Showing papers in "Journal of Patient-Reported Outcomes in 2017"

Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract: The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.

Two-item PROMIS® global physical and mental health scales

Abstract: Self-reports of health provide useful information about function and well-being that can improve communication between patients and clinicians. Global health items provide summary information that are predictive of health care utilization and mortality. There is a need for parsimonious global health scales for use in large sample surveys. This study evaluates the reliability and validity of brief measures of global physical health and mental health in the Patient Reported Outcomes Measurement and Information System (PROMIS®) project. A total of 21,133 persons included in the PROMIS development sample: 52% female; 82% White, 9% Black, 9% Hispanic; median age of 50 years. We identified two global physical health items (GPH-2) and two global mental health items (GMH-2) with highest discrimination parameters and compared their reliabilities and construct validity to that of the original 4-item scales (GPH-4 and GMH-4) and a single global health item (Global01). Internal consistency reliability was 0.73 for the GPH-2 (versus 0.81 for the GPH-4) and 0.81 for the GMH-2 (versus 0.86 for the GMH-4). Marginal reliabilities were 0.55 for Global01, 0.70 for GPH-2, 0.79 for GPH-4, 0.80 for GMH-2, and 0.86 for GMH-4. The product-moment correlation between the GPH-2 and GPH-4 was 0.94 and between GMH-2 and GMH-4 was 0.97. The 2-item and 4-item versions of the scales had similar correlations with PROMIS domain scores, the EQ-5D-3L and comorbidities, but the 4-item scales were more strongly correlated with these measures. Adding a single item to a large cross-sectional population survey can cost as much as $100,000. The 2-item variants of the PROMIS global health scales reduce the cost of use on national surveys by 50%, a substantial cost savings. These briefer scales are also more practical for use in clinical practice. The 2-item versions of the PROMIS global health scales display adequate reliability for group comparisons and their associations with other indicators of health are similar to that of the original 4-item scales. The briefer scales are psychometrically sound and reduce burden of survey administration.

Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients

Abstract: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer treatment setting. Danish-speaking men with castration-resistant metastatic prostate cancer receiving treatment at the Department of Oncology, Rigshospitalet, Copenhagen between March 9, 2015 and June 8, 2015 were invited to participate (n = 63 eligible). Participants completed the PRO-CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel, Cabazitaxel, Abiraterone, Alpharadin), were selected. Participants’ PRO-CTCAE responses were presented graphically to their treating oncologists via an AmbuFlex dashboard, for real-time use to enhance the patient-clinician dialogue that occurs during the consultation prior to each treatment cycle. Technical and clinical barriers and acceptability were evaluated through semi-structured interviews with both patients and oncologists. Patients receiving active treatment at the end of the study period completed an evaluation questionnaire. Fifty-four out of sixty-three (86%) eligible patients were enrolled. The PRO-CTCAE questionnaire was completed a total of 168 times by 54 participants (median number per patient was 3, range 1–5). Eight surveys were missed, resulting in a compliance rate of 97%. At the end of the study period, 35 patients (65%) were still receiving active treatment and completed the evaluation questionnaire. Patients reported that their PRO-CTCAE responses served as a communication tool. Oncologists stated that the availability of the PRO-CTCAE self-reports during the consultation improved patient-clinician communication about side effects. Electronic capture of symptomatic toxicities using PRO-CTCAE and the submission of self-reports to clinicians prior to consultation were feasible among metastatic prostate cancer patients receiving chemotherapy in an outpatient setting, and this procedure was acceptable to both patients and clinicians. Continued research, including a cluster-randomized trial, will evaluate the effects of submitting patients’ PRO-CTCAE results to clinicians prior to consultation on the quality of side-effects management and resultant clinical outcomes.

