Virtual Reality for Pain Management in Orthopaedic Patients: A Prospective Randomized Control Pilot Study
Phase: NA
Conditions: Pain, Musculoskeletal
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Marilyn Heng MD, MPH, FRCSC  
 
PROTOCOL TITLE 
Virtual Reality for Pain Management in Orthopaedic Patients: A Prospective 
Randomized Control Study 
 
FUNDING 
Orthopedic Trauma Association  
 
VERSION DATE 
8/13/20 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
1. We will determine the feasibility of a virtual reality pain control 
program (VR-PCP) as a non-pharmacologic adjunct for pain 
management while in the hospital (i.e. patient ability and willingness 
to use the system measured by average time spent on the device). 
2. We will evaluate if there is a difference between the average daily use 
of opioid medications taken by patients who received usual care pain 
management versus patients using a VR-PCP. 
3. We will assess for differences in short-term postoperative patient-
reported pain intensity (PROMIS Patient Intensity v1.0) for patients 
who received usual care pain management versus those who also have 
access to a VR-PCP. 
 
Null Hypothesis: The use of a virtual reality pain control program does not 
decrease opioid pain medication consumption by patients during 
hospitalization after fracture fixation compared to patients who do not use 
VR. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
Orthopedic surgeons rank third amongst physician prescribers of opioids to 
adults in the United States4. The deleterious effects of the opioid epidemic 
have been well studied at both the individual and population level.2 3 
Orthopaedic trauma patients in particular have high rates of psychological 
stress and disability related to protracted narcotic usage 5. However, opioid 
medications may not need to be the mainstay of pharmacologic pain 

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Version Date:  October 15, 2014 
 
  
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management for patients with orthopaedic injuries. For example, one recent 
study from the Netherlands showed that 82% of patients with ankle 
fractures treated in the United States were prescribed opioids at discharge, 
whereas only 6% of Dutch patients were given narcotics. 6 
 
Non-pharmacologic interventions for pain management in the acute 
orthopaedic injury setting deserve full investigation. Virtual reality for pain 
management has been used in burn patients, pediatric patients, for 
procedures under local anesthesia and in the chronic pain setting. Results of 
these investigations are promising and demonstrate reduced narcotic usage 
and improved pain scores.7 8 9 Currently, there are no published reports on 
the use of virtual reality for pain management in the orthopaedic literature. 
By investigating VR as a non-pharmacologic intervention for pain, 
orthopaedic trauma patients may be able to avoid the known risks of 
narcotic medication while still controlling their pain and regaining function 
after their injury. Our study will lay groundwork for longer-term studies to 
evaluate the impact of virtual reality on functional outcomes, opioid usage 
after hospital discharge and patient satisfaction scores. VR can also be 
investigated for post-operative pain control across other orthopedic 
subspecialties.  
 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
In this prospective randomized control study, all patients presenting to MGH 
for orthopaedic trauma surgery will be eligible for inclusion. Subjects will be 
identified by reviewing the list of patients admitted to the hospital or 
presenting to the outpatient Orthopedic Trauma clinics. Patients will be 
recruited from the inpatient floors, or during an outpatient clinic visit. A 
research team member will explain the study and its objectives to the 
subject. The subject will be provided a fact sheet, which outlines the study 
goals, data points collected, and what will happen to subject PHI. Cognitive 
screenings are standard of care for any patient 65 and older and are 
performed by a doctor on the treating team. If there is any suspicion of 
cognitive impairment in a patient under the age of 65, a doctor on the team 
will perform a cognitive screening. 
 
Once consent has been obtained, patients will be randomized to either 1) 
usual care pain management or 2) usual care plus the use of a virtual reality 
pain control program (VR-PCP). The primary outcome of the study will be 
opioid usage during the postoperative hospitalization. This will be measured 
in average daily morphine milligram equivalents (MME).  Secondary 

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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outcomes will include length of stay and patient-reported pain scores, which 
will be measured using the PROMIS Pain Intensity Scale.  
 
