Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
Phase: NA
Conditions: Hip Osteoarthritis, Knee Osteoarthritis
Sponsor: Massachusetts General Hospital

Study Title: Comparative Effectiveness of Decision Support Strategies for Joint Replacement 
Surgery 
 
NCT: NCT02729831 
 
Date: December 21, 2017 
 
 
 
Document Title: Study Protocol (Approved Human Subjects Research Protocol)  

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
1 
 
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 
Karen R. Sepucha Ph.D. 
 
PROTOCOL TITLE 
Comparative effectiveness of decision support strategies for joint replacement 
surgery 
 
FUNDING 
Patient Centered Outcomes Research Institute (PCORI) 
 
VERSION DATE 
December 21, 2017 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested
The orthopaedic total joint replacement care teams at Massachusetts General Hospital and 
Newton Wellesley Hospital have been working with the Shared Decision Making Center to 
integrate the delivery of patient decision aids (PDAs) to patients who are consulting with a 
specialist. As these efforts have materialized over the past few years, there is an increasing 
interest in learning which types of patient decision aids are most effective.  The purpose of this 
study is to compare the effectiveness of two different types of decision aids for hip and knee 
osteoarthritis by examining the decision process and overall decision quality of patients who 
received either decision aids.     
 
This study will advance our understanding of how to communicate medical evidence and how to 
engage both patients and health care providers in shared decision making. We plan to compare 
two high quality PDAs that differ in the amount of content and level of interactivity, and will 
examine the impact on decision quality, treatments and health outcomes. The study will also 
examine the impact of two different surgeon-focused interventions—a standard summary report 
that includes patient reported outcomes (PROs) such as pain and functional status versus an 
enhanced report worksheet that provides patients’ goals and treatment preferences. The study 
will enroll 1,120 patients considering total joint replacement for hip or knee osteoarthritis in a 
2X2 factorial randomized trial and will accomplish the following specific aims:  
 
Aim 1: Evaluate comparative effectiveness of two patient decision aids (a long PDA versus a 
short PDA) and a surgeon-focused intervention (usual care versus intervention, a summary that 
includes patients’ goals and treatment preferences) on their ability to achieve high decision 
quality.  
 
Hypothesis 1.1: Overall, patients who receive the long PDA will have higher decision quality 
than those who receive the short PDA.  
Hypothesis 1.2: Patients who receive the long PDA, with more comprehensive information 
and videos to make the information more salient, will have higher knowledge 
scores than those who receive the short PDA.  

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Hypothesis 1.3: More patients who receive the short PDA, with the explicit values 
clarification exercise, will have a clear treatment preference than those who 
receive the long PDA.  
 
 Aim 2:  Follow participants for 12 months to determine the impact of the decision support 
strategies on treatment choices and health outcomes, specifically, overall quality of life and 
functional status. 
 
Hypothesis 2.1: Patients with high decision quality (i.e. informed and received preferred 
treatments) at one week will have better health outcomes at one year 
compared to those with low decision quality.  
Hypothesis 2.2: Patients with high decision quality at one week will have lower surgical rates 
at one year compared to those with low decision quality.  
 
Aim 3:  Identify patient-, physician- and intervention-level factors associated with effectiveness 
for the PDAs. These factors include (1) patient characteristics (e.g. age, gender, education 
level, and joint (hip or knee), (2) provider characteristics (e.g. years since graduation, surgical 
volume), (3) intervention compliance (e.g. whether patients reviewed the decision aids and 
amount of time spent reviewing the decision aids) and (4) mode of delivery (online or hardcopy). 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
Osteoarthritis is a common and debilitating disease and a leading cause of disability in the U.S. 
and a growing public health problem. More than one-third of adults 65 and older have OA (1) 
and the majority report at least some degree of limitation. A significant percentage of patients 
with OA (40%) report that their overall health is only “fair” or “poor” (2). Studies have also found 
that adults with OA have higher rates of death from all causes, cardiovascular deaths, and 
dementia deaths (1.6, 1.7, and 2.0 times higher respectively) compared with the general 
population (3).  
 
Joint replacement surgery is a common treatment for OA and more than 1,000,000 hip and 
knee replacements were performed in 2010 in the U.S (4). The decision about whether or not to 
have joint replacement surgery requires patients and clinicians to make tradeoffs between the 
chance of symptom relief and potential complications. For example, total hip or knee 
replacement provides a high likelihood of near complete pain relief (80-90%) but carries a small 
chance of serious complications (1-5%) and requires considerable time and effort for recovery 
(5,6).  Delaying or waiting for surgery does not decrease the effectiveness, so in order to 
determine whether or when surgery may be warranted, providers need to understand how 
bothered patients are by their symptoms and how concerned they are about the prospect of 
having surgery. The decision to have surgery depends on a complex interplay of having an 
appropriate clinical condition and patients’ informed preferences.  
 
Patients are not routinely informed or engaged in decisions about total joint replacement. 
Clinical guidelines for treatment of OA emphasize the importance of informing patients and 
engaging in shared decision making (SDM) to determine the best treatment (5,7). However, 
studies have found little evidence of shared decision making in routine care (8,9). Patients with 
hip and knee osteoarthritis are not well informed about the options and outcomes, and one third 

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report that they were never asked about their goals or treatment preferences for this elective 
procedure (8,9).  
 
