RESUMEN
BACKGROUND: Supported self-management can improve clinical and psychosocial outcomes in people with cancer; the considerations required to implement self-management support (SMS) for people living with a lower-grade glioma (LGG)-who often have complex support needs-are not known. We aimed to identify and understand these implementation considerations through the lens of normalisation process theory (NPT), from the perspectives of healthcare professionals (HCP) and people with LGG. METHODS: We conducted semistructured interviews with HCPs who support adults with brain tumours (n = 25; 12 different healthcare professions), and people with LGG who had completed primary treatment (n = 28; male n = 16, mean age 54.6 years, mean time since diagnosis 8.7 years), from across the United Kingdom. Interviews were transcribed and inductive open coding conducted, before deductively mapping to constructs of NPT. We first mapped HCP data, then integrated data from people with LGG to explore alignment in experiences and perspectives. RESULTS: We generated supporting evidence for all four NPT constructs and related subconstructs, namely: 'Coherence', 'Cognitive participation', 'Collective action' and 'Reflexive monitoring'. Data from HCPs and people with LGG clearly demonstrated that effective SMS constitutes a collective activity. Key implementation considerations included: ensuring awareness of, and access to, support; building strong HCP-support recipient relationships; and careful inclusion of close family and friends. We identified pertinent challenges, such as identifying support needs (influenced by the extent to which those with LGG engage in help-seeking), resistance to support (e.g., technology literacy), training for HCPs and HCP cooperation. CONCLUSIONS: This study demonstrates the collective nature of, and provides insight into the individual roles within, supported self-management. We outline considerations to operationalise, sustain and appraise the implementation of SMS for people with LGG. PATIENT OR PUBLIC CONTRIBUTION: People with brain tumours, and informal caregivers, were involved in the development of information materials and topic guides to ensure accessibility and pertinence. They also had opportunities to comment on interview findings.
Asunto(s)
Neoplasias Encefálicas , Glioma , Entrevistas como Asunto , Automanejo , Humanos , Masculino , Persona de Mediana Edad , Femenino , Glioma/terapia , Glioma/psicología , Reino Unido , Neoplasias Encefálicas/terapia , Neoplasias Encefálicas/psicología , Adulto , Investigación Cualitativa , Personal de Salud/psicología , Apoyo Social , AncianoRESUMEN
Those closest to people with lower-grade gliomas (LGGs) often assume the role of informal caregiver (IC). The additional responsibilities mean ICs of people with cancer can experience adverse impacts on their own lives. We explored the emotional impact of informal caregiving for people with LGGs. This was a descriptive qualitative study within the multi-method Ways Ahead project. We conducted semi-structured interviews with individuals from the United Kingdom, who currently, or in the past 5 years, informally cared for someone with an LGG. Interviews encompassed experiences of emotional impact as a consequence of caregiving for someone with an LGG. Inductive thematic analysis was undertaken. We interviewed 19 ICs (mean age 54.6 years; 14 females, 5 males). Participants reported substantial emotional impact. Four themes and associated subthemes were generated: Emotional responses to the illness (e.g. feeling helpless), Emotional responses to the unknown (e.g. anxiety about future uncertainty), Emotional consequences of care recipient changes (e.g. challenges of changed relationship dynamics), and Emotional weight of the responsibility (e.g. feeling burnout). Emotional impact in one area often exacerbated impact in another (e.g. future uncertainty impacted feelings of helplessness). Participants detailed the factors that helped them manage the emotional impact (e.g. being resilient). ICs of people with LGGs can experience wide-ranging emotional responses to and impacts of the illness, uncertain prognosis, care recipient changes, and the toll of caregiving. Adjustment and resilience are key protective factors, though further consideration of ways to identify and fulfil the emotional support needs of ICs of people with LGGs is required.
