Humanistic Impact Research Articles

The IMPACT Survey: the humanistic impact of osteogenesis imperfecta in adults

BackgroundThe IMPACT Survey explored the humanistic, clinical, and economic burden of osteogenesis imperfecta (OI) on individuals with OI, their families, caregivers, and wider society. Two previous publications report research methodology, initial insights of the survey, and cost of illness of OI. Here, we present data on the impact of OI on the quality of life (QoL) of adults with OI and explore potential drivers of this impact.MethodsThe IMPACT Survey was an international mixed methods online survey in eight languages (fielded July–September 2021), aimed at adults (aged ≥ 18 years) or adolescents (aged 12–17 years) with OI, caregivers (with or without OI) of individuals with OI, and other close relatives. Survey domains included demographics, socioeconomic factors, clinical characteristics, treatment patterns, QoL, and health economics. We conducted a descriptive analysis of the QoL data, as well as exploratory regression analyses to identify drivers of impact of OI on QoL (independent associations between patient characteristics and the impact on QoL).Results1,440 adults with OI participated in the survey. The proportion who reported an impact of OI on their QoL across individual areas in the physical, socioeconomic, and mental well-being domains ranged between 49 and 84%. For instance, 84% of adults reported an impact of OI on the types of leisure activities they could do and 74% on the type of job they could do. More severe self-reported OI and higher fracture frequency were consistently identified as drivers of OI’s impact on QoL. The proportion of adults who reported worrying about different aspects of their lives due to their OI, such as mobility loss, future fractures, and ageing, ranged between 31 and 97%.ConclusionIMPACT provides insights into the humanistic burden of OI on adults, revealing that OI has a substantial impact on the QoL of adults. OI severity and fracture frequency were consistently identified as drivers of impact on QoL across all domains. Understanding these drivers may aid in identifying areas for targeted interventions, such as fracture prevention.

The IMPACT Survey: the economic impact of osteogenesis imperfecta in adults

BackgroundThe IMPACT survey aimed to elucidate the humanistic, clinical and economic burden of osteogenesis imperfecta (OI) on individuals with OI, their families, caregivers and wider society. Research methodology, demographics and initial insights from the survey have been previously reported. The cost of illness (healthcare resource use, productivity loss, out-of-pocket spending) and drivers of the economic impact of OI are reported here.MethodsIMPACT was an international mixed-methods online survey in eight languages (fielded July–September 2021) targeting adults (aged ≥ 18 years) or adolescents (aged ≥ 12–17 years) with OI, caregivers with or without OI and other close relatives. Survey domains included demographics, socioeconomic factors, clinical characteristics, treatment patterns, quality of life and health economics. The health economic domain for adults, which included questions on healthcare resource use, productivity loss and out-of-pocket spending, was summarised. Regression and pairwise analyses were conducted to identify independent drivers and associations with respondent characteristics.ResultsOverall, 1,440 adults with OI responded to the survey. Respondents were mostly female (70%) and from Europe (63%) with a median age of 43 years. Within a 12-month period, adults with OI reported visiting a wide range of healthcare professionals. Two-thirds (66%) of adults visited a hospital, and one-third (33%) visited the emergency department. The mean total number of diagnostic tests undergone by adults within these 12 months was 8.0. Adults had undergone a mean total of 11.8 surgeries up to the time point of the survey. The proportions of adults using queried consumables or services over 12 months ranged from 18–82%, depending on the type of consumable or service. Most adults (58%) were in paid employment, of which nearly one-third (29%) reported missing a workday. Of the queried expenses, the mean total out-of-pocket spending in 4 weeks was €191. Respondent characteristics such as female sex, more severe self-reported OI and the experience of fractures were often associated with increased economic burden.ConclusionIMPACT provides novel insights into the substantial cost of illness associated with OI on individuals, healthcare systems and society at large. Future analyses will provide insights into country-specific economic impact, humanistic impact and the healthcare journey of individuals with OI.