There are several gaps in our understanding of how to best improve the quality of decisions. 
Patient decision aids (PDAs) can help inform and engage patients in medical decisions, and 
international standards have been created for the development of high quality decision aids 
(10).  Recently, there has been considerable controversy around PDAs, specifically whether 
traditional, longer programs can be replaced by shorter, more interactive tools (11,12). Although 
there are more than 115 randomized controlled trials comparing the use of decision aids to 
usual care (without decision aids), the published literature does not include many head-to-head 
comparisons of different tools (13).   Second, most studies focus on patient interventions, so 
relatively little is known about effectiveness of interventions targeted at physicians or at the visit 
itself. Third, few studies have examined whether using interventions to improve decision quality 
results in better health outcomes. This study will address each of these gaps.  
 
As patient decision aids (PDAs) proliferate and efforts to integrate shared decision making into 
routine care expand, understanding the comparative effectiveness of different interventions is 
critical. This study will be the first study to compare effectiveness of PDAs from two leading 
vendors. The vendors, Health Dialog and Healthwise, employ different design features (e.g. use 
of video for patient narratives, interactive values clarification exercise) and the study will help 
advance our understanding of the relative impact of the different features on decision quality. 
This study will also allow us to determine the impact of a provider facing intervention through the 
delivery of an enhanced patient reported summary sheet.  
 
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.”
This is a randomized trial with a 2x2 factorial design to examine the comparative effectiveness 
of two PDAs and an in-visit intervention. In the study, patients will be surveyed shortly before 
their initial visit with an orthopedic specialist and again about 1 week and 1 year after the visit. 
Patients scheduled for an appointment with the orthopedic specialist will be screened for 
eligibility (criteria are listed in Table 1) and if eligible, will be randomized to receive either the 
Health Dialog or Healthwise decision aids to review before their visit.  A computer generated 
randomization allocation sequence will be created for participants. Eligible patients will receive a 
cover letter and an information sheet about the study that includes instructions about how to 
opt-out in the mail before their visit. Those who do not opt out will then be enrolled in the study. 
The random assignment originally assigned to patients who are found ineligible after their visit 
will be put back to the queue and become available for the next eligible patient.   
 
Providers will be randomly assigned to usual care or intervention group (a worksheet which 
includes patient’s goals and preferences).  Providers in the worksheet group will receive short 
training on the use of the worksheet.  
 
The study will enroll patients at three sites: an academic center, the Arthroplasty Department at 
Massachusetts General Hospital (MGH), a community hospital, Kaplan Joint Center at Newton 
Wellesley Hospital (NWH), and an orthopedic specialty hospital, New England Baptist Hospital 
(NEBH). MGH and NWH share common resources that are critical to the conduct of the study, 
including patient registries which routinely collect similar patient reported data and clinical 
outcomes for hip and knee osteoarthritis patients.  Both these sites also have access to both 

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Healthwise and Health Dialog decision aids through Partners Healthcare’s contracts with those 
vendors. NEBH is not a Partners-affiliated hospital and therefore requires separate coordination 
efforts to execute the research study.  
 
Table 1: Eligibility for survey study   
  
Eligible 
Ineligible 
Knee and Hip 
Osteoarthritis  
• 
Diagnosis of knee or hip OA 
• 
Adults, age 21 or older 
• 
Scheduled new patient visit with 
participating orthopaedic 
specialist  
• Prior partial or total knee or hip 
replacement surgery on joint of concern 
within 5 years 
• Hip fracture or aseptic necrosis at any 
time in 12 months prior to visit 
• Rheumatoid arthritis or psoriatic arthritis  
• Does not read or write in English or 
Spanish 
• Unable to consent for self due to 
cognitive or other medical issue(s) 
• Prior decision aid order for joint of 
concern 
 
Patient participants will be surveyed at three time points, before their visit with the surgeon, 
about one week after the visit, and again 12 months after the visit.  Data from our previous 
studies suggests that we will have about 65 eligible new patients each month for the study 
enrollment period. We plan to enroll patients for about 12 months and estimate 1,120 patients 
will complete the first assessment in-clinic or  before the visit with the surgeon, 840 (75%) will 
complete the second assessment one week after the visit, and 716 will complete the third 
assessment about one year after the visit. The sample size calculations consider both the 
potential for interaction effects between the interventions as well as the potential impact of 
clustering of patient participants within surgeons. Figure 2 offers a more detailed look at the 
projected screening and enrollment numbers. 
 
 
 

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Figure 2: CONSORT Flow diagram with estimates for screening, enrollment and response rates 
                  
 
Legend: PDA=patient decision aid, T1=in clinic before surgeon visit, PRO=patient reported outcomes; T2=1 week 
post visit; T3=6-12 month post visit 
 
New patients coming to see a specialist in the Arthroplasty group at MGH complete surveys 
in the clinic via a computer or tablet. The surveys cover quality of life, pain, functioning and 
symptoms and are administered through the Harris Joint Registry (IRB #  2002-P-001823). 
The surveys for this study will be incorporated as an additional module in the Harris joint 
registry for arthroplasty patients at MGH and will be administered by paper, by computer in 
the clinic or via Redcap depending on the patients’ preference and the timing of the visit.  
The new patients at NWH will similarly be offered to complete the patient reported quality 
and functional status surveys by paper, by computer or tablet in the clinic, or by email in 
advance of their visit as covered by their patient reported outcome registry protocol (IRB 
protocol 2014P000696). New patients at NEBH will be asked to complete the quality of life 
surveys as part of the initial pre-visit survey for the study. 
 
