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.

The Transthyretin Amyloidosis - Quality of Life (ATTR-QOL) Questionnaire: Development of a Conceptual Model and Disease-Specific Patient-Reported Outcome Measure.

Purpose: Patients with transthyretin amyloidosis (ATTR) experience a wide variety of symptoms and impacts on health-related quality of life (HRQoL). However, the lack of an ATTR-specific patient-reported outcome (PRO) measure has made consistent measurement of HRQoL in ATTR challenging. This paper describes the development of a conceptual model and subsequent content for the Transthyretin Amyloidosis - Quality of Life Questionnaire (ATTR-QOL), an ATTR-specific PRO measure. Methods: This was a cross-sectional, non-interventional, US-based study. The study design included three stages: 1) a targeted literature review followed by qualitative data collection with patients and experts; 2) development of a conceptual model and PRO measure; and 3) review of the PRO measure using a modified Delphi method, translatability assessment, and interviews with patients and experts. Revisions were made to the measure after each round of review. Results: Forty-four patients and 29 experts participated in this study. The conceptual model included two primary concepts of interest: symptoms (cardiac, neuropathic-peripheral, neuropathic-autonomic, and other) and impacts (eg, physical, role, and mental/emotional functioning). Seventy-two items were created (32 symptoms; 40 impacts) to align with the model. A recall period of one month was selected based on participant input. Conclusion: The ATTR-QOL was created with significant patient involvement and guidance from a multidisciplinary group of experts. The mix of patient and clinical perspectives helped to ensure a balanced representation of all relevant disease experiences and clinical specialties. With further refinement from psychometric testing, the ATTR-QOL will provide a standard, comprehensive measure for all ATTR-specific research including both clinical trials and clinical practice.

Content Validation of the Movement Disorder-Childhood Rating Scale (MD-CRS) for Dyskinetic Cerebral Palsy.

BACKGROUND: Dyskinetic cerebral palsy (DCP), a lifelong neurological disorder beginning in early childhood, manifests with hyperkinetic movements and dystonia. The Movement Disorder-Childhood Rating Scale (MD-CRS) is a clinician-reported outcome measure assessing the intensity of movement disorders and their effect on daily life in pediatric patients. Content validity of clinical outcome assessments is key to accurately capturing patient perspective. Evidence demonstrating content validity of the MD-CRS in patients with DCP is needed. This study captures input from patients with DCP and their caregivers regarding the content validity of the MD-CRS. METHODS: This qualitative, noninterventional, cross-sectional study included interviews with children/adolescents (aged six to 18 years) with DCP and caregivers of children with DCP. Participants were asked to describe body regions and daily functions affected by DCP. Caregivers also reviewed MD-CRS Part I to evaluate the relevance of the items and corresponding response options. Descriptions of DCP were coded and mapped to MD-CRS items and response options. Caregiver feedback on MD-CRS Part I was analyzed using inductive content analysis. RESULTS: Eight patients and 12 caregivers were interviewed. Participants confirmed that the body regions and activities listed in the MD-CRS were affected by DCP and that involuntary movements interfered with all motor, oral/verbal, self-care, and video protocol activities. Caregivers endorsed the response options for 12 of 15 items in MD-CRS Part I and suggested clarifications for others. CONCLUSIONS: Participants confirmed that affected body regions and activities listed in the MD-CRS were relevant to their experience with DCP, demonstrating the content validity of this tool in children/adolescents with DCP.

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.

Pediatric Palliative Care Education Model in Low Resource Settings: A Mixed-Methods Evaluation.

