Patient Generated Index Research Articles

Portrait of mental health identified by people with the post-covid syndrome.

This study aimed to produce a patient-centered understanding of mental health symptoms of people with the post-COVID-19 syndrome (PCS). A cross-sectional analysis of 414 participants in a longitudinal study was carried out involving people who self-identified as having symptoms of PCS. People were asked to name their most frequent and most bothersome mental health symptoms affected by PCS using the structure of the Patient Generated Index (PGI). The text threads from the PGI were grouped into topics using BERTopic analysis. 20 topics were identified from 818 text threads referring to PCS mental health symptoms. 35% of threads were identified as relating to anxiety, discussed in terms of five topics: generalized/social anxiety, fear/worry, post-traumatic stress, panic, and nervous. 29% of threads were identified as relating to low mood, represented by five topics: depression, discouragement, emotional distress, sadness, and loneliness. A cognitive domain (22% of threads) was covered by four topics referring to concentration, memory, brain fog, and mental fatigue. Topics related to frustration, anger, irritability. and mood swings (7%) were considered as one domain and there were separate topics related to motivation, insomnia, and isolation. This novel method of digital transformation of unstructured text data uncovered different ways in which people think about classical mental health domains. This information could be used to evaluate whether existing measures cover the content identified by people with PCS, to initiate a clinical conversation, or to justify the development of a new measure of the mental health impact of PCS.

Use of the Patient Generated Index to Identify Physical Health Challenges among People Living with HIV: A Cross-sectional Study

Many people living with HIV experience physical health challenges including mobility problems, pain, and fatigue. Purpose: To estimate how many people living with HIV identify physical health challenges as important using the patient generated index (PGI). Secondary Objectives: a. Identify factors associated with reporting physical health challenges; b. Identify relationships between reporting physical health challenges and standardized health-related quality of life (HRQOL) items; and c. Estimate the extent to which reporting a physical health challenge explains downstream HRQOL outcomes. Methods: Cross-sectional data came from a large Canadian cohort. We administered the PGI and three standardized HRQOL measures. PGI text threads were coded according to the World Health Organization's International Classification of Functioning, Disability, and Health. Regression, discriminant analysis, and chi-square tests were used. Results: Of 865 participants, 248 [28.7%; 95% CI (25.7%, 31.8%)] reported a physical health challenge on the PGI. Participants with better pain (OR: 0.81, 95% CI: 0.71, 0.90) and vitality (OR: 0.71, 95%CI: 0.63, 0.80) by 20 points had lower odds of reporting a physical health challenge. Those who reported a physical health challenge had significantly lower HRQOL on some standardized items. Conclusion: The PGI is well-suited to identify the physical challenges of people living with HIV.

The impact of restorative proctectomy versus permanent colostomy on health-related quality of life after rectal cancer surgery using the patient-generated index

BackgroundThe impact of bowel dysfunction versus colostomy on quality of life after rectal cancer surgery is poorly understood. BackgroundTo evaluate the quality of life after rectal cancer surgery in patients with colostomy versus restorative proctectomy. MethodsA mixed-methods study measuring quality of life using the Patient-Generated Index, patients were asked to list up to 5 areas of their life affected by their surgery. Areas were then weighted according to patients’ preferences for improvement to generate a score from 0-100. The areas reported by patients were linked to the International Classification of Functioning for content analysis. Bowel dysfunction was measured using the low anterior resection syndrome score, and patients were then grouped according to (1) colostomy, (2) no/minor, or (3) major low anterior resection syndrome. Quality of life was compared between groups. ResultsOverall, 121 patients were included (colostomy n = 39, restorative proctectomy n = 82). There were no differences in demographics, neoadjuvant radiotherapy, or time to follow-up between groups. In the restorative proctectomy group, 53% had no/minor, and 47% had major low anterior resection syndrome. Overall, patients with colostomy had significantly lower quality-of-life scores than those with restorative proctectomy. However, patients with major low anterior resection syndrome scored similarly to those with colostomy. On content analysis, patients with colostomies reported more problems with sexual function, body image, and sports. Patients with restorative proctectomy reported more problems with sleep, using transportation, and taking care of themselves. ConclusionColostomy has a more detrimental impact on quality of life than restorative proctectomy. However, bowel dysfunction severity is important to consider. The patient experience between treatments differs.

