Identifying health-related quality of life concepts to inform the development of the WOUND-Q.

OBJECTIVE: The impact of hard-to-heal wounds extends beyond traditional clinical metrics, negatively affecting a patient's health-related quality of life (HRQoL). Yet treatment outcomes are seldom measured from the patient's perspective. The purpose of the present study was to perform in-depth qualitative interviews with patients diagnosed with varying types of hard-to-heal wounds to identify outcomes important to them. METHOD: Participants were recruited from wound care clinics in Canada, Denmark, the Netherlands and the US, and were included if they had a hard-to-heal wound (i.e., lasting ≥3 months), were aged ≥18 years, and fluent in English, Dutch or Danish. Qualitative interviews took place between January 2016 and March 2017. An interpretive description qualitative approach guided the data analysis. Interviews were audio-recorded, transcribed and coded line-by-line. Codes were categorised into top-level domains and themes that formed the final conceptual framework. RESULTS: We performed 60 in-depth interviews with patients with a range of wound types in different anatomic locations that had lasted from three months to 25 years. Participants described outcomes that related to three top-level domains and 13 major themes: wound (characteristics, healing); HRQoL (physical, psychological, social); and treatment (cleaning, compression stocking, debridement, dressing, hyperbaric oxygen, medication, suction device, surgery). CONCLUSION: The conceptual framework developed as part of this study represents the outcome domains that mattered the most to the patients with hard-to-heal wounds. Interview quotes were used to generate items that formed the WOUND-Q scales, a patient-reported outcome measure for patients with hard-to-heal wounds.

"I Want It to Look Natural": Development and Validation of the FACE-Q Aesthetics Natural Module.

BACKGROUND: The concept of "natural" after a facial aesthetic treatment represents an understudied area. We added scales to FACE-Q Aesthetics to provide a means to measure this concept from the patient's perspective. OBJECTIVES: The objective of this study was to develop and validate the FACE-Q Aesthetic Natural module. METHODS: Concept elicitation interviews with people having minimally invasive treatments were conducted to explore the natural concept and develop scales. Patient and expert input refined scale content. An online sample (ie, Prolific) of people who had a facial aesthetic treatment was analyzed with Rasch measurement theory to examine psychometric properties. A test-retest reliability study was performed, and construct validity was examined. RESULTS: Interviews with 26 people were conducted. Three scales were developed and refined with input from 12 experts, 11 patients, and 184 online survey participants. Data from 1358 online participants provided evidence of scale reliability and validity. Reliability was high with person separation index, Cronbach alpha, and intraclass correlation coefficient values without extremes ≥0.82. Tests of construct validity confirmed that the scales functioned as hypothesized. Higher scores on the Expectations scale were associated with how important it was to have a natural look and movement after treatment. In addition, higher scores on the Natural Appearance and Natural Outcome scales correlated with better scores on other FACE-Q Aesthetics scales, and were associated with the face looking and feeling natural and with overall satisfaction with facial appearance. CONCLUSIONS: Many people seeking facial aesthetic treatments want to look natural after treatment. These new FACE-Q Aesthetics scales provide a means to measure the concept of natural from the patient's perspective.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

Time-Driven Activity-Based Costing in Breast Cancer Care Delivery.

BACKGROUND: Accurate measurement of healthcare costs is required to assess and improve the value of oncology care. OBJECTIVES: We aimed to determine the cost of breast cancer care provision across collaborating health care organizations. METHODS: We used time-driven activity-based costing (TDABC) to calculate the complete cost of breast cancer care-initial treatment planning, chemotherapy, radiation therapy, surgical resection and reconstruction, and ancillary services (e.g., psychosocial oncology, physical therapy)-across multiple hospital sites. Data were collected between December 2019 and February 2020. TDABC steps involved (1) developing process maps for care delivery pathways; (2) determine capacity cost rates for staff, medical equipment, and hospital space; (3) measure the time required for each process step, both manually through clinic observation and using data from the Real-Time Location System (RTLS); and (4) calculate the total cost of care delivery. RESULTS: Surgical care costs ranged from $1431 for a lumpectomy to $12,129 for a mastectomy with prepectoral implant reconstruction. Radiation therapy was costed at $1224 for initial simulation and patient education, and $200 for each additional treatment. Base costs for chemotherapy delivery were $382 per visit, with additional costs driven by chemotherapy agent(s) administered. Personnel expenses were the greatest contributor to the cost of surgical care, except in mastectomy with implant reconstruction, where device costs equated to up to 60% of the cost of surgery. CONCLUSION: The cost of complete breast cancer care depended on (1) treatment protocols; (2) patient choice of reconstruction; and (3) the need for ancillary services (e.g., physical therapy). Understanding the actual costs and cost drivers of breast cancer care delivery may better inform resource utilization to lower the cost and improve the quality of care.