Abstract PO4-10-06: Cost-effectiveness analysis of ribociclib in the treatment for premenopausal or perimenopausal women with HR+/HER2− advanced breast cancer: a public health care system perspective in Mexico

Abstract BACKGROUND: Ribociclib (RIB) an inhibitor of cyclin-dependent kinase 4 and 6 for the treatment of advanced breast cancer (ABC), has demonstrated significant efficacy in prolonging progression-free survival and overall survival when added to endocrine therapy (ET). Because of the high-cost perception of this therapeutic class, it is crucial to assess their relative value compared to existing standards of care in the local setting. Chemotherapy is used as the first line of treatment in a conservative case in almost three-quarters of ABC patients with positive hormone receptors in the Public Health System in Mexico. Additionally, the high use of chemotherapy presents additional clinical and economic challenges for the Institute. Among the clinical challenges, the toxicity associated with chemotherapy regimens stands out. We evaluated the cost-effectiveness of the inclusion of RIB+ ET to usual care in the treatment of premenopausal or perimenopausal ABC from the perspective of the Public Health System in Mexico. Direct medical costs were considered. METHODS: We developed a partitioned survival model to simulate time to cancer progression and to compare lifetime clinical benefit and cost of standard alternative treatment strategies for patients with metastatic disease. Per approved indication, endocrine treatment-naive patients were assigned to RI plus ET or usual care (different chemotherapy schemes). Costs in Mexican Pesos (MXN) were estimated from the perspective of the Public Health System in Mexico. Costs and clinical benefits were discounted at 5% annually. The model assumptions were informed based on published clinical trial data from the randomized Phase III MONALEESA-7 trial and other peer-reviewed studies and indirect treatment comparisons. We carried out one-way and probabilistic sensitivity analyses to assess the robustness of our results to the changes in model assumptions. RESULTS: Ribociclib reduced monthly direct medical costs associated with the administration of breast cancer treatment and the management of adverse events. Direct drug acquisition costs per month of ribociclib were in the range of the cost of current available and used therapies. Indirect treatment comparisons did not show statistical significance of the benefit of ribociclib vs. standard of care, primarily due to heterogeneity leading to a mixed evaluation vs. two comparator groups according to the statistical significance of the survival improvement. Ribociclib is a 100% oral therapy with a manageable safety profile with dosage adjustments, so it does not require institutional resources for its administration or for managing adverse events. Its consolidated cost at 28 days of treatment is up to 40% less than combined chemotherapy regimens and up to 30% less than monotherapy schemes. Average cost-effectiveness for progression-free survival for ribociclib is among the lowest considering chemotherapy options even though generic versions are available for many of them. For the comparators with comparable efficacy, ribociclib was cost-saving at current public market prices. For the comparators where ribociclib showed a significant benefit, the incremental cost-effectiveness ratio of ribociclib vs. standard of care is also below the threshold of 3 GDPs per capita vs. most options, leading to cost-effectiveness. A longer treatment duration due to progression delay was a main driver of incremental cost. CONCLUSIONS: Ribociclib is cost-saving or cost-effective vs. standard of care in the Public Health System in Mexico. Other variables must be considered to inform clinical and funding decisions, such as disease burden and humanistic impact on this young, economically active population. Citation Format: Saúl Campos-Gomez, Christian Pichardo Piña. Cost-effectiveness analysis of ribociclib in the treatment for premenopausal or perimenopausal women with HR+/HER2− advanced breast cancer: a public health care system perspective in Mexico [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-10-06.

HSD42 The Humanistic Impact of X-Linked Retinitis Pigmentosa (XLRP): Results from the Explore Xlrp-2 Retrospective Chart Review and Cross-Sectional Survey of Patients and Caregivers in 10 Countries

HSD42 The Humanistic Impact of X-Linked Retinitis Pigmentosa (XLRP): Results from the Explore Xlrp-2 Retrospective Chart Review and Cross-Sectional Survey of Patients and Caregivers in 10 Countries

Development and Psychometric Validation of the 27 Item Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD-27).

