Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
Phase: NA
Conditions: Cognitive Dysfunction
Sponsor: Brisbane Hand and Upper Limb Research Institute

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STUDY PROTOCOL: POCD 
Prediction of post-operative cognitive decline following shoulder surgery in the beach chair 
position: the value of cerebral oximetry. 
Version: 4.0, 1 June 2018 
Superseded: Version 3, 17 June 2016 
 
Primary Investigators: Associate Professor Mark Ross, Dr Phillip Duke, Dr David Gilpin, Dr 
Phil Melksham 
 
Associate Investigators: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms 
Louise Lee, Mr Glen Russell 
 
 
 
 
 
 
Primary Investigator Signature: ______________________    Date: 17/06/2016 
 
 
 

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CONTENTS 
1 
CLINICAL INVESTIGATION PLAN SUMMARY – PART ONE .................................................. 6 
2 
INTRODUCTION .................................................................................................................... 7 
 
KEY TERMS ................................................................................................................................. 9 
 
LAYMAN’S SUMMARY ............................................................................................................... 9 
3 
PURPOSE OF THE INVESTIGATION ..................................................................................... 10 
 
INTERVENTION GROUPS .......................................................................................................... 10 
 
AIM OF THE STUDY .................................................................................................................. 10 
 
RESEARCH QUESTION .............................................................................................................. 10 
 
NULL HYPOTHESES .................................................................................................................. 11 
 
PRIMARY HYPOTHESES ............................................................................................................ 11 
4 
INVESTIGATOR RESPONSIBILITY ........................................................................................ 11 
5 
STUDY DESIGN AND METHODS ......................................................................................... 12 
 
GENERAL .................................................................................................................................. 12 
 
DESIGN ..................................................................................................................................... 12 
 
PARTICIPANT ELIGIBILITY CRITERIA ......................................................................................... 12 
5.3.1 
INCLUSION CRITERIA ............................................................................................................ 12 
5.3.2 
EXCLUSION CRITERIA ............................................................................................................ 12 
5.3.3 
WITHDRAWAL OF PARTICIPANTS DURING TRIAL ................................................................. 13 
 
RECRUITMENT ......................................................................................................................... 13 
 
SAMPLE SIZE ............................................................................................................................ 13 
6 
SCREENING /ENROLMENT ................................................................................................. 14 
 
STUDY INTERVENTIONS ........................................................................................................... 14 
7 
DATA COLLECTION ............................................................................................................. 14 
 
DATA COLLECTION INTERVALS ................................................................................................ 15 
 
DATA COLLECTION FORMS FOR PRIMARY AND SECONDARY OUTCOMES ............................. 15 
7.2.1 
ELIGIBILITY CRITERIA CHECKLIST .......................................................................................... 15 
7.2.2 
DEMOGRAPHIC AND MEDICAL INFORMATION FORM ......................................................... 15 
7.2.3 
DATA COLLECTION FORMS FOR PRIMARY AND SECONDARY HYPOTHESES ........................ 16 
8 
OUTCOME MEASURES ....................................................................................................... 16 
 
COGNITIVE ASSESSMENT TOOLS ............................................................................................. 16 
8.1.1 
NEUROPSYCHOLOGICAL TESTS ............................................................................................ 16 

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8.1.2 
PSYCHOLOGICAL MEASURES ................................................................................................ 17 
 
CEREBRAL DESATURATION ...................................................................................................... 18 
 
PAIN ......................................................................................................................................... 18 
 
ADVERSE EVENTS ..................................................................................................................... 18 
9 
CONFIDENTIALITY .............................................................................................................. 19 
10 DATA ANALYSIS ................................................................................................................. 19 
 
STATISTICAL METHODS ......................................................................................................... 19 
11 RISK ANALYSIS ................................................................................................................... 20 
12 BUDGET AND FUNDING IN-KIND SUPPORT ...................................................................... 21 
13 DISSEMINATION ................................................................................................................ 21 
14 CLINICAL INVESTIGATION PLAN SUMMARY- PART TWO ............................................... 22 
15 INTRODUCTION ................................................................................................................ 22 
 
LAYMAN’S SUMMARY ........................................................................................................... 23 
 
PURPOSE OF THE INVESTIGATION ........................................................................................ 23 
 
INTERVENTION GROUPS ....................................................................................................... 23 
 
GENERAL AIM OF THE STUDY ................................................................................................ 23 
 
RESEARCH QUESTIONS .......................................................................................................... 23 
 
HYPOTHESES .......................................................................................................................... 23 
 
STUDY TWO PARTICIPANT ELIGIBILITY CRITERIA .................................................................. 23 
15.7.1 
INCLUSION CRITERIA .......................................................................................................... 23 
15.7.2 
EXCLUSION CRITERIA .......................................................................................................... 24 
 
RECRUITMENT ....................................................................................................................... 24 
 
SAMPLE SIZE .......................................................................................................................... 24 
16 SCREENING /ENROLMENT ................................................................................................ 24 
17 DATA COLLECTION ............................................................................................................ 24 
 
DATA COLLECTION FOR PRIMARY AND SECONDARY OUTCOMES ........................................ 24 
17.1.1 
DEMOGRAPHIC AND MEDICAL INFORMATION FORM ...................................................... 24 
18 OUTCOME MEASURES ...................................................................................................... 25 
 
SURVEY .................................................................................................................................. 25 
19 CONFIDENTIALITY ............................................................................................................. 25 
20 DATA ANALYSIS ................................................................................................................. 25 
 
STATISTICAL METHODS ......................................................................................................... 25 
21 RISK ANALYSIS ................................................................................................................... 25 

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22 BUDGET AND FUNDING IN-KIND SUPPORT ...................................................................... 26 
23 DISSEMINATION ................................................................................................................ 26 
24 REFERENCES ...................................................................................................................... 27 
 
Eligibility Checklist ................................................................................................................. 30 
24.1.1 
PARTICIPANT ELIGIBILITY CRITERIA .................................................................................... 30 
24.2 Participant Information Form ................................................................................................... 32 
24.3 Participant Consent Form ......................................................................................................... 35 
24.4 Data Collection Form ................................................................................................................ 36 
24.5 Participant Withdrawal Form .................................................................................................... 41 
24.6 Participant Survey – STUDY TWO ............................................................................................. 42 
24.7  Participant Information Form – STUDY TWO ........................................................................... 45 
24.8 Participant Consent Form – STUDY TWO .................................................................................. 48 
 
 
 
 
 
 
 
 
 

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SUMMARY OF CHANGES TO THIS VERSION 
Section 
Change 
Reason for update 
Version 
Version 3 to version 4.0 
Investigator changes 
Contents page 
Addition of section “Summary of Changes to 
this Version” 
Clarity 
1. Clinical 
investigation plan 
summary – part 
one 
Addition and deletion of investigators 
UQ team leaves 
project, staff 
turnover 
9. Confidentiality 
Change UQ HREC to Bellberry HREC 
Error correction 
14. Clinical 
investigation plan 
summary – part 
two 
Addition and deletion of investigators, 
reference to “The University of Queensland” 
deleted 
UQ team leaves 
project, staff 
turnover 
15.8. Recruitment 
References to “The University of Queensland” 
and “UQ School of Psychology” deleted 
UQ team leaves 
project 
19 Confidentiality 
Change UQ HREC to Bellberry HREC, 
change the University of Queensland to 
Brisbane Hand and Upper Limb Research 
Institute 
Error correction, UQ 
team leaves project 
24.2 Participant 
Information Form 
Addition and removal of investigators, change 
of project contact, references to the University 
of Queensland deleted 
UQ team leaves 
project, staff 
turnover 
24.2 Participant 
Information Form 
Expected date of study conclusion changed 
from 2018 to 2019 
Updated estimate 
24.3 Participant 
Consent Form 
References to the University of Queensland 
deleted 
UQ team leaves 
project 
24.5 Participant 
Withdrawal Form 
Addition and removal of investigators, change 
of project contact 
UQ team leaves 
project, staff 
turnover 
24.6 Participant 
survey – STUDY 
TWO 
Change of contact email, expected date of 
study conclusion changed from 2018 to 2019 
UQ team leaves 
project, updated 
estimate 
24.7 Participant 
Information Form 
– STUDY TWO 
Addition and removal of investigators, change 
of project contact, references to the University 
of Queensland deleted, expected date of 
study conclusion changed from 2018 to 2019, 
change of project contact 
UQ team leaves 
project, staff 
turnover, updated 
estimate 
24.8 Participant 
Consent Form – 
STUDY TWO 
references to the University of Queensland 
deleted 
UQ team leaves 
project 
 
 

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1 CLINICAL INVESTIGATION PLAN SUMMARY – PART ONE 
 
TITLE 
Prediction of post-operative cognitive decline following shoulder surgery in 
the beach chair position: the value of cerebral oximetry. 
INVESTIGATORS 
Principal:  Associate Professor Mark Ross, Dr Phillip Duke, Dr David Gilpin, 
Dr Phil Melksham  
Associate: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms 
Louise Lee, Mr Glen Russell 
 
OBJECTIVES 
Primary aim: 
To examine the relationship between cerebral desaturation during shoulder 
surgery in the beach chair position, and post –operative cognitive decline. 
 
 Secondary aims: 
1. To determine the variation in cerebral oxygenation recorded using 
simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, 
during shoulder surgery in the beach chair position. 
2. Assess the relationship between cerebral oxygen desaturation and 
mean arterial pressure, incidence of nausea / vomiting, duration of 
hospital stay, BMI, hypertension and adverse events. 
STUDY DESIGN 
A prospective cohort study. 
SITES 
Brisbane Private Hospital.  
NUMBER OF 
SUBJECTS 
Approximately 200 participants will be recruited to this study.   
 
TARGET 
POPULATION 
Participants will be adults who require shoulder surgery in the beach chair 
position. 
LENGTH OF 
CLINICAL 
INVESTIGATION 
It is anticipated that this study will require 27 months from commencement 
of recruitment to final data collection phases (24 month recruitment period).  
The primary end point of the study will be 3 months post-surgery. 
Participants will be assessed 1 day prior to surgery (baseline), at day 1 post- 
surgery (early), between 10 & 14 days (mid), at 1 month (late) and at 3 
months post –surgery (late). 
OUTCOMES 
Primary  
Post- operative cognitive decline will be defined as a drop of 1 standard 
deviation or more from baseline on 2 or more neuropsychological indices 
(Tournay-Jette et al., 2011). The following neuropsychological tests will be 
used; 
• Logical memory test 
• Trail making test: Delis-Kaplan Executive Function System  
• Single letter verbal fluency 
• Stroop test: Victoria’s version 
• List Learning: Rey Auditory Verbal Learning Test 
• Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th 
edition). 
 
