Publications by authors named "Claudia Rutherford"

46 Publications

Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops.

Qual Life Res 2022 May 12. Epub 2022 May 12.

NHMRC Clinical Trial Centre, University of Sydney, Sydney, Australia.

Introduction: Failure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018.

Method: Annual workshops were conducted 2011-2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann-Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall.

Results: Participants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: 'specify PRO concepts/domains' (p = 0.05); 'methods for handling missing data' (p = 0.044).

Conclusion: Although participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.
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http://dx.doi.org/10.1007/s11136-022-03127-wDOI Listing
May 2022

A Quality-of-Life Evaluation Study Assessing Health-Related Quality of Life in Patients Receiving Medicinal Cannabis (the QUEST Initiative): Protocol for a Longitudinal Observational Study.

JMIR Res Protoc 2021 Nov 24;10(11):e32327. Epub 2021 Nov 24.

School of Psychology, Faculty of Science, The University of Sydney, Sydney, Australia.

Background: Evidence supports several countries introducing legislation to allow cannabis-based medicine as an adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis (MS), epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice.

Objective: This study aims to collect real-world data to evaluate health-related quality of life in patients prescribed medicinal cannabis oil and describe any differences over time, from before starting therapy to after 3 and 12 months of therapy.

Methods: Adult patients newly prescribed medicinal cannabis oil by authorized prescribers and under the Special Access Schemes across Australia will be screened for eligibility and invited to participate. A sample size of 2142 is required, with a 3-month follow-up. All participants will complete the EuroQol 5-Dimension; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30; Depression, Anxiety, and Stress Scale-21; Patients' Global Impression of Change; Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) version 1.0: Sleep Disturbance 8b; and PROMIS SF Fatigue 13a questionnaires. Patients with chronic pain conditions will also complete the PROMIS SF version 1.0: Pain Intensity 3a and PROMIS SF version 1.0: Pain Interference 8a. Patients with movement disorders will also complete Quality of Life in Neurological Disorders (Neuro-QoL) SF version 1.0: Upper Extremity Function (Fine Motor and Activities of Daily Living) and if chorea is indicated, the Neuro-QoL SF version 2.0: Huntington's Disease health-related Quality of LIFE-Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly up to 3 months, and then every 2 months up to 1 year.

Results: Recruitment commenced in November 2020. By June 2021, 1095 patients were screened for the study by 69 physicians in centers across 6 Australian states: Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the patients screened, 833 (39% of the target sample size) provided consent and completed baseline questionnaires. Results are expected to be published in 2022. Results of this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3 months and whether any changes are maintained over a 12-month period. This study will also identify differences in improvements in patient-reported outcomes among patients with different chronic conditions (eg, chronic pain, MS, epilepsy, Parkinson disease, or cancer).

Conclusions: This protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have the potential to be integral to treatment assessment and recommendations for patients with chronic pain and other health indicators for accessing medicinal cannabis.

Trial Registration: Australian New Zealand Clinical Trials Registry: ANZCTRN12621000063819; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380807&isReview=true.

International Registered Report Identifier (irrid): DERR1-10.2196/32327.
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http://dx.doi.org/10.2196/32327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8663597PMC
November 2021

Decision coaching for people making healthcare decisions.

Cochrane Database Syst Rev 2021 11 8;11:CD013385. Epub 2021 Nov 8.

School of Nursing, University of Ottawa, Ottawa, Canada.

Background: Decision coaching is non-directive support delivered by a healthcare provider to help patients prepare to actively participate in making a health decision. 'Healthcare providers' are considered to be all people who are engaged in actions whose primary intent is to protect and improve health (e.g. nurses, doctors, pharmacists, social workers, health support workers such as peer health workers). Little is known about the effectiveness of decision coaching.

Objectives: To determine the effects of decision coaching (I) for people facing healthcare decisions for themselves or a family member (P) compared to (C) usual care or evidence-based intervention only, on outcomes (O) related to preparation for decision making, decisional needs and potential adverse effects.

Search Methods: We searched the Cochrane Library (Wiley), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (Ebsco), Nursing and Allied Health Source (ProQuest), and Web of Science from database inception to June 2021.

Selection Criteria: We included randomised controlled trials (RCTs) where the intervention was provided to adults or children preparing to make a treatment or screening healthcare decision for themselves or a family member. Decision coaching was defined as: a) delivered individually by a healthcare provider who is trained or using a protocol; and b) providing non-directive support and preparing an adult or child to participate in a healthcare decision. Comparisons included usual care or an alternate intervention. There were no language restrictions.

Data Collection And Analysis: Two authors independently screened citations, assessed risk of bias, and extracted data on characteristics of the intervention(s) and outcomes. Any disagreements were resolved by discussion to reach consensus. We used the standardised mean difference (SMD) with 95% confidence intervals (CI) as the measures of treatment effect and, where possible, synthesised results using a random-effects model. If more than one study measured the same outcome using different tools, we used a random-effects model to calculate the standardised mean difference (SMD) and 95% CI. We presented outcomes in summary of findings tables and applied GRADE methods to rate the certainty of the evidence.