Asunto(s)
Glioma , Resiliencia Psicológica , Masculino , Femenino , Humanos , Persona de Mediana Edad , Glioma/psicología , Emociones , Ansiedad , Cuidadores/psicologíaRESUMEN
PURPOSE: Low-grade glioma (LGG) patients may face health-related quality-of-life (HRQoL) impairments, due to the tumour, treatment and associated side-effects and prospects of progression. We systematically identified quantitative studies assessing HRQoL in adult LGG patients, for: aspects of HRQoL impacted; comparisons with non-cancer controls (NCC) and other groups; temporal trends; and factors associated with HRQoL. METHODS: MEDLINE, CINAHL, Embase, PubMed, and PsycINFO were systematically searched from inception to 14th September 2021. Following independent screening of titles and abstracts and full-texts, population and study characteristics, and HRQoL findings were abstracted from eligible papers, and quality appraised. Narrative synthesis was conducted. RESULTS: Twenty-nine papers reporting 22 studies (cross-sectional, n = 13; longitudinal, n = 9) were identified. Papers were largely good quality, though many excluded patients with cognitive and communication impairments. Comparators included high-grade gliomas (HGG) (n = 7); NCCs (n = 6) and other patient groups (n = 3). Nineteen factors, primarily treatment (n = 8), were examined for association with HRQoL. There was substantial heterogeneity in HRQoL instruments used, factors and aspects of HRQoL assessed and measurement timepoints. HRQoL, primarily cognitive functioning and fatigue, in adult LGG patients is poor, and worse than in NCCs, though better than in HGG patients. Over time, HRQoL remained low, but stable. Epilepsy/seizure burden was most consistently associated with worse HRQoL. CONCLUSION: LGG patients experience wide-ranging HRQoL impairments. HRQoL in those with cognitive and communication impairments requires further investigation. These findings may help clinicians recognise current supportive care needs and inform types and timings of support needed, as well as inform future interventions.
Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Glioma , Humanos , Adulto , Estudios Transversales , Calidad de Vida/psicología , CogniciónRESUMEN
BACKGROUND: The Health Economics Research Centre (HERC) Database of Mapping Studies was established in 2013, based on a systematic review of studies developing mapping algorithms predicting EQ-5D. The Mapping onto Preference-based measures reporting Standards (MAPS) statement was published in 2015 to improve reporting of mapping studies. We aimed to update the systematic review and assess the extent to which recently-published studies mapping condition-specific quality of life or clinical measures to the EQ-5D follow the guidelines published in the MAPS Reporting Statement. METHODS: A published systematic review was updated using the original inclusion criteria to include studies published by December 2016. We included studies reporting novel algorithms mapping from any clinical measure or patient-reported quality of life measure to either the EQ-5D-3L or EQ-5D-5L. Titles and abstracts of all identified studies and the full text of papers published in 2016 were assessed against the MAPS checklist. RESULTS: The systematic review identified 144 mapping studies reporting 190 algorithms mapping from 110 different source instruments to EQ-5D. Of the 17 studies published in 2016, nine (53%) had titles that followed the MAPS statement guidance, although only two (12%) had abstracts that fully addressed all MAPS items. When the full text of these papers was assessed against the complete MAPS checklist, only two studies (12%) were found to fulfil or partly fulfil all criteria. Of the 141 papers (across all years) that included abstracts, the items on the MAPS statement checklist that were fulfilled by the largest number of studies comprised having a structured abstract (95%) and describing target instruments (91%) and source instruments (88%). CONCLUSIONS: The number of published mapping studies continues to increase. Our updated database provides a convenient way to identify mapping studies for use in cost-utility analysis. Most recent studies do not fully address all items on the MAPS checklist.
Asunto(s)
Lista de Verificación/normas , Bases de Datos Factuales/normas , Evaluación de Resultado en la Atención de Salud/normas , Calidad de Vida , Encuestas y Cuestionarios/normas , Algoritmos , Análisis Costo-Beneficio , Guías como Asunto , HumanosRESUMEN
Background: Quantitative studies show people living with a lower-grade glioma (LGG) often report low health-related quality of life. However, it is unclear how this impact is experienced; resulting supportive care needs are also poorly understood. We explored how people experience the impact of living long-term with an LGG, to help identify potential supportive care needs. Methods: We conducted semi-structured interviews with a diverse group of people with LGG (nâ =â 28) across the United Kingdom, who had completed primary treatment (male nâ =â 16, female nâ =â 12, mean age 54.6 years, mean time since diagnosis 8.7 years). Interviews were transcribed and inductive thematic analysis was conducted. Results: Four themes relating to the impact experiences of people with LGG were generated: "Emotional response to the diagnosis," "Living with the 'What ifs'," "Changing relationships," and "Faltering independence." These reflect participants' experiences with symptoms (eg, fatigue, seizures) and impairments (eg, motor dysfunction, cognitive deficits), and how these, in turn, drive impacts on daily living (including on work, relationships, social activities, and transport). Participants spoke about their experiences with profound emotion throughout. Conclusions: People with LGG can experience wide-ranging everyday impacts and may have extensive supportive care needs. This study highlights how this impact is experienced and what it means to people with LGG. Best practice suggestions for conducting comprehensive needs assessments tailored to those with LGG, and the development of personalized plans to meet those needs, would be a critical step to ensure that people with LGG are best supported in living with their condition.