 

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Secondary 
Frequency of cerebral desaturation events (CDE) measured (INVOS™ vs 
FORE-SIGHT®). Cerebral desaturation will be defined as a decrease in rSO2 
greater than, or equal to 20% from baseline or a fall below 50% absolute (after 
Murphy et al., 2010; Salazar et al., 2013). Variables associated with this 
outcome include: 
• Mean Arterial Pressure (mmHg) 
• BMI 
• Hypertension 
• Nausea and Vomiting – within 48 hours 
• Duration of hospital stay 
• Adverse Events  
 
 
2 INTRODUCTION 
The “beach chair position” (BCP) has been used to perform shoulder surgery since the early 1980s and 
has several cited advantages compared to alternative positions.  These include; reduced strain on the 
brachial plexus, less risk of neurovascular injury compared to a lateral decubitus approach and excellent 
intra-articular visualization (Murphy et al., 2010).  However, despite these advantages and the 
widespread use of this position during shoulder surgery, the BCP has also been associated with some 
rare but severe adverse clinical outcomes.  These have included; ischaemic brain and spinal cord injury, 
stroke, visual loss and opthalmoplegia (Pohl & Cullen, 2005; Murphy et al., 2010). This has highlighted 
the need to routinely monitor cerebral oxygenation during shoulder surgery in the beach chair position 
and has prompted the development of clinical protocols to minimise the effect of cerebral desaturation 
events (CDE) (Closhen et al., 2013; Salazar et al., 2013).  
It has been hypothesized that a combination of factors may contribute to the increased risk of CDE 
occurring in the BCP. Normal physiological changes associated with sitting upright are magnified in the 
context of a general anaesthetic.  Venous return is reduced by the effect of gravity and compromised 
further by vasodilation and the myocardial depressant effect of anaesthesia.  In the non- anaesthetised 
patient, changes in the sympathetic nervous system produce an increase in systemic vascular 
resistance to counteract the effect of gravity.  This modulation of haemodynamics via the autonomic 
nervous system is lost in the anaesthetised patient increasing the risk of cerebral hypoxia (Pohl & 
Cullen, 2005).  
The relationship between CDE and post- operative cognitive decline (POCD) is not well understood 
(Lopez et al., 2013). Little is known about the significance of the type and duration of CDE and whether 
or not this has any bearing on cognitive outcome.  Some authors continue to question the relationship 
between CDE and subsequent cognitive impairment (Parra et al., 2011; Zheng et al., 2013; Kok et al., 
2014). Salazar et al., (2013) provide the only study that examines the relationship between CDE in 
shoulder surgery using the BCP and subsequent cognitive impairment.  These authors did not find a 
statistically significant relationship between CDE and cognition as assessed using the “Repeatable 

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Battery for Assessment of Neuropsychological Status “(RBANS) with either composite scores or using 
the sub-indices. They attribute this lack of significant findings to insufficient study power. The incidence 
of cerebral desaturation in their study was 18% (9/50 participants). In contrast, de Tournay-Jette et al, 
(2011) found a significant relationship between CDE and POCD in elderly patients following coronary 
artery bypass graft surgery.  These authors used a detailed battery of neuropsychological assessments 
and highlight the need for sensitive assessments of cognitive function.   
This difficulty in clarifying the relationship between CDE and POCD may be further compounded by our 
ability to accurately measure cerebral perfusion.  To date, no clear definition of cerebral ischaemia 
exists and little is known about individual patient factors (e.g. pre-existing cerebral vascular disease) 
that may influence cognitive outcome (Murphy et al., 2010). Additionally, changes in the proportion of 
venous versus arterial components of blood pressure will vary with changes in body position.  This is 
not necessarily reflected in the observed change in overall oxygen concentration (Murphy et al., 2010).  
Individual variation in acceptable mean arterial blood pressure has also been reported.  Whilst 50mmHg 
is generally the accepted level, the required level in some cases has been found to be as high as 70-
80mmHg (Murphy et al., 2010). Hence, the conditions leading up to a CDE associated with cognitive 
impairment may vary from one patient to another and are influenced by patient specific characteristics 
(Murphy et al., 2010). 
A number of cerebral oximeters are commercially available.  Douds et al. (2014) completed a systematic 
review of devices commonly used in cardiac surgery and concluded that there were only a very limited 
number of high quality papers available.  Most of these papers were based on the INVOS™ system.  
These authors highlighted the need for further RCTs to investigate the role of cerebral oximetry and the 
efficacy of devices currently available.  Hessel et al., (2014) examined cerebral oxygenation in 
newborns using both the FORE-SIGHT® and INVOS™ monitors.  They found that the FORE-SIGHT® 
monitor demonstrated greater repeatability and hypothesised that this may indicate a lower 
responsiveness to change in oxygen saturation. In contrast, Closhen et al., (2013) compared the use 
of the INVOS™ and FORE-SIGHT® monitors to detect oxygen saturation in the beach chair position 
and found no significant difference according to monitor type. The study by Bickler et al., (2013) 
compared the performance of several cerebral oximeter devices including the FORE-SIGHT® and 
INVOS™ monitors.  It compares the performance of different cerebral oximetry devices using an 
invasive reference standard and a common sample population (health adult volunteers), simultaneous 
testing methodology and data analysis. It is important that the monitors are being used within their 
approved indication for and that care must be taken to avoid optical cross-talk between the sensors of 
different manufacturers.  In addition, the sensors will be placed randomly on the forehead in terms of 
superior and inferior in the same position to avoid sequential bias.  Both the FORE-SIGHT® and 
INVOS™ cerebral oximetry measurements have been assessed and shown to be valid surrogates for 
true cerebral oxygenation . 
 

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Monitoring cerebral oxygenation in the BCP is an area of evolving attitudes in regards to standard of 
care.  There are many hospitals in Australia who have now adopted cerebral oximetry as a standard of 
care for monitoring patients in the beach chair position.  It is the feeling of all of the surgeons involved 
in the investigation that in fact, cerebral oxygenation monitoring is part of an adequate standard of care 
for patients in the beach chair position and it is routinely utilised currently in all beach chair position 
surgeries.  It is not expected that there will be any significant alteration to operative time by placing two 
oxygen monitors and there is certainly no risk to the surgeon, anaesthetist or the nursing team.  Data 
is recorded using monitors that output the data digitally and all of the data will be compared using 
standard timestamp methods so that they can be directly compared.  The oximetry and MAP data will 
be simultaneously digitally recorded for the research data collection and analyses. 
In conclusion, the relationship between shoulder surgery in the BCP and cerebral oxygenation is 
suggestive and requires further investigation. In addition, factors associated with cerebral desaturation 
and the incidence of POCD are not well understood.  The value of cerebral oximetry in predicting CDE 
and POCD remains unclear. Further research in these areas is indicated and the proposed study aims 
to address the issues raised here.  
 
KEY TERMS 
BCP – beach chair position 
POCD – post operative cognitive decline 
CDE – cerebral desaturation event 
rSO2 – regional cerebral oxygen saturation 
MAP – mean arterial pressure 
BMI – body mass index 
 
LAYMAN’S SUMMARY 
Surgery to the shoulder may be performed with patients seated upright in a position known as the “Beach 
Chair Position (BCP).”  This position has certain advantages compared to alternative surgical positions (eg 
side lying) in some situations.  However, it has been found that surgery in the BCP can temporarilly decrease 
the amount of oxygen in the brain as a result of the combined effects of gravity and anaesthesia. This can 
result in complications following surgery such as some memory loss and confusion. Rarely, more serious 
complications have been reported in the past including death and stroke.  
Due to these reported complications the use of “cerebral oximetry”  during shoulder surgery in the BCP has 
become more common.  Before and during surgery, a monitor placed on the patients forehead measures the 
amount of oxygen present in the brain to help control this to an acceptable level.  A number of monitors are 
now commercially available.  Two monitors are commonly discussed in the literature; the INVOS™ 5100 and 
the FORE-SIGHT® machines. However, the actual relationship between the supply of oxygen to the brain 

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during surgery and the chance of later developing problems with memory and thinking (known as “post 
operative cognitive decline” – POCD) is not clear.  It is also not known if one monitor is more accurate than 
another at predicting these complications. 
Therefore, the main aim of this study is to examine the relationship between cerebral oxygen levels during 
shoulder surgery and the incidence of POCD (i.e. problems with memory and thinking).  A second aim  is to 
compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to measure cerebral oxygen and CDE as well 
as the importance of other key clinical variables (e.g. blood pressure, nausea, body fat etc). 
3 PURPOSE OF THE INVESTIGATION 
The purpose of this investigation is to generate evidence about cerebral oxygenation during shoulder 
surgery and the incidence of POCD.  Currently, evidence relating to POCD following surgery is 
conflicting and relates mostly to outcomes following cardiac surgery.  There is a strong need to explore 
this relationship in the specific context of shoulder surgery in the BCP.  
 
INTERVENTION GROUPS  
The first study, hereby named STUDY ONE will involve a single prospective cohort.  Patients who meet 
the selection criteria will be recruited to the study following voluntary informed consent .  Cerebral  
 
STUDY ONE 
 
AIM OF THE STUDY 
This study has three aims; 
(i) 
To examine the relationship between cerebral desaturation during shoulder surgery in the 
BCP, and the incidence of POCD. 
(ii) To determine the variation in cerebral oxygenation recorded using randomised (for 
superior/inferior) simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, 
during shoulder surgery in the beach chair position. 
(iii) Assess the relationships between cerebral oxygen desaturation during shoulder surgery 
in the BCP and variables including mean arterial pressure, incidence of nausea/vomiting, 
duration of hospital stay, BMI, hypertension and adverse events. 
 
RESEARCH QUESTION 
There are three research questions correlating with the three research aims; 
(i) 
Is cerebral desaturation during shoulder surgery associated with POCD? 
(ii) Do the FORE-SIGHT® and INVOS™ 5100 devices vary in their measurement of cerebral 
oxygenation during shoulder surgery in the BCP? 

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(iii) Is there a relationship between cerebral desaturation events during shoulder surgery in 
the BCP and variables including mean arterial blood pressure, post-operative 
nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse events? 
 
NULL HYPOTHESES 
The three null hypotheses are; 
(i) 
Cerebral desaturation as measured using cerebral oximetry is not related to POCD after 
shoulder surgery in the BCP. 
(ii) There is no significant difference between the INVOS™ 5100 and the FORE-SIGHT® 
monitors assessment of cerebral oxygenation during shoulder surgery in the BCP. 
(iii) There is no relationship between cerebral desaturation events during shoulder surgery in 
the BCP and variables including mean arterial blood pressure, the frequency of post-
operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse 
events. 
 
