Lynda Doward

• Master of Research
• European Head at RTI Health Solutions

Background Caring for someone with Alzheimer’s disease (AD) can have a profound impact on care partners’ wellbeing and daily life. We conducted a social media (SM) review to gain insights into how the impact of AD on care partners is described by persons‐living‐with‐AD (PwADs)/care partners/family members. Method Web‐based searches identified SM d...

[This corrects the article DOI: 10.2196/39852.].

Background: Adult patients with acute lymphoblastic leukemia (ALL) report substantial disease- and treatment-related impacts on their health-related quality of life (HRQOL). Patient-reported information (PRI) shared on social media may provide a distinct opportunity to understand the patient experience outside of formal research contexts and help...

Background Hypoparathyroidism (HPT) is a rare condition in which the parathyroid glands fail to produce enough parathyroid hormone (PTH) or the PTH produced lacks biologic activity. The aim of this study was to explore the patient experience of HPT. Methods Adult patients with HPT, recruited via a medical recruitment agency and the US hypoPARAthyr...

Introduction: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), and improvements in health-related quality of life (HRQoL) in CARTITUDE-1 (NCT03548207). Patient...

BACKGROUND Adult patients with acute lymphoblastic leukemia (ALL) report substantial disease- and treatment-related impacts on their health-related quality of life (HRQOL). Patient-reported information (PRI) shared on social media may provide a distinct opportunity to understand the patient experience outside of formal research contexts and help in...

Background Relapsed refractory multiple myeloma (RRMM) is a disease that is nonresponsive or progressive on therapy, and although patients can achieve remission, relapse is common. As more treatment options become available for multiple myeloma (MM), it is important to understand patients' experiences of current and emerging therapies. Aims This s...

Social media (SM) data is emerging as an important source of information on patient disease and treatment experiences. SM data provide researchers access to unsolicited information shared by patients/caregivers (CGs)/healthcare providers (HCPs), without burdens associated with traditional research methods or influence of interviewer bias. SM facili...

Background Pulmonary arterial hypertension (PAH) is characterized by progressive limitations on physical activity, right heart failure, and premature death. The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning, but no equivalent patient-reported version o...

Purpose: We evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS. Methods: Cross-se...

Background Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease characterized by excessive liver fat accumulation, inflammation, cell injury, and fibrosis. It is viewed as largely asymptomatic in its earlier (non-cirrhotic) stages, and information on the patient-perceived impact of NASH is scarce.Objective...

Background: Patients (pts) with multiple myeloma (MM) experience health-related quality of life (HRQoL) decrement due to symptoms such as fatigue, pain, and insomnia. Pt perspectives of their disease and treatment expectations can help inform clinical decision-making. The phase 1b/2 CARTITUDE-1 study (NCT03548207) is evaluating the efficacy and saf...

Background: Patients with relapsed refractory MM (RRMM) report a decline in HRQOL with disease progression and after each relapse, may experience cumulative toxicities from exposure to several lines of therapy. Social media (SM) platforms are rich databases of unfiltered, real-world evidence, where patients share their experiences about diseases an...

Background: Interim results from a randomized, double‐blind, placebo‐controlled trial of tropifexor (TXR; a non‐bile acid farnesoid X receptor agonist) (FLIGHT‐FXR; NCT02855164) demonstrated improvements in several relevant clinical biomarkers compared with placebo at week 12 in patients with nonalcoholic steatohepatitis (NASH). This analysis descr...

Background: Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved understanding of the challenges/opportunities for patient and healthcare professional (HCP) engagement in clinical research is ne...

Background Patient-focused literature on fatigue in progressive forms of multiple sclerosis (MS) is sparse. This study aimed to explore progressive MS patients’ experiences of fatigue. Methods Adult patients in the United States with primary progressive MS (n=21) and secondary progressive MS (n=23), recruited from research panels, completed the fo...

Background The inflammatory form of non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), is known to have a negative impact on patients’ health-related quality of life (HRQoL), even before progression to cirrhosis has occurred. Previous work has been undertaken to develop a Patient Reported Outcome Measure (PROM) to asse...

The Salford Lung Study was a 12-month trial during which patients were either given the drug fluticasone furoate/vilanterol (FF/VI) in addition to existing treatment or continued their usual medication. Henrik Svedsater at GlaxoSmithKline plc. UK and co-workers conducted follow-up interviews with 400 study participants to examine patient perception...

