update of the 
SCAR studies 
3.1.02 Is this proposal an extension or renewal of an 
existing approval (for example to conduct a study 
over a wider geographic area or for a longer 
period of time)? Please provide details, include 
the reference number of the original approval, 
and summarise the changes requested 
No 
3.1.03 Is this new proposal related to a previous 
application (approved or not)? Please give 
details, indicate if this is a resubmission, including 
the reference number of the original submission 
No 
3.1.04 What is(are) the substantive purpose(s) of the proposal? (tick all that apply) 
 
☒  Patient Care 
☒  Research 
 
☐  Audit 
☐  Performance Monitoring/Management 
 
☐  Service Planning/Improvement 
☐  Health/Social Care Administration 
 
☐  Systems Implementation/Testing 
☐  Training/Education 
 
☐  Quality (Clinical, Educational, etc) 
 
 
If other clearly defined purpose, please give details: 
 
3.1.05 Does the proposal require the use of information 
which can identify or potentially identify 
individuals?  
No  
3.1.06 Access is being requested to data from which sources? (tick as many as are relevant) 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 11 
 
 
☐    A single NHS Scotland Board (excluding NSS)  
☐    NHS National Services Scotland  
☐    More than one NHS Scotland Board 
☒    A national NHS Scotland system/database 
☐    More than one NHS Scotland system/database 
☐    Community Health Index (CHI) database 
☐   NHS Central Registry 
 
 
If other, please give details: 
3.1.07 Provide a full, clear concise outline of the proposal background – describe why it is 
needed, aims and objectives and envisaged benefits to the public and/or patients: 
 
Adhesion formation is the most common cause for long – term complications in 
abdominal surgery. Abdominal surgery is performed by a multitude of specialist, 
including general surgeons, gynaecologists, vascular surgeons and urologists. In 
Scotland, like many other developed countries, adhesion- related complications cause a 
huge burden of morbidity. Adhesion-related complications comprise various clinical 
entities such as small bowel obstruction, chronic pain and female infertility. 
 In 1999 Prof. Ellis demonstrated in the SCAR studies, using data from the Scottish 
National Health Service record linkage database, that as many as 34.6% of patients 
undergoing abdominal surgery are readmitted for complications directly or possibly 
related to adhesion formation in 10 years after surgery.  
Since this landmark study a number of strategies were introduced to reduce adhesion 
formation. First are the so-called 'anti-adhesion' barriers. Almost simultaneously there 
has been the rise of minimal invasive surgery. Minimal invasive surgery is associated 
with less extensive peritoneal injury and adhesion formation.  
While minimal invasive surgery became adopted quickly, the use of anti-adhesion 
barriers remains marginal. Many surgeons therefore feel that with laparoscopy further 
adhesion prevention is not necessary, despite some evidence that incidence of 
adhesion- related complications is still considerable. 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 12 
 
 To evaluate the impact of laparoscopic surgery on adhesion- related formation, we are 
planning to perform an update of the SCAR studies to recent years in which a large 
number of laparoscopic surgeries have been performed. Comparison of readmissions for 
adhesion- related complications after open and laparoscopic surgery will be made. 
The study will provide an estimate of the current burden of adhesion-related morbidity in 
Scotland, which could also serve as a model for the current burden in other European 
countries. Further such estimate can be used to model the impact of further 
implementation of anti-adhesion barriers on adhesion-related morbidity and healthcare 
costs in both Scotland and abroad. 
 
3.1.08 Provide a full, clear and concise outline of the proposal design, listing: data sources; 
sample size ; inclusion/exclusion criteria (eg involvement in trial/survey; health event, 
etc); relevant date range; need for identifiable or potentially identifiable data; requirement 
for a matched control cohort etc. 
 
We intend to use the Scottish National Health Service record linkage capabilities. 
Inclusion criteria are all patients undergoing initial abdominal or pelvic surgery between 
June 2009 and June 2011. Selection will be made by OPCS-4 codes related to the 
admission. A list of relevant codes can be found in the appendix. We choose for these 
years to allow inclusion of an incident population in a time that laparoscopic surgery had 
already been implemented and that allows for 4 to 5-years of follow-up.  
We will exclude patient who had had abdominal or pelvic operation in the 5 years before 
2009, as pre-existing adhesions from this prior surgery might influence results. There are 
no further exclusion criteria. 
For analyses patients will be grossly divided in three groups of anatomical location of the 
surgery: hindgut, female reproductive tract, and foregut or other. Within each group 
subgroups of laparoscopic and open procedures will be made. 
We expect approximately 70,000- 100,000 patients to have had abdominal or pelvic 
surgery in the period June 2009- June 2011. Approximately 25,000 are expected to have 
had prior abdominal surgery in the previous 5 years. Thus, we expect an incident 
population of 45,000 to 75,000 to be included in the study. 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 13 
 
