Patients' and clinicians' perspectives on item importance, scoring, and clinically meaningful differences for the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS).

BACKGROUND: The Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials and clinical practice. The ESD is a daily electronic diary assessing symptom severity; the EIS is a weekly electronic diary assessing symptom impact. This study explored the importance of symptoms (ESD items) and impacts (EIS domains), perspectives on scoring algorithms, and clinically important difference (CID) thresholds to inform clinical trial score interpretation. METHODS: Endometriosis patients in Germany (n = 8) and the US (n = 17), and expert clinicians (n = 4) in Germany, the US, Spain, and Finland participated in semi-structured qualitative interviews comprising structured tasks. Interview transcripts were analyzed using thematic analysis techniques. RESULTS: Quality and severity of endometriosis-associated pelvic pain varied considerably among patients; some experienced pelvic pain daily, others during menstrual bleeding (dysmenorrhea) only. Patients and clinicians ranked "worst pelvic pain" as the most meaningful pain concept assessed by the ESD, followed by constant and short-term pelvic pain. Preferences for summarizing daily pain scores over the 28-day menstrual cycle depended on individuals' experience of pain: patients experiencing pain daily preferred scores summarizing data for all 28 days; patients primarily experiencing pain during selected days, and their treating clinicians preferred scores based on the most severe pain days. Initial CID exploration for the "worst pelvic pain" 0-10 numerical rating scale (0-10 NRS) revealed that, for most patients, a 2- or 3-point reduction was considered meaningful, depending on baseline severity. Patients and clinicians ranked "emotional well-being" and "limitations in physical activities" as the most important EIS domains. CONCLUSIONS: This study informs the use of the ESD and EIS as clinically relevant measures of endometriosis symptoms and their impact. Findings from the ESD highlight the importance of individual-patient assessment of pain experience and identify "worst pelvic pain" as the most meaningful symptom assessed. Aggregating scores over the 28-day menstrual cycle may inform meaningful endpoints for clinical trials. Diverse EIS concepts (e.g. impact on emotional well-being and physical activities) are meaningful to patients and clinicians, emphasizing the importance of evaluating the impact on both to comprehensively assess treatment efficacy and decisions. TRIAL REGISTRATION: Not applicable. Qualitative, non-interventional study; registration not required.

Development of a patient-centered conceptual model of the impact of living with autism spectrum disorder.

The aim of this study was to generate a patient-centered conceptual model of the impact of living with autism spectrum disorder, which can be used to support the selection of outcome measures for clinical trials. Following an initial literature review to identify preliminary concepts and inform an interview guide, in-depth face-to-face interviews were conducted with adolescents and adults with autism spectrum disorder (IQ ⩾ 70) (n = 10), as well as parents of children, adolescents, and adults with autism spectrum disorder (IQ ⩾ 70) (n = 26). Data were analyzed using established qualitative research methods. The resultant conceptual model contains three interrelated domains reflecting core symptoms of autism spectrum disorder (communication deficits, socialization deficits, and restrictive, repetitive patterns of behavior), three domains reflecting associated symptoms of autism spectrum disorder (physical, cognitive, and emotional/behavioral), and three domains representing the impacts of living with autism spectrum disorder (impacts on activities of daily living, school/work, and social life). Interview respondents also cited social communication deficits as priority targets for new treatments. The conceptual model provides a patient-centered perspective of relevant concepts of autism spectrum disorder from the perspectives of people with autism spectrum disorder and their parents and offers a valuable tool for identifying valid patient-centered outcome measures for future clinical trials.

A comparison of three methods to generate a conceptual understanding of a disease based on the patients' perspective.

