Claudia Rutherford

• PhD
• Associate Professor at The University of Sydney

Aims Since 2016, more than one million new patients with chronic health conditions have been prescribed medicinal cannabis in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, depression, and motor function in a large real-world sample of patients prescribed medicinal cannabis. We previously...

Background and objective Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring frequent follow-up with endoscopic examinations, tumour resections and intravesical treatments. In this clinical context, patient-reported outcomes (PROs) have enormous potential to inform treatment assessment and recommendations for NMIBC. We aimed...

Background Monitoring for the side effects of novel therapies using patient-reported outcomes (PROs) is critical for ensuring patient safety. Existing static patient-reported outcome measures may not provide adequate coverage of novel side effects. Item libraries provide a flexible approach to monitoring for side effects using customized item lists...

Introduction As patient-reported outcomes (PROs) are increasingly used in the evaluation of medical treatments, it is important that PROs are carefully analyzed and interpreted. This may be challenging due to substantial missing values. The missingness in PROs is often closely related to patients’ disease status. In that case, using observed inform...

Purpose There is evidence of low completion of patient-reported outcome measures (PROMs) by people from culturally and linguistically diverse (CALD) backgrounds and Indigenous Peoples with chronic health conditions. We aimed to systematically identify ways to support and promote PROM completion by CALD communities and Indigenous Peoples in clinical...

Background Remote monitoring using electronic patient-reported outcomes (ePROs) may help identify immune-related adverse events (irAEs) and direct self-management. There is no consensus regarding thresholds to alert providers about potentially severe irAEs or when to instigate evidence-based self-management. We aimed to develop consensus around ale...

Background/Objectives: Knowledge of the symptoms and side effects (SSEs) of Bacille Calmette–Guerin (BCG) therapy for non-muscle invasive bladder cancer (NMIBC) is critical when establishing selecting appropriate therapies for patients. The aim of our study was to systematically review the common patient-reported SSEs associated with BCG-based and...

Background Utilising electronic patient-reported outcomes (ePRO) to monitor symptoms can improve patient outcomes. However, ePRO systems are typically not co-designed with end-users which may limit their utility and long-term sustainability. We aimed to co-design a real-time ePRO symptom monitoring system for immune checkpoint inhibitor (ICI) toxic...

Purpose There is evidence of poor completion of patient-reported outcome measures (PROMs) by culturally and linguistically diverse (CALD) and Indigenous populations with chronic health conditions. We aimed to systematically review strategies used to increase PROM uptake and completion of PROMs by CALD and Indigenous Peoples in clinical care setting...

Introduction Patient-reported outcome measures (PROMs) are validated and standardised questionnaires that capture patients’ own reports of their symptoms, functioning and well-being. PROMs can facilitate communication between patients and clinicians, reduce symptom burden, enhance quality of life and inform health service re-design. We aim to deter...

PURPOSE Electronic patient-reported outcome (ePRO) symptom monitoring may support the safe delivery of immune checkpoint inhibitors (ICI). There is no consensus on which side effects should be monitored in routine care. We aimed to develop a prioritized list of ICI side effects to include in ePRO systems and compare this to existing ICI-specific pa...

Importance Chemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings. Objective To compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory function...

Patient-reported outcomes (PROs) are being increasingly integrated into routine clinical practice to enhance individual patient care. This has been driven by recognition of the benefits of PROs in enhancing symptom management, patient satisfaction, quality of life, and overall survival, and reductions in acute health care utilization. These benefit...

12016 Background: Chemotherapy-induced peripheral neurotoxicity (CIPN) is a significant and persisting toxicity of anticancer treatments, impacting dose delivery and quality of life. There is a lack of consensus on the optimal method of CIPN assessment in clinical settings. This study compared the validity and responsiveness of patient reported out...

Background Many colorectal cancer (CRC) survivors experience ongoing sequelae from their cancer treatment. Limited evidence exists regarding how CRC survivors and general practitioners (GPs) manage these sequelae in the community. This study aimed to explore the experiences and perspectives of CRC survivors and GPs on current approaches to monitori...

PURPOSE Electronic patient-reported outcomes (ePROs) are an evidence-based means of detecting symptoms earlier and improving patient outcomes. However, there are few examples of successful implementation in routine cancer care. We conducted a qualitative study to identify barriers and facilitators to implementing ePRO symptom monitoring in routine...

