Publications by authors named "Elena Tsangaris"

45 Publications

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

Cochrane Database Syst Rev 2021 Oct 12;10:CD011589. Epub 2021 Oct 12.

Health Services & Policy Research, Exeter Collaboration for Academic Primary Care (APEx), NIHR School for Primary Care Research, NIHR ARC South West Peninsula (PenARC), University of Exeter, Exeter, UK.

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.
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http://dx.doi.org/10.1002/14651858.CD011589.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509115PMC
October 2021

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

Ann Surg Oncol 2021 Aug 10. Epub 2021 Aug 10.

Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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.
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http://dx.doi.org/10.1245/s10434-021-10465-5DOI Listing
August 2021

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

Ann Surg Oncol 2021 Sep 5;28(9):5166-5182. Epub 2021 Jul 5.

Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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.
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http://dx.doi.org/10.1245/s10434-021-09887-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349351PMC
September 2021

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

Ann Surg Oncol 2021 Nov 24;28(12):7410-7420. Epub 2021 May 24.

Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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.
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http://dx.doi.org/10.1245/s10434-021-10090-2DOI Listing
November 2021

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

Ann Surg Oncol 2021 Nov 14;28(12):7842-7853. Epub 2021 May 14.

Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.

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.
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http://dx.doi.org/10.1245/s10434-021-10094-yDOI Listing
November 2021

Clinical and Demographic Factors Associated with Distress in Adolescent and Young Adults with Cancer.

J Adolesc Young Adult Oncol 2021 Apr 12. Epub 2021 Apr 12.

Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.

Distress in cancer is defined as multifactorial unpleasant experience of an emotional, psychological, social, or spiritual nature that interferes with ones' ability to cope with cancer and its symptoms and treatment. The aim of this study was to determine clinical and demographic factors associated with the presence of distress in adolescent and young adults (AYAs) with cancer. Data were collected as part of a field-test study conducted between August 2016 and November 2017 in Canada (Toronto, Edmonton, and Vancouver) to determine the reliability and validity of CDS-AYA (Cancer Distress Scales for Adolescent and Young Adults). The CDS-AYA consist of five independently functioning scales including impact of cancer, physical, emotional, cognitive, and cancer worry. Multivariate logistic regression analyses, using established CDS-AYA cut points, were performed to identify clinical and demographic factors associated with the presence of distress in AYAs of ages 15-39 years with cancer. Across all scales, increased distress was associated with female gender ( < 0.05), on-treatment status ( < 0.05), and reported poor overall health ( < 0.001). For the emotional scale, distress was also associated with being of age 15-19 years ( = 0.01). The greatest effect size for all scales was associated with treatment status [ = 1.78-4.6], except for the cognitive scale where gender had a slightly greater effect size. Factors associated with distress in AYA patients with cancer were similar across five CDS-AYA scales. Although it is important to screen all patients for distress, our findings reveal that patients who are female, on treatment, or who report having poorer health may be at a greater risk.
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http://dx.doi.org/10.1089/jayao.2020.0196DOI Listing
April 2021

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

Int Wound J 2021 Aug 10;18(4):487-509. Epub 2021 Mar 10.

Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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.
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http://dx.doi.org/10.1111/iwj.13549DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273613PMC
August 2021

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

Ann Surg Oncol 2021 Sep 26;28(9):5183-5193. Epub 2021 Feb 26.

McMaster University, Hamilton, ON, Canada.

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 (X(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.
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http://dx.doi.org/10.1245/s10434-021-09619-2DOI Listing
September 2021

An international study to develop the EAR-Q patient-reported outcome measure for children and young adults with ear conditions.

J Plast Reconstr Aesthet Surg 2021 Sep 5;74(9):2341-2348. Epub 2021 Feb 5.

Modus Outcomes, Suite 210b, Spirella Building, Letchworth Garden City SG6 4ET, UK. Electronic address:

Background: There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective.

Methods: Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties.

Results: Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X(80) = 90.9, p = 0.19) and Adverse Effects (X(20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales.

