No / Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials. Objective Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems. Design Qualitative semi-structured interviews in participants' homes. Participants Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke. Methods Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure. Results Participants identified important impacts of their ‘invisible’ cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like ‘bothered’ and ‘frustration’ were often used. Conclusions The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers.

京都大学 / 新制・課程博士 / 博士(人間健康科学) / 甲第25503号 / 人健博第123号 / 新制||人健||8(附属図書館) / 京都大学大学院医学研究科人間健康科学系専攻 / (主査)教授 宮下 美香, 教授 千葉 理恵, 特定教授 古川 壽亮 / 学位規則第4条第1項該当 / Doctor of Human Health Sciences / Kyoto University / DFAM

Yes / Introduction: Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials. Methods and analysis: WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches. Ethics and dissemination: The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities. / This work was supported by NIHR Programme Grants for Applied Research (grant number: NIHR202862).

BACKGROUND:Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately.METHODS:From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation.RESULTS:The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was anchored by the positive and negative extremes relevant to the experiential domain. Because of frequent informant allusions to response set shifts from before to after CAM therapies, we chose a retrospective pretest format. Items cover physical, emotional, cognitive, social, spiritual, and whole person domains.CONCLUSIONS:This paper reports the success of a novel approach to the development of outcome instruments, in which items are extracted from patients' words instead of being distilled from pre-existing theory. The resulting instrument, focused on measuring shifts in patients' perceptions of health and well-being along pre-specified axes, is undergoing continued testing, and is available for use by cooperating investigators.

In recent years, there has been an ever increasing emphasis placed on the collection and use of patient reported outcome measures (PROM) in mental health services. This emphasis stems from a culture of evidence based practice, wherein PROM are shown to improve therapeutic outcomes at the clinical level, as well as provide information for the appropriate development of services and commissioning at a national level. This study uses an online survey to explore the use of PROM by mental health staff (n=112) in various Child and Adolescent Mental Health Services across England. Attitudes toward routine outcome monitoring practices and perceived competency around PROM use were also measured. Results found that although significant numbers of staff were using PROM, the amount of data being collected falls short of policy targets. Staff’s attitudes towards the practice are shown to be ambivalent, whereas overall perceived levels of competency were reasonably good. The relationships between attitudes, competence and PROM usage are discussed and a prediction model for PROM usage is developed in light of existing psychological theory. Results showed that training played an important role in the uptake of PROM and implications for the dissemination of training programs are emphasised.

Bakgrund: Integrated Palliative care Outcome Scale (IPOS) syftar till att ge en multidimensionell bild av patienters situation. IPOS används som ett sätt att bedöma patienters upplevelse av sina symtom, sin funktionsförmåga och sitt välbefinnande i relation till svår sjukdom. Få studier har dock utgått från patienternas perspektiv för att undersöka upplevelser av att använda IPOS. Syfte: Att undersöka patienters erfarenheter av att använda Integrated Palliative care Outcome Scale under pågående specialiserad palliativ hemsjukvård. Metod: Studien är genomförd med en kvalitativ ansats och en tolkande beskrivande design. Rekrytering till studien gjordes från tre specialiserade palliativa hemsjukvårdsenheter. Intervjuer genomfördes med 10 patienter, sju män och tre kvinnor med medelåldern 72 år. En majoritet var diagnostiserade med obotlig cancer. Data analyserades genom tolkande beskrivning så som den beskrivs av Sally Thorne. Resultat: Patienterna upplevde att använda IPOS medförde säker vård eftersom att det underlättade för sjuksköterskorna att göra korrekta bedömningar av patienternas behov. Således var IPOS en hjälp att planera vården utifrån patienternas specifika behov. Detta gav patienterna en känsla av att vården de fick var anpassad för dem, vilket gav en känsla av trygghet. De upplevde även att använda IPOS försäkrade att information fördes vidare på ett korrekt sätt från patienterna till vårdpersonalen genom att det minskade risken för missförstånd. De uppgav att IPOS underlättade diskussioner mellan dem och sjuksköterskorna om sådant de upplevde som viktigt. Patienterna upplevde även att använda IPOS möjliggjorde för dem att reflektera över sitt välbefinnande och sin livssituation. Att göra detta tillsammans med en sjuksköterska var berikande eftersom att det kunde ge nya perspektiv. Slutsats: Resultatet indikerar att patienterna i denna studie upplever att använda IPOS var givande för dem. Det kan konstateras att IPOS med fördel kan användas i specialiserad palliativ hemsjukvård. / Background: The Integrated Palliative care Outcome Scale (IPOS) is intended to provide a multidimensional view of patients’ concerns. IPOS can be used with the purpose of assessing patients’ perceptions of their functional status and wellbeing. Few studies have undertaken the patients’ perspective when exploring experiences of using IPOS. Aim: To explore patients’ experiences of using the Integrated Palliative care Outcome Scale during specialized palliative home care. Method: The study adopted a qualitative approach with an interpretive descriptive design. The patients were recruited from three different specialized palliative home care settings. Interviews were performed with 10 patients, seven men and three women, with a mean age of 72 years. A majority of the patients were diagnosed with incurable cancer. Data were analysed using interpretive description, as described by Sally Thorne. Results: Patients experienced that the use of IPOS entailed secure care as it facilitated nurses in making accurate assessments of patient care needs. IPOS helped to plan the care according to patients’ specific needs, making them feel confident that the care provided was tailored to them, giving a sense of security. Patients expressed that IPOS facilitated discussions between them and the nurse about care needs. They believed that using IPOS enabled opportunities for reflection on their wellbeing and life situation. Doing so with a nurse present was enriching, providing new perspectives. Conclusions: Patients experienced that using IPOS was beneficial. It can be concluded that IPOS provide an effective way to enable person-centred care and with advantage could be used in specialized palliative home care.

