Concept Mapping Versus InterviewsVOICeNCT02792777
Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes
An observational study of Concept Mapping Versus Interviews, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The goal of this study is to improve the methods with which researchers identify patient centered outcomes for use in research. Specifically, the investigators will test the application of concept mapping as compared to one-on-one interviews as a comprehensive and efficient method of identifying patient-important… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concept Mapping Versus Interviews
- What is being tested?
- Interviews and Concept Mapping (CM)
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 2 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators aim to engage a discrete population of patients who have recently sought care at Thomas Jefferson University for treatment needs related to moderately to poorly controlled diabetes. Consistent with the overall population served by Jefferson, the investigators expect greater than 50% of enrolled patients to be African American and approximately 30% of them to be at the <20% federal poverty line. All data will be collected prospectively. The investigators decided to engage patients with moderately to poorly controlled DM because these patients have a known high risk of severe complications related to poor diabetes control, and a significant proportion of patients remain poorly controlled despite available therapies. The investigators thus determined in discussion with the PAKSAB that this population is a good candidate for testing the method of concept mapping to identify patient-important outcomes.
Who may be able to join
- Adult patient (age 18 and older)
- English speaking
- Provide informed consent
- Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for interview groups):
- Acute care setting: patient in the Jefferson Emergency Department (ED) for a diabetes-related problem determined to require medical treatment
- Post-acute care setting: patient was discharged from the Jefferson Family Medicine Associates (JFMA) hospital service within the past 7 days after admission for a diabetes-related problem
Show all 11Show fewer
- Primary care setting: patient currently attending a routine scheduled care visit (not urgent need) at the JFMA practice and has at least 2 measurements of HgbA1C > 7.5 in the prior one year
- Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for concept mapping groups):
- Acute care setting: patient within the Jefferson ED patient contact database (see below) who has had a visit to the Jefferson ED over the past 6 months (as determined on chart review) for a diabetes-related problem
- Post-acute care setting: patient was discharged from the JFMA hospital service within the past 6 months after admission for a diabetes-related problem
- Primary care setting: patient has had routine scheduled office visit within the past 6 months to the JFMA practice and has at least 2 measurements of HgbA1C > 7.5 in the prior one year
Who cannot join
- Patient has had a significant permanent complication related to DM including:
- End stage renal disease
- History of amputation
- Blindness related to diabetes complication
- Patient undergoing medical clearance for a detox center or any involuntary court or magistrate order
- Patient in police custody or currently incarcerated individual
- Patient who has, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to improve the methods with which researchers identify patient centered outcomes for use in research. Specifically, the investigators will test the application of concept mapping as compared to one-on-one interviews as a comprehensive and efficient method of identifying patient-important outcomes for use in research.
Read the detailed description
This is an observational study comparing two methods - concept mapping and one-on-one interviews. The investigators will test the methods themselves by comparing the comprehensiveness of the lists of patient-important outcomes obtained through each method (primary outcome) as well as the efficiency, as measured by resource intensiveness, of the methods (secondary outcome). The aims of this study will be tested with adult patients with moderately to poorly controlled diabetes mellitus who receive care at a large, urban, academic health system. In order to allow comparisons of the comprehensiveness of the methods in producing patient-important outcomes regardless of the healthcare setting in which outcomes are elicited, the investigators will recruit patients for the interview group from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The investigators will then recruit patient-participants from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. In Aim 2, the investigators will test the hypothesis that concept mapping in a research setting produces outcomes consistent with those elicited from patients in the "real-world" settings. In Aim 3, the investigators will assess the overall resource utilization, assessed primarily by time required from patients, the research team, and the advisory board, of qualitative interviews conducted to thematic saturation within a single healthcare setting compared to resources used for a single iteration of concept mapping.
Findings from this work will improve patient-centered outcomes research methods by providing researchers with information about standardized scalable methods to identify patient-important outcomes for use in research studies, so that individual patients are able to select outcomes that are most useful to them. In addition to providing insight regarding methods for eliciting patient-centered outcomes, the study will also provide valuable information to stakeholders regarding how patients' priorities vary across the care continuum. The investigators will report how findings from concept mapping apply across healthcare settings, and the degree to which patient priorities (based on interviews) differ across healthcare settings. If concept mapping results (collected in the research setting) capture the priorities identified by patients across different healthcare settings, this finding would enhance researchers' ability to perform studies in different, or multiple, settings. If the findings do not generalize across settings, this will be a valuable finding demonstrating that patient priorities differ across interview settings and patient acuity and will validate researchers' needs to be specific about the setting in which they choose to perform research to ensure they are reaching their intended patient population.
The work is being performed in close collaboration with the Patient and Key Stakeholder Advisory Board (PAKSAB) - equal partners with the research team who have been involved with the proposal from inception. PAKSAB members will be part of the research team throughout conducting the aims and assisting with all analysis and data interpretation.
- Conditions
- Concept Mapping Versus Interviews
- Being tested
- Interviews, Concept Mapping (CM)
- Keywords
- Concept Mapping, VOICe, Interviews, Patient-Centered Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis.