Enhancing Patient-Centered Surgical Care With Mobile Health Technology.

From smartphones or wearables to portable physiologic sensors and apps, healthcare is witnessing an exponential growth in mHealth-digital health tools used to support medical and surgical care, as well as public health. In surgery, there is interest in harnessing the capabilities of mHealth to improve the quality of patient-centered care delivery. Digitally delivered surveys have enhanced patient-reported outcome measurement and patient engagement throughout care. Wearable devices and sensors have allowed for the assessment of physical fitness before surgery and during recovery. Smartphone-based digital phenotyping has introduced novel methods of integrating multiple data streams (accelerometer, global positioning system, call and text logs) to create multidimensional digital health footprints for patients following surgery. Yet, with all the technological sophistication and 'big data' mHealth provides, widespread implementation has been elusive. Do clinicians and patients find these data valuable or clinically actionable? How can mHealth become integrated into the day-to-day workflows of surgical systems? Do these data represent opportunities to address disparities of care or worsen them? In this review, we discuss experiences and future opportunities to use mHealth to enhance patient-centered surgical care.

Development and Psychometric Validation of the BREAST-Q Animation Deformity Scale for Women Undergoing an Implant-Based Breast Reconstruction After Mastectomy.

BACKGROUND: To assess the impact of animation deformity on health-related quality of life, a content-specific, valid, and reliable patient-reported outcome measure is needed. This report describes the development and validation of the BREAST-Q Animation Deformity scale. METHODS: Women with breast cancer who had an implant-based reconstruction provided data. In phase 1 (January 2017 and December 2018), qualitive and cognitive patient interviews and expert input were used to develop and refine scale content. In phase 2 (March to June 2019), a field test study with members of the Love Research Army (LRA) was conducted. Rasch Measurement Theory (RMT) analysis was used to examine psychometric properties. RESULTS: In phase 1 of the study, qualitative (n = 11) and cognitive (n = 4) interview data and expert input (n = 9) led to the development of a 12-item scale measuring animation deformity. In phase 2, 651 LRA members provided data and 349 participated in a test-retest study. In the RMT analysis, the data fit the Rasch model (X2(96) = 104.06; p = 0.27). The scale's reliability was high, with person separation index and Cronbach alpha values with/without extremes of ≥ 0.84 and ≥ 0.92 respectively, and an intraclass correlation coefficient of 0.92 (95% confidence interval, 0.90-0.94). Mean scores on the Animation Deformity scale varied as predicted across subgroups of participants who reported differing amounts of change in breast appearance when their arms were lifted overhead or when they lifted something heavy, and for increasing happiness with the overall outcome of their breast reconstruction. CONCLUSION: The 12-item Animation Deformity scale forms a new scale in the BREAST-Q Reconstruction Module that can be used in comparative effectiveness research or to inform clinical care.

Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction.

BACKGROUND: Reconstructive techniques for restoring sensation to the breast after mastectomy continue to evolve. The BREAST-Q is a patient-reported outcome measure that can be used to evaluate outcomes of breast cancer treatments; however, it previously lacked scales to measure breast sensation. This paper outlines the development and validation of the BREAST-Q Sensation Module. METHODS: Phase 1 (January 2017 through December 2018) involved qualitative and cognitive interviews with women who had undergone breast reconstruction, as well as expert input, to develop and refine the scales. In phase 2 (March through June 2019), Love Research Army (LRA) members completed the scales, and Rasch Measurement Theory (RMT) analysis was performed to examine the reliability and validity of the scales. RESULTS: In this study, 36 qualitative and 7 cognitive interviews were conducted, and input from 18 experts was obtained. Three scales were developed to measure breast Symptoms (e.g., throbbing, burning, tingling), Sensation (e.g., feeling with light touch, through clothing, sexually), and Quality of Life impact of sensation loss. In phase 2, 1204 LRA members completed the scales. Data for each scale fit the RMT model. Reliability was high, with Person Separation Index, Cronbach alpha, and intraclass correlation coefficient values of 0.81 or higher (with and without extremes) for all three scales. Mean scores were higher (better) on the Symptoms and Quality of Life impact scales for the participants with unilateral (vs. bilateral) and autologous (vs. alloplastic) reconstruction, and for the participants who were farther out from their reconstruction. CONCLUSION: The BREAST-Q Sensation Module can be used alone or in conjunction with other BREAST-Q scales to inform clinical care and to evaluate outcomes of new surgical approaches to restoration of breast sensation.

