Development and validation of a patient reported experience measure for experimental cancer medicines (PREM-ECM) and their carers (PREM-ECM-Carer).

BACKGROUND: Our aim was to develop a validated Patient Reported Experience Measure (PREM) to capture patient and carer experience during participation in experimental cancer medicine trials (ECM): called PREM-ECM. METHODS: Mixed method design, consisting of four stages. Questionnaire items were produced for both patients and carers using interviews, focus groups, and cognitive interviews with patients and carers separately. For both patient and carer PREMs, a cross-sectional questionnaire study was conducted to identify final items for inclusion using hierarchical item reduction and Rasch analysis. Questionnaire validity and reliability were assessed, including administration feasibility. RESULTS: Initial interview participants suggested the need for three PREMs, two specific to patients: (i) a 'prior' questionnaire that captured experiences of trial introduction, screening, consenting, and early trial experience (< 6 weeks post consent); and (ii) 'on-trial' that captured experiences of ongoing consent and trial participation; and (iii) a PREM specific for carers. The draft 25-item 'prior' questionnaire was completed by 162 patients and 162 patients completed the draft 35-item 'on-trial' questionnaire. Hierarchical and Rasch analysis produced a 14-item 'prior' list and a 15-item list for 'on-trial'. Both patient PREM's demonstrated a good fit to the Rasch model following Bonferroni correction (X2p = 0.008). The carer 34-draft item questionnaire was completed by 102 participants. Hierarchical and Rasch analysis produced a 13-item list for PREM-ECM-Carer, with good fit to the Rasch model ( X2p = 0.62). The pilot testing demonstrated the feasibility of all the PREMs in capturing patient and caregiver experiences in routine clinical settings. CONCLUSIONS: The three PREM-ECM questionnaires will be the first validated experience measures for ECM trial patients and their carers. These questionnaires may be used to assess patients' and their carers' experiences of ECM and enable robust comparisons across cancer trial units highlighting areas for service improvement.

Effectiveness of creative arts therapy for adult patients with cancer: a systematic review and meta-analysis.

OBJECTIVES: This systematic review and meta-analysis aimed to assess the effectiveness of creative arts therapy (CAT) interventions on the health outcomes of adult patients with cancer. METHODS: A comprehensive search was conducted in six databases from their inception to June 10, 2023, with no restrictions on sex, age, cancer type, cancer stage, or treatment type. The Cochrane Risk of Bias (RoB2) tool for randomized controlled trials (RCTs) and the equivalent tool for non-RCTs (ROBINS-I) were used to assess the risk of bias. Meta-analyses were conducted to pool estimates of the effects of CAT on patients' health-related outcomes. A narrative synthesis of outcomes was performed where meta-analysis was not appropriate. RESULTS: A total of 25 studies (8 RCTs and 17 quasi-RCTs) involving 1489 cancer patients and survivors were included in the final data analysis. Most studies focused on patients with mixed cancer diagnoses who were undergoing active chemotherapy treatment. Most studies utilized painting, drawing, and/or sculpting as CAT interventions. The overall risk of bias in the included studies was moderate to high. Meta-analysis demonstrated a significant improvement in quality of life (SMD with 95% CI = 17.50, 10.05-24.95, P =.0000) and the social aspect of quality of life in cancer patients (SMD with 95% CI = 03.1 (0.06-0.55), P = .01), but no significant effects were found for depressive symptoms and coping strategies among patients who participated in CAT compared to control groups. Narrative analysis and non-RCTs suggested the potential of CAT in reducing levels of depression and anxiety, as well as improving self-image, hope, emotional expression/state, and processing in patients with cancer. However, inconsistent findings were reported regarding the effectiveness of CAT interventions on fatigue, spirituality, and psychosomatic distress/symptom intensity. CONCLUSION: The findings indicated significant and potential benefits of CAT for individuals with cancer, primarily related to quality of life. However, caution is needed in interpreting these findings due to limitations in the methodologies utilized in the included studies. Further large-scale RCTs are needed to examine the effectiveness of CAT on health outcomes, particularly in relation to self-image, hope, and emotional expression/state and processing among patients with cancer or those in palliative care.

