Importance Of Patient-reported Outcomes Research Articles

Pilot study of iPad-based patient-reported outcomes at the MGH Cancer Center.

190 Background: Patient reported outcomes (PROs) have been shown to improve outcomes in cancer patients in clinical trials and have also been shown to improve the patient experience, provide real-time access to patient reported symptoms and are increasingly used across disciplines. Given the importance of PROs, at the MGH Cancer Center, we implemented a pilot using iPADs to capture patient reported outcomes for patients receiving IV chemotherapy in the breast and lymphoma clinics as well all IV chemotherapy patients at one of the MGH satellite clinics where patients across all disease groups are seen. Methods: 12 measures from the PRO-CTCAE were selected to be applicable to all cancer patients. Working with the technology team and EPIC team at MGH the selected PROs were loaded into iPADs and are automatically assigned to patients receiving IV chemotherapy. Staff and clinicians were trained in the breast, lymphoma and satellite clinic. Patient who were receiving IV chemotherapy were assigned iPADs at check in. Patients completed the questionnaire and in real-time, the data was available in the EPIC chart. The objectives of the pilot were to assess the feasibility of collecting iPAD based PROs at the MGH Cancer Center. Results: In the 4-month pilot, there were 2,304 visit types that were eligible to receive an iPAD for PRO collection, 79% (N = 1,1816) patients were assigned an iPAD. Of the 1,816 patients assigned an iPAD, 65% (N = 1,173) patients completed the PROs, 4% (N = 36) partially completed the PROs. In terms of completion at the main disease specialty clinic vs the satellite, completion rates were higher at the satellite (77% vs 44%). During one week, we asked the front desk to record why patients did not complete the PROs-93 patients were assessed, 45% of patient refused the iPAD, in 28% of these patients the staff did not capture the reason and 22% were not given an iPAD. Conclusions: This pilot demonstrates the feasibility of collecting PROs in an oncology clinic for patients receiving IV chemotherapy. We plan to continue to improve the assignment of PROs to eligible patients, educate staff, providers and patients on the important of PROs and plan to expand to all the clinics at MGH Cancer Center and satellite centers.

Agreement of child and parent-proxy reported health-related quality of life in children with mental disorder.

The purpose of the study was to test whether elevated levels of depressive and anxiety symptoms affect parent-proxy reports of health-related quality of life (HRQL) of children with mental disorder. A sample of 114 children, who screened positive for mental disorder using the Mini International Neuropsychiatric Interview were studied. Parents' depressive symptoms were measured using the Center for Epidemiological Studies Depression Scale (CES-D) and anxiety symptoms using the State Trait Anxiety Inventory (STAI). To examine whether parental psychopathology moderated their reports of child HRQL (using the KIDSCREEN-27), a series of multiple regression analyses with product-term interactions were conducted. Significant interactions were found for the moderating effect of parental depressive [β= 0.025 (0.007, 0.042)] and anxiety symptoms [β = 0.033 (0.011, 0.054)] on the domain of child social support and peers relations, as well as for the moderating effect of parental levels of depression on parent proxy child physical well-being [β=-0.017 (-0.031, -0.003)]. Parents with elevated levels of depressive or anxiety symptoms reported lower scores for those domains of child HRQL. Symptoms of depression and anxiety in parents influence their reports of the HRQL of their children with mental disorder, particularly in the areas of physical well-being and social support and peers. Given the importance of patient-reported outcomes in the assessment and monitoring of children with chronic conditions, including HRQL, health professionals caring for children with mental disorder should be aware of how parental psychopathology contributes to informant bias. Future research examining why psychopathology influences parental reports of child HRQL is warranted.

Dutch translation and validation of the pelvic organ prolapse/incontinence sexual questionnaire-IUGA revised (PISQ-IR).

Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Dutch. The translated PISQ-IR was linguistically validated, followed by psychometrical validation among women presenting with symptoms of pelvic floor dysfunction in urogynecology clinics. For analysis of the criterion validity, the Pelvic Floor Dysfunction Inventory-20 (PFDI-20) and Female Sexual Function Index (FSFI) were used. Descriptive statistics, floor and ceiling effects, internal consistency using Cronbach's alpha coefficient and Pearson's and Spearman's correlations were calculated for all PISQ-IR subscales. The PISQ-IR was completed by 220 women, of whom 61 (27.7%) considered themselves not sexually active (NSA) and 159 (72.3%) sexually active (SA). The mean age of participating women was 57years; 49.5% reported symptoms of pelvic organ prolapse (POP), 66.8% urinary incontinence and 2.3% anal incontinence. The PISQ-IR subscales were analyzed separately for SA and NSA women with Cronbach's alpha coefficient ranging from 0.61 to 0.87. Moderate to high correlations were observed between PISQ-IR subscales and corresponding FSFI subscales and a moderate correlation between urinary distress and the condition impact (CI) subscale among NSA subjects. The Dutch PISQ-IR demonstrated a good internal consistency and criterion validity compared with the FSFI, but criterion validity compared with the PFDI-20 was poor except for urinary distress in NSA women and needs further attention.

What Is Health-Related Quality of Life? Perspectives from Diabetes Care Providers

Background: While health-related quality of life (HRQoL) is gaining recognition as an important patient-reported outcome, little is known about how diabetes care providers define or apply HRQoL in practice. The purpose of this study was to identify how diabetes care providers conceptualize HRQoL for youth and adults with type 1 diabetes (T1D) to help guide efforts to more routinely assess and intervene to improve HRQoL. Methods: As part of a larger qualitative study on T1D-specific HRQoL, semi-structured qualitative interviews were conducted with 8 diabetes care providers (5 pediatric providers, 3 adult providers, 62.5% male) via focus groups or individually. Sessions were audio-recorded, transcribed, and coded to derive common themes. Results: Providers identified three key components of T1D-specific HRQoL: (1) their patients’ day-to-day functioning, including the ability to engage in everyday activities and its impact on their emotional well-being; (2) their patients’ medical management, including diabetes self-management behaviors and presence of complications and hypo/hyperglycemia; and (3) the impact of T1D on their patients’ personal relationships, including the impact on the HRQoL of their parents/partners. Conclusion: Providers described three aspects of T1D-specific HRQoL: everyday functioning, medical considerations, and interpersonal relationships. This extends the HRQoL literature from other chronic condition populations, which has not emphasized provider perceptions of HRQoL, has primarily identified medical domains such as disease-specific symptoms/complications, and provides little understanding of HRQoL of other family members. Together with findings about patient/family perspectives on HRQoL from the larger study, the current findings about how diabetes care providers conceptualize diabetes-specific HRQoL are necessary to help guide clinical processes to routinely assess and enhance HRQoL across the lifespan. Disclosure V.T. Cao: None. S.S. Eshtehardi: None. B.M. McKinney: None. B. Anderson: Advisory Panel; Self; Sanofi-Aventis. D.G. Marrero: None. D. Thompson: None. M.E. Hilliard: None.

The dynamics of self-care in the course of heart failure management: data from the IN TOUCH study.

IntroductionSelf-care is an important patient-reported outcome (PRO) for heart failure (HF) patients, which might be affected by disease management and/or telemonitoring (TM). The number of studies reporting the influence of TM on self-care is limited.AimsThis study aimed: to assess whether TM, in addition to information-and-communication-technology (ICT)-guided disease management system (ICT-guided DMS), affects self-care behavior; to evaluate the dynamics of self-care during the study; to investigate factors contributing to self-care changes; and to identify a patient profile that predisposes the patient to improvement in self-care.MethodsIn the INnovative ICT-guided-DMS combined with Telemonitoring in OUtpatient clinics for Chronic HF patients (IN TOUCH) study, 177 patients were randomized to either ICT-guided DMS or TM+ICT-guided DMS, with a follow-up of 9 months. The current analysis included 118 participants (mean age: 69±11.5 years; 70% male) who filled the following PRO instruments: the nine-item European Heart Failure Self-care Behaviour scale (EHFScBs), Hospital Anxiety and Depression scale (HADs), and Minnesota Living with HF Questionnaire (MLHFQ).ResultsThe baseline level of self-care was better in the TM+ICT-guided-DMS group (n=58) compared to ICT-guided-DMS group (n=60, p=0.023). Self-care behavior improved in the ICT-guided-DMS group (p<0.01) but not in the TM+ICT-guided-DMS group. Factors associated with self-care worsening were as follows: higher physical subscale of MLHFQ (per 10 points, p<0.05), lower left ventricular ejection fraction (LVEF) (per 5%, p<0.05), lower New York Heart Association (NYHA) class (class III vs class II, p<0.05). The subgroups of patients who had an initial EHFScBs total score >28, or from 17 to 28 with concomitant HADs depression subscale (HADs_D) score ≤8, demonstrated the greatest potential to improve self-care during the study.ConclusionTM did not have an advantage on self-care improvement. Poor physical aspect of quality of life, lower LVEF, and lower NYHA class were associated with self-care worsening. The greatest self-care improvement may be achieved in those patients who have low or medium initial self-care level in the absence of depression.