For the study we will analyse re-admission in the years following surgery that are directly 
related to adhesions, possibly related to adhesions, and readmission with surgery that 
might be complicated by adhesions. For this purpose we will need a patient identifier that 
allows to link readmissions to the initial surgery. The data can be anonymized so that the 
identifier represent just a random number. As baseline characteristics we will only require 
age and sex. No further potentially identifiable data such as birth date, postal code or 
NHS number is required.  
From the initial admission with abdominal or pelvic surgery we need ICD- 10 codes and 
OPCS- 4 codes describing the type of surgery performed as well as information whether 
the operation was performed laparoscopic ally or open. This same set of information is 
needed for any readmission in follow-up. Further we need the time interval (in months) 
between the index operation and the readmission. Only readmissions coded by one or 
more relevant ICD-10 or OPCS-4 code need to be included. 
For a readmission to be classified as directly related to adhesions, an explicit adhesion 
reference was required in the operative OPCS-4 or diagnostic ICD-10 coding. Adhesions 
might however not always be coded, especially not if readmission goes without surgery. 
For example, a conservative treated small bowel obstruction might only be coded as 
abdominal pain, nausea, and vomiting. Therefore we will define a broader set of 
operative codes and diagnostic codes that might indicate a possibly adhesion- related 
complication. 
Data from follow-up is requested to the latest date from which a complete record can be 
extracted. 
3.1.09 Does the proposal have implications for, or target, sensitive groups or vulnerable 
populations? Please give details 
 
 
No 
 
3.1.10 Does the proposal seek to use information exclusively about deceased persons? Please 
give details 
 
 
No 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 14 
 
3.1.11 Have any members of the public/lay representatives been involved in the proposal 
design? Please give details 
 
 
No 
 
3.1.12 Has any peer review of the proposal been undertaken? Please give details (for example 
formal review by a peer organisation or funding body, informal internal review, review by 
a third party) 
 
Informal internal review has been performed within the Radboud University Medical 
Center, department of Surgery. The research proposal and internal funding for 
performing the study were approved. 
 
3.1.13 Is there any commercial aspect or dimension to the proposal or its outcomes? Please 
give details 
 
 
No 
 
 
 
 
 
 
 
 
3.2 Proposal Geography Please read section 3.2 of the guidance 
☐   Local/Regional (relating to one or more specific areas within Scotland) 
☒   National (relating to the whole of Scotland) 
☐   UK-wide (relating to the whole of the UK, or to UK regions outside Scotland) 
☐   International (relating to areas within the EEA) 
☐   International (relating to areas beyond the EEA) 
 
3.3 
Proposal Duration and Frequency Please read section 3.3 of the guidance  

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 15 
 
3.3.01 What is the proposed duration of the proposal? 
We now requested for access to the 
data until 2019-12-31, for the purpose 
of answering a few questions of the 
editorial team of Lancet on the 
presentation of the data (e.g. adding 
standard deviations to data 
presented) 
3.3.02 Does the proposal require updates of 
information at regular intervals? Please give 
details 
no 
3.3.03 Are you seeking approval to iterate the proposal 
(ie the whole project, audit or study) at regular 
intervals? Please give details 
no 
 
3.4 
Statutory and Regulatory Context Please read section 3.4 of the guidance  
3.4.01 Does your proposal have a statutory or 
regulatory justification - is the proposal 
responding to a statutory or regulatory 
instruction, duty or order? Please give details 
NO 
3.4.02 Which Data Protection Act schedule 2 and 
schedule 3 conditions are relevant? (a list of 
conditions can be found at Appendix B) 
Schedule 2:  
Condition 3; the use of patient 
identifying data is not necessary to 
carry out the research. The linking 
code can be anonymized using a 
random number. The researcher 
therefore do not need identifying data 
for carrying our analyses. Also the 
use of data which is not directly 
identifiable is minimized, by 
requesting a minimum in baseline 
characteristics and only data from 
readmissions with a relevant code.  
Schedule 3, Condition 8:  

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 16 
 
The processing is necessary for 
medical researcher, and analyses is 
undertaking by health professional 
who completed information 
governance training.  
3.4.03 Are there any relevant information sharing 
agreements, protocols or contracts in place 
which support your proposal? Please give 
details and attach as supporting documentation 
if available 
No 
3.4.04 Has a Privacy Impact Assessment been carried 
out which supports your proposal? Please give 
details and attach as supporting documentation 
if available 
Yes, see attachment. Privacy risk can 
be adequately eliminated. 
3.4.05 Has local Caldicott approval been given for your 
proposal at a local level? Please give details 
No 
3.4.06 Are approvals from Caldicott Guardians outside 
Scotland pending or received? Please give 
details 
No 
 
