scholarly journals Patient-Reported Disease Burden: In-Depth Interviews of Patients with CAD

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Jun Su ◽  
Katherine Kosa ◽  
Dana DiBenedetti
Keyword(s):  
Content Validity ◽  
Leisure Activities ◽  
Panel Member ◽  
The United States ◽  
Daily Activities ◽  
Outdoor Activities ◽  
Concept Elicitation ◽  
Cold Environments ◽  
Patient Reported ◽  
Social Leisure

Introduction Cold agglutinin disease (CAD) is a rare disorder (a prevalence of 16 cases per 1 million people), accounting for approximately 15%-25% of all autoimmune hemolytic anemias (Berentsen. Semin Hematol. 2018). Currently, there is no approved drug for the treatment of CAD. Debilitating fatigue that greatly affects quality of life is common among patients with CAD (Roth et al. Blood. 2019). The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale has recently been used to quantify fatigue in patients with CAD (Roth et al. Blood. 2019). However, the appropriateness of FACIT-F in these patients has not been assessed. In-depth individual interviews of adults with CAD were conducted primarily to identify the symptoms and effects of CAD reported as important by patients and to better understand their experiences with CAD. The secondary objective was to obtain patient feedback regarding the relevance and importance of the items on the FACIT-F. Methods Participants were identified and recruited from a proprietary panel of patients with CAD. Of 1,250 panel members, approximately 600 members from the United States (US) were invited to participate in an in-depth interview. Systematic random sampling was used to select every nth panel member from each of 4 US regions to receive an email invitation. A semi-structured interview guide was used to ensure consistent systematic collection of data pertaining to study objectives, while maintaining a conversational tone and encouraging spontaneity of answers. Results Twenty-two members expressed interest in participating; of these, 18 could be reached for screening and 16 were eligible for interview. The sample was 100% White and non-Hispanic, 62.5% female, and had an average age of 67.8 years. Participants resided in the West (37.5%), Midwest and South (both 25%), and Northeast (12.5%). The date of CAD diagnosis averaged 6 years before the interview, and 68.8% of patients had received their diagnosis within the last 1.5 years. Seven (43.8%) patients reported that they were not taking any prescription or over-the-counter (OTC) medication for CAD, whereas 9 (56.3%) were taking prescribed or OTC folic acid for CAD (of these, 4 also took prescription strength vitamin B12). In this sample, no patient reported current use of other prescription medications for CAD. A few patients spontaneously reported previous treatments for CAD (eg, transfusions and rituximab or other injections). However, previous CAD treatment was not systematically collected for all subjects and is a limitation of the study. Concept-elicitation of symptoms The most frequently reported symptoms were fatigue/tiredness/lack of energy (93.8%), reaction to cold environments (93.8%), breathlessness (68.8%), and trouble thinking/concentrating (68.8%). When probed, 43.8% of patients reported sleep disturbances (Figure 1A). Concept-elicitation of effects Most participants (68.8%) reported lifestyle or behavioral changes to help treat CAD symptoms (eg, taking gloves/extra clothing to places that may be cold). Others reported giving up/limiting enjoyable or outdoor activities and making major changes (eg, discontinuing outdoor activities, restricting travel). Other CAD-related effects included impairment in daily activities, overall health/physical activities, and social/leisure activities/relationships (Figure 1B). For the evaluation of the FACIT-F in this CAD population, participants reported that FACIT-F instructions and items were clear and easy to understand, response options were distinct from each other, and they could recall their fatigue over the previous 7 days. They reported that FACIT-F measured one or more concepts personally important to them and important concepts were not missing. This provides support for the content validity of the FACIT-F in patients with CAD. Conclusions Patients with CAD experienced negative effects on daily activities, physical health/activities, social/ leisure activities/relationships, the ability to concentrate/recall, and mood/emotions mostly owing to fatigue/lack of energy and reactions to cold environments. Most patients required modifying their lifestyle/behavior to manage CAD symptoms. FACIT-F measured concepts important to patients with CAD, which supports its content validity and use in this patient population. Disclosures Su: Sanofi: Current Employment. Kosa:Sanofi: Other: RTI Health Solutions was contracted by Sanofi to conduct this work; RTI Health Solutions: Current Employment. DiBenedetti:Sanofi: Other: RTI Health Solutions was contracted by Sanofi to conduct this work; RTI Health Solutions: Current Employment, Other.