PRO labeling for oncology drugs approved by FDA and EMA, 2012-2016.

e18730Background: Although both the FDA and EMA note the importance of patient-reported outcomes (PROs) in oncology drug development, a recently published comparison of new drugs approved by these ...

The importance of patient-reported outcomes in cancer studies

ABSTRACTIntroduction: Cancer incidence is increasing; one in two people in the UK are expected to develop cancer during their lifetime. However, survival rates of people living with cancer have imp...

Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review

Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.

Predictors of self-reported health-related quality of life according to the EQ-5D-Y in chronically ill children and adolescents with asthma, diabetes, and juvenile arthritis: longitudinal results.

Health-related quality of life (HRQoL) is an important patient-reported outcome in clinical and health research. The EQ-5D-Y assesses child and adolescent HRQoL by five items on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as a visual analogue scale (VAS) on the current health state. This study investigates predictors of self-reported HRQoL according to the EQ-5D-Y in chronically ill children and adolescents using longitudinal data. Data from the German Kids-CAT study on children and adolescents with asthma, diabetes, and juvenile arthritis gathered over a period of six months were analyzed (n = 310; 7-17years old; 48% female). Self-, parent-, and pediatrician-reported data were collected from June 2013 to October 2014. Generalized linear mixed models and linear mixed models served to examine effects of socio-demographic as well as disease- and health-specific predictors on the items as well as on the VAS of the EQ-5D-Y. Ceiling effects for the EQ-5D-Y indicated low burden of disease in the analyzed sample. Longitudinal analyses revealed associations between less health complaints and better HRQoL for all investigated HRQoL domains. Further, age- and gender-specific effects, and associations of better disease control, longer duration of the disease and less mental health problems with better HRQoL were found. Subjective health complaints and mental health problems should be considered in the care of children and adolescents with asthma, diabetes, and juvenile arthritis. Future research should suggest administering the items of theEQ-5D-Y with five instead of three response options, and investigate HRQoL over a longer period.

Abstract 20897: Patient-Reported Outcomes in Tetralogy of Fallot: Baseline Results From a Prospective, International, Multi-Site Study

Introduction: In addition to understanding causes of morbidity and mortality following tetralogy of Fallot repair (rTOF), the importance of patient-reported outcomes (PROs) such as quality of life (QOL) is increasingly being recognized. Hypothesis: We hypothesized that PROs in rTOF would be associated with selected sociodemographic factors, functional status, and/or clinical variables. Methods: As part of a prospective study of patients ≥12 years with rTOF and significant pulmonary regurgitation, participants completed PRO surveys: SF-12 Health Status (physical component summary [PCS] and mental component summary [MCS] t-scores), EQ-5D (5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a 0-100 QOL linear analogue scale (QOL-LAS). With multivariable regression analysis, we determined the association between PROs and selected predictors. Results: We studied n=627 participants (55% male, 26±13 years, 75% adult) at 14 sites (North America, Europe and Asia). Median age at repair was 1.6 years (IQR 0.6, 4.2). In general, scores on the SF-12 and QOL-LAS suggested good outcomes: SF-12 PCS &lt;18 years 52±6 and ≥18 years 51±9; SF-12 MCS &lt;18 years 52±9 and ≥18 years 49±10; QOL-LAS &lt;18 years 83±14 and ≥18 years 78±16. On the EQ-5D, difficulties were reported with usual activities (16%), pain (25%) and anxiety/depression (38%). In multivariable regression analysis, younger age at enrollment emerged as an independent predictor of better physical health status and worse mental health status (p=0.0005 and p=0.029, respectively), but not QOL. Better NYHA functional class was a predictor of better SF-12 PCS and MCS (p&lt;0.0005 and p=0.002) as well as better QOL (p&lt;0.0001). Other factors (including complexity of underlying TOF anatomy, previous shunt palliation and need for arrhythmia intervention) were not associated with PROs. Conclusions: Age and NYHA functional class at enrollment were found to be predictors of PROs in rTOF. While global measures of health status and QOL (SF-12 and QOL-LAS) suggest relatively good PROs, this study demonstrates the importance of inquiring about specific health problems (EQ-5D) to achieve a richer understanding of PROs in order to potentially maximize patient well-being.