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.
 
Study Procedures: 
1. The principal investigator will obtain permission from participating clinicians at each site to 
screen their patients for eligibility and enroll eligible patients onto the study. Some, but not 
all, participating clinicians may also be co-investigators. 
2. The statistician will generate a random allocation sequence to indicate which decision aid 
each participant should receive. The statistician will also group providers at each site by patient 
Allocated to enhanced report (n=4 )
Allocated to standard report (n=4 )
Patients Randomized (n= 1400)
Provider Randomized (n=8 )
Allocated to short PDA (n=700)
Received intervention (n= )
Did not receive (reasons) (n= )
Excluded (n=600)
Not meet inclusion 
criteria (n= )
Other reasons (n=)
Patients assessed for eligibility (n=2000)
Lost to follow up 
(n=62) 
Allocated to long PDA (n=700)
Received intervention (n= )
Did not receive (reasons) (n= )
T1 (in clinic) N=560
Standard or Enhanced PRO report as 
assigned by provider 
Received intervention (n= )
Did not receive (reasons) (n= )
Lost to follow up 
(n=140)
T2 (1 week): N=420
T3 (12 months): N=358
T1 (in clinic) N=560
Standard or Enhanced PRO report 
as assigned by provider 
Received intervention (n= )
Did not receive (reasons) (n= )
Lost to follow up 
(n=140)
T2 (1 week): N=420
T3 (12 months): N=358
Lost to follow up 
(n=62) 
Lost to follow up 
(n=140)
Lost to follow up 
(n=140)

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volume and randomly assign each group to the usual care or intervention group for the in visit 
intervention.  
3. The research coordinator, with support from the research nurse or other clinic staff, 
will review the schedules of participating clinicians and the Epic research report, if available, to 
complete the eligibility screener to the extent possible and identify potentially eligible 
participants 
4. The research coordinator may call potentially eligible patients to clarify any information about 
eligibility.  
5. The staff at Health Decision Sciences Center will send the assigned decision aid, cover letter, 
information sheet, and appropriate survey (depending on provider assignment) to eligible 
patients in advance of their upcoming visit in the arthroplasty service. The letter will include 
information about how to opt-out of the study. The packet for subjects will include the survey 
(T1) so they have the option of completing the survey at home and bringing it with them to the 
visit.   
6. Two days before the scheduled visit, study staff may call subjects who did not opt out to 
answer any questions about the study, and to remind them to review the decision aid before the 
visit, and complete the survey. Study staff can administer the survey over the phone if the 
patient prefers to do so.   
7.  On the day of the visit, the study staff will discuss the study with the eligible patients who did 
not opt-out. If the patient agrees to participate, then study staff will administer the survey either 
on paper or electronically if tablet or computer is available.  
8. By completing this first assessment, participants will give consent to enroll in the study.  
9. Study staff will work with the Harris Joint Registry at MGH and NWH data registry to 
download the completed quality of life and the study questionnaires for all participants. 
10. The surgeon will receive the enhanced report (depending on their study assignment) for 
their participating patients.  
11. A research coordinator will review medical record after the visit to complete the eligibility 
screener, as needed, and will send the second survey (T2) by mail or email within a week of the 
specialist visit to all confirmed eligible patients who did not opt out. If patients have not 
completed the routinely collected quality of life while at their visit, it will be included with this 
survey.  
12. Study staff will follow-up with a phone reminder about one week after sending the survey, 
followed by a mailed reminder or up to three email reminders, and a second phone reminder for 
all the participants who did not complete the surveys. Participants who are receiving the survey 
by email will also get one mailed reminder if it is not completed in two weeks. Patients will be 
given the option to complete the survey by phone. 
13. All participants who complete the T2 survey will receive a thank you note.  
14. About 6 months from the date of their initial visit, study staff will confirm participant surgical 
status and will send participants the third survey (T3) by mail or email. Non-surgical patients will 
receive T3 about 6 months from their consultation and surgical patients will receive T3 about 6 
months from their surgery date. Study staff will follow up with a phone reminder within 1 week, a 
second mailing or up to three reminder emails as appropriate, and a second phone reminder for 
non-responders.  For those who do not respond to the email reminders, we will mail them a 
survey before the second phone reminder.  
15. All patients who receive the final survey will also be able to indicate their consent to be 
contacted in the future for other studies run out of the Health Decision Sciences Center. Of 
those patients who’ve given consent to be re-contacted: study staff may contact these patients 
via email or telephone, depending on their preferred method indicated, to invite them to 
participate in future projects and studies.      
16. Study staff will review completed surveys soon after receipt and enter survey data into the 
study database as needed. If there are large portions of the surveys that are missing the study 
coordinator will contact the participant to determine whether the items were intentionally skipped 

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(in which case no further action will be taken) or whether it was not intentional and in this case 
will provide any needed clarification and request that the items be completed.  
17. All participants who complete the T3 survey will receive a thank you note including an 
answer key to the knowledge section of the T1 and T2 surveys. 
18. Study staff will collect additional data from the medical record (including patient 
demographics, treatments received for the hip/knee, co-morbidities, and clinician visits related 
to the hip/knee) in the 12 months since the initial visit, patient-reported quality of life and 
functional status data from the Harris Joint Registry and Newton Wellesley Hospital’s Kaplan 
Joint Center registry  (IRB# 2014P000696) databases, and use of decision aids from the Shared 
Decision Making database (IRB 2005p-002282).  
19. Limited data will be kept on non-responders including joint, age, gender, physician, decision 
aid assignment, reason for refusal (if available), and all elements in the eligibility screener. This 
information will be used to examine non-response bias.   
20. Study data will be cleaned, surveys will be scored, analyzed and manuscripts will be 
prepared for publication.  
 
