Attitudes, barriers, and facilitators to adherent completion of the recombinant zoster vaccine regimen in Canada: Qualitative interviews with healthcare providers and patients.

This qualitative, cross-sectional study aimed to understand the barriers and facilitators related to the adherence and completion of the recombinant zoster vaccine (RZV) two-dose series in Canada, as perceived by healthcare providers (HCPs) and patients. Data collection occurred via 60-minute concept elicitation interviews with 12 HCPs (4 physicians, 2 nurse practitioners, 6 pharmacists) who had prescribed and/or administered RZV in Canada, and 21 patients aged ≥50 years who had received ≥1 dose of RZV. Patients were categorized as adherent (received both doses within the recommended 2-to-6-month timeframe; n = 11) or non-adherent (received only one dose or second dose outside the recommended timeframe; n = 10). Interview transcripts were coded and analyzed using a two-part thematic analysis approach. HCP-identified barriers to RZV adherence included high out-of-pocket cost, inconsistent/lack of health plan coverage, inconvenient processes for accessing RZV, and patient forgetfulness. HCP-identified facilitators included desire for shingles protection, HCP encouragement, and reminders. Barriers to RZV adherence identified by patients included lack of HCP knowledge/experience with RZV, receiving unreliable/confusing information, having unpleasant/severe side effects following the first dose, high out-of-pocket cost, lack of insurance coverage, and forgetfulness. Patient-identified facilitators included self-motivation, financial support, convenient processes for obtaining RZV, and reminders. In conclusion, many factors can influence RZV series completion and adherence among adults in Canada, including cost, insurance coverage, HCP knowledge and encouragement, and reminders. Awareness of these factors may inform HCPs in helping patients overcome barriers and identify opportunities for future consideration, facilitating protection against herpes zoster.

A concept elicitation study to understand the relationship between sleep and pain in rheumatoid arthritis and axial spondyloarthritis.

PURPOSE: This qualitative study (GSK study: 213635) was designed to better understand sleep disturbance as experienced by individuals with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA), and the relationship between sleep disturbance and pain and other aspects of the disease and disease activity. METHODS: Sixty-minute, one-on-one, concept elicitation interviews were conducted with 30 participants (15 with RA and 15 with axSpA) from the US. Interviews were audio-recorded and transcribed verbatim. Interview transcripts were coded and analyzed to explore themes related to pain and sleep disturbance, and relationships among those themes. RESULTS: Pain was a prominent driver of sleep disturbance; 12 participants with RA (80%) and 14 with axSpA (93%) reported that pain impacted their ability to fall asleep, while all 15 with RA (100%) and 14 with axSpA (93%) reported that pain impacted their ability to stay asleep. Two-thirds of participants with RA (67%) or axSpA (60%) described a bi-directional relationship, whereby pain worsened sleep disturbance and sleep disturbance further aggravated pain. Factors other than pain, such as fatigue and emotional health, were also reported as important contributors to sleep disturbance (RA: n = 12/15, 80%; axSpA: n = 14/15, 93%). Participants with RA or axSpA described complex interconnections between fatigue, emotional health, pain, and sleep, often labeling these relationships as "vicious cycles". Notably, half of all participants reported sleep disturbance occurring without pain or other understood causes. CONCLUSION: These perspectives collected from people with RA or axSpA suggest that reducing sleep disruption directly may offer clinically relevant benefits.

Unmet needs with antipsychotic treatment in schizophrenia and bipolar I disorder: patient perspectives from qualitative focus groups.