Inclusion criteria  
-18 and older 
-Patients who sustained factures treated with open reduction internal 
fixation. Polytrauma patients whose fractures are definitively fixed in one 
discrete operating room visit will be included. Presence of CAM/Mini-Cog 
assessments for patients over 65.  
 
 
Exclusion criteria  
-Cognitive impairment 
-Injuries requiring staged surgical fixation (i.e. ex-fix to ORIF) 
-Seizure disorder or other contraindication to VR usage 
-Significant medical complications during hospitalization precluding use of a 
VR headset 
-Significant surgical complication during hospitalization requiring 
unanticipated return to the operating room during index admission. 
 
Data variables to collect 
Data gathered encompasses three broad categories: Demographic data, 
hospitalization data, PROMIS data. Basic demographic data: MRN, DOB, 
DOS, age at surgery (calculated), sex, height, weight, BMI (calculated), ASA 
classification (anesthesia note) and race. Hospitalization data includes: AO 
fracture classification, narcotic type, dose, total MME (morphine milligram 
equivalents) and hospital LOS. PROMIS pain (v 1.0 short form 3a) 
questionnaires will be collected daily. 
Assuming patients take an average of 45mg of morphine equivalents daily, a 
robust RCT would be powered at 90% to detect a 10% decrease in opioid 
use amongst the experimental arm. The goal of the study will be to enroll 
200 patients.  
 
Computer-generated randomization through REDCap will be utilized. 
Assuming a normal data distribution, mean daily opioid consumption will be 
analyzed using independent samples t-test. The change in PROMIS pain 
scores between the immediate post-op period and discharge will be 
compared between groups using a repeated measures ANOVA test. 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
If patients consent to the study, they will be randomized to either 1) usual 
care pain management or 2) usual care plus the use of a virtual reality pain 

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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control program (VR-PCP). Patients may be randomized before or after their 
surgical treatment.  
 
 
 
The intervention arm will receive standard analgesia plus access to the use 
of a VR-PCP as designed by VRHealth™. After a brief orientation, the device 
will be left with the patient for the duration of their post-operative hospital 
stay. While many of our patients may have an easy time understanding and 
using the product, some patients may find it more challenging to use the 
device. We will spend the necessary time with all patients to ensure safe and 
appropriate use of the VR system. If at any time there is question of safe 
usage of the VR system, we will terminate that patients’ study participation 
immediately.  
 
The VRHealth™ software records time spent using the device. Please see the 
attached brochure for specific details about the product. 
 
Data collection will take place in two phases. Phase one will be at the time of 
enrollment where basic demographic data, fracture characteristics and AO 
classification will be recorded in a database. The enrollment questionnaire 
will also include questions about recent narcotic use.  Patients will fill out a 
baseline PROMIS pain intensity questionnaire at time of enrollment and will 
be given a packet of pain intensity questionnaires to be filled out daily during 
the hospitalization. Phase two will be after discharge where data will tallied 
from the PROMIS questionnaires and also be collected from the electronic 
medical record.  
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
The usual care for pain management at our institution consists of standing 
Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing 
MGH nursing protocols evaluate when to give PRN narcotics to patients 
based on functional pain levels and are aimed at minimizing narcotic use. In 
elderly patients, the PRN dose of narcotics prescribed is generally half that of 
their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in 
younger patients).  
 
Geriatric fracture patients admitted to the orthopaedic trauma service are 
comanaged with geriatricians who also carefully monitor the effects of these 
medications. In this manner, the standard of care for orthopaedic trauma 
patients is a multimodal pain management approach aimed at minimizing 
narcotic usage, particularly in our geriatric fracture patients. Standard 
practice is to never give so much opioids, to any patient, that the renders 
them confused or obtunded.  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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We have attached the standard MGH nursing protocol for administration of 
PRN narcotics for your review. This is completely independent of our study 
and all patients in the hospital are administered PRN narcotics in this 
manner.   
 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
The orthopaedic trauma service at MGH has a very broad range of patients 
with a variety of lifestyles and baseline levels of health. We recognize that in 
one room may be a healthy young woman who broke her ankle and in the 
next may be a geriatric patient with a hip fracture. We also recognize that 
treating a broad patient population necessitates sensitivity to the needs of 
different types of patients. In particular, geriatric hip fracture patients can 
be medically complicated and may have needs beyond their acute hip 
fracture. It is standard of care on the orthopaedic trauma service at MGH 
that patients over the age of 65 be comanaged with our geriatrician 
colleagues. They are an excellent resource and steward most of the post 
operative care for these patients.  
 