The Patient Generated Index (PGI) as an early-warning system for predicting brain health challenges: a prospective cohort study for people living with Human Immunodeficiency Virus (HIV).

In research people are often asked to fill out questionnaires about their health and functioning and some of the questions refer to serious health concerns. Typically, these concerns are not identified until the statistician analyses the data. An alternative is to use an individualized measure, the PatientGenerated Index (PGI) where people are asked to self-nominate areas of concern which can then be dealt with in real-time. This study estimates the extent to which self-nominated areas of concern related to mood, anxiety and cognition predict the presence or occurrence of brain health outcomes such as depression, anxiety, psychological distress, or cognitive impairment among people aging with HIV at study entry and for successive assessments over 27months. The data comes from participants enrolled in the Positive Brain Health Now (+ BHN) cohort (n = 856). We analyzed the self-nominated areas that participants wrote on the PGI and classified them into seven sentiment groups according to the type of sentiment expressed: emotional, interpersonal, anxiety, depressogenic, somatic, cognitive and positive sentiments. Tokenization was used to convert qualitative data into quantifiable tokens. A longitudinal design was used to link these sentiment groups to the presence or emergence of brain health outcomes as assessed using standardized measures of these constructs: the Hospital Anxiety and Depression Scale (HADS), the Mental Health Index (MHI) of the RAND-36, the Communicating Cognitive Concerns Questionnaire (C3Q) and the Brief Cognitive Ability Measure (B-CAM). Logistic regressions were used to estimate the goodness of fit of each model using the c-statistic. Emotional sentiments predicted all of the brain health outcomes at all visits with adjusted odds ratios (OR) ranging from 1.61 to 2.00 and c-statistics > 0.73 (good to excellent prediction). Nominating an anxiety sentiment was specific to predicting anxiety and psychological distress (OR 1.65 & 1.52); nominating a cognitive concern was specific to predicting self-reported cognitive ability (OR 4.78). Positive sentiments were predictive of good cognitive function (OR 0.36) and protective of depressive symptoms (OR 0.55). This study indicates the value of using this semi-qualitative approach as an early-warning system in predicting brain health outcomes.

Reliability and validity of the Patient Generated Index (PGI) in patients with chronic kidney disease (CKD) on dialysis, a new approach to quality of life

Purpose To evaluate the test-retest reliability and validity of the Patient Generated Index (PGI) in individuals with Chronic Kidney Disease (CDK) undergoing hemodialysis. Methods Through a non-experimental study with repeated measures, PGI was applied twice to assess internal consistency and test-retest reliability. Correlations with the Kidney Disease Quality of Life Short Form (KDQOL-SF), the Human Activity Profile (HAP) questionnaire, the Social Participation Scale, and the Glittre ADL Test were used. Results 91 individuals with CKD were evaluated. There was high reliability for the PGI (ICC= 0.97) PGI correlated with KQDOL – SF in Functional Capacity r = 0.38 (p < 0.001), Emotional Well-Being r = 0.31 (p = 0.003), Social Aspect r = 0.22 (p = 0.036), Emotional Function r = 0.22 (p = 0.038) and Effect of Kidney Disease r = 0.21 (p = 0.042), and Physical scores r = 0.24 (p = 0.021)), Mental r = 0.21 (p = 0.05) and General r = 0.22 (p = 0.037) summarized. There was a significant correlation between PGI and HAP r = 0.40 (p < 0.001) and the Social Participation Scale r = −0.36 (p < 0.001). There was no correlation between the PGI and Glittre ADL scores r = 0.12 (p = 0.247). Conclusion In adults receiving hemodialysis, the PGI proved to be an accurate and reliable instrument for the assessment of the quality of life from the perspective of the patient. IMPLICATIONS FOR REHABILITATION Although hemodialysis treatment is associated with increased survival and symptom control, there is a significant change in the patient’s lifestyle. In order to provide a more focused view of the individual, the Patient Generated Index (PGI) was created to evaluate the quality of life. PGI is reliable and correlates with KQDOL – SF and the Social Participation Scale in this population.