Interpretation: The EAR-Q can be used in those 8-29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally.
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http://dx.doi.org/10.1016/j.bjps.2021.01.014DOI Listing
September 2021

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

BMC Womens Health 2021 01 6;21(1). Epub 2021 Jan 6.

Brigham and Women's Hospital, 75 Francis S, Boston, MA, 02116, USA.

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.
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http://dx.doi.org/10.1186/s12905-020-01125-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789506PMC
January 2021

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

Ann Surg Oncol 2021 Mar 28;28(3):1656-1668. Epub 2020 Nov 28.

Department of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.

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.
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http://dx.doi.org/10.1245/s10434-020-09346-0DOI Listing
March 2021

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

Int Wound J 2020 Aug 21;17(4):1052-1061. Epub 2020 Apr 21.

Department of Surgery, Patient Reported Outcome, Value, and Experience (PROVE) Center, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA.

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.
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http://dx.doi.org/10.1111/iwj.13374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949344PMC
August 2020

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q).

BMJ Open 2020 03 25;10(3):e032332. Epub 2020 Mar 25.

Department of Surgery, Patient Reported Outcome, Value, and Experience (PROVE) Center, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA

Introduction: Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.

Methods And Analysis: In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.

Ethics And Dissemination: This study is coordinated at Brigham and Women's Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.
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http://dx.doi.org/10.1136/bmjopen-2019-032332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170563PMC
March 2020

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

Cleft Palate Craniofac J 2020 07 12;57(7):840-848. Epub 2020 Feb 12.

Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Canada.

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.
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http://dx.doi.org/10.1177/1055665620902877DOI Listing
July 2020

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

Ann Surg Oncol 2020 Jul 21;27(7):2238-2247. Epub 2020 Jan 21.

Division of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

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.
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http://dx.doi.org/10.1245/s10434-019-08195-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174155PMC
July 2020

Comparison of Patient-Reported Outcome Measures for Use as Performance Metrics in Adolescent and Young Adult Psychosocial Cancer Care.

J Adolesc Young Adult Oncol 2020 04 4;9(2):262-270. Epub 2019 Nov 4.

Department of Supportive Care, Princess Margaret Cancer Center, Toronto, Canada.

To compare the Cancer Distress Scales for Adolescents and Young Adults (CDS-AYA)-Emotional and Impact scales-with the Edmonton Symptom Assessment Scale-revised (ESAS-r), Hospital Anxiety and Depression Scale (HADS), and the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT) for use as a patient-reported outcome-performance measure (PRO-PM) for AYA cancer care. Data were collected as part of the field test study of CDS-AYA. Assessment criteria were based on a National Quality Forum report. Internal and test-retest (TRT) reliability was assessed using Cronbach's alpha and intraclass correlation coefficients, respectively. A content sort of items in each scale was performed to determine AYA-specific content. Two predefined hypotheses for gender and treatment status were assessed using -test. Four hundred twenty-one participants were included in the analyses. Cronbach's alpha ranged from 0.79 to 0.94, with only the two scales of CDS-AYA achieving >0.90. TRT reliability for HADS was considered excellent (>0.90), with remaining scales having moderate to good reliability (>0.70). Only the Impact scale of CDS-AYA had items that addressed the specific concerns of AYAs (e.g., romantic relationships). In all scales, active therapy patients had higher levels of distress than patients not receiving treatment ( ≤ 0.05). Distress was greater for females than males for all scales, but nonsignificant for both the ESAS-r ( = 0.07) and the HADS depression subscale ( = 0.13). The proportion of AYAs screening positive for distress varied by instrument. The Impact scale of CDS-AYA met the most criteria for selection of a PROM for use in performance measurement for the AYA cancer population.
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http://dx.doi.org/10.1089/jayao.2019.0033DOI Listing
April 2020

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

Psychiatr Danub 2019 Sep;31(Suppl 3):406-410

Department of Psychiatry, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium,

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.
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September 2019

Further construct validation of the CLEFT-Q: Ability to detect differences in outcome for four cleft-specific surgeries.