scholarly journals SUN-LB102 Development of a Conceptual Model to Present the Impacts of Obesity on Physical Functioning

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Jiat Ling Poon ◽  
Chris Marshall ◽  
Chloe Johnson ◽  
Hannah Pegram ◽  
Maile Hunter ◽  
...  
Keyword(s):  
Conceptual Model ◽  
Physical Functioning ◽  
Content Validity ◽  
Clinical Studies ◽  
Negative Impact ◽  
The United States ◽  
Overweight And Obesity ◽  
Spontaneous Reports ◽  
Patient Reported ◽  
The Impact

Abstract Background. Obesity is a chronic disease with a significant negative impact on health-related quality of life (HRQoL) and specifically, physical functioning, including the ability to complete activities of daily living (ADLs). Weight loss based on lifestyle management (e.g. diet, exercise), surgery, and pharmacotherapy can improve physical functioning; however, there is a need for further qualitative research to support the content validity of patient-reported outcome (PRO) measures for use in clinical studies of obesity and thus inform regulatory decision-making. Objective. To explore the impacts of obesity on physical functioning and develop a conceptual model (a visual representation of the concepts of importance and relevance to the experience of living with obesity) to ultimately support the content validity of PRO measures.Methods. Qualitative semi-structured interviews were conducted in the United States with individuals who have overweight and obesity (Body Mass Index [BMI] ≥ 27.0 kg/m2) with a history of at least one unsuccessful dietary effort to lose body weight. Recruitment quotas targeted a sample with diverse demographic and clinical characteristics, including participants with and without diabetes. Experienced qualitative interviewers used open-ended questions to elicit spontaneous reports of the impact of obesity on individuals’ daily lives, and specific probing questions to explore impacts on physical functioning. Interviews were audio-recorded, transcribed and analyzed using thematic techniques. Results. A total of 33 participants were interviewed (mean BMI of 37.6 kg/m2 [27.4 kg/m2 to 56.6 kg/m2]; mean age of 45 years [19 to 81 years]). The sample included a mix of races (Caucasian: n=12, 36%), education completed (high school: n=17, 51%) and split of gender (female: n=16, 48%). During development of the conceptual model, two separate domains were identified to group the reported impacts on physical functioning: ‘Mobility/Movement’ and ‘ADLs’. The most frequently reported impacts related to Mobility/Movement were ‘running’ (n=31/33, 94%), ‘bending’ (n=27/33, 82%), ‘walking’ (n=26/33, 79%), ‘difficulty standing for prolonged periods’ (n=22/33, 67%), and ‘lifting’ (n=19/33, 58%). All participants reported effects on some aspect of physical functioning, which were often characterized in terms of their direct impact on ADLs such as ‘household chores’ (n=21/33, 64%). Conclusions. The conceptual model will serve as a basis to identify fit-for-purpose PRO measures with strong content validity to evaluate the impact of anti-obesity therapies on physical functioning in future clinical studies. Obesity has a consistent and significant impact on physical functioning, leading to limitations in various aspects of mobility and affecting an individual’s ability to carry out specific daily activities.

scholarly journals Development of a novel patient-reported measure for acromegaly: the Acro-TSQ

Pituitary ◽  
2019 ◽  
Vol 22 (6) ◽  
pp. 581-593 ◽  
Author(s):  
Maria Fleseriu ◽  
Leon Fogelfeld ◽  
Murray B. Gordon ◽  
Jill Sisco ◽  
Hilary H. Colwell ◽  
...  
Keyword(s):  
Side Effects ◽  
Disease Burden ◽  
Symptom Control ◽  
Somatostatin Analogs ◽  
Well Being ◽  
The United States ◽  
Daily Activities ◽  
Response Options ◽  
Patient Reported ◽  
The Impact