Clinician surveys: 
Participating clinicians will complete a short survey for a subset of their participating patients. 
The survey will include questions about satisfaction with the visit and rating of the quality of the 
decision. Research coordinators will approach the clinician in person with paper survey shortly 
after the initial visit. If they are not able to connect in person, they will send an email with the 
survey for each patient and will make up to three reminders via email to encourage the surgeon 
complete the survey. 
 
All study staff are CITI certified and will receive training from the PI and program manager in the 
study protocol.  
 
Outcomes: 
This study will capture three main types of outcomes – these include patient-reported measures 
related to decision making (e.g. decision quality, decision making process and regret), patient-
reported health outcomes (e.g. knee and hip pain, quality of life and functioning) and medical 
treatments received by participants.   
 
 
We will collect the measures listed below. Table 3 shows the measures assessed at each time 
point as part of this study and the estimated burden on participants.  
 
Measures: 
Decision Making Measures (timing of use) 
1. Hip OA and Knee OA Decision Quality Instruments (T1, T2, T3):  Each DQI contains 5 
decision-specific, multiple-choice knowledge items, 5 decision-specific goals and concerns 
(rated on an 11 point importance scale), one treatment preference item. The DQI results in a 
knowledge score (0-100%) and a concordance score (0-100%) indicating the percentage of 
patients who received treatments that matched their stated preference, and an involvement 
score (0-100%) with higher scores indicating more patient involvement in decision making.  The 
minimal important changes (MIC) in knowledge and concordance scores are 10% (14).  
2. Decision Process Score (T2, T3): 7 items that assess the decision-making process 
including whether options, outcomes and preferences were discussed. A total score is 
generated and scaled to (0-100%) with higher scores indicating more patient involvement in 
decision making. 3 items that assess general satisfaction with the visit.(9) 
3. Functional goals (T2, T3): participants will list the top three things that they need or want to 
do but are unable to do because of their knee or hip pain (at T2). Then at T3, they will indicate 
to what extent they are able to do those three things.  

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4. SURE scale (T2): A brief, 4-item version of the widely used Decisional Conflict Scale (15) 
that measures patients' uncertainty about which treatment to choose and factors contributing to 
uncertainty (feeling uninformed, unclear values, and unsupported in decision making).  
5. Decision regret (T3): 5-item Likert scale that measures distress or remorse after a decision. 
A total score (0-100) is calculated with higher scores indicating more regret. The scale has 
demonstrated strong internal consistency (0.81-0.92) and correlates with decision satisfaction 
and quality of life (16). 
 
Health Outcomes Measures (timing of use) 
6. EQ-5D (T1, T3) is a 6-item summary measure of health status for use in evaluating health 
and healthcare (17). It also generates a single index value for health status on which full health 
is assigned a value of 1 and death a value of 0. In conjunction with weights established for the 
243 different combinations, the EQ-5D can be used to obtain quality-adjusted life years (18).  
The minimally important change is 0.1 points (19).   
7. Knee injury and osteoarthritis score (KOOS) (T1, T3) The KOOS and HOOS 
questionnaires were developed to assess the patients’ opinions about their knee or hip and 
associated problems and have been used extensively (20-28). Three subscales, pain, 
symptoms and functional status will be used in this study. A normalized score (100 indicating no 
pain/symptoms and 0 indicating extreme pain/symptoms) is calculated for each subscale.  
8. Harris Hip Score (HHS) (T1, T3): The HHS assesses pain, function, range of motion and 
deformity for each hip. Pain receives 44 points, function 47 points, range of motion 5 points, and 
deformity 4 points for a total of 100 points. Function is subdivided into activities of daily living (14 
points) and gait (33 points).The higher the HHS, the less dysfunction. A total score of 70 is 
considered a poor result; 70 – 80 is considered fair, 80 –90 is good, and 90 –100 is an excellent 
result. No normative values are available. 
 
 
Additional items    
9. PDA use (T1, T2): items will assess how much of the DVD, booklet and/or website was 
reviewed (all, some, a little, none)  and how much time did they spend reviewing it (0-5 minutes; 
6-10 minutes; 11-20 minutes; 21-30 minutes; >30 minutes). 
10. Treatment received (T3, chart review): surgical and non surgical treatments tried in the 
twelve months after the visit will be self reported by patients and also collected via chart review.  
11. Expectations (T2, T3): 4 items will assess expectations for pain relief, limitations in daily 
activities, overall success of surgery and complications (29).  
12. Demographics (T2):  information such as education, employment, marital status will be self 
reported. 
13. Satisfaction (T2, T3): questions to assess overall satisfaction with quality of visit or 
treatment outcome 
14. Information use (T3): 1 question to assess what sources of information patient about their 
health condition they found important  
15. IMPACT index (T2, T3): 7 items assessing the impact of hip and knee osteoarthritis on 
patients’ perception of their condition: worry, pain, limitation, confidence, and involvement in 
decision making. 
 