Understanding the experiences of lung cancer patients during the COVID-19 pandemic: a qualitative interview study.

PURPOSE: The study explores experiences of lung cancer patients during COVID-19 and considers how changes to care delivery and personal lives affected patient needs. METHODS: Semi-structured telephone interviews were conducted to explore experiences of lung cancer patients during COVID-19. Interviews were audio-recorded, transcribed verbatim and analysed thematically. Interview participants were purposively selected based on age, gender, treatment status, timing of diagnosis (pre/post first COVID-19 lockdown) from a sample of lung cancer patients (any histological subtype/any cancer stage/any point in treatment) who had completed a questionnaire exploring how participants' lives were impacted by the pandemic and their thoughts on clinical care and remote communication. RESULTS: Thirty lung cancer patients who participated in the questionnaire study were approached and participated in an interview. Three themes were identified: (1) Adapting to new modes of communication (focusing on experiences of remote communication); (2) Experience of care delivery during the pandemic (describing how all aspects of care delivery had been affected); (3) Impact of the COVID-19 pandemic on quality of life (QOL) (focus on the psychological impact and feeling of reduced support). Themes 1 and 2 are heavily interlinked and both had bearing on patients' QOL experience. CONCLUSION: Lung cancer patients were impacted psychologically by changes to care delivery and changes in their personal life. The findings highlight some benefits to remote consultations but the stage of the treatment pathway and illness trajectory should be considered when determining if this is appropriate. Participants felt support from peers, family and friends was limited during the pandemic.

Development and validation of the MAnchester Needs Tool for Injured Children (MANTIC).

OBJECTIVE: To develop a measure of the needs injured children and their families' needs throughout recovery; The MAnchester Needs Tool for Injured Children (MANTIC). DESIGN: Tool development, psychometric testing. SETTING: Five children's major trauma centres in England. PARTICIPANTS: Children aged 2 to 16 years with any type of moderate/severe injury(ies) treated in a major trauma centre within 12 months of injury, plus their parents. METHODS: Stage 1a (Item generation): Interviews with injured children and their parents to generate draft items. Stage 1b (Co-production): Feedback about item clarity, relevance and appropriate response options was provided by parents and the patient and public involvement group. Stage 2 (Psychometric development): Completion of the prototype MANTIC by injured children and their parents with restructuring (as necessary) to establish construct validity. Concurrent validity was assessed by correlation with quality of life (EQ-5D-Y). MANTICs were repeated 2 weeks later to assess test-retest reliability. RESULTS: Stages 1a,b: Interviews (13 injured children, 19 parents) generated 64 items with semantic differential four-point response scale (strongly disagree, disagree, agree, strongly agree). Stage 2: One hundred and forty-four participants completed MANTIC questionnaires (mean age 9.8 years, SD 3.8; 68.1% male). Item responses were strong requiring only minor changes to establish construct validity. Concurrent validity with quality of life was moderate (r = 0.55, P < 0.01) as was test-retest reliability (ICC = 0.46 and 0.59, P < 0.001). Uni-dimensionality was strong (Cronbach's α > 0.7). CONCLUSION: The MANTIC is a feasible, acceptable, valid self-report measure of the needs of injured children and their families, freely available for clinical or research purposes.

ERS statement: a core outcome set for clinical trials evaluating the management of COPD exacerbations.

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritised for inclusion in the core outcome set through a two-round Delphi survey completed by 1063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in five continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to 1) finalise the core outcome set and 2) prioritise a single measurement instrument to be used for evaluating each of the prioritised outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for at all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, the need for a higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimise some of the selected measurement instruments. The panel did not consider the prioritised set of outcomes and associated measurement instruments to be burdensome for patients and health professionals to use.

Associations of symptoms of anxiety and depression with health-status, asthma control, dyspnoea, dysfunction breathing and obesity in people with severe asthma.