Utilizing virtual reality in geriatric patients is not unprecedented. Here are 
two examples:  
 
1) Marivian et al. Rehabilitation of the psychomotor consequences of falling 
in an elderly population: A pilot study to evaluate feasibility and tolerability 
of Virtual Reality Training. Technol Health Care. 2016 24 (2):169-75;  
 
2)https://www.npr.org/sections/healthshots/2016/06/29/483790504/virtual
-reality-aimed-at-the-elderly-finds-new-fans 
 
In our experience, many of our geriatric hip fracture patients are out of bed 
on post operative day one, working with physical therapy, taking minimal 
narcotics and doing very well. These are the patients who, we hypothesize, 
may benefit from use of a virtual reality pain control program. 
 
However, we also recognize that this is not always the case. Geriatric 
fracture patients are certainly at risk of delirium while in the hospital and can 
have other medical complications. Please note that any patient, regardless of 
age, who fails their Mini-Cog or CAM test (administered by a physician, 
further explained in the recruitment and consent process outlined below and 
mentioned as part of the exclusion criteria) will not be considered for this 
study. This means that geriatric patients with baseline dementia will not be 
considered and patients with delirium will not be enrolled. Furthermore, if 
enrolled, patients who demonstrate a change in mental status or fluctuating 

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awareness, be it from narcotic medication or otherwise, will be immediately 
disenrolled from the study.  
 
The risk to subjects and their privacy is no more than minimal risk because 
subject participation is limited to the safe use of a VR device and completing 
short questionnaires. 
 
Any protected (identifiable) health information will be de-identified when the 
study has been completed. PHI will be stored on a password-protected 
Partners network computer with access limited to study staff. We will be 
using REDCap to collect survey responses, which is hosted behind the 
Partners Firewall.  
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
Patients who indicate that they do not wish to participate will not be included 
in the study.  
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
The one other risk we can foresee is a breach of patient confidentiality. We 
will take the utmost care to ensure that confidentiality is maintained. Patient 
specific identifiers will be erased once data analysis is completed. 
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
Some patients may find that he VR pain control program helps with their 
pain management and reduces their use of narcotic pain medications.  
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
All eligible patients over the age of 18 presenting to MGH will be included 
without regard to race, ethnicity, or gender. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
Individuals who do not speak English will be excluded from this study 
because the pain control program is only available in English.  
 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Non-
English_Speaking_Subjects.1.10.pdf
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
Research staff familiar with the study inclusion and exclusion criteria will 
review the day’s inpatient list and outpatient clinic schedule to identify 
potential subjects. Subjects eligible for inclusion will be approached by a 
member of the patient’s care team to first ascertain interest in participating 
in research. If they indicate interest, research staff will either approach the 
patient in-person, or, if remote-working procedures are in place, will contact 
the patient via room phone or cell phone. Research staff will not contact 
patients who are cognitively-impaired, the designation of which is outlined 
below. 
 
It is standard of care on the orthopaedic trauma service that preoperative, 
geriatic patients who demonstrate lack of mental competency are screened 
with a CAM and Mini-Cog test. If they fail these screens, the health care 
proxy must sign the consent form for surgery. Any patient who fails a CAM 
or Mini-Cog test at the time of consent for surgery will not be approached for 
enrollment.  
 
All subjects eligible for inclusion in the study and who consented themselves 
for surgery will be approached by a physician to evaluate mental status in 
person. A CAM and Mini-Cog screen will be performed. 