 
Table 3: Measures including in surveys  
Measures 
Pre-visit (T1) 
~ 1 week (T2) 
 
~ Follow-up  
(T3) 
Visit goals and functional 
goals 
2 (physician 
intervention 
group only) 
 
 
 
 
12 
 

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Decision Quality Instrument 
9 
0 
Decision aid use 
 
1 
 
1 
 
Not asked 
Decision making process 
 
0 
 
11 
 
7 
Functional goals 
 
Not asked 
 
2 
 
1 
SURE 
 
Not asked 
 
4 
Not asked 
Expectations 
Not asked 
10 
10 
Quality of life, pain and 
functioning (KOOS or HHS, 
EQ-5D)* 
Routinely 
collected 
Not asked 
 
Routinely 
collected 
 
Decision Regret 
Not asked 
 
 
Not asked 
 
5 
Satisfaction 
Not asked 
1 
 
 
2 
Demographics and treatment 
history 
 
5 
2 
Health literacy 
1 
Not asked 
Not asked 
Impact Index 
Not asked 
7 
7 
Total number of items 
 
13 (MD usual 
care group)/ 15 
(MD intervention 
group) 
53 
34 
Total time estimate 
 
5 minutes 
 
15 minutes 
 
15 minutes 
*These items are asked as part of routine care at this time point.  
 
 
Randomization and blinding  
Provider randomization will be stratified by site. Within each site, surgeons will be divided into 
two groups with similar patient volume. One of the two groups will be randomly assigned to 
usual care and the other to receive the in-visit worksheet. It will not be possible to blind the 
research staff, patient or providers to the group assignment for providers; however, those 
entering data and those analyzing the data will be blinded to group assignment.  
 
A computer-generated randomization allocation sequence will be created for patients from each 
site. After confirming eligibility, the staff at the Health Decision Sciences Center that fulfills PDA 
orders will have access to the sequence in order to deliver the appropriate decision aid. The 
staff who fulfill the orders will not be the same staff that approach patients in clinic. To the extent 
possible, the research staff calling participants on the phone and/or approaching them in clinic 
will be blinded to the PDA assignment. In our pilot, several patients brought the decision aid to 
the clinic with them, and as a result, it was clear which intervention they received. Patient 
participants have the opportunity to opt-out before their visit, and those who do not opt out will 
be enrolled in the study. The random assignment originally assigned to subjects who are found 
ineligible will be put back to the queue and become available for the next eligible subject. 
 
Patient participants will not be blinded to the PDA assigned to them; however, they will not be 
given any explicit information on the surgeon assignment. Likewise, surgeons will not be blinded 

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to their intervention group, but they will not be given any information on the type of PDA the 
patient used.  The study staff doing chart review and data entry will be blinded to the patient and 
provider assignments to avoid unintended bias. The statistician analyzing the data will also be 
blinded to the study assignments.  
 
 
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.
 
This study involves reviewing patient educational materials, completing surveys and conducting 
medical chart review.  No diagnostic tests or treatments will be offered or administered as part 
of this study.   
 
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.
 
There are minimal risks to participating individuals associated with or attributable to this study. 
The main risks are associated with loss of privacy of their health information.  
 
The time required for patient participants to complete the first survey is about 5 minutes and the 
time required to complete the follow-up surveys is about 15 minutes each.  
 
Consent for participants will be implied by completion of the first survey. Participants may opt 
out of the study, may refuse to answer any question (or set of questions) and may discontinue 
their participation at any time. It will also be emphasized that whether or not subjects participate 
will not impact the medical care that they receive. 
 
The surgeons will complete surveys for about 30% of their patient participants. Each surgeon 
survey should take 1-2 minutes to complete.  
 
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 group
 
The participation of subjects in the study involves completing one to three surveys. Participants 
will be told that participating in the study and completing the survey(s) is voluntary and that they 
may refuse to answer any questions or set of questions and may discontinue their participation 
at any time.  
 
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 infan
 

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As stated above, there are minimal risks to individuals participating in this project.  The main 
risks are the time and effort involved in participating (about 5 minutes for initial survey and 15 
minutes for each follow up survey) and loss of privacy. The surveys will programmed into the 
IRB approved Harris Joint Registry (2002-P-001823), IRB approved NWH Kaplan Joint Center’s 
registry (2014P000696) and/or REDCap web-based survey. All patient identifiers will be kept in 
a password protected files (Excel, Access database). Only members of the research team will 
have passwords to access the files and they will only access the files from Partners computers 
or encrypted laptops that are protected with SafeBoot. All patient information on eligibility 
screeners, chart reviews, and surveys collected at NEBH will be sent securely using a secure 
file transfer to the Partners network. To ensure confidentiality, all paper surveys will be identified 
by study code number only and kept in a locked file cabinet and the electronic files will be on 
password protected Partners server. To address issues of psychological discomfort, research 
assistants will inform patients that they may refuse to answer any question and may withdraw 
from the study at any time. Reminders will also include contact information for the PI and study 
staff in case participants have questions or concerns.   
 
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. 
 
The patients may benefit from reviewing the educational materials, as these types of tools have 
been shown to improve knowledge, reduce decisional conflict and help patients participate in 
treatment decisions. There are no direct benefits to patients from completing the surveys.  By 
completing the decision making survey items, participants may identify some gaps in knowledge 
that the clinicians are able to address during or after the visit and they may clarify their goals to 
share with the clinician. The study will provide evidence for comparative effectiveness of two 
different tools, as well as an in-visit intervention. The results will help the field understand the 
best way to inform and engage patients in significant medical decisions. 
 