Concept Mapping (CM)Other
The CM process consists of 3 steps that take place over 3 sessions:
Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.
Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.
Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.
Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group.
| Study group | Role | What they receive |
|---|---|---|
| Interviews | Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants. Receives: Other: Interviews | |
| Concept Mapping | Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. The total recruitment goal for this cohort is 60 people. Receives: Other: Concept Mapping (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensiveness of Interviews as Compared to One Concept Mapping Group
The investigators will use a qualitative content analysis approach to analyze interview transcripts from one healthcare setting, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in the interviews from one healthcare setting that are present in the list of patient-important outcomes generated from the initial concept mapping group during the brainstorming session. The investigators will also identify the presence of unique outcomes found in each method.
Measured: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
The investigators will use a qualitative content analysis approach to analyze interview transcripts, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in interviews that are present in an aggregate list of patient-important outcomes generated from the brainstorming session of all three concept mapping groups. The investigators will also identify the presence of additional patient-important outcomes in three concept mapping groups that were not identified in interviews.
Measured: Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days
Comprehensiveness of Concept Mapping
The investigators will measure the comprehensiveness of outcomes elicited in one concept mapping group compared to multiple groups. The investigators will assess "concept mapping saturation," wherein we compare the patient-important outcomes that emerge from each CM group. The investigators will use the outcomes from our first group as the "baseline data," and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic "concept mapping saturation curve."
Measured: 3 days for one concept mapping group
Secondary outcomes (2)
Comparison of Method Efficiency in Terms of Time
The investigators will assess the efficiency of implementation of the two methods, with efficiency including time required by researchers (team of 3) and patient-participants to complete each method. The investigators will compare the efficiency of conducting one concept mapping iteration (24 participants) to the efficiency of performing one set of interviews done to theme saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation.
Measured: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Comparison of Method Efficiency in Terms of Cost
The investigators will assess the efficiency of implementation of the two methods, with efficiency assessed by cost to complete a single concept mapping iteration (24 participants) and cost to complete one set of interviews performed to saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation.
Measured: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2016
- Primary completion29 Jan 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Concept Mapping Versus InterviewsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792777
- Sponsor's protocol ID
- 15G.667
- Acronym
- VOICe
- Status last verified
- Oct 2019
- First submitted
- 2 Jun 2016
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gentsch AT, Reed MK, Cunningham A, Chang AM, Kahn S, Kovalsky D, Doty AMB, Mills G, Hollander JE, Rising KL. "Once I take that one bite": the consideration of harm reduction as a strategy to support dietary change for patients with diabetes. BMC Endocr Disord. 2024 Jan 2;24(1):3. doi: 10.1186/s12902-023-01529-6.
PubMed 38166864LaNoue M, Gentsch A, Cunningham A, Mills G, Doty AMB, Hollander JE, Carr BG, Loebell L, Weingarten G, Rising KL. Eliciting patient-important outcomes through group brainstorming: when is saturation reached? J Patient Rep Outcomes. 2019 Feb 4;3(1):9. doi: 10.1186/s41687-019-0097-2.
PubMed 30714080Rising KL, LaNoue M, Gentsch AT, Doty AMB, Cunningham A, Carr BG, Hollander JE, Latimer L, Loebell L, Weingarten G, White N, Mills G. The power of the group: comparison of interviews and group concept mapping for identifying patient-important outcomes of care. BMC Med Res Methodol. 2019 Jan 8;19(1):7. doi: 10.1186/s12874-018-0656-x.
PubMed 30621586
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes
- ClinicalTrials.gov ID
- NCT02792777
- Acronym / sponsor ID
- VOICe / 15G.667
- Conditions
- Concept Mapping Versus Interviews
- Keywords
- Concept Mapping, VOICe, Interviews, Patient-Centered Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jan 2016
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to improve the methods with which researchers identify patient centered outcomes for use in research. Specifically, the investigators will test the application of concept mapping as compared to one-on-one interviews as a comprehensive and efficient method of identifying patient-important outcomes for use in research.
Detailed description
This is an observational study comparing two methods - concept mapping and one-on-one interviews. The investigators will test the methods themselves by comparing the comprehensiveness of the lists of patient-important outcomes obtained through each method (primary outcome) as well as the efficiency, as measured by resource intensiveness, of the methods (secondary outcome). The aims of this study will be tested with adult patients with moderately to poorly controlled diabetes mellitus who receive care at a large, urban, academic health system. In order to allow comparisons of the comprehensiveness of the methods in producing patient-important outcomes regardless of the healthcare setting in which outcomes are elicited, the investigators will recruit patients for the interview group from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The investigators will then recruit patient-participants from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. In Aim 2, the investigators will test the hypothesis that concept mapping in a research setting produces outcomes consistent with those elicited from patients in the "real-world" settings. In Aim 3, the investigators will assess the overall resource utilization, assessed primarily by time required from patients, the research team, and the advisory board, of qualitative interviews conducted to thematic saturation within a single healthcare setting compared to resources used for a single iteration of concept mapping.