BACKGROUND: Schizophrenia (SZ) and bipolar I disorder (BD-I) are chronic mental health disorders often treated with antipsychotic medications. This qualitative study sought to better understand disease burden and treatment experiences with oral antipsychotic medications in participants living with SZ or BD-I. METHODS: Six 90-min focus groups were conducted with participants diagnosed with SZ or BD-I. Trained moderators facilitated discussions using a semistructured guide. Participants described symptoms, impacts of disease, and experiences with oral antipsychotic medications, whether favourable or unfavourable. RESULTS: Among participants with SZ (n = 15; 3 groups, 5 per group), 53% were male and 33% were white, with a mean of 18.6 years since diagnosis. Of participants with BD-I (n = 24; 3 groups, 8 per group), 33% were male and 42% were white, with a mean of 13.0 years since diagnosis. Participants described numerous symptoms of their illnesses that impacted relationships and daily life, including effects on emotional health, the ability to work, and encounters with law enforcement. Previous antipsychotic medications were deemed effective by 14/15 (93%) participants with SZ and 12/16 (75%) participants with BD-I. Most participants with SZ (13/15; 87%) or with BD-I (16/24; 67%) reported discontinuing their antipsychotic medication at some point. Side effects were a common reason for discontinuing or switching medications for participants with SZ (8/15; 53%) and for those with BD-I (11/24; 46%). The most common side effects reported in both cohorts were weight gain, drowsiness, sexual problems, and neurologic symptoms. Side effects negatively affected quality of life, leading to serious health problems and issues with self-esteem. CONCLUSIONS: People living with SZ or BD-I cited a range of favourable and unfavourable experiences with oral antipsychotic medications. Most participants reported that their antipsychotics were effective at controlling their symptoms, but multiple side effects impacted their quality of life, caused additional serious health problems, and often led to discontinuation of or switching antipsychotics. Findings from this study contribute to a better understanding of patients' experiences with antipsychotics and highlight a need for new medications with favourable benefit/risk profiles.

Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus©) instrument in patients with COVID-19.

PURPOSE: A well-defined and reliable patient-reported outcome instrument for COVID-19 is important for assessing symptom severity and supporting research studies. The InFLUenza Patient-Reported Outcome (FLU-PRO) instrument has been expanded to include loss of taste and smell in the FLU-PRO Plus, to comprehensively cover COVID-19 symptoms. Our studies were designed to evaluate and validate the FLU-PRO Plus among patients with COVID-19. METHODS: Two studies were conducted: (1) a qualitative, non-interventional, cross-sectional study of patients with COVID-19 involving hybrid concept elicitation and cognitive debriefing interviews; (2) a psychometric evaluation of the measurement properties of FLU-PRO Plus, using data from COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial-Intent to Care Early). RESULTS: In the qualitative interviews (n = 30), all 34 items of the FLU-PRO Plus were considered relevant to COVID-19, and participants determined the questionnaire was easily understood, well written, and comprehensive. In the psychometric evaluation (n = 845), the internal consistency reliability of FLU-PRO Plus total score was 0.94, ranging from 0.71 to 0.90 for domain scores. Reproducibility (Day 20-21) was 0.83 for total score, with domain scores of 0.67-0.89. Confirmatory factor analysis with the novel smell/taste domain demonstrated an acceptable fit to the data. CONCLUSION: The content, reliability, validity, and responsiveness of the FLU-PRO Plus in the COVID-19 population were supported. Our results suggest that FLU-PRO Plus is a content- and psychometrically-valid, fit-for-purpose measure which is easily understood by patients. FLU-PRO Plus is a suitable PRO measure for evaluating symptoms of COVID-19 and treatment benefit directly from the patient perspective. TRIAL REGISTRATION: ClinicalTrials.Gov: NCT04545060, September 10, 2020; retrospectively registered.

Validation of the PROFAD-SSI-SF in Patients with Primary Sjögren's Syndrome with Organ Involvement: Results of Qualitative Interviews and Psychometric Analyses.