The responsiveness of the PROMIS instruments and the qDASH in an upper extremity population

Abstract: This study evaluated the responsiveness of several PROMIS patient-reported outcome measures in patients with hand and upper extremity disorders and provided comparisons with the qDASH instrument. The PROMIS Upper Extremity computer adaptive test (UE CAT) v1.2, the PROMIS Physical Function (PF) CAT v1.2, the PROMIS Pain Interference (PI) CAT v1.1 and the qDASH were administered to patients presenting to an orthopaedic hand clinic during the years 2014–2016, along with anchor questions. The responsiveness of these instruments was assessed using anchor based methods. Changes in functional outcomes were evaluated by paired-sample t-test, effect size, and standardized response mean. There were a total of 255 patients (131 females and 124 males) with an average age of 50.75 years (SD = 15.84) included in our study. Based on the change and no change scores, there were three instances (PI at 3 months, PI >3 months, and qDASH >3 months follow-ups) where scores differed between those experiencing clinically meaningful change versus no clinically meaningful change. Effect sizes for the responsiveness of all instruments were large and ranged from 0.80–1.48. All four instruments demonstrated high responsiveness, with a standardized response mean ranging from 1.05 to 1.63. The PROMIS UE CAT, PF CAT, PI CAT, and qDASH are responsive to patient-reported functional change in the hand and upper extremity patient population.

Exploring the quality of life issues in people with retinal diseases: a qualitative study.

Abstract: The lack of an appropriate retina-specific patient-reported outcome instrument restricts the understanding of the full impact of hereditary retinal diseases and other less common but potentially blinding acquired retinal diseases such as, vascular occlusions, epiretinal membrane, macular hole, central serous retinopathy and other vitreoretinopathies on quality of life. This study aims to explore the quality of life issues in people with hereditary retinal diseases and acquired retinal diseases to develop disease-specific patient-reported outcome instruments. A qualitative research methodology to understand the lived experiences of people with retinal diseases was carried out. Data were collected through semistructured interviews. The coding, aggregation and theme development was carried out using the NVivo −10 software. Seventy-nine interviews were conducted with participants with hereditary retinal diseases (n = 32; median age = 57 years) and acquired retinal diseases (n = 47; median age = 73 years). We identified nine quality of life themes (domains) relevant to people with retinal diseases. Difficulty in performing important day-to-day activities (activity limitation) was the most prominent quality of life issue in the hereditary retinal diseases group whereas concerns about health, disease outcome and personal safety (health concerns) was the most prominent quality of life issue in the acquired retinal diseases group. Participants with hereditary retinal diseases had more issues with social interaction (social well-being), problems with mobility and orientation (mobility), and effect on work and finance (economic) than participants with acquired retinal diseases. On the contrary, participants with acquired retinal diseases reported more inconveniences (conveniences) than participants with hereditary retinal diseases, which were mostly attributed to treatment. Participants with hereditary retinal diseases were coping better compared to participants with acquired retinal diseases. Our study found that participants with both hereditary and acquired retinal diseases are living with myriad of disease-specific quality of life issues. Many of these issues are completely different and unique to each disease group. Hence, these group of diseases would need separate patient-reported outcome instruments to capture the disease-specific quality of life impacts.

A comparison of three methods to generate a conceptual understanding of a disease based on the patients’ perspective

Abstract: The Food and Drug Administration patient-reported outcome (PRO) guidance provides standards for PRO development, but these standards bring scientific and logistical challenges which can result in a lengthy and expensive instrument development process. Thus, more pragmatic methods are needed alongside traditional approaches. Partnering with the National Ankylosing Spondylitis (AS) Society, we compared three methods for eliciting patient experiences: 1) concept elicitation (CE) interviews with 12 individuals with AS, 2) “group concept mapping” (GCM) with 16 individuals with AS, 3) a social media review (SMR) of AS online chatrooms. Three conceptual models were developed and compared to explore data breadth/depth, as well as the practicalities and patient-centeredness. Overlap in concepts was observed between conceptual models; 35% of symptoms were identified by all methods. The SMR approach identified the most concepts (n = 23), followed by CE interviews (n = 18), and GCM (n = 15). Eight symptoms were uniquely identified using GCM and SMR. Eliciting in-depth data was challenging for SMR as detail was not always provided. Insight into the relationships between symptoms was obtained as a “concept map” in GCM, via effective probing within interviews, and through the subject’s descriptions in SMR. Practical investment varied; CE interviews were the most resource intensive, whereas SMR was the least. Individuals in GCM and CE interviews reported high engagement. Primary CE interviews achieved the greatest depth in conceptual understanding of patient experience; however, novel methods (GCM, SMR) provide complementary approaches for identifying measurement concepts. Each method has strengths and weaknesses and should be selected based on specific research objectives.