3.5 
Research and Ethics Governance Please read section 3.5 of the guidance 
3.5.01 
Has your proposal sought research/ethics 
approval? 
Yes  
3.5.01a 
If yes, please provide committee details  and 
status of approval (ie pending, approved, etc). 
Please attach as supporting documentation if 
available 
Radboud University medical Center- 
Institutional review board  
PO box 9101 
6500 HB, Nijmegen, the Netherlands 
T +3124 361 31 54 
E:commissiemensgebondenonderzoek@
RadboudUMC.nl 
- approved - 
3.5.01b If no, please explain why research/ethics 
approval is not sought: 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 17 
 
3.6 
Safe Havens Please read section 3.6 of the guidance 
3.6.01 Do you intend to access the data requested 
exclusively through a safe haven listed at 
Appendix A? Please provide details of which safe 
haven/s 
Yes, 
NHS 
NSS 
ISD 
Electronic 
Data 
Research Innovation Service (@Farr 
Institute) 
3.6.02 If you applying to use NHS NSS data and you do 
not intend to do this through the National Safe 
Haven, please explain why 
Not applicable 
 
 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 18 
 
 
Section 4 – Data & Data Subjects 
4.1 Data yet to be collected  Please read section 4.1 of the guidance 
Not applicable 
Dataset/source 
Name 
Collection by 
(whom)? 
Explicit consent sought? If Yes, describe how 
explicit consent being sought – provide copies of 
participant consent/registration forms, etc. If No, 
explain why consent is not being sought (eg 
impractical, risk associated with seeking consent, 
etc) 
 
 
 
 
 
 
 
 
 
 
4.2 All Other Datasets / sources Please read section 4.2 of the guidance 
Dataset/source 
Name 
Data Controller (Organisation) 
Original purpose compatible with 
proposal? 
Scottish Morbidity 
Record (SMR01) 
National Services Scotland 
Yes 
NRS Deaths 
NRS 
Yes 
CHI Database 
NHS Boards  
Yes 
How were individuals originally informed of the use of their data? (if known) 
Project specific consent was impractical for this study because of large size of the survey group 
and patients are not contacted. However:  
a) no identifiable patient data will be disclosed 
b) the necessary linkage will be performed by data controllers from the NHS Scotland board, 
that already hold the data. After linkage the data will be anonymised.  
c) the medical research serves public interest as outlined under 3.1.07. 
The final dataset for analysis will not hold data that could result in indirect identification. 
For existing dataset/sources for which the data controller is not an NHSScotland board, please 
append evidence of the data controllers permission to use the data 
 
4.3 Data Variables Please read section 4.3 of the guidance  

                                                                                                                        
 
 
 
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Dataset/source 
Name 
Variable 
Time Period/Range 
Processing only? 
Anonymised ID 
Scottish 
Morbidity 
Record (SMR 01) 
CHI 
2004- Dec  2016 
Yes 
Scottish 
Morbidity 
Record (SMR 01) 
Date of admission 
2004- Dec  2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
Sex 
2009- Dec 2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
Age (Date of admission- 
birth date) 
2009- Dec 2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
ICD-10 codes 
2009- Dec 2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
OPCS-4 codes 
2009- Dec 2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
Duration 
since 
index 
operation 
(date 
of 
admission 
from 
readmission - date of 
admission 
from 
index 
operation) 
2009- Dec 2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
Details of operation - 
laparoscopic/ open 
2009- Dec  2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
End of follow-up (month) 
(Date of end of follow-up, 
typically 
June 
2016; 
however 
some 
patient 
might not complete follow-
up because of mortality or 
migration) 
2004- Dec  2016 
No 
Scottish 
Morbidity 
Record (SMR 01) 
Continuous Inpatient Stay 2009- Dec 2016 
No 
CHI Database 
Migration Month / year 
2004- Dec  2016 
No 

                                                                                                                        
 
 
 
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NRS Deaths  
Patient alive or death by 
end of follow-up 
2004- Dec  2016 
(measured 
in 
months, 
no 
date 
provided) 
No 
Please justify your need for identifiable or potentially identifiable variables: 
Identifiable data is only needed during the processing of data. Data will be collected during a range 
of 5 years from index surgery. Patients with a relevant OPCS-4 code as listed in the appendix are 
selected, if no prior such operation was found in the five years previous to the index operation. 
Identifiable information, NHS number and birth date are needed during processing to select 
reoperations that are definitely or potentially related to adhesion in patients following their index 
surgery. After processing these data can be removed. Age is potential risk factor for adhesions and 
will therefore be calculated. 
 