Development of a Prototype for a Bilingual Patient-Reported Outcome Measure of the Important Health Aspects of Quality of Life in People Living with HIV: The Preference Based HIV Index (PB-HIV).

(1) Background: The aim of this project was to develop a short, HIV-specific, health-related quality of life measure with a scoring system based on patient preferences for the different dimensions of the Preference-Based HIV Index (PB-HIV). (2) Methods: This study is a cross-sectional analysis of data from the Canadian Positive Brain Health Now cohort (n = 854; mean age 53 years). Items from the standardized measures were mapped to the areas from the Patient-Generated Index and formed the domains. A Rasch analysis was used to identify the best performing item to represent each dimension. Each item was then regressed on self-rated health (scored 0 to 100) and the regression parameters were used as scaling weights to form an index score for the prototype measure. (3) Results: Seven independent dimensions with three declarative statements ordered as response options formed the PB-HIV Index (pain, fatigue, memory/concentration, sleep, physical appearance/body image, depression, motivation). Regression parameters from a multivariable model yielded a measure with a scoring range from 0 (worst health) to 100 (perfect health). (4) Conclusions: Preference-based measures are optimal, as the total score reflects gains in some dimensions balanced against losses in others. The PB-HIV Index is the first HIV-specific preference-based measure.

Efficacy of Acupuncture on Quality of Life, Functional Performance, Dyspnea, and Pulmonary Function in Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Clinical Trial

Chronic obstructive pulmonary disease (COPD) is a respiratory disease characterized by the presence of chronic airflow obstruction. Previous studies have evaluated the effect of acupuncture treatment (AT) in patients with COPD. Nevertheless, these studies show a great deal of heterogeneity in treatment protocols, having sample sizes that are too small to estimate and clarify effect size and heterogeneity in patients’ baseline. The aim of this study is to evaluate the effectiveness of acupuncture on quality of life, functional performance, dyspnea, and pulmonary function in patients with COPD. As such, patients will go through the following three phases: Phase I–pretreatment: period of subject selection and inclusion in the protocol, with an interview and performance of exams and tests as follows: Mini-Cog, dual-energy X-ray absorptiometry, spirometry, the Patient-Generated Index, Saint George’s Respiratory Questionnaire, the six-minute walk test, the London Chest Activity of Daily Living, and the COPD Assessment Test. Phase II–8 weeks of treatment, with AT 3 times a week, with two parallel groups: Group I–with 50 subjects–AT according to the recommended technical standards; Group II–with 50 subjects–Control, without acupuncture. Phase III–Continuation of AT for 8 weeks, maintaining the subjects in the previously allocated groups and following the same methodology.

Personally Generated Quality of Life Outcomes in Adults With Juvenile Idiopathic Arthritis

To explore quality of life (QOL) using the individualized Patient Generated Index (PGI) in young adults who were diagnosed with juvenile idiopathic arthritis (JIA) in childhood, and to examine associations between PGI ratings and standardized health-related outcome measures. Patients (N = 79, mean age 25.1 [SD 4.2] yrs, 72% female) completed the PGI and the standardized measures: Health Assessment Questionnaire-Disability Index, 12-item Short Form Health Survey (SF-12; physical and mental health-related QOL [HRQOL]), Brief Pain Inventory (pain severity and interference), 5-item Hopkins Symptom Checklist, and visual analog scale for fatigue. Information on morning stiffness, medications, and demographics was also collected. Patients were compared to 79 matched controls. The most frequently nominated areas of importance for patients' personally generated QOL (assessed by PGI) were physical activity (n = 38, 48%), work/school (n = 31, 39%), fatigue (n = 29, 37%) and self-image (n = 26, 33%). Nomination of physical activity was associated with older age, morning stiffness, and more pain interference. Nomination of fatigue was associated with current use of disease-modifying antirheumatic drugs, whereas nomination of self-image was associated with polyarticular course JIA and pain interference. Nomination of work/school was not associated with other factors. Higher PGI scores (indicating better QOL) correlated positively with all SF-12 subscales except role emotional, and negatively with disability, pain severity, pain interference, and morning stiffness. Compared to controls, patients had more pain, poorer physical HRQOL, and less participation in full-time work or school. Physical activity, work/school, fatigue, and self-image were frequently nominated areas affecting QOL in young adults with JIA. The PGI included aspects of QOL not covered in standardized measures.