PRIMARY HYPOTHESES  
The primary research hypotheses are; 
(i) 
Cerebral desaturation events during surgery in the BCP will be related to POCD. 
(ii) The INVOS™ 5100 and the FORE-SIGHT® monitors will show no significant difference in 
their ability to measure cerebral oxygenation. 
(iii) Cerebral desaturation events experienced during shoulder surgery in the BCP are related 
to a drop in mean arterial blood pressure, an increased likelihood of post-operative nausea 
and vomiting, greater length of hospital stay, a higher BMI, hypertension and greater 
frequency of adverse events. 
4 INVESTIGATOR RESPONSIBILITY 
The investigators will be responsible for: 
• 
Obtaining ethical clearance prior to the commencement of the study; 
• 
Recruitment;  
• 
Providing participants with informed consent prior to allocation of intervention; 
• 
Provision of intervention; 
• 
Concise and comprehensive collection of medical history, baseline demographic data, 
intra-operative measures and cognitive assessments; 
• 
Ensuring confidentiality of data collection forms and results; 
• 
Ensuring data is kept in a safe, secure and lockable location, and electronic copies have 
been backed up on a secure server; 

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• 
Ensuring the study is conducted in a safe and ethical manner in line with Queensland 
Health policies and procedures, National Health and Medical Research Council (NHMRC) 
guidelines and relevant laws;  
• 
Maintaining the confidentiality of participant records and data collected, and abiding by the 
NHMRC guidelines for Human Research; 
• 
Data input from paper into electronic format; 
• 
Paper preparation and submission;  
• 
Adherence to the Good Clinical Practice Guidelines. 
A statistician will assist with the power calculation, data analysis and interpretation. 
The Primary Investigators will be responsible for monitoring the implementation of the study and study 
processes in line with the study protocol.  Any adverse events will be reported to the ethics committee.  
5 STUDY DESIGN AND METHODS 
 
GENERAL 
This study aims to examine the relationship between cerebral desaturation measured via oximetry 
during shoulder surgery in the BCP, and POCD. Patients treated by the Principal Investigators who 
meet the selection criteria, will be invited to participate in this prospective study. The investigation will 
be conducted at the Brisbane Hand and Upper Limb Research Institute at the Brisbane Private 
Hospital, Brisbane, Australia. 
 
DESIGN 
A prospective cohort design will be implemented. 
 
PARTICIPANT ELIGIBILITY CRITERIA 
5.3.1 INCLUSION CRITERIA  
Patients meeting the following inclusion criteria will be invited to participate in the study (see 15.1);  
• 
Receiving treatment primarily by, but not restricted to, one of the Primary investigators 
for a shoulder condition that requires surgery in the BCP. 
• 
Over 18 years of age 
• 
Able to read and speak English 
5.3.2 EXCLUSION CRITERIA 
Patients will be excluded from the study for the following reasons (see 15.1); 
• 
Under 18 years of age 
• 
Pregnant women 

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• 
Pre- operative Mini-Mental State Examination (MMSE) < 24  
• 
Pre-existing cerebrovascular disease as reported by the assessing medical consultant and 
recorded in patient charts  
• 
Orthostatic hypotension 
• 
ASA physical status IV and V*  
• 
History of drug and/or alcohol abuse  
• 
Neurological disease (e.g. previous stroke) 
• 
Significant mood and anxiety disorders as determined by treating consultant. 
• 
Any other condition, which in the opinion of the investigators, would render the patient 
unsuitable for participation in the study 
* ASA = the American Society of Anaesthesiologists physical status classification system. Level IV 
indicates the presence of severe systemic disease that is a threat to life. Level V is a moribund person 
who is not expected to survive without some form of surgery. 
5.3.3 WITHDRAWAL OF PARTICIPANTS DURING TRIAL 
Participants may decide not to proceed with their surgery for personal reasons. We will, however, 
record any other type of intervention they have chosen to have at this stage (e.g. physiotherapy, 
injection). Those who withdraw during the follow up period will be noted and this will be reported in the 
final report. The sample size calculation in the study has allowed for dropouts.  Dropouts will be 
compared to study participants according to their baseline characteristics as part of the final analysis 
in order to assess for differential attrition. 
 
 RECRUITMENT 
The study patient population will be recruited primarily from the private consulting practices 
of the Principal investigators at the Brisbane Hand and Upper Limb Clinic at the Brisbane 
Private Hospital. All patients who are undergoing surgery in the beach chair position will be 
approached by a member of the research team or a research assistant employed by BHULI 
after they have indicated to the consultant their interest in participating in the study after the 
decision to undertake surgery has been made.  Indeed all patients who are undergoing 
shoulder surgery in beach chair position by any of the surgeons involved the study would be 
undergoing surface cerebral oximetry anyway.  There is no question that the discussion 
regarding participating in the study would not happen until it was already established that the 
patient was undergoing shoulder surgery in the beach chair position.  It has nothing to do with 
the clinical discussion regarding the patient’s treatment. 
 
SAMPLE SIZE 
Approximately 200 participants will be recruited to the study.  Based on historical patient presentation 
rates for this group, it is anticipated that recruitment will take approximately 24 months. This allows for 
75% recruitment rate and 30% loss to follow up.  
 
 

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6 SCREENING /ENROLMENT 
Patients will be screened according to the selection criteria (see 5.3.1 and 5.3.2) and the eligibility 
checklist completed (24.1). Those who meet the selection criteria will be invited to participate in the 
study. After reviewing the Participant Information form (24.3) and acknowledging that they have 
understood the purpose of the study, their involvement, risks and benefits, they will be asked to provide 
written consent (24.3).  Any participant who refrains from participation will not be disadvantaged in any 
way. Any participant who wishes to withdraw during the study of his/her own accord and for whatever 
reason is entitled to do so without obligation and prejudice. In the event of this occurring, the investigator 
will record this clearly on the Data Collection Form (24.4). 
 
STUDY INTERVENTIONS 
Following recruitment to the study participants will be booked for surgery.  An initial assessment (pre-
operative screening test) will be conducted one day prior to surgery.  Demographic information will be 
collected and the initial cognitive screen will be conducted at this assessment. Cognitive assessment 
will then be repeated at day 1, 10 days post-surgery and at one month and 3 months post-surgery.  
These time points coincide with standard follow-up intervals post shoulder surgery. Minor changes in 
the timing of these assessments will be made if necessary to accommodate pre and post-operative 
surgery schedules. 
The intra- operative procedure will be as follows; 
1. 
The patient’s bed will be inclined between 30-70 degrees, with the angle being measured 
by an inclinometer.   
2. 
The anaesthetic and surgical procedure will continue as usual whilst the oximeters record 
cerebral oxygenation.  
3. 
Any CDE will be recorded on the data collection sheet.  Additionally, a digital record will 
be obtained of mean arterial pressure and also oxygenation from the oximeters until 
surgery is complete and the patient has regained consciousness.  This will allow more 
detailed analysis by the statistician. 
4. 
Intraoperative drug administration data will be recorded on the data collection sheet (24.4). 
This will allow for analysis of potential confounding effects. 
5. 
The type of surgical procedure and the duration of surgery will be recorded (24.4) to again 
reduce further confounding affects.  
6. 
Any variations from the usual surgical/anaesthetic protocol or adverse events will be 
recorded on the data collection form (24.4). 
7. 
Post-operative analgesia data will be recorded in the data collection form (24.4).  
 
7 DATA COLLECTION 

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DATA COLLECTION INTERVALS 
Data Collection Interval 
Review Method 
Baseline (approx. 24 hours prior to surgery) 
In person at the clinic 
Day 1 
In person on the ward 
Between 10 and 14 days 
In person at the clinic 
1 month 
In person at the clinic 
3 months 
In person at the clinic 
 
Data will be collected by an independent assessor who is not involved in the provision of treatment. 
These data collection points have been chosen to assess both the immediate and longer term effects 
of cerebral desaturation on cognitive function.  
The follow-up period for this study is 3 months.  Assessment of cognitive function will be conducted 1 
day pre-operatively and as part of routine follow-up appointments at approximately 1 day and 10 days 
post-op, 1 month and 3 months. In this way we hope to maximise study retention by avoiding the 
necessity for participants to return for additional appointments beyond those required for normal care. 
 
DATA COLLECTION FORMS FOR PRIMARY AND SECONDARY OUTCOMES 
Clinical and demographic data collection forms will be completed for each participant, and will be 
performed as per the standard care of the study site.  The investigators will perform all of the 
assessments. Data will be collected on the appropriate paper data collection forms as described below, 
and later transcribed into electronic databases.  
7.2.1 ELIGIBILITY CRITERIA CHECKLIST 
An Eligibility Criteria Checklist will be completed prior to seeking informed voluntary consent (24.3). 
7.2.2 DEMOGRAPHIC AND MEDICAL INFORMATION FORM 
Demographic and medical information will be obtained from each participant who is recruited to the 
study (see 15.4). This information will include, but is not limited to: 
 
 
• 
Age 
• 
Gender 
• 
Occupation 

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• 
Information pertinent to surgery and/or neuropsychological assessment (e.g. recreational 
activities) 
• 
Current medical status (e.g. diagnosis, side of injury) and co-morbidities (e.g. diabetes 
mellitus)  
• 
Medical History e.g. cerebrovascular disease, hypertension 
• 
History of current and previous medication, supplements 
7.2.3 DATA 
COLLECTION 
FORMS 
FOR 
PRIMARY 
AND 
SECONDARY 
HYPOTHESES 
Primary and secondary outcomes will be recorded for each participant on their data collection form. 
This form will include demographic, clinical and outcome data (24.4). The primary outcome to be 
measured is the incidence of Post-operative Cognitive Decline. This has been defined as a drop of 1 
standard deviation or more from baseline on 2 or more of the neuropsychological indices included. The 
secondary outcome to be measured is the incidence of cerebral desaturation as well as the importance 
of other key clinical variables (e.g. blood pressure, nausea, body fat etc).  
8 OUTCOME MEASURES  
 