Cognitive difficulties can persist for months and years after stroke and adversely impact confidence, mood and functional recovery. Stroke survivors, carers and healthcare professionals collectively agree that improving cognition is the number one research priority for life after stroke. Future research should include measurements of outcome that service users deem important. Patient reported outcome measures (PROMs) are a means of gaining patient perspectives that can be standardised for use in a trial. PROMs should be developed with service users to incorporate their priorities but people with cognitive difficulties are often systematically excluded from the development and use of PROMs. Study 1 used qualitative interviews (N=16) to explore stroke survivor perspectives on the important and measureable impacts of persisting cognitive problems. The results of this study generated requirements for a PROM that related to conceptual underpinning and face validity of a measurement tool. Study 2 was a systematic review of existing PROMs related to cognition. 20 Identified PROMs were critically appraised against the requirements generated in the qualitative study. No existing PROMs were identified that met all of the qualitative study review criteria. The next stage described in chapter 3, was to develop a new PROM that: utilised the strengths of existing tools; met qualitative study requirements; and was refined through consultation with different stakeholders, prioritising feedback of stroke survivors with cognitive difficulties. The result of this work was the Patient Reported Evaluation of Cognitive State (PRECiS) scale. Study 3 was a psychometric study with stroke survivors (N=164) to test PRECiS in a large sample. Quantitative and qualitative data were collected on acceptability, feasibility and other psychometric properties of validity and reliability. PRECiS demonstrated good acceptability to stroke survivors and performed well psychometrically. Future validation work required for PRECiS is described in discussion chapter 4. Subject to further validation work, PRECiS may be particularly useful for pragmatic trials of cognitive rehabilitation after stroke.

The effectiveness of treatments for degenerative spine conditions, where the primary symptom is back pain, is typically determined using patient-reported quality of life (QoL) measures. However, patients may adjust their internal standards when scoring QoL based on factors other than their health. This response shift phenomenon could confound the interpretation of study data and impact effectiveness conclusions. In the current study, response shift was examined using structural equation modeling (SEM) and previously collected clinical trial data comparing 2 minimally invasive medical devices in lumbar spinal stenosis patients through 1 year postintervention. In subject QoL results, reprioritization shift between 3 months and 12 months that could confound standard analysis was identified. Treatment group did not influence response shift identified at 12 months. SEM provided an effective and practical tool for clinical investigators to assess response shift in available clinical study data. As response shift could lead to invalid conclusions when QoL measures are analyzed, clinical investigators should include response shift assessment in the design of clinical trials. This research into how response shift phenomenon can impact clinical trial results improves the ability of clinical investigators to interpret clinical trial data, potentially preventing erroneous conclusions. This research may also assist researchers and government regulators in the identification and reimbursement of beneficial, cost-effective medical treatments for patients worldwide. For clinical research designers, this study demonstrates a practical application of response shift assessment.

