Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
Phase: NA
Conditions: De Quervain Disease
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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 
Neal Chen, M.D 
 
PROTOCOL TITLE 
Treating Depression in Patients with De Quervain's tenosynovitis; An integrated web based skills 
intervention and decision aid 
 
FUNDING 
N/A 
 
VERSION DATE 
1.17.19 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Aim 1: To develop a feasible and acceptable decision aid (DA) combined with a web-based 
depression treatment (Toolkit-depression) to help patients with de Quervain's tenosynovitis make 
informed choices with regard to their treatment, for de Quervain's tenosynovitis and comorbid 
depression. 
Hypothesis: NA 
 
Aim 2: To conduct an RCT of patients with de Quervain's tenosynovitis and compare patients 
who screen in for depression and are randomized to the Toolkit-depression versus patients who 
screen in for depression and undergo enhanced usual care (EUC). Primary outcomes are: pain 
intensity (NRS pain) and disability (DASH). Secondary outcomes are depression and 
catastrophic thinking about pain.  
 
Hypothesis 1a: The DA will be feasible (>75% of participants will agree to participate) and 
accepted by patients (scores on the Client Satisfaction Scale above median split).  
 
Hypothesis 1b: The Toolkit-depression will be feasible (>75% participants randomized to the 
Toolkit-depression will agree to participate and complete at least 3 out of the 4 web modules) 
and accepted by patients (scores on the Client Satisfaction Scale above median split).  
 
Hypothesis 2: Patients randomized to Toolkit-depression will show short-term (pre to post) 
improvements in both primary and secondary outcomes when compared to those randomized to 
enhanced usual care. Improvements will be both statistically and clinically significant. 
 
Hypothesis 3: Patients randomized to Toolkit-depression will show similar improvement (pre to 
post) in both primary and secondary outcomes when compared to those who did not screen in for 
depression and did not use the Toolkit.  
 

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Aim 3: To determine if improvements are durable at 6 month follow up. 
 
Hypothesis 3: Among patients who screen in for depression, those randomized to Toolkit-
depression will show sustained (post 6 months) improvements in both primary and secondary 
outcomes when compared to those randomized to EUC. Improvements will be both statistically 
and clinically significant.  
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
De Quervain’s tenosynovitis is prevalent and treated with discretionary medical 
approaches.  De Quervain's tenosynovitis is a self-limiting condition involving tendinosis of the 
abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons within the first 
extensor compartment of the wrist. It has a prevalence of 1.3-2.1% in women and 0.5-0.6% in 
men. The standard care treatment for de Quervain's tenosynovitis includes a variety of medical 
options including nonsteroidal anti-inflammatory medication (NSAIDs), orthoses, corticosteroid 
injections and surgery. One study showed a significant variation in use of corticosteroid injection 
and surgery between 10 hand surgeons in 2 medical centers. Because de Quervain's tenosynovitis 
is a self-limiting condition surgery is discretionary.  
 
Depression and coping explain the challenges faced by many patients in managing de 
Quervain’s. Research has shown that there is limited correlation between impairment and 
disability is in many orthopedic conditions. A biopsychosocial model that considers the complex 
interactions of biological, psychological and social variables may explain this discrepancy. 
Indeed, studies have shown that depression affects patient reported outcome measures in de 
Quervain's tenosynovitis. Disability is significantly correlated with symptoms of depression, 
anxiety, pain-escaping behavior, and catastrophizing. Multivariable linear regression models 
showed symptoms of depression accounted for 32% of the variability in functional outcomes, 
suggesting that depression is a risk factor for poor outcomes in patients with de Quervain's 
tenosynovitis.  
 
 
Psychosocial skills interventions that target depression may improve outcomes in patients 
with de Quervain’s. A number of studies have shown that psychosocial treatments that are 
focused on teaching coping skills are effective in improving depression as well as decreasing 
disability across many conditions from fibromyalgia, tinnitus distress to chronic pain. Depression 
also predicts outcomes after elective minor surgeries include de Quervain's. The 
multidisciplinary team at MGH has developed a 4 session psychosocial skills intervention 
(Toolkit for Optimal Recovery) for patients with acute musculoskeletal trauma at risk for 
persistent pain and disability, which has been shown to improve pain at rest function, pain with 
activity, pain catastrophizing, depression and pain anxiety when compared to standard care. This 
intervention may also be beneficial for individuals with de Quervain’s who also report 
depression. To date, there are no studies of psychosocial interventions to improve outcome in 
individuals with de Quervain's tenosynovitis. Treating depression represents an unexplored 
opportunity to improve outcomes for patients with de Quervain's tenosynovitis regardless of the 
medical treatment modality they choose.  
 