BACKGROUND: The Food and Drug Administration patient-reported outcome (PRO) guidance provides standards for PRO development, but these standards bring scientific and logistical challenges which can result in a lengthy and expensive instrument development process. Thus, more pragmatic methods are needed alongside traditional approaches. METHODS: Partnering with the National Ankylosing Spondylitis (AS) Society, we compared three methods for eliciting patient experiences: 1) concept elicitation (CE) interviews with 12 individuals with AS, 2) "group concept mapping" (GCM) with 16 individuals with AS, 3) a social media review (SMR) of AS online chatrooms. Three conceptual models were developed and compared to explore data breadth/depth, as well as the practicalities and patient-centeredness. RESULTS: Overlap in concepts was observed between conceptual models; 35% of symptoms were identified by all methods. The SMR approach identified the most concepts (n = 23), followed by CE interviews (n = 18), and GCM (n = 15). Eight symptoms were uniquely identified using GCM and SMR. Eliciting in-depth data was challenging for SMR as detail was not always provided. Insight into the relationships between symptoms was obtained as a "concept map" in GCM, via effective probing within interviews, and through the subject's descriptions in SMR. Practical investment varied; CE interviews were the most resource intensive, whereas SMR was the least. Individuals in GCM and CE interviews reported high engagement. CONCLUSIONS: Primary CE interviews achieved the greatest depth in conceptual understanding of patient experience; however, novel methods (GCM, SMR) provide complementary approaches for identifying measurement concepts. Each method has strengths and weaknesses and should be selected based on specific research objectives.

The effect of medical device dose-memory functions on patients' adherence to treatment, confidence, and disease self-management.

BACKGROUND: Adherence to treatment is an important issue in chronic disease management and an indicator of patients' ability to self-manage their condition and treatment. Some drug-dispensing and drug-delivery devices have been designed to support patients' medication-taking behavior by including dose-memory and combined dose-memory and dose-reminder functions, which electronically store, and visually display dose-history information, enabling the patient to review, monitor, and/or be actively reminded about their medication doses. PURPOSE: This literature review explored the role and impact of these devices on patients' treatment adherence, confidence with, and self-management of their condition and treatment. MATERIALS AND METHODS: A search of MEDLINE, Embase, and PsycINFO was performed to identify articles published in English from 2003-2013 that studied the effect of devices with dose-memory and combined dose-memory and dose-reminder functions on treatment adherence and users' (patients, health care professionals [HCPs], and caregivers) confidence, self-management behavior, and attitudes. RESULTS: The database searches yielded 940 abstracts from which 13 articles met the inclusion criteria and were retained. Devices with dose-memory and combined dose-memory and dose-reminder functions were found to improve self-reported and electronically monitored treatment adherence in chronic conditions such as asthma, diabetes, and HIV. The ability of the devices to provide dose-history information and active medication reminders was considered valuable in disease management by patients, caregivers, and HCPs. The devices were found to enhance patients' confidence in, and motivation to manage their medication and condition, and help reduce forgotten or incorrect medication dosing. CONCLUSION: The incorporation of dose-memory and combined dose-memory and dose-reminder functions in drug-delivery devices can improve patients' adherence, confidence, and self-management behavior. They can target non-intentional barriers to adherence and can provide a means of improving disease control and clinical outcomes, thereby offering clinical and economic value. This review highlights the importance of conducting further qualitative and quantitative research to further understand the value and impact of these types of devices on patients' long-term adherence to, and self-management of treatment.

The development and validation of the anxiety inventory for respiratory disease.

BACKGROUND: Anxiety is a common comorbidity in patients with COPD, yet it remains underrecognized. Existing anxiety measures contain somatic items that can overlap with symptoms of COPD and side effects of medications. There is a need for a disease-specific nonsomatic anxiety scale to screen and measure anxiety in patients with COPD. METHODS: In phase 1, 88 patients with COPD (mean age 71 years, 36% men) completed a 16-item scale developed with patients and clinicians. Six items were removed using item and factor analysis. In phase 2, 56 patients with COPD (mean age 70 years, 48% men) completed the 10-item scale and other self-report measures of anxiety, quality of life, and functional limitations. Of these, 41 patients completed the scale on a second occasion, 14 days later. Construct validity (using confirmatory factor analysis [CFA]), discriminant validity, convergent validity, and anxiety screening accuracy were explored. RESULTS: The Anxiety Inventory for Respiratory Disease (AIR) had high internal consistency (Cronbach α = 0.92) and test-retest reliability (intraclass correlation coefficient = 0.81) and excellent convergent validity, correlating with the Hospital Anxiety and Depression-Anxiety subscale (r = 0.91, P < .001). The scale also discriminated between patients with clinical anxiety (measured using the Patient Health Questionnaire) and those without (U = 9, P < .001). A cutoff score of 14.5 yielded a sensitivity of 0.93 and specificity of 0.98 for detection of clinical anxiety. A two-factor model of general anxiety and panic symptoms had the best fit according to CFA. CONCLUSIONS: The AIR is a short, user-friendly, reliable, and valid scale for measuring and screening anxiety in patients with COPD.