BACKGROUND: Anxiety and depression are comorbidities of severe asthma. However, clinical characteristics associated with coexisting severe asthma and anxiety/depression are poorly understood. The study objective is to determine clinical characteristics associated with anxiety and depressive symptoms in severe asthma. METHODS: Severe asthma participants (N = 140) underwent a multidimensional assessment. Categorization of symptoms of anxiety and depression were based on HADS scale sub-scores and divided into four groups (< 8 on both subscales; ≥ 8 on one subscale; ≥ 8 on both subscales). Clinical characteristics were compared between subgroups. Multivariate logistic regression determined associations of clinical characteristics and anxiety and/or depressive symptoms in people with severe asthma. RESULTS: Participants were (mean ± SD) 59.3 ± 14.7 years old, and 62% female. There were 74 (53%) severe asthma participants without symptoms of anxiety/depression, 11 (7%) with symptoms of anxiety, 37 (26%) with symptoms of depression and 18 (13%) with symptoms of anxiety and depression. Quality of life impairment was greater in participants with symptoms of depression (4.4 ± 1.2) and combined symptoms of anxiety and depression (4.4 ± 1.1). Asthma control was worse in those with symptoms of depression (2.9 ± 1.1) and combined anxiety and depression (2.6 ± 1.0). In multivariate models, dysfunctional breathing was associated with symptoms of anxiety (OR = 1.24 [1.01, 1.53]). Dyspnoea was associated with symptoms of depression (OR = 1.90 [1.10, 3.25]). Dysfunctional breathing (OR 1.16 [1.04, 1.23]) and obesity (OR 1.17 [1.00, 1.35]) were associated with combined symptoms of anxiety and depression. CONCLUSION: People with severe asthma and anxiety and/or depressive symptoms have poorer QoL and asthma control. Dyspnoea, dysfunctional breathing and obesity are associated with these symptoms. These key clinical characteristics should be targeted in severe asthma management.

Prognostic value of patient-reported outcome measures (PROMs) in adults with non-small cell Lung Cancer: a scoping review.

BACKGROUND: There is growing interest in the collection and use of patient-reported outcome measures (PROMs) to support clinical decision making in patients with non-small cell lung cancer (NSCLC). However, an overview of research into the prognostic value of PROMs is currently lacking. AIM: To explore to what extent, how, and how robustly the value of PROMs for prognostic prediction has been investigated in adults diagnosed with NSCLC. METHODS: We systematically searched Medline, Embase, CINAHL Plus and Scopus for English-language articles published from 2011 to 2021 that report prognostic factor study, prognostic model development or validation study. Example data charting forms from the Cochrane Prognosis Methods Group guided our data charting on study characteristics, PROMs as predictors, predicted outcomes, and statistical methods. Two reviewers independently charted the data and critically appraised studies using the QUality In Prognosis Studies (QUIPS) tool for prognostic factor studies, and the risk of bias assessment section of the Prediction model Risk Of Bias ASsessment Tool (PROBAST) for prognostic model studies. RESULTS: Our search yielded 2,769 unique titles of which we included 31 studies, reporting the results of 33 unique analyses and models. Out of the 17 PROMs used for prediction, the EORTC QLQ-C30 was most frequently used (16/33); 12/33 analyses used PROM subdomain scores instead of the overall scores. PROMs data was mostly collected at baseline (24/33) and predominantly used to predict survival (32/33) but seldom other clinical outcomes (1/33). Almost all prognostic factor studies (26/27) had moderate to high risk of bias and all four prognostic model development studies had high risk of bias. CONCLUSION: There is an emerging body of research into the value of PROMs as a prognostic factor for survival in people with NSCLC but the methodological quality of this research is poor with significant bias. This warrants more robust studies into the prognostic value of PROMs, in particular for predicting outcomes other than survival. This will enable further development of PROM-based prediction models to support clinical decision making in NSCLC.

Aprepitant for Cough in Lung Cancer. A Randomized Placebo-controlled Trial and Mechanistic Insights.