Caring for an individual with Alzheimer's disease (AD) is an allencompassing challenge that affects daily life. Assessment of the care partner experience is needed to support the development and evaluation of successful interventions for people with AD and their care partners. We developed the 27-item Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD-27) to assess the impact of informal caregiving in the context of AD. We assessed the psychometric validity of the ZCI-AD-27 in a population of care partners for individuals with moderate AD, and established thresholds for meaningful score change. Secondary data were obtained from informal care partners of participants in a clinical trial (NCT01677754). Psychometric analyses were conducted to assess validity, reliability, and responsiveness of the ZCI-AD-27. Anchor-based and distribution-based methods were performed to determine clinically meaningful score change. The ZCI-AD-27 had a 12-domain factor structure, including a second-order domain termed Humanistic impact that included four key domains (Physical, Emotional, Social, and Daily life) as confirmed by confirmatory factor analysis with the adequate fit. Internal consistency (Cronbach's alpha ranging from 0.66 to 0.93 for domains), convergent validity, and discriminant validity indicated the good performance of the ZCI-AD-27. Known-groups validity analyses showed a greater impact on care partners with increasing disease severity. Responsiveness results demonstrated that the ZCI-AD- 27 is sensitive to change over time and meaningful change analyses indicated a range of meaningful score changes in this population. The ZCI-AD-27 is a comprehensive, psychometrically valid measure to assess the impact of caring for individuals with moderate AD.

Experience of Daily Life with Generalized Myasthenia Gravis: A Qualitative Investigation and Assessment of Instrument Content Validity.

Generalized myasthenia gravis (gMG) is a rare autoimmune disease. Symptoms of gMG are diverse, and understanding of their impact on patients is limited. This qualitative study aimed to provide an in-depth exploration of patients' daily experiences of gMG. Published qualitative studies were reviewed to identify the most important signs, symptoms, and functional impacts related to the patient experience in gMG. Semi-structured hybrid concept elicitation interviews (allowing spontaneous generation of disease concepts) and cognitive debriefing interviews (assessing the validity of existing disease assessments) were conducted with clinicians and adult patients with gMG. Signs, symptoms, and impacts were reviewed to understand which were most salient (i.e., reported by at least 50% of patients, with disturbance rating 5 or higher [10-point numeric scale]); concept saturation was also assessed. The disease conceptual model was updated. Existing clinical outcomes assessments (COAs) that capture how patients feel, function, and survive were assessed. Interviews with patients (n = 24) identified seven new signs and symptoms and 37 new impacts compared with the literature. Concept saturation was reached. Signs and symptoms identified by patients as most important (salient) were shortness of breath, general fatigue, muscle weakness of arms, legs, and neck, dysphonia, dysarthria, trouble swallowing liquids, choking, and heat sensitivity. Patient-identified salient impacts were worklife, depression, difficulty walking, grooming hair, showering, and brushing teeth, eating, personal relationships, family life, and participating in social activities. Clinicians considered ocular, respiratory, swallowing, speech/talking, and extremity function as key clinical manifestations of gMG. Patients and clinicians found clinical outcome assessments (COAs) to be conceptually relevant and comprehensive. This research provides a holistic understanding of gMG signs, symptoms, and impacts experienced by patients, as observed by patients and clinicians. The conceptual model of gMG highlights the range of signs, symptoms, and impacts that adult patients with gMG experience in their everyday lives, emphasizing the humanistic impact and unmet needs.

Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial

BackgroundInterdisciplinary collaboration between general practitioner, nurses and pharmacists can favour the control of patients treated with vitamin K antagonists (VKA), increasing their safety and effectiveness. The aim of the study was to evaluate the impact of pharmaceutical interventions on patients treated with VKA within the framework of a Pharmacotherapeutic Follow-up service on clinical, economic and humanistic outcomes. MethodsControlled and randomized study in patients from two health areas of Zaragoza in treatment with VKA with Time in Therapeutic Range (TTR) according to the Rosendaal method less than 70% in the last 6 months. Patients were recruited at the pharmacy and assigned to two groups: control and intervention. A Pharmacotherapeutic Follow-up Program was established for the intervention group for 6 months. The outcome variables were INR stability, pharmacological adherence, vitamin K intake, knowledge about the use of acenocoumarol, quality of life, satisfaction with treatment, associated costs and avoided costs. A descriptive analysis was performed, and the Students' T test or Mann-Whitney U test was used for the association between quantitative variables and Chi-square or Fisher's test for qualitative variables. ResultsA total of 123 patients were included, 65 in the intervention group (IG) and 58 in the control group (CG). A total of 108 interventions were conducted (1.7 interventions/patient) and the most common were those related to the proper taking of medications (41.0%). In IG, TTR (p = 0.019), adherence to treatment (p = 0.038) and knowledge about acenocoumarol (p = 0.031) improved, compared to CG. A higher proportion of patients in IG achieved a TTR>65% (p = 0.024). In addition, patients whose interventions were accepted by the physician (p = 0.027) and those who received vitamin K optimization interventions (p = 0.003) achieved TTR>65% in greater proportion. ConclusionsCommunity pharmacist medication review, in collaboration with general practitioners improve knowledge and adherence of patients treated with oral anti-vitamin K agents and enhances the achievement of their therapeutic INR ranges. Investment needed to achieve this clinical impact is low and patient satisfaction is high. Trial registrationThis study has been registered with Clinical Trials.gov dated 25/05/2017: NCT03154489.