Background While there is increasing evidence on the benefits of PROMs in cancer care, the extent of routine collection and use of PROMs in clinical cancer practice across Australia and New Zealand (ANZ) is unknown. This study examined the prevalence and characteristics of PROMs use in routine clinical cancer care in ANZ. Methods An online survey...

Introduction Radiation therapy (RT) can benefit approximately 50% of cancer patients and contribute to 40% of all cancer cures, yet its utilisation in cancer is low globally. Several factors contribute to this including perceived inconvenience related to accessing and utilising RT. To quantitatively assess the latter, a new tool – the Radiation the...

Aims Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal c...

Management of low-risk ductal carcinoma in situ (DCIS) is controversial, with clinical trials currently assessing the safety of active monitoring amidst concern about overtreatment. Little is known about general community views regarding DCIS and its management. We aimed to explore women’s understanding and views about low-risk DCIS and current and...

Introduction Colorectal cancer (CRC) is prevalent in the developed world, with unhealthy lifestyles and diet contributing to rising incidence. Advances in effective screening, diagnosis, and treatments have led to improved survival rates, but CRC survivors suffer poorer long-term gastrointestinal consequences than the general population. However, t...

Aims: Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, includin...

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakehold...

Purpose: Increasing use of immune checkpoint inhibitors (ICIs) in routine cancer care will increase the incidence of immune-related adverse events (irAEs). Systems are needed to support remote monitoring for irAEs. Electronic patient-reported outcome (ePRO) symptom monitoring systems can help monitor and manage symptoms and side effects. We assess...

Objective: Pressure ulcers (PU) are the most prevalent of the dependency-related injuries, affecting the quality of life of the patients who suffer them. However, there are no instruments adapted to the Spanish context to evaluate this quality of life. The use of specific tools in Spanish to evaluate the quality of life perceived by patients with...

Purpose Colorectal cancer (CRC) survivors experience treatment-effects such as symptoms and functional impairments. There is limited evidence about how these are managed and what services or supports are available in the community. We aimed to identify current practice and available supports for managing consequences of treatment from clinician and...

Background: Chemotherapy-induced peripheral neurotoxicity (CIPN) is a common complication of cancer treatment that produces functional disability. Increasingly, patient-reported outcome measures (PROMs) are used to assess CIPN, providing a broader symptom perspective than clinician-graded scales. Understanding when a reported change in CIPN sympto...

Background Patient-reported experience measures (PREMs) assess quality-of-care from patients’ perspectives. PREMs can be used to enhance patient-centered care and facilitate patient engagement in care. With increasing quality improvement studies in clinical practice, the use of PREMs has surged. As a result, knowledge about stakeholder experiences...

Ovarian cancer and its treatments can have profound and diverse impacts on patients’ quality of life. Within research contexts, “health-related quality of life” (HRQL) is used as an umbrella term to encompass and assess all of these impacts. Specific impacts include physical symptoms and functioning impairment caused by the disease, and the psychol...

Research waste relating to the production and reporting of health and medical research is a major problem. Each year, resources are wasted on research that asks the wrong questions, uses inappropriate designs, includes unrepresentative or small samples, uses incorrect methods of analysis, and is inappropriately reported, disseminated, or translated...

Objectives DCIS is a breast malignancy contained within the milk ducts. Prognostic uncertainty means discussing DCIS and its treatment are challenging. Recognition that some DCIS lesions might remain indolent for many years has led to concern about overtreatment, with international clinical trials underway assessing the safety of active monitoring...

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...

Objectives Organised breast screening has greatly increased DCIS incidence. Recognition that some DCIS lesions might remain indolent for many years has led to concern about overtreatment, and international clinical trials are currently assessing the safety of active monitoring for low-risk DCIS. Women may not be aware of what DCIS is and the dilemm...

Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is a common toxicity of cancer treatment, with potential to significantly impact cancer survivors’ long-term quality of life. Patient reported outcome measures (PROMs) are increasingly utilised to evaluate CIPN. However, guidance remains lacking on how to identify fit for purpose PROMs with...

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 impr...

Background Body image is a subjective concept encompassing a person’s views and emotions about their body. Head and neck cancer (HNC) diagnosis and treatment affects several psychosocial concepts including body image. Large numbers of HNC patients are diagnosed each year in India but there are no suitable measures in regional languages to assess th...

Objective Ability to assess flares in osteoarthritis (OA) of the knee and hip (KHOA) is important in clinical care and research. Using mixed methods, we developed a self-reported instrument measuring flare and assessed its psychometric properties. Methods We constructed questionnaire items from semi-structured interviews and a focus group (patient...