4.4 
NRS/NHSCR Data Sources Please read section 4.4 of the guidance  
Complete this section if access to NHSCR is required, or if there is any National Records of 
Scotland involvement 
4.4.01 
Does the proposal require access to NHS Central Registry 
as a sampling frame for cohorts? 
No  
4.4.02 
Does the proposal involve flagging of individuals on the 
NHSCR for long term follow up? 
Choose an item.  
4.4.03 
If yes, is flagging necessary: 
 
☐  To trace and contact individuals throughout the UK?  
 
☐  To be informed of fact and cause of death?  
 
☐  To be informed of the incidence of on-going cancers?  
 
☐  To be informed of emigrations prospectively and retrospectively?  
4.4.04 
Is any other NRS involvement required? 
Please provide details 
 
 
4.5 
Making Contact with Individuals Please read section 4.5 of the guidance  
4.5.01 
Is any direct contact with any group of individuals required? If 
Yes, please provide details below 
No  
 
Contact Group and Method of contact 
Contact by (whom) 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 21 
 
 
☐  Hospital Consultants  
 
☐ Letter  ☐ Phone  ☐ Other 
(specify) : 
 
 
☐  Other NHSS Staff 
☐ Letter  ☐ Phone  ☐ Other 
(specify) : 
 
 
☐  General Practitioners 
☐ Letter  ☐ Phone  ☐ Other 
(specify) : 
 
 
☐  Patients/Public 
☐ Letter  ☐ Phone  ☐ Other 
(specify) : 
 
 
☐  Relatives of 
participants 
☐ Letter  ☐ Phone  ☐ Other 
(specify): 
  
 
☐  Others (please 
specify): 
 
☐ Letter  ☐ Phone  ☐ Other 
(specify) : 
 
 
4.5.02 
Please explain why contact is being made – append copies of relevant 
correspondence as supporting evidence 
 
 
If applicable 
 
4.6 
Community Health Index (CHI) Database Please read section 4.6 of the guidance 
Complete this section if access to CHI Database is required 
Not applicable 
4.6.01 What monitoring and audit of the use of 
CHI is planned? Please provide details 
 
4.6.02 What technical method will be used to 
access CHI (online read-only, download, 
other extract, anonymised extract, etc)? 
Please provide details 
 

                                                                                                                        
 
 
 
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4.6.03 Have any risks been identified in the 
proposal which relate specifically to 
CHI? 
 
 
 
 

                                                                                                                        
 
 
 
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Section 5 – Methodology & Data Processing  
5.1 
Methodology Please read section 5.1 of the guidance 
5.1.01 Does the proposal require any of the following: 
☒  Data 
matching/linking 
☐   Use of matched 
controls 
☐  Single anonymised data extract  
 
Other (please specify): 
 
5.1.02 Who is carrying out any indexing/ 
linkage/anonymisation, and where? 
Data controler - national 
Services Scotland (@Farr 
Institute) 
5.1.03 Which data sources listed at section 4.1 and 4.2  will 
NSS/NRS receive identifiers for linkage purposes? 
Scottish Morbidity Record 
(SMR 01) 
5.1.04 What variables will be provided for linkage?  
 
X  CHI Number 
☐  Forename 
☐  Surname 
☐  Date of Birth 
☐  Address or Postcode 
☐  NHS Number 
Other Please Specify: 
 
 
5.2 
Access Please read section 5.2 of the guidance 
Complete the following section if you answered ‘No’ to question 3.6.1 
5.2.01 
At what location is identifiable or potentially identifiable  
data being accessed? 
 
5.2.02 
Please provide details of security policy/procedure  
governing access to this physical and technical 
environment – append supporting documentation  
 
5.2.03 
Does this policy/procedure cover password policy in 
detail? Please provide details/ append supporting 
documentation 
 

                                                                                                                        
 
 
 
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5.2.04 
Does this policy/procedure cover user account 
management, including review or removal of access to 
sensitive/personal data, in detail? Please provide details/ 
append supporting documentation  
 
5.2.05 
Will individuals with access to data have individual or 
shared accounts? 
 
5.2.06 
Will the data be accessed by staff working off site eg staff 
working from home at any time during the duration of the 
proposal?  
Choose an item.  
5.2.06b If yes, are policies/procedures in place to facilitate, 
monitor and audit this access? Please provide details/ 
append supporting documentation 
If applicable 
5.2.07 
Provide any additional detail of how data is protected  
from unauthorised access 
If applicable 
 