Patient-Reported Outcome Measures in Lymphedema: A Systematic Review and COSMIN Analysis.

BACKGROUND: Lymphedema is a chronic and debilitating condition that affects many cancer survivors. Patient-reported outcome measures (PROMs) can give valuable insight into the impact of lymphedema on a patient's quality of life and can play an essential role in treatment decisions. This study aims to (1) identify PROMs used to assess health-related quality of life (HRQoL) in patients with lymphedema; and (2) assess the quality of the lymphedema-specific PROMs. METHODS: We performed a systematic search to identify articles on lymphedema, quality of life, and PROMs. An overview was created of all PROMs used to assess HRQoL in patients with lymphedema. The methodological quality of the lymphedema-specific PROMs was assessed using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. RESULTS: A total of 235 articles met the inclusion criteria, of which 200 described studies using one or more PROMs as an outcome measure in patients with lymphedema. The other 35 studies described the development and/or validation of a lymphedema-specific PROM. The COSMIN assessment demonstrated that none of these PROMs met all quality standards for development. CONCLUSION: The use of PROMs in lymphedema is increasing; however, based on our findings, we cannot fully support the use of any of the existing instruments. A well-developed lymphedema-specific PROM, based on patient input, is needed to gain better insight into the impact of this condition, and can be used to measure the effect of possible medical and surgical treatments.

Development and Psychometric Validation of a Patient-Reported Outcome Measure for Arm Lymphedema: The LYMPH-Q Upper Extremity Module.

BACKGROUND: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). METHODS: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. RESULTS: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach's alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. CONCLUSIONS: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

Development and Psychometric Validation of BREAST-Q Scales Measuring Cancer Worry, Fatigue, and Impact on Work.

BACKGROUND: The BREAST-Q is a patient-reported outcome measure for women with breast cancer. The aim of this study was to develop new BREAST-Q scales to measure Cancer Worry, Fatigue and Impact on Work. METHODS: Data were collected between January 2017 and November 2019. Phase 1 (qualitative) included participants from Canada and the USA, pre/post any type of breast cancer treatment (surgery, adjuvant, neoadjuvant). Interviews were audio-recorded, transcribed verbatim and coded line-by-line. New scales were drafted and refined through cognitive interviews and expert input. Phase 2 (field-test study) involved USA members of the Love Research Army (LRA). Rasch measurement theory analysis was used to examine reliability and validity. RESULTS: In phase 1, 57 women were interviewed. Three concepts were identified as important to the breast cancer experience that are not currently covered in the BREAST-Q and developed into scales, i.e., Cancer Worry, Fatigue and Impact on Work. Feedback from nine women and 23 experts was used to establish content validity. The scales were field-tested in the LRA sample (n = 1680), of whom 1006 completed a test-retest. Reliability was > 0.81 for the person separation index, > 0.89 for Cronbach's alpha and > 0.83 for interclass correlation coefficients. Lower scores on all three scales were significantly associated with being closer in time to diagnosis and having a higher cancer stage at diagnosis (p < 0.001 on ANOVA). CONCLUSION: These new scales expand the BREAST-Q measurement system and provide a means to evaluate additional important outcomes for breast cancer patients in clinical care and research.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

An international mixed methods study to develop a new preference-based measure for women with breast cancer: the BREAST-Q Utility module.