Abstract Purpose Somatostatin analogs (SSAs) represent a mainstay of medical treatment for acromegaly, currently available as either intramuscular or deep subcutaneous injections. Patient-reported outcomes (PROs) are increasingly common as relevant outcomes in studies of acromegaly and its treatment, but there are no validated PRO measures available that focus on the disease burden and the impact of treatment, specifically designed for use in patients with acromegaly. We sought to develop a new and unique PRO measure, the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ). Methods Concept elicitation (CE) interviews were conducted with acromegaly patients in the United States receiving SSA injections at a stable dose for ≥ 6 months. A questionnaire was drafted based on these interviews; combined CE and cognitive debriefing (CE/CD) interviews were then conducted to confirm the content, clarity, and relevance of the questionnaire. Results Nineteen subjects completed interviews [n = 9 CE, n = 10 CE/CD; n = 15 Lanreotide Depot/Autogel (Somatuline), n = 4 Octreotide LAR (Sandostatin LAR)]. Most subjects responded positively when asked about the effectiveness of their current treatment; however, breakthrough symptoms, injection site reactions, and side effects were commonly reported and had negative impacts on social and emotional well-being and daily activities. All 10 subjects involved in debriefing interviews found the questionnaire to be relevant, easy to complete, and found the response options to be clear. The resulting 26-item Acro-TSQ covers symptoms and symptom control, gastrointestinal side effects and their impact on daily activities, the emotional impact of treatment, convenience and ease of use, and overall satisfaction. Conclusions The Acro-TSQ is a novel PRO, focused on both disease burden and impact of treatment; it was found to be comprehensive, clear, and relevant for patients with acromegaly receiving injectable SSA treatment.

scholarly journals Assessing the impacts of having a child with achondroplasia on parent well-being

2020 ◽  
Author(s):  
Kathryn M. Pfeiffer ◽  
Meryl Brod ◽  
Alden Smith ◽  
Jill Gianettoni ◽  
Dorthe Viuff ◽  
...  
Keyword(s):  
Focus Group ◽  
Well Being ◽  
The United States ◽  
Patient Reported Outcome ◽  
Concept Elicitation ◽  
Qualitative Evidence ◽  
Parent Experience ◽  
Patient Reported ◽  
Family And Work ◽  
Group Interviews

Abstract Purpose This study’s purpose was to develop a better understanding of the experiences of parents of children with achondroplasia and to provide qualitative evidence to support the development of a patient-reported outcome (PRO) measure of parent impacts. Methods Concept elicitation (CE) individual/focus group interviews were conducted with parents of children aged 2 to < 12 years with achondroplasia in the United States and Spain. The qualitative analysis informed the PRO measure development. Cognitive debriefing (CD) interviews were conducted to ensure parent understanding and item relevance. Results Thirty-six parents participated in individual/focus group CE interviews. The analysis identified parent impacts in four domains, including caretaking responsibilities, emotional well-being, family, and work, and results informed the development of the Achondroplasia Parent Experience Measure (APEM). Caretaking responsibilities included managing child’s medical care (92%), helping child with self-care (67%), advocating for child (64%), assisting child (56%), and observing/monitoring child (e.g., to ensure safety; 47%). Impacts on parents’ emotional well-being included worry about the future (75%), worry about child’s physical health (67%), safety concerns (50%), feeling stressed/overwhelmed (44%), and worry about child’s social relationships (42%). Impacts on family and work included family strain (56%), limiting/adapting family activities (42%), and missed work time (50%). CD interviews with an additional 16 parents of children with achondroplasia confirmed understanding and item relevance. Conclusion The results improve our understanding of the experiences of parents of children with achondroplasia and provide qualitative evidence to support the content validity of the APEM. A psychometric study is needed to validate the measure.

scholarly journals POS0269-HPR CONTENT VALIDITY OF A MULTIPLE LANGUAGES QUESTIONNAIRE FOR MEASURING FLARE IN KNEE AND HIP OA: DEVELOPMENT OF THE FLARE-OA