Main Results: Out of 12,984 citations screened, we included 28 studies of decision coaching interventions alone or in combination with evidence-based information, involving 5509 adult participants (aged 18 to 85 years; 64% female, 52% white, 33% African-American/Black; 68% post-secondary education). The studies evaluated decision coaching used for a range of healthcare decisions (e.g. treatment decisions for cancer, menopause, mental illness, advancing kidney disease; screening decisions for cancer, genetic testing). Four of the 28 studies included three comparator arms.  For decision coaching compared with usual care (n = 4 studies), we are uncertain if decision coaching compared with usual care improves any outcomes (i.e. preparation for decision making, decision self-confidence, knowledge, decision regret, anxiety) as the certainty of the evidence was very low.  For decision coaching compared with evidence-based information only (n = 4 studies), there is low certainty-evidence that participants exposed to decision coaching may have little or no change in knowledge (SMD -0.23, 95% CI: -0.50 to 0.04; 3 studies, 406 participants). There is low certainty-evidence that participants exposed to decision coaching may have little or no change in anxiety, compared with evidence-based information. We are uncertain if decision coaching compared with evidence-based information improves other outcomes (i.e. decision self-confidence, feeling uninformed) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with usual care (n = 17 studies), there is low certainty-evidence that participants may have improved knowledge (SMD 9.3, 95% CI: 6.6 to 12.1; 5 studies, 1073 participants). We are uncertain if decision coaching plus evidence-based information compared with usual care improves other outcomes (i.e. preparation for decision making, decision self-confidence, feeling uninformed, unclear values, feeling unsupported, decision regret, anxiety) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with evidence-based information only (n = 7 studies), we are uncertain if decision coaching plus evidence-based information compared with evidence-based information only improves any outcomes (i.e. feeling uninformed, unclear values, feeling unsupported, knowledge, anxiety) as the certainty of the evidence was very low.

Authors' Conclusions: Decision coaching may improve participants' knowledge when used with evidence-based information. Our findings do not indicate any significant adverse effects (e.g. decision regret, anxiety) with the use of decision coaching. It is not possible to establish strong conclusions for other outcomes. It is unclear if decision coaching always needs to be paired with evidence-informed information. Further research is needed to establish the effectiveness of decision coaching for a broader range of outcomes.
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http://dx.doi.org/10.1002/14651858.CD013385.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575556PMC
November 2021

Using feedback tools to enhance the quality and experience of care.

Qual Life Res 2021 Nov;30(11):3007-3013

Faculty of Science, School of Psychology, Quality of Life Office, The University of Sydney, Sydney, Australia.

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http://dx.doi.org/10.1007/s11136-021-03008-8DOI Listing
November 2021

Perceived benefits and limitations of using patient-reported outcome measures in clinical practice with individual patients: a systematic review of qualitative studies.

Qual Life Res 2022 Jun 27;31(6):1597-1620. Epub 2021 Sep 27.

The University of Sydney, Faculty of Science, School of Psychology, Sydney Quality of Life Office, Sydney, Australia.

Purpose: Patient-reported outcome measures (PROMs) are increasingly used in clinical settings to inform individual patient care. In-depth understanding of end-users' experiences may help identify factors that promote or hinder their use in clinical decision-making. We aimed to examine stakeholder perceptions of the utility of using PROMs in clinical practice based on real-life experience.

Methods: Systematic review searching Medline, Embase and PsychINFO from inception to May 2021. Qualitative studies examining patients' and/or clinicians' experiences of using PROMs in clinical settings were included. Study screening and data extraction were performed by two independent reviewers. Qualitative data from included studies was analysed thematically.

Results: Of 2388 abstracts retrieved, 52 articles reporting 50 studies met eligibility. Five key benefits were identified: (1) promotes active patient involvement (enables goal setting and discussion of sensitive topics); (2) enhances the focus of consultations (prioritizes patient needs); (3) improves quality of care (enables tailored, holistic care and prompts action); (4) enables standardized monitoring of patient outcomes; and (5) enhances the patient-clinician relationship (provides reassurance). Perceived limitations included the capacity of PROMs to shift the focus of consultations; inaccurately estimate problems; raise unrealistic expectations for care; inhibit patient-clinician interaction; lack clinically meaningful information; and not be suitable for all patients.

Conclusion: Both patients and clinicians reported benefits of using PROMs across diverse health conditions and clinical settings, but also highlighted several limitations. These limitations shed some light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives.
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http://dx.doi.org/10.1007/s11136-021-03003-zDOI Listing
June 2022

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

Qual Life Res 2022 Feb 12;31(2):317-327. Epub 2021 Jul 12.

Faculty of Medicine, Sydney Medical School, Central Clinical School, The University of Sydney, Sydney, NSW, Australia.

Aims: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations.

Methods: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use.

Results: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures.

Discussion: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies.

Systematic Review Registration: PROSPERO No. CRD42018103179.
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http://dx.doi.org/10.1007/s11136-021-02937-8DOI Listing
February 2022

'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension.

BMJ Open 2021 06 30;11(6):e046450. Epub 2021 Jun 30.

Institute of Applied Health Research, Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK

Objectives: (a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.

Design: A 1-day patient and public involvement session.

Participants: Seven patient partners.

Methods: A patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.

Results: Two user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.

Conclusions: These tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.
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http://dx.doi.org/10.1136/bmjopen-2020-046450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246365PMC
June 2021

Patient-reported anxiety and depression measures for use in Indian head and neck cancer populations: a psychometric evaluation.

J Patient Rep Outcomes 2021 Jun 7;5(1):44. Epub 2021 Jun 7.

Faculty of Science, School of Psychology, Quality of Life Office, The University of Sydney, Sydney, New South Wales, Australia.