COGNITIVE ASSESSMENT TOOLS  
8.1.1 NEUROPSYCHOLOGICAL TESTS 
Logical Memory (5 minutes) - impairment in perceptions of and/or psychometrically determined, 
immediate and delayed recall and recognition memory following surgery has been frequently noted 
in research examining POCD (Krenk et al., 2010; Salazar et al., 2013). Commonly used 
psychometrically viable tests are prose story memory recall and recognition tests. The prose story 
is administered at the beginning of the session and the immediate recall occurs straight after. 
Delayed recall for the story occurs after 20-30 minutes. The test-retest reliability, construct and 
convergent validity of this test has been proven time again, commonly rendering an adequate to 
good coefficient (Sullivan, 2005).   
Trails: Delis-Kaplan Executive Function System (10 minutes) - The D-KEFS was designed to 
detect even mild forms of executive dysfunction (Strauss et al., 2006). Executive dysfunction has 
been inadvertently linked with significant post-operative cognitive declines following surgery 
(Krenk, et. al., 2010). The D-KEFs Trails subtest has four trials; visual scanning, number 
sequencing, letter sequencing and letter number sequencing.  The internal and test-retest 
reliability, and convergent and predictive validity of the D-KEFS is consistently adequate to high, 
and this subtest in particular renders a good to high coefficient (Strauss, et al., 2006). 
Single Letter Verbal Fluency (1 minute) - Performance on brief verbal fluency tasks have been 
found to change pre- to post- surgery following cerebral desaturation events (Salazar et al., 2013). 
Aside from being a suitable assessment of both premorbid and current intellectual performance, 
tasks of verbal fluency examine spontaneous production of language and verbal associations. The 
task requires the individual to spontaneously generate a list of words in 60 seconds, where the 
words cannot be name of places, people or other proper nouns. A one-letter task is administered 
per package and has been found to be as valid as a three-letter fluency task (i.e. FAS or PGH; 

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Strauss, et al., 2006).  Verbal fluency tasks have been found to have high internal and test-retest 
reliability and adequate to high content, construct and predictive validity (Strauss, et al., 2006).  
Stroop Test Victoria’s Version (5 minutes) - The stroop task has three components. The first 
examines colour discrimination, selective attention and visual scanning. The second assesses 
word discrimination and selective attention. The third examines the ability to inhibit responses and 
cognitive flexibility, it requires an individual to verbalise the colour the word is written in, when the 
words are colours. This version of the Stroop test was selected for the purposes of large font size, 
a brief amount of items in comparison to other versions thus requiring less administration time. 
The reliability of the test is adequate and the test itself has been found to be sensitive enough to 
detect changes from baseline (Strauss, et al., 2006).  
List Learning – Rey Auditory Verbal Learning Test (RAVLT; 5-10 minutes) - Performance on a 
brief list-learning task has been found to change pre- to post- surgery following cerebral 
desaturation events (Salazar et al, 2013). Due to the poor validity and reliability of such a brief 
task, however, a full list-learning task is designed to be more sensitive to change as well as having 
a greater validity and reliability (Strauss, et al., 2006). The RAVLT assesses immediate and 
delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 
trials with a free recall after each presentation. The order of presentation remaining fixed across 
trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), 
following a free recall of that list. Immediately after this, delayed recall of the first list is tested. 
Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.  
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, fourth edition subtest 
(WAIS-IV), 5-10 minutes) - This particular subtest of the WAIS-IV assesses attention and 
concentration. The examinee is verbally presented with a combination of numbers and letters or 
increasing amounts. The examinee is required to recall the numbers in ascending order then 
letters in alphabetical order. The WAIS-IV as an overall measure is one of the most widely used 
tests of intelligence and has consistently rendered highly valid and reliable results. This subtest of 
the WAIS-IV has high internal consistency and adequate test-retest reliability (Strauss, et al., 
2006; Wechsler, 2008). 
8.1.2 PSYCHOLOGICAL MEASURES 
The following measures capture different aspects of psychological functioning including perceptions of 
cognitive impairment, mood and social participation. Psychological and social distress are known to 
influence performance on cognitive tests over and above that of any effects of POCD (e.g. Kizilbash, 
A. H., Vanderploeg, R. D., & Curtiss, G. (2002). Including these variables allows us to control for their 
influence in statistical analysis. There is evidence of increased risk of social disconnection when 
people face life changes and periods of vulnerability (Jones et al., 2011; Jetten, Haslam & Haslam, 
2012). Surgery involves a period of such vulnerability, which is why two very brief validated measures 
of this construct are included within the study (i.e., n=3 items). These have the capacity to be 
delivered face-to-face or online using iPad that will be provided. 
European Brain Injury Questionnaire (EBIQ) (10-15 minutes)- The European Brain Injury 
Questionnaire (EBIQ), is a self-report and relative-report measure of the subjective experience of 
cognitive, emotional and social difficulties experienced by people with any form of acquired brain 
injury (Teasdale et al., 1997). It is a clinically reliable measure that assesses change in subjective 
concerns in these areas over time (Sopena et al., 1997).   In the present study it will serve as a 
subjective index of cognitive change. The measure comprises 66 items rated on a 3-point scale 
(1=not at all to 3=a lot).     
Depression Anxiety and Stress Scale-21 (DASS-21; 3 minutes) - Depression, anxiety and 
stress both pre- and post- surgery have been shown to hinder recovery and increase the risk of 

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short- term and long-term complications (Tully et al., 2008). The DASS-21 has 21 questions that 
index the level of depression, anxiety and stress an individual has experienced in the pre- ceding 
week. It is a valid and reliable measure that is frequently used in clinical practice and research 
alike (Henry & Crawford, 2005).  
Social Relationships and Support (2 x 4-item scales; 3 minutes) - There is a vast 
epidemiological and medical evidence base showing the important role that social connectedness 
with others plays in health and recovery (Holt-Lunstad et al., 2010; Marmot, 2005;). Recent 
evidence shows that the nature of social participation with individuals and groups of others can 
make differential contributions to these outcomes. The social support measures we propose are 
those that been used more extensively in previous research to address the issues of social 
process in a range different clinical populations (e.g., Gleibs et al., 2011; Haslam et al., 2014; 
Jetten et al., 2010; Morton et al., 2015). 
Loneliness Scale (3 minutes) - People who are less connected socially also experience higher 
perceived loneliness and social isolation. To capture this, the study incorporates a standardised 3-
item Loneliness scale (Hughes et al., 2004) comprising items from the well-validated UCLA 
Loneliness scale (Russell et al., 1980). 
Total expected time for all cognitive assessment tools (including Pain 7.3 below): 45-60 minutes. All 
neuropsychological tests will be given in a counterbalanced order; with four different packages, 
randomly assigned at the four time points comprising the alternate versions of specific tests to 
manage practice effects. 
 
 CEREBRAL DESATURATION 
The incidence of cerebral desaturation events using both the INVOS™ and FORE-SIGHT® machines 
will be recorded on the data collection form. Cerebral desaturation will be defined as a decrease in 
rSO2 greater than, or equal to 20% from baseline or a fall below 50% absolute (after Murphy et al., 
2010; Salazar et al., 2013). 
We will use data capture software that will simultaneously provide a record from which we can 
determine the number, severity and length of CDEs from both INVOS and Foresight sensors plus MAP. 
Subanalyses performed on these may attempt to ascertain whether or not any of these factors are 
important. 
 
PAIN 
Pain is a common occurrence with any injury and a highly predominant outcome post-surgery (Mitchell, 
Adebajo, Hay, & Carr, 2005). To capture this; the study will incorporate a validated, analogue global 
pain scale (0-100; Williamson & Hoggart, 2005). Each increment is a Likert-type scale of 0-100, where 
“0” is no pain, “50” is moderate pain and “100” is the worst imaginable pain.  The participant will be 
asked to label which increment at which their current pain is falling.  
 
ADVERSE EVENTS  
Any adverse events arising during the trial will be closely monitored and followed up until the resolution 
of symptoms. These will be checked at each assessment stage and recorded on the data collection 
form (24.4). 

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9 CONFIDENTIALITY 
Information about study subjects will be kept confidential and managed accordingly to the requirement 
of Human Research as determined by the NHMRC, and the local ethics review board, in this case, the 
Bellberry Human Research Ethics Committee. 
All raw data forms will be kept in an individually identifiable format.  The data collection forms and the 
master participant list with patient names; contact details and a study specific number will be kept in a 
secure lockable cabinet at the Brisbane Hand and Upper Limb Research Institute.  All data will be 
transcribed in a re-identifiable format and analysed and reported in a non-identifiable format. 
10 DATA ANALYSIS 
Data will be transcribed from the participants data collection forms into excel spreadsheets in a re-
identifiable format.  Analysis will be performed with the assistance of a statistician and the statistical 
package used will be SPSS. 
 STATISTICAL METHODS 
Baseline demographic and clinical data will be examined using descriptive statistics (means, standard 
deviations [SDs], and percentages). Dropouts will be compared to those who complete the study. For 
initial data screening, descriptive statistics (means, standard deviations [SDs], and percentages) will be 
completed for all predictor and outcome variables.  Based on the findings of de Tournay - Jette et al. 
(2011), we assume that 62% of patients will not experience desaturation, and that the probability of 
postoperative cognitive dysfunction in these patients is 29%. To observe an increased risk of cognitive 
dysfunction of 1.75 times in patients who experienced desaturation (i.e. to 50%) we will be required to 
collect postoperative data on 193 participants, assuming alpha=0.05 and power=80%. For the 
secondary outcome, which is the concordance between the INVOS™ 5100 and FORE-SIGHT® devices 
during shoulder surgery, the agreement between these pairs of observations will be assessed using 
intra-class correlation (ICC 3,1) (Portney & Watkins,  1993). 
 
A number of statistical analyses will be used to explore the relationship between CDE and other study 
variables to allow for use of continuous and categorical data (e.g. linear & logistic regression). With an 
anticipated sample size of 200 this should provide adequate numbers for our analysis (Portney & 
Watkins, 1993). Prior to the use of a regression analysis, exploratory bivariate analyses (e.g. 
correlation, chi square, one-way ANOVA) will be conducted among all predictor variables to identify 
multi-collinearity.  Bivariate analyses between each predictor and outcome variable will then be 
conducted.  Significant predictor variables identified from bivariate analyses will be entered into the 
regression model.  A process of backward elimination will then be used to identify the best model 
considering main effects and two-way interactions at p≤ 0.05. Data analysis will be conducted using 
SSPS version 23. Any complication rates will be reported in terms of frequency and analysed. The 
potential contribution of type of surgery, the length of surgery and the nature of the anaesthetic agents 

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used are recorded as standard practice and will be included in analyses to assess whether or not they 
represent confounding factors. The final multivariable model will include the main effects of interest and 
variables identified as potential confounders. 
 