Quality of life in pediatric-onset multiple sclerosis: Different disease course, different impact, different measurement approach needed

ObjectiveTo understand the impact of pediatric multiple sclerosis (MS), health-related quality of life (HRQL) measures have been used. However, specific areas of concern of youths with MS are not known. The objective of this study was to contribute content for inclusion in a new condition-specific measure of the life impact of MS for children and adolescents. MethodsA patient engagement framework was used, and an online survey was developed using the Patient Generated Index (PGI). Text threads generated by the PGI were mapped to the International Classification of Functioning, Disability, and Health (ICF) and the Comprehensive ICF Core Set for MS. ResultsA total of 20 people completed the PGI survey of which 11 were youths with MS aged 14 to 22 years. Over 75% of the areas nominated by youths with MS were related to activities and participation and approximately 20% were related to body function. In contrast, 60% of the areas nominated by parents were related to body function. This finding indicated that a measure of life impact would need to include both impairments associated with MS and important activities and roles. This new approach has a disability component covers MS-related impairments and is completed using the PGI system where the youth select disability areas affected by MS, rate, and prioritize each area for improvement. The "quality of life" component queries those areas that are going well. ConclusionThis new measurement approach could prove useful in overcoming challenges in developing condition-specific measures for rare conditions.

Health related quality of life among pregnant women living with HIV in Kenya, results from comparing a patient generated index and the Euroqol 5 dimension 3 level

BackgroundStandardized tools are used to measure health-related quality of life (HRQoL) and they focus on selected physical, emotional, and social functioning. This approach may miss out on the heterogeneity of HRQoL among various sub-populations. The patient-generated index (PGI) is a tool used to measure HRQoL based on patients' expectations. Among patients living with HIV, HRQoL is an important indicator as the world moves beyond the UNAIDS 90-90-90 goals, towards the so-called fourth 90 that aims at good HRQoL. We compared the PGI and the Euroqol 5 Dimension 3-level (EQ-5D-3L) to identify areas of importance to pregnant women living with HIV affecting thier HRQoL.MethodsThrough convenience sampling, we surveyed 100 pregnant women living with HIV attending antenatal and postnatal clinics in Western Kenya, using both the PGI and the EQ-5D-3L questionnaires. A PGI score and EQ-5D-3L index were generated for each participant. Data from the PGI was also summarized into themes. The PGI scores and EQ-5D-3L index scores were correlated using Pearson correlation.ResultsFrom the PGI tool, 64% of the women reported having two to three main priority areas of their lives affected by their HIV status. These areas centered on themes of economic wellbeing (84% of the women), physical health (58%), psychological/emotional health (49%), and relationships (28%). The mean PGI score was 2.01 [SD = 1.10; median 1.10]. The majority of the women reported having no problems in any of the 5 dimensions captured in the EQ-5D-3L. The mean EQ-5D-3L score was 0.94 [SD = 1.10; median 1.00]. Both the EQ-5D-3L and the PGI showed less than perfect HRQoL. There was no correlation between the PGI and the EQ-5D-3L scores.ConclusionThe PGI may capture aspects of contextual social and emotional life for Kenyan pregnant women living with HIV that are not identified by generic tools. Highlighting areas of importance to patients’ HRQoL is key as focus shifts towards the fourth 90 and may also inform the design of care programs aligned to patient needs.