5.3 
Store & Use Please read section 5.3 of the guidance 
Complete the following section if you answered ‘No’ to question 3.6.1 
5.3.01 Where is data being stored and used? (location, 
organisation,  address – refer to addresses in previous 
sections if appropriate) 
 
5.3.02 Data Protection Registration Number 
If applicable 
5.3.03 ISO 27001 Cert. No. 
If applicable 
5.3.04 Please provide details of security policy/procedure  
governing storage and use of data within this physical and 
technical environment – append supporting 
documentation 
 
5.3.05 Does this policy/procedure cover the implementation of 
up-to-date controls for the detection and prevention of 
malware? Please provide details/ append supporting 
documentation 
 
5.3.06 Does this policy/procedure cover access control and 
auditing of system administrator activity? Please provide 
details/ append supporting documentation 
 

                                                                                                                        
 
 
 
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5.3.07 Does this policy/procedure cover the production of 
backups and the controls in place around these? Please 
provide details/ append supporting documentation 
 
5.3.08 Does this policy/procedure describe the controls in place 
to prohibit unauthorised copying of data? Please provide 
details/ append supporting documentation 
 
5.3.09 Does this policy/procedure describe physical and site 
controls? Please provide details/ append supporting 
documentation 
 
5.3.10 Does this policy/procedure cover hardware repair, 
replacement or disposal and protection of data from 
inappropriate access during such procedures? Please 
provide details/ append supporting documentation 
 
5.3.11 Describe the systems, software and security used to store 
and use data - please provide details/ append supporting 
documentation 
 
5.3.12 Is outsourced IT in use? Please give details 
 
Please repeat section 5.3 above for each relevant location in the proposal – see guidance 
 
 
 
5.4 
Transfer Please read section 5.4 of the guidance 
5.4.01 
Please provide details of security policy/procedure to 
ensure that data will be transferred in such a way that it is 
protected from inappropriate or unauthorised access 
(mention email encryption, secure file transfer protocols 
SFTP, device encryption, physical controls, etc, as 
appropriate) - append supporting documentation 
Identifiable data will not be 
transported. Only results 
from statistical analyses will 
be downloaded through 
secure file transfer 
protocols while connecting 
to the safe haven. 
Downloaded data will be 
stored solely on computer 
at the Radboud University 
Medical Center, complying 

                                                                                                                        
 
 
 
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to its electronic safety 
protocols. 
5.4.02 
At what intervals/ trigger points will data transfer take 
place? 
Analysed data will be 
transferred regularly, during 
a period of 4 months. 
5.4.03 
Will any identifiable or potentially identifiable data be 
transferred outside of the UK? 
No  
5.4.03b 
If yes, please provide details of the country of destination, 
the method of transfer, the proposed location and method 
of storage outside of the UK, and details of any further 
onward transfer 
If applicable 
5.4.04 
Other than initial transfers from source systems, is there 
any copying of data required within the proposal? Please 
give details 
No 
 
5.5 
Dissemination  Please read section 5.5 of the guidance 
5.5.01 
Will proposal findings be published or disseminated 
beyond the proposal team? 
Yes  
5.5.01a If yes, how will proposal findings be published or 
disseminated, to what audience and in what format? 
Please give details 
Results will be published 
as a paper in a peer- 
reviewed medical journal.  
Results will further be 
presented a surgical 
conferences and 
congresses using 
powerpoint format. 
5.5.01b If yes, what steps will be taken to ensure that persons 
cannot be identified in published findings (eg disclosure 
control procedures (safe haven), use of aliases, 
numbers, avoidance of small geographical areas, 
avoidance of small numbers , etc)? Please give details 
Graphs and tables in 
publications will provide 
only large nationwide 
number that is not 
identifiable. 
5.5.01c If yes,  are there any circumstances where a living or 
dead individual would be cited? (eg where a person 
No 

                                                                                                                        
 
 
 
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consented to their data being used as a case study)? 
Please give details 
5.5.01d If yes, were any permissions to publish data required or 
sought (for example from data controllers)? Please 
provide details 
No 
 
5.6 
Retain/Dispose Please read section 5.6 of the guidance  
5.6.01 Which information/data/records retention policy will you be 
applying to the proposal data (details of the policy and the 
organisation to which it belongs)? 
 
5.6.02 How long do you intend to retain identifiable or potentially 
identifiable data after the conclusion of the proposal 
(including archive/backup copies)? 
 
5.6.03 Who will retain the data and where? 
 
5.6.04 What is the purpose for retaining the data for the specified 
time? 
 
5.6.05 What method of disposal or destruction will be used when 
this period has expired (including archive/backup copies)? 
 