CONTEXT: Globally, approximately 21.6 million children need pediatric palliative care (PPC). The greatest burden lies in low- and middle-income countries, where the demand for PPC exceeds available resources. OBJECTIVES: The objective of this study was to assess the impact of a PPC workshop on healthcare providers' self-efficacy, comfort and confidence related to the provision of PPC in a Bhutanese referral-level hospital. METHODS: This mixed-methods study included a one-and-a-half day PPC workshop with surveys administered to participants at three time points (before, immediately after, and six months after the workshop) to evaluate changes in self-efficacy, comfort and confidence. The study was conducted in January 2017 with healthcare providers at the Jigme Dorji Wangchuck National Referral Hospital in Thimphu, Bhutan. RESULTS: Forty-one providers participated in the workshop; 38 completed the post-workshop survey and 27 completed the six months post-workshop survey. Results showed statistically significant increases in comfort levels from pre- to post-workshop surveys across nearly all areas. Qualitative results supported these findings. CONCLUSION: The results of this study suggest that a short, interactive and interdisciplinary workshop, originally designed for the United States setting but adapted to a low resource context, is an effective way to improve providers' self-efficacy, comfort and confidence in the provision of PPC in resource-limited settings.

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.

An awareness-raising framework for global health networks: lessons learned from a qualitative case study in respectful maternity care.

BACKGROUND: The increase in global health networks as mechanisms for improving health and affecting social change has been recognized as a key component of the global health landscape today. To successfully raise awareness of shared causes, global health networks need tools to help them plan successful campaigns and evaluate the impact of their work, as well as to coordinate and reinforce each other's efforts. One global health network, the Respectful Maternity Care (RMC) Global Council, can be credited with raising the profile of the issues of disrespect and abuse (D&A) in childbirth and the need for RMC within global maternal health. We set out to learn from the work of the RMC Global Council and the RMC movement at large to develop a tool-a framework for planning and evaluating awareness-raising efforts-useful for networks focused on global health and human rights. METHODS: We reviewed the literature for theoretical models on awareness raising and, finding a lack of appropriate tools, developed a new, draft framework using components of the Framework for Effective Campaigns, the SpitFire SmartChart 3.0, and Network Theory. We conducted semi-structured interviews with members of the RMC Global Council to validate the draft framework and identify any additional strategies or tactics that were used during their efforts to raise awareness of D&A and RMC. We also interviewed "influenced" individuals to validate inputs from the influencers and determine the key documents, events, individuals, and organizations that made the greatest contribution to the increased awareness of D&A/RMC. Data were analyzed using deductive and inductive qualitative research methods. RESULTS: The validated awareness-raising framework includes five strategies that characterize a successful awareness-raising effort. Each strategy has a set of tactics that can operationalize those strategies. Each tactic is classified as essential, helpful, or variable based on the number of key informants who utilized it. CONCLUSION: This case study offers an example of how global health networks can create a movement that effects change at global and local levels by providing an empirically-grounded framework to help plan, coordinate, and evaluate future campaigns designed to raise awareness and create momentum in global health, human rights, and quality of care.

Ending preventable maternal mortality: phase II of a multi-step process to develop a monitoring framework, 2016-2030.

BACKGROUND: In February 2015, the World Health Organization (WHO) released "Strategies toward ending preventable maternal mortality (EPMM)" (EPMM Strategies), a direction-setting report outlining global targets and strategies for reducing maternal mortality in the Sustainable Development Goal (SDG) period. In May 2015, the EPMM Working Group outlined a plan to develop a comprehensive monitoring framework to track progress toward the achievement of these targets and priorities. This monitoring framework was developed in two phases. Phase I, which focused on identifying indicators related to the proximal causes of maternal mortality, was completed in October 2015. This paper describes the process and results of Phase II, which was completed in November 2016 and aimed to build consensus on a set of indicators that capture information on the social, political, and economic determinants of maternal health and mortality. FINDINGS: A total of 150 experts from more than 78 organizations worldwide participated in this second phase of the process to develop a comprehensive monitoring framework for EPMM. The experts considered a total of 118 indicators grouped into the 11 key themes outlined in the EPMM report, ultimately reaching consensus on a set of 25 indicators, five equity stratifiers, and one transparency stratifier. CONCLUSION: The indicators identified in Phase II will be used along with the Phase I indicators to monitor progress towards ending preventable maternal deaths. Together, they provide a means for monitoring not only the essential clinical interventions needed to save lives but also the equally important political, social, economic and health system determinants of maternal health and survival. These distal factors are essential to creating the enabling environment and high-performing health systems needed to ensure high-quality clinical care at the point of service for every woman, her fetus and newborn. They complement and support other monitoring efforts, in particular the "Survive, Thrive, and Transform" agenda laid out by the Global Strategy for Women's, Children's and Adolescents' Health (2016-2030) and the SDG3 global target on maternal mortality.

