Presenting Patient-Reported Outcomes (PROs) So That They Can Actually Be Understood by Patients and their Clinicians
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1 Presenting Patient-Reported Outcomes (PROs) So That They Can Actually Be Understood by Patients and their Clinicians KATHERINE CLEGG SMITH, PHD PROFESSOR DEPARTMENT OF HEALTH, BEHAVIOR & SOCIETY JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
2 Acknowledgments Other Authors: Elissa T. Bantug, Elliott Tolbert, Amanda Blackford, Michael D. Brundage, Claire F. Snyder, PRO Data Presentation Stakeholder Advisory Board This research was supported by a Patient-Centered Outcomes Research Institute (PCORI) Award (R ). All statements including findings and conclusions are those of the authors and do not necessarily reporesent the views of the PCORI or its Board of Governors or Methodology Committee
3 What are Patient Reported Outcomes (PROs)? The Food and Drug Administration defines Patient Reported Outcomes as, any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. 1 Cochrane PRO methods group also states, PROs can relate to symptoms, signs, functional status, perceptions, or other aspects such as convenience and tolerability & represent what is most important to patients about a condition and its treatment"
4 Example patient reported outcomes ØPain ØFatigue ØSocial Function ØSexual Function ØSleep ØNausea NIH Collaboratory
5 How can PROs be measured? PROs are signs and symptoms that can be measured in absolute terms (does something exist or how much of something is experienced?) PROs can also be measured in terms of change (how much more or less of something is experienced now compared to X weeks ago?) PROs can be used to put an individual in the context of a comparator group
6 Why are PROs important? ØPROs give primacy to the patient s experience ØIn clinical trials, PROs can be used to compare intervention A vs B ØIn clinical care, individual PRO data can be used to assess health status as well as improvement or worsening over time ØPROs have been found to be influential in treatment decisions ØBUT For PRO data to inform patient-centered treatment decisions, both patients and clinicians must be able to interpret them accurately
7 PRO data and their presentation are complicated Percent of Patients Changed Nausea/Vomiting: Cumulative Percent of Patients Changed at 9 months p=.2 Cut-point for change at 9 months: Improved at 9 months =no change Worsened at 9 months Function Scores: Each panel shows scores for the last four visits. High scores represent high levels of functioning. Yellow highlighting indicates concerning scores that have worsened since last visit Score 7 Physical Function 7 Symptom Scores: Each panel shows scores for the last four visits. High scores represent high levels of symptoms. Yellow highlighting indicates concerning scores that have worsened since last visit Better Score 7 Nausea or Vomiting 7 Percentage of Patients 7 Physical Function Treatment "L" Treatment "P" p=.1 Percentage of Patients 7 Nausea/Vomiting p=.5 Treatment "L" Treatment "P" Better 2/27 3/12 3/26 4/9 4/23 Visit date (Today) 2/27 3/12 3/26 4/9 4/23 Visit date (Today) Emotional Function Pain Better Score 7 Emotional Function 2/27 3/12 3/26 4/9 4/23 Visit date (Today) 7 Better Score 7 Fatigue 2/27 3/12 3/26 4/9 4/23 Visit date (Today) 7 Percentage of Patients 7 Treatment "L" Treatment "P" Global Quality of Life p=.4 Percentage of Patients 7 Treatment "L" Fatigue Treatment "P" p=.3 Better Score Overall Quality of Life 7 2/27 3/12 3/26 4/9 4/23 Visit date (Today) 7 Better Score Pain 7 2/27 3/12 3/26 4/9 4/23 Visit date (Today) 7 Percentage of Patients 7 Treatment "L" Treatment "P" p=.1 Percentage of Patients 7 Treatment "L" Treatment "P" p=.5
8 The goal of our PRO Presentation research ØThis research program entailed a 3-stage, stakeholder-informed, mixed-methods process to examine & improve approaches for presenting PRO data ØResearch involved examining existing presentation approaches, working with stakeholders to develop alternative presentations and then testing candidate approaches with the audiences who need to be able to understand and use them. ØToday, I will be presenting data from the 3 rd phase, where we evaluate improved presentations of clinical trial data to be used in clinical decision making