Rationale: Effective cough treatments are a significant unmet need in patients with lung cancer. Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors, a mechanism also implicated in cough.Objectives: To assess aprepitant in patients with lung cancer with cough and evaluate mechanisms in vagal nerve tissue.Methods: Randomized double-blind crossover trial of patients with lung cancer and bothersome cough. They received 3 days of aprepitant or matched placebo; after a 3-day washout, patients crossed to the alternative treatment. The primary endpoint was awake cough frequency measured at screening and Day 3 of each treatment; secondary endpoints included patient-reported outcomes. In vitro, the depolarization of isolated guinea pig and human vagus nerve sections in grease-gap recording chambers, indicative of sensory nerve activation, was measured to evaluate the mechanism.Measurements and Main Results: Twenty patients with lung cancer enrolled, with a mean age 66 years (±7.7); 60% were female and 80% had non-small cell cancer, 50% had advanced stage, and 55% had World Health Organization performance status 1. Cough frequency improved with aprepitant, reducing by 22.2% (95% confidence interval [CI], 2.8-37.7%) over placebo while awake (P = 0.03), 30.3% (95% CI, 12.7-44.3) over 24 hours (P = 0.002), and 59.8% (95% CI, 15.1-86.0) during sleep (P = 0.081). Patient-reported outcomes all significantly improved. Substance P depolarized both guinea pig and human vagus nerve. Aprepitant significantly inhibited substance P-induced depolarization by 78% in guinea pig (P = 0.0145) and 94% in human vagus (P = 0.0145).Conclusions: Substance P activation of NK-1 receptors appears to be an important mechanism driving cough in lung cancer, and NK-1 antagonists show promise as antitussive therapies.

Attitudes towards the integration of smoking cessation into lung cancer screening in the United Kingdom: A qualitative study of individuals eligible to attend.

INTRODUCTION: There is limited research exploring how smoking cessation treatment should be implemented into lung cancer screening in the United Kingdom. This study aimed to understand attitudes and preferences regarding the integration of smoking cessation support within lung cancer screening from the perspective of those eligible. METHODS: Thirty-one lung cancer screening eligible individuals aged 55-80 years with current or former smoking histories were recruited using community outreach and social media. Two focus groups (three participants each) and 25 individual telephone interviews were conducted. Data were analysed using the framework approach to thematic analysis. RESULTS: Three themes were generated: (1) bringing lung cancer closer to home, where screening was viewed as providing an opportunity to motivate smoking cessation, depending on perceived personal risk and screening result; (2) a sensitive approach to cessation with the uptake of cessation support considered to be largely dependent on screening practitioners' communication style and expectations of stigma and (3) creating an equitable service that focuses on ease of access as a key determinant of uptake, where integrating cessation within the screening appointment may sustain increased quit motivation and prevent loss to follow-up. CONCLUSIONS: The integration of smoking cessation into lung cancer screening was viewed positively by those eligible to attend. Screening appointments providing personalized lung health information may increase cessation motivation. Services should proactively support participants with possible fatalistic views regarding risk and decreased cessation motivation upon receiving a good screening result. To increase engagement in cessation, services need to be person-centred. PATIENT OR PUBLIC CONTRIBUTION: This study has included patient and public involvement throughout, including input regarding study design, research materials, recruitment strategies and research summaries.

The multidisciplinary team perspectives on agitation management in critical care: A qualitative study.

BACKGROUND: People who are experiencing a period of critical illness frequently experience severe agitation. The presence of agitation can pose risks to the patient, family, and clinical team. AIMS AND OBJECTIVES: To capture the views and opinions of critical care multidisciplinary teams concerning the approaches in the management of agitation, and to understand and identify the perceived risks and benefits of current management strategies. DESIGN: A descriptive qualitative design. METHODS: Data were gathered using semi-structured interviews with multidisciplinary teams from adult critical care units from one region in the United Kingdom. FINDINGS: A total of 19 participants participated between February to September 2017. There were two group interviews (GIs) (n = 12, GI 1 n =  8, GI 2 n = 4) and seven one-to-one interviews, across four hospital organisations with one participant working via an agency. The mean length (± SD) of each interview, one to one or group, was 58.86 minutes (5.81 minutes). Three major themes were generated about the complex clinical decision-making required to manage an agitated patient. These themes represented: the burden of care, continuity of clinical decision-making, and uncertainty and indecision experienced by participants. CONCLUSION: Participants described caring for an agitated patient as challenging and stressful. Staff sought clarification on what level of restrictive practice is allowed. Feelings of anxiety and stress generated by the decisions made may have an impact on staff, particularly those who are more inexperienced, which in the longer term could lead to fatigue or moral distress. RELEVANCE TO CLINICAL PRACTICE: The study has emphasised the challenges faced by multidisciplinary teams and how decision-making may impact on individuals within the team.