5.6.06 What evidence will be obtained that destruction has 
occurred (eg IT supplier certificate of destruction, etc)? 
 
 
5.7 
Review Please read section 5.7 of the guidance 
5.7.01 Describe how the mechanisms which safeguard data 
security will be audited and reviewed at regular intervals to 
ensure their continued efficacy 
 
5.7.02 Describe any resource implications to any of the proposed 
measures for the protection of  physical or technical 
security of information which are unresolved at the time of 
this application? (for example encryption of devices is an 
intention not yet fulfilled, training is not yet undertaken, etc) 
 
5.7.03 Describe the breach reporting mechanisms to be invoked 
in the event of any inappropriate access to data or other 
information security incident 
 

                                                                                                                        
 
 
 
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Section 6 – Declaration 
 
• I DECLARE THAT this application is accurate, and that, should it be successful, any health 
data made accessible will be used for no other purpose, and in no other way, than as 
described above.  
• I UNDERTAKE TO notify the Public Benefit and Privacy Panel of any future changes to 
the purpose or manner in which data is processed in accordance with this application. 
• I UNDERSTAND THAT any future applications by me, or my employing or sponsoring 
organisation, may be refused should any health data made accessible be used for any 
other purpose or in any other way than that described above.   
• I CERTIFY THAT all those who have access to health data in this proposal are aware of 
the requirements of confidentiality and understand that any breach (eg disclosure of 
confidential information to a person not authorised to receive it) will be reported to the data 
controller, and in the case of NHS Scotland originated data to Scottish Government 
eHealth division. 
• I GUARANTEE THAT no publication will appear in any form in which an individual may be 
identified without the written permission of that individual, and that I will  apply appropriate 
disclosure control when planning publications involving the data requested. 
• I UNDERSTAND THAT the Data Controller, and agents acting on its behalf, reserves the 
right to inspect the data on the sites where it is being processed. 
 
To be signified by the APPLICANT    
Name (in Capitals): RICHARD TEN BROEK 
Date: 22-04-2018 
 
• I DECLARE THAT (the applicant named above) is a bona fide worker engaged in a 
reputable project and that the data he/she asks for can be entrusted to him/her in the 
knowledge that he/she will conscientiously discharge his/her obligations, including in 
regard to confidentiality of the data, as stated in the declaration above. 
 
To be signified by the INFORMATION CUSTODIAN named in Section 1.3  above (where the 
Information Custodian is not the applicant). 

                                                                                                                        
 
 
 
Public Benefit and Privacy Panel for Health and Social Care – Application Form v 1.1                     Page 30 
 
Name (in Capitals): 
Date: 
 
Section 7 - Supporting Evidence  
 
Supporting Evidence Please read section 7 of the guidance  
Please list each piece of supporting evidence which you have included with your 
application in the box below – the name of each should clearly indicate what the 
document/file/reference is about 
 
- Appendix with list of OPCS 4.7 and ICD10 codes relevant for selection of data 
- Certificates of Research data and confidentiality training 
- Protocol as send for IRB approval 
- IRB approval 
- Privacy Impact assessment 
 
 
 
 
 

                                                                                                                        
 
 
 
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Appendix A – Reference lists for applicants 
1. Examples of Existing Datasets and Data Sources 
SMR 00 Outpatients 
SMR 04 Mental Health 
SMR 01 Inpatients and Day Cases 
SMR 06 Cancer Registration 
SMR 02 Maternity 
SMR 11/SBR Neonatal/Scottish Birth 
Records 
Scottish Drugs Misuse Database (SDMD) 
Birth Registrations 
A&E – Accident & Emergency 
Stillbirth Registrations 
PIS Prescribing Information 
Death Registrations 
CHSP-PS/CHSP-S/SIRS – Child Health 
Surveillance and Immunisation 
SCI-DC 
NHS National Service Scotland’s Information Services Division (ISD) maintains a National 
Dataset Catalogue (NDC) containing details of all health and health related datasets that are 
held by ISD. The Administrative Data Liaison Service (ADLS) publishes further information 
on key NHSScotland datasets 
 
2. Common Identifiable Variables 
Forename 
Middle Name 
Surname 
CHI Number 
Date of Birth 
UK NHS Birth Registration Number 
Gender 
Postcode 
 
 
3. Recognised Safe Havens  
NHS NSS ISD Electronic Data Research Innovation Service (@Farr Institute) 
NHS Research Scotland South East (ACCORD) 
NHS Research Scotland East (TASC) 
NHS Research Scotland North (DaSH) 
NHS Research Scotland West 
University of Dundee Health Informatics Centre (HIC) 
National Records Scotland Scottish Longitudinal Study (SLS) 
Robertson Centre @ Glasgow University 
 