9 Emergent challenges to understanding PRO data The lines represent the average (mean) scores of patients on each treatment at baseline () and at each assessment point up to 12 months. The vertical bars represent variation in the scores at each point (95% confidence limits around the average scores). p-values less than.5 indicate significant differences between treatments. Higher scores represent better function or global QOL Treatment P Higher scores represent a higher level of symptoms (greater symptom burden) Treatment L ØData scoring Does higher mean better or more of something? ØData scale What is the possible range of scores? Are scales normed? If so, to whom? ØData presentation What information is important for data to be understood? p=.1 p=.3 p=.1 p=.1 p=.7 p=.1
10 Interpretation & preferences for presentation of PRO trial results ØInformed by developmental work with stakeholders, fielded 3 versions of line graphs comparing outcomes for treatment X vs Y over time ØMixed Methods Approach: Internet survey and semi-structured interviews with patients, clinicians & researchers ØEach participant saw 1 improved version of line graphs: More, Better or Normed ØTested interpretation accuracy and enquired about preference through 3 questions (same questions and data for all formats) ØUsed one-on-one interviews to provide insight for survey data responses
11 Regular ( More ) Line Graphs
12 Reversed ( Better ) Line Graphs
13 Normed Line Graphs
14 At 12 months, on which treatment are patients better able to do PHYSICAL activities? Better
15 Study Participants ØInternet survey yielded 17 participants: 629 patients, 139 clinicians, 249 PRO researchers ØPatients varied in terms of cancer type ØClinicians varied in terms of area of specialization and years in practice ØOne-on-One interviews: patients & 5 clinicians from local clinical research network Characteristic Survivors (n=629) Clinicians (n=139) Researchers (n=249) Age Mean(SD) 58.1 (11.3) 43.8 (12.56) 45. (11.92) Male n(%) 7 (13.3) 58 (46.) 74 (33.3) Race n(%) White 494 (94.1) 87 (7.2) 175 (79.2) Black/African- 16 (3.) 3 (2.4) 4 (1.8) American Asian 6 (1.1) 23 (18.5) 32 (14.5) Other 9 (1.7) 11 (8.9) (4.5) Hispanic n(%) 16 (3.1) 9 (7.3) 9 (4.1) Country n(%) United States 4 (85.6) 62 (49.2) 7 (48.6)
16 Accuracy % Patients Clinicians Researchers % % 7% % % % % % % % Legend One Correct Two Correct All Correct "More" Normed "Better" "More" Normed "Better" "More" Normed "Better" Proportion of Respondents
17 Accuracy % Patients Clinicians Researchers % % 7% % % % % % % % Legend One Correct Two Correct All Correct "More" Normed "Better" "More" Normed "Better" "More" Normed "Better" Proportion of Respondents
18 Accuracy % Patients Clinicians Researchers % % 7% % % % % % % % Legend One Correct Two Correct All Correct "More" Normed "Better" "More" Normed "Better" "More" Normed Proportion of Respondents "Better" Patients & Clinicians randomized to see the line graphs where higher always meant better were more likely to accurately answer questions than those in the more or normed versions. For researchers the more version was best
19 Clarity assessments & interview insights ØAll conditions were generally rated (>75%) as somewhat or very clear Ø Better formats were more likely to be rated as clear than the others The fact that the positive/negative scale changes between functioning and symptoms (so that up means different things) makes error much, much more likely in interpreting these graphs (patient) Because the axes reverse between function and symptom graphs, people might judge the graphs wrong depending on which they look at first (researcher) If you don t read the chart header, it can be confusing to switch from better being the line going up to worse being the line going up, so consistency in that might be helpful, which is understandably hard considering what s being measured. (patient)
20 In conclusion ØPRO data from clinical trials can only empower patients to make informed decisions if they (and their clinicians!) can understand data as presented ØThere are many challenges in presenting PRO data its not easy! ØLine graphs where higher scores always reflected better outcomes over time were most accurately interpreted by patients and clinicians ØThis type of work on visual format of presentation should inform standards for decision aids and other clinical tools
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