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Decision aids may help patients make a more informed choice about their treatment for de 
Quervain’s and depression. Decision aids (DA; shared decision making tools—websites, 
videos, or pamphlets) are interventions to prepare patients to make more informed and satisfying 
decisions that match their preferences and values. DA's are designed to provide patients with 
balanced, complete and understandable information about their options as well as risks and 
benefits, in order to help them determine their preferences according to their values16. A 
systematic review of decision aids for treatment or screening decisions found participants felt 
more knowledgeable and better informed with a more active role in decision making17.  A 
decision aid component that educates patients about their depressive symptoms and association 
with symptoms and disability may also be a more sensitive and cost effective way to get timely 
treatment for patients in need. By being more involved in the treatment choice, patients can feel 
empowered and may show better recovery.  
 
This study aims to develop a decision aid (DA) for helping patients with de Quervain's 
tenosynovitis to determine their preferences for treatment (including treatment for depression for 
those with clinical depression) according to their values and relationship with pain and disability.  
 
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 prospective randomized controlled trial of Toolkit depression compared to enhanced 
standard care with a decision aid for patients with de Quervain's tenosynovitis and symptoms of 
major depression.  
 
Inclusion criteria 
Adults (≥18 years) diagnosed with de Quervain's tenosynovitis 
English fluency and literacy 
Ability to give informed consent 
 
Exclusion criteria 
Inability or unwillingness to participate in decision aid (DA) and/or Toolkit-depression 
Major medical comorbidity expected to worsen in the next 6 months 
Comorbid chronic pain condition 
Antidepressant medications changes in the past 6 months 
Severe and untreated mental health conditions or active substance dependence 
Secondary gains such as litigations or worker compensation procedures that may interfere with 
patients' motivation for treatment 
No online device available to use the DA and Toolkit-depression 
 
We expect to enroll 90 patients diagnosed with de Quervain's tenosynovitis. The primary 
outcome measure is change in QuickDASH score. A minimum sample size of 54 patients would 
allow the study 90% power to detect a difference of 15 points in QuickDASH score between 
patients who received the Toolkit-depression intervention and those that did not. Therefore we 
would want to enroll a minimum of 27 patients in each group.  

Partners Human Subjects Research Application 
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In an RCT of the Toolkit, 14% did not complete the intervention at 6 weeks. If we anticipate 
experiencing similar levels, we will need to recruit a minimum sample size of 90 patients (30 
patients in each group) to maintain sufficient power at 6 months follow up.  
 
In a study of depression in patients with common hand diagnoses, 46% of patients with de 
Quervain's tenosynovitis had a PHQ-9 or CES-D score consistent with symptoms of major 
depression. However, while some studies found almost 50% of their patients with de Quervain's 
tenosynovitis had symptoms of major depression, this may be as low as 10%.  
 
A study of de Quervain's tenosynovitis at Massachusetts General Hospital (MGH) and Brigham 
and Women's Hospital (BWH) recruited 2513 patients over 12 years equating to approximately 
200 patients per year. Therefore, it may take between 6 months and just over 3 years to recruit 70 
participants to our trial. 
 
It is also possible that patients may choose to answer the HADS questionnaire in a way that 
underestimates their symptoms of depression. This would then further reduce the rate of 
recruitment of participants to our study.  
 
Participants will complete the base measures at their initial clinical visit, then they receive email 
invitations to complete online surveys at 6 weeks and 6 months. Patients unable to fill out the 
survey will be contacted by telephone and assisted with completion of the questionnaire. 
 
Nested Feasibility Study 
As this study involves introduction of a new concept - a decision aid that introduces the concept 
of depression as a factor affecting the outcome of patients with de Quervain's tenosynovitis, we 
propose a nested feasibility study. During recruitment of the first 10 patients into the study, we 
review their satisfaction scores to see how acceptable they found the DA and if there are any 
ways that we could improve the DA or the recruitment process.  
 