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 
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.
 
We have restricted the study to adults, both men and women. Children are not eligible as they 
rarely have these conditions.    
 
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.
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  12 
At this time, the patient decision aids are only available in English and Spanish so there will not 
be an intervention for patients who do not speak or understand English or Spanish. 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
 
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.
 
1. The principal investigator will obtain permission from participating clinicians at each site to 
screen their patients for eligibility and enroll eligible patients onto the study. Some, but not 
all, participating clinicians may also be co-investigators. 
2. The statistician will generate a random allocation sequence to indicate which decision aid 
each participant should receive. The statistician will also group providers at each site by patient 
volume and randomly assign each group to the usual care or intervention group for the in visit 
intervention.  
3. The research coordinator, with support from the research nurse or other clinic staff, 
will review the schedules of participating clinicians and the EPIC research report, if available, to 
complete the eligibility screener to the extent possible and identify potentially eligible 
participants. 
4. The research coordinator may call potentially eligible patients to clarify any information about 
eligibility. 
5. The staff at Health Decision Sciences Center will send the assigned decision aid, cover letter, 
information sheet, and appropriate survey (depending on provider assignment) to eligible 
patients in advance of their upcoming visit in the arthroplasty service. The letter will include 
information about how to opt-out of the study. The packet for subjects will include the survey 
(T1) so they have the option of completing the survey at home and bringing it with them to the 
visit.   
6. Two days before the scheduled visit, study staff may call subjects who did not opt out to 
answer any questions about the study, and to remind them to review the decision aid before the 
visit, and complete the survey. Study staff can administer the survey over the phone if the 
patient prefers to do so.   
7.  On the day of the visit, the study staff will discuss the study with the eligible patients who did 
not opt-out. If the patient agrees to participate, then study staff will administer the survey either 
on paper or electronically if tablet or computer is available.  
8. By completing this first assessment, participants will give consent to enroll in the study.  
9. Study staff will work with the Harris Joint Registry at MGH and NWH data registry to 
download the completed quality of life and the study questionnaires for all participants.  
10. The surgeon will receive the enhanced report (depending on their study assignment) for 
their participating patients.  
11. A research coordinator will review medical record after the visit to complete the eligibility 
screener, as needed, and will send the second survey (T2) by mail or email within a week of the 
specialist visit to all confirmed eligible patients who did not opt out. If patients have not 
completed the routinely collected quality of life while at their visit, it will be included with this 
survey.  

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  13 
12. Study staff will follow-up with a phone reminder about one week after sending the survey, 
followed by a mailed reminder or up to three email reminders, and a second phone reminder for 
all the participants who did not complete the surveys. Participants who are receiving the survey 
by email will also get one mailed reminder if it is not completed in two weeks. Patients will be 
given the option to complete the survey by phone. 
13. All participants who complete the T2 survey will receive a thank you note.  
14. About 6 months from the date of their initial visit, study staff will confirm participant surgical 
status and will send participants the third survey (T3) by mail or email. Non-surgical patients will 
receive T3 about 6 months from their consultation and surgical patients will receive T3 about 6 
months from their surgery date. Study staff will follow up with a phone reminder within 1 week, a 
second mailing or up to three reminder emails as appropriate, and a second phone reminder for 
non-responders.  For those who do not respond to the email reminders, we will mail them a 
survey before the second phone reminder.  
15. All patients who receive the final survey will also be able to indicate their consent to be 
contacted in the future for other studies run out of the Health Decision Sciences Center. Of 
those patients who’ve given consent to be re-contacted: study staff may contact these patients 
via email or telephone, depending on their preferred method indicated, to invite them to 
participate in future projects and studies.      
16. Study staff will review completed surveys soon after receipt and enter survey data into the 
study database as needed. If there are large portions of the surveys that are missing the study 
coordinator will contact the participant to determine whether the items were intentionally skipped 
(in which case no further action will be taken) or whether it was not intentional and in this case 
will provide any needed clarification and request that the items be completed.  
17. All participants who complete the T3 survey will receive a thank you note including an 
answer key to the knowledge section of the T1 and T2 surveys. 
 
All study staff are CITI certified and will receive training from the PI and program manager in the 
study protocol. The study staff will also be supported by the research nurse, Janet Dorrwachter, 
for eligibility screening and patient contact.  
 
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
 
Participants will be given a $5 cash incentive with both the second (T2) and third (T3) surveys.   
 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  14 
 
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.
 
There are no formal written consent procedures in this study. The research presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required. Consent for the study will be implied by completion of the first questionnaire.  
 
A cover letter and study information sheet will be mailed prior to the initial visit along with the 
decision aid and first survey to eligible participants. The letter will contain information for 
patients to call or email to opt out of the study if they prefer. Eligible participants will be able to 
review the information sheet and decide whether they are interested in participating in the study. 
The principal investigator’s name and contact information will also be available on the 
information sheet if participants have any questions or concerns about the study. The study staff 
at the time of the visit will discuss the study and answer any questions, the research nurse will 
be available by pager and study staff/PI will be available by phone to answer any questions.  
 