J Plast Reconstr Aesthet Surg 2019 Dec 8;72(12):2049-2055. Epub 2019 Aug 8.

Department of Pediatrics, McMaster University, Room HSC 3N27, 1280 Main Street West, Hamilton, Ontario L8S 4L8, Canada. Electronic address:

Background: The CLEFT-Q is a patient-reported outcome measure developed for use in patients with cleft lip and/or palate. A significant indicator of the CLEFT-Q's validity relates to its ability to detect differences between the impact of specific aspects of clefting before and after surgery. This study compares relevant sub-scale scores of the CLEFT-Q for patients requiring four specific surgical treatments against those who either have had surgery or never needed surgery.

Methods: CLEFT-Q scores and clinical information regarding the past and future need for jaw surgery, lip revision, rhinoplasty, and speech surgery were obtained from the CLEFT-Q field-test data. Eight one-way analysis of variance (ANOVA) models were developed to compare mean scores of relevant CLEFT-Q scales between those who needed surgery, those who have had surgery, and those who never needed surgery. Only patients from high-income countries were included to minimize the impact of any economic confounders that could result in treatment variation. In the rhinoplasly and lip revision models, patients without a cleft lip were excluded. In the jaw surgery and speech surgery models, patients without a cleft palate or alveolus were excluded.

Results: The CLEFT-Q field test included 1938 participants from high-income countries. Participants who needed surgery scored significantly lower (worse) than those who have had surgery in each of the eight relevant CLEFT-Q scales (p < 0.001 in each ANOVA).

Conclusion: The ability of the CLEFT-Q to detect differences between groups based on surgical status further supports its validity.
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http://dx.doi.org/10.1016/j.bjps.2019.07.029DOI Listing
December 2019

Development and Psychometric Evaluation of the Cancer Distress Scales for Adolescent and Young Adults.

J Adolesc Young Adult Oncol 2019 10 8;8(5):566-580. Epub 2019 Jul 8.

Department of Pediatrics, McMaster University, Hamilton, Canada.

The use of valid and reliable screening tools to measure distress may help to identify adolescent and young adults (AYA) with cancer who need additional support. Our study describes a two-phase approach to adapt the Australian AYA oncology and survivorship distress screening tools for use in Canada. Phase 1 involved refining the Australian AYA oncology and survivorship screening tools using cognitive interviews with AYA with cancer and feedback from experts. In phase 2, a field-test study was performed, and Rasch Measurement Theory (RMT) analysis was used for item reduction and to examine reliability and validity. Cognitive interviews with 45 AYA with cancer and feedback from 25 experts resulted in a field-test version of the Cancer Distress Scales for AYA (CDS-AYA) consisting of 91 items that measure 9 constructs. The field-test sample included 515 participants. RMT analysis identified five scales (impact of cancer, physical, emotional, cancer worry, and cognitive) with ordered thresholds, good item fit (-3.70 to 2.82), and acceptable reliability (0.85-0.94). Reliability for the remaining four scales (employment, education, practical, and social) was low, and the scales were retained as checklists, with the exception of the social scale that was dropped. The final item-reduced CDS-AYA consist of 48 items in 5 scales, with 2 stand-alone items in the physical and emotional scales and 23 items in 3 checklists. The CDS-AYA can be used in research and in clinical practice to measure distress in AYA with cancer.
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http://dx.doi.org/10.1089/jayao.2019.0005DOI Listing
October 2019

CLEFT-Q: Detecting Differences in Outcomes among 2434 Patients with Varying Cleft Types.

