Bollington, United Kingdom
Bollington, United Kingdom

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Serpell M.,University of Glasgow | Gater A.,Adelphi Values | Carroll S.,Sanofi S.A. | Abetz-Webb L.,Adelphi Values | And 2 more authors.
Health and Quality of Life Outcomes | Year: 2014

Background: Post-herpetic neuralgia (PHN) is the most common complication of herpes zoster (shingles). As a chronic condition, PHN can have a substantial adverse impact on patients' lives. However, UK-specific data concerning the burden of PHN on individual patients, healthcare systems and wider society, are lacking. As the first UK-wide cross-sectional study of its kind, The Zoster Quality of Life (ZQOL) study was designed to address these concerns.Methods: Patients (n = 152) with a confirmed diagnosis of PHN (defined as pain persisting ≥ 3 months following rash onset) and aged ≥50 years were recruited from primary and secondary/tertiary care centres throughout the UK. All patients completed validated questionnaires, including the Zoster Brief Pain Inventory (ZBPI), the Medical Outcomes Study Short-Form 36 (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Treatment Satisfaction with Medication (TSQM) questionnaire. Where available, mean patient population scores on these questionnaires were compared to scores derived from age-matched normative samples to quantify the burden associated with PHN.Results: Despite numerous consultations with healthcare professionals and receiving multiple medications for the management of their PHN, the majority of patients reported being in pain 'most of the time' or 'all of the time'. A total of 59.9% (n = 91) of all PHN patients reported pain in the preceding 24 hours to assessment at levels (ZBPI worst pain ≥ 5) typically considered to have a significant impact on Health Related Quality of Life (HRQoL). Accordingly, scores for SF-36 and EQ-5D indicated significant deficits in HRQoL among PHN patients compared to age-matched norms (p < 0.05) and patients reported being dissatisfied with the perceived efficacy of therapies received for the management of PHN. Increased pain severity was observed among older participants and higher levels of pain severity were associated with greater HRQoL deficits.Conclusions: The inadequate relief provided by PHN therapies available in the UK is associated with a significant burden among PHN patients in terms of pain severity and deficits in HRQoL which may persist for years. Therefore, alternative means such as prevention of shingles and PHN, are essential for reducing the impact on individual patients, healthcare systems and society as a whole. © 2014 Serpell et al.; licensee BioMed Central Ltd.

Dunlop W.,Mundipharma International Ltd | Iqbal I.,Mundipharma International Ltd | Khan I.,University College London | Ouwens M.,Mapi HEOR | Heron L.,Adelphi Values
ClinicoEconomics and Outcomes Research | Year: 2013

Background: Assessing the cost-effectiveness of treatments in rheumatoid arthritis (RA) is of growing importance due to the chronic nature of the disease, rising treatment costs, and budget-constrained health care systems. This analysis assesses the cost-effectiveness of modified-release (MR) prednisone compared with immediate-release (IR) prednisone for the treatment of morning stiffness due to RA. Methods: A health state transition model was used to categorize RA patients into four health states, defined by duration of morning stiffness. The model applied a 1-year time horizon and adopted a UK National Health Service (NHS) perspective. Health benefits were measured in quality-adjusted life years (QALYs) and the final output was the incremental cost-effectiveness ratio (ICER). Efficacy data were derived from the CAPRA-1 (Circadian Administration of Prednisone in Rheumatoid Arthritis) study, drug costs from the British National Formulary (BNF), and utility data from a direct elicitation time-trade-off (TTO) study in the general population. Sensitivity analyses were conducted. Results: Mean treatment costs per patient were higher for MR-prednisone (£649.70) than for IR-prednisone (£46.54) for the duration of the model. However, the model generated an incremental QALY of 0.044 in favor of MR-prednisone which resulted in an ICER of £13,577. Deterministic sensitivity analyses did not lead to significant changes in the ICER. Probabilistic sensitivity analysis reported that MR-prednisone had an 84% probability of being cost-effective at a willingness-to-pay threshold of £30,000 per QALY. The model only considers drug costs and there was a lack of comparative long-term data for IR-prednisone. Furthermore, utility benefits were not captured in the clinical setting. Conclusion: This analysis demonstrates that, based on the CAPRA-1 trial and directly elicited public preference values, MR-prednisone is a cost-effective treatment option when compared with IR-prednisone for RA patients with morning stiffness over one year, according to commonly applied UK thresholds (£20,000-£30,000 per QALY). Further research into the costs of morning stiffness in RA is required. © 2013 Dunlop et al.

Gater A.,Adelphi Values | Uhart M.,Sanofi S.A. | McCool R.,Adelphi Values | Preaud E.,Sanofi S.A.
BMC Public Health | Year: 2015

Background: Herpes zoster (HZ) or "shingles" is common in persons aged 50 years or over. HZ is characterised by a painful dermatological rash which typically resolves in approximately one month. Persistent pain for months or years after rash onset, however, is a common complication of HZ; referred to as post-herpetic neuralgia (PHN). Both HZ and PHN have a significant impact on patients' lives, with considerable implications for healthcare systems and wider society. The aim of the present review is to provide comprehensive documentation and critical appraisal of published data concerning the humanistic, economic and societal burden of HZ in Europe. Methods: Systematic literature searches were conducted in Medline, EMBASE, PsycINFO, EconLit, HEED and CRD databases. Searches were conducted in July 2014 and restricted to articles published in the past 20 years. Articles were selected for full review by two independent researchers in accordance with predefined eligibility criteria. Results: From a review of 1619 abstracts, 53 eligible articles, were identified which reported data concerning healthcare resource use (n = 38), direct costs (n = 20), indirect costs (n = 16), total costs (n = 10) and impact on health-related quality of life (HRQoL) (n = 21). Findings highlight that PHN is associated with greater impairments in HRQoL and higher costs of management than HZ. For both HZ and PHN, pain severity is a significant predictor of impact on individuals, healthcare systems and society. While the incidence of HZ and PHN increase with age, age does not appear to be a key driver of overall costs for HZ and PHN. Specifically, while direct costs (e.g. GP, specialists, medications, hospitalisations) tend to be higher for older patients, indirect costs (e.g. work time missed) are higher for younger patients. Conclusions: Available evidence highlights that HZ and PHN result in significant humanistic and economic burden for patients, healthcare systems and wider societies. A tendency to focus upon healthcare resource use and the direct costs of management at the expense of other impacts (e.g. informal caregivers and formal social care) may result in an underestimation of the true burden of HZ and PHN. © 2015 Gater et al.; licensee BioMed Central.

Hall R.L.,Adelphi Values | Willgoss T.,Adelphi Values | Humphrey L.J.,Adelphi Values | Kongso J.H.,Novo Nordisk AS
Patient Preference and Adherence | Year: 2014

Background: Adherence to treatment is an