Psychometric validation of the Dysphagia Symptom Questionnaire in patients with eosinophilic esophagitis treated with budesonide oral suspension

Abstract: Eosinophilic esophagitis (EoE) is characterized by high levels of eosinophils in the esophageal mucosa. Patients with the disease present with a range of symptoms, including dysphagia (difficulty swallowing). The aim of this analysis was to assess the psychometric properties of the Dysphagia Symptom Questionnaire (DSQ), a patient-reported outcome (PRO) measure of dysphagia associated with EoE. Psychometric properties of the DSQ were assessed using data collected from a 12-week, phase 2, multicenter, randomized, double-blind, placebo-controlled trial of budesonide oral suspension in adolescents and adults (11–40 years old) with EoE. The study population comprised 93 patients with EoE; 94.6% of whom were white, 68.8% were male and the mean age (standard deviation) was 21.6 (7.7) years. Patients had been diagnosed with EoE for a mean of 37.6 months before study initiation. The DSQ was feasible to implement with few item-level data missing at baseline. Item discrimination was high, with floor and ceiling effects below the predefined threshold (≤9%). Higher DSQ scores corresponded with presence and increased severity of dysphagia, indicative of strong item discrimination among patients at baseline (threshold >50%). The DSQ was able to detect changes in symptoms over time and produced similar outcomes to those from physician- and other patient-rated measures, supportive of construct validity. The DSQ had strong test–retest reliability (intraclass correlation coefficient, r = 0.82); and was also responsive to disease-level changes, with higher DSQ scores corresponding to increased esophageal eosinophilic burden. Lastly, the percentage changes in the minimal clinically important difference and clinically important difference in DSQ score were estimated at −27.4% and −55.4%, respectively. These analyses support the DSQ as a valid and reliable measure of dysphagia in patients with EoE. Changes in DSQ scores suggest a level of agreement between clinician, patient and histologic response. The DSQ should therefore be considered a viable PRO measure of dysphagia for use in future therapeutic studies of EoE.

A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice.

Abstract: This study aimed to evaluate the patient-reported outcome (PRO) content of ovarian cancer randomised-controlled trial (RCT) publications, describe PRO compliance, and explore potential relationships among these and completeness of PRO protocol content. Publications of Phase III ovarian cancer RCTs with PRO endpoints were identified by Medline and Cochrane systematic search: January 2000 to February 2016. Two reviewers determined the number of Consolidated Standards of Reporting Trials (CONSORT)-PRO Extension items addressed in publications. Compliance rates (defined as the proportion of participants included in the principal PRO analysis, of those from whom PRO assessments were expected) were extracted. The relationship between CONSORT-PRO score and compliance rates was explored using scatter plots. Additionally CONSORT-PRO score and PRO compliance rates respectively were compared with corresponding PRO protocol scores obtained from a previous study. Thirty-six eligible RCTs (n = 33 with secondary PRO endpoint) were identified and analysed. The average number of CONSORT-PRO items addressed in publications was 6.7 (48%; Range 0–13.5/14). Three RCTs did not report PRO results; in 1 case due to poor compliance. Some compliance information was reported in 26 RCTs, but was considered complete for only 10 (28%) RCTs. Compliance rates were poor overall, ranging from 59 to 83%; therefore missing PRO data from 17 to 41% of participants in these trials could have been avoided. Of the 26 (73%) RCTs for which PRO protocol completeness scores were available, 6 RCTs reported complete compliance information and the 3 of these RCTs with highest PRO compliance had highest protocol checklist scores. Few RCTs reported PRO compliance information in a manner enabling assessment of the generalisability of PRO results. This information is particularly important in RCTs of advanced ovarian cancer because it is important to be able to determine if missing data was due to worsening illness compared to methodological issues. Poor compliance appeared related to poor PRO protocol content, and in one case prevented PRO results from being reported, highlighting the need to address compliance strategies in the protocol. Adhering to protocol and CONSORT-PRO reporting guidance should improve PRO implementation and reporting respectively in ovarian cancer RCTs and allow results to meaningfully inform clinical practice.