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 in...

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 wo...

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...

PurposeTo 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 operatio...

BACKGROUND Existing evidence supports several countries introducing legislations to allow cannabis-based medicine as adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis, epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the en...

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 enti...

IntroductionFailure 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 impro...

AimsProxy 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...

Background Flare in osteoarthritis (OA) of the knee and hip (KHOA) is an important outcome for patients’ daily life and clinical research. A definition of a flare was set, and a core set of domains was recently endorsed by OMERACT/OARSI. No patient reported outcome (PRO) yet focusses on flare in OA specifically. Objectives To develop a self-report...

Background Hip and knee OA is characterised by disease flares – understanding the determinants and consequences of OA flares has been hampered by lack of a standardized flare measure beyond the pain aspect. The patients point of view on the different aspect of their flares is essential. Objectives The objective was to assess the psychometric prope...

Introduction La poussée d’arthrose du genou et de la hanche est un évènement important dans la vie quotidienne des patients et pour la recherche clinique. Une définition de la poussée a été établie, et un ensemble de domaines qui la caractérise a été récemment approuvé par l’OMERACT/OARSI. Aucune mesure rapportée par le patient (PRO) ne s’est focal...

Introduction L’arthrose des membres inférieurs est une maladie fréquente et invalidante, dont l’évolution se fait par poussées de durée variable et de survenue imprévisible, difficile à mettre en évidence pour le médecin. Le point de vue des patients est essentiel. L’objectif était d’évaluer les propriétés psychométriques d’un auto-questionnaire en...

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...

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 NM...

État de la question L’objectif était de développer un questionnaire mesurant les poussées dans l’arthrose et évaluer ses propriétés psychométriques. Matériel et méthodes Les items ont été générés à partir d’entretiens semi-structurés et d’un groupe de discussion (patients, cliniciens) en utilisant une approche bilingue. La sélection des items a ét...

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...

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...

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...

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...

PurposeGiven the high survival rate of cervical cancer patients, understanding women’s health-related quality of life (HRQL) during and after treatment is of major clinical importance. We conducted a systematic review to synthesize all available evidence about the effects of each contemporary treatment modality for cervical cancer on all dimensions...

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 underw...

Background In order to overcome inconsistencies in the reporting of outcomes in clinical trials, core outcome sets (COS) have been developed in many clinical areas and the awareness of this concept is growing steadily. The Outcomes for Pressure Ulcer Trials (OUTPUTs) project aims to improve the quality of evidence on pressure ulcer prevention trial...

Purpose Due to increasing numbers of colorectal and anal cancer survivors, more individuals are living with long-term symptoms after treatment. A systematic review was undertaken to assess the extent to which practice guidelines for colorectal and anal cancer provide recommendations for managing long-term symptoms and functioning impairments. Meth...

Use of patient-reported measures (PRMs) in healthcare is increasing internationally. In New South Wales (NSW) Australia the implementation of a system-wide PRMs program is underway. This program is an enabler for value based healthcare. We report an evaluation (2015/16) of this program’s first year. We evaluated the program using mixed methods. Peo...

Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities...

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 pre...

Introduction The incidence of ductal carcinoma in situ (DCIS) has increased greatly since the introduction of organised breast screening. Because DCIS encompasses a spectrum of disease, including some indolent lesions that may not progress, there is growing concern about overdiagnosis and overtreatment. Women aged 70–74 years are included in the ex...

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 pr...

Objective: Morbidity from head and neck cancers (HNCs) and their treatment is 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...

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...

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-...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the effects of decision coaching when used to provide non‐directive support to help people prepare to make decisions related to their health care.

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 def...

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 wer...

Patient‐reported outcomes (PRO) can be included as endpoints 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 resea...

Purpose Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized contr...

BACKGROUND Pressure ulcers (PUs) represent a major challenge to patient safety in healthcare contexts, presenting high incidence and increased financial costs in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of PUs in long-term care centres and in patients’ own homes is proposed as a priority indicator o...

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 an...

For many patients with end‐stage kidney disease, transplantation improves survival and quality of life compared to 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 iden...

Cervical cancer and its treatments can affect quality of life in many ways, both positively and negatively, from diagnosis through to the acute treatment and survivorship phases. In research settings, the collective term used for all these impacts is health-related quality of life (HRQOL). These include psychological distress related to impairment...

BACKGROUND: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis, but complications and side effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidn...

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...

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 functio...

Purpose Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized contr...

Aims: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was n...