Patients will need to give consent if they wish to receive the T2 and T3 surveys via unencrypted 
emails. The IRB information regarding send-secure vs. unencrypted emails will be included on 
the T1 survey and research staff will discuss this subject with the patients when they join the 
study. Patients will also be read the IRB policy and asked for verbal consent to receive 
unencrypted emails over the phone before they are sent the T3 survey. Participants can choose 
to receive the surveys via a send-secure email or on paper in the mail if they do not wish to 
receive unencrypted emails. 
 
Clinicians who agree to enroll patients on the study will be informed that they will be asked to 
complete a short questionnaire for a subset of patients as part of their participation. By agreeing 
to enroll patients on the study, clinicians will give consent to be surveyed.  
 
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: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
 
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 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  15 
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. 
 
Participation in this study involves the completion of three surveys.  There are no foreseeable 
safety risks to participants for completing the surveys. Study staff will be instructed to review 
surveys within a week of receipt and will notify the PI and clinical investigators on the team 
about any serious events immediately and all other events at regularly scheduled meetings.  
Study staff will keep records of any feedback, questions, concerns and/or complaints that are 
received and we will address them as needed.  
 
Patient names or any other identifying information will not be included in any paper survey and 
will only be referenced by study code number. The file that links the study code numbers to 
names and contact information will be kept separately on a Partners password protected server. 
The medical record chart review data will be kept on Partners password protected server and 
identifying information. All patient information on eligibility screeners, chart reviews, and surveys 
collected at NEBH will be sent securely using a secure file transfer to the Partners network.. The 
survey data will be collected in the IRB approved Harris Joint Registry (2002-P-001823), the 
NWH registry (2014P000696), or using REDCap.   
 
 
 
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based 
application hosted by the Partners HealthCare Research Computing, Enterprise Research 
Infrastructure & Services (ERIS) group. Vanderbilt University, with collaboration from a 
consortium of academic and non-profit institutional partners, has developed this software toolset 
and workflow methodology for electronic collection and management of research and clinical 
study data. Data collection projects rely on a study-specific data dictionary defined by members 
of the research team with planning assistance from Harvard Catalyst | The Harvard Clinical and 
Translational Science Center EDC Support Staff. The iterative development and testing process 
results in a well-planned data collection strategy for individual studies. Using REDCap, the 
research team can also design web-based surveys and engage potential respondents using a 
variety of notification methods. REDCap provides flexible features that can be used for a variety 
of research projects and provides an intuitive interface to enter data with real time validation 
(automated data type and range checks). The system offers easy data manipulation with audit 
trails, reports for monitoring and querying participant records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).  
For the approved NWH registry (IRB 2014P000696): All data is encrypted and stored in a 
relational database at a secure data center with advanced security framework safeguarding 
both the interior and exterior. The servers are highly secure and use HIPAA compliant anti-virus 
and data security procedures including multiple firewalls, intrusion detection and traffic 
monitoring. The system will be monitored and audited regularly to track the frequency and 
reasons for logging onto the system. Only IRB-approved Partners study staff members will have 
password access to the system. 
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  16 
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
 
No serious adverse events are expected. However, if a serious adverse event occurs then the 
principal investigator will report the event to the IRB within 24 hours and will file an HRC 
Adverse Event Form within 10 working days.  If a mild or moderate adverse event occurs, the 
principal investigator will summarize the event in the progress report at continuing review. 
 
Study staff will be instructed to review surveys within a week of receipt and will notify the PI and 
clinical investigators on the team about any serious events immediately and all other events at 
regularly scheduled meetings.  Study staff will keep records of any feedback, questions, 
concerns and/or complaints that are received and we will address them as needed.  
 
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 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The study staff and the principal investigator will have weekly meetings throughout the study 
and will meet at least monthly with clinician and research nurse co-investigators to ensure the 
project proceeds as intended per the protocol.  All participant enrollment will be tracked using a 
password protected Access database. We will track recruitment rates, initial response rates and 
follow-up completion rates routinely and identify issues as they come up. The study staff will 
complete all required documents for the study binder and this will be reviewed quarterly by the 
principal investigator.  
 
Limited data will be kept on non-responders including joint, age, gender, physician, decision aid 
assignment, and all elements in the eligibility screener. This information will be used to examine 
non-response bias.   
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  17 
          http://healthcare.partners.org/phsirb/guidance.htm#13
 
          Reporting Unanticipated Problems (including Adverse Events)
          http://healthcare.partners.org/phsirb/guidance.htm#7
 
 
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.
 
Special efforts will be made to protect the privacy of subjects.  We will have names, addresses, 
phone numbers and email addresses of eligible participants and this information will be kept 
separate from the study data. The participants who complete the surveys through the Harris 
registry or the NWH Kaplan Joint Center registry will follow their approved process.  For the 
participants who receive the survey via mail or email, all patients will receive a study code 
number and the surveys will only be identified by code number.  
 
Surveys sent by email will be sent either using an IRB approved mechanism through the 
approved Harris and NWH registries or REDCap. On the T1 survey, patients will be given the 
option of receiving follow-up surveys on paper, through the send-secure email system, or in an 
unencrypted email containing the REDCap link. For patients who have not given consent to be 
sent unencrypted emails earlier in the study, consent can be given over the phone to research 
staff before the final T3 survey. All paper or verbal consent for unencrypted surveys will be 
recorded in the study database. The data collected via the medical record review will also be 
identified by study code number only.  The study code number will be used to identify who 
needs to be followed up for non-response.  A separate password-protected electronic file will 
contain the codes linked to identifying information.  Only the MGH and NWH investigators will 
have access to this file.  These will be kept as long as required by the research project.  After 
the study has been completed, all study files containing personal contact information of 
participants will be destroyed 
 
To ensure confidentiality, all paper surveys will be kept in a locked file cabinet or in a secure 
offsite file storage location.  
 