Methodological considerations in using patient reported measures in dialysis clinics.

Abstract: Patient reported measures (PRMs), including patient-reported outcomes, play a critical role in dialysis care. The usage of PRMs is extensive in dialysis clinics. While there are excellent PRMs to choose from, and their implementation as part of quality improvement and performance monitoring is extensive, there are still methodological challenges to be addressed. In this paper, we identify key methodological concerns around use of PRMs in dialysis centers in the United States and make recommendations for improving the use of PRMs in dialysis related to Selection of PRMs, Mode of Administration, and Support for PRM Use. These recommendations include: (1) Continue the use of Kidney Disease Quality of Life 36-item survey (KDQOL™-36) for dialysis centers' internal quality improvement activities and the In-Center Hemodialysis Consumer Assessment of Health Care Providers and Systems (ICH-CAHPS survey®) for public dialysis center performance monitoring, but promote efforts to modify these instruments by incorporating PROMIS general health items (KDQOL-36) and reducing the length of the ICH-CAHPS. (2) Adopt a PRM of whether dialysis patients have been informed about all dialysis and transplant options. (3) Evaluate equivalence between electronic and paper versions of PRMs prior to widespread use of electronic administration. (4) Explore reimbursement of costs of PRM administration by the Centers for Medicare and Medicaid Services and kidney organizations. (5) Continue development of provider trainings in PRM administration and interpretation. These recommendations will help dialysis care decision-makers, clinicians, and applied researchers take the next steps toward enhancing PRM use in dialysis.

Content validation of the SF-36v2® health survey with AL amyloidosis patients

Abstract: This study examined the content validity of the SF-36v2® Health Survey (SF-36v2) in patients with AL amyloidosis using qualitative interviews with physicians and patients. The study included three distinct phases of qualitative research: concept elicitation interviews among physicians, concept elicitation interviews among patients, and cognitive debriefing interviews among patients. The concept elicitation interviews focused on areas of health-related quality of life that are affected by AL amyloidosis and may be affected by treatment, while patient cognitive debriefings aimed to confirm whether the SF-36v2 instructions, recall period, items, and response choices were comprehensive and understandable to AL amyloidosis patients. Physicians discussed the importance of measuring physical functioning, general health, mental/emotional health, sleep, fatigue, and work impact; though they also reported that they do not routinely use a standard Patient-Reported Outcome (PRO) measure of health-related quality of life. Patients described social, physical, role, and emotional impacts of AL amyloidosis and various treatments. Cognitive debriefing interviews confirmed the relevance of the concepts measured by the SF-36v2 and indicated that patients found the SF-36v2 both easy to understand and complete, that the SF-36v2 instructions and items were comprehensive and understandable without change, and the response choices and recall period were appropriate for use with patients with AL amyloidosis. The findings support the content validity of the SF-36v2 as an appropriate measure of health-related quality of life in patients with AL amyloidosis.

The content validity of the PSS in patients with plaque psoriasis.

Abstract: The primary objective of this study was to evaluate the content validity of the Psoriasis Symptom Scale (PSS), with a specific focus on understanding of the content of the PRO measure by conducting one-on-one interviews with patients with moderate to severe plaque psoriasis. This was a cross-sectional, qualitative study conducted with 20 patients with plaque psoriasis who participated in in-person, one-on-one interviews. Participants were asked to describe their psoriasis symptoms, completed the PSS, and were cognitively debriefed on its content. Interviews were conducted in two separate rounds. Following Round 1, the study data were examined to determine if modifications to the PSS were required. All interviews were audio-recorded and transcribed. Sociodemographic and clinical data were collected for sample descriptive purposes. The 20 study participants had a mean age of 50.2 ± 12.0 years (range: 25.0–73.0), and 55% were female. Thirty-five percent of the sample reported their psoriasis severity as moderate or severe. The average time since diagnosis of plaque psoriasis was almost 18 years, ranging from less than one to over 38 years. The most frequently reported symptoms and signs during the concept elicitation portion of the interviews included redness (N = 20, 100%), itching (n = 20, 100%), pain (n = 15, 75%), burning (n = 13, 65%), and flaking (n = 11, 55%). Overall, participants provided positive feedback on the PSS and felt that it was comprehensive and relevant to their experience with psoriasis. The item meaning and response options were well-understood for the majority of the items. Findings indicate that for the patient-reported symptom of redness, which is also a sign that can be reported by clinicians, redness or the perception of redness is most accurately captured by patient report. Study results did not support modifications to the instrument and no changes to the PSS were recommended. The evidence gained in this study provided support for the content validity of the PSS for use as clinical trial endpoint among patients with plaque psoriasis. This study found that the symptoms included in the PSS are important to and well-understood by patients with plaque psoriasis. The PSS is appropriate for inclusion in future studies designed to measure the effect of treatment on psoriasis-related symptoms.