The type and duration of anaesthesia is being recorded (see 15.4). Although the choices of anaesthetic 
medications and techniques may affect the incidences of cerebral desaturation event, they do not have 
any impact on correlating cerebral desaturation events, should they occur, and the postoperative 
metrics we are seeking to measure other than the secondary outcomes of pain and postoperative 
nausea and vomiting.  By recording these additional data sets we will seek to ascertain any confounding 
effects they may have on the pain and postoperative nausea and vomiting but they will not be relevant 
to cerebral desaturation events since we are looking at the effects of the cerebral desaturation events 
rather than their incidence. 
11 RISK ANALYSIS 
Shoulder surgery in the BCP is routinely used in clinical practice.  Participants who agree to be part of 
the trial will experience no additional risks above those normally associated with this routine procedure. 
X-ray imaging is performed for some surgical procedures as the normal course of intraoperative patient 
care. Suspected adverse neurological outcomes associated with the surgery may require further 
imaging in the form of cerebral CT / MRI as is standard practice. Such imaging would be unrelated to 
the monitoring of cerebral oximetry. 
If a participant is found to be experiencing psychological distress (i.e. depression, anxiety or 
suicidality) or is found to have a significant cognitive impairment, the following procedures will be put 
in place. Psychological distress will be monitored initially through the psychological measures being 
used and will be administered by a clinical psychology trainee or other health professional. These 
measures are standardised and have recognised clinical cut-off criteria. The medical consultant in the 
project team will be informed of anyone meeting the criteria for at least mild to moderate levels of 
distress. As the medical consultant is responsible for the care of all patients, he will take responsibility 
for any onward referral or medical management as per standard clinical practice. A similar procedure 
will be followed in the case of significant cognitive impairment. The neuropsychological tests are 
standardised with norms provided to indicate possible impairment. The medical consultant will be 
informed of anyone meeting the criteria for mild to moderate impairment and this will managed as per 
standard clinical practice with referral for further assessment. Additionally, any mood- or cognitive-
related concerns raised by participants will be brought to the attention of the medical consultant.   
 
 
 
 
 

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12 BUDGET AND FUNDING IN-KIND SUPPORT 
 
13 DISSEMINATION 
Findings from this investigation will be disseminated locally through existing state and nation 
wide clinical networks and in-service education amongst relevant clinical teams (e.g. multi-disciplinary 
upper limb teams in hospital facilities).  
 
Research outcomes will also be disseminated widely through peer-reviewed publications as well as 
through local, national and/or international conferences. The proposed dissemination of these findings 
is likely to guide models of healthcare both nationally and internationally.  
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 
Source 
Details 
Costs to 
BHULRI & UQ 
1 
Investigator time & 
Research assistant 
BHULRI & UQ 
Protocol development, ethics, study 
assessments, participant follow-up, data 
entry, analysis, writing paper for publication, 
submission. 
In Kind 
2 
 INVOS™ 
monitors/sensors 
Supplier 
Standard monitors/sensors used at 
Brisbane Private Hospital for this population 
Nil  
3 
FORE-SIGHT® 
monitors/sensors 
Supplier 
Sufficient monitors/sensors to be provided 
for purpose of research 
Nil 

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14 CLINICAL INVESTIGATION PLAN SUMMARY- PART TWO 
TITLE 
Health professionals’ experiences of post-operative cognitive decline 
INVESTIGATORS 
Principal:  Associate Professor Mark Ross, Dr Phillip Duke, Dr David Gilpin, 
Dr Phil Melksham  
Associate: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms 
Louise Lee, Mr Glen Russell 
 
OBJECTIVES 
The general aim of the study is to understand what professionals experience 
and understand of POCD, and/or what they might expect to experience. 
STUDY DESIGN 
Descriptive Survey 
SITES 
Brisbane Private Hospital  
NUMBER OF 
SUBJECTS 
Approximately 200 participants will be recruited to this study.   
 
TARGET 
POPULATION 
Participants will be currently practicing medical, nursing and allied health 
practitioners.  
LENGTH OF 
CLINICAL 
INVESTIGATION 
It is anticipated that this study will require 6 months from commencement.  
 
OUTCOME 
Demographic data and outcome variables will be examined using descriptive 
statistics (means, standard deviations [SDs], and percentages). Factors 
examined will be: 
• 
Whether each individual clinician has encountered POCD in practice 
• 
 What cognitive functions were affected or what they would expect to 
see 
• 
The duration seen or expected 
• 
Whether there were any emotional symptoms or whether they would 
expect emotional symptoms 
• 
How it was managed or how they would expect it to be managed 
• 
What else could be done to manage POCD 
 
15 INTRODUCTION 
There are no published studies on the experiences of POCD from a health professionals’ perspective. 
With so many debates surrounding the nature and duration of POCD in the literature (e.g. Berger et al., 
2015), an understanding of experiences and expectations from the treating clinician’s perspectives 
would be an important supplement to the current research base. As a result the nature, duration, 
prevention techniques and management of POCD from a practicing clinicians’ perspective particularly, 
require further investigation. Further research in these areas indicated and the proposed study aims to 
address the issues raised here. 
 
 

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 LAYMAN’S SUMMARY 
As there is no existing literature base, it would be invaluable to examine POCD from a clinicians perspective, 
particularly surrounding the duration, current prevention techniques and management in a clinical setting. 
 PURPOSE OF THE INVESTIGATION 
The purpose of this investigation is to gain clinicians’ perspectives regarding the experience of POCD 
in Australian practice.  Currently, there is no existing literature base to suggest what clinicians encounter 
day to day in clinical practice and what is actually being done to manage POCD and possible 
psychological sequela. A clinician’s perspective would provide practical implications for the clinical 
stakeholders and their patients as well as for the management of POCD and potential for services.  
 INTERVENTION GROUPS  
The study will involve a descritpive survey. Clinicians who meet eligibility critieria will be able to 
complete the survery.   
 GENERAL AIM OF THE STUDY 
The general aim of the study is to understand what professionals experience and understand of POCD, 
and/or what they might expect to experience.  
 RESEARCH QUESTIONS 
STUDY TWO has five research questions, based on the perspective of practicing clinicians;   
(i) 
How many times has POCD been seen in a clinical setting? 
(ii) 
How often are psychological symptoms seen comorbidly with POCD? 
(iii) 
How POCD is currently managed in clinical practice? 
(iv) 
What are clinician perspectives on how POCD should be managed? 
(v) 
Does the experience of POCD differ between professions and clinical populations? 
 HYPOTHESES 
As this is a descriptive study no specific hypotheses have  
 STUDY TWO PARTICIPANT ELIGIBILITY CRITERIA 
15.7.1 INCLUSION CRITERIA  
Participants meeting the following inclusion criteria will be invited to participate in the study (see 15.1);  
• 
Over 18 years of age 
• 
Able to read and speak English 
• 
A clinician currently practicing in the fields of medicine, nursing or allied health 

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15.7.2 EXCLUSION CRITERIA 
Participants will be excluded from the study for the following reasons (see 15.1); 
• 
Under 18 years of age 
• 
Not currently registered with Australia Health Practitioner Regulation Association  
 RECRUITMENT 
The survey population will be recruited from The Brisbane Private Hospital. A link to complete the survey 
will be emailed through existing email lists associated with BHULRI.  
 SAMPLE SIZE 
As this is a descriptive study examining practicing clinicians perspectives of POCD no power analyses 
can be conducted.  
16 SCREENING /ENROLMENT 
Patients will be screened according to the selection criteria. Those who meet the selection criteria will 
be invited to complete the survey. After reviewing the Participant Information form (24.7) and 
acknowledging that they have understood the purpose of the study, their involvement, risks and 
benefits.  Any participant who refrains from participation will not be disadvantaged in any way.  
17 DATA COLLECTION 
 DATA COLLECTION FOR PRIMARY AND SECONDARY OUTCOMES 
Demographic data and survey data will be completed by each participant on an online database 
QUALTRICS.  
17.1.1 DEMOGRAPHIC AND MEDICAL INFORMATION FORM 
Demographic information will be obtained from each participant who agrees to participate in the survey. 
This information will include, but is not limited to:  
 
• 
Age 
• 
Gender 
• 
State 
• 
Profession 
• 
Level within that profession 
• 
Years in Clinical Practice 
• 
Client groups the participant works with (e.g. adult internal medicine, geriatric neurology) 
• 
Based in hospitals (e.g. public or private) or private practice. 

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18 OUTCOME MEASURES  
 SURVEY 
A survey has been designed and developed on Qualtrics to examine each individual clinician’s 
experiences of POCD in practice (24.6). The participant information sheet and consent form will be 
provided online at the beginning of the survey (24.7 & 24.8). The questions will identify whether each 
individual clinician has encountered POCD or not in practice. If they have encountered POCD in 
clinical practice follow up examination includes how many times they have encountered POCD, what 
cognitive functions were effected, the duration of POCD, were there any emotional symptoms, how it 
was managed and what else could have been done to manage POCD. If they have not previously 
encountered POCD in clinical practice follow up examination includes what cognitive functions they 
expect to be effected, would they expect emotional symptoms and how they might manage a patient 
experiencing POCD. The survey is expected to take 10 minutes to complete.  
 
19 CONFIDENTIALITY 
Information about study subjects will be kept confidential and managed accordingly to the requirement 
of Human Research as determined by the NHMRC, and the local ethics review board, in this case, the 
Bellberry Human Research Ethics Committee. 
All data will be downloaded in non-identifiable format from the Qualtrics Database and stored on 
securely on electronically on password-protected computers by the research team based at the 
Brisbane Hand and Upper Limb Research Institute, for purposes of analysis. 
20 DATA ANALYSIS 
Data will be downloaded directly from Qualtrics into an SPSS datasheet. Analysis will be performed 
with the assistance of a statistician and the statistical package used will be SPSS. 
 STATISTICAL METHODS 
As this is a descriptive study, demographic data and outcome variables will be examined using 
descriptive statistics (means, standard deviations [SDs], and percentages).  
21 RISK ANALYSIS 
This is a low risk study with no foreseeable risks.  
 