RESUMEN
PURPOSE: Self-management can have clinical and quality-of-life benefits. However, people with lower-grade gliomas (LGG) may face chronic tumour- and/or treatment-related symptoms and impairments (e.g. cognitive deficits, seizures), which could influence their ability to self-manage. Our study aimed to identify and understand the barriers and facilitators to self-management in people with LGG. METHODS: We conducted semi-structured interviews with 28 people with LGG across the United Kingdom, who had completed primary treatment. Sixteen participants were male, mean age was 50.4 years, and mean time since diagnosis was 8.7 years. Interviews were audio-recorded and transcribed. Following inductive open coding, we deductively mapped codes to Schulman-Green et al.'s framework of factors influencing self-management, developed in chronic illness. RESULTS: Data suggested extensive support for all five framework categories ('Personal/lifestyle characteristics', 'Health status', 'Resources', 'Environmental characteristics', 'Healthcare system'), encompassing all 18 factors influencing self-management. How people with LGG experience many of these factors appears somewhat distinct from other cancers; participants described multiple, often co-occurring, challenges, primarily with knowledge and acceptance of their incurable condition, the impact of seizures and cognitive deficits, transport difficulties, and access to (in)formal support. Several factors were on a continuum, for example, sufficient knowledge was a facilitator, whereas lack thereof, was a barrier to self-management. CONCLUSIONS: People with LGG described distinctive experiences with wide-ranging factors influencing their ability to self-manage. IMPLICATIONS FOR CANCER SURVIVORS: These findings will improve awareness of the potential challenges faced by people with LGG around self-management and inform development of self-management interventions for this population.
RESUMEN
OBJECTIVES: This study aimed to explore the work experiences of people living with an oligodendroglioma. DESIGN: This was a descriptive qualitative study. One-time semi-structured interviews exploring supportive care needs were conducted; work was discussed at various points throughout each interview. An inductive thematic analysis was undertaken. SETTING: Participants were recruited across the UK through four National Health Service hospitals and the Brain Tumour Charity research involvement networks. PARTICIPANTS: 19 people with grade 2 or 3 oligodendroglioma (mean age 52 years; male n=11). At diagnosis, 16 participants were working, 2 studying and 1 retired. At the interview (mean time since diagnosis 9.6 years; range 1-18 years), seven participants were working, eight retired (four on medical grounds) and four unable to work due to illness. RESULTS: Seven themes were constructed: (1) physical and cognitive limitations; (2) work ability and productivity; (3) work accommodations; (4) changing roles; (5) attitudes of clients and coworkers; (6) feelings and ambitions; and (7) financial implications. Fatigue, seizures and cognitive deficits influenced work ability. A stressful work environment could exacerbate symptoms. Changes in job roles and work environment were often required. Employer and coworker support were integral to positive experiences. Work changes could result in financial stress and strain. CONCLUSIONS: This study has highlighted, for the first time, influences on work experiences in this understudied population. These findings have implications for clinicians and employers, when considering the importance of work in rehabilitation for people with oligodendrogliomas, and the individually assessed adjustments required to accommodate them, should employment be desired.
Asunto(s)
Oligodendroglioma , Humanos , Masculino , Persona de Mediana Edad , Medicina Estatal , Empleo/psicología , Investigación Cualitativa , JubilaciónRESUMEN
PURPOSE: Lower-grade gliomas (LGG) are mostly diagnosed in working-aged adults and rarely cured. LGG patients may face chronic impairments (e.g. fatigue, cognitive deficits). Self-management can improve clinical and psychosocial outcomes, yet how LGG patients self-manage the consequences of their tumour and its treatment is not fully understood. This study, therefore, aimed to identify and understand how LGG patients engage in the self-management of their condition. METHODS: A diverse group of 28 LGG patients (age range 22-69 years; male n = 16, female n = 12; mean time since diagnosis = 8.7 years) who had completed primary treatment, were recruited from across the United Kingdom. Semi-structured interviews were conducted. Informed by a self-management strategy framework developed in cancer, directed content analysis identified and categorised self-management types and strategies used by patients. RESULTS: Overall, 20 self-management strategy types, comprising 123 self-management strategies were reported; each participant detailed extensive engagement in self-management. The most used strategy types were 'using support' (n = 28), 'creating a healthy environment' (n = 28), 'meaning making' (n = 27), and 'self-monitoring' (n = 27). The most used strategies were 'accepting the tumour and its consequences' (n = 26), 'receiving support from friends (n = 24) and family' (n = 24), and 'reinterpreting negative consequences' (n = 24). CONCLUSIONS: This study provides a comprehensive understanding of the strategies used by LGG patients to self-manage their health and wellbeing, with a diverse, and substantial number of self-management strategies reported. IMPLICATIONS FOR CANCER SURVIVORS: The findings will inform the development of a supported self-management intervention for LGG patients, which will be novel for this patient group.