Additionally, we would like to administer 2 questionnaires that ask about symptoms of 
depression at enrolment to these first 10 participants in the study. The PHQ-9 and Hospital 
Anxiety and Depression Scale (HADS) are both used widely in the research literature, and it 
would be useful to know preference of participants so that we can use the preferred questionnaire 
for future studies. We would like to use both questionnaires at enrolment for the first 10 people 
recruited to the study, and ask them which questionnaire they prefer. After the first 10 people 
recruited, we would select the most popular questionnaire and continue with this one alone.  
 
After the first 10 people were recruited, the HADS was chosen as the questionnaire to be used 
for symptoms of depression in the rest of the study. Participants who score 7 on the HADS will 
be eligible to be randomized to the Toolkit intervention. Where a participant HADS score 
indicates symptoms of severe depression (HADS ≥15), REDCap will notify Dr Vranceanu who 
will be able to conduct a psychological assessment of the patient's safety (including suicidality).  
 
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.
 

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Patients will be prescreened by clinical notes and referrals and either contacted before their 
appointment or approached in clinic. Potential subjects will be pre-screened for inclusion and 
exclusion criteria by a questionnaire and questions asked by study staff. Those eligible who wish 
to participate will complete the informed consent process to enroll in the study. Additional detail 
is available in the Recruitment Procedures section of this document.  
 
At enrollment, patients will be asked to complete a questionnaire on symptoms of depression 
(HADS) and the DA for de Quervain's tenosynovitis. Additionally, demographic data will be 
collected, including age, gender, ethnicity, race, marital status, current work status, consulting 
hand surgeon, occupation, education, hand dominance, affected side and current analgesia intake. 
They will also be asked to complete surveys to assess pain intensity (NRS), disability 
(QuickDASH), depression (HADS) and catastrophic thinking (PCS-13) in REDCap.  
 
During their consultation, a hand surgeon will confirm the diagnosis of de Quervain’s. Patients 
that do not have de Quervain's tenosynovitis will be excluded from the study. After their 
consultation, participants randomized to Toolkit-depression will be given a link to access the 
Toolkit online at home.  
 
At 2 weeks, participants will be contacted via REDCap to record initial choice of treatment 
(observation, NSAIDs, orthoses, corticosteroid injection, surgery), acceptability of the decision 
aid (Client Satisfaction Scale CSQ-3) and decisional conflict (Decisional Conflict Scale).  
 
At 6 weeks, participants will be contacted to assess pain intensity (NRS), disability (QuickDASH), 
depression (HADS), catastrophic thinking (PCS-13) and decisional conflict (DCS) online on 
REDCap. Participants randomized to the Toolkit-depression will also be asked about its 
acceptability (CSQ-3).  
 
At 6 months, participants will be contacted to assess pain intensity (NRS), disability 
(QuickDASH), depression (HADS), catastrophic thinking (PCS-13) and decisional conflict (DCS) 
online in REDCap. All participants will be asked about their final choices of treatment 
(observation, NSAIDs, orthoses, corticosteroid injection, surgery) and satisfaction with the DA 
and Toolkit if used (SCQ-3). 
 
In a single-center study of patient-centered care for de Quervain's tenosynovitis, 57% of patients 
who opted for non-operative treatment noted resolution of symptoms within 6 months. In an 
RCT of full-time compared to as-desired splint wearing for patients with de Quervain's 
tenosynovitis, DASH score only improved by a mean of 7 points at follow up after 8 weeks. The 
minimum clinically important difference in DASH score is approximately 10 so it would be 
better to wait until 6 months when symptoms are more likely to have resolved.  
 
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.
 
Enhanced Standard Care includes; options for management explained as observation (see if it 
goes away on its own), NSAIDs, orthoses, corticosteroid injection and surgery in the DA. This 
may include follow up visits with surgeons as required.  
 

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Toolkit-depression includes: a web-based intervention with 4 sessions focused on teaching 
relaxation strategies as well as cognitive and behavioral aspects of acute pain. 
 
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.
 
We do not foresee major additional risks for patients participating in this study. Patients receive 
usual care, regardless of their participation.  
 
There is the possibility that some patients are initially identified as having de Quervain's 
tenosynovitis and complete enrollment questionnaires, but having seen the Specialist Hand 
Surgeon it is determined that they do not have de Quervain's tenosynovitis. This may be 
distressing for some patients. However, this did not pose any problems in a recent study at this 
center (IRB Protocol Number 2015P002550) when 12 patients were excluded after initial likely 
diagnosis of thumb carpometacarpal joint arthritis but were later excluded due to a different 
diagnosis. 
 