Background: Head and neck cancers (HNC) are one of the most traumatic forms of cancer because they affect essential aspects of life such as speech, swallowing, eating and disfigurement. HNCs are common in India, with over 100,000 cases being registered each year. HNC and treatment are both associated with considerable anxiety and depression. With increasing multinational research, no suitable measures in Indian languages are available to assess anxiety and depression in Indian HNC patients. This study evaluated the psychometric properties of cross-culturally adapted versions of Zung's self-rating Anxiety Scale (SAS) and the Patient health questionnaire - 9 (PHQ-9) in Tamil, Telugu and Hindi speaking Indian HNC populations.

Methods: HNC patients were recruited from three tertiary cancer centres in India. Patients completed the cross-culturally adapted versions of SAS and PHQ-9. We assessed targeting, scaling assumptions, construct validity (exploratory and confirmatory factor analyses), convergent validity, and internal consistency reliability.

Results: The study sample included 205 Tamil, 216 Telugu and 200 Hindi speaking HNC patients. Exploratory and confirmatory factor analyses indicated a two-factor solution for PHQ-9 and four-factor solution for SAS in all three languages. Cronbach's alpha coefficients ranged between 0.717 and 0.890 for PHQ-9 and between 0.803 and 0.868 for SAS, indicating good reliability. Correlations between hypothesized scales were as expected providing evidence towards convergent validity.

Conclusions: This first psychometric evaluation of the measurement properties of Tamil, Telugu and Hindi versions of the SAS and PHQ-9 in large, Indian HNC populations supported their use as severity and outcome measures across the disease and treatment continuum.
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http://dx.doi.org/10.1186/s41687-021-00316-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184912PMC
June 2021

Enabling cross-cultural data pooling in trials: linguistic validation of head and neck cancer measures for Indian patients.

Qual Life Res 2021 Sep 2;30(9):2649-2661. Epub 2021 Apr 2.

Quality of Life Office, School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia.

Background: Head and neck cancers (HNC) and their treatments cause dysfunction and distress. Ongoing psychological assessment using disease-specific patient-reported measures may optimize clinical decision-making, facilitate interventions to reduce psychosocial burden. As most such measures are developed in English, non-English speaking patients are disadvantaged. This study translated HNC-specific measures (Body Image Scale, Patient Concerns Inventory, Zung's Self-Rating Anxiety and Depression Scales and Patient Health Questionnaire-9) into three Indian languages (Hindi, Tamil and Telugu) and linguistically validated them.

Methods: Translation followed established guidelines on translation and linguistic validation of measures. Process involved two independent forward translations, reconciliation, two independent backward translations by bilingual experts, and cognitive debriefing interviews with nine healthcare professionals (HCPs) and 29 HNC patients. Translated versions were compared with the original versions for semantic, cultural and conceptual equivalence.

Results: Overall, 17 Hindi items, 19 Tamil items and 13 Telugu items were identified to have semantic, cultural and/or conceptual issues. These were resolved to achieve equivalence with the original measures. Interviews with HCPs indicated that equivalent terms for words such as anxiety, panicky, sexuality, and self-conscious might be difficult to understand. Interviews with patients indicated all items were understandable, easy, sensitive, unambiguous and relevant. Hence, no further revisions were made.

Conclusions: The translated Hindi, Tamil and Telugu versions of the Body image scale, Patient concerns inventory, Zung's self-rating anxiety and depression scales and Patient health questionnaire-9 measures are conceptually and linguistically validated and equivalent with the original English versions. Psychometric validation of these measures with relevant patient populations is needed.
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http://dx.doi.org/10.1007/s11136-021-02837-xDOI Listing
September 2021

How is quality of life defined and assessed in published research?

Qual Life Res 2021 Aug 1;30(8):2109-2121. Epub 2021 Apr 1.

Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia.

Purpose: To ensure clarity in communication in the field of quality of life research, and meaningful use of 'quality of life' as a research outcome, requires two things: awareness that there is a range of conceptualisations and definitions of 'quality of life', and for any particular study, consistency between the way the term is defined and operationalised in that setting. We aimed to identify how frequently research articles described (HR)QOL as a construct of interest, how frequently they referred to "patient-reported outcome (measures)", which patient-reported outcome measures were used, and how (HR)QOL was defined.

Methods: We reviewed all Quality of Life Research articles published in 2017 and recorded whether they described health-related quality of life or quality of life as constructs of interest, and/or mentioned the term(s) patient-reported outcome (measures). We recorded definitions of (HR)QOL stated and questionnaires used. We classified articles according to constructs assessed and instruments used, and examined whether articles citing the same definition used the same questionnaires.

Results: We reviewed 300 articles; 65% stated that (HR)QOL was a construct of interest, 27% mentioned patient-reported outcome (measures), and 20% mentioned neither. Fifty-one articles provided definitions of (HR)QOL, citing 66 sources, with 11 definitions cited more than once. PROMIS, SF, EQ-5D, and EORTC instruments were the most commonly used. The only definition and questionnaire consistently used together were the WHO definitions/instruments.

Conclusion: These results demonstrate considerable heterogeneity in the definition and operationalisation of (HR)QOL, between and within studies. This limits meaningful interpretation of (HR)QOL scores and complicates literature searches. Investigators should define constructs and select instruments aligned with their definitions.
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http://dx.doi.org/10.1007/s11136-021-02826-0DOI Listing
August 2021

Validation of a Core Patient-Reported Outcome Measure for Fatigue in Patients Receiving Hemodialysis: The SONG-HD Fatigue Instrument.

Clin J Am Soc Nephrol 2020 11 22;15(11):1614-1621. Epub 2020 Oct 22.