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 358.2-358
Author(s):  
F. Guillemin ◽  
A. Barcenilla-Wong ◽  
M. Vitaloni ◽  
L. Adarmouch ◽  
M. T. Duruöz ◽  
...  
Keyword(s):  
Focus Group ◽  
Health Care Professionals ◽  
Content Validity ◽  
The United States ◽  
Consensus Method ◽  
Expert Committee ◽  
Delphi Consensus ◽  
Culturally Adapted ◽  
Patient Reported ◽  
Classical Arabic

Background:Flare in osteoarthritis (OA) of the knee and hip (KHOA) is an important outcome for patients’ daily life and clinical research. A definition of a flare was set, and a core set of domains was recently endorsed by OMERACT/OARSI. No patient reported outcome (PRO) yet focusses on flare in OA specifically.Objectives:To develop a self-reporting instrument measuring flare in 5 languages, using qualitative methods and international Delphi consensus.Methods:We generated items using a dual-language (English and French) approach involving patients with OA from Australia, France and the United States and health care professionals (HCP) from international societies (OARSI, SFR, OMERACT). Item generation relied on semi-structured individual interviews conducted with OA patients and HCP and one focus group with patients. Content analysis allowed for identifying verbatim statements that were meaningful for patients and HCP. A Delphi consensus method was used to select the most relevant items, according to core domains set (OMERACT). A cross-cultural approach using current guidelines (1) was applied to produce Spanish (in Spain), Turkish and classical Arabic (in Morocco) versions using independent translation and expert committee to preserve its content validity.Results:From semi-structured interviews with 29 patients and 16 HCPs and one focus group with 10 patients, 180 statements in French (106) and English (77) were generated. Based on similarity or redundancy, 50 items with equivalent meaning in both languages were retained by an expert committee. After two Delphi rounds involving 50 patients and 116 HCPs from 17 countries on four continents, it was reduced to 33 items (response 0=not at all, to 10=absolutely) in five domains (pain, swelling, stiffness, consequences of symptoms and psychological aspects). This questionnaire was cross-culturally adapted into Spanish, Turkish and classical Arabic. The Spanish version uncovered one inappropriate item in the original questionnaire that was amended accordingly in all 5 languages.Conclusion:Flare is more than just an exacerbation of pain. The Flare-OA questionnaire includes all OMERACT recommended core domains. High content validity was seen in 2 original and 3 cross-culturally adapted languages. The Flare-OA should be considered as fit for purpose and evaluation of responsiveness in clinical studies in 5 languages.Disclosure of Interests:None declared

scholarly journals Investigating the Association between Outdoor Environment and Outdoor Activities for Seniors Living in Old Residential Communities

2021 ◽  
Vol 18 (14) ◽  
pp. 7500
Author(s):  
Shiwang Yu ◽  
Na Guo ◽  
Caimiao Zheng ◽  
Yu Song ◽  
Jianli Hao
Keyword(s):  
Regression Analysis ◽  
Leisure Activities ◽  
Age Groups ◽  
Outdoor Environment ◽  
Daily Activities ◽  
Outdoor Activities ◽  
Factors Associated ◽  
Residential Communities ◽  
Slip Resistance ◽  
Nanjing City

Many seniors live in old residential communities (ORCs) with low-quality outdoor environment (OE), which hinders the residents’ outdoor daily activities (ODAs). This paper empirically investigates the association of OE on ODAs for seniors living in ORCs. A questionnaire was designed and distributed in six central districts of Nanjing city. A total of 258 questionnaires was finally collected, of which 60.08%, 29.46%, 9.69%, and 0.78% respondents were scattered into four age groups (61–69, 70–79, 80–89, and ≥90), respectively. Based on reliability analysis, correlation analysis, and regression analysis, the results show that: (1) social activities are mainly associated with noise; (2) leisure activities are significantly associated with road accessibility, slip-resistance measures, greenery, and staff; (3) utilitarian-type activities are significantly associated with stairway accessibility, slip-resistance measures, greenery, and seating; (4) there is a significant association between nature-exposure activities and layout, greenery, and poor air quality. The findings could guide Chinese officials when renewing ORCs by addressing the most important outdoor environmental factors associated with ODAs.