Exploring perceptions of group antenatal Care in Urban India: results of a feasibility study.

BACKGROUND: Making high-quality health care available to all women during pregnancy is a critical strategy for improving perinatal outcomes for mothers and babies everywhere. Research from high-income countries suggests that antenatal care delivered in a group may be an effective way to improve the provision, experiences, and outcomes of care for pregnant women and newborns. A number of researchers and programmers are adapting group antenatal care (ANC) models for use in low- and middle-income countries (LMIC), but the evidence base from these settings is limited and no studies to date have assessed the feasibility and acceptability of group ANC in India. METHODS: We adapted a "generic" model of group antenatal care developed through a systematic scoping review of the existing evidence on group ANC in LMICs for use in an urban setting in India, after looking at local, national and global guidelines to tailor the model content. We demonstrated one session of the model to physicians, auxiliary nurse midwives, administrators, pregnant women, and support persons from three different types of health facilities in Vadodara, India and used qualitative methods to gather and analyze feedback from participants on the perceived feasibility and acceptability of the model. RESULTS: Providers and recipients of care expressed support and enthusiasm for the model and offered specific feedback on its components: physical assessment, active learning, and social support. In general, after witnessing a demonstration of the model, both groups of participants-providers and beneficiaries-saw group ANC as a vehicle for delivering more comprehensive ANC services, improving experiences of care, empowering women to become more active partners and participants in their care, and potentially addressing some current health system challenges. CONCLUSION: This study suggests that introducing group ANC would be feasible and acceptable to stakeholders from various care delivery settings, including an urban primary health clinic, a community-based mother and child health center, and a private hospital, in urban India.

Group antenatal care models in low- and middle-income countries: a systematic evidence synthesis.

In high-income countries, group antenatal care (ANC) offers an alternative to individual care and is associated with improved attendance, client satisfaction, and health outcomes for pregnant women and newborns. In low- and middle-income country (LMIC) settings, this model could be adapted to address low antenatal care uptake and improve quality. However, evidence on key attributes of a group care model for low-resource settings remains scant. We conducted a systematic review of the published literature on models of group antenatal care in LMICs to identify attributes that may increase the relevance, acceptability and effectiveness of group ANC in such settings. We systematically searched five databases and conducted hand and reference searches. We also conducted key informant interviews with researchers and program implementers who have introduced group antenatal care models in LMICs. Using a pre-defined evidence summary template, we extracted evidence on key attributes-like session content and frequency, and group composition and organization-of group care models introduced across LMIC settings. Our systematic literature review identified nine unique descriptions of group antenatal care models. We supplemented this information with evidence from 10 key informant interviews. We synthesized evidence from these 19 data sources to identify attributes of group care models for pregnant women that appeared consistently across all of them. We considered these components that are fundamental to the delivery of group antenatal care. We also identified attributes that need to be tailored to the context in which they are implemented to meet local standards for comprehensive ANC, for example, the number of sessions and the session content. We compiled these attributes to codify a composite "generic" model of group antenatal care for adaptation and implementation in LMIC settings. With this combination of standard and flexible components, group antenatal care, a service delivery alternative that has been successfully introduced and implemented in high-income country settings, can be adapted for improving provision and experiences of care for pregnant women in LMIC. Any conclusions about the benefits of this model for women, babies, and health systems in LMICs, however, must be based on robust evaluations of group antenatal care programs in those settings.