RESUMEN
Self-management can improve clinical and psychosocial outcomes in cancer survivors. Which intervention characteristics and components are beneficial is unclear, hindering implementation into practice. We systematically searched six databases from inception to 17 November 2021 for studies evaluating self-management interventions for adult cancer survivors post-treatment. Independent reviewers screened for eligibility. Data extraction included population and study characteristics, intervention characteristics (TIDieR) and components (PRISMS), (associations with) quality of life (QoL), self-efficacy, and economic outcomes. Study quality was appraised, and narrative synthesis was conducted. We identified 53 papers reporting 32 interventions. Studies had varying quality. They were most often randomised controlled trials (n = 20), targeted at survivors of breast (n = 10), prostate (n = 7), or mixed cancers (n = 11). Intervention characteristics (e.g., provider, location) varied considerably. On average, five (range 1-10) self-management components were delivered, mostly "Information about condition and its management" (n = 26). Twenty-two studies reported significant QoL improvements (6 also reported significant self-efficacy improvements); these were associated most consistently with combined individual and group delivery. Economic evaluations were limited and inconclusive. Self-management interventions showed promise for improving QoL, but study quality was variable, with substantial heterogeneity in intervention characteristics and components. By identifying what to adapt from existing interventions, these findings can inform development and implementation of self-management interventions in cancer.
RESUMEN
INTRODUCTION: Living with and beyond a diagnosis of a low- and intermediate-grade glioma (LIGG) can adversely impact many aspects of people's lives and their quality of life (QoL). In people with chronic conditions, self-management can improve QoL. This is especially true if people are supported to self-manage. Supported self-management programmes have been developed for several cancers, but the unique challenges experienced by LIGG survivors mean these programmes may not be readily transferable to this group. The Ways Ahead study aims to address this gap by exploring the needs of LIGG survivors to develop a prototype for a supported self-management programme tailored to this group. METHODS AND ANALYSIS: Ways Ahead will follow three sequential phases, underpinned by a systematic review of self-management interventions in cancer. In phase 1, qualitative methods will be used to explore and understand the issues faced by LIGG survivors, as well as the barriers and facilitators to self-management. Three sets of interviews will be conducted with LIGG survivors, their informal carers and professionals. Thematic analysis will be conducted with reference to the Theoretical Domains Framework and Normalisation Process Theory. Phase 2 will involve co-production workshops to generate ideas for the design of a supported self-management programme. Workshop outputs will be translated into a design specification for a prototype programme. Finally, phase 3 will involve a health economic assessment to examine the feasibility and benefits of incorporating the proposed programme into the current survivorship care pathway. This prototype will then be ready for testing in a subsequent trial. ETHICS AND DISSEMINATION: The study has been reviewed and approved by an National Health Service Research Ethics Committee (REC ref: 20/WA/0118). The findings will be disseminated through peer-reviewed journals, conference presentations, broadcast media, the study website, The Brain Tumour Charity and stakeholder engagement activities.
Asunto(s)
Glioma , Automanejo , Glioma/terapia , Humanos , Calidad de Vida , Proyectos de Investigación , Medicina Estatal , Revisiones Sistemáticas como AsuntoRESUMEN
Precision medicine is part of five focus areas of the Challenges in IBD research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and pragmatic clinical research. The Challenges in IBD Research document provides a comprehensive overview of current gaps in inflammatory bowel diseases (IBD) research and delivers actionable approaches to address them. It is the result of a multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient centric research prioritization. In particular, the precision medicine section is focused on highlighting the main gap areas that must be addressed to get closer to treatments tailored to the biological and clinical characteristics of each patient, which is the aim of precision medicine. The main gaps were identified in: 1) understanding and predicting the natural history of IBD: disease susceptibility, activity, and behavior; 2) predicting disease course and treatment response; and 3) optimizing current and developing new molecular technologies. Suggested approaches to bridge these gaps include prospective longitudinal cohort studies to identify and validate precision biomarkers for prognostication of disease course, and prediction and monitoring of treatment response. To achieve this, harmonization across studies is key as well as development of standardized methods and infrastructure. The implementation of state-of-the-art molecular technologies, systems biology and machine learning approaches for multi-omics and clinical data integration and analysis will be also fundamental. Finally, randomized biomarker-stratified trials will be critical to evaluate the clinical utility of validated signatures and biomarkers in improving patient outcomes and cost-effective care.