The only other discomfort participants may endure is the time required to complete the 
questionnaires and for those randomized to the Toolkit-depression there will be additional time 
required to complete these sessions. There are 4 sessions that will each take approximately 30 
minutes to complete. 
 
In the event that a patient has a severe adverse emotional disturbance while in the study, the 
patient will meet with a psychologist for diffusion and or referral. 
 
Questionnaires will require approximately 20 minutes at the time of the in person visit, and 
online at 6 weeks and 6 months.  
 
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.
 
Study physicians will be readily accessible for consultation should a study patient experience 
increasing discomfort while completing questionnaires. 
 
Where a participant HADS score indicates symptoms of severe depression (HADS ≥15), 
REDCap will notify Dr Vranceanu who will be able to conduct a psychological assessment of 
the patient's safety (including suicidality).  
 
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.

Partners Human Subjects Research Application 
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Since all patients will receive the usual care, participation in this trial does not impose additional 
risks to the patients. This trial does not interfere with the surgical process or postoperative care. 
If the completion of questionnaires causes discomfort for patients, study physicians will be 
readily accessible for consultation.  
 
Where a participant HADS score indicates symptoms of severe depression (HADS ≥15), 
REDCap will notify Dr Vranceanu, a clinical psychologist, who will be able to conduct a 
psychological assessment of the patient's safety (including suicidality).  
 
The greatest discomfort associated with participation is the time required to complete the 
Toolkit-depression. This is anticipated to take approximately 30 minutes to complete each of the 
4 sessions. Additionally, the questionnaires at enrolment, 6 weeks and 6 months will take 
approximately 20 minutes to complete, but this can be done online via REDCap at home.  
 
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. 
 
For subjects receiving enhanced standard care, using the DA may improve satisfaction with their 
decision making with reduced decisional conflict. We hope that patients managed with the 
Toolkit-depression may experience improvement in their symptoms of depression as well as 
improvement in pain intensity and disability in terms of their de Quervain's tenosynovitis. The 
study may also benefit society as a whole by providing a better understanding of the factors that 
influence patient-reported outcomes in de Quervain's tenosynovitis.  
 
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.
 
All adult subjects who satisfy the inclusion/exclusion criteria are eligible for enrollment in this 
study regardless of sex, race or ethnicity. Vulnerable populations will not be recruited.   
 
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.
 

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We must restrict the study to English speaking patients because the web based intervention 
Toolkit-depression is only in English. Additionally many of our questionnaires are validated in 
English only. 
 
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.
 
We will use three recruitment methods in this study: 1. First contact via invitation letters to 
patients with specific mention of de Quervain’s or symptoms thereof per referral or clinical 
notes; 2. First contact during clinical visit for patients with possible de Quervain’s per symptoms 
documented in referral or clinical notes; and 3. First contact made by patients to study staff in 
response to study advertisement on clinicaltrials.partners.org   
 
Recruitment by screening clinic schedule 
Potential subjects will be identified by screening the schedule of the Hand and Arm Center at 
Massachusetts General Hospital. For patients referred to a hand surgeon with a probable diagnosis 
of de Quervain’s tenosynovitis, a recruitment letter may be sent to them by mail or via Patient 
Gateway. The letter explains the purpose of the research - study procedures, and duration of 
participation.  
 
Patients who opt in to the study and will be contacted by study staff to explain the study, obtain 
consent from the subject and answer all remaining questions. Subjects that agree to participate will 
electronically sign the consent form in REDCap. Subjects will receive a copy of the consent form 
via e-mail.  
 
Patients will therefore have the opportunity to start working with the decision-aid prior to their 
appointment and be able to make a more informed decision making process with the specialist. 
They will also be asked to complete enrollment questionnaires, including HADS for symptoms of 
depression.  
 
Recruitment at first clinical visit 
Patients whose referrals do not mention de Quervain’s specifically but that could be presenting for 
de Quervain’s or patients whose appointments are made close enough in the future that it is not 
logistically feasible to contact them for pre-screening will be approached in clinic by study staff. 
Study staff will briefly describe the study and ask if the patient may be interested in participating 
if eligible. If the patient agrees, they will be asked to sign the consent form and proceed with the 
pre-screening questionnaire (HADS) and DA. They will also be asked to complete enrollment 
questionnaires if they have time before their consultation.  