Oral health-related quality of life, measured using the five-item version of the Oral Health Impact Profile, in relation to socio-economic status: a population survey in Sweden.

Oral health-related quality of life (OHRQoL) is an important patient-reported outcome measure in dental research. This study was conducted to analyse the association between OHRQoL, as measured using the five-item version of the Oral Health Impact Profile (OHIP-5), and different socio-economic indices. A national survey of randomly selected adult individuals in Sweden (n=3,500) was performed using telephone interviews. The questions asked for the purpose of this study were defined by the items of the OHIP-5, just as questions were asked regarding socio-economic variables, including education, income, and economic resources. Poor OHRQoL, as identified by an OHIP-5 score of 3 or higher on at least two of the five items, was statistically significantly associated in multivariate analysis with low income (OR=1.84) and having no economic resources (OR=2.19). The statistical models were adjusted for age, gender, ethnicity, marital status, dental-care utilization, dental anxiety, and smoking. The OHIP-5 may be used in larger epidemiological surveys because it demonstrates the ability to discriminate for a range of important areas of measurement in dental public health, including social determinants.

Perceptions of Disease-Related Stress: A Key to Better Understanding Patient-Reported Outcomes Among Survivors of Congenital Heart Disease.

Disease-related stressors for survivors of congenital heart disease (CHD) have been qualitatively described but not quantified nor examined in relationship to important patient-reported outcomes (PROs). The aims of this study are to (1) identify the types and degree of disease-related stress experienced by CHD survivors based on age, functional status, and sex, (2) examine differences in stress and PROs by age, functional status, and sex, and (3) determine the unique contribution of perceived stress to variability in PROs. A cross-sectional study of 173 adolescents and emerging and young adults who were recruited from both pediatric and adult CHD clinics was conducted. Participants rated the degree to which they found various aspects of CHD stressful and completed PROs of health-related quality of life and emotional distress. Differences in perceptions of stress across predictors were determined using analyses of variance and χ analyses. The relative contribution of perceived stress predicting PROs was examined using stepwise linear regression. Two items emerged as being stressful for almost half of the sample, including concerns about future health and having scars or other signs of medical procedures. Adolescents reported less perceived stress than emerging or young adults, and survivors with even mild functional limitations reported higher perceived stress than did those without any symptoms. Perceptions of stress significantly contributed to variability in PROs above and beyond other predictors and was the only variable to explain unique variance in emotional distress. Having even mild functional impairment may have significant deleterious consequences on PROs via increased perceptions of stress. Stress may be modifiable using cognitive behavioral therapy.

Predictors of noninstitutionalized survival 1 year after hip fracture: A prospective observational study to develop the Marburg Rehabilitation Tool for Hip fractures (MaRTHi).