Partners Human Subjects Research Application Form 
  
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Version Date:  October 15, 2014 
 
  
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The Confusion Assessment Method (CAM)  
 
A series of 4 questions: (1) Acute onset and fluctuating course: Is there 
evidence of an acute change in mental status from the patient’s baseline? 
Did this behavior fluctuate during the past day, that is, tend to come and go 
or increase and decrease in severity? (2) Inattention: Does the patient have 
difficulty focusing attention for example, being easily distractible or having 
difficulty keeping track of what was being said? (3) disorganized thinking: is 
the patient’s speech disorganized or incoherent, such as rambling or 
irrelevant conversation, unclear or illogical flow of ideas or unpredictable 
switching from subject to subject? (4) Alerted level of consciousness: overall 
how would you rate their level of consciousness—alert, vigilant, lethargic, 
stupor or coma.  
 
The diagnosis of delirium requires a present/abnormal rating for criteria: 1 
and 2 AND EITHER 3 or 4.  
 
A positive CAM test will automatically exclude the patient from study 
participation.  
 
Ref: Inouye SK et al Ann intern Med. 1990; 113:941-8  
 
Mini-Cog 
  
1)Registration: Ask the patient to remember 3 words—apple, table penny—
have them repeat it back to you. Then tell the patient that they need to 
remember these words to repeat them back to you later.  
2) Clock draw test: give the patient a pre-drawn circle and as them to place 
the numbers on the face of the clock and draw the hands to read “ten after 
eleven”. 
3) Recall: Ask the patient to recall the three words.  
 
The Mini-Cog test is then scored based on number of words recalled and the 
ability to draw a normal clock.  
 
If the Mini-Cog test suggests any underlying dementia, the patient will 
immediately be excluded from study participation.   
 
(Ref: Borson S et al. Int J of geriatr Psychiatr 2000: 15: 2031-1027) 
 
By using these two screening tools, our goal is to enroll patients who will be 
able to successfully use the VR tool without subjecting them to an 
unnecessary risk of confusion or delirium. Vigilance in the application of 
these screening tools will ensure that we safely implement this study. 
 

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Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
Subjects will receive no remuneration. 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf
 
          Remuneration for Research Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
All subjects eligible for inclusion in the study and who consented themselves 
for surgery will be approached by a clinician investigator for consent to study 
participation. A CAM and Mini-Cog screen will be performed. Any patient who 
is CAM positive or whose Mini-Cog screen raises concern for underlying 
dementia will not be enrolled in the study. 
 
Research staff will thoroughly explain the study and its objective and will 
give the subject time to decide whether to participate. If research staff are 
working remotely and call the patient on their room phone or cell phone, 
they will also e-mail an electronic version of the consent form via a RedCap 
survey for the patient to review. The consent form will also be available to 
download on this link. Subjects will be given time to weigh the risks and 
benefits of participation in the study. After any and all questions from the 
subject have been answered by the research staff or the clinician 
investigator, written consent will be obtained from the subject. If an 
experienced research assistant/coordinator is the one obtaining consent, 
they will offer that a physician investigator will answer any additional 
questions posed by the patient, if preferred. If research staff are working 
remotely, they will obtain consent via e-signature on RedCap. This signed e-

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consent form will then be sent back to the patient for their records once it 
has been signed by research staff, either via secure e-mail or paper copy.  
 
Investigators and research staff will reinforce with their own patients that 
participation is voluntary, that they do not have to participate, and the 
decision not to participate will not affect their care, now or in the future. 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
Adverse events will be categorized as follows:  
1. Non-medical issue (NMI) –- i.e. device technical problem  
 
2. Adverse Event, not device related (AENDR) – an adverse event that 
occurs during the hospitalization that is unrelated to the VR headset. 
For example, this may include a postoperative bleeding event, cardiac 
complication.  
 
3. Adverse Event, device related (AEDR) — an adverse event thought to 
be directly related to usage of the VR headset. For example, a patient 
acutely develops a medical condition secondary to using the headset. 
These can be subclassified as “serious” and “non-serious”, see below.   
 