                                                                                                                        
 
 
 
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4. Research and Information Governance Training 
MRC Research Data and Confidentiality online module 
University of Edinburgh SHIP Information Governance training 
NHS Health and Social Care Information Centre On-line Information Governance training 
NHSScotland Information Governance eLearning: 
• Safe Information Handling (Foundation Level) 
• Information Handling in Practice (Intermediate Level) 
 
5. Sensitive Data Categories  
 
 
Abortion 
Mental health 
Contraception 
Pregnancy in age < 16 years 
Drugs and alcohol misuse 
Crime related statistics 
Sexually transmitted disease 
Suicide 
Ethnicity 
Assisted conception 
 
 
 
6. Vulnerable Populations 
Adults with Incapacity 
Drugs users 
Minority ethnic groups 
Specific religious affiliation 
 
 
 
 
 
 
 
 

                                                                                                                        
 
 
 
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Appendix B –The Caldicott Principles & the Data Protection Principles (& Schedules) 
1. Caldicott Principles 
1. Justify the purpose(s) 
Every single proposed use or transfer of patient identifiable information within or from an 
organization should be clearly defined and scrutinized, with continuing uses regularly 
reviewed, by an appropriate guardian. 
2. Don't use patient identifiable information unless it is necessary 
Patient identifiable information items should not be included unless it is essential for the 
specified purpose(s) of that flow. The need for patients to be identified should be considered 
at each stage of satisfying the purpose(s). 
3. Use the minimum necessary patient-identifiable information 
Where use of patient identifiable information is considered to be essential, the inclusion of 
each individual item of information should be considered and justified so that the minimum 
amount of identifiable information is transferred or accessible as is necessary for a given 
function to be carried out. 
4. Access to patient identifiable information should be on a strict need-to-know basis 
Only those individuals who need access to patient identifiable information should have 
access to it, and they should only have access to the information items that they need to see. 
This may mean introducing access controls or splitting information flows where one 
information flow is used for several purposes. 
5. Everyone with access to patient identifiable information should be aware of their 
responsibilities 
Action should be taken to ensure that those handling patient identifiable information - both 
clinical and non-clinical staff - are made fully aware of their responsibilities and obligations to 
respect patient confidentiality. 
6. Understand and comply with the law 
Every use of patient identifiable information must be lawful. Someone in each organization 

                                                                                                                        
 
 
 
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handling patient information should be responsible for ensuring that the organization 
complies with legal requirements. 
7. The duty to share information can be as important as the duty to protect patient 
confidentiality 
Health and social care professionals should have the confidence to share information in the 
best interests of their patients within the framework set out by these principles. They should 
be supported by the policies of their employers, regulators and professional bodies. 
 
2. Data Protection Principles 
1. Personal data shall be processed fairly and lawfully and, in particular, shall not be 
processed unless – 
(a) at least one of the conditions in Schedule 2 is met, and 
(b) in the case of sensitive personal data, at least one of the conditions in Schedule 3 is 
also met 
2. Personal data shall be obtained only for one or more specified and lawful purposes, and 
shall not be further processed in any manner incompatible with that purpose or those 
purposes 
3. Personal data shall be adequate, relevant and not excessive in relation to the purpose or 
purposes for which they are processed 
4. Personal data shall be accurate and, where necessary, kept up to date 
5. Personal data processed for any purpose or purposes shall not be kept for longer than is 
necessary for that purpose or those purposes 
6. Personal data shall be processed in accordance with the rights of data subjects under this 
Act 
7. Appropriate technical and organizational measures shall be taken against unauthorized or 
unlawful processing of personal data and against accidental loss or destruction of, or 
damage to, personal data 

                                                                                                                        
 
 
 
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8. Personal data shall not be transferred to a country or territory outside the European 
Economic Area unless that country or territory ensures an adequate level of protection for 
the rights and freedoms of data subjects in relation to the processing of personal data 
 