Critically ill patients' experience of agitation: A qualitative meta-synthesis.

BACKGROUND: Acute episodes of agitation are frequently experienced by patients during critical illness, yet what is not understood is the experience of agitation from the patient and family perspectives. AIMS AND OBJECTIVES: To search existing literature, appraise it and then provide a synthesized interpretation to broaden the understanding of patients' and their families' experience of agitation during an adult critical care admission. DESIGN: Qualitative meta-synthesis. METHODS: A qualitative meta-synthesis based on a systematic literature search registered with PROSPERO. The search conducted between July and September 2019 was applied to ProQuest, Cumulative Index to Nursing and Allied Health, British Nursing Index, Cochrane Library, Ovid Medline, Web of Science, and PsycINFO databases. We appraised the selected literature and presented a synthesized interpretation. Analysis was based on the approach of Gadamerian hermeneutics. Due to the lack of data identified; the family experiences of agitation could not be addressed within the review. RESULTS: In total, 8 studies were included capturing the experiences of 494 patients, aged between 18 and 92 years, with 225 (45%) women. The analysis generated three core themes: (a) What is real, what is not, (b) loss of communication and dependency, and (c) what helps, what does not. Fear of death, the emotion of anxiety, and feelings of pain alongside transient periods of fluctuating conscious levels provoked a feeling of intense vulnerability. The loss of effective communication and the feeling of dependence incite agitation and distress. CONCLUSIONS: The patient's recollection of their critical illness can be completely or partially absent and disjointed with uncertainty around what is real and what is not. Family members observe the full effect of the patient's critical care illness and could be a wealth of untapped information. RELEVANCE TO CLINICAL PRACTICE: Increasing awareness of the critically ill patients' experience of agitation highlights possible contributing factors to agitation development, such as staff interaction and communication skills, and the critical care environment.

EmPHasis-10 health-related quality of life score predicts outcomes in patients with idiopathic and connective tissue disease-associated pulmonary arterial hypertension: results from a UK multicentre study.

Health-related quality of life (HRQoL) scores assess symptom burden in pulmonary arterial hypertension (PAH) but data regarding their role in prognostication and risk stratification are limited. We assessed these relationships using the emPHasis-10 HRQoL measure.1745 patients with idiopathic PAH (IPAH), drug-induced PAH (DPAH), heritable PAH (HPAH) (collectively "(I/D/H)PAH"), or connective tissue disease-associated PAH (CTD-PAH), who had completed emPHasis-10 questionnaires at one of six UK referral centres between 2014 and 2017, were identified. Correlations with exercise capacity and World Health Organization (WHO) functional class were assessed, and exploratory risk stratification thresholds were tested.Moderate correlations were seen between emPHasis-10 scores and 6-min walk distance (r=-0.546), incremental shuttle walk distance (r=-0.504) and WHO functional class (r=0.497) (all p<0.0001). Distribution of emPHasis-10 score differed significantly between each WHO functional class (all p<0.0001). On multivariate analysis, emPHasis-10 score, but not WHO functional class, was an independent predictor of mortality. In a risk stratification approach, scores of 0-16, 17-33 and 34-50 identified incident patients with 1-year mortality of 5%, 10% and 23%, respectively. Survival of patients in WHO functional class III could be further stratified using an emPHasis-10 score ≥34 (p<0.01). At follow-up, patients with improved emPHasis-10 scores had improved exercise capacity (p<0.0001) and patients who transitioned between risk groups demonstrated similar survival to patients originally in those risk groups.The emPHasis-10 score is an independent prognostic marker in patients with (I/D/H)PAH or CTD-PAH. It has utility in risk stratification in addition to currently used parameters. Improvement in emPHasis-10 score is associated with improved exercise capacity.

Attack, flare-up, or exacerbation? The terminology preferences of patients with severe asthma.