The Salford Lung Study in Asthma (SLS Asthma) was a multicentre, randomised, controlled, open-label trial that assessed initiating once-daily, single-inhaler fluticasone furoate/vilanterol (FF/VI) 100 μg/25 μg or 200 μg/25 μg versus continuing usual care. A subgroup (n = 400) from SLS Asthma was enrolled in this exploratory, interview-based follow-...

Expectations relating to treatment and survival, and factors influencing treatment decisions are not well understood in adult patients with acute myeloid leukemia. This study analyzed combined findings from a targeted literature review with patient-reported information shared on YouTube to further understand patient perspectives in hematologic canc...

INTRODUCTION: Older patients (≥65 years) with acute myeloid leukemia (AML) have a poorer prognosis and more contentious treatment landscape than younger AML patients. Expectations relating to treatment and survival, and factors influencing treatment decisions are not well understood for older AML patients. Given the lack of published data in this a...

Background: The increasing emphasis on patient-reported outcomes in health care decision making has prompted greater rigor in the evidence to support the instruments used. Acceptability and content validity are important properties of any measure to ensure it assesses the relevant aspects of the target concept. The purpose of this study was to eva...

This study investigated patient perceptions, experiences and management of COPD throughout the SLS COPD study. Follow-up interviews were conducted with 400 patients who completed SLS COPD; a mixed-methods approach was used to collect quantitative and qualitative information. Structured interviews using closed-ended questions were conducted with 360...

Background: A review of new drug approvals (NDAs) by the Food and Drug Administration (FDA) for 2006 to 2010 showed that 24.1% of new drugs had patient-reported outcome (PRO) labeling. Objectives: To review PRO labeling for NDAs for 2011 to 2015 and to compare key findings reported previously. Methods: A review of the FDA drug approval reports...

Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most importan...

PURPOSE: The development of patient-centred approaches and of reduction in consumption strategies in alcohol use disorder requires giving a larger place to qualitative assessments that are closer to patients' concerns and more clinically relevant than drinking outcomes and generic health-related quality of life instrument. Our purpose was to develo...

The US Food and Drug Administration (FDA) provides formal guidance for the use of patient-reported outcomes (PROs) in support of labeling claims, whereas the European Medicines Agency (EMA) offers insight in a reflection paper relating to health-related quality of life in lieu of formal guidance. PRO label claims granted for new molecular entities...

The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific measure of needs-based quality of life developed in the UK and the Netherlands. This study describes translation, validation, and reliability of the scale into Turkish population. The ASQoL was translated into Turkish using the dual-panel process. Content validit...

This chapter outlines the value of patient-reported outcome (PRO) questionnaires to our understanding of the impact of disease. It summarizes the different types of PROs, their required scaling and psychometric properties and their development. The most common PRO constructs used in clinical studies are measures of impairment (symptoms), activity l...

Objective Acceptability and tolerability of bowel cleansers influence whether patients are able to complete the prescribed dose and, consequently, the quality of the cleansing achieved. No standardised means of assessing patients’ experience of using bowel cleansing is currently available. The aim of the study was to develop the Bowel Cleansing Imp...

Available patient-reported outcome (PRO) measures for chronic obstructive pulmonary disease (COPD) focus primarily on impairment (symptoms) and activities (functioning). The purpose of the study was to develop a patient-based PRO measure for COPD that captures the overall everyday impact of living with COPD from the patient's perspective. LCOPD ite...

Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition...

The Patient-Reported Indices for Multiple Sclerosis (PRIMUS) comprises a suite of three scales for assessing symptoms, activity limitations, and quality of life in multiple sclerosis (MS). It was developed in the UK and has been shown to have excellent psychometric properties. This study describes the adaptation of eight language versions for Canad...

The PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of t...

The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ult...

Current asthma patient-reported outcome (PRO) measures focus on symptoms and functioning and may not capture the holistic impact of asthma on the quality of life of the patient. To develop a PRO measure capturing the overall impact of asthma on patient's quality of life. Items for the Asthma Life Impact Scale (ALIS) were generated from patients wit...

The 22-item Unidimensional Fatigue Impact Scale (U-FIS) provides an index of the impact of fatigue on patients with multiple sclerosis (MS). The objective is to produce eight new language versions of the U-FIS: Canadian-English, Canadian-French, French, German, Italian, Spanish, Swedish, and US-English. The U-FIS was translated via two translation...