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For all patients, during their consultation a hand surgeon will confirm the diagnosis of de 
Quervain’s. Patients that do not have de Quervain's tenosynovitis will be excluded from the 
study.  
 
Patients that do have de Quervain's tenosynovitis but do not score 7 or above on the HADS will 
be invited to participate in the study to evaluate the decision aid and allow comparison with 
patients who do have symptoms of major depression. 
 
After the initial appointment with the specialist, patients with a diagnosis of de Quervain's 
tenosynovitis and symptoms of major depression will be randomized to the Toolkit-depression 
(Cohort 1) or Standard Care (Cohort 2). The randomization is done within REDCap via generated 
randomization sequence. Subjects randomized to the Toolkit-depression will be given the online 
link to the Toolkit.  
 
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 not receive monetary remuneration for their participation in this study, and patients 
will return to the Hand and Arm Center for their usual practice follow-up examination. 
 
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.
 
Recruitment by screening clinic schedule 

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For those patients receiving a letter prior their appointment and deciding to opt in, they will be 
asked to send their contact information (name, date of birth, e-mail address, and phone number) to 
the principal investigator and study coordinator. A member of the study staff will then get in touch 
with the subject to explain the study.  
 
Subjects that agree to participate will electronically sign the consent form in REDCap. Subjects 
will receive a copy of the consent form via e-mail.  
 
Recruitment at first clinic visit 
For those patients recruited at first clinic visit, study staff will briefly describe the study and ask if 
the patient may be interested in participating if eligible. If the patient agrees to participate, they 
will be asked to sign the consent form and proceed with the pre-screening questionnaire (HADS) 
and DA. 
 
Advertisements on clinicaltrials.partners.org 
For those patients recruited via a study card on Partners’ clinicaltrials.partners.org website, 
subjects that agree to participate will electronically sign the consent form in REDCap. Subjects 
will receive a copy of the consent form via e-mail. 
 
For all patients, during their consultation a hand surgeon will confirm the diagnosis of de 
Quervain’s. Patients that do not have de Quervain's tenosynovitis will be excluded from the 
study.  
 
After the patient is included in the study, a member of study staff will be available to help 
subjects complete questionnaires and for those randomized to the Toolkit-depression will give 
them the link to access it online. 
 
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.        

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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. 
 
Study data will be collected and managed electronically using REDCap, a free online research 
management tool. It enables researchers to create study-specific websites for capturing 
participant data securely. Subjects can log in to complete online questionnaires.  
 
REDCap enables customization of items or instruments (e.g., format, randomization, skip 
patterns), storage of protected health information in a separate, secure database, automated 
accrual reports, real-time data export, among many other features. REDCap is well secured and 
effectively protected and a compliant application that includes databases which store 
confidential, personal health information. All of the questionnaires, including the questionnaires 
filled out by the subject, will be stored on Partners encrypted computers and only members of the 
study staff will have access to this information. If paper copies are used, they will be stored in 
locked filing cabinets or converted to certified digital copies and originals shredded, and only the 
study staff will have access to the documents. 
 
The information collected during the study will not become part of the patient’s medical record. 
Only the investigators and member of the study staff will have access to this information. 
Hardcopies of study related data and forms will be stored in a lockable file cabinet or converted 
to certified digital copies and originals shredded. Only the investigators and study staff specified 
on the consent form will have access to this information. Any magnetic or electronic information 
will be saved in password-protected computers to which only research coordinator and persons 
involved with the research project will have access. 
 
All subjects are given a participation number/code at time of enrollment for this study. While the 
data remains in REDCap it will be stored with subjects’ identifiers, but can be exported into 
deidentified reports. Subject information is only accessible by Partners authorized investigators 
and will not be shared with outside entities.  
 
Subject information will not be accessible to any of the referring hand surgeons at non-Partners 
sites. Each referring hand surgeon will only provide the x-rays and diagnostic information for the 
surgeon’s own patients.  
 