3. Data Protection Schedule 2 & 3 Conditions 
Schedule 2 – Conditions for Processing any Personal Data 
1. The data subject has given his consent to the processing 
2. The processing is necessary— 
(a) for the performance of a contract to which the data subject is a party, or 
(b) for the taking of steps at the request of the data subject with a view to entering into a 
contract 
3. The processing is necessary for compliance with any legal obligation to which the data 
controller is subject, other than an obligation imposed by contract 
4. The processing is necessary in order to protect the vital interests of the data subject 
5. The processing is necessary— 
(a) for the administration of justice, 
(aa) for the exercise of any functions of either House of Parliament, 
(b) for the exercise of any functions conferred on any person by or under any enactment, 
(c) for the exercise of any functions of the Crown, a Minister of the Crown or a 
government department, or 
(d) for the exercise of any other functions of a public nature exercised in the public 
interest by any person 
6. (1) The processing is necessary for the purposes of legitimate interests pursued by the data 
controller or by the third party or parties to whom the data are disclosed, except where the 
processing is unwarranted in any particular case by reason of prejudice to the rights and 
freedoms or legitimate interests of the data subject. 
(2) The Secretary of State may by order specify particular circumstances in which this condition 
is, or is not, to be taken to be satisfied 
Schedule 3 – Conditions for Processing any Sensitive Personal Data 
1. The data subject has given his explicit consent to the processing of the personal data 

                                                                                                                        
 
 
 
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2. (1) The processing is necessary for the purposes of exercising or performing any right or 
obligation which is conferred or imposed by law on the data controller in connection with 
employment 
3. The processing is necessary— 
(a) in order to protect the vital interests of the data subject or another person, in a case 
where— 
(i) consent cannot be given by or on behalf of the data subject, or 
(ii) the data controller cannot reasonably be expected to obtain the consent of the 
data subject, or 
(b) in order to protect the vital interests of another person, in a case where consent by or 
on behalf of the data subject has been unreasonably withheld 
4. The processing— 
(a) is carried out in the course of its legitimate activities by any body or association which— 
(i) is not established or conducted for profit, and 
(ii) exists for political, philosophical, religious or trade-union purposes, 
(b) is carried out with appropriate safeguards for the rights and freedoms of data subjects, 
(c) relates only to individuals who either are members of the body or association or have 
regular contact with it in connection with its purposes, and 
(d) does not involve disclosure of the personal data to a third party without the consent of 
the data subject 
5. The information contained in the personal data has been made public as a result of steps 
deliberately taken by the data subject 
6. The processing— 
(a) is necessary for the purpose of, or in connection with, any legal proceedings (including 
prospective legal proceedings), 
(b) is necessary for the purpose of obtaining legal advice, or 
(c) is otherwise necessary for the purposes of establishing, exercising or defending legal 
rights 
7. (1) The processing is necessary— 
(a) for the administration of justice, 
(aa) for the exercise of any functions of either House of Parliament, 
(b) for the exercise of any functions conferred on any person by or under an enactment, or 

                                                                                                                        
 
 
 
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(c) for the exercise of any functions of the Crown, a Minister of the Crown or a 
government department 
(2)The Secretary of State may by order— 
(a) exclude the application of sub-paragraph (1) in such cases as may be specified, or 
(b) provide that, in such cases as may be specified, the condition in sub-paragraph (1) is not 
to be regarded as satisfied unless such further conditions as may be specified in the order 
are also satisfied 
7A.  (1) The processing— 
(a) is either— 
(i) the disclosure of sensitive personal data by a person as a member of an anti-fraud 
organisation or otherwise in accordance with any arrangements made by such an 
organisation; or 
(ii) any other processing by that person or another person of sensitive personal data 
so disclosed; and 
(b) is necessary for the purposes of preventing fraud or a particular kind of fraud 
(2) In this paragraph “an anti-fraud organisation” means any unincorporated association, body 
corporate or other person which enables or facilitates any sharing of information to prevent fraud 
or a particular kind of fraud or which has any of these functions as its purpose or one of its purposes 
8. (1) The processing is necessary for medical purposes and is undertaken by— 
(a) a health professional, or 
(b) a person who in the circumstances owes a duty of confidentiality which is equivalent to 
that which would arise if that person were a health professional 
(2) In this paragraph “medical purposes” includes the purposes of preventative medicine, medical 
diagnosis, medical research, the provision of care and treatment and the management of 
healthcare services 
9. (1) The processing— 
(a) is of sensitive personal data consisting of information as to racial or ethnic origin, 
(b) is necessary for the purpose of identifying or keeping under review the existence or 
absence of equality of opportunity or treatment between persons of different racial or 
ethnic origins, with a view to enabling such equality to be promoted or maintained, and 
(c) is carried out with appropriate safeguards for the rights and freedoms of data subjects 

                                                                                                                        
 
 
 
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(2) The Secretary of State may by order specify circumstances in which processing falling within 
sub-paragraph (1)(a) and (b) is, or is not, to be taken for the purposes of sub-paragraph (1)(c) to 
be carried out with appropriate safeguards for the rights and freedoms of data subjects 
10. The personal data are processed in circumstances specified in an order made by the Secretary 
of State for the purposes of this paragraph