The economic burden and quality of life of patients with psoriasis treated with biologics in China

BackgroundAlthough biologics improve the quality of life of psoriasis patients, they also impose a substantial economic burden. There is a lack of research addressing the economic and humanistic impact of biologics in China.ObjectiveThis cross-sectional investigation aims to assess the economic cost, quality of life, and patient satisfaction among individuals with psoriasis treated with biologics and non-biologics.MethodsFrom July 2021 to December 2022, eligible patients with psoriasis were recruited through both on-site and online questionnaire completion. The questionnaires collected sociodemographic data, clinical characteristics of psoriasis, economic costs associated with treatment, and the Dermatological Life Quality Index (DLQI).Results481 patients with a mean age of 40.8 ± 13.4 years old were included and classified into a non-biologic (n = 195) and biologic (n = 286) treatment group. The direct medical cost for non-biologics patients was 7,249 CNY, accounting for 70.0% of the total cost, while biologics patients incurred 15,176 CNY, making up 94.3% of the total cost. The non-biologic group had higher costs related to hospitalization, self-purchase of drugs, and indirect costs than the biologic treatment group. Additionally, DLQI scores were higher in the non-biologic group.ConclusionPatients in the biologic group experienced a higher economic burden and better quality of life than those in the non-biologic group.

SECURE EXISTENCE OF SOCIAL SYSTEMS IN A TURBULENT WORLD: AXIOLOGICAL CONTEXT

The value guidelines of the society’s secure existence under conditions of increasing global instability are determined. The stabilizing role of social solidarity in the functioning of modern social systems is revealed. The axiological essence and significance of social justice for reducing the level of conflict in the existence of social formations is analyzed. The humanistic impact of democratic values on the progressive development of social systems is substantiated.

Clinical, Economic, and Humanistic Impact of Short-Bowel Syndrome/Chronic Intestinal Failure in Portugal (PARENTERAL Study)

Introduction: This study aimed to assess the clinical, economic, and humanistic impact of short-bowel syndrome/chronic intestinal failure (SBS/CIF) in Portugal. Methods: This is a retrospective multicenter cohort chart review study, with a cross-sectional component for quality-of-life (QoL) evaluation. Inclusion criteria comprised patients with SBS/CIF, aged ≥1 year, with stable parenteral nutrition (PN). Data collection included patient chart review over a 12-month period and patient/caregiver self-report and SF-36/PedsQL™ questionnaires. Main endpoints comprised clinical and PN characterization, healthcare resource use (HRU), direct costs, and patient QoL. Results: Thirty-one patients were included (11 adults and 20 children). Patients’ mean age (standard deviation [SD]) was 57.9 (14.3) years in adults and 7.5 (5.0) years in children, with a mean time since diagnosis of 10.2 (5.9) and 6.6 (4.2) years, respectively. PN was administered for a mean of 5.2 and 6.6 days/week in adults and children, respectively; home PN occurred in 81.8% of adults and 90.0% of children for a mean of 9.6 and 10.8 months/year, respectively. The mean annual number of hospitalizations was 1.9 and 2.0 which lasted for a mean of 34.0 and 29.4 days in adults and children, respectively. Twenty-one and forty hospitalization episodes were reported in adults and children, respectively, of which 71.4% and 85.0% were due to catheter-related complications. Mean annual direct costs per patient amounted to 47,857.53 EUR in adults and 74,734.50 EUR in children, with PN and hospitalizations as the main cost-drivers. QoL assessment showed a clinically significant impaired physical component in adults and a notable deterioration in the school functioning domain in children. Conclusion: In Portugal, SBS/CIF patient management is characterized by a substantial therapeutic burden and HRU, translating into high direct costs and a substantial impairment of the adults’ physical function and children’s school functioning.