scholarly journals Content validity of a novel patient-reported and observer-reported outcomes assessment to evaluate ocular symptoms associated with infectious conjunctivitis in both adult and pediatric populations

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Sujata P. Sarda ◽  
Marie De La Cruz ◽  
Emuella M. Flood ◽  
Magdalena Vanya ◽  
David G. Hwang ◽  
...  
Keyword(s):  
Foreign Body ◽  
Content Validity ◽  
Pediatric Patients ◽  
Cognitive Interview ◽  
Signs And Symptoms ◽  
Foreign Body Sensation ◽  
Bacterial Conjunctivitis ◽  
Concept Elicitation ◽  
Body Sensation ◽  
Patient Reported

Abstract Background Acute infectious conjunctivitis is a common condition most frequently caused by viruses or bacteria. Clinical outcome assessments have been used to assess signs and symptoms of bacterial and viral conjunctivitis, but have not been evaluated for content validity. We aimed to develop content-valid patient- (PRO) and observer-reported outcome (ObsRO) instruments to assess symptoms of ocular discomfort associated with viral or bacterial conjunctivitis in adult and pediatric patients. Methods Draft items were developed from a previous review of published studies from 2001 to 2015. Patients and caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the past 6 months were recruited. Concept elicitation with open-ended questions explored signs and symptoms, followed by cognitive interviewing to assess clarity and relevance of the draft items. Patients aged ≥8 years were interviewed for the PRO; parents/caregivers of children aged 1–10 years were interviewed for the ObsRO. Interviews were conducted in three rounds to allow changes. Concept saturation was documented using a saturation grid. Cognitive interview data were analyzed iteratively and focused on clarity, relevance and inconsistent interpretation of the instrument’s content. Results Overall, 23 patients or parents/caregivers participated (round 1, n = 10; round 2, n = 6; round 3, n = 7). Data saturation was reached by the 16th interview. The most frequent spontaneously reported signs/symptoms were: discharge, red/pink eyes, itchiness, swelling/puffiness, watery eyes, pain, burning and foreign body sensation. Itching, pain/burning/stinging and foreign body sensation were most commonly reported as the top three most bothersome symptoms. Interview results indicated that items on pain, itching and foreign body sensation for the PRO and pain or discomfort for the ObsRO were relevant to the patients’ experience of conjunctivitis and were clear and easy to understand. Conclusions PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key viral and bacterial conjunctivitis symptoms in adult and pediatric patients.

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

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brandon Becker ◽  
Kimberly Raymond ◽  
Carol Hawkes ◽  
April Mitchell Foster ◽  
Andrew Lovley ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Disturbance ◽  
Content Validity ◽  
Sleep Disturbances ◽  
Measurement Precision ◽  
Pain Interference ◽  
Concept Elicitation ◽  
Short Forms ◽  
Item Banks ◽  
Patient Reported

Abstract 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.

scholarly journals Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Marci English ◽  
Boyka Stoykova ◽  
Christina Slota ◽  
Lynda Doward ◽  
Emad Siddiqui ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Content Validity ◽  
Short Form ◽  
Work Productivity ◽  
The United States ◽  
Vasomotor Symptoms ◽  
Response Options ◽  
Short Forms ◽  
Patient Reported ◽  
The Impact

Abstract Purpose We evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS. Methods Cross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40–64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing. Results Thirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct. Conclusion VMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS.

scholarly journals Development and Content Validity of a Patient-Reported Experience Measure for Home Dialysis

2021 ◽  
pp. CJN.15570920
Author(s):  
Matthew B. Rivara ◽  
Todd Edwards ◽  
Donald Patrick ◽  
Lisa Anderson ◽  
Jonathan Himmelfarb ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Content Validity ◽  
Cognitive Debriefing ◽  
Home Hemodialysis ◽  
Home Dialysis ◽  
Care Experience ◽  
Concept Elicitation ◽  
Experience Of Care ◽  
Patient Reported ◽  
Experience Measure