Plast Reconstr Surg 2019 07;144(1):78e-88e

From the Division of Plastic and Reconstructive Surgery, Department of Surgery, Hospital for Sick Children, University of Toronto; the Departments of Pediatrics, Surgery, and Health Research Methods, Evidence and Impact, McMaster University; the Spires Cleft Center, Oxford University Hospitals NHS Foundation Trust; the Department of Otolaryngology-Head and Neck Surgery, University of Colorado School of Medicine; the Division of Plastic Surgery, Department of Surgery, University of British Columbia, BC Children's Hospital; the Department of Plastic Surgery, University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh; the National Maxillofacial Unit, St. James' Hospital; the Department of Plastic and Reconstructive Surgery, Memorial Sloan Kettering Cancer Center; West Midlands Cleft Service, Birmingham Children's Hospital; and Fundación Operación Sonrisa Colombia and Division of Plastic Surgery, Universidad el Bosque.

Background: Measuring the patient perspective is important in evaluating outcomes of cleft care. Understanding how treatment outcomes vary depending on cleft type may allow for better planning of treatments, setting of expectations, and more accurate benchmarking efforts. The CLEFT-Q is a patient-reported outcome measure for patients with cleft lip and/or palate.

Methods: The 12 CLEFT-Q scales measuring appearance (i.e., face, nose, nostrils, lips, cleft lip scar, teeth, and jaws), function (i.e., speech), and health-related quality of life (i.e., psychological, school, social, and speech-related distress) were field tested in a cross-sectional study in 30 centers in 12 countries. Patients with cleft lip and/or cleft palate aged 8 to 29 years were recruited from clinical settings. Differences in CLEFT-Q scores by cleft subtypes were evaluated using one-way analysis of variance or Kruskal-Wallis H tests, with Tukey or Dunn procedure with Bonferroni corrections post hoc analyses, respectively. Scores are presented using radar charts to visualize all outcomes simultaneously.

Results: The field test included 2434 patients. Scores on all CLEFT-Q scales varied significantly with cleft subtype. Patients with unilateral or bilateral cleft lip and/or palate scored lower on all appearance scales compared with patients with cleft palate or unilateral incomplete cleft lip. Scores on the speech function and speech-related distress scales decreased with each progressive group in the Veau classification. Patients with complete bilateral cleft lip and palate scored lowest on the social, school, and psychological scales.

Conclusions: Patient-reported outcomes measured with the CLEFT-Q vary significantly with cleft type. Visualizing multiple outcomes simultaneously with radar charts allows for an understanding of a patient's overall status in a single graph.
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http://dx.doi.org/10.1097/PRS.0000000000005723DOI Listing
July 2019

Distress Screening in Adolescents and Young Adults with Cancer: Development of Cut-Points for the Cancer Distress Scales-Adolescent and Young Adults.

J Adolesc Young Adult Oncol 2019 10 20;8(5):560-565. Epub 2019 Jun 20.

Department of Supportive Care, Princess Margaret Cancer Center, Toronto, Ontario, Canada.

Distress is an important issue facing adolescent and young adults (AYA) with cancer due to their stage of development. Metrics are necessary to help improve psychosocial outcomes in this population. This study determined cut-points for the newly developed Cancer Distress Scales (CDS)-AYA. The CDS-AYA is a new patient-reported outcomes measure that comprises five independently functioning scales, including the following: Impact of Cancer (12 items), Physical (12 items), Emotional (11 items), Cognitive (8 items), and Cancer Worry (5 items). Canadian AYA with cancer 15-39 years of age completed the CDS-AYA and the Hospital Anxiety and Depression Scale (HADS), as part of the CDS-AYA field test. Only patients who had completed responses to the CDS-AYA and HADS were included in these analyses. Receiver operating characteristic (ROC) curve analysis was used to generate cut-points for five CDS-AYA scales based on distress defined by the HADS anxiety and HADS depression scale. In total 453 of 515 respondents had complete data for the CDS-AYA and HADS were included in analyses. Area under the curve (AUC) in the ROC analyses ranged from 0.75 to 0.85. The CDS-AYA Emotional scale had the greatest AUC. The cutoff value for the Emotional scale was 27 based on the HADS anxiety scores (78.3% and 78.9%). The five CDS-AYA scales had fair to good accuracy when classifying the none/low and moderate/severe distress categories based on HADS anxiety and depression scales. For screening purposes, it is recommended that the Emotional scale or Impact of Cancer scale be utilized.
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http://dx.doi.org/10.1089/jayao.2019.0032DOI Listing
October 2019

Development and Validation of a Nipple-Specific Scale for the BREAST-Q to Assess Patient-Reported Outcomes following Nipple-Sparing Mastectomy.