Asunto(s)
Biomarcadores/análisis , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/terapia , Medicina de Precisión , Biología de Sistemas/métodos , Progresión de la Enfermedad , Genómica , Humanos , Enfermedades Inflamatorias del Intestino/genéticaRESUMEN
The association between low family income and socio-emotional behaviour problems in early childhood has been well-documented, and maternal psychological distress is highlighted as central in mediating this relationship. However, whether this relationship holds for older children, and the precise mechanisms by which income may influence child behaviour is unclear. This study investigated the relationship between family income and child socio-emotional behaviour at 11 years of age, and examined the mediating role of maternal psychological distress over time using the UK Millennium Cohort Study. The primary outcome was parent-reported behavioural problems, as captured by the Total Difficulties Score (TDS), derived from the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes were the emotional, peer-related, conduct, and hyperactivity/inattention problems subscales of the SDQ; and teacher-reported TDS. Permanent family income was the primary exposure variable; frequency of poverty up to age 11 years was the secondary exposure variable. Maternal psychological distress was operationalised to reflect the trajectory from child birth to age 11. Multivariable logistic regression models were used to estimate the effect of permanent family income on child behaviour at age 11, controlling for maternal psychological distress and other relevant covariates. Results showed a statistically significant protective effect of increased permanent family income on the likelihood of behavioural problems at age 11. This finding was consistent for all SDQ subscales apart from emotional problems, and was strongest for teacher-reported behavioural problems. Maternal distress was an important mediator in the income-child behaviour relationship for parent-reported, but not teacher-reported, behavioural problems. The results of this study strengthen empirical evidence that the child behaviour-income gradient is maintained in older childhood. Mother's psychological distress, particularly longstanding or recurrent, appears to contribute to this relationship. These findings may validate calls for psychosocial and financial supports for families affected by parental mental health issues.
RESUMEN
OBJECTIVES: To quantify the costs, benefits and cost-effectiveness of three multipathogen point-of-care (POC) testing strategies for detecting common sexually transmitted infections (STIs) compared with standard laboratory testing. DESIGN: Modelling study. SETTING: Genitourinary medicine (GUM) services in England. POPULATION: A hypothetical cohort of 965 988 people, representing the annual number attending GUM services symptomatic of lower genitourinary tract infection. INTERVENTIONS: The decision tree model considered costs and reimbursement to GUM services associated with diagnosing and managing STIs. Three strategies using hypothetical point-of-care tests (POCTs) were compared with standard care (SC) using laboratory-based testing. The strategies were: A) dual POCT for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); B) triplex POCT for CT-NG and Mycoplasma genitalium (MG); C) quadruplex POCT for CT-NG-MG and Trichomonas vaginalis (TV). Data came from published literature and unpublished estimates. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes were total costs and benefits (quality-adjusted life years (QALYs)) for each strategy (2016 GB, £) and associated incremental cost-effectiveness ratios (ICERs) between each of the POC strategies and SC. Secondary outcomes were inappropriate treatment of STIs, onward STI transmission, pelvic inflammatory disease in women, time to cure and total attendances. RESULTS: In the base-case analysis, POC strategy C, a quadruplex POCT, was the most cost-effective relative to the other strategies, with an ICER of £36 585 per QALY gained compared with SC when using microcosting, and cost-savings of £26 451 382 when using tariff costing. POC strategy C also generated the most benefits, with 240 467 fewer clinic attendances, 808 fewer onward STI transmissions and 235 135 averted inappropriate treatments compared with SC. CONCLUSIONS: Many benefits can be achieved by using multipathogen POCTs to improve STI diagnosis and management. Further evidence is needed on the underlying prevalence of STIs and SC delivery in the UK to reduce uncertainty in economic analyses.