Hip fractures are frequent fractures in geriatric patients. These fractures have great socioeconomic implications because of the significantly higher risk of mortality and institutionalization. The aim of this study was to develop a prognostic tool to predict survival without institutionalization within 1 year after hip fracture.A total of 402 hip fracture patients aged >60 years (84% community-dwelling) were included in a prospective observational cohort study. Multiple regression analyses determined independent predictors for noninstitutionalized 1-year survival. Finally, the Marburg Rehabilitation Tool for Hip fractures (MaRTHi) was developed based on these independent predictors.Of the 312 patients who were followed up for 1 year, 168 (54%) survived noninstitutionalized, 104 (33%) died, and 40 (13%) lived in nursing homes. Independent predictors for patients’ noninstitutionalized survival included the American Society of Anesthesiologists (ASA) score [ASA 1 or 2: odds ratio (OR) = 7.828; 95% confidence interval (CI) = 2.496–24.555 and ASA 3: OR = 8.098; 95% CI = 2.982–21.993 compared with ASA 4 or 5], the Mini Mental State Examination upon admission to the hospital (OR = 7.365; 95% CI = 2.967–18.282 for 27–30 compared with 0–10), patients’ age (OR = 2.814; 95% CI = 1.386–5.712 for 75–89 y and OR = 2.520; 95% CI = 0.984–6.453 for 90–99 y compared with 60–74 ys), and prefracture EQ-5D (OR = 2.163; 95% CI = 1.119–4.179 for EQ-5D >0.80 compared with <0.60). The area under the receiver-operating characteristic curve was 0.756 (95% CI = 0.703–0.809), and the sensitivity analysis yielded a MaRTHi score that ranged from 0 to 12 points.The MaRTHi score is the first instrument to predict noninstitutionalized survival with only 4 variables. In addition to 3 well-known factors influencing outcome (age, comorbidities, and cognitive ability), prefracture health-related quality of life was identified as an independent predictor of noninstitutionalized survival. Further studies must be conducted to validate the MaRTHi score and define cutoff scores. Health-related quality of life seems to be an important patient-reported outcome measurement and may play a role in determining patient prognosis.

Social inequalities in children\u2019s oral health-related quality of life: the Generation R Study

PurposeOral health-related quality of life (OHRQoL) is the most important patient-reported outcome measure in oral health research. The purpose of the present research was to study the association of family socioeconomic position (SEP) with children’s OHRQoL.MethodsThis cross-sectional study was embedded in the Generation R Study, a population-based cohort study conducted in Rotterdam, The Netherlands. For the present study, OHRQoL was assessed of 3871 ten-year old children. Family SEP was assessed with the following indicators: maternal/paternal education level, maternal/paternal employment status, household income, benefit dependency, and family composition. Linear regression analyses were performed to evaluate the (independent) associations of family SEP indicators with OHRQoL.ResultsThe median (90% range) OHRQoL score of the participating children was relatively high [50.0 (43.0–53.0)]; however, OHRQoL was consistently lower in children with low family SEP. Positive associations were found for all SEP indicators (p-values <0.05) except maternal employment status and family composition. Benefit dependency, paternal employment, and household income were the most strongly associated with OHRQoL. No family SEP indicator was significantly associated with OHRQoL independent of the other indicators.ConclusionsBased on the present findings, interventions and policies promoting good oral health and oral well-being should target children from low socioeconomic position. More research is needed, however, to understand the pathways of social inequalities in children’s OHRQoL especially for the effects of material resources on subjective oral health measures.

Depression—A Major Contributor to Poor Quality of Life in Patients With Advanced Cancer

ContextQuality of life (QoL) and depression are important patient-reported outcomes in cancer care. However, the relative importance of depression severity in predicting QoL remains unclear because of few methodologically sound studies. ObjectivesTo examine whether depression contributes to impairment of QoL irrespective of prognostic factors and symptom burden. MethodsA total of 563 patients were included from the European Palliative Care Research Collaborative–Computerized Symptom Assessment Study, an international, multi-center, cross-sectional study. The relative importance of prognostic factors (systemic inflammation [modified Glasgow Prognostic Score—mGPS]), co-morbidities and physical performance (Karnofsky Performance Status), symptom burden (loss of appetite, breathlessness, nausea [Edmonton Symptom Assessment Scale], and pain [Brief Pain Inventory]), and depression severity (Patient Health Questionnaire 9) in predicting Global Health/QoL (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30]) were assessed using hierarchical multiple regression models. ResultsFifty-five percent were women, median age was 64 years, 87% had metastatic disease, median Karnofsky Performance Status was 70, and mean global QoL was 50.5 (SD = 23.3). Worse QoL was associated with increased systemic inflammation (mGPS = 1 β = −0.12, P = 0.003; mGPS = 2 β = −0.09, P = 0.023), lower physical performance (β = 0.17, P < 0.001), reduced appetite (β = −0.15, P < 0.001), breathlessness (β = −0.11, P = 0.004), pain (β = −0.14, P = 0.002), and higher depression severity (β = −0.27, P < 0.001). The full model accounted for 29% of the observed variance in QoL scores. The strongest predictor was depression severity, accounting for 5.8% of the variance. ConclusionDepression severity was the strongest single predictor of poorer QoL in this sample of patients with advanced cancer, after accounting for a wide range of clinically relevant variables. Future studies should investigate the contribution of psychosocial variables on QoL. Our findings emphasize the importance of managing depression to achieve the best possible QoL for these patients.