Plast Reconstr Surg 2019 Apr;143(4):1010-1017

From the Divisions of Plastic and Reconstructive Surgery and Breast Surgery, Department of Surgery, University of California, San Francisco; the Department of Pediatrics, McMaster University; and Plastic and Reconstructive Surgery, Memorial Sloan Kettering Cancer Center.

Background: Nipple-sparing mastectomy and immediate reconstruction has become increasingly popular for prophylactic and therapeutic indications. Patient-reported outcomes instruments such as the BREAST-Q provide important information regarding patient satisfaction and aesthetic and functional outcomes. However, a validated patient-reported outcomes scale specifically addressing nipple-related outcomes following nipple-sparing mastectomy is not currently available.

Methods: The authors developed a new scale measuring nipple outcomes by adapting nipple reconstruction questions from the BREAST-Q breast reconstruction module. Patients completed the questions using the think-aloud method and underwent semistructured cognitive interviews to discuss their nipple-sparing mastectomy experience to elicit new concepts. Interviews were coded and additional questions were added based on this analysis after receiving additional input from a multidisciplinary group of breast cancer providers. The final scale was distributed electronically to a larger group with solicitation for any issues that were not addressed in the question set.

Results: Ten patients completed the initial questionnaire. Analysis of the cognitive interviews identified nipple sensation, position, projection, scarring, symmetry, and surgical expectations as key content areas. After revising the questionnaire, an additional 35 patients completed it electronically. All respondents felt the questions were clear and no additional issues needed to be addressed. Feedback was used to clarify the instructions for how to respond to the questions if bilateral nipple-sparing mastectomy had been performed.

Conclusions: Through qualitative patient interviews and adaptation of existing BREAST-Q questions, appropriate nipple-focused questions were developed to assess outcomes following nipple-sparing mastectomy. Incorporating these questions into patient-reported outcomes assessment of patients undergoing nipple-sparing mastectomy can help improve future techniques and optimize outcomes.
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http://dx.doi.org/10.1097/PRS.0000000000005426DOI Listing
April 2019

Development of a New Patient-reported Outcome Measure for Ear Conditions: The EAR-Q.

Plast Reconstr Surg Glob Open 2018 Aug 7;6(8):e1842. Epub 2018 Aug 7.

Department of Surgery, Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Ontario, Canada.

Background: Patient-reported outcome measures are widely used to improve health services and patient outcomes. The aim of our study was to describe the development of 2 ear-specific scales designed to measure outcomes important to children and young adults with ear conditions, such as microtia and prominent ears.

Methods: We used an interpretive description qualitative approach. Semi-structured qualitative and cognitive interviews were performed with participants with any type of ear condition recruited from plastic surgery clinics in Canada, Australia, United States, and United Kingdom. Participants were interviewed to elicit new concepts. Interviews were audio-recorded, transcribed, and coded using the constant comparison approach. Experts in ear reconstruction were invited to provide input via an online Research Electronic Data Capture survey.

Results: Participants included 25 patients aged 8-21 years with prominent ears (n = 9), microtia (n = 14), or another condition that affected ear appearance (n = 2). Analysis of participant qualitative data, followed by cognitive interviews and expert input, led to the development and refinement of an 18-item ear appearance scale (eg, size, shape, look up close, look in photographs) and a 12-item adverse effects scale (eg, itchy, painful, numb).

Conclusions: The EAR-Q in currently being field-tested internationally. Once finalized, we anticipate the EAR-Q will be used in clinical practice and research to understand the patient's perspective of outcomes following ear surgery.
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http://dx.doi.org/10.1097/GOX.0000000000001842DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6181510PMC
August 2018

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.