Asunto(s)
Técnicas de Laboratorio Clínico/economía , Costos de la Atención en Salud/estadística & datos numéricos , Sistemas de Atención de Punto/economía , Enfermedades de Transmisión Sexual/diagnóstico , Enfermedades de Transmisión Sexual/economía , Infecciones por Chlamydia/diagnóstico , Infecciones por Chlamydia/tratamiento farmacológico , Infecciones por Chlamydia/economía , Ahorro de Costo , Análisis Costo-Beneficio , Árboles de Decisión , Femenino , Gonorrea/diagnóstico , Gonorrea/tratamiento farmacológico , Gonorrea/economía , Humanos , Prescripción Inadecuada/economía , Modelos Económicos , Infecciones por Mycoplasma/diagnóstico , Infecciones por Mycoplasma/tratamiento farmacológico , Infecciones por Mycoplasma/economía , Años de Vida Ajustados por Calidad de Vida , Enfermedades de Transmisión Sexual/tratamiento farmacológico , Enfermedades de Transmisión Sexual/transmisión , Vaginitis por Trichomonas/diagnóstico , Vaginitis por Trichomonas/tratamiento farmacológico , Vaginitis por Trichomonas/economíaRESUMEN
OBJECTIVES: To undertake an economic analysis assessing the cost-effectiveness of a single dose of oral dexamethasone compared with placebo for the relief of sore throat. DESIGN: A UK-based, multicentre, two arm, individually randomised, double blind trial. SETTING AND POPULATION: Adults (≥18 years) with acute sore throat and painful swallowing judged to be infective in origin, recruited and randomised in primary care. INTERVENTION: a single dose of 10 mg oral dexamethasone compared with placebo given at primary care visit. MAIN OUTCOME: Incremental cost-effectiveness ratios (ICERs), cost per quality-adjusted symptom resolution using the EuroQol-five dimensions-five levels instrument, were estimated as part of a cost-utility analysis performed on an intention-to-treat cohort adopting a health payers perspective. RESULTS: Differences in health-related quality of life (HRQoL) over 7 days from baseline and at 24 hours in the dexamethasone compared with the placebo group (2.9% and 2.5% higher, respectively) were observed. After controlling for the baseline HRQoL imbalances, the economic impact of the intervention was not statistically significant: the quality-adjusted life year difference was -0.00005 (95% CI -0.0002 to 0.00011) equivalent to a loss in HRQoL of a half hour in the dexamethasone group. The average cost per patient associated in the dexamethasone and placebo groups in the basecase analysis was £73 and £69, respectively. In the basecase probabilistic analysis, the mean ICER was -£6440 (95% CI -£132 151 to £126 335) and the median ICER was -£304 (IQR-£5816 to £3877); suggesting considerable uncertainty. CONCLUSIONS AND RELEVANCE: The economic burden associated with sore throat is substantial and was estimated at £2.35 billion to the healthcare services payer based on reported resource use and 2015 UK unit costs. There is considerable uncertainty regarding the cost-effectiveness of a single dose of oral dexamethasone as a treatment strategy and therefore insufficient evidence to support its use in clinical practice. TRIAL REGISTRATION NUMBER: ISRCTN17435450; Post-results.
Asunto(s)
Antiinflamatorios , Dexametasona , Faringitis , Adolescente , Adulto , Anciano , Antiinflamatorios/administración & dosificación , Antiinflamatorios/economía , Análisis Costo-Beneficio , Dexametasona/administración & dosificación , Dexametasona/economía , Método Doble Ciego , Inglaterra , Femenino , Humanos , Masculino , Persona de Mediana Edad , Faringitis/tratamiento farmacológico , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Adulto JovenRESUMEN
BACKGROUND: Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). OBJECTIVES: To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. DESIGN: We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. SETTING: Five NHS hospitals in England. PARTICIPANTS: Men with unilateral, intermediate-risk, clinically localised PCa. INTERVENTIONS: Radical prostatectomy compared with HIFU. PRIMARY OUTCOME MEASURE: The randomisation of 80 men. SECONDARY OUTCOME MEASURES: Findings of the QRI and assessment of data capture methods. RESULTS: Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and 'tips' documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) - with University College Hospital failing to enrol any participants - than centres offering HIFU in the trial context only. CONCLUSIONS: Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted. FUTURE WORK: Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99760303. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 52. See the NIHR Journals Library website for further project information.