Clinical and humanistic impact of pharmacotherapeutic follow-up in patients with type 1 diabetes mellitus treated judicially

BackgroundThere is a lack of studies that assess the effectiveness of pharmacotherapeutic follow-up in the context of the judicialization of insulin analogues.AimsTo evaluate the clinical and humanistic impact of pharmacotherapeutic follow-up in patients with type 1 diabetes mellitus who receive insulin analogues by judicial decision in a Brazilian municipality.MethodsA quasi-experimental study of the before-and-after type was carried out through pharmacotherapeutic follow-up. Patients who accepted to participate in the study underwent laboratory tests of glycemic and lipid profile before and after the intervention, and underwent five pharmaceutical consultations. In addition, quality of life and health, knowledge, and skills related to insulin application techniques were analyzed.Results28 patients participated in all stages. Of these, most were female (53.6%), with a mean age of 32.8 ± 11.6 years. After the intervention, there was a reduction in blood glucose levels, blood pressure, and increased body mass index. In addition, there was greater knowledge and skills regarding insulin application techniques, improved quality of life, health, greater number of medications used, reduction of pharmacotherapeutic problems, and improvement in eating habits.ConclusionThe pharmacotherapeutic follow-up promoted clinical and humanistic benefits, with improvement in quality of life and health.

What Matters to Patients with Alzheimer’s Disease and Their Care Partners? Implications for Understanding the Value of Future Interventions

Alzheimer’s Disease (AD) is the most common cause of dementia. Recent thinking portrays AD as a continuum consisting of three stages: an asymptomatic preclinical period, a mild cognitive impairment phase, and dementia, which can be further classified as mild, moderate or severe. While many studies explore the cognitive and functional aspects of AD, fully understanding AD pathophysiology, as well as the potential value of pharmacological and psycho-social interventions, requires a deeper understanding of patient and care partner priorities, particularly in the early stages where such interventions may have the greatest impact in slowing or delaying progression. Available studies highlight a diverse range of patient and care partner priorities, including impacts on their emotions, moods, and social lives. These priorities have not been systematically incorporated in the clinical and value assessments of potential interventions. We propose approaches to better understand the humanistic impact of AD including conducting additional research into the impacts of interventions from the point of view of patients and care partners, expanding notions of ‘value’ and improving health system capacity for diagnosis.

Cost-effectiveness of ribociclib for premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer: a Brazilian public health care system perspective.

The MONALEESA-7 trial compared ribociclib plus endocrine therapy (ET) with placebo as first-line treatment of advanced luminal/HER2-negative breast cancer (ABC) in premenopausal and perimenopausal women (age <50 years) and showed significant benefits to progression-free survival and overall survival. This study aimed to compare the cost-effectiveness of ribociclib + ET versus ET alone in patients with ABC from the perspective of the Brazilian public national health system. We calculated the incremental cost-effectiveness ratio (ICER) using a Markov model with progression-free survival, post-progression survival, and death states. We expressed ICER as incremental costs per progression-free life-year (PFLY) and quality-adjusted life-year (QALY) gained in a 10-year time horizon. We used parametric survival distributions fit to MONALEESA-7 data to generate survival distributions for progression-free and post-progression survival. The largest British preference study in breast cancer served as the basis to estimate health-state utilities. We estimated direct costs (ABC treatment, follow-up, monitoring, and adverse events) using Brazilian-specific values from public sources. An expert consensus panel determined the resource patterns required. We applied annual discounts of 5% to costs and QALYs. Ribociclib + ET resulted in an incremental gain of 1.03 PFLYs and 0.80 QALYs at a cost of $37,319.31. The ICER of ribociclib + ET versus ET was $36,379.41 per PFLY gained and $46,590.79 per QALY gained. In deterministic sensitivity analysis, results were primarily affected by the annual discount rate, followed by the cost of ribociclib. In probabilistic sensitivity analysis, simulations agreed with the base-case. Ribociclib increased PFLYs and QALYs in patients with HR+/HER2- ABC when added to ET. Because Brazil does not have a formally defined cost-effectiveness threshold, other domains need to be considered for incorporation decisions, such as disease burden and humanistic impact on this young, economically active population. These findings may be useful in discussions for incorporation of ribociclib into the Brazilian public health system.