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

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The principal investigator will be responsible for insuring that any adverse events are reported to 
the IRB or federal agencies as necessary.  Adverse events will be reported to the IRB in 
compliance with Partners policy as they are discovered by any study staff member and discussed 
with the PI or designee. The research coordinator, supervised by the principal investigator will be 
responsible for cataloging and tallying adverse events. Serious adverse events (SAEs) will be 
reported to the PHRC in accordance with Partners policy. All proposed staff have participated in 
the NIH required trainings in participation and conduct of studies that involve human subjects, 
and any future study staff will do so upon hiring.  If any study staff discovers any untreated 
condition (e.g. onset of substance abuse or physical condition), they will refer participants to 
appropriate treatment immediately. Study staff will follow Massachusetts’s laws regarding 
mandated reporting for psychologists (i.e. discovery of abuse to a child, elder, or disabled 
person, participant is imminent danger of hurting themselves or an identifiable other person).  
Fluctuations in depressed mood (that do not involve suicidality) are not considered adverse 
events.    
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.
 
There will be a full-time research coordinator and principal investigator responsible for 
adherence to all IRB rules and guidelines and for the accuracy and completeness of all forms, 
entries, and informed consent.  
 
Study data will be maintained in a locked filing cabinet and on password protected computers. 
Questionnaires and self-reported responses will not become part of the subject’s medical record. 
Hardcopies of study related data and forms will be stored in a lockable file cabinet or converted 
to certified digital copies and originals shredded. Subject information will remain confidential by 
keeping identifying information (name and subject number) in a separate locked file cabinet or 
password protected computer or approved database (REDCap). Only the investigators and study 
staff specified on the protocol will have access to this information. Any magnetic or electronic 
information will be saved in password-protected computers to which only research coordinator 
and persons involved with the research project will have access. REDCap, secure and HIPAA-
compliant, will be used to collect all answers. The Principal Investigator oversees and monitors 
this process. 
 
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  

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  October 15, 
2014  
  13 
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_A
dverse_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. Research data will not 
become part of the medical record. Patient information specific to the study will be maintained in 
a private database on a secure network, to which access is limited. Hardcopies of study related 
data and forms will be stored in a lockable file cabinet or converted to certified digital copies and 
originals shredded. All participants are given a participation number/code at the time of 
enrollment. Subject information is only accessible by Partners authorized investigators and 
outside investigators who have been approved by the data use agreement process by the IRB and 
Research Management. Subject information will not be accessible to any of the referring hand 
surgeons at non-Partners sites.  
 
All data will be maintained at MGH in accordance with Partners policy. Data may be shared and 
stored as a limited data set with non-Partners investigators through a Data Use Agreement 
(DUA) with approval of the IRB and Research management. Non-Partners investigators may 
temporarily store the data on password protected, encrypted laptops. 
 
Once the research is complete, all direct patient identifiers will be destroyed. 
 
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.
 
Limited data sets (LDS) may be shared with outside collaborators for the study, including current 
study staff who return to their institution but will continue to collaborate on the study to prepare 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  October 15, 
2014  
  14 
the work for publication and presentation at scientific meetings. Data use agreements will be 
executed as necessary for the sharing of any data to comply with current Partners policy. 
 
Institutions and 
Responsible 
Researchers 
Type of Data 
Explanation 
Massachusetts 
General Hospital 
(Dr. Neal Chen) 
 
University of 
Bristol (Dr. Julia 
Blackburn) 
  
 
Participant information 
(including marital status, 
education level, current 
work status, occupation, 
household income, hand 
dominance), affected 
side, pain medication 
currently taken, 
QuickDASH score, VAS 
pain score, Pain 
Catastrophizing Scale 
score, Hospital Anxiety 
and Depression Scale 
score, Decision Conflict 
Scale score, arm of the 
trial that the participant 
is in, treatment choice, 
satisfaction with the 
Decision Aid and 
Toolkit interventions 
This data will be collected at MGH by a researcher in 
coordination with Dr. Chen. Dr. Chen would like to continue the 
research project with a researcher at the University of Bristol. Dr. 
Neal Chen is the PI for the protocol under which the data was 
collected at MGH. Dr. Julia Blackburn is the responsible PI at the 
University of Bristol. 
  
Use of data: Data will be analysed and used to produce 
publication(s) for peer reviewed journals and poster or podium 
presentations at conferences.  
 
 
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.
 
Data will be stored at the receiving institution for the purpose of conducting research as outlined 
in this protocol. Data at the receiving institution will be stored on a password-protected 
computer, and only study staff will have access to the shared data. Once data is shared, it will be 
stored and records maintained in accordance with the receiving institution’s IRB policies. 
Subjects may withdraw their data by contacting the MGH Arm and Hand Center, who can 
exclude the specified data or contact the receiving institution to delete the specified data. 
 
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.
 
N/A 
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  October 15, 
2014  
  15