Faculty of Science, Quality of Life Office, School of Psychology, University of Sydney, Sydney, Australia.

Background And Objectives: Fatigue is a very common and debilitating symptom and identified by patients as a critically important core outcome to be included in all trials involving patients receiving hemodialysis. A valid, standardized measure for fatigue is needed to yield meaningful and relevant evidence about this outcome. This study validated a core patient-reported outcome measure for fatigue in hemodialysis.

Design, Setting, Participants, & Measurements: A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (Standardized Outcomes in Nephrology-Hemodialysis Fatigue [SONG-HD Fatigue]). Eligible and consenting patients completed the measure at three time points: baseline, a week later, and 12 days following the second time point. Cronbach and intraclass correlation coefficient were calculated to assess internal consistency, and Spearman rho was used to assess convergent validity. Confirmatory factor analysis was also conducted. Hemodialysis units in the United Kingdom, Australia, and Romania participated in this study. Adult patients aged 18 years and over who were English speaking and receiving maintenance hemodialysis were eligible to participate. Standardized Outcomes in Nephrology-Hemodialysis, the Visual Analog Scale for fatigue, the 12-Item Short Form Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue were used.

Results: In total, 485 participants completed the study across the United Kingdom, Australia, and Romania. Psychometric assessment demonstrated that Standardized Outcomes in Nephrology-Hemodialysis is internally consistent (Cronbach =0.81-0.86) and stable over a 1-week period (intraclass correlation coefficient =0.68-0.74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue and had moderate correlations with other measures that assessed related but not the same concept (the 12-Item Short Form Survey and the Visual Analog Scale). Confirmatory factor analysis supported the one-factor model.

Conclusions: SONG-HD Fatigue seems to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis.
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http://dx.doi.org/10.2215/CJN.05880420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646231PMC
November 2020

Views of healthcare professionals about the role of active monitoring in the management of ductal carcinoma in situ (DCIS): Qualitative interview study.

Breast 2020 Dec 15;54:99-105. Epub 2020 Sep 15.

Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; Sydney Health Literacy Lab, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, NSW, Australia. Electronic address:

Background: Ductal carcinoma in situ (DCIS) is an in-situ (pre-cancerous) breast malignancy whereby malignant cells are contained within the basement membrane of the breast ducts. Increasing awareness that some low-risk forms of DCIS might remain indolent for many years has led to concern about overtreatment, with at least 3 clinical trials underway internationally assessing the safety of active monitoring for low-risk DCIS. This study aimed to understand healthcare professionals' (HCPs) views on the management options for patients with DCIS.

Methods: Qualitative study using semi-structured interviews with HCPs involved in the diagnosis and management of DCIS in Australia and New Zealand. Interviews were audio-recorded, transcribed and analysed thematically using Framework Analysis method.

Results: Twenty-six HCPs including 10 breast surgeons, 3 breast physicians, 6 radiation oncologists, and 7 breast care nurses participated. There was a strong overall consensus that DCIS requires active treatment. HCPs generally felt uncomfortable recommending active monitoring as a management option for low-risk DCIS as they viewed this as outside current standard care. Overall, HCPs felt that active monitoring was an unproven strategy in need of an evidence base; however, many acknowledged that active monitoring for low-risk DCIS could be appropriate for patients with significant co-morbidities or limited life expectancy. They believed that most patients would opt for surgery wherever possible.

Conclusions: This study highlights the important need for robust randomised controlled trial data about active monitoring for women with low-risk DCIS, to provide HCPs with confidence in their management recommendations and decision-making.
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http://dx.doi.org/10.1016/j.breast.2020.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509786PMC
December 2020

Registered Reports at "Quality of Life Research".

Qual Life Res 2020 10;29(10):2605-2607

Faculty of Science, School of Psychology, Quality of Life Office, The University of Sydney, Sydney, Australia.

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http://dx.doi.org/10.1007/s11136-020-02638-8DOI Listing
October 2020

Patient-reported outcomes in non-muscle invasive bladder cancer: a mixed-methods systematic review.

Qual Life Res 2021 Feb 22;30(2):345-366. Epub 2020 Sep 22.

Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia.

Objective: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can occur life-long. In this context, patient-reported outcomes (PROs) are important considerations to patients and managing clinicians. We undertook a systematic review to synthesise PRO results relevant to NMIBC treatment to explore trajectories overtime and differences between treatment options.

Methods: We searched databases AMED, MEDLINE, EMbase, PsycINFO, Web of Knowledge and Scopus (inception to 5th December 2019), reference lists and contacted key authors to identify studies that reported PROs after NMIBC treatment. Two reviewers independently applied inclusion and quality criteria and extracted findings. Results for PROs were synthesised for treatment groups across three time periods: acute/during induction therapy; during maintenance therapy; and long-term follow-up (> 1 year).

Results: Of 3193 papers screened, 29 were eligible. These provided evidence about induction treatment effects, but few reported maintenance or long-term evidence, and evidence about differences between NMIBC treatment options was lacking. A range of symptoms (pain in bladder area, urinary frequency and urgency, pain or burning during urination) were commonly experienced during and soon after treatment for NMIBC. Less common symptoms included fatigue, disrupted sleep and gastrointestinal problems.