Background: People with severe asthma experience frequent life-threatening acute asthma events. A Lancet commission recently highlighted that terms "exacerbations" and "flare-ups" are seen to trivialize these episodes and recommended use of the term "attacks." Clinicians however, preferentially use the term "exacerbation" and some guidelines recommend the use of "exacerbation" with patients.Objective: This descriptive qualitative study aimed to understand the patient's experience and perspectives of these events and language used to describe them.Methods: Semi-structured one-on-one interviews were conducted in Australia and the UK in 18 people with severe asthma and 10 with mild-moderate asthma regarding their usage and preferences for such terminologies. Additionally, nine people with severe asthma participated in two focus groups in which use of preferred terminology was explored.Results: Mean age of participants was 57 ± 14.03 yr and 65% were female. A total 67 quotes were recorded in which 16 participants with severe asthma spontaneously used either the term "attack," "flare-up" and/or "exacerbation." Of these quotes, all 16 participants used "attack," one used all three terms and two used both "exacerbation" and "attack." The term "attack" was used to describe frightening events having major impacts on participant's lives, whereas "exacerbation" and "flare-up" were used to refer to both severe and mild, transient asthma-related events.Conclusion: Usage of the term "attack" was preferred by patients with severe asthma. Adoption of this language may assist in patient-clinician communication and disease management and outcomes. Wider stakeholder engagement is needed to confirm this suggestion. AbbreviationsFEV1forced expiratory volume in 1 secondATSAmerican Thoracic SocietyERSEuropean Respiratory SocietyACQAsthma Control QuestionnaireICSinhaled corticosteroidsOCSoral corticosteroidsBTSBritish Thoracic SocietySIGNScottish Intercollegiate Guidelines NetworkWAPwritten action plan.

Evaluation of the safety and effectiveness of prostate-specific antigen (PSA) monitoring in primary care after discharge from hospital-based follow-up following prostate cancer treatment.

OBJECTIVE: To examine follow-up procedures after men are discharged into primary care following prostate cancer and highlight any areas for service improvement. METHODS: Patient record data from two Greater Manchester boroughs were retrieved retrospectively to investigate discharge instructions and monitoring adherence. Questionnaires were sent to patients exploring their understanding of the follow-up process. RESULTS: A total of 300 records were accessed. Prostate-specific antigen (PSA) re-referral level was provided to GPs in 39% of cases. Forty- six percent of men were not tested frequently enough, and 6% had no PSA testing recorded post-discharge. A total of 222 patient questionnaires were returned. Sixty-seven percent felt GPs should be responsible for PSA monitoring, and 60% felt confident that their GP was doing so effectively. Conversely, 12% felt their PSA monitoring had been neglected. CONCLUSION: The findings highlight the complex nature of the follow-up and monitoring processes for prostate cancer patients. There is an urgent need for consensus in terms of monitoring frequency and referral pathways. Many patients do not engage in accurate monitoring post-treatment which has implications for early diagnosis of recurrence. Findings will be used to create an evidence-based, uniform Greater Manchester PSA monitoring service which is safe, acceptable and effective for all.

The impact of injury: The experiences of children and families after a child's traumatic injury.

OBJECTIVE: To explore the experiences of children and families after a child's traumatic injury (Injury Severity Score >8). DESIGN: Qualitative interview study. SETTING: Two children's major trauma centres in England. PARTICIPANTS: 32 participants: 13 children with traumatic injuries, their parents/guardians (n = 14) and five parents whose injured child did not participate. METHODS: Semi-structured interviews exploring the emotional, social, practical and physical impacts of children's injuries, analysed by thematic analysis. RESULTS: Interviews were conducted a median of 8.5 months (IQR 9.3) post-injury. Injuries affected the head, chest, abdomen, spine, limbs or multiple body parts. Injured children struggled with changes to their appearance, physical activity restrictions and late onset physical symptoms, which developed after hospital discharge when activity levels increased. Social participation was affected by activity restrictions, concerns about their appearance and interruptions to friendships. Psychological impacts, particularly post-traumatic stress type symptoms often affected both children and parents. Parents' responsibilities suddenly increased, which affected family relationships and roles, their ability to work and carry out daily tasks. Rapid hospital discharge was wanted, but participants often felt vulnerable on return home. They valued continued contact with a healthcare professional and practical supports from family and friends, which enabled resumption of their usual lives. CONCLUSIONS: Injured children experience changes to their appearance, friendships, physical activity levels and develop new physical and mental health symptoms after hospital discharge. Such challenges can be addressed by the provision of advice about potential symptoms, alternative activities during recovery, strategies to build resilience and how to access services after hospital discharge.