Validation of the Patient Generated Index for people with severe mental illness.

The Patient Generated Index (PGI) is a personalized quality of life (QOL) measure. This secondary analysis examined its psychometric properties with people with severe mental illness. Three hundred and eleven people with severe mental illness participated in structured interviews at baseline, 9 months, and 18 months. The PGI captured a range of self-defined life areas. PGI scores were correlated with measures of QOL, hope, and functioning, indicating concurrent (criterion) validity. The correlation with QOL, with the finding that PGI scores were significantly higher for people who were employed (n = 42) versus unemployed (n = 269) and for people without substance use disorder (n = 269) versus those with substance use disorder (n = 42), is indicative of construct validity. The results support the suitability of the PGI as an idiographic measure for monitoring personalized QOL of people with severe mental illness. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Do Generic Preference-Based Measures Accurately Capture Areas of Health-Related Quality of Life Important to Individuals with Amyotrophic Lateral Sclerosis: A Content Validation Study.

ObjectiveThe objectives of this study were to 1) assess the content validity of generic preference-based measures (GPBMs), and (2) examine the convergent validity of the EuroQol 5 Dimension 5 Level (EQ-5D-5L), against the Patient Generated Index (PGI) in Amyotrophic Lateral Sclerosis (ALS).MethodsParticipants were recruited from 3 clinical sites across Canada. The PGI, EQ-5D-5L and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) were administered through an online or hardcopy survey and scores compared for convergent validation. Domains nominated by participants as important to their health-related quality of life were generated using the PGI, classified using the International Classification of Functioning, Disability and Health (ICF) and mapped onto GPBMs to determine content coverage.ResultsFifty-two participants (N=28 female; 61.3 ± 11.6 mean age ± standard deviation (SD); 3.5 ± 2.9 mean ± SD years since diagnosis) completed this study. The top three ICF domains identified by participants were recreation and leisure, lower limb mobility, and interpersonal relationships. The Quality of Well-Being Self-Administered (QWB-SA) scale had the highest content coverage (87%) and the Health Utilities Index 3 (HUI3) had the lowest (33%). Two domains were covered by all GPBMs and no GPBM included all domains identified as important by participants. A moderate correlation coefficient of 0.52 between the PGI and EQ-5D-5L was found.ConclusionThe majority of GPBMs covered only approximately half of the domains important to individuals with ALS suggesting the need for an ALS specific preference-based measure to better reflect the health-related quality of life of this population.

Content validity of preference-based measures for economic evaluation in chronic obstructive pulmonary disease

BackgroundGeneric preference-based measures (GPBMs) are health-related quality of life (HRQoL) measures commonly used to evaluate the cost-utility of interventions in healthcare. However, the degree to which the content of GPBMs reflect the HRQoL of individuals with chronic obstructive pulmonary disease (COPD) has not yet been assessed. The purpose of this study was to examine the content and convergent validity of GPBMs in people with COPD.MethodsCOPD patients were recruited from healthcare centers in Ontario, Canada. The Patient-Generated Index (PGI) (an individualized HRQoL measure) and the RAND-36 (to obtain SF-6D scores; a GPBM) were administered. Life areas nominated with the PGI were coded using the International Classification of Functioning Disability and Health and mapped onto GPBMs.ResultsWe included 60 participants with a mean age of 70 and FEV1% predicted of 43. The mean PGI score was 34.55/100 and the top three overarching areas that emerged were: ‘mobility’ (25.93%), ‘recreation and leisure’ (25.19%) and ‘domestic life’ (19.26%). Mapping of the nominated areas revealed that the Quality of Well-Being scale covered the highest number of areas (84.62%), Health Utilities Indices covered the least (15.38% and 30.77%) and other GPBMs covered between 46 and 62%. A correlation of 0.32 was calculated between the SF-6D and the PGI.ConclusionsThe majority of GPBMs covered approximately half of the areas reported as being important to individuals with COPD. When areas relevant to COPD are not captured, HRQoL scores generated by these measures may inaccurately reflect patients’ values and affect cost-effectiveness decisions.