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All adverse events will be recorded immediately in the Redcap database 
being used for the study.  
 
Management of Adverse Events:  
 
Non-medical Issue (NMI) 
 
These issues may arise while patients are using the VR headset. For 
example, the device runs out of charge, malfunctions, or freezes. These 
events will be reported to the study staff and triaged appropriately on an 
event by event basis. These issues will be addressed at the monthly study 
group meeting to ensure efficient device usage and study implementation. 
They will be reported to the device manufacturer.   
 
Adverse Event, not device related (AENDR) 
 
These are the medical and surgical complications that unfortunately occur 
after orthopaedic surgery. These include postoperative bleeding, cardiac or 
pulmonary complications or a multitude of other postoperative complications 
that occur on the orthopaedic trauma service.  
 
When postoperative complications occur in a patient enrolled in the study, 
the PI will immediately be notified. The PI will be responsible for collecting 
laboratory data and medical history to ensure that the AE was not device 
related. The PI will also be ultimately responsible for determining if it is safe 
to continue using the VR headset in that patient. Patients who are 
transferred off of the orthopaedic trauma service due to a post op 
complication will automatically be disenrolled. All AENDRs will be re-
reviewed in the weekly research meeting.  
 
Adverse Event, Device Related (AEDR) 
 
These are complications thought to be directly related to the device. They 
can be subclassified as “serious” and “not serious.”  
 
Not serious AEDRs include nausea, motion sickness, eye soreness, 
claustrophobia. In these cases, the Not Serious AEDR will be immediately 
reported to the PI. The decision to disenroll the patient from the study will 
be made in a conversation between the patient and the PI of the study.  
 
Serious AEDRs such as seizure, loss of consciousness, acute change in 
mental status or delirium will be immediately reported to the PI. 
Disenrollment from the study and removal of the VR headset will occur 
immediately. All necessary medical care will be expeditiously provided to the 
patient. The AEDR will be reported to the VR headset manufacturer. 
Following a serious AEDR, the PI will convene all members of the research 

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team, any members of the patients’ medical care team and the 
representative from the device manufacturer for a discussion about any 
broader implications of the serious AEDR. The event will be reported to the 
IRB within 24 hours of the event.  
 
Geriatric Patient Safety Monitoring 
 
Finally, our geriatric colleagues will be acutely aware of any geriatric patients 
enrolled in the study and will be extra vigilant in ensuring the devices are 
being safely utilized. We recognize that our geriatric patient population are 
at increased risk of delirium and occasionally have more volatile hospital 
courses. Pain scores collected daily will give the study team an opportunity 
to evaluate each patient daily. If at any time, the patient seems to have 
altered mental status or a significant change in their hospital course, they 
will be immediately assessed clinically, and an adverse event will be 
investigated.  
 
This is a non-invasive study which does not require a DSMB. The PI will 
regularly monitor safety. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
This is a non-invasive study and there will be no additional risk by 
participating in the study; however, if adverse events are encountered, they 
will be reported immediately to the PI, Site PI, and to the IRB in accordance 
with the IRB adverse event reporting guidelines.  
 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 

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accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
The principal investigator is responsible for adherence to all IRB rules and 
guidelines. The research staff will be responsible for the accuracy and 
completeness of all forms, entries, and informed consent.  
 
As an added quality assurance measure, study staff will hold monthly 
meetings to ensure adherence to protocol is maintained by all of the study 
staff as well as to monitor the status and quality of the study. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
            https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf  
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_Adverse_Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
Care will be taken to preserve the confidentiality of patient information.  
Information specific to the study (the questionnaires and scores) will be 
maintained in a private database on a secure network, to which access is 
limited. All iPads used for administering questionnaires are encrypted and 
password protected, and REDCap software is behind Partner’s Firewall. Only 
IRB approved staff will have access to these data. 
 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
14 
None of the information collected will be sent to research collaborators 
outside of Partners.  
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
No specimens/data will be stored at sites outside of partners for future use. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
No specimens/data will be received from sites outside of partners for future 
use.