POSA268 Economic and Humanistic Impact of Vasospasm-Related Complications Following Aneurysmal Subarachnoid Hemorrhage; Results of a Systematic Literature Review

Cerebral vasospasm (VSP) is the main risk factor of neurological deterioration (i.e., delayed cerebral ischemia [DCI] and cerebral infarction [CI]) after initial aneurysmal subarachnoid hemorrhage (aSAH) and a cause of mortality and morbidity. To identify and present the economic and humanistic burden of VSP-related complications following aSAH. PRISMA guidelines were followed. Systematic searches were conducted in MEDLINE and EMBASE (January 2021) to identify studies published in English presenting economic outcomes and/or humanistic (quality of life [QoL]) for patients with VSP (asymptomatic and symptomatic) following aSAH. Related conferences and additional sources (HTA databases, clinical trial registries) were manually searched. Dual screening, data extraction and qualitative analysis was conducted. Of 3818 studies identified, 40 met inclusion criteria and were selected. Majority of included studies were retrospective analyses or chart reviews based in US single-center hospitals. Economic outcomes were reported in 32 studies (up to 2 years follow up). 10 studies presented humanistic outcomes (up to 12 years follow up). A consistent finding across the studies was the significantly higher economic burden (hospital-care-resource-use [HCRU], hospital costs) for patients with symptomatic VSP vs patients without, after the first aSAH episode and following subsequent re-admissions (p<0.05). Patients with DCI were less likely to retain their independence at 3 months and return to full employment 24 months after aSAH. Symptomatic VSP was also strongly related to depressed mood and poor QoL at 1 year which seems to persist over the long-term (up to 5 years). There was a persistent effect of VSP severity on greater HRCU [5 extra days], requirement for care, institutionalisation, worst QoL at 3 months and hospital costs over time. A substantial direct and indirect economic burden is linked to VSP-related complications. Although limited evidence was identified for humanistic outcomes, these patients tend to suffer from poor QoL with long-lasting burden.

Will Africans take COVID-19 vaccination?

The economic and humanistic impact of COVID-19 pandemic is enormous globally. No definitive treatment exists, hence accelerated development and approval of COVID-19 vaccines, offers a unique opportunity for COVID-19 prevention and control. Vaccine hesitancy may limit the success of vaccine distribution in Africa, therefore we assessed the potentials for coronavirus vaccine hesitancy and its determinants among Africans. An online cross-sectional African-wide survey was administered in Arabic, English, and French languages. Questions on demographics, self-reported health status, vaccine literacy, knowledge and perception on vaccines, past experience, behavior, infection risk, willingness to receive and affordability of the SARS-COV-2 vaccine were asked. Data were subjected to descriptive and inferential statistics. A total of 5,416 individuals completed the survey. Approximately, 94% were residents of 34 African countries while the other Africans live in the Diaspora. Only 63% of all participants surveyed were willing to receive the COVID-19 vaccination as soon as possible and 79% were worried about its side effects. Thirty-nine percent expressed concerns of vaccine-associated infection. The odds of vaccine hesitancy was 0.28 (95% CI: 0.22, 0.30) among those who believed their risk of infection was very high, compared to those who believed otherwise. The odds of vaccine hesitancy was one-fifth (OR = 0.21, 95% CI: 0.16, 0.28) among those who believed their risk of falling sick was very high, compared to those who believed their risk of falling very sick was very low. The OR of vaccine hesitancy was 2.72 (95% CI: 2.24, 3.31) among those who have previously refused a vaccine for themselves or their child compared to counterparts with no self-reported history of vaccine hesitancy. Participants want the vaccines to be mandatory (40%), provided free of charge (78%) and distributed in homes and offices (44%). COVID-19 vaccine hesitancy is substantial among Africans based on perceived risk of coronavirus infection and past experiences.