Measuring quality of life and identifying what is important to Jordanian living with multiple sclerosis using the Arabic version of the patient-generated index.

Patient-generated index (PGI) is one of the individualized measures used to measure the quality of life (QOL) in people with different chronic conditions including multiple sclerosis (MS). However, the psychometric properties of the Arabic version of the PGI have not been fully established in Jordanian living with MS. Therefore, the objective of this study is to identify what matters to Jordanian living with MS and to contribute evidence toward the psychometric properties of the Arabic version of the PGI. A total of 75 participants with MS completed three QOL measures; PGI, the patient determined disease steps (PDDS), and EQ-5D. Generalized estimating equations were used to compare the total score of three QOL measures. Bland-Altman plot and Spearman's correlation coefficient were used to study the relationships and differences between the PGI and the other study measures (PDDS and EQ-5D). Only 66 (88%) of the participants were able to complete the PGI. Overall, 36 areas of QOL concern were nominated by the participants using the PGI with the top three areas were emotional function (47%), involuntary movement reaction functions (45.5%), and walking (44 %). The average global score of the PGI was lower (34±22) than the global score of the EQ-5D (69±23), and the PDDS (68±24). PGI had a moderate correlation with EQ-5D and PPDS. The Arabic version of the PGI is a feasible, acceptable, and valid measure among Jordanians with MS. PGI also captures more important areas that contribute to QOL than EQ-5D and PDDS. PGI could improve the decision making and guide healthcare professionals to provide appropriate intervention programs to reduce the burdens from MS disease and improve QOL.

The patient generated index and decision regret in adolescent idiopathic scoliosis.

AIS patients and their parents will have distinct perspectives regarding the impact of AIS on patients' lives. Current outcome assessment tools for AIS do not fully assess patient-specific disease impact and fail to distinguish between patient and parent perspectives. Patient Generated Index (PGI) has been used in other disease states to assess individual experiences. This study assesses PGI in operative AIS patients and their parents. Level 1, prospective multi-center study. 44 AIS patient and parent pairs completed the PGI questionnaire comprised of three stages (S1, S2, S3) and decision regret (DR). S1 asks for five areas of the patient's life most affected by AIS and a 6th encompassing all other areas of their lives affected, S2 focuses on the magnitude of effect, S3 identifies desire to improve affected areas and DR if the surgery did not improve the specific area. S1 free responses were organized into 14 domains. Descriptive statistics were reported for stage scores; free-response format of PGI and DR limited ability for paired sample t test analysis. Mean age at surgery was 14.3 years, 84% female, and mean major curve magnitude was 61°. The three most common patient-reported concerns prior to surgery were (in descending order): sports, general function, and general fitness. However, the three most common parent-reported concerns were (in descending order): general function, sports, and appearance. Patients reported self-esteem and parents reported physical appearance as the most affected domain (S2). Patients reported pain and self-esteem and parents reported sleep and self-esteem as main operative aspirations (S3). Decision regret was the highest for uncertainty of future health in patients and sleep in parents. AIS patients and their parents reported different concerns and DR regarding surgical treatment. PGI provides insight into patient and parent views toward the disease as well as treatment aspirations.

Validation of an Individualized Measure of Quality of Life, Patient Generated Index, for Use with People with Parkinson's Disease.

Methods Patients with PD completed the PGI and various standard patient-reported outcome (PRO) measures. The PGI and standard PRO measures were compared at the total score, domain, and item levels. Pearson's correlations and independent t-tests were used, as well as positive and negative predictive values. Results The sample (n = 76) had a mean age of 69 (standard deviation 9) and were predominantly men (59%). The PGI was moderately correlated (r = −0.35) with the standardized disease-specific QOL measure Parkinson's Disease Questionnaire (PDQ-8). Within one severity rating, agreement between the PGI and different standard outcome measures ranged from 85 to 100% for walking, 69 to 100% for fatigue, 38 to 75% for depression, and 20 to 80% for memory/concentration. Conclusion This study demonstrates that nominated areas of QOL on the PGI provide comparable results to standard PRO measures, and provides evidence in support of the validity of this individualized measure in PD.