Conclusions: Treatments for NMIBC can cause symptoms and functional impairment during the acute treatment phase and reduce quality of life. Clinicians should be aware of these impairments to prepare patients for short-term sequelae and enable those with treatment options to exercise preferences in choosing among them. However, gaps in current evidence limit our understanding of PRO trajectories from diagnosis through to long-term survivorship and treatment effects.
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http://dx.doi.org/10.1007/s11136-020-02637-9DOI Listing
February 2021

Patient-reported outcomes and experiences from the perspective of colorectal cancer survivors: meta-synthesis of qualitative studies.

J Patient Rep Outcomes 2020 Apr 25;4(1):27. Epub 2020 Apr 25.

The University of Sydney, Susan Wakil School of Nursing and Midwifery, Cancer Nursing Research Unit (CNRU), Faculty of Medicine and Health, Sydney, Australia.

Background: Colorectal cancer (CRC) is prevalent in the developed world. Favourable survival rates highlight the need to better understand CRC survivors' experiences of long-term impacts of treatment, which can in turn inform decision making. This systematic review aimed to identify and synthesise CRC survivors' experiences of long-term impacts on health-related quality of life.

Methods: We searched Medline, Embase and PsychINFO from inception to January 2019. Qualitative studies describing CRC survivors' experiences at least 1-year post-treatment were included. Study eligibility, quality assessment (COREQ guidelines), and data synthesis was performed independently by two reviewers and discussed with the study team.

Results: Of 1363 papers retrieved, 20 reporting 15 studies met eligibility. Thematic synthesis produced 12 themes: symptoms, physical, social, psychological and sexual functioning, impact on relationships, informal care needs provided by family/friend, supportive care needs provided by healthcare professional, health care experiences, health behaviour, financial toxicity and occupational experiences. Stoma problems (e.g. leakage, skin irritation) were common in ostomates. Survivors with no/reversed stoma experienced unexpected, long-term altered and unpredictable bowel functioning. Survivors often regulated timing, amount and foods consumed to manage bowel functioning. Less common symptoms included fatigue, impaired sleep and anal pain. Stoma problems and altered bowel functioning impaired survivors' physical, social, sexual and psychological functioning. Cognitive functioning and heredity issues were not reported in any paper.

Conclusion: CRC survivors experience ongoing symptoms and functioning impairments more than 1-year post-treatment completion. Many survivors find their own ways to manage symptoms rather than seek professional help. Follow-up care for CRC survivors should integrate screening for long-term effects and provide targeted supportive care.
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http://dx.doi.org/10.1186/s41687-020-00195-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183519PMC
April 2020

What are the optimal measures to identify anxiety and depression in people diagnosed with head and neck cancer (HNC): a systematic review.

J Patient Rep Outcomes 2020 Apr 23;4(1):26. Epub 2020 Apr 23.

University of Sydney, School of Psychology, Centre for Medical Psychology and Evidence-Based Decision-Making, Sydney, Australia.

Background: A cancer diagnosis is potentially life-threatening, likely causing distress and uncertainty, which may be psychologically debilitating. Depression and anxiety are commonly underdiagnosed and undertreated in cancer patients. Head and neck cancer (HNC) patients face particular challenges that may contribute to distress. This review aims to: i) identify patient reported outcome measures (PROMs) designed to assess anxiety and depression in HNC; and ii) determine their suitability for use in research and clinical practice to screen patients.

Methods: We searched five electronic databases between July 2007 to July 2019 for studies assessing anxiety and depression in HNC patients. Searches were limited to this period to account for advances in cancer treatment. Records were screened for eligibility by one reviewer and 10% cross-checked by a second across all stages of the review. In addition to the electronic searches, PROM databases were searched for additional measures of anxiety and depression. All retrieved PROMs were mapped against Diagnostic and Statistical Manual-5 criteria for anxiety and depression to assess content coverage. Then, their psychometric properties appraised against the COSMIN checklist.

Results: Electronic searches identified 98 records, from which five anxiety and eight depression measures were retrieved. PROM database searches retrieved an additional four anxiety and four depression measures; a total of nine anxiety and 12 depression measures were appraised. Content coverage of anxiety measures ranged from 50% to 75% and depression measures from 42% to 100%. Demonstration of psychometric properties against COSMIN criteria ranged from 57% to 71% for anxiety measures (three PROMs > 70%) and from 29% to 86% for depression measures (nine PROMs > 70%). Three anxiety and seven depression measures had established clinical cut-offs in cancer populations.

Conclusions: The Patient Health Questionnaire-9, Zung Self-rating Depression and Zung Self-rating Anxiety Scales demonstrated good content coverage along with excellent psychometric properties, and thus were considered the most suitable PROMs to assess psychological distress in HNC populations. It is important to have PROMs assessing psychological distress that capture a comprehensive set of subjective symptoms. The identified PROMs will help researchers and health professionals in clinical-decision making, thereby potentially improving quality of life in HNC patients.
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http://dx.doi.org/10.1186/s41687-020-00189-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7181465PMC
April 2020

Impact of weight loss interventions on patient-reported outcomes in overweight and obese adults with type 2 diabetes: a systematic review.

J Behav Med 2020 12 14;43(6):873-891. Epub 2020 Feb 14.

School of Psychology, Quality of Life Office, Level 6, Chris O' Brien Lifehouse C39Z, University of Sydney, Sydney, NSW, 2006, Australia.