What impact does medicines shortages have on patients? A qualitative study exploring patients\u2019 experience and views of healthcare professionals

BackgroundThe shortage of medicines represents a complex global phenomenon that triggers patient care and safety issues. The study was undertaken to explore the impact of medicines shortages on patients in Pakistan. The study also identified barriers which hinder the solutions of medicines shortages issue.MethodsA qualitative study design was adopted and the data was collected in stages between July and September 2019using an in-depth interview approach. The purposive and convenient sampling strategy was used to recruit the study participants. Sample size was limited by using the saturation point criteria. All interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis.ResultsA total of 35 stakeholders including 13 physicians, 12 pharmacists and 10 patients participated in the study. The findings of the study were classified into five key themes and seven subthemes. The five themes included, ‘impact of medicine shortages on patients’, ‘patients’ practices in response to medicine shortages’, ‘influence of medicines shortages on medical practice or pharmaceutical business’, ‘barriers to solutions for medicines shortages’, and ‘suggestions to assuage the impact of medicine shortages.’This study showed that the medicine shortages had significant clinical and financial impact on patients. Patients’ opted for a number of risk-prone practices to avoid treatment disruption during shortages. An array of pharmaceutical market, medicines quality and patient related factors refrain physicians to switch from brand name medicine to generics and lead to ineffective management of medicines shortages. Promotion of generic prescription, implementation of punitive policies and proper patient consultation was advised to assuage the impact of medicine shortages on patients.ConclusionThe adverse clinical, economic and humanistic impact affirmed in this study demand the introduction of risk-management strategies for medicines shortages in hospital and community settings in accordance with the international standards. Promotion of effective patient counselling by the healthcare professionals to deter risk-prone practices associated with medicines shortages is mandatory.

Pediatric Family-Centered Rounds and Humanism: A Systematic Review and Qualitative Meta-analysis.

Pediatric family-centered rounds (FCRs) have been shown to have benefits in staff satisfaction, teaching, and rounding efficiency, but no systematic review has been conducted to explicitly examine the humanistic impact of FCRs. The objective with this review is to determine if FCRs promote the core values of humanism in medicine by answering the question, "Do FCRs promote humanistic pediatric care?" Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a search of PubMed, Web of Science, Cumulative Index of Nursing and Allied Health Literature, and Dissertation Abstracts for peer-reviewed pediatric studies through January 1, 2020. We used search terms including FCRs, communication, humanism, and the specific descriptors in the Gold Foundation's definition of humanism. Abstracts (n = 1003) were assessed for 5 primary outcomes: empathy, enhanced communication, partnership, respect, and satisfaction and service. We evaluated 158 full-text articles for inclusion, reconciling discrepancies through an iterative process. Data abstraction, thematic analysis, and conceptual synthesis were conducted on 29 studies. Pediatric family-centered rounds (FCRs) improved humanistic outcomes within all 5 identified themes. Not all studies revealed improvement within every category. The humanistic benefits of FCRs are enhanced through interventions targeted toward provider-family barriers, such as health literacy. Patients with limited English proficiency or disabilities or who were receiving intensive care gained additional benefits. Pediatric FCRs promote humanistic outcomes including increased empathy, partnership, respect, service, and communication. Limitations included difficulty in defining humanism, variable implementation, and inconsistent reporting of humanistic outcomes. Future efforts should include highlighting FCR's humanistic benefits, universal implementation, and adapting FCRs to pandemics such as coronavirus disease 2019.

A Systematic Literature Review of the Humanistic Burden of COPD.

BackgroundChronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, causing substantial economic and social burden.ObjectiveThis review assessed the patient-reported humanistic burden associated with moderate to very severe COPD, specifically the impact on health-related quality of life (HRQoL), symptoms, limitations in daily life, and emotional implications, through the use of HRQoL instruments.MethodsA systematic review was conducted to retrieve relevant clinical data from published literature using a representative sample of countries where healthcare systems provide wide availability of COPD medications and/or universal coverage includes respiratory medicines (Australia, Canada, China, France, Germany, Italy, Spain, the UK, and the USA). The primary inclusion criteria were patients with moderate to very severe COPD. HRQoL was quantified with non-disease-specific and disease-specific questionnaires.ResultsIn total, 82 studies from 95 publications presented HRQoL data from patients with moderate to very severe COPD. Patient-reported HRQoL declined with worsening airflow limitation, advancing GOLD group, and increasing exacerbation frequency. Both increasing frequency of hospitalization for COPD exacerbations and recurrent hospitalization adversely impacted HRQoL. Comorbidity incidence was higher in patients with increased airflow limitation. It was associated with a further decline in HRQoL and increased depression and anxiety, particularly as disease-associated pain worsened. Physical activity improved HRQoL over time.ConclusionThis review highlighted the impact of exacerbations and associated hospitalizations on the humanistic burden of COPD. These findings underline the importance of managing COPD actively, including prompt and appropriate use of pharmacological and non-pharmacological therapies that can improve symptoms and reduce the risk of exacerbations, thereby lessening the humanistic burden. Future reviews could consider a broader range of countries and publications to further assess the humanistic impact of COPD in low- and middle-income economies.