Core patient-reported outcome domains for routine clinical care in chronic pain management: patients' and healthcare professionals' perspective.

To identify a core patient-reported outcome (PRO) domain set to be used in routine clinical care in settings offering specialized and supra-specialized multidisciplinary care to individuals with chronic pain (CP). Two online cross-sectional surveys were administered: one with healthcare professionals (HCPs) and one with individuals with CP. Both surveys included domains of health-related quality of life (HRQoL) from the Patient-Reported Outcomes Measurement Information System (PROMIS) framework. The patients' survey also included the Patient Generated Index (PGI). Areas affected by CP identified in the PGI were mapped to The International Classification of Functioning, Disability and Health (ICF). According to HCPs, the five most relevant HRQoL domains to be assessed in routine clinical care were pain interference, pain intensity, physical function, anxiety and depression. The five areas that were the most valued by individuals with CP were recreation and leisure; global mental function; work and employment; household tasks and walking and moving. In total, these represented 74% of all nominated areas. When triangulating both frameworks (ICF/PROMIS) and perspectives (HCPs/patients), 10 core PRO domains were identified: pain interference, pain intensity, physical function, sleep disturbance, anxiety, depression, ability to participate in social roles and activities, fatigue, sleep-related impairments and self-efficacy. This study identified 10 core PRO domains covering the physical, psychological and social consequences of CP on an individual's life from the perspective of individuals with CP and HCPs. The results can help identify appropriate PRO measures to assess the outcomes of multidisciplinary interventions.

Portuguese translation and validation of the Patient Generated Index (PGI) instrument for patients with Chronic Obstructive Pulmonary Disease: individualized quality of life assessment.

Objective To translate, adapt and validate the Patient Generated Index (PGI) for Brazilians with chronic obstructive pulmonary disease (COPD). Methods 50 volunteers with COPD, mostly men (74%), with 73.1 ± 8.9 years of age, FEV1 of 52.3 ± 14.5% of predicted and FEV1 / FVC of 56.2 ± 8.6% of predicted responded to PGI, to the Saint George Respiratory Questionnaire (SGRQ) and to perform Glittre Activities of Daily Living test (Glittre ADL). After 1-2 weeks, PGI was again applied for the analysis of relative and absolute reliability. Results The translation occurred without changes in the questionnaire. The score obtained in PGI had weak correlation with the SGRQ total score (r = -0.44, p <0.001) and with the impact domain (r = -0.40, p <0.05), presented a moderate correlation with the symptoms domain of the SGRQ (r = -0.55, p <0.001) and weak correlation with the activity domain (r = -0.31, p <0.05). A weak correlation was observed between PGI and Glittre ADL (r = -0.30; p <0.05). It was observed high reliability among the measures of PGI (ICCr = 0.94). Conclusion This study shows that the Brazilian version of PGI is a reliable and valid instrument to measure health-related quality of life (HRQL) in patients with COPD. It is a new and individualized form of evaluation of COPD patient-centered quality of life.

Design and Evaluation of the Electronic Patient-Generated Index.

The patient-generated index (PGI) is an individualized measure of health-related quality of life. Previous work testing the PGI in the oncology setting identified threats to content validity due to navigational and computational completion errors using the paper format. The purpose of this pilot study was to refine and evaluate the usability and acceptability of an electronic PGI (ePGI) prototype in the outpatient radiation oncology setting. This pilot study used adaptive agile web design, cognitive interview, and survey methods. Three iterations of testing and refining the ePGI were required. Fifteen patients completed the refined ePGI using touch screen tablets with little or no coaching required. Nearly all participants rated the ePGI as "easy" or "very" easy to use, understand, and navigate. Up to one half stated they did not share this type of information with their clinician but felt the information on the ePGI would be useful to discuss when making decisions about their care. Eight clinicians participated, all of whom felt the ePGI was a useful tool to initiate dialogue about quality of life issues, reveal infrequent or unusual effects of treatment, and assist with symptom management. The pilot study indicates the ePGI may be useful for use at the point of care. Larger studies are needed to explore the influence it may have in decision-making and restructuring patient/provider communication.