Background: Urinary incontinence (UI) and urgency are common conditions and can have a profound influence on many aspects of life. Approximately one in four women has UI and one in ten has daily symptoms. Knowledge is lacking, however, on the impact of UI and urgency on the lives of affected women and their partners and on the situation of women with urinary leakage one year postoperatively. Aims: To study the consequences of female UI and urgency for patients and their partners on quality of life (QoL), the partner relationship, and their sexual lives. Also to evaluate the success rates of three operation methods: tension-free vaginal tape (TVT), tension-free vaginal tape-obturator (TVT-O), and transobturator tape (TOT) for stress urinary incontinence (SUI), with a particular focus on women who still have urinary leakage one year after surgery. Methods: Women seeking healthcare for UI and/or urgency and their partners were invited to answer questionnaires. The women completed disease-specific questionnaires and both the women (n = 206) and their partners (n = 109) answered questions about their psychosocial situation, partner relationship, and sexual life. Patient-reported outcomes one year after surgery with TVT, TVT-O, or TOT (n = 3334) were derived from the Swedish National Quality Register for Gynaecological Surgery. Results: Most of the women reported that their urinary problems negatively affected their physical activities, and almost half reported negative consequences for their social life. Women aged 25–49 years were less satisfied with their psychological health, sexual life, and leisure than women aged 50–74 years. One third of both the women and their partners (all the partners were men) experienced a negative impact on their relationship, and sexual life was negatively affected in almost half of the women and one in five of their men. Coital incontinence was reported in one third of the women. Most of their men did not consider this a problem, but the majority of the affected women did. Satisfaction with outcome of the operation did not differ between TVT, TVT-O, and TOT, but TVT showed a higher success rate for SUI than TOT did. Higher age, higher body mass index, a diagnosis of mixed urinary incontinence, and a history of urinary leakage in combination with urgency each constitute a risk for a lower operation success rate. After one year, 29% of the women still had some form of UI, but half of these were satisfied with the outcome and most reported fewer negative impacts on family, social, working, and sexual life than before the operation. Conclusions: Female UI and/or urgency impaired QoL, particularly in young women, and had negative effects on partner relationships and on some partners’ lives. Sexual life was also affected, more often in women with UI and/or urgency than in their partners. At one-year follow-up after surgery, about one third of the women still had some form of UI, but the negative impact on their lives was reduced. A challenge for health care professionals is to initiate a dialogue with women with urinary symptoms about sexual function and what surgery can realistically be expected to accomplish.

While the importance of assessing the occupational consequences of insomnia and other sleep disorders is emphasised in clinical nosologies and research guidelines, there is little consensus on which aspects of occupational performance should be assessed, how such impairment should be measured, and how outcomes should be reported. The research programme described in this thesis aimed to address this issue. Chapter 1 presents a systematic review and methodical critique of studies reporting those aspects of occupational performance most impacted by (or most frequently associated with) insomnia symptoms and degraded sleep quality. Equivocal results, wide variations in reporting conventions, and the overall lack of comparability among studies, strongly indicated the need to develop a standardised metric able to quantify sleep related occupational performance and serve as an assessment and outcome instrument suitable for use in research and clinical settings. Informed by the literature review, Chapters 2-4 describe the development and validation of the Loughborough Occupational Impact of Sleep Scale ( LOISS ), a unidimensional 19 item questionnaire that captures sleep-related occupational impairment across a number of workplace domains over a 4-week reference period. Chapters 5-7 describe LOISS outcomes from: i) surveys in a random population sample; ii) a representative sample of the UK workforce; and iii) a clinical sample of patients with obstructive sleep apnoea (before and after treatment with CPAP). Overall, the scale showed strong internal consistency (Cronbach s alpha range=0.84-0.94) and test-retest reliability (r=0.77, r2=0.59, p<0.001), high levels of criterion validity (significantly discriminating between good and poor sleepers), and proved an effective outcome measure in OSA. From the survey data reported in Chapters 2-7, LOISS score distributions showed no consistent gender difference but did show a significant ageing gradient, with sleep-related occupational impairment declining with increasing age. In conclusion, the work presented here supports the usability, validity and reliability of the LOISS as an assessment and outcome instrument, and also demonstrates the utility of this instrument in exploring the dynamics of sleep-related occupational performance