BACKGROUND: Generic preference-based measures (PBM), though commonly used, may not be optimal for use in economic evaluations of breast cancer interventions. No breast cancer-specific PBM currently exists, and the generic PBMs fail to capture the unique concerns of women with breast cancer (e.g., body image, appearance, treatment-specific adverse effects). Hence, the objective of this study was to develop a breast cancer-specific PBM, the BREAST-Q Utility module. METHODS: Women diagnosed with breast cancer (stage 0-4, any treatment) were recruited from two tertiary hospitals in Canada and one in the US. The study followed an exploratory sequential mixed methods approach, whereby semi-structured interviews were conducted and at the end of the interview, participants were asked to list their top five health-related quality of life (HRQOL) concerns and to rate the importance of each item on the BREAST-Q. Interviews were audio-recorded, transcribed verbatim, and coded. Constant comparison was used to refine the codes and develop a conceptual framework. Qualitative and quantitative data were triangulated to develop the content of the Utility module  that was refined through 2 rounds of cognitive debriefing interviews with women diagnosed with breast cancer and feedback from experts. RESULTS: Interviews were conducted with 57 women aged 55 ± 10 years. A conceptual framework was developed from 3948 unique codes specific to breasts, arms, abdomen, and cancer experience. Five top-level domains were HRQOL (i.e., physical, psychological, social, and sexual well-being) and appearance. Data from the interviews, top 5 HRQOL concerns, and BREAST-Q item ratings were used to inform dimensions for inclusion in the Utility module. Feedback from women with breast cancer (N = 9) and a multidisciplinary group of experts (N = 27) was used to refine the module. The field-test version of the HSCS consists of 10 unique dimensions. Each dimension is measured with 1 or 2 candidate items that have 4-5 response levels each. CONCLUSION: The field-test version of the BREAST-Q Utility module was derived from extensive patient and expert input. This comprehensive approach ensured that the content of the Utility module is relevant, comprehensive, and includes concerns that matter the most to women with breast cancer.

International study to develop the WOUND-Q patient-reported outcome measure for all types of chronic wounds.

Patient-reported outcome measures (PROMs) for chronic wounds mainly focus on specific types of wounds. Our team developed the WOUND-Q for use with all types of wounds in any anatomic location. We conducted 60 concept elicitation interviews with patients in Canada, Denmark, the Netherlands, and the United States. Analysis identified concepts of interest to patients and scales were formed and refined through cognitive interviews with 20 patients and input from 26 wound care experts. Scales were translated into Danish and Dutch. An international field-test study collected data from 881 patients (1020 assessments) with chronic wounds. Rasch measurement theory (RMT) analysis was used to refine the scales and examine psychometric properties. RMT analysis supported the reliability and validity of 13 WOUND-Q scales that measure wound characteristics (assessment, discharge, and smell), health-related quality of life (life impact, psychological, sleep impact, and social), experience of care (information, home care nurses, medical team, and office staff), and wound treatment (dressing and suction device). The WOUND-Q can be used to measure outcomes in research and clinical practice from the perspective of patients with any type of wound.

Development and Validation of the BREAST-Q Breast-Conserving Therapy Module.

BACKGROUND: In breast cancer surgery, patient-reported outcome measures are needed to measure outcomes best reported by patients (e.g., psychosocial well-being). This study aimed to develop and validate a new BREAST-Q module to address the unique concerns of patients undergoing breast-conserving therapy (BCT). METHODS: Phase 1 involved qualitative and cognitive interviews with women who had BCT and clinical expert input to establish content for the BCT module. A field-test (phase 2) was performed, and Rasch measurement theory (RMT) analysis was used for item reduction and examination of reliability and validity. Validation of the item-reduced scales in a clinical sample (phase 3) was conducted for further assessment of their psychometric properties. RESULTS: Qualitative interviews with 24 women resulted in the addition of 15 new items across multiple existing BREAST-Q scales and the development of two new scales (Adverse Effects of Radiation and Satisfaction With Information-Radiation Therapy). Feedback from 15 patients and 5 clinical experts were used to refine the instructions, response options, and item wording. An RMT analysis of data from 3497 women resulted in item reduction. The final set of scales showed evidence of ordered response option thresholds, good item fit, and good reliability, except for the Adverse Effects of the Radiation Scale. Validity and reliability were further supported by the phase 3 data from 3125 women. CONCLUSIONS: The BREAST-Q BCT module can be used in research and clinical care to evaluate quality metrics and to compare surgical outcomes across all breast cancer surgery patients.

Impact of Completing CLEFT-Q Scales That Ask About Appearance on Children and Young Adults: An International Study.