Previous reviews explored weight loss-induced metabolic changes in overweight and obese adults with type 2 diabetes (T2D) but did not report on the impact on patient-reported outcomes (PROs). This systematic review investigated the effect of weight loss interventions on weight loss and PROs in overweight and obese adults with T2D. We searched three electronic databases from inception to March 2018 for randomised controlled trials (RCTs) of weight loss interventions in overweight and obese (according to BMI) adults aged ≥ 18 years reporting changes in PROs from baseline to at least one follow-up assessment during or post-intervention. One reviewer screened abstracts, performed data extraction, and conducted the narrative synthesis, with 25% cross-checking by a second reviewer. We extracted data relating to sample characteristics, intervention and comparison conditions, weight loss, and change in PROs. We identified 540 papers of which 23 met eligibility reporting on 19 RCTs. Four types of interventions (diet, surgery, pharmacological, and multi-component lifestyle interventions) significantly reduced weight. Weight loss was consistently associated with improvements in sexual and physical function across all intervention types, with diet and multi-component lifestyle interventions producing more substantial improvements than surgical or pharmacological interventions. Findings for other PROs, such as HRQOL and depressive symptoms, were inconsistent across studies and intervention types. The four weight loss interventions can be prescribed to engender weight loss in overweight and obese adults with T2D, with multi-component lifestyle interventions generating substantial improvements in physical and sexual function, perhaps due to the potency of exercise in improving PROs.
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http://dx.doi.org/10.1007/s10865-020-00140-7DOI Listing
December 2020

A conceptual framework of patient-reported outcomes in people with venous leg ulcers.

Wound Repair Regen 2020 05 14;28(3):355-363. Epub 2019 Dec 14.

Wound Research Unit, Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.

Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects individual's health-related quality of life (HRQoL). Numerous patient-reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU-QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi-structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU-QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU-QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3-6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU-QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU-specific issues. Overall, the VLU-QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings.
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http://dx.doi.org/10.1111/wrr.12787DOI Listing
May 2020

Content comparison of unmet needs self-report measures used in patients with head and neck cancer: A systematic review.

Psychooncology 2019 12 6;28(12):2295-2306. Epub 2019 Nov 6.

Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, Faculty of Science, University of Sydney, Camperdown, New South Wales, Australia.

Objective: Morbidity from head and neck cancers (HNCs) and their treatment are significant, given their proximity to anatomical sites impacting facial appearance and function. Assessing the needs of HNC patients throughout their cancer journey is critical to informing quality care and improving quality of life. We aimed to identify available unmet needs measures in the HNC setting and appraise their content and psychometric properties.

Methods: We conducted a systematic search of five electronic databases (July 2007-July 2019) to identify studies of unmet needs in patients with HNC. In addition, three web-based patient-reported outcome measures (PROMs) databases were searched for unmet needs measures. Citations were screened for eligibility and identified measures reviewed for content coverage and psychometric properties. From identified measures and literature, a conceptual framework with 12 clinically relevant aspects of unmet needs was developed and used to assess the conceptual coverage of available unmet needs measures.

Results: Literature search identified 273 records of which 28 studies assessing unmet needs in HNC cancer met eligibility criteria. Seven unmet needs measures were identified from retrieved studies and seven additional measures from PROM databases. Thus, 14 measures in total were reviewed. Content mapping revealed that three measures demonstrated excellent content validity (greater than 80% conceptual coverage): Patient Concerns Inventory (PCI), Needs Assessment for Advanced Cancer Patients (NA-ACP), and James Supportive Care Screening (JSCS).

Conclusion: We recommend PCI be used to measure unmet needs in the HNC setting considering the importance of content validity over quantitative psychometric properties.
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http://dx.doi.org/10.1002/pon.5257DOI Listing
December 2019

Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT.

Health Technol Assess 2019 09;23(52):1-176

Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Background: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients.

Primary Objective: Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM).

Design: A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element).

Setting: The trial was set in 42 secondary and community inpatient facilities in the UK.

Participants: Adult inpatients with evidence of acute illness and at a high risk of PU development.

Interventions And Follow-up: APM or HSFM - the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up.

Main Outcome Measures: Time to event.

Results: From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( = 1016) or HSFM ( = 1013). Primary end point - 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93;  = 0.0176 and 2.6% absolute difference). Secondary end points - 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62;  = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed - there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68;  = 0.6122 and absolute difference 2.9%). Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy - the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was 'very good' (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy - the Pressure Ulcer Quality of Life - Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness.

Limitations: A lower than anticipated event rate.

Conclusions: In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU.

Future Work: Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore 'what works for whom and in what circumstances'.

Trial Registration: Current Controlled Trials ISRCTN01151335.

Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta23520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790649PMC
September 2019

Introduction to "Advancing quality‑of‑life research by deepening our understanding of response shift".

Qual Life Res 2019 10;28(10):2621-2622

Faculty of Science, School of Psychology, Quality of Life Office, The University of Sydney, Sydney, Australia.

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http://dx.doi.org/10.1007/s11136-019-02294-7DOI Listing
October 2019

Monitoring Immobilized Elderly Patients Using a Public Provider Online System for Pressure Ulcer Information and Registration (SIRUPP): Protocol for a Health Care Impact Study.

JMIR Res Protoc 2019 Aug 12;8(8):e13701. Epub 2019 Aug 12.

Distrito Sanitario Granada-Metropolitano (Servicio Andaluz de Salud), Armilla, Spain.

Background: Pressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients' own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment.

Objective: This project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a sample of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers-associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a sample of 1700 patients.

Methods: The DSGM runs SIRUPP, which is linked to patients' electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version.

Results: The project commenced in June 2017 and is expected to conclude in April 2020.

Conclusions: This study addresses two main health outcomes-the time needed for wound healing and the mortality associated with pressure ulcers-both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers.