 

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22 BUDGET AND FUNDING IN-KIND SUPPORT 
 
23 DISSEMINATION 
Dissemination will be the same as study one (13). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 
Source 
Details 
Costs to 
BHULRI & UQ 
1 
Investigator time & 
Research assistant 
BHULRI & UQ 
Protocol development, ethics, data entry, 
analysis, writing paper for publication, 
submission. 
In Kind 

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M. (2010). Cerebral oxygen desaturation events assessed by near-infrared spectroscopy 
during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesthesia & 
Analgesia, 111(2), 496-505. 
Parra, V. M., Sadurni, M., Donate, M., Rovira, I., Roux, C., Ríos, J., & Fita, G. (2011). 
[Neuropsychological dysfunction after cardiac surgery: Cerebral saturation and bispectral 
index: A longitudinal study]. Revista medica de Chile, 139(12), 1553-1561. 
Pohl, A., & Cullen, D. J. (2005). Cerebral ischemia during shoulder surgery in the upright position: a 
case series. Journal of clinical anesthesia, 17(6), 463-469. 
Portney, L. G. & Watkins, M.P. (1993). Foundations of clinical research. Aplications to practice. 
Appleton & Lange, Stamford.  
Russell, Dan; Peplau, Letitia A.; Cutrona, Carolyn E. The Revised UCLA Loneliness Scale: Concurrent 
and Discriminant Validity Evidence. Journal of Personality and Social Psychology 
1980;39:472–80. 
Salazar, D., Sears, B. W., Aghdasi, B., Francois, A., Tonino, P., & Marra, G. (2013). Cerebral 
desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors 
and neurocognitive effects. Journal of Shoulder and Elbow Surgery, 22(9), 1228-1235. 
Sopena S., Dewar B.K., Nannery R., Teasdale T.W. & Wilson B.A. (2007). The European Brain Injury 
Questionnaire (EBIQ) as a reliable outcome measure for use with people with brain injury. Brain 
Inj. 21(10):1063-8. 
Strauss, E., Sherman, E. M., & Spreen, O. (2006). A compendium of neuropsychological tests: 
Administration, norms, and commentary. Oxford University Press, USA. 
Sullivan, K. (2005). Alternate forms of prose passages for the assessment of auditory-verbal memory. 
Archives of Clinical Neuropsychology, (20): 745-753. 
de Tournay-Jetté, E., Dupuis, G., Bherer, L., Deschamps, A., Cartier, R., & Denault, A. (2011). The 
relationship between cerebral oxygen saturation changes and postoperative cognitive 
dysfunction in elderly patients after coronary artery bypass graft surgery. Journal of 
cardiothoracic and vascular anesthesia, 25(1), 95-104. 

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Tully, P. J., Baker, R. A., Turnbull, D., & Winefield, H. (2008). The role of depression and anxiety 
symptoms 
in 
hospital 
readmissions 
after 
cardiac 
surgery. Journal 
of 
behavioral 
medicine, 31(4), 281-29. 
Wechsler, D. (2008). Wechsler adult intelligence scale–Fourth Edition (WAIS–IV). San Antonio, TX: 
NCS Pearson. 
Williamson, A., & Hoggart, B. (2005). Pain: a review of three commonly used pain rating scales. 
Journal of Clinical Nursing, 14(7), 798-804. doi: 10.1111/j.1365-2702.2005.01121.x 
Zheng, F., Sheinberg, R., Yee, M. S., Ono, M., Zheng, Y., & Hogue, C. W. (2013). Cerebral Near-
Infrared Spectroscopy (NIRS) monitoring and neurologic outcomes in adult cardiac surgery 
patients and neurologic outcomes: a systematic review. Anesthesia and analgesia, 116(3)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 Eligibility Checklist 
Does the patient meet the following inclusion criteria? 
1. Able to read and speak English                                           □ 
2. Over 18 years of age                                                            □ 
3. Requires shoulder surgery in the Beach Chair position       □ 
 
Does the patient have any other clinical characteristics requiring exclusion from the study?  
Exclusion Criteria 
Yes  
No 
Under 18 years of age 
 
 
Pre- operative Mini-Mental State Examination 
(MMSE) < 24    
 
 
Pre-existing Cerebrovascular Disease                      
 
Orthostatic hypotension                                             
 
ASA physical status IV and V*                                   
 
History of drug and/or alcohol abuse                         
 
Unstable mental health condition                               
 
Neurological disease (e.g. previous stroke)              
 
Currently pregnant or suspected to be pregnant 
 
 
 
ASA = the American Society of Anaesthesiologists physical status classification system. Level IV 
indicates the presence of severe systemic disease that is a threat to life. Level V is a moribund person 
who is not expected to survive without some form of surgery. 
 
24.1.1 PARTICIPANT ELIGIBILITY CRITERIA 
INCLUSION CRITERIA  
Patients meeting the following inclusion criteria will be invited to participate in the study (see 14.1);  
• Have a shoulder condition for which surgery in the BCP is appropriate. 
• Over 18 years of age 
• Able to read and speak English 
EXCLUSION CRITERIA 
Patients will be excluded from the study for the following reasons (see 14.1); 
• 
Under 18 years of age 
• 
Pregnant women 
• 
Pre- operative Mini-Mental State Examination (MMSE) < 24  

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• 
Pre-existing cerebrovascular disease as reported by the assessing medical consultant 
and recorded in patient charts  
• 
Orthostatic hypotension 
• 
ASA physical status IV and V*  
• 
History of drug and/or alcohol abuse  
• 
Neurological disease (e.g. previous stroke) 
• 
Significant mood and anxiety disorders as determined by treating consultant 
• 
Any other condition, which in the opinion of the investigators, would render the patient 
unsuitable for participation in the study 
* ASA = the American Society of Anaesthesiologists physical status classification system. Level IV 
indicates the presence of severe systemic disease that is a threat to life. Level V is a moribund person 
who is not expected to survive without some form of surgery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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24.2 Participant Information Form 
 
Participant Information Form 
Brisbane Private Hospital 
 
 
Project Title:  
Prediction of cognitive decline following shoulder surgery in the beach chair 
position: the value of cerebral oximetry. 
 
You are being advised of this research because you have decided to undergo shoulder surgery in the 
Beach Chair Position (BCP). You are being asked to take part in a study evaluating the use of cerebral 
(brain) oxygen monitors in shoulder surgery to predict and potentially prevent what is known as post-
operative cognitive decline (i.e. memory and thinking problems) that occurs in a very small number of 
people. This Study is being conducted by The Brisbane Hand & Upper Limb Research Institute in 
conjunction with the University of Queensland.   
 
Who is doing the Research? 
Primary Investigators:  
 
 
 
 
Associate Professor Mark Ross 
 
Orthopaedic Surgeon  
 
 
 
 
Dr Phillip Duke 
 
 
 
 
Orthopaedic Surgeon 
 
 
 
 
Dr David Gilpin 
 
 
 
 
Orthopaedic Surgeon 
Dr Phillip Melksham 
 
 
 
Anaesthetist 
 
The primary investigatory team comprises staff of the Brisbane Private Hospital (BPH) and the 
University of Queensland (UQ). The including consultant orthopaedic surgeons, A/Prof Ross (BPH, 
UQ) and Dr’s Duke and Gilpin, and an anaesthetist, Dr Melksham. 
 
Associate Investigators: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms Louise Lee, 
Mr Glen Russell 
Contact:  
 
 
Dr Silvia Manzanero 
 
 
 
 
 
 
 
 
Research Manager 
 
 
 
 
Phone: (07) 3834 7069  
 
 
 
 
 
 
 
Email:  researchmanager@upperlimb.com  
 
What does this form tell me?  
 
This is an important form. Please read it carefully. This form tells you about the research project. It 
explains the procedures involved. Knowing what is involved will help you decide if you want to take part 
in the research.  If you agree to take part in this study, you need to sign this form.  Your signature means 
that you have been told about the study and what the risks are.  Your signature on this form also means 
that you want to take part in this study.  This form or the consent form may contain words that you do 
not understand.  Please ask the study doctor or study staff to explain any words or information that you 
do not clearly understand. Participation in this research is voluntary. If you don’t wish to take part, you 
don’t have to. You will receive the best possible care whether you take part or not.  If you decide you 
want to take part in the research project, you will be asked to sign the consent section. By signing it you 
are telling us that you: 
• understand what you have read;  
• consent to take part in the research project; 
• consent to participate in the research processes that are described; 
• consent to the use of your personal and health information as described. 
 

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What is the purpose of this research project? 
Surgery to the shoulder may be performed with patients seated upright in a position known as the 
“Beach Chair Position (BCP).”  This position has certain advantages compared to other surgical 
positions (e.g. side lying) in some situations.  However, it has been found that surgery in the BCP can 
temporarily decrease the amount of oxygen found in the brain as a result of the combined effects of 
gravity and anesthesia. Occasionally, this has been associated with some mild memory loss and 
confusion. As a result, the use of a “cerebral oxygen monitor” (a machine that measures oxygen content 
in the brain) during shoulder surgery in the BCP has become part of standard care.  Before and during 
surgery, a monitor placed on the your forehead measures the amount of oxygen present in the brain to 
help control this to an acceptable level.  A number of monitors are now commercially available. 
However, the actual relationship between the supply of oxygen to the brain during surgery and the 
chance of later developing problems with memory and thinking (known as “post operative cognitive 
decline” – POCD) is not clear.  It is also not known if one monitor is more accurate than another at 
predicting these. Therefore, this study will examine the relationship between brain oxygen levels during 
shoulder surgery and the incidence of POCD (problems with memory and thinking).  A second aim is 
to compare two commonly used oxygen monitors as well as the importance of other key clinical 
variables (e.g. blood pressure, nausea, body fat etc). Two sets of adhesive sensors, (one set from each 
of the two monitors we are comparing), will be placed on your forehead to allow us to compare them.  
 
What does participation in this research project involve? 
We aim to recruit approximately 200 people for this study. Your part in the project will involve you an 
assessment of emotional status, memory and concentration using pen and paper and verbal tasks. The 
measures of your emotional status are being taken, as this too can sometimes be associated with 
changes memory and concentration. These tasks take approximately an hour of your time to complete 
and you will be asked to complete them at five time points (the day before surgery, day one, between 
ten and fourteen days post-surgery, at one month post-surgery and at 3 months). Should you agree to 
participate in the project, we will organize for these post-operative assessments to take place alongside 
your usual follow up visits with your Orthopaedic surgeon. You will not be paid to take part in this 
research. You will not be required to pay for any time spent completing the tests involved in this study, 
specifically there will be no extra costs to you outside of what would be normal for your usual follow up 
assessment. It is important for you to understand that there will be questions relating to your mood and 
feelings including sensitive information about possible depression and suicidality. As participation is 
voluntary, you do not have to answer these questions if you find them upsetting.  
 
What are the possible benefits? 
We cannot guarantee or promise that you will receive any benefits from this research. However, you 
will be provided with feedback about the results of the assessments should you wish. The findings from 
this research will add to our existing knowledge base and may benefit patients in the future.  
 
What are the possible risks? 
There are no anticipated risks involved with participating in this study beyond the inconvenience 
associated with time required to complete the assessments.  
 
If you have any concerns about possible cognitive changes after surgery, these will be brought to the 
immediate attention of your medical consultant for management (which could involve an appointment 
with your consultant and in some cases, the possibility of referral for further investigation).  
 