A cross sectional study to determine the prevalence of cough and its impact in patients with lung cancer: a patient unmet need.

BACKGROUND: There is absence of literature related to cough prevalence and its characteristics in lung cancer patients, with information deriving only from broader symptoms occurrence studies. The aims of this study were to provide a snapshot of the prevalence of all-cause-cough in lung cancer patients and to characterise cough in terms of its impact and severity. METHODS: A cross-sectional study recruiting consecutive lung cancer patients over a pre-defined period of time and using cough-specific validated tools in a tertiary referral centre in the UK, including a cough severity VAS and the Manchester Cough in Lung Cancer scale (MCLCS). RESULTS: Data was collected from 202 patients. All-cause cough prevalence was 57% (through VAS) both in the screened (N = 223) and research (N = 202) population or 67% (through the MCLCS), and cough severity was moderate at a mean of 32 mm (in a 100 mm VAS). Age, sex, smoking status, lung cancer histology, stage and comorbidities were not associated with cough prevalence. The only variable associated with lower cough reports was being 'on anticancer treatment'; fewer patients on treatment reported a cough (40%) compared to those off treatment (54%) (p = 0.04). The impact of cough (as measured by MCLCS) was also significant (mean score = 22). About 18% of patients felt moderate/severe distress from their cough and about 15% often or always reported disturbed sleep due to coughing. Half the patients felt their cough warranted treatment. CONCLUSIONS: Cough is a common symptom in lung cancer with considerable impact on patients' lives. Cough presence and severity should regularly be assessed in clinical practice. There is an urgent need to focus on developing more potent antitussive treatments and improve the management of this complex and distressing symptom.

Psychometric testing of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy.

BACKGROUND: The aim of this study was to evaluate the psychometric properties of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy. METHODS: Patients were assessed with the FACT/GOG-Ntx subscale, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Scale 20 (EORTC QLQ-CIPN20), National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE), and light touch test using 10 g monofilament for up to ten assessment points from baseline (prior to initiation of first chemotherapy), after the end of each cycle (up to 6 cycles, 3 weeks per cycle), and at 6, 9, and 12 months after starting chemotherapy. Psychometric analyses included internal consistency reliability, convergent validity, factorial validity, sensitivity to change and responsiveness (minimal clinically important difference, MCID). RESULTS: Cronbach's alpha coefficients of the FACT/GOG-Ntx subscale were 0.82-0.89 across assessment points. The subscale strongly correlated with the EORTC QLQ-CIPN20 (r = 0.79-0.93) but low-to-moderately correlated with the NCI-CTCAE sensory (rs = 0.23-0.45) and motor items (rs = 0.15-0.50) as well as the monofilament test (rs = 0.23-0.47). The hypothesized 4-factor structure of the FACT/GOG-Ntx subscale was not confirmed at assessment points (χ2/df = 2.26-8.50; all P < 0.001). The subscale exhibited small-to-moderate sensitivity to change (r = 0.17-0.37). The MCIDs were between 1.38 and 3.68. CONCLUSION: The FACT/GOG-Ntx subscale has satisfactory reliability, validity, sensitivity to change and responsiveness to evaluate CIPN in cancer patients. Future research is needed to explore the factorial structure of the FACT/GOG-Ntx subscale as the published four-factor structure was not supported in this study.

The Role of e-Health in the Delivery of Care for Patients with Hematological Cancers: A Systematic Literature Review.