Will Africans Take COVID-19 Vaccination?

Background: The economic and humanistic impact of the COVID-19 pandemic has been tremendous globally, including in Africa. No definitive treatment exists yet. The accelerated development and approval of COVID-19 vaccines, therefore, offers a unique opportunity for the prevention and control of COVID-19. The extent to which vaccine hesitancy may limit the success of vaccine distribution is unclear. The objective of this study was to assess the potential coronavirus vaccine hesitancy, and explore the determinants of vaccine hesitancy among Africans.Methods: An online cross-sectional continent-wide (Africa), pretested questionnaire was administered in Arabic, English, and French languages among Africans. The questionnaire comprised questions on demographics of respondents, self-reported health status and literacy, knowledge and perception of vaccines, past experience and behavior, risk assessment of SARS-COV-2, and willingness to receive, voluntariness, and affordability of the SARS-COV-2 vaccine, and vaccine education and distribution. Data obtained were subjected to descriptive and inferential statistics.Results: A total of 5,416 individuals completed the survey. Approximately, 94% were residents of 34 African countries while the others were Africans living in the Diaspora. Only 62% of participants surveyed were willing to receive the COVID-19 vaccination. A total of 79% were worried about the side effects of the vaccine, and 39% actually expressed concerns that they might get infected by receiving the vaccine. The odds ratio (OR) of vaccine hesitancy was 0.28 (95% CI: 0.22, 0.30) among those who believed their risk of infection was very high, compared to those who believed their risk of infection was very low. The OR of vaccine hesitancy was 0.21 (95% CI: 0.16, 0.28) among those who believed their risk of falling very sick was very high, compared to those who believed their risk of falling very sick was very low. The OR of vaccine hesitancy was 2.72 (95% CI: 2.24, 3.31) among those who have previously refused a vaccine for themselves or their child compared to counterparts with no self-reported history of vaccine hesitancy. Many participants want the vaccines to be made mandatory (40%), provided free of charge (78%) and distributed at homes and offices (44%).Conclusion: COVID-19 vaccine hesitancy is substantial among Africans, and this is related to perceived risk of coronavirus infection and past experiences.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: Institutional review boards from Nigeria (University of Ilorin) and Egypt (Ahram Canadian University, Faculty of Oral and Dental Medicine) approved the study.

Medication-Related Needs and Humanistic Impact of Patient-Centered Pharmaceutical Care at University of Gondar Comprehensive Specialized Hospital, North-West Ethiopia.

PurposeTo assess patients’ medication-related needs and the humanistic impact of patient-centered pharmaceutical care.Patients and MethodsA hospital-based cross-sectional study was conducted using self-administered structured questionnaires from February 4 to 28, 2019, on patients attending ambulatory care for chronic non-communicable diseases at the University of Gondar specialized teaching hospital, North-west Ethiopia. Data were entered to SPSS version 22 for analysis. Descriptive statistics was used to describe the socio-demographic characteristics and medication-related needs of study participants. Independent sample t-test and one-way ANOVA analysis were performed to check for possible associations between dependent and independent variables.ResultsInformation about what to do if patients missed doses and the potential side-effects or abnormal conditions caused by the prescribed medicines were not explained for most of the 425 patients studied. The majority of the study participants reported that they felt worried about adverse medicine effects, drug interactions, and long-term medicine use. Patients who were older than 50 or those receiving two or more medications were less satisfied with the effect of their medicine as compared to younger ones and those on monotherapy, respectively. People who were illiterate or had attended only primary schools thought that they received less disease and medicine information from health professionals than people who attended tertiary education.Conclusion and RecommendationMost of the participants were particularly unhappy with the amount of information received about side-effects and what to do if doses were missed. Special emphasis should be given to patients with a low level of education as they were not satisfied with medicine and disease information obtained from health professionals, experienced more psychological impacts of medicine use, and had poor overall quality-of-life.