Do I have to take part in this research project? 
Participation in the research project is voluntary. If you do not wish to take part you don’t have to. If you 
decide to take part and later change your mind, you are free to withdraw from the project at any stage. 
Your decision whether to take part or not to take part will not affect your ongoing treatment in any way 
at The Brisbane Private Hospital.  

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How will I be informed of the results of this research project? 
You can be informed of the final results of the research if you wish. Your individual results will not be 
provided to you. If you would like to learn the outcome of the study, a summary of results from the study 
will be published on our website (www.upperlimb.com) at the conclusion of the study which is expected 
to be in 2019. 
 
What will happen to information about me? 
Any information obtained in connection with this research project, which can identify you, will remain 
confidential and will only be used for the purpose of this research project. It will only be disclosed with 
your permission, except as required by law. Your data will be stored securely on-site at the Brisbane 
Hand and Upper Limb Research Institute Office, Brisbane Private Hospital. The investigators in this 
study will also use information from your medical records.  
 
Data from this study may be published in journals or books and may be used for educational purposes 
or presentations. However, your name and other identifying information will not be used.   
 
How can I access my information? 
In accordance with relevant Australian privacy laws, you have the right to access the information 
collected and stored by the researchers about you. You also have the right to request that any 
information, with which you disagree, be corrected. Please contact one of the researchers if you would 
like to access your information. 
 
Is this research project approved? 
The ethical aspects of this research project have been approved by Bellberry HREC.  This project will 
be carried out according to the National Statement on Ethical Conduct in Human Research (2007) 
produced by the National Health and Medical Research Council of Australia. This statement has been 
developed to protect the interests of people who agree to participate in human research studies. 
 
COMPENSATION for Injury 
If, as a result of your participation in this study, you become ill or injured, immediately advise your study 
doctor of your condition. In the first instance your study doctor will evaluate your condition and then 
discuss treatment with both you and your regular treating doctor. Since you are participating in a non-
sponsored study any question about compensation must initially be directed to your study doctor who 
should advise their insurer of the matter. It is the recommendation of the independent ethics committee 
responsible for the review of this study that you seek independent legal advice.  
 
Advice and Information 
If you have any further questions regarding this study please do not hesitate to contact Dr Silvia 
Manzanero on (07) 38347069. If you have any questions regarding ethics, please contact Bellberry 
HREC on (08) 8361 3222.  
 
 
 
 
 
 
 
 
 
 

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24.3 Participant Consent Form 
 
Participant Informed Consent Form - Brisbane Private Hospital 
Project Title:  Prediction of cognitive decline following shoulder surgery in the beach 
chair position: the value of cerebral oximetry. 
• 
I am over 18 years old. 
• 
I have read this document and I understand the purposes, procedures and risks of this 
research project. 
• 
I have given permission for access to my medical records, for the purpose of this 
research.  
• 
I give permission for my GP to be informed of my participation in the study and be 
provided with any relevant clinical information. 
• 
I give permission for my doctors, other health professionals, hospitals or laboratories 
outside this hospital to release information to the Brisbane Hand and Upper Limb Research 
Institute concerning my treatment that is needed for this project. I understand that such 
information will remain confidential and will be safe-guarded.  
• 
I have had an opportunity to ask questions and I am satisfied with the answers I have 
received. 
• 
I understand that my results will remain confidential, and that my data will be kept at the 
Brisbane Hand and Upper Limb Research Institute. 
• 
I freely agree to participate in this research project.  
 
• 
I understand that I am free to withdraw at any time. 
• 
I understand that if I do withdraw or decline to participate, this will have no impact on the 
treatment I receive. 
• 
I understand that I will be given a signed copy of this document to keep. 
 
 
 
 
 
 
Participant’s name (printed) …………………………………………………… 
Signature 
 
 
 
 
 
 
 
Date 
 
Declaration by researcher*: I have given a verbal explanation of the research project, its procedures and 
risks and I believe that the participant has understood that explanation. 
Researcher’s name (printed) …………………………………………………… 
Signature 
 
 
 
 
 
 
 
Date 

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24.4 Data Collection Form 
 
Data Collection Form – Cerebral Perfusion Beach Chair Position  
Patient Identifier: 
Surgeon: 
Date of Surgery: 
Investigator to Complete 
Date of Assessment: Pre-op:                Day 1:             Day 10-14:           1 month:                  3 months: 
Gender: Male □   
Female □ 
Date of Birth: 
Age: 
Height:                       
(cm) 
Weight:                         (kg) 
BMI:  
Operative Side: Left   □                   Right   □            
Dominance:    Left □             Right   □         Ambidextrous □ 
Occupation:(Please note previous occupation of retired participants)  
Current work status:    Part time ☐        Full time ☐           Other (e.g. voluntary work): 
Recreational activities (including sports): 
 

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Primary Diagnosis (check 
one) 
□ OA 
□ Trauma a) Mechanism - 
             
                b) Date of Injury –  
 
□ Chronic Condition 
□ Other, specify –  
 
Presenting Symptoms (select yes or no) 
 
Pain 
Weakness 
Decreased 
motion 
Instability 
Impaired 
sensation 
Other 
Yes 
 
 
 
 
 
 
No 
 
 
 
 
 
 
 
Current treatments: 
• 
Therapy – 
 
• 
Medications – 
 
• 
Other (including supplements)- 
 
Co-morbidity 
□Current smoker               □    Genitourinary disorder ________________________________________     
□Past smoker                    □    Haematological disorder _______________________________________ 
□Type 1 Diabetes              □    Cardiovascular disorder _______________________________________ 
□Type II Diabetes              □   Gastrointestinal Disorder _______________________________________    
□Osteoporosis                   □  Respiratory Disorder      ________________________________________    
□High blood pressure        □   Mental Health Condition ________________________________________ 
□Low blood pressure         □  Endocrine/metabolic disorder ___________________________________ 
                                           □   Other (please specify) ________________________________________ 
                        

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Medical/Surgical history: 
 
                                                                                                                      
 
 
 
 
Cognitive Testing  
Assessment 
Pre-op 
Day 1 
Day 10-14 
1 month 
3 months 
MMSE (pre-
op only) 
x 
 
Logical 
memory test 
x 
x 
x 
x 
x 
Trail making 
test 
x 
x 
x 
x 
x 
Single letter 
verbal fluency 
x 
x 
x 
x 
x 
Stroop test 
x 
x 
x 
x 
x 
List learning 
x 
x 
x 
x 
x 
Letter-number 
sequencing 
x 
x 
x 
x 
x 
EBIQ 
x 
x 
x 
x 
x 
Depression 
anxiety stress 
x 
x 
x 
x 
x 
Social 
support 
x 
x 
x 
x 
x 
Loneliness 
scale 
x 
x 
x 
x 
x 
Surgical Record  

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Type of Shoulder 
Surgery 
BCP:  □                                        Other: □ 
Duration of 
Surgery 
Time (hh:mm)  
Beach Chair 
Angle 
 
 
What angle was used? 
Was this altered at all during surgery? Yes  □        No □ 
If so how?____________________________________________________ 
Cerebral O2 
1. What was baseline cerebral O2?  
2. Did cerebral O2 drop >20% from baseline?  Yes  □  No □       
             If yes how many occasions and duration/occasion?                                       
_____________________________ 
3. Did cerebral O2 drop < absolute value of 50%? Yes  □  No □ 
If yes how many occasions and duration/occasion? 
_____________________________ 
4. What was the average cerebral O2 over the entire 
procedure?_____________________________________________ 
Mean Arterial 
Blood Pressure  
What was the mean arterial blood pressure range during surgery?____________ 
Did the mean arterial blood pressure drop significantly during surgery? Yes□ No□ 
If yes how much did this drop?___________________________________ 
Adverse Events 
Were any complications experienced during surgery? Yes  □  No □ 
If yes please specify____________________________________________ 
____________________________________________________________ 
Duration of 
Anaesthetic 
How long was the patient anaesthetised? hh:mm 
__________________________ 
Anaesthetic 
medication 
What medications were used during surgery and what doses were given? 
1. 
2. 
3. 
4. 
Intraoperative 
Drug Record 
What medications (other than anaesthetics) were used during the surgery and 
what doses were given? 
1. 
2. 
3. 

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____________________________ 
 
 
 
 
INVESTIGATOR SIGNATURE 
 
 
 
 
 
 
 
 
 
4. 
Perioperative 
Drug Record 
What medications (other than anaesthetics) were provided before and/or after the 
surgery and what doses were given? 
1. 
2. 
3. 
4. 
Post -Operative Record 
Analgesic Protocol 
Medications used:- 
Nausea 
Yes  □  No □  
Vomiting 
Yes  □  No □  Frequency _________ 
Length of Hospital Stay 
 

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24.5 Participant Withdrawal Form 
 
Participant Withdrawal Form - Brisbane Private Hospital 
Project Title:  Prediction of cognitive decline following shoulder surgery in the beach 
chair position: the value of cerebral oximetry.  
Protocol Number: HREC2015-12-832 
Primary Investigators: Associate Professor Mark Ross, Dr Phillip Duke, Dr David Gilpin, 
Dr Phil Melksham 
Associate Investigator: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms 
Louise Lee, Mr Glen Russell 
 
Declaration by Participant 
I wish to withdraw from participation in the above research project and understand that such 
withdrawal will not affect my routine treatment, my relationship with those treating me or my 
relationship with Brisbane Hand & Upper Limb Research Institute. 
Name of Participant (please print) 
Signature 
Date 
In the event that the participant’s decision to withdraw is communicated verbally, the Study 
Doctor/Senior Researcher will need to provide a description of the circumstances below. 
 
 
 
 
Declaration by Study Doctor/Senior Researcher† 
I have given a verbal explanation of the implications of withdrawal from the research project and I 
believe that the participant has understood that explanation. 
Name of Study Doctor/ Senior 
Researcher† (please print) 
 
Signature 
Date 
† A senior member of the research team must provide the explanation of and information concerning 
withdrawal from the research project. 
Note: All parties signing the consent section must date their own signature. 

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24.6 Participant Survey – STUDY TWO 
 
HEALTH PROFESSIONALS’ EXPERIENCES OF POST OPERATIVE COGNITIVE DECLINE 
 
PROFESSIONAL BACKGROUND  
 
The following questions are about you and your profession. 
 