Background: Hematological cancer survivors have significant unmet needs. The use of e-health interventions has been shown to be effective in improving patient experiences and outcomes in other diseases. The aim of this review is to explore the role of e-health interventions in the delivery of care for patients with hematological cancers across the illness trajectory. Methods: A systematic narrative review approach using thematic analysis was used to identify the key issues and themes in the literature. Medical subject headings and keywords were used in several databases: Medline, Embase, PsycInfo, CINAHL, and The Cochrane Collaboration Cochrane Review Database. This review focuses on the use of e-health interventions for patients with hematological cancers within any study design. Results: Twenty-three (n = 23) studies were identified in this review. The studies were of varying designs: randomized controlled trials (n = 6); pre- and postdesign (n = 1); feasibility and acceptability (n = 11) and varying methodological quality. Seven studies included patients with any cancer diagnosis rather than focusing specifically on hematology patients. Our thematic analysis identified four main categories of intervention: information provision (n = 4); self-help (n = 6); communication facilitation (n = 5); and patient-reported outcome recording or monitoring (n = 8). Conclusion: The clinical management of patients with hematological cancers, particularly those in survivorship, presents opportunities to explore e-health approaches to improve patient care. This review highlights that e-health tools may be acceptable and feasible to use with a hematology patient population, but more robust and well-designed trials that engage patients and health professionals are required to determine which and how interventions can be used most effectively.

Development and first validation of a patient-reported experience measure in chronic obstructive pulmonary disease (PREM-C9).

We developed a chronic obstructive pulmonary disease (COPD) patient-reported experience measure (PREM-C9). 174 patients with COPD (86 [49%] with a confirmed diagnosis and 88 [51%] with a self-reported diagnosis of COPD) completed a 38-item list, COPD Assessment Test (CAT) and Hospital Anxiety and Depression Scale (HADS). Hierarchical and Rasch analysis produced a 9-item list (PREM-C9). It demonstrated fit to the Rasch model (χ² p=0.33) and correlated moderately with CAT (r=0.42), HAD-anxiety (r=0.30) and HAD-depression (r=0.41) (p<0.05). A substudy confirmed its ability to detect change prepulmonary and postpulmonary rehabilitation. The PREM-C9 is a simple, valid measure of experience of patients living with COPD, validated in this study population with mild to very severe disease; it may be a useful measure in research and clinical audits.

Validation of the IPF-specific version of St. George's Respiratory Questionnaire.

BACKGROUND: Patients with idiopathic pulmonary fibrosis (IPF) have impaired health-related quality of life (HRQL). To measure HRQL, an IPF-specific version of the St. George's Respiratory Questionnaire (SGRQ-I) was developed, but not sufficiently validated. This study aimed to assess the validity (i.a. known-groups validity and concurrent validity) and test-retest reliability of SGRQ-I in IPF patients with different disease durations. METHODS: Patients with IPF were consecutively recruited and completed SGRQ, SGRQ-I, King's Brief Interstitial Lung Disease questionnaire (K-BILD), University of California, San Diego Shortness of Breath Questionnaire (SOBQ) and Short Form-36 (SF-36) along with pulmonary function tests and a 6-min walk test (6MWT) at baseline. After two weeks, SGRQ-I and Global Rating of Change Scales (GRCS) were completed. RESULTS: At baseline and after two weeks, 150 and 134 patients completed the questionnaires, respectively. The internal consistency of SGRQ-I was high (Cronbach's α = 0.92). Good concurrent validity was demonstrated by high intraclass correlation coefficients (ICC = 0.97), Bland-Altman plots and moderate to strong correlations to K-BILD, SOBQ and SF-36 (r = - 0.46 to 0.80). High ICC (0.92) and a Bland-Altman plot indicated good test-retest reliability. SGRQ-I was good at discriminating between patients with different stages of disease (Δscore > 18.1, effect sizes > 0.10). Validity was similar across groups of different disease duration. CONCLUSIONS: SGRQ-I proved to be valid at distinguishing between different disease severities, valid compared to other HRQL instruments, applicable across different disease durations and reliable upon repetition. SGRQ-I is a valid option for measuring HRQL in patients with IPF. TRIAL REGISTRATION: The study was registered at clinicaltrials.org ( NCT02818712 ) on 15 June 2016.