Asunto(s)
Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Proyectos de Investigación , Anciano , Análisis Costo-Beneficio , Inglaterra , Estudios de Factibilidad , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Satisfacción del Paciente , Estudios Prospectivos , Neoplasias de la Próstata/patología , Calidad de Vida , Ultrasonido Enfocado Transrectal de Alta Intensidad/métodosRESUMEN
PURPOSE: This study sought to test the acceptability and feasibility of a nurse-led psycho-educational intervention (NLPI) delivered in primary care to prostate cancer survivors, and to provide preliminary estimates of the effectiveness of the intervention. METHODS: Men who reported an ongoing problem with urinary, bowel, sexual or hormone-related functioning/vitality on a self-completion questionnaire were invited to participate. Participants were randomly assigned to the NLPI plus usual care, or to usual care alone. Recruitment and retention rates were assessed. Prostate-related quality of life, self-efficacy, unmet needs, and psychological morbidity were measured at baseline and 9 months. Health-care resource use data was also collected. An integrated qualitative study assessed experiences of the intervention. RESULTS: 61% eligible men (83/136) participated in the trial, with an 87% (72/83) completion rate. Interviews indicated that the intervention filled an important gap in care following treatment completion, helping men to self-manage, and improving their sense of well-being. However, only a small reduction in unmet needs and small improvement in self-efficacy was observed, and no difference in prostate-related quality of life or psychological morbidity. Patients receiving the NLPI recorded more primary care visits, while the usual care group recorded more secondary care visits. Most men (70%; (21/30)) felt the optimal time for the intervention was around the time of diagnosis/before the end of treatment. CONCLUSIONS: Findings suggest a nurse-led psycho-educational intervention in primary care is feasible, acceptable and potentially useful to prostate cancer survivors.
Asunto(s)
Supervivientes de Cáncer/educación , Supervivientes de Cáncer/psicología , Educación del Paciente como Asunto/métodos , Atención Primaria de Salud/métodos , Neoplasias de la Próstata/enfermería , Neoplasias de la Próstata/psicología , Calidad de Vida/psicología , Anciano , Inglaterra , Femenino , Humanos , Masculino , Persona de Mediana Edad , Rol de la Enfermera , Relaciones Enfermero-Paciente , Proyectos Piloto , Encuestas y CuestionariosRESUMEN
BACKGROUND: Malignant blood disorders are a leading contributor to cancer incidence and mortality across Europe. Despite their burden, no study has assessed the economic effect of blood cancers in Europe. We aimed to assess the economic burden of malignant blood disorders across the 28 countries in the European Union (EU), Iceland, Norway, and Switzerland. METHODS: Malignant blood disorder-related costs were estimated for 28 EU countries, Iceland, Norway, and Switzerland for 2012. Country-specific costs were estimated with aggregate data on morbidity, mortality, and health-care resource use obtained from international and national sources. Health-care costs were estimated from expenditure on primary, outpatient, emergency, inpatient care, and drugs. Costs of informal care and productivity losses due to morbidity and early death were also included. For countries in the EU, malignant blood disorders were compared with the economic burden of overall cancer. FINDINGS: Malignant blood disorders cost the 31 European countries 12 billion in 2012. Health-care cost 7·3 billion (62% of total costs), productivity losses cost 3·6 billion (30%), and informal care cost 1 billion (8%). For the EU countries, malignant blood disorders cost 6·8 billion (12%) of the total health-care expenditure on cancer (57 billion), with this proportion being second only to breast cancer. In terms of total cancer costs in the EU (143 billion), malignant blood disorders cost 12 billion (8%). INTERPRETATION: Malignant blood disorders represent a leading cause of death, health-care service use, and costs, not only to European health-care systems, but to society overall. Our results add to essential public health knowledge needed for effective national cancer-control planning and priorities for public research funding. FUNDING: European Hematology Association.