Leveraging pediatric PROMIS item banks to assess physical functioning in children at risk for severe functional loss

Abstract: Pediatric neuromuscular illnesses often result in decreased health-related quality of life (HRQL), notably in physical functioning. Generic HRQL measures have been developed for use in general populations, but may not adequately assess patients with severe functional loss. To address this measurement gap, we created two custom parent-proxy physical functioning short forms for use among children at risk for low levels of functioning, using pediatric Patient Reported Outcomes Measurement Information System (PROMIS) item banks for Upper Extremity and Mobility. Two custom short forms from PROMIS Upper Extremity (13 items) and Mobility (13 items) parent-proxy item banks were created and administered to parents of children (ages 5 – 22 years) enrolled in an integrated care program for management of chronic respiratory insufficiency, largely due to neuromuscular illnesses. Standardized PROMIS T-scores have a mean of 50 (SD = 10); higher scores indicate better functioning. Physicians rated clinical severity. Single proxy-rated items on mental and physical health from the Child Health Rating Inventories (CHRIs) global health scale were completed by parents. Psychometric properties, including known groups comparisons, were explored. Fifty-seven parents completed the parent-proxy custom PROMIS short forms. The mean Upper Extremity T-score was 21 (SD = 13); the mean Mobility T-score was 22 (SD = 11). Some participants scored at the measurement floor; two items on assistive devices did not perform well in this sample and were excluded from the Mobility T-score. Known groups comparisons showed that those with lower clinical severity had better median Upper Extremity (22 vs. 14, p < 0.001) and Mobility (28 vs. 16, p = 0.004) function than those with worse clinical severity. Both Upper Extremity and Mobility T-scores were higher in the subgroups defined by better physical and mental health, as measured by the CHRIs. Upper Extremity and Mobility T-scores were nearly three standard deviations below the PROMIS pediatric calibration population mean. Preliminary psychometrics demonstrated the potential to more accurately measure lower physical functioning using items from PROMIS item banks. However, some participants scored at the measurement floor despite targeting items at the lower end of the scale. Further short form refinement, enrichment of the item banks, and larger-scale field testing are needed.

Barnhöft: a hip specific 6-item questionnaire for children

Abstract: Health-related quality of life instruments, both general and more disease specific, would ideally be included in the evaluation of outcome in paediatric orthopaedics. The aim of this study was to translate and culturally adapt an instrument measuring hip function and pain for Swedish children 8-15 years old with a hip disorder. Translation of an established questionnaire for hip disorder in children, CHOHES, was performed and called Barnhoft. Retrospective and cognitive debriefing interviews were conducted with 15 healthy children to test for the comprehensibility of the instrument. Children with slipped capital femoral epiphysis (n = 25) and healthy children (n = 35) participated in further testing through test-retest and with the comparison of answers given in a general health-related quality of life test, EQ-5D-Y ( www.euroqol.org ). A multi-professional expert committee supervised the process and judged the content validity. The test-retest method with a weighted Cohen’s kappa showed a good stability of the instrument. The construct validity for the pain domain (1-item) in EQ-5D-Y compared to the pain domain in Barnhoft showed a Spearman’s correlation coefficient of 0.73. The degree of hip pain in Barnhoft was also compared with the item “doing usual activities” in EQ-5D-Y with a Spearman’s correlation coefficient of 0.67. Barnhoft could be used as a simple 6-item questionnaire to identify children with pain and/or functional limitations due to sequelae related to a hip disease in childhood.