Patient confidentiality will be maintained as is routine for all patient care privacy guidelines. All 
research staff are CITI certified and will be trained on the importance of data confidentiality. 
 
 
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  18 
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.
 
As per requirements of the funder, PCORI, the study team will create a complete, cleaned, de-identified 
copy of the final data set that will include pre-visit, 1 week and 12 month data. Information for 
investigators interested in using this data will be made available on the Health Decision Sciences website. 
Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved 
MGH policies for data sharing. We will never share the key that will enable an investigator to link the 
coded data to an individual. Investigators from other sites will be able to request the data and will be 
required to complete a data use agreement that ensures that all local IRB requirements are met before 
using the data, that they will not attempt to identify any data in the dataset, and that they will not share the 
data set with anyone outside their project team, etc.  
 
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 data on MGH or NWH patients will be stored outside Partners. NEBH patient data that is 
collected outside Partners will be received by the MGH research team (see below). 
 
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
Eligibility screeners and chart review information will be collected from patient medical records 
at NEBH, by NEBH-affiliated study staff. This patient health information is necessary for 
assessing patient eligibility for participation and for administering the study protocol.  As such, 
this patient information will be sent from NEBH to MGH study staff via a secure file transfer or 
REDCap. The paper surveys collected at NEBH will be scanned and sent to the MGH research 
team using a secure file transfer, and the paper copies will be transported for ultimate storage at 
MGH.  
 
All patient identifiers will be kept in a password protected files (Excel, Access database, 
REDCap). Patient eligibility information and medical chart review data from NEBH will be 
collected via REDCap. 
 
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based 
application hosted by the Partners HealthCare Research Computing, Enterprise Research 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  19 
Infrastructure & Services (ERIS) group. Vanderbilt University, with collaboration from a 
consortium of academic and non-profit institutional partners, has developed this software toolset 
and workflow methodology for electronic collection and management of research and clinical 
study data. Data collection projects rely on a study-specific data dictionary defined by members 
of the research team with planning assistance from Harvard Catalyst | The Harvard Clinical and 
Translational Science Center EDC Support Staff. The iterative development and testing process 
results in a well-planned data collection strategy for individual studies. Using REDCap, the 
research team can also design web-based surveys and engage potential respondents using a 
variety of notification methods. REDCap provides flexible features that can be used for a variety 
of research projects and provides an intuitive interface to enter data with real time validation 
(automated data type and range checks). The system offers easy data manipulation with audit 
trails, reports for monitoring and querying participant records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).  
 
 
 
 
 
 
 
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  20 
REFERENCES:  
 
1. Osteoarthritis. Available at: http://www.cdc.gov/arthritis/basics/osteoarthritis. 
 
2. Guccione A, Felson D, Anderson J, Anthony J, Zhang Y, Wilson P, et al. The effects of specific medical 
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5. Katz JN, Earp BE, Gomoll AH. Surgical management of osteoarthritis. Arthritis Care Res (Hoboken) 
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7. Jevsevar D. Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad 
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decision quality for treatment of hip and knee osteoarthritis. J Am Coll Surg 2013 Oct;217(4):694-701. 
 
9. Zikmund-Fisher BJ, Couper MP, Singer E, Ubel PA, Ziniel S, Fowler FJJ, et al. Deficits and variations 
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10. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria 
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11. Elwyn G, Lloyd A, Joseph-Williams N, Cording E, Thomson R, Durand M, et al. Option Grids Shared 
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2001;33(5):337-343. 
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  21 
18. Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing 
of the D1 valuation model. Med Care 2005;43(3):203-220. 
 
19. Jansson KA and Granath F. Health-related quality of life (EQ-5D) before and after orthopedic surgery. 
Acta Orthop 2011;82(1):82-89. 
 
20. Roos EM and Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation 
and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes 2003;1:17. 
 
21. Rodriguez-Merchan EC. Knee instruments and rating scales designed to measure outcomes. J 
Orthop Traumatol 2012;13(1):1-6-doi: 10.1007/s10195-011-0177-4. 
 
22 Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International 
Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis 
Outcome Score (KOOS), Knee Injury and Ostoearthritis Outcome Score Physical Function Short Form 
(KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring 
Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index 
(WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res 
2011;63(Suppl 11):S208-S228-doi: 10.1002/acr.20632. 
 
23. Alviar MJ, Olver J, Brand C, Hale T, Khan F. Do patient-reported outcome measures used in 
assessing outcomes in rehabilitation after hip and knee arthroplasty capture issues relevant to patients? 
Results of a systematic review and ICF linking process. J Rehabil Med 2011;43(5):374-381. 
 
24. Collins NJ and Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly 
used instruments and attributes of a "good" measure. Clin Geriatr Med 2012;28(3):367-394. 
 
25. Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of 
the Western Ontario and McMaster Universities Osteoarthritis Index. Scan J Rheumatol 2003;32(1):46-
51. 
 
26. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a 
health status instrument for measuring clinically important patient relevant outcomes to antirheumatic 
drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988 Dec;15(12):1833-1840. 
 
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