CMAJ 2018 04;190(15):E455-E462

Department of Pediatrics (Klassen), McMaster University, Hamilton, Ont.; Division of Plastic and Reconstructive Surgery (Wong Riff), Department of Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ont.; Department of Pediatrics (Longmire), McMaster University, Hamilton, Ont.; Department of Pediatric Surgery (Albert), Hospital Sant Joan de Déu, Universitat de Barcelona, Spain; Department of Otolaryngology - Head & Neck Surgery (Allen), University of Colorado School of Medicine, Aurora, Colo.; Department of Plastic Reconstructive and Aesthetic Surgery (Aydin), School of Medicine, Suleyman Demirel University, Isparta Turkey; Inova Children's Hospital (Baker), Falls Church, Va.; Department of Plastic Surgery (Baker), MedStar Georgetown University Hospital, Washington, DC; Modus Outcomes (Cano), Letchworth Garden City, UK; Department of Plastic Surgery (Chan), Flinders Medical Centre, Bedford Park, South Australia; Division of Plastic Surgery, Department of Surgery (Courtemanche), University of British Columbia; BC Children's Hospital, Vancouver, BC; Department of Plastic Surgery (Dreise), University Medical Centre Groningen, University of Groningen, The Netherlands; Department of Plastic Surgery (Goldstein), University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pa.; Spires Cleft Centre (Goodacre), Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Department of Pediatrics (Harman), McMaster University, Ron Joyce Children's Health Centre, Hamilton, Ont.; Maxillofacial Surgery Department (Munill), Hospital Vall d'Hebron, Barcelona, Spain; National Maxillofacial Unit (Mahony), St James's Hospital, Dublin, Ireland; Fundación Gantz, departamento de Fonoaudiología (Aguilera), El Lazo, Pudahuel, Chile; Department of Reconstructive Plastic Surgery (Peterson), Karolinska University Hospital, Stockholm, Sweden; Plastic and Reconstructive Surgery (Pusic), Memorial Sloan-Kettering Cancer Center, New York, NY; West Midlands Cleft Service (Slator), Birmingham Children's Hospital, Birmingham, UK; Department of Clinical Sciences in Malmö (Stiernman), Lund University, Lund, Sweden; Department of Health Research Methods, Evidence, and Impact (Tsangaris), McMaster University, Hamilton, Ont.; Indiana University School of Medicine (Tholpady), R.L. Roudebush Veterans Affairs Medical Center, Indianapolis, Ind.; Division of Plastic Surgery Universidad el Bosque (Vargas), Fundación Operación Sonrisa Colombia, Bogotá, Colombia; The Centre for Craniofacial Care and Research (Forrest), The Hospital for Sick Children, Toronto, Ont.

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.
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http://dx.doi.org/10.1503/cmaj.170289DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5903887PMC
April 2018

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

Cleft Palate Craniofac J 2018 03 14;55(3):442-450. Epub 2017 Dec 14.

6 Department of Pediatrics, McMaster University, Hamilton, Canada.

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.
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http://dx.doi.org/10.1177/1055665617732854DOI Listing
March 2018

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

Gastroenterol Nurs 2018 Jan/Feb;41(1):19-28

Romy Cho, MD, is with Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. Natasha M. Wickert, MSc, is with Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. Anne F. Klassen, BA, DPhil, is with Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. Elena Tsangaris, MSc, is with Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. John K. Marshall, MD, MSc, FRCPC, AGAF, is with Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Herbert Brill, MD, MBA, FRCPC, is with Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.

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.
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http://dx.doi.org/10.1097/SGA.0000000000000288DOI Listing
October 2018

Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain.

Health Qual Life Outcomes 2017 Nov 28;15(1):228. Epub 2017 Nov 28.

Department of Pediatrics, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.

Background: Cleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual's appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain.

Methods: The CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed.

Results: The field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions.

Conclusion: Translation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved.
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http://dx.doi.org/10.1186/s12955-017-0805-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5704495PMC
November 2017
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