The development of a patient-reported outcome measure for patients with obstructive sleep apnea: the Patient-Reported Apnea Questionnaire (PRAQ).

Abstract: Obstructive sleep apnea (OSA) is a chronic condition that can have a wide range of consequences for a patient’s health-related quality of life. Monitoring aspects of quality of life in clinical practice has the potential to improve the patient-centeredness of care for patients with OSA. The aim of this article is to describe the development of the Patient-Reported Apnea Questionnaire (PRAQ), a patient-reported outcome measure (PROM) that is designed for use in clinical practice on an individual patient level, as well as subsequent outcome measurement on an aggregate level. We used the items of available PROMs for OSA to create a new PROM with focus on its applicability in clinical practice. We used a tailored development process to come to a selection of domains and items. Patients and healthcare professionals were intensively involved in the development of the PRAQ via membership of the development team, online surveys and focus groups, as well as two rounds of cognitive validation. This first version of the PRAQ consists of 43 items and 10 preliminary domains, and covers the aspects of quality of life that healthcare professionals and patients wish to discuss in clinical practice. Patients indicate that PRAQ is comprehensive and that its length is acceptable. Comprehensive patient involvement has ensured good content validity for the PRAQ. This article shows how a PROM can be developed with a specific focus on its applicability in clinical practice.

Cognitive testing of the Colon Cancer Screening Behaviours Survey with South Asian immigrants in Canada

Abstract: The purpose of this study was to cognitively test the Urdu and English language versions of a survey to assess colon cancer screening behaviours among South Asian immigrants in Canada. The Colon Cancer Screening Behaviours Survey was cross-culturally translated and adapted into the Urdu language followed by cognitive interviews using an evidence-informed cross-cultural cognitive interview framework. The cognitive interviews were conducted in English and Urdu in three rounds; a preliminary round, round one, and round two. Two bilingual cognitive interviewers administered interviews in person with South Asian immigrants in Hamilton, Ontario. Scripted verbal and emergent probe techniques were used concurrently with survey item administration. A total of 30 South Asian immigrant participants, 12 English speaking and 18 Urdu speaking completed a cognitive interview. These groups were similar in age, gender, and years of residence in Canada. General design, culture, gender, and translation issues were identified. Revisions were made to improve the survey and the interview protocol was modified for future data collection. The cross-cultural cognitive interview framework led to a systematic and rigorous process of pre-testing and revising the Colon Cancer Screening Behaviours Survey, which may be used to gain insights on beliefs, benefits, facilitators and barriers to colon cancer screening among South Asian immigrants. The study methods and experience may also inform the cross-cultural translation and adaptation and cognitive testing of other survey tools.

Journal of Patient-Reported Outcomes: aims and scope.

Abstract: As founding Co-Editors-in-Chief of the Journal of Patient-Reported Outcomes (JPRO), we are excited to announce the launch of a new journal sponsored by the International Society for Quality of Life Research (ISOQOL). JPRO is intended to complement and extend ISOQOL’s existing journal, Quality of Life Research. Clearly, Quality of Life Research has a long and successful history of publishing research on methods and applications of health-related quality of life (HRQL) and patient-reported outcomes (PROs). Given increased HRQL and PRO research, and the wider application of these outcomes across a variety of health care and population health settings, there is a need for more publication outlets for scientifically sound PRO research. The aims and scope of the Journal of Patient-Reported Outcomes focus on high quality research in five major areas: (1) PROs in clinical trials; (2) applications of PROs in clinical practice; (3) patient, family, community and public engagement in PRO research; (4) qualitative studies on the development and application of PROs; and (5) social and behavioral determinants of health and PRO measures. These focus areas are only some examples of the types of papers that are considered for publication in JPRO. JPRO is a peer-reviewed journal, with occasional special non-peer reviewed articles relevant to the journal’s aims and scope.