INTRODUCTION: The Profile of Fatigue and Discomfort-Sicca Symptoms Inventory-Short Form (PROFAD-SSI-SF) is a 19-item patient-reported outcome (PRO) measure to assess pain, fatigue, and dryness in patients with primary Sjögren's syndrome (pSS). This analysis identified concepts important to measure, and evaluated the content validity and measurement properties of the PROFAD-SSI-SF, in patients with pSS. METHODS: Qualitative analyses (GSK Study 208396) used transcripts from an online concept elicitation (CE) discussion forum with patients with pSS and interviews with key opinion leaders (KOLs) to finalize a disease model depicting important concepts for patients with pSS. Cognitive debriefing (CD) interviews with patients with pSS were conducted to further evaluate the content validity of the PROFAD-SSI-SF. Quantitative analyses (GSK Study 213253) used post hoc analyses of blinded data from a phase 2 trial to assess PROFAD-SSI-SF measurement properties. RESULTS: The CE discussion forum (N = 46) revealed dryness (oral 87.0%, ocular 73.9%, cutaneous 37.0%, vaginal 23.9%, nasal 15.2%, otic 6.5%), pain (89.1%), and fatigue (87.0%) as the most reported symptoms. KOLs (N = 5) found the concepts identified in the disease model accurate and understandable, and confirmed that PROs used in pSS studies should focus on dryness, joint pain, and fatigue. In the CD interviews (N = 20), of the 19 participants asked, all found the PROFAD-SSI-SF easy to understand, and 14/19 items were considered relevant by ≥ 18/20 participants. The quantitative analyses found an acceptable fit of the PROFAD-SSI-SF factor structure, with adequate internal consistency, test-retest reliability, convergent validity with other PRO measures, known-groups validity with Patient Global Assessment, and ability to detect change in patients with pSS. CONCLUSION: The final disease model confirmed that the PROFAD-SSI-SF assesses concepts that are relevant and important to patients with pSS. Our findings support the content validity and measurement properties of the PROFAD-SSI-SF as a fit-for-purpose PRO measure appropriate for use in clinical trials in patients with pSS. CLINICAL TRIAL REGISTRATION NUMBER FOR THE PHASE 2 TRIAL: Clinicaltrials.gov NCT02631538.

Primary Sjögren's syndrome (pSS) is a disease where the immune system attacks the body, causing a number of symptoms, most notably dryness (sicca) of the eyes and mouth. The Profile of Fatigue and Discomfort­Sicca Symptoms Inventory­Short Form (PROFAD-SSI-SF) is a questionnaire for patients with pSS that asks about their symptoms. This paper evaluates how relevant the PROFAD-SSI-SF questions are to patients with pSS, and how consistently and accurately the questionnaire can measure changes in their symptoms. We reviewed information about the symptoms and impacts of pSS from an online discussion forum for patients with pSS. Patients said that dryness, fatigue, and pain were the symptoms that most affected their day-to-day lives and well-being. We combined this information with previous research on pSS to design a diagram explaining the key symptoms and day-to-day impacts of pSS, which was reviewed by five experts in pSS. In doing so, we aimed to confirm whether the most important things to patients about living with pSS are asked in the PROFAD-SSI-SF questionnaire. Next, we asked 20 patients with pSS how easy they found the PROFAD-SSI-SF to complete and if any important concepts were missing; they reported that the PROFAD-SSI-SF was easy to fill in and that the important questions were included. Finally, we looked at data from a clinical trial that used the PROFAD-SSI-SF and found it accurately measures changes in symptoms of patients with pSS. This means that the PROFAD-SSI-SF could be used in clinical trials to help assess new medicines for pSS.

Qualitative research with patients and caregivers of patients with PIK3CA related overgrowth spectrum: content validity of clinical outcome assessments.

BACKGROUND: PIK3CA-Related Overgrowth Spectrum (PROS) are rare syndromes caused by a mutation in the PIK3CA gene, including fibroadipose hyperplasia or overgrowth; congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal (CLOVES); megalencephaly-capillary malformation (MCAP or M-CM); fibro-adipose vascular anomaly (FAVA); Klippel-Trenaunay syndrome (KT; also known as, Klippel-Trenaunay-Weber syndrome); capillary, lymphatic, and venous malformations (CLVM); and lymphatic malformation (LM). Characterized by malformations and tissue overgrowth, PROS manifests at birth or in early childhood. Pain and functional limitations associated with these conditions may greatly impact the health-related quality of life (HRQoL) of persons with PROS including physical functioning, work/school, social functioning, and emotional well-being. RESULTS: Selected clinical outcome assessments (COAs), identified during a literature review, were tested with adults with PROS, and children with PROS and their caregivers to determine comprehensibility, relevance, and appropriateness for measuring symptom severity and HRQoL. Tested were the Patient Global Impression of Symptom Severity (PGI-S), Brief Pain Inventory (BPI), Wong-Baker FACES, Patient-Reported Outcomes Measurement Information System (PROMIS) Profile, PROMIS Pediatric Short Form Sleep Disturbance, and PROMIS Dyspnea Severity. Qualitative interviews tested the self-report adult, self-report pediatric, and observer-report COAs with adults with PROS, and children with PROS and their caregivers. Ten adults (≥ 18 years old) with PROS, and 20 children (6-17 years old) with PROS and their caregivers, participated. All reported positive feedback on item relevance. Adults and children over the age of 12 comprehended and responded to self-reported items. Secondary objectives examined the age children could self-report their conditions using pediatric versions and assessed available observer-report versions of the COAs with caregivers. Some participants under the age of 12 had trouble understanding some terminology. Further, adults and children with cognitive impairment associated with MCAP/M-CM sometimes had difficulty with self-report. Caregivers were able to report their child's symptoms and impacts using observer-report COAs. Participant feedback prompted further consideration of the measurement of pain in this population, including variability of pain over time, location of pain, and type. CONCLUSIONS: This study provided valuable information from patients about PROS, supporting the content validity of the COAs, with recommended revisions. COAs are easily understood by persons with PROS and caregivers and are appropriate for measuring symptoms and disease-related impacts across diverse PROS syndromes in clinical trials.