Does Specialized Inpatient Rehabilitation Affect Whether or Not People with Traumatic Spinal Cord Injury Return Home?

Return to living at home is an important patient-reported outcome following traumatic spinal cord injury (tSCI). Specialized inpatient rehabilitation assists such patients in maximizing function and independence. Our project aim was to describe those patients receiving specialized rehabilitation after tSCI in Canada, and to determine if such rehabilitation improved the likelihood of returning home. This cohort study utilized data from the Rick Hansen Spinal Cord Injury Registry (RHSCIR) to identify patients with tSCI discharged from 1 of 18 participating acute specialized spine facilities between 2011 and 2015 to either 1 of 13 participating specialized rehabilitation facilities, or to another discharge destination. To determine if specialized rehabilitation affected likelihood of returning home, multiple logistic regressions and propensity score matchings were performed to account for age at injury, gender, neurological severity and level, acute length of stay (LOS), and region of residence. The χ2 test was used to compare rate of return home between matched groups. Of the 1599 patients included, 71% received specialized rehabilitation. Receiving specialized rehabilitation was a significant and strong predictor of return to home after controlling for covariates (adjusted odds ratio = 3.1; 95% confidence interval [CI], 1.6-5.9). The rate of return to home was significantly higher in the matched rehabilitation group than the no rehabilitation group (98% vs. 87%, p = 0.0004). For the matched patients, an extra 11 patients returned home for every 100 patients receiving specialized rehabilitation. However, effect of age on returning home requires further investigation. Improving access to specialized rehabilitation could potentially reduce discharges to nursing homes or other non-home destinations.

A systematic review examining quality of life following pelvic exenteration for locally advanced and recurrent rectal cancer.

Pelvic exenteration is a complex surgical procedure associated with considerable morbidity. Quality of life (QoL) is a crucial metric of surgical outcome. The aim of this review was to assess the QoL following pelvic exenteration for locally advanced rectal cancer (LARC) and local recurrent rectal cancer (LRRC). A comprehensive search of studies published between 2000 and 2016 that examined QoL outcome following pelvic exenteration was performed. Functional Assessment of Cancer Therapy - Colorectal (FACT-C), SF-36 version 2, European Organization for Research and Treatment of Cancer QLQ-C30, and Brief Pain Inventory assessments from these studies were reviewed. Seven studies reporting on 382 patients were included. Baseline QoL was the strongest predictor of postoperative QoL. Female gender, total pelvic exenteration with or without bone resection, and positive surgical margins were associated with a reduced QoL. In the majority of patients, QoL gradually improved between 2 and 9months post-operation. QoL is an important patient-reported outcome. This review highlights factors associated with reduced postoperative QoL that should be borne in mind when surgical resection is being considered.

Patient reported outcome measures (PROMs) in sarcoidosis.