Should I stay or should I go? A study exploring why healthcare students consider leaving their programme.

BACKGROUND: Attrition in healthcare programmes is a growing concern internationally. Students leave for a variety of reasons but it is difficult to understand the complex interactions that eventually lead to attrition. OBJECTIVES: The objectives of this study were to identify the factors that prompted students to consider leaving their programme, and to make recommendations regarding strategies to reduce attrition. DESIGN: One aspect of a larger survey, which itself was part of a larger sequential mixed methods study. SETTINGS: Nine universities in the North West of England. METHODS: An online survey developed as part of a mixed methods sequential exploratory study was completed by students on nursing and allied-health programmes. The detailed responses obtained for a question relating to if the students have ever considered leaving their current programme were analysed both quantitatively (content analysis) and qualitatively (framework analysis). RESULTS: 1080 students completed the survey (an estimated 11% response rate); of this group 999 students answered the question 'have you ever considered leaving your current programme?' 465 students (47%) indicated that they had considered leaving and provided detailed comments explaining the circumstances that induced them to deliberate whether or not to stay. A thematic analysis of the data found three distinct themes: dissatisfaction with academic workload and support; difficulties associated with clinical placements, and personal concerns and challenges. A significant number of student comments combined two or more of these themes. A number of students also detailed why they decided to stay. CONCLUSIONS: Those students that had considered leaving frequently described how a combination of diverse factors accumulated to lead to them contemplating leaving their programme. Strategies to reduce attrition in healthcare students need to consider the student lifecycle from recruitment to graduation, to set reasonable student expectations and ensure that a career within healthcare is both desired and valued.

Anxiety disorders in patients with COPD: a systematic review.

BACKGROUND: There is a growing interest in the role of comorbid anxiety in patients with COPD. Comorbid anxiety has a major impact on physical functioning, health-related quality of life, and healthcare utilization. However, the prevalence of clinical anxiety, particularly specific anxiety diagnoses, in patients with COPD remains unclear. OBJECTIVE: We performed a systematic review of studies that report the prevalence of clinical anxiety and specific anxiety disorders in patients with COPD. METHODS: We searched for articles in CINAHL, EMBASE, MEDLINE, and PsycINFO, from 1966 to January 31, 2012, with a focus on studies that utilized clinical interviews for a robust psychiatric diagnosis in patients with COPD. RESULTS: Of 410 studies identified, 10 met the inclusion criteria for review. The studies had small to modest sample sizes (n = 20-204) and included mainly male COPD subjects (71% male). The prevalence of clinical anxiety ranged from 10-55% among in-patients and 13-46% among out-patients with COPD. The reported prevalence of specific anxiety disorders ranged considerably, and included generalized anxiety disorder (6-33%), panic disorder (with and without agoraphobia) (0-41%), specific phobia (10-27%), and social phobia (5-11%). Women were significantly more likely to have a clinical anxiety disorder, particularly specific phobia and panic disorder. CONCLUSIONS: There is a high prevalence of clinical anxiety in patients with COPD. Social phobia and specific phobia appear to be particularly prevalent, yet they have received little attention within existing literature. Further research into effective management and screening for clinical anxiety disorders is warranted.

What are reasonable expectations? Healthcare student perceptions of their programmes in the North West of England.

BACKGROUND: Concerns about current levels of attrition from some healthcare programmes have emphasised the need to gain a greater insight into students' expectations and experiences. OBJECTIVES: The aim of this study was to determine how students in the North West of England perceived their studies and to identify the factors that could contribute to students' dissatisfaction. DESIGN: A mixed methods sequential exploratory study. SETTINGS: Nine universities in the North West of England. METHODS: Phase one used narrative interviews with a purposive sample of 24 students to investigate their expectations and experiences. Data from these interviews were analysed using a thematic framework and direct quotes from key themes were incorporated into online survey for phase 2. Survey respondents were asked to rate their agreement to statements on a four-point Likert-type response format. There was also an opportunity to leave comments through open questions relating to each theme. RESULTS: A total of 1080 respondents completed the online survey in phase 2. The majority of students reported positive experiences of their course. There was strong agreement in the importance of the role of the personal tutor and of a supportive placement mentor. Some students indicated that the workload and academic level were a shock at first. Students identified difficulties around the cost of placement travel and the impact of placements on family life. Financial hardship was a frequently cited issue that students attributed to thoughts of discontinuation. CONCLUSIONS: Most students had positive learning experiences which meet their expectations. Students who have unmet expectations report poor placement experiences, lack of support, unexpectedly high workloads and financial difficulties. Clear guidance on the role of personal tutor and placement mentor is recommended.