International Registered Report Identifier (irrid): DERR1-10.2196/13701.
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http://dx.doi.org/10.2196/13701DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709896PMC
August 2019

Patient-reported outcomes as predictors of survival in patients with bowel cancer: a systematic review.

Qual Life Res 2019 Nov 30;28(11):2871-2887. Epub 2019 Jul 30.

Faculty of Science, School of Psychology, Quality of Life Office, The University of Sydney, Sydney, NSW, Australia.

Introduction: The prognostic value of patient-reported outcomes (PROs) has been determined in some cancers, but a focussed review in colorectal cancer (CRC) has not yet been conducted. We systematically reviewed PRO predictors of CRC patient survival.

Methods: We searched four electronic databases (from inception to May 2018), reference lists and professional organisations to identify studies reporting pre-treatment PRO predictors of overall survival (OS) or progression-free survival (PFS) in CRC identified through univariate or multivariate models. Two reviewers independently applied inclusion criteria and extracted data on study characteristics, median and 1-year survival rates, PROs assessed and model results.

Results: In 25 of 27 studies (n = 12,544), at least one PRO was significantly associated with survival. Physical functioning, fatigue, pain and appetite loss predicted OS more often than other PROs in metastatic disease (19/27 studies). One study explored PRO predictors in early-stage CRC, finding emotional well-being and mood predicted OS. In mixed-stage samples (7/27 studies), physical functioning predicted OS more often than other PROs. Few studies modelled PFS, for which few PROs had predictive value.

Conclusions: Physical and psychological functioning, pain, fatigue and appetite loss had prognostic significance above and beyond clinical predictors in CRC. Routine monitoring of these PROs may allow earlier detection and amelioration of problems, which may improve quality of life and perhaps extend survival. More research is needed to determine prognostic value of PROs in early-stage CRC, and prognostic significance of changes in PRO scores.
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http://dx.doi.org/10.1007/s11136-019-02255-0DOI Listing
November 2019

Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions.

Trials 2019 Jul 22;20(1):449. Epub 2019 Jul 22.

Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Background: Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS.

Methods/design: The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders.

Discussion: After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups.

Trial Registration: The OUTPUTs project is registered in the COMET database: ( http://www.comet-initiative.org/studies/details/283 ). Registered on 2015.
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http://dx.doi.org/10.1186/s13063-019-3543-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647312PMC
July 2019

A systematic review of body image measures for people diagnosed with head and neck cancer (HNC).

Support Care Cancer 2019 Oct 15;27(10):3657-3666. Epub 2019 Jun 15.

Quality of Life Office, School of Psychology, Faculty of Science, University of Sydney, Sydney, NSW, Australia.

Purpose: Head and neck cancer (HNC) is a relatively common cancer which causes a significant health burden, impacting individuals physically and psychologically. HNC treatment may result in facial disfigurement, eating and communication difficulties, and body image disturbances. We aimed to (1) identify HNC-specific patient-reported outcome measures (PROMs) used to assess body image, (2) evaluate their conceptual coverage, (3) appraise their development process and psychometric properties, and (4) determine appropriate body image PROM(s) for use in the HNC setting.

Methods: Online databases were searched (July 2007-July 2017) for studies that assessed body image in patients with HNC. Studies were screened for eligibility. In addition, we searched three PROM databases for relevant PROMs. From available body image frameworks, we compiled a conceptual schema consisting of 18 clinically relevant body image issues important in the HNC setting, against which PROMs were assessed. Selected measures were appraised for psychometric characteristics, content, and readability.

Results: A total of 245 records were retrieved. 18 studies with PROMs met our inclusion criteria, reporting eight PROMs. The PROM databases searched yielded 62 measures. After screening, eleven measures were short-listed and appraised. The Derriford Appearance Scale (DAS)-59, DAS-24, and body image scale (BIS) cover > 55% of issues within the body image conceptual schema; were developed based on literature, patient interviews, and clinician opinions; and have evidence of internal consistency (Cronbach alpha > 0.7), validity, and responsiveness.

Conclusions: We recommend the DAS-24 and BIS as having adequate coverage of HNC-related issues, and suitable for use in future research.
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http://dx.doi.org/10.1007/s00520-019-04919-6DOI Listing
October 2019

Developing a Preliminary Definition and Domains of Flare in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group.

J Rheumatol 2019 09 15;46(9):1188-1191. Epub 2019 May 15.

From the INSERM, CIC 1433 Clinical Epidemiology; Université de Lorraine, APEMAC unit, MICS team, Nancy; Université de Lorraine, APEMAC unit, EPSAM team, Metz; Sorbonne Université, GRC 08; AP-HP, Rheumatology Department, Pitié-Salpétrière Hospital, Paris, France; University of Sydney, Institute of Bone and Joint Research, Kolling Institute; Rheumatology Department, Royal North Shore Hospital; Inner West Psychology; Faculty of Science, School of Psychology, and Faculty of Medicine and Health & Nursing School, University of Sydney, Sydney, Australia; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, UK; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.

Flare in knee and hip osteoarthritis (OA) is more than just an exacerbation of pain. Unstructured, semistructured, and focus group interviews followed by Delphi surveys with patients and health professionals (HP) generated candidate domains of an OA flare. Content analysis of interviews with 29 patients and 16 HP extracted 180 statements, which were grouped into 9 clusters. Delphi consensus with 50 patients (Australia, Canada, and France) and 116 HP (17 countries on 4 continents) identified 5 flare domains: pain, swelling, stiffness, psychological aspects, and effect of symptoms. Elements for a preliminary definition of an OA flare are proposed. Registered at clinicaltrials.gov NCT02892058.
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http://dx.doi.org/10.3899/jrheum.181085DOI Listing
September 2019

Comparison of generic and disease-specific measures in their ability to detect differences in pressure ulcer clinical groups.