Patients with sarcoidosis present with a variety of symptoms which may impair many aspects of physical and mental well-being. Traditionally, clinicians have been concerned with physical health aspects of sarcoidosis, assessing disease activity and severity with radiological imaging, pulmonary function and blood tests. However, the most reported symptom of sarcoidosis patients, fatigue, has been shown not to correlate with the most commonly used parameters for monitoring disease activity. Studies have shown poor agreement between physicians and patients in assessing sarcoidosis symptoms. This underlines the importance of patient reported outcomes (PROs) in addition to traditional outcomes in order to provide a complete evaluation of the effects of interventions in clinical trials and everyday clinical assessment of sarcoidosis. We have undertaken a systematic review to identify and provide an overview of PRO concepts used in sarcoidosis assessment the past 20 years and to evaluate the tools used for measuring these concepts, called patient reported outcome measures (PROMs). Various PROMs have been used. By categorizing these PROMs according to outcome we identified the key PRO concepts for sarcoidosis to be Health Status and Quality of Life, Dyspnea, Fatigue, Depression, Anxiety and Stress and Miscellaneous. There is no perfect sarcoidosis-specific PROM to cover all concepts and future intervention studies should therefore contain multiple complementary questionnaires. Based on our findings we recommend the Fatigue Assessment Scale (FAS) for assessing fatigue. Dyspnea scores should be chosen based on their purpose; more research is needed to examine their validity in sarcoidosis. The Modified Medical Research Council Dyspnea Scale (MRC) can be used to screen for dyspnea and the Baseline Dyspnea Index (BDI) to detect changes in dyspnea. We recommend The World Health Organization Quality of Life assessment instrument (WHOQOL-100) for assessing quality of life, although a shorter questionnaire would be preferable. For assessing health status we recommend the Sarcoidosis Assessment Tool (SAT), and have great expectations for this new and promising assessment tool. Supplementary to the WASOG meeting of 2011's recommendation on assessing QoL, we recommend incorporating fatigue, dyspnea and HS assessment in clinical trials and everyday clinical assessment of sarcoidosis. (Sarcoidosis Vasc Diffuse Lung Dis 2017; 34: 2-17).

The Use of patient Reported Outcome Measures for Rheumatoid Arthritis in Japan: A Systematic Literature Review.

Background:Patient-reported outcomes (PRO) obtained through routine medical care may identify patients’ day-to-day burden and help tackle the disease from the patients’ perspective. However, there is a paucity of information regarding the availability of PRO data and PRO tools for rheumatoid arthritis (RA) in Japan.Objective: We reviewed the literature on PRO data availability and to identify PRO measures implemented in Japan for RA patients. Method: We conducted a systematic literature review using ICHUSHI and the PubMed databases on PRO measures for RA published from January 2011 to August 2015 in Japan.Results:After removing duplicates, 2423 manuscripts were found. From these, 100 manuscripts were included for review and analysis. We found 29 PRO tools that were used to assess various domains of health such as general well-being, pain, functionality, and fatigue. More than 90% of the studies utilized PRO tools for research purpose. Only one study reported PRO tool implementation in the routine medical care.Conclusion:The importance of PROs is recognized in Japan. PRO tools varied significantly and were mostly used for research purposes, while reports on the use of PRO measures in routine medical care were limited. Despite the awareness of PROs in the research community, unmet needs remain among RA patients in Japan. Further work is needed to investigate ways in which PROs can better reflect these unmet needs and be utilized in routine medical care.

Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recommendations on incorporating patient-reported outcomes in clinical trials in epithelial ovarian cancer

Despite the support for including patient-reported outcomes (PROs) and health-related quality of life in clinical trials, there have been deficiencies in how these have been assessed and reported in epithelial ovarian cancer (EOC) clinical trials. To redress this, the 5th Ovarian Cancer Consensus Conference, included a plenary session entitled ‘How to include PROs in clinical trials’. The perspective is a summary of the recommendations made by the Gynecologic Cancer InterGroup unanimously agreed on the importance of PROs and PRO end-points in EOC clinical trials. They recognised that effort must be made to ensure the integrity of collection of PRO data and to avoid missing data. PRO end-points should be based on the PRO hypotheses, be context specific and reflect the patient population and the objectives of treatment (e.g. first line, maintenance therapy, early or late relapse). The PRO end-points inform the choice of PRO measures used in the trial and how the results are analysed and reported. There was agreement that progression-free survival should be supported by PROs among patients with late relapse (platinum sensitive) and that progression-free survival alone was not sufficient as the primary end-point of clinical trials in patients with platinum resistant/refractory EOC and PROs should be included as either the primary/co-primary end-point in this subset of patients. Novel approaches to measure the benefit of palliative chemotherapy such as time until definitive deterioration of Health-Related Quality of Life were recommended. There was consensus to endorse the ISOQOL and CONSORT-PRO guidelines on the inclusion and reporting of PRO endpoints in protocols and that all future EOC Gynecologic Cancer InterGroup trials should adhere to these.