OBJECTIVE: To describe the impact of completing the CLEFT-Q appearance scales on patients with cleft lip and/or palate and to identify demographic and clinical characteristics and CLEFT-Q scores associated with reporting a negative impact. DESIGN: International cross-sectional survey. SETTING: Recruitment took place between October 2014 and November 2016 at 30 craniofacial clinics located in 12 countries. PATIENTS: Aged 8 to 29 years with cleft lip and/or palate. MAIN OUTCOME MEASURE(S): Participants were asked 4 questions to evaluate the impact of completing the field test version of a patient-reported outcome measure (the CLEFT-Q) that included 154 items, of which 79 (51%) asked about appearance (of the face, nose, nostrils, teeth, lips, jaws, and cleft lip scar). RESULTS: The sample included 2056 participants. Most participants liked answering the CLEFT-Q (88%) and the appearance questions (82%). After completing the appearance scales, most participants (77%) did not feel upset or unhappy about how they look, and they felt the same (67%) or better (23%) about their appearance after completing the questionnaire. Demographic and clinical variables associated with feeling unhappy/upset or worse about how they look included country of residence, female gender, more severe cleft, anticipating future cleft-specific surgeries, and reporting lower (ie, worse) scores on CLEFT-Q appearance and health-related quality-of-life scales. CONCLUSION: Most participants liked completing the CLEFT-Q, but a small minority reported a negative impact. When used in clinical practice, CLEFT-Q scale scores should be examined as soon as possible after completion in order that the clinical team might identify patients who might require additional support.

Patient-reported experience measures are essential to improving quality of care for chronic wounds: An international qualitative study.

Traditional quality measures for chronic wounds have focused on objective outcomes that are challenging to risk adjust, lack patient input, and have limited ability to inform quality improvement interventions. Patient-reported experience measures (PREMs) provide information from the patient perspective regarding health care quality and have potential to improve patient-centredness, increase care efficiency, and generate actionable data for quality improvement. The purpose of this study was to understand patient experiences and health care processes that impact quality of care among patients with chronic wounds. Sixty patients at least 18 years of age with various wound aetiologies were recruited from Canada, Denmark, The Netherlands, and the United States as part of a larger phase 1 qualitative study to develop a patient-reported outcome measure for chronic wounds (WOUND-Q). All patients had a chronic wound for at least 3 months, were fluent in their native speaking language, and able to participate in a one-on-one semi-structured interview. Interviews were digitally recorded and transcribed verbatim. Interpretive description was used to identify recurrent themes relating to patient experience and quality of care. We identified five domains (care coordination, establishing/obtaining care, information delivery, patient-provider interaction, and treatment delivery) and 21 sub-domains (access to patient information, interdisciplinary communication, encounter efficiency, provider availability, specialist referral, staff professionalism, travel/convenience, modality, reciprocity, understandability/consistency, accountability, continuity, credentials, rapport, appropriateness, complication management, continuity, environment/setting, equipment and supply needs, expectation, and patient-centred) as potential opportunities to measure and improve quality of care in the chronic wound population. PREMs for chronic wounds represent an important opportunity to engage patients and longitudinally assess quality across clinical settings and providers. Future research should focus on developing PREMs to complement traditional objective and patient-reported outcome measures for chronic wounds.

French translation and linguistic validation of a new Patient Reported Outcome instrument: the BODY-Q: A description of the process.

BACKGROUND: Bariatric surgery or reconstructive body contouring surgery performed after weight loss, has the potential to have a major impact one's body image, health-related quality of life (HRQOL) and mental wellbeing. Many researches show interest in measuring this impact using generic instruments that unfortunately are not specifically oriented toward bariatric or surgery patients. The BODY-Q is a new patient-reported outcome (PRO) instrument designed to measure patient perceptions of weight loss and/or body contouring. In this article, we describe the methods used to translate and culturally adapt the French version of the BODY-Q. MATERIAL AND METHOD: We followed the recommendation for translation process established by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) and the World Health Organisation (WHO). This process included two forward translations, one backward translation, a review by a panel of expert and cognitive debriefing interviews with patient. Our aim was to ensure a conceptual and culturally valid translation. RESULTS: This translation process led to a conceptually and culturally equivalent French version of the Body-Q. Backward translation comparison to the English original version led to the identification of 16 differences necessitating re-translation. The expert panel offered support to identify inadequate expressions and proposed changes to the translations. The cognitive debriefing interviews with 15 patients contributed to minor changes in the translation. CONCLUSIONS: This thorough method of translation and cultural adaptation allowed us to develop a conceptually and culturally valid French translation of the BODY-Q.