Impact of respiratory syncytial virus disease on quality of life in adults aged ≥50 years: A qualitative patient experience cross-sectional study.

BACKGROUND: Information about the impact of respiratory syncytial virus (RSV) on quality of life in older adults is limited. This study characterized the patient experience of RSV illness in USA older adults and assessed the content validity of the InFLUenza Patient Reported Outcome (FLU-PRO) in this population. METHODS: This qualitative, non-interventional, cross-sectional study included hybrid concept elicitation and cognitive debriefing interviews with 30 individuals (age ≥50 years) with polymerase chain reaction-confirmed RSV diagnosed within 6 months of screening. Targeted literature review was first conducted to inform the development of interview materials. Webcam or telephone interviews were conducted by qualitative researchers using a semistructured interview guide. Interview transcripts were coded and analyzed using Excel and NVivo software. RESULTS: All participants reported impacts on daily activities, social activities, and relationships during RSV disease. Physical functioning was impaired in 25 (83%) participants, and 18 (60%) reported not engaging in leisure activities/hobbies. All nine participants who were working reported major impacts on work. Most (n = 28; 93%) described emotional impacts. A majority (n = 19; 63%) reported symptoms lasting beyond the acute disease stage from a week to >1 month. Symptom concepts reported generally matched FLU-PRO items and domains. Cognitive debriefing indicated that FLU-PRO was easy to understand and captured participants' experiences of RSV illness. CONCLUSIONS: This study indicates that RSV disease in adults aged ≥50 years in the USA has substantial impacts on daily life and that the concepts included in FLU-PRO are appropriate and fit for purpose as a measure of RSV symptoms in this population.

Development, psychometric evaluation and cognitive debriefing of the rheumatoid arthritis symptom and impact questionnaire (RASIQ).

BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory disease often associated with persistent pain. There is a need for a patient-reported outcome measure (PROM) that is rooted in the patient experience and psychometrically validated. We describe the development of the Rheumatoid Arthritis Symptom and Impact Questionnaire (RASIQ), a novel PROM with potential to record key symptoms and impacts of RA with a 24-h recall period. RESULTS: A literature review identified RA concepts that patients considered most important to their disease experience, including pain, fatigue, joint swelling and stiffness. From this, an initial item pool (33 items; 27 related to symptoms, 6 related to impacts) was developed with a recall period of 24 h. Two rheumatologists evaluated each item's relevance, and the second version of the RASIQ was refined (29 items; 21 related to symptoms, 8 related to impacts). Next, three rounds of cognitive debriefing interviews were conducted with patients with RA (n = 15 overall). The RASIQ was revised to remove items deemed irrelevant or redundant, leaving 16 items measuring symptoms (joint pain, energy/tiredness, joint stiffness) and impacts (rest, sleep). A parallel series of semi-structured concept elicitation interviews (n = 30) facilitated the design of a conceptual model of RA symptoms, impacts and treatment experiences. Post-hoc comparison of the model with RASIQ revealed that all items selected were among the most important and relevant symptoms and impacts for patients. A final round of cognitive debriefing interviews (n = 12) confirmed that the final 16-item RASIQ was relevant and easy to understand, with no further changes recommended. Psychometric evaluation using data from two Phase II RA clinical trials confirmed a 3-factor structure, as well as the reliability and validity of the scale scores, and the ability of RASIQ to detect changes in symptoms and impacts when administered at specific study timepoints, using a 24-h recall period. CONCLUSIONS: RASIQ is a novel, 16-item PROM developed with substantial patient input. Results from concept elicitation, cognitive debriefing, and psychometric evaluation confirmed the validity of the instrument, which has the potential to measure symptoms and impacts through a 24-h recall period and complement existing disease activity instruments with longer recall periods.