Background and objectivesThe population of patients with kidney failure in the United States using home dialysis modalities is growing rapidly. Unlike for in-center hemodialysis, there is no patient-reported experience measure for assessment of patient experience of care for peritoneal dialysis or home hemodialysis. We sought to develop and establish content validity of a patient-reported experience measure for patients undergoing home dialysis using a mixed methods multiple stakeholder approach.Design, setting, participants, & measurementsWe conducted a structured literature review, followed by concept elicitation focus groups and interviews among 65 participants, including 21 patients on home dialysis, 33 home dialysis nurses, three patient care partners, and eight nephrologists. We generated a list of candidate items for possible measure inclusion and conducted a national prioritization exercise among 91 patients on home dialysis and 39 providers using a web-based platform. We drafted the Home Dialysis Care Experience instrument and conducted cognitive debriefing interviews to evaluate item interpretability, order, and structure. We iteratively refined the measure on the basis of interview findings.ResultsThe literature review and concept elicitation phases supported 15 domains of home dialysis care experience in six areas: communication and education of patients, concern and helpfulness of the care team, proficiency of the care team, patient-centered care, care coordination, and amenities and environment. Focus groups results showed that domains of highest importance for measure inclusion were patient education and communication, care coordination, and personalization of care. Prioritization exercise results confirmed focus group findings. Cognitive debriefing indicated that the final measure was easily understood and supported content validity.ConclusionsThe Home Dialysis Care Experience instrument is a 26-item patient-reported experience measure for use in peritoneal dialysis and home hemodialysis. The Home Dialysis Care Experience instrument represents the first rigorously developed and content-valid English-language instrument for assessment of patient-reported experience of care in home dialysis.

scholarly journals A qualitative exploration of the patient experience of erosive and non-erosive hand osteoarthritis

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Charlotte Panter ◽  
Pamela Berry ◽  
Deven Chauhan ◽  
Sofia Fernandes ◽  
Sally Gatsi ◽  
...  
Keyword(s):  
Content Validity ◽  
Small Sample Size ◽  
The United States ◽  
Small Sample ◽  
Hand Osteoarthritis ◽  
Structured Interviews ◽  
Time Data ◽  
Erosive Disease ◽  
Concept Elicitation ◽  
Improve Measurement

Abstract Background Many patients with hand osteoarthritis (HOA) experience reduced health-related quality of life. This study sought to better understand the disease and treatment experience of individuals with HOA, explore any differences in experiences between erosive and non-erosive HOA sub-types, and evaluate content validity of the Michigan Hand Outcomes Questionnaire (MHQ) in HOA. Methods Thirty subjects from the United States (n = 15 erosive HOA; n = 15 non-erosive HOA) participated in semi-structured interviews: concept elicitation explored symptoms/impacts important to patients; cognitive interviews assessed understanding and relevance of the MHQ. A sub-sample participated in real-time data capture (RTDC) activities via a smartphone/tablet app over 7 days. Verbatim transcripts were coded using Atlas.ti software and thematically analyzed. Concept saturation and MHQ content validity were evaluated. Results Most participants reported experiencing pain, swelling and stiffness, symptoms that most commonly had a direct impact on physical functioning. Substantial impacts on activities of daily living, emotional functioning, sleep and work were also reported. RTDC findings corroborated concept elicitation findings. There were no notable differences between erosive and non-erosive HOA, except nodules were reported more frequently in erosive disease. Most participants used analgesic treatments, but effects were short-lived. Pain was the symptom most frequently reported as most bothersome and important to treat. Concept saturation was achieved. MHQ items and instructions were well understood and relevant to most participants; stiffness and swelling were reported as important symptoms not included in the MHQ. Conclusions This study characterizes key symptoms of HOA which are burdensome for patients and not well controlled by current therapies, highlighting an unmet treatment need. Although the study is limited by a small sample size that may not be representative of the broader erosive and non-erosive HOA population, concept saturation was achieved, and our findings suggest that disease experience is similar for patients with erosive and non-erosive HOA. Evaluation of stiffness and swelling items in conjunction with the MHQ may enhance relevance and improve measurement precision to assess important domains of HQRoL in an HOA population.

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