241. Towards a cervical deformity-specific outcome instrument: use of the patient-generated index to capture the disability of cervical deformity

BACKGROUND CONTEXT Existing health outcome (HRQL) metrics fail to correlate with malalignment of the cervical spine and do not adequately capture disability from cervical deformity (CD). The purpose of this study is to introduce the cervical deformity patient generated index (PGI), where patients report their greatest difficulties related to their CD. These responses can then be used to identify the disabling features of CD that are not captured by existing HRQLs and determine items to be included in a CD specific HRQL. PURPOSE To introduce the Cervical Deformity Patient Generated Index (PGI) to determine disabling features of CD that are appropriate for a CD specific HRQL. STUDY DESIGN/SETTING Retrospective review of a prospective operative CD database and prospective development of a novel CD-PGI metric. PATIENT SAMPLE A total of 139 CD patients and 12 PGI patients. OUTCOME MEASURES Existing outcome metrics: NDI, NRS Back/Neck, mJOA, EQ5D, EQ5DVAS, and SWAL-QOL. Cervical Deformity Patient Generated Index (CD-PGI). METHODS CD patients completed the CD-PGI by describing the most important aspects of their disability. Patients wrote five things that bothered them most (Stage 1). Next patients rated the severity for each answer on a scale of 0 (max disability) to 10 (no disability) (Stage 2). Finally, patients “spent” up to 60 points on whichever responses they would like to improve (Stage 3). The PGI score was obtained by summing the product of Stage 2 and Stage 3 values for each response. PGI responses were categorized to find which aspects were most important to CD patients. A CD database was analyzed to assess whether legacy HRQLs correlate with cervical malalignment (CL, TSCL, cSVA, T1S, and C2S). Next PGI responses were analyzed to find how commonly responses were captured by existing cervical HRQL metrics: NDI, NRS Back/Neck, mJOA, EQ5D, EQ5DVAS and SWAL-QOL. Finally NDI and PGI were compared to elucidate major drivers of HRQL scores. RESULTS A total of 139 CD patients (mean cSVA: 46.2mm) and 12 PGI patients (mean cSVA: 62mm) were included. PGI responses were grouped into 6 categories: Pain, Sagittal Discomfort/ROM, Horizontal Gaze/Walking Safety, Activities of Daily Living (ADL), Social Life and Hobbies and Neurologic. mJOA correlated with CL (r=0.21, p=0.01), TS-CL (r=-0.20, p=0.02), and C2S (r=-0.18, p=0.03). PGI scores did not correlate with any HRQLs. 34/60 PGI responses (57%) were found to be captured by existing HRQLs. The EQ5D addressed 53% of PGI responses compared to 43% for NDI, 3% for mJOA address and 0% for SWALQOL. PGI-Pain, -neurologic, -social life, and -ADL responses were addressed by existing HRQLs. However, only 40% horizontal gaze and 0% sagittal discomfort responses were addressed. The main drivers of NDI score were reading, pain, and recreation questions, explaining 80% of variability (r2=0.80). The main drivers of PGI were ADL, sagittal discomfort and social life, explaining 75% of variability (r2=0.75). NDI-Concentration NDI-Reading, NDI-Driving and NDI-Sleep correlated with multiple individual PGI items including PGI-ADL, -sagittal discomfort, and -social life (all r>.75, p CONCLUSIONS Existing HRQL do not adequately capture CD disability and do not correlate with cervical malalignment. PGI items not addressed in existing HRQLs include Sagittal Discomfort/ROM and Horizontal Gaze/Walking Safety. In addition, the most important categories driving PGI scores were found to be ADLs, Sagittal Discomfort/ROM, and Social Life/Hobbies. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.