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis.

BACKGROUND: Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. METHODS: A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). RESULTS: Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. CONCLUSION: Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Content validation of a self-report daily diary in patients with sickle cell disease.

BACKGROUND: Sickle Cell Disease (SCD) is a genetic progressive vascular disease that impacts patients overall health and quality of life. Sickle-cell pain crises (SCPCs) are a hallmark clinical presentation of SCD and have been associated with increased morbidity and mortality. The Sickle Cell Pain Diary- Self Report (SCPD-S) was developed as a daily patient-reported outcome (PRO) measure primarily intended to capture the frequency and severity of SCD-related pain during and outside of a SCPC. The SCPD-S also examines the impact of the pain associated with an SCPC on other health-related quality of life concepts. The objective of this study was to investigate the content validity of the SCPD-S. METHODS: The content validation testing included 18 in-depth hybrid concept elicitation and cognitive debriefing interviews conducted with SCD patients in the US aged 12 years and older. Interviewers used a semi-structured interview guide and a think-aloud approach for the cognitive debriefing portion. All interviews were recorded, transcribed, coded and analyzed. RESULTS: Eighteen interviews across two rounds were conducted. Round 1 hybrid interviews (n = 12) resulted in the expansion of the SCPD-S from 13 to 19 items. Items on the impact of an SCPC on social and recreational activities, sleep, and emotional well-being were added. Five items were significantly revised, as were three response choice sets. Round 2 hybrid interviews (n = 6) confirmed the comprehensiveness of the revised diary, understandability of the wording, and appropriateness of the recall period and response sets. Saturation analyses specific to concept elicitation revealed that no additional interviews were needed. CONCLUSIONS: This study provided evidence to support the content validity of the SCPD-S, a self-report daily diary. Data gathered during patient interviews indicated that the SCPD-S is a fit for purpose measure of SCD and SCPC-related pain frequency and severity and the impact of this pain on other health-related quality of life concepts including fatigue and emotional health. The numerous changes to the SCPD-S as a result of the study findings highlight the importance of the content validation process when developing a PRO measure.

Patient Experience With Fatigue and Qualitative Interview-Based Evidence of Content Validation of The FACIT-Fatigue in Systemic Lupus Erythematosus.

INTRODUCTION: Fatigue is highly prevalent and burdensome in systemic lupus erythematosus (SLE). The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a patient-reported questionnaire that measures physical and mental fatigue and consequent impact on daily living. Qualitative evidence of content validity in SLE is limited. This study (GSK Study 209226) assessed the content validity of the FACIT-Fatigue for SLE and explored patients' experiences of SLE-related fatigue using qualitative methods. METHODS: Fatigue-related themes were identified through semi-structured, hybrid cognitive debriefing and concept elicitation interviews and evaluated for concordance with the FACIT-Fatigue. RESULTS: Fatigue was experienced regularly by all participants (N = 15, 86.7% female) and was rated as the most bothersome symptom of SLE by 11/15 participants. All participants reported emotional impacts of fatigue, while 14/15 and 9/15 participants also reported impacts on social life and physical functioning, respectively. Most (12/15) reported that fatigue interfered with their ability to fulfill work- or school-related roles, and activities of daily living were limited in all participants. All (14/14) reported that a meaningful change in their level of fatigue would be the ability to have a more active and normal lifestyle. Concept mapping showed that all 13 FACIT-Fatigue items mapped directly onto concepts spontaneously mentioned by participants. Cognitive debriefing revealed that 13/15 participants found the instructions easy to understand and 11/15 participants endorsed the recall period (7 days) as appropriate. Participants found the FACIT-Fatigue items were clear and relevant. Most participants (11/15) reported that all response options adequately captured their experience of fatigue. CONCLUSIONS: Qualitative evaluation of the content validity of the FACIT-Fatigue supports it as an appropriate measure for assessing the impact of fatigue on daily living of patients with SLE. The tool is easily understood by patients and a valuable resource for measuring a common and debilitating symptom of this condition.

Patient-reported burden of hereditary transthyretin amyloidosis on functioning and well-being.

