Sam Salek

Equivalence of electronic and paper-based patient-reported outcome measures.

AbstractAimnElectronic formats (ePROs) of paper-based patient-reported outcomes (PROs) should be validated before they can be reliably used. This review aimed to examine studies investigating measurement equivalence between ePROs and their paper originals to identify methodologies used and to determine the extent of such validation.MethodsThree databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROs with their validated paper-based originals, with regard to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time.ResultsFifty-five studies investigating 79 instruments met the inclusion criteria. 53xa0% of the 79 instruments studied were condition specific. Several instruments, such as the SF-36, were reported in more than one publication. The most frequently reported formats for ePROs were Web-based versions. In 78xa0% of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Of the 30 publications that provided preference data, 87xa0% found that overall participants preferred the electronic format.ConclusionsWhen examining equivalence between paper and electronic versions of PROs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of ePROs.n

The Practical Reality of Using a Patient-Reported Outcome Measure in a Routine Dermatology Clinic

Objective: To explore whether clinicians used formal quality of life (QoL) information if provided by patients completing the Dermatology Life Quality Index (DLQI) questionnaire and whether the information influenced treatment decision-taking. Methods: The DLQI was completed by adult patients attending a dermatology secondary-care clinic as they arrived at their appointment and given to the clinician. Clinicians recorded whether the DLQI information was used and whether it influenced treatment decision-making. Results: A total of 417 patients attended and 268 questionnaires (64.3%) were completed. The mean DLQI score was 7 (median = 5, range = 0–30). In 64 consultations (28.8%), clinicians used the DLQI information; in 37 of these consultations (57.8%) the DLQI information influenced the clinicians’ treatment decision-making. The mean DLQI score for these 37 consultations was 11.3 (median = 10.0, range = 0–29), indicating a large effect on patients’ QoL. QoL discussion occurred in 85 of 98 consultations observed. The domains of QoL most frequently discussed concerned symptoms (74 consultations) and problems caused by the treatment (24 consultations). Conclusions: Clinicians may use formal QoL information if available in routine clinics. Treatment decisions may be influenced for those with high QoL impairment. Routine systematic assessment of QoL may therefore be of benefit.

Emerging Guidelines for Patient Engagement in Research

There is growing recognition that involving patients in the development of new patient-reported outcome measures helps ensure that the outcomes that matter most to people living with health conditions are captured. Here, we describe and discuss different experiences of integrating patients as full patient research partners (PRPs) in outcomes research from multiple perspectives (e.g., researcher, patient, and funder), drawing from three real-world examples. These diverse experiences highlight the strengths, challenges, and impact of partnering with patients to conceptualize, design, and conduct research and disseminate findings. On the basis of our experiences, we suggest basic guidelines for outcomes researchers on establishing research partnerships with patients, including: 1) establishing supportive organizational/institutional policies; 2) cultivating supportive attitudes of researchers and PRPs with recognition that partnerships evolve over time, are grounded in strong communication, and have shared goals; 3) adhering to principles of respect, trust, reciprocity, and co-learning; 4) addressing training needs of all team members to ensure communications and that PRPs are conversant in and familiar with the language and process of research; 5) identifying the resources and advanced planning required for successful patient engagement; and 6) recognizing the value of partnerships across all stages of research. The three experiences presented explore different approaches to partnering; demonstrate how this can fundamentally change the way research work is conceptualized, conducted, and disseminated; and can serve as exemplars for other forms of patient-centered outcomes research. Further work is needed to identify the skills, qualities, and approaches that best support effective patient-researcher partnerships.

Impairment of sexual life in 3,485 dermatological outpatients from a multicentre study in 13 european countries

Skin conditions may have a strong impact on patients sexual life, and thus influence personal relationships. Sexual issues are difficult to discuss directly in clinical practice, and a mediated instrument may be useful to capture such information. In this study item 9 of the Dermatology Life Quality Index was used to collect information on sexual impact of several skin conditions in 13 European countries. Among 3,485 patients, 23.1% reported sexual problems. The impairment was particularly high in patients with hidradenitis suppurativa, prurigo, blistering disorders, psoriasis, urticaria, eczema, infections of the skin, or pruritus. Sexual impact was strongly associated with depression, anxiety, and suicidal ideation. It was generally more frequent in younger patients and was positively correlated with clinical severity and itch. It is important to address the issue of sexual well-being in the evaluation of patients with skin conditions, since it is often linked to anxiety, depression, and even suicidal ideation.

Using PROMs in Healthcare: Who Should Be in the Driving Seat—Policy Makers, Health Professionals, Methodologists or Patients?

The recent Cancer Strategy for England (2016) highlights that by March 2017 NHS England will have agreed an approach for data collection which includes patient-reported outcome measures (PROMs) as a means for assessing long-term quality of life (QoL) for cancer patients [1]. Moreover, it indicates that ‘‘people affected by cancer (and clinical leaders) ... will be in the driving seat for improving quality across cancer pathways’’ ([1] p. 18). For this to work and be sustained requires all stakeholders and end-users—including policy makers, health professionals, methodologists and patients—to contribute to the co-construction of a process (including PROM selection) that is relevant and fit for purpose. Several key questions must drive the process: what do the different stakeholders need from the QoL data? (what to measure?); how will these needs be reflected in the choice of PROM? (how to measure?); when should QoL be assessed? (when to measure?); and how can agreement between stakeholders be achieved? (what does consensus look like?). Additionally, consideration must be given to the education and support required to support data interpretation (what does the data mean?). Strong collaborative relationships between key players will be crucial throughout the process, from question definition to implementation, to ensure buyin for the recommendations [2] and to ensure consistency in the way data are interpreted.

Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective

PurposeActive patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL research does not exist, the evidence-base for practice is limited, and we know relatively little about underpinning values that can impact on PE practice. This is the first study to explore the values that should underpin PE in contemporary HRQoL research to help inform future good practice guidance.MethodsA modified ‘World Café’ was hosted as a collaborative activity between patient partners, clinicians and researchers: self-nominated conference delegates participated in group discussions to explore values associated with the conduct and consequences of PE. Values were captured via post-it notes and by nominated note-takers. Data were thematically analysed: emergent themes were coded and agreement checked. Association between emergent themes, values and the Public Involvement Impact Assessment Framework were explored.ResultsEighty participants, including 12 patient partners, participated in the 90-min event. Three core values were defined: (1) building relationships; (2) improving research quality and impact; and (3) developing best practice. Participants valued the importance of building genuine, collaborative and deliberative relationships—underpinned by honesty, respect, co-learning and equity—and the impact of effective PE on research quality and relevance.ConclusionsAn explicit statement of values seeks to align all stakeholders on the purpose, practice and credibility of PE activities. An innovative, flexible and transparent research environment was valued as essential to developing a trustworthy evidence-base with which to underpin future guidance for good PE practice.

Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives

Currently, there is no qualified understanding of the influences, behaviours and other factors that impact the decision‐making of individuals and organisations involved in the development of new medicines. The aim of this qualitative study was to investigate and identify the important issues that influence quality decision‐making.

Concept of major life-changing decisions in life course research.

Chronic diseases can severely impair patients quality of life but little information is available about the long-term impact of chronic diseases. The chronic nature of disease may decrease patients psychosocial well-being, may change their attitude towards life goals and influence major life-changing decisions (MLCDs). Understanding of the impact on MLCDs is largely missing from health outcomes research. It is potentially important in the assessment of the overall burden and cumulative impact of chronic disease. This chapter reviews the concepts of life events, life transition, life goals concepts and what constitutes a long-term impact, essential background to this area. We also describe the relationship of the concept of MLCD with the concept of cumulative life course impairment. Chronic disease has long-term impact on patients lives, particularly by influencing MLCDs related to career, job, relationships, education, having children and early retirement. We describe qualitative research carried out in Cardiff that has sought to give more detailed insight into what decisions constitute MLCDs, in patients both from dermatology and from several general medical disciplines. We have also proposed the MLCD Profile to measure the number of MLCDs that an individual patient may have experienced as being influenced by chronic disease. Adding the domain of MLCDs to how we think about the burden of disease experienced by an individual, could broaden understanding of the true extent of disease impact.

Measuring the impact of dermatological conditions on family and caregivers: a review of dermatology-specific instruments

The patient is the centre of a web of relationships, and the impact of his/her disease on family members and caregivers must be taken into account. The aim of this study was to identify the specific instruments that measure the impact of a dermatological disease on the quality of life (QoL) of family members, by performing a systematic search of the literature. Fifteen papers were identified, describing the creation and validation of nine instruments. Four of them concerned atopic dermatitis (Dermatitis Family Index, DFI; Parents’ Index QoL Atopic Dermatitis, PiQoL‐AD; QoL in primary caregivers of children with atopic dermatitis, QPCAD; Childhood Atopic Dermatitis Impact Scale, CADIS), two measured the impact of psoriasis in family members (Psoriasis Family Index, PFI; FamilyPso), one the impact of epidermolysis bullosa (Epidermolysis Bullosa Burden of Disease, EB‐BoD), one of ichthyosis (Family Burden Ichthyosis, FBI), and one was generic for dermatological conditions (Family Dermatology Life Quality Index, FDLQI). The European Academy of Dermatology and Venereology quality of life taskforce recommends that the impact of a skin disease on family and caregivers should be measured as part of any thorough evaluation of the burden of a disease. Guidelines are given to choose the most appropriate instruments.

Determinants of Psychosocial Health in Psoriatic Patients: A Multi-national Study

There are limited data on the differences in the impact of psoriasis between various countries with respect to quality of life (QoL). The aim of this study was to explore the psychosocial health of patients with psoriasis in different European countries. A total of 682 patients were recruited in 13 European countries. All patients completed a questionnaire regarding socio-demographic information, negative life events, suicidal ideation and satisfaction with their dermatologist. Depression and anxiety were assessed with the Hospital Anxiety and Depression Scale (HADS), and QoL with the Dermatology Life Quality Index (DLQI) and EuroQoL (EQ-5D). The lowest anxiety and depression scoring was noted in patients from Denmark, the lowest level of impairment in QoL in subjects from Spain, and the highest level of impairment in QoL in patients from Italy. The most relevant parameters influencing patients well-being were severity of pruritus and satisfaction with their dermatologist. The level of anxiety and depression symptoms correlated significantly with suicidal ideation.