Asunto(s)
Costos y Análisis de Costo , Atención a la Salud/economía , Costos de la Atención en Salud/tendencias , Gastos en Salud/tendencias , Neoplasias Hematológicas/economía , Europa (Continente)/epidemiología , Neoplasias Hematológicas/epidemiología , Neoplasias Hematológicas/prevención & control , HumanosRESUMEN
BACKGROUND: Blood disorders comprise a wide range of diseases including anaemia, malignant blood disorders, and haemorrhagic disorders. Although they are a common cause of disease, no systematic cost-of-illness studies have been done to assess the economic effect of non-malignant blood disorders in Europe. We aimed to assess the economic burden of non-malignant blood disorders across the 28 countries of the European Union (EU), Iceland, Norway, and Switzerland. METHODS: Non-malignant blood disorder-related costs (WHO International Classification of Diseases, 10th revision [ICD] D50-89) were estimated for 28 EU countries, Iceland, Norway, and Switzerland for 2012. Country-specific costs were estimated with aggregate data on morbidity, mortality, and health-care resource use obtained from international and national sources. Health-care costs were estimated from expenditure on primary care, outpatient care, emergency care, hospital inpatient care, and drugs. Costs of informal care and productivity losses due to morbidity and early death were also included. To these costs we added those due to malignant blood disorders (ICD-10 C81-96 and D47) as estimated in a Burns and colleagues' companion Article to obtain the total costs of blood disorders. FINDINGS: Non-malignant disorders of the blood cost the 31 European countries 11 billion in 2012. Health-care costs accounted for 8 billion (75% of total costs), productivity losses for 2 billion (19%), and informal care for less than 1 billion (6%). Averaged across the European population studied, non-malignant disorders of the blood represented an annual health-care cost of 159 per ten citizens. Combining malignant and non-malignant blood disorders, the total cost of blood disorders was 23 billion in 2012. INTERPRETATION: Our study highlights the economic burden that non-malignant blood disorders place on European health-care systems and societies. Our study also shows that blood disorder costs were evenly distributed between malignant and non-malignant blood disorders. Our results should be of use to decision makers and research-funding authorities charged with allocating health-care resources and research funds. FUNDING: European Hematology Association.
Asunto(s)
Costos y Análisis de Costo , Atención a la Salud/economía , Costos de la Atención en Salud/tendencias , Gastos en Salud/tendencias , Enfermedades Hematológicas/economía , Europa (Continente)/epidemiología , Enfermedades Hematológicas/epidemiología , Enfermedades Hematológicas/prevención & control , HumanosRESUMEN
BACKGROUND: Prostate cancer (PCa), the most commonly diagnosed cancer among men in the United States and Europe, is an escalating resource allocation issue across healthcare systems in the Western world. The impact of skeletal-related events, associated with castration-resistant prostate cancer (CRPC), is considerable with many new therapies being sought to treat these events in a cost-effective manner. AIMS: The aim of this paper is to provide insight into the level of constraints associated with devising cost frameworks for economic analysis of CRPC in the Irish healthcare setting. METHODS: An informal questionnaire was devised to obtain estimates of utilisation to populate a decision tree model; existing parameters from the literature were also employed. Cost parameters included Irish reference costs, and a costs literature review was undertaken; a healthcare payer perspective was adopted. Pharmacy dosages used for modelling costs were calculated for an average 75 kg male. RESULTS: The estimated average cost of care associated with adverse events in CRPC was 23,264. Approximately 40% of the costs of CRPC are attributed to skeletal-related events; therefore, reducing the number of skeletal-related events could significantly reduce the cost of care. In attempting to generate accurate and reliable cost parameters, this study highlights the challenges of conducting economic analysis in the Irish healthcare setting. CONCLUSION: This study presents leading treatments and associated costs for CRPC patients in the Republic of Ireland (RoI), which are expected to steadily increase with demographic shifts. Further research is warranted in this area due to the limitations encountered in the study.
RESUMEN
OBJECTIVE: To investigate the effects of two monetary incentives on response rates to postal questionnaires from primary care physicians (PCPs). STUDY DESIGN AND SETTING: The PCPs were randomized into three arms (n=550 per arm), namely (1) 5 sent with the questionnaire (cash); (2) entry into a draw on return of completed questionnaire (prize); or (3) no incentive. Effects of incentives on response rates and item nonresponse were examined, as was cost-effectiveness. RESULTS: Response rates were significantly higher in the cash (66.1%; 95% confidence interval [CI]: 61.9, 70.4%) and prize arms (44.8%; 95% CI: 40.1, 49.3%) compared with the no-incentive arm (39.9%; 95% CI: 35.4, 44.3%). Adjusted relative risk of response was 1.17 (95% CI: 1.02, 1.35) and 1.68 (95% CI: 1.48, 1.91) in the prize and cash arms, respectively, compared with the no-incentive group. Costs per completed questionnaire were 9.85, 11.15, and 6.31 for the cash, prize, and no-incentive arms, respectively. Compared with the no-incentive arm, costs per additional questionnaire returned in the cash and prize arms were 14.72 and 37.20, respectively. CONCLUSION: Both a modest cash incentive and entry into a prize draw were effective in increasing response rates. The cash incentive was most effective and the most cost-effective. Where it is important to maximize response, a modest cash incentive may be cost-effective.