Findings from this work will improve patient-centered outcomes research methods by providing researchers with information about standardized scalable methods to identify patient-important outcomes for use in research studies, so that individual patients are able to select outcomes that are most useful to them. In addition to providing insight regarding methods for eliciting patient-centered outcomes, the study will also provide valuable information to stakeholders regarding how patients' priorities vary across the care continuum. The investigators will report how findings from concept mapping apply across healthcare settings, and the degree to which patient priorities (based on interviews) differ across healthcare settings. If concept mapping results (collected in the research setting) capture the priorities identified by patients across different healthcare settings, this finding would enhance researchers' ability to perform studies in different, or multiple, settings. If the findings do not generalize across settings, this will be a valuable finding demonstrating that patient priorities differ across interview settings and patient acuity and will validate researchers' needs to be specific about the setting in which they choose to perform research to ensure they are reaching their intended patient population.
The work is being performed in close collaboration with the Patient and Key Stakeholder Advisory Board (PAKSAB) - equal partners with the research team who have been involved with the proposal from inception. PAKSAB members will be part of the research team throughout conducting the aims and assisting with all analysis and data interpretation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interviews | – | Other: InterviewsInterview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants. |
| Concept Mapping | – | Other: Concept Mapping (CM)Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. The total recruitment goal for this cohort is 60 people. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to engage a discrete population of patients who have recently sought care at Thomas Jefferson University for treatment needs related to moderately to poorly controlled diabetes. Consistent with the overall population served by Jefferson, the investigators expect greater than 50% of enrolled patients to be African American and approximately 30% of them to be at the <20% federal poverty line. All data will be collected prospectively. The investigators decided to engage patients with moderately to poorly controlled DM because these patients have a known high risk of severe complications related to poor diabetes control, and a significant proportion of patients remain poorly controlled despite available therapies. The investigators thus determined in discussion with the PAKSAB that this population is a good candidate for testing the method of concept mapping to identify patient-important outcomes.
Key inclusion criteria (11 listed)
- Adult patient (age 18 and older)
- Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for interview groups):
- Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for concept mapping groups):
Key exclusion criteria (7 listed)
- Patient has had a significant permanent complication related to DM including:
- Patient undergoing medical clearance for a detox center or any involuntary court or magistrate order
- Patient in police custody or currently incarcerated individual
- Patient who has, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsPatients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis. | Other | Interviews |
| Concept Mapping (CM)The CM process consists of 3 steps that take place over 3 sessions: Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group. Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software. Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters. Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group. | Other | Concept Mapping |
Primary outcome
Comprehensiveness of Interviews as Compared to One Concept Mapping Group
Time frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
The investigators will use a qualitative content analysis approach to analyze interview transcripts from one healthcare setting, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in the interviews from one healthcare setting that are present in the list of patient-important outcomes generated from the initial concept mapping group during the brainstorming session. The investigators will also identify the presence of unique outcomes found in each method.
Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
Time frame: Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days
The investigators will use a qualitative content analysis approach to analyze interview transcripts, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in interviews that are present in an aggregate list of patient-important outcomes generated from the brainstorming session of all three concept mapping groups. The investigators will also identify the presence of additional patient-important outcomes in three concept mapping groups that were not identified in interviews.
Comprehensiveness of Concept Mapping
Time frame: 3 days for one concept mapping group
The investigators will measure the comprehensiveness of outcomes elicited in one concept mapping group compared to multiple groups. The investigators will assess "concept mapping saturation," wherein we compare the patient-important outcomes that emerge from each CM group. The investigators will use the outcomes from our first group as the "baseline data," and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic "concept mapping saturation curve."
2 secondary outcomes
Comparison of Method Efficiency in Terms of Time
Time frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Comparison of Method Efficiency in Terms of Cost
Time frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38166864Gentsch AT, Reed MK, Cunningham A, Chang AM, Kahn S, Kovalsky D, Doty AMB, Mills G, Hollander JE, Rising KL. "Once I take that one bite": the consideration of harm reduction as a strategy to support dietary change for patients with diabetes. BMC Endocr Disord. 2024 Jan 2;24(1):3. doi: 10.1186/s12902-023-01529-6.
- Derived from this study: PubMed 30714080LaNoue M, Gentsch A, Cunningham A, Mills G, Doty AMB, Hollander JE, Carr BG, Loebell L, Weingarten G, Rising KL. Eliciting patient-important outcomes through group brainstorming: when is saturation reached? J Patient Rep Outcomes. 2019 Feb 4;3(1):9. doi: 10.1186/s41687-019-0097-2.
- Derived from this study: PubMed 30621586Rising KL, LaNoue M, Gentsch AT, Doty AMB, Cunningham A, Carr BG, Hollander JE, Latimer L, Loebell L, Weingarten G, White N, Mills G. The power of the group: comparison of interviews and group concept mapping for identifying patient-important outcomes of care. BMC Med Res Methodol. 2019 Jan 8;19(1):7. doi: 10.1186/s12874-018-0656-x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concept Mapping Versus Interviews, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensiveness of Interviews as Compared to One Concept Mapping Group (time frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792777, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.