Wound Repair Regen 2019 07 30;27(4):396-405. Epub 2019 Mar 30.

Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.
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http://dx.doi.org/10.1111/wrr.12716DOI Listing
July 2019

Patient-reported outcome measures for life participation in kidney transplantation: A systematic review.

Am J Transplant 2019 08 28;19(8):2306-2317. Epub 2019 Feb 28.

Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.

For many patients with end-stage kidney disease, transplantation improves survival and quality of life compared with dialysis. However, complications and side effects in kidney transplant recipients can limit their ability to participate in activities of daily living including work, study, and recreational activities. The aim of this study was to identify the characteristics, content, and psychometric properties of the outcome measures used to assess life participation in kidney transplant recipients. We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception to July 2018 for all studies that reported life participation in kidney transplant recipients. Two authors identified instruments measuring life participation and reviewed for characteristics. In total, 230 studies were included: 19 (8%) randomized trials, 17 (7%) nonrandomized trials, and 194 (85%) observational studies. Across these studies, we identified 29 different measures that were used to assess life participation. Twelve (41%) measures specifically assessed aspects of life participation (eg, disability assessment, daily activities of living), while 17 (59%) assessed other constructs (eg, quality of life) that included questions on life participation. Validation data to support the use of these measures in kidney transplant recipients were available for only 7 measures. A wide range of measures have been used to assess life participation in kidney transplant recipients, but validation data supporting the use of these measures in this population are sparse. A content relevant and validated measure to improve the consistency and accuracy of measuring life participation in research may inform strategies for transplant recipients to be better able to engage in their life activities.
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http://dx.doi.org/10.1111/ajt.15267DOI Listing
August 2019

Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).

Qual Life Res 2019 Apr 15;28(4):955-962. Epub 2018 Dec 15.

Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, USA.

Aims: A proxy is someone other than a patient who reports a patient's outcomes as if they are the patient. Due to known discordance with patient reports, proxies are often not recommended in clinical trials; however, proxies may be needed in certain research contexts. We aimed to identify and describe trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) with proxy-reported endpoints.

Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with proxy-reported endpoints. Primary and secondary endpoints for each trial retrieved by the search were individually coded (proxy-reported: yes/no), and trials with confirmed proxy-reported endpoints were included in the analysis.

Results: Of 13,666 registered trials, 469 (3.4%) included a proxy-reported endpoint (867 individual proxy-reported endpoints in total: 62% family member proxy, 22% health professional). Proxy endpoint inclusion did not significantly increase over time (r = 0.18, p = 0.59). Mental health (11.5%), stroke (10.3%) and neurological (8.3%) trials had the highest proportion of trials using proxies. Of the 469 trials, 123 (26.2%) studies involved paediatric patients.

Discussion: Proxy-reported endpoints are included in a small but notable number of studies, which may indicate other types of outcomes are used for patients unable to self-report, or that these patients are under-researched.
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http://dx.doi.org/10.1007/s11136-018-2080-4DOI Listing
April 2019

A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation.

Health Qual Life Outcomes 2018 Dec 10;16(1):227. Epub 2018 Dec 10.

Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK.

Introduction: Pressure ulcer-specific patient-reported outcome (PRO) instruments should be used to inform patient care and provide a strong evidence base for interventions aimed at preventing pressure ulcers. The aim was to carry out a comprehensive evaluation of the psychometric properties of a PRO instrument designed to assess symptoms and functional outcomes in patients at high-risk of developing pressure ulcers, the PU-QOL-P instrument.

Methods: We modified the original PU-QOL instrument to be suitable for patients at high risk of pressure ulcer development based on feedback from patients, specialist nurses and PRO methodologists. The modified PU-QOL-P instrument was administered to a sub-set of patients participating in the PRESSURE 2 trial. Patients completed PU-QOL-P and SF12 instruments at baseline, weeks 1 and 3, and 30 days post-treatment. We undertook psychometric evaluation of the modified PU-QOL-P to test scale targeting, scaling assumptions, reliability, validity and responsiveness.

Results: The analysis sample consisted of 617 patients that completed both instruments at baseline. We found that the PU-QOL-P instrument, consisting of nine PU-specific outcomes: three symptom and six function scales, meets established criteria for reliability, construct validity, and responsiveness. Internal consistency reliability was high with all scale Cronbach alpha > 0.795 (range 0.795-0.970). The factor analysis mostly supported the six-function scale structure. Scaling assumptions were satisfied; all item-total correlations above 0.30. Convergent validity was confirmed by significant correlations between hypothesized scales as expected. PU-QOL-P scales were responsive to change: mean scale scores from baseline to 30 days post-treatment were statistically significant for all scales apart the daily activities scale (effect sizes ranged from moderate to high). As expected, worse symptoms and functioning was observed in patients who had a category 1 or 2 PU compared to patients who did not have a PU.

Conclusions: The PU-QOL-P provides a standardised method for assessing pressure ulcer-specific symptoms and functional outcomes for quantifying the benefits of associated interventions from the patient's perspective. It can be used in research with adults at risk of pressure ulcer development in all UK healthcare settings.
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http://dx.doi.org/10.1186/s12955-018-1049-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288857PMC
December 2018
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