Psychometric findings and normative values for the CLEFT-Q based on 2434 children and young adult patients with cleft lip and/or palate from 12 countries.

BACKGROUND: Patients with cleft lip and/or palate can undergo numerous procedures to improve appearance, speech, dentition and hearing. We developed a cleft-specific patient-reported outcome instrument to facilitate rigorous international measurement and benchmarking. METHODS: Data were collected from patients aged 8-29 years with cleft lip and/or palate at 30 hospitals in 12 countries between October 2014 and November 2016. Rasch measurement theory analysis was used to refine the scales and to examine reliability and validity. Normative CLEFT-Q values were computed for age, sex and cleft type. RESULTS: Analysis led to the refinement of an eating and drinking checklist and 12 scales measuring appearance (of the face, nose, nostrils, teeth, lips, jaws and cleft lip scar), health-related quality of life (psychological, social, school, speech distress) and speech function. All scales met the requirements of the Rasch model. Analysis to explore differential item functioning by age, sex and country provided evidence to support the use of a common scoring algorithm for each scale for international use. Lower (worse) scores on CLEFT-Q scales were associated with having a speech problem, being unhappy with facial appearance, and needing future cleft-related treatments, providing evidence of construct validity. Normative values for age, sex and cleft type showed poorer outcomes associated with older age, female sex and having a visible cleft. INTERPRETATION: The CLEFT-Q represents a rigorously developed instrument that can be used internationally to collect and compare evidence-based outcomes data from patients aged 8-29 years of age with cleft lip and/or palate.

What Matters to Patients With Cleft Lip and/or Palate: An International Qualitative Study Informing the Development of the CLEFT-Q.

OBJECTIVE: The goal of treatment for individuals with cleft lip and/or palate (CL/P) is to improve physical, psychological, and social health. Outcomes of treatment are rarely measured from the patient's perspective. The aim of the study was to develop a conceptual framework for a patient-reported outcome (PRO) instrument for individuals with clefts (CLEFT-Q) by developing an in-depth understanding of issues that individuals consider to be important. DESIGN: The qualitative methodology of interpretive description was used. Setting, Participants, and Intervention: We performed 136 individual in-depth interviews with participants with clefts of any age, presenting for cleft care, across 6 countries. Parents were involved if the child was more comfortable. Interviews were audio-recorded, transcribed verbatim, and coded using constant comparison. The data were used to develop a refined conceptual framework. RESULTS: Participants described concepts of interest in 3 top-level domains, each of which included subdomains: appearance (face, nose, nostrils, teeth, lips, jaw, cleft lip scar), health-related quality of life (psychological, social, school, speech-related distress), and facial function (speech, eating/drinking). Participants were able to describe changes over time with regard to the 3 domains. CONCLUSIONS: A conceptual framework of concepts of interest to individuals with CL/P formed the basis of the scales in the CLEFT-Q. Each subdomain represents an independently functioning scale. Understanding what matters to patients is essential in guiding PRO measurement.

Identifying Needs in Young Adults With Inflammatory Bowel Disease: A Qualitative Study.

Successful transitional care for young adults entails that healthcare teams recognize and understand the attitudes, perspectives, and developmental maturity of young adults. The aim of this study was to identify the needs of young adults with inflammatory bowel disease. Young adults 18-30 years of age were recruited from the McMaster University Medical Centre adult inflammatory bowel disease (IBD) clinic between July 2012 and May 2013. Semistructured interviews were audio taped, transcribed verbatim, and coded using a constant comparative method. QSR NVivo10 software was used to manage the data. Twenty-one young adults, including 15 subjects diagnosed as adolescents (younger than 18 years) and 6 subjects diagnosed as young adults, were interviewed. Four broad categories of needs were identified: psychosocial, informational, self-advocacy, and daily living needs. The most commonly reported needs were psychosocial and the least common were daily living needs. Results from this study may be used to inform clinical practitioners of potential needs that may be important to the overall quality of patient health during young adulthood. In addition, these findings may be used to evaluate existing transition and self-management tools to measure success of transition interventions more effectively.