BACKGROUND: Hereditary transthyretin (hATTR) amyloidosis is a rare, systemic, progressive, and life-threatening disease in which transthyretin proteins misfold and aggregate as insoluble amyloid deposits, disrupting nervous, cardiac, gastrointestinal, and other organ tissues. There are limited available data about the experience of patients living with hATTR amyloidosis. This study used a qualitative, non-interventional design to explore the humanistic burden of hATTR amyloidosis from the patient's perspective. RESULTS: Fourteen adults with hATTR amyloidosis, recruited from a patient advocacy group or an academic clinical center, participated in individual semi-structured interviews either in person or by telephone. Patients were asked to describe their experiences living with the condition, including symptoms and disease-related impacts on functioning and well-being, work, and activities of daily living (ADLs). Interviews were transcribed verbatim and analyzed for key concepts using a grounded theory approach. Patients described many symptoms of hATTR amyloidosis, particularly those associated with peripheral neuropathy such as pain, numbness, weakness, and paresthesia. Symptoms of autonomic neuropathy, such as gastrointestinal dysfunction, and symptoms related to cardiac dysfunction were also common. Worsening symptoms, especially those impacting patients' ability to walk or use their hands, often led to a loss of autonomy and an inability to work or perform ADLs. Disease-related disability also interfered with patients' participation in social activities, and contributed to feelings of fear, frustration, or sadness. CONCLUSIONS: The impacts of hATTR amyloidosis were profound for the patients interviewed for this study. They described a sense of loss as their condition progressed and impacted them physically, emotionally, and socially. Patients' reports of symptoms and impacts of hATTR amyloidosis illustrate the complex and varied manifestations of this disease. The progression of symptoms and increasing impacts of hATTR amyloidosis also highlight the need for an earlier diagnosis and effective clinical intervention to preserve patients' functioning and well-being.

Content validation of the SF-36v2® health survey with AL amyloidosis patients.

BACKGROUND: This study examined the content validity of the SF-36v2® Health Survey (SF-36v2) in patients with AL amyloidosis using qualitative interviews with physicians and patients. The study included three distinct phases of qualitative research: concept elicitation interviews among physicians, concept elicitation interviews among patients, and cognitive debriefing interviews among patients. The concept elicitation interviews focused on areas of health-related quality of life that are affected by AL amyloidosis and may be affected by treatment, while patient cognitive debriefings aimed to confirm whether the SF-36v2 instructions, recall period, items, and response choices were comprehensive and understandable to AL amyloidosis patients. RESULTS: Physicians discussed the importance of measuring physical functioning, general health, mental/emotional health, sleep, fatigue, and work impact; though they also reported that they do not routinely use a standard Patient-Reported Outcome (PRO) measure of health-related quality of life. Patients described social, physical, role, and emotional impacts of AL amyloidosis and various treatments. Cognitive debriefing interviews confirmed the relevance of the concepts measured by the SF-36v2 and indicated that patients found the SF-36v2 both easy to understand and complete, that the SF-36v2 instructions and items were comprehensive and understandable without change, and the response choices and recall period were appropriate for use with patients with AL amyloidosis. CONCLUSIONS: The findings support the content validity of the SF-36v2 as an appropriate measure of health-related quality of life in patients with AL amyloidosis.

Helpful hints: caregiver-generated asthma management strategies and their relation to pediatric asthma symptoms and quality of life.

OBJECTIVE: This mixed-methods study examined the relation between caregiver-generated asthma management strategies and asthma severity in a sample of 200 children with persistent asthma (ages 5-12 years). METHODS: Caregivers were interviewed about asthma management strategies they found helpful in controlling their child's symptoms. A qualitative content analysis was used to identify household strategies. Indicators of asthma severity included lung functioning (FEV(1)) and functional severity (FSS). Child quality of life was also assessed (PQLQ). RESULTS: Six primary household strategies were identified: Reactive, Planning Ahead, Social, Emotional, Avoiding Triggers, and Cleaning. In general, strategies offered by caregivers did not differ by socioeconomic status. Caregivers who endorsed Avoiding Triggers as effective strategies had children with better lung functioning. Caregivers who endorsed Planning Ahead or Emotional strategies had children with better asthma-related quality of life. CONCLUSION: These household strategies hold promise for reducing pediatric asthma symptoms and improving child quality of life.