The multidimensional assessment of fatigue is complicated by the interrelation of its multiple causes and effects. The purpose of the research was to develop a unidimensional assessment of fatigue (U-FIS). Data collected with the Fatigue Impact Scale (FIS) were subjected to Rasch analysis to identify potential problems with the scale. Additional it...

Background Complex diseases such as multiple sclerosis (MS) present dilemmas over the choice of patient-reported outcome measures as no single scale can inform on all types of MS impact from the patient’s perspective. Objective To develop an outcome tool, the Patient-Reported Indices for Multiple Sclerosis (PRIMUS), to assess MS symptoms, activitie...

ABSTRACT: Retraction of Revivki DA, Rentz AM, Luo MP, Wong RL, Doward LC, McKenna SP: Psychometric characteristics of the ankylosing spondylitis quality of life questionnaire, short form 36 health survey, and functional assessment of chronic illness therapy-fatigue subscale. Health and Quality of Life Outcomes 2009, 7:6.

To develop measures of the day-to-day symptomatic and functional impact of recurrent genital herpes (RGH) outbreaks. The Herpes Outbreak Impact Questionnaire (HOIQ) and the Herpes Symptom Checklist (HSC) were designed to be acceptable to clinical professionals and to reflect patients' experience. Scale content was derived via literature review and...

ABSTRACT: BACKGROUND: We evaluated the psychometric characteristics of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire, Short Form 36 (SF-36) Health Survey, and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale in patients with AS. METHODS: We analyzed clinical and patient-reported outcome (PRO) data col...

Over the last few years major advances have been made in the conceptualization of quality of life and new instruments have been developed for assessing the construct in paediatric atopic dermatitis. This review looks at these developments and reports on recently published articles on the impact of the condition on affected children and other member...

To develop and validate a disease-specific quality of life (QOL) measure for osteoarthritis (OA), the OAQoL, using the needs-based conceptual model. In the first phase of this study, in-depth, semistructured interviews were conducted with 44 OA patients to explore the issues associated with impact of OA and to derive items for a draft OAQoL questio...

Lipoatrophy is a noteworthy adverse effect of antiretroviral therapy. A 2-part literature review was conducted to assess the impact of lipoatrophy in HIV-infected persons: the first reviewed the qualitative studies that reported lipoatrophy data, and the second reviewed the clinical studies that recorded patient-reported outcome end points. This li...

Complex diseases, such as systemic lupus erythematosus (SLE), present dilemmas over choice of outcome measures. Using a battery of instruments to capture the impact of different impairments or activity limitations experienced does not provide assessment of the wider impact on quality of life (QoL). This paper describes the development and testing o...

The importance of using quality of life measures for clinical practice and research in dementia is well established. Quality of life being people's perception of their position in life in context of their culture, hence the need for developing culturally sensitive quality of life measures. This study aimed at producing the UK version of the US Deme...

Items do not always function equally in different groups (e.g. across genders, languages and cultures). Consequently, where patient-reported outcomes are used and different groups are compared, data should be checked for differential item functioning (DIF). An item that functions with the same constant magnitude of difference across a construct mea...

The Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire is a unidimensional, disease-specific measure developed in the UK and the Netherlands. This study describes its adaptation into other languages. The UK English ASQOL was translated into US English; Canadian French and English; French; German; Italian; Spanish; and Swedish (dual-panel...

A previous study had identified 45 items assessing the impact of atopic dermatitis (AD) on the whole family. From these it was intended to develop two separate scales, one assessing impact on carers and the other determining the effect on the child. The 45 items were included in three clinical trials designed to test the efficacy of a new topical t...

The last three decades have seen a dramatic rise in the implementation of screening programmes for cancer in industrialised countries. However, in contrast to screening for infectious diseases, most cancer screening programmes only have the potential to reduce mortality; they cannot lower the incidence of cancer in a population. In fact, most cance...

No outcome measures specific to pulmonary hypertension (PH) currently exist. The aim of the study was to develop health-related quality of life (symptoms and functioning) scales and a quality of life scale that would allow comprehensive, accurate and valid patient-reported outcome assessment in clinical studies. The content of the Cambridge Pulmona...

Outcomes of health care interventions can be measured in many different ways, but there has been growing interest in the role that quality-adjusted life-years (QALYs) can play in informing priorities in health care. While existing generic preference-based measures can be used to obtain QALYs, these measures may often be inappropriate for some condi...