 
Age:  ______ 
 
Gender:  
 
 
 
Male 
 
   
 
 
Female  
   
 
State: 
Queensland 
 
 
      
New South Wales     
 
     
Victoria  
 
 
   
South Australia  
 
   
Canberra 
 
 
      
Western Australia     
 
     
Tasmania 
 
 
   
Other:   
 
 
 
 
What is your profession?  
Medical   
 
 
 
    
Area:  _____________ 
Nursing  
 
 
 
 
       
Psychology  
 
 
 
 
   
Neuropsychology  
 
 
      
Occupational Therapy      
 
 
     
Speech Pathology 
 
 
 
   
Physiotherapy 
 
 
 
 
   
Other 
 
 
 
 
 
 
 
What level are you currently in your profession? _________ (e.g. interns, registrar, fellow, professor)  
 
 
How senior is your position in your current organization:  
Very senior 
 
Senior 
 
Intermediate 
 
Junior 
 
Very junior  
 
 
How many years have you been in clinical practice (years)?  
≤1 
            
1-3 
   
4-7  
          
 
8-10 
 
≥10 
 
 
 

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How long have you worked for your current organisation? _________ (weeks/months/years) 
 
       
Who is your employer?  
Public Sector 
 
Private Sector 
 
Private Practice  
 
University 
 
Multiple 
 
 
What population(s) do you currently work with? 
Paediatric 
 
Adult 
 
Geriatric  
 
In which areas (e.g. surgical, neurology, internal medicine, allied health): _________________ 
 
Postoperative cognitive dysfunction (POCD) is a decline in cognitive function more typically seen after a few 
days to several months following surgery, but can last for several years.. It is distinct from delirium, which only 
occurs within the first few days. The decline in cognitive function is not attributed to any adverse complications 
and occurs peri-operatively. What we would like to know is your experiences of POCD in a clinical setting.  
 
1. Have you encountered POCD before?  
YES 
 
NO 
 
If you answered yes please complete questions 2 to 9. If you answered no please go to question 10. 
 
2. How many times have you encountered it? _________ (number) 
 
 
3. What cognitive functions were impacted? If you have seen more than one case of POCD, identify all the areas 
that were affected across the people you have seen: 
Short Term Memory 
 
Long Term Memory 
 
Attention/ Working Memory  
 
Planning/Organisation 
 
Inhibition 
 
Initiation 
 
Self-monitoring 
 
Emotional Control 
 
Gross and Fine Motor Control 
 
Language 
 
Learning 
 
 
 
4. For the problems you identified, please number them in order of the general impact you felt this had on the 
person’s (or people, if you have encountered more than one case) everyday functioning from 1= least impactful 
to 5 = most impactful.  
Short Term Memory 
 
Long Term Memory 
 
Attention/ Working Memory  
 
Planning/Organisation 
 
Inhibition 
 
Initiation 
 
Self-monitoring 
 
Emotional Control 
 

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Gross and Fine Motor Control 
 
Language 
 
Learning 
 
5. How long did the POCD last? 
3-7 days 
 
8-28 days 
 
4-6 weeks  
 
6 weeks to 3 months 
 
>3 months 
 
>12 months 
 
Unknown 
 
 
6. Did people experience any associated emotional changes? Please tick all that apply 
Low mood 
 
Nervousness/Worry 
 
Panic  
 
Stress 
 
Fatigue 
 
Change in sleep 
 
Irritability 
 
Weight gain/loss 
 
Change in appetite  
 
Excessive crying 
 
Poor concentration  
 
Restlessness 
 
None 
 
 
 
7. How was the POCD and/or emotional changes managed? 
No additional intervention to treatment-as-usual  
 
It was monitored 
  
 
 
Assessment 
  
 
 
Brief screen (e.g. MMSE) 
Full Cognitive Battery 
   
Referral 
  
 
 
Clinical Psychologist 
  
Neuropsychologist 
  
Speech Therapist 
  
Occupational Therapist  
Neurologist 
  
Other professional 
  
Other: ______________________ 
 
 
8. In your opinion could anything else have been done to manage the cognitive and/or mood 
symptoms?____________________ 
 
 
9. If you have any additional information you would like to share about POCD or to provide comments on the 
survey, please do so here. _________________________ 
 
 
 
 

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10. Given the nature of POCD as described above, what  cognitive functions do you feel might be vulnerable? 
Please rank these in order from the 1=most likely to 5= least likely: 
Short Term Memory 
 
Long Term Memory 
 
Attention/ Working Memory  
 
Planning/Organisation 
 
Inhibition 
 
Initiation 
 
Self-monitoring 
 
Emotional Control 
 
Gross and Fine Motor Control 
 
Language 
 
Learning 
 
 
 
11. Would you anticipate changes to emotional functioning? If so, what might you expect to see? Please rank 
these in order from the 1=most likely to 5= least likely 
Low mood 
 
Nervousness/Worry 
 
Panic  
 
Stress 
 
Fatigue 
 
Change in sleep 
 
Irritability 
 
Weight gain/loss 
 
Change in appetite  
 
Excessive crying 
 
Poor concentration  
 
Restlessness 
 
None 
 
 
 
12. In your opinion, how do you feel POCD should be managed? 
No additional intervention to treatment-as-usual 
 
Monitor the POCD 
 
Provide Assessment 
 
Brief screen (e.g. MMSE) 
Full Cognitive Battery 
   
Further Referral 
 
Clinical Psychologist 
  
Neuropsychologist 
  
Speech Therapist 
  
Occupational Therapist  
Neurologist 
  
Other professional 
  
Other: ______________________ 
 
 
9. Any other comments_________________________ 
 
Thank you for your participation. If you would like to know the outcome of the survey please email 
researchmanager@upperlimb.com otherwise a summary of results from the study will be finalized and 
published on our website (www.upperlimb.com) in 2019.   
24.7  Participant Information Form – STUDY TWO 

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Participant Information Form 
 
 
Project Title:  
Health professionals’ experiences of post operative cognitive decline 
 
You are being advised of this research, as you are a provisional or qualified professional who are 
currently employed within the field of medicine, nursing or allied health. You are being asked to take 
part in a study exploring health professionals’ experiences of post operative cognitive decline in a 
clinical setting.  
 
 
Who is doing the Research? 
Primary Investigators: Associate Professor Mark Ross, Ms Sarah Graham, Dr Phillip Duke, Dr 
David Gilpin, Dr Phil Melksham, Professor Catherine Haslam 
Associate Investigators: Dr Silvia Manzanero, Ms Ruby Strauss, Ms Chelsea Duke, Ms Louise Lee, 
Mr Glen Russell 
Contact:  
 
 
 
 
Dr Silvia Manzanero  
 
 
 
 
Research Manager 
 
 
 
 
Phone: (07) 3834 7069  
 
 
 
 
 
 
 
Email:  researchmanager@upperlimb.com  
 
What does this form tell me?  
 
This is an important form. Please read it carefully. This form tells you about the research project. It 
explains the procedures involved. Knowing what is involved will help you decide if you want to take part 
in the research.  If you agree to take part in this study, you need to sign this form.  Your signature means 
that you have been told about the study and what the risks are.  Your signature on this form also means 
that you want to take part in this study.  This form or the consent form may contain words that you do 
not understand.  Please ask the study doctor or study staff to explain any words or information that you 
do not clearly understand. Participation in this research is voluntary. If you don’t wish to take part, you 
don’t have to. You will receive the best possible care whether you take part or not.  If you decide you 
want to take part in the research project, you will be asked to sign the consent section. By signing it you 
are telling us that you: 
• understand what you have read;  
• consent to take part in the research project; 
• consent to participate in the research processes that are described; 
• consent to the use of your personal and health information as described. 
 
What is the purpose of this research project? 
Postoperative cognitive dysfunction (POCD) is a decline in cognitive dysfunction more typically seen 
after a few days to several months following surgery, but can last for several years. It is distinct from 
delirium, which only occurs within the first few days. The decline in cognitive function is not attributed 
to any adverse complications and occurs peri-operatively. There are a number of debates however, 
within the POCD literature, particularly where the duration of decline and assessment are concerned. 
What we would like to know is a health professional’s experiences of POCD in a clinical setting.  
 
 
What does participation in this research project involve? 
Your part in the project will involve completing an online survey, which will take approximately 10 

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minutes of your time. You will not be paid to take part in this research. There will be no cost to you if 
you decide to complete this study.  
 
What are the possible benefits? 
We cannot guarantee or promise that you will receive any benefits from this research. However, you 
will be provided with feedback about the results of the assessments should you wish. The findings from 
this research will add to our existing knowledge base and may benefit patients in the future.  
 
What are the possible risks? 
There are no anticipated risks involved with participating in this survey beyond the inconvenience 
associated with time required to complete the assessments.  
 
Do I have to take part in this research project? 
Participation in the research project is voluntary. If you do not wish to take part you don’t have to. If you 
decide to take part and later change your mind, you are free to withdraw from the project at any stage.  
 
How will I be informed of the results of this research project? 
You can be informed of the final results of the research if you wish. Your individual results will not be 
provided to you. If you would like to learn the outcome of the study, a summary of results from the study 
will be finalized in 2019.   
 
What will happen to information about me? 
Any information obtained in connection with this research project, which can identify you, will remain 
confidential and will only be used for the purpose of this research project. Your data will be stored 
securely on-site at the electronically on password-protected computers by the research team based at 
the Brisbane Hand and Upper Limb Research Institute, for purposes of analysis. Non-identifiable data 
from this study may be published in journals or books and may be used for educational purposes or 
presentations.  
 
How can I access my information? 
In accordance with relevant Australian privacy laws, you have the right to access the information 
collected and stored by the researchers about you. You also have the right to request that any 
information, with which you disagree, be corrected. Please contact one of the researchers if you would 
like to access your information. 
 
Is this research project approved? 
The ethical aspects of this research project have been approved by Bellberry HREC.  This project will 
be carried out according to the National Statement on Ethical Conduct in Human Research (2007) 
produced by the National Health and Medical Research Council of Australia. This statement has been 
developed to protect the interests of people who agree to participate in human research studies. 
 
Advice and Information 
If you have any further questions regarding this study please do not hesitate to contact Dr Silvia 
Manzanero on (07) 38347069. If you have any questions regarding ethics, please contact Bellberry 
HREC on (08) 8361 3222.  
 
 
 
 
 
 
 
 

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24.8 Participant Consent Form – STUDY TWO 
Participant Informed Consent Form  
Project Title:  Health professionals’ experiences of post-operative cognitive decline 
• 
I am over 18 years old. 
• 
I have read this document and I understand the purposes, procedures and risks of this 
research project. 
• 
I understand that my results will remain confidential, and that my data will be kept at the 
Brisbane Hand and Upper Limb Research Institute for the Duration of this Study. 
• 
I freely agree to participate in this research project.  
 
• 
I understand that I am free to withdraw at any time. 
 
 
 
 
 
YES 
 