"Everything was spiraling out of control": experiences of anxiety in people with chronic obstructive pulmonary disease.

OBJECTIVE: This study sought to elicit and describe the first-hand experiences of anxiety in community patients with stable chronic obstructive pulmonary disease (COPD). Anxiety is common among patients with COPD. Clinical anxiety affects up to two thirds of patients, leading to reduced quality of life and physical functioning. There has been little research exploring the experiences of anxiety in patients with COPD, particularly in individuals with stable respiratory symptoms. METHODS: We interviewed 14 community patients with stable COPD and self-reported symptoms of anxiety. Data were analyzed using thematic network analysis to develop basic, organizing, and global themes. RESULTS: Patients reported intense thoughts of fear, hopelessness, and confusion that were associated with the anxiety and panic attacks. Self-management was important, particularly self-talk coping strategies. CONCLUSIONS: Unmanaged anxiety seems to be particularly distressing for patients with COPD. Self-management strategies can be highly effective in preventing and managing anxiety.

Relationship between anxiety, depression, and quality of life in adult patients with cystic fibrosis.

BACKGROUND: The impact of anxiety and depression on quality of life (QOL) in adult patients with cystic fibrosis (CF) is fully unknown. We investigated the prevalence and factors associated with anxiety and depression, including QOL, in adult CF patients. METHODS: One hundred twenty-one adult CF subjects, age ≥ 18 years were recruited from our out-patient clinic. Participants self-completed the Hospital Anxiety Depression Scale and the Cystic Fibrosis Quality of Life Questionnaire (CF-QOL). Socio-demographic data and values for lung function were extracted from the medical notes. RESULTS: Mean ± SD age was 30 ± 8.8 years, and age ranged 18-70 years. Forty (33%) were identified with anxiety symptoms, 20 (17%) with depressive symptoms. Factors related with depression were impaired QOL and low lung function. Anxiety was associated with difficulty in interpersonal relationships and severity of chest symptoms. The CF-QOL sub-domains (physical functioning, social functioning, treatment issues, chest symptoms, emotional functioning, concerns for the future, interpersonal relationships, body image, future/career concerns, and total CF-QOL) were all significantly correlated with anxiety (P < .001) and with depression (P < .001), respectively. CONCLUSIONS: Anxiety and depressive symptoms are common in adult CF patients. They are associated with poorer QOL, low lung function, reduced physical functioning, and severity of chest symptoms. Therefore, routine screening for symptoms of anxiety and depression is a worthy endeavor, and those identified with elevated clinical symptoms should be referred to receive appropriate treatment.

'The placement was probably the tipping point' - the narratives of recently discontinued students.

Much has been written on student attrition from healthcare programmes and we know that it is often multifactorial. However in order to reduce attrition we need to gain a greater understanding of how multiple factors impact upon and compound one another to prompt a student to decide to leave. The purpose of this study was to explore healthcare students' experiences of university and the circumstances that initiated their decision to leave their programme. Sixteen students that had recently left healthcare programmes within the North West of England were interviewed by telephone, using a narrative prompt to facilitate them to tell their stories. All the students gave detailed narrative accounts that described their learning experiences, growing dissatisfaction and subsequent attrition. In the majority dissatisfaction and difficulties around clinical placements acted as a tipping point that precipitated departure.

COPD and anxiety: its impact on patients' lives.

BACKGROUND: Anxiety is a common comorbidity in people with chronic obstructive pulmonary disease (COPD) but its identification and management are often insufficient. AIM: To explore the experience of living with and managing comorbid anxiety and COPD from a patient's perspective. METHOD: The study followed a qualitative approach. In-depth interviews were carried out with 14 patients who had COPD. RESULTS: Participants believed anxiety had a significant impact on their quality of life. It made them feel isolated and caused them to avoid social occasions and daily activities. Identifying anxiety was a challenge because of the overlap in the symptoms of anxiety and those of COPD, and the side-effects of medication. CONCLUSION: Nurses can play a vital role in screening and managing anxiety, and educating people in strategies to prevent episodes of panic.

Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes.

OBJECTIVE: To systematically review recent evidence on the effectiveness of tiotropium versus placebo, ipratropium, and long-acting ß(2) agonists on outcomes relevant to patients with stable COPD, including health-related quality of life, dyspnea, exacerbations and hospitalizations. METHODS: Our inclusion criteria for trials were: ≥ 12 weeks; compared tiotropium to placebo, ipratropium, or long-acting ß agonists; patients ≥ 40 y old and with stable COPD. Sixteen trials (16,301 patients) met the inclusion criteria. RESULTS: Tiotropium improved health-related quality of life (measured with St George's Respiratory Questionnaire) compared to placebo (odds ratio [OR] 1.61, 95% CI 1.38-1.88, P < .001) and ipratropium (OR 2.03, 95% CI 1.34-3.07, P = .001). Tiotropium also improved dyspnea (measured with the Transitional Dyspnea Index) compared to placebo (OR 1.96, 95% CI 1.58-2.44, P < .001) and ipratropium (OR 2.10, 95% CI 1.28-3.44, P = .003). Tiotropium decreased the likelihood of an exacerbation (OR 0.83, 95% CI 0.72-0.94, P = .004) and related hospitalizations (OR 0.89, 95% CI 0.80-0.98, P = .02) but not serious adverse events (OR 1.06, 95% CI 0.97-1.17, P = .19), compared to placebo. The cumulative incidence of dry mouth was 7.4% with tiotropium, compared to 3.9% with ipratropium, 1.6% with salmeterol, and 2.0% with placebo. CONCLUSIONS: In stable COPD, tiotropium showed superior efficacy in improving quality of life and dyspnea, compared to placebo and ipratropium. However, tiotropium's differences with salmeterol were less clear.

Review of risk factors and preventative strategies for fall-related injuries in people with intellectual disabilities.

AIMS: To explore the risk factors and management of falls in people with intellectual disabilities and develop evidence-based recommendations. BACKGROUND: Falling is a common cause of physical injury and impaired quality of life in people with intellectual disability. Risk factors for falls and falls prevention have been extensively researched in the general population but there is a paucity of evidence specific to people with intellectual disabilities. DESIGN: Systematic review and comment. METHOD: Publications on the prevalence, risk factors and prevention of falls in people with intellectual disability were sought. We searched MEDLINE, CINAHL, PsychInfo and AMED (1 January 2000-7 January 2009). Search terms used to extract the relevant articles were 'intellectual disability', 'falls', 'injury', 'fractures', 'risk factors' and 'prevention'. RESULTS: Seven articles met the inclusion criteria. Up to 57% of people with intellectual disabilities experienced a fall. Falling was the cause of 50-62% of all recorded injuries. Risk factors for falls in people with intellectual disabilities may include older age, impaired mobility, epilepsy and behavioural problems. There was a paucity of evidence for intervention strategies identified. CONCLUSION: There is a lack of evidence for falls management in people with intellectual disabilities. Findings suggest that falls are a common cause of injury, institutionalisation and impaired quality of life in people with intellectual disabilities. Environmental safety, careful medical management and exercise interventions may play an important role in minimising fall-related injuries. Further research is needed to explore risk factors for falls and falls management in this vulnerable group. RELEVANCE TO CLINICAL PRACTICE: Early identification of the risk factors and prevention of falls will inform nurses and other healthcare professionals those who are at most risk and how to minimise injury in people with an intellectual disability. A multi-model approach of comprehensive assessment and tailored intervention are worthy of endeavour.

Falls in people with learning disabilities: what are the risk factors and prevention strategies?

There is a high prevalence of falls and related injuries in adults with learning disabilities. This article highlights the latest evidence on the diverse risk factors for falls among this group. Research into effective falls management strategies is sparse, but there is some evidence to indicate that environmental management, strength and balance training, and careful management of medications may help to reduce falls. Nurses can play an important role by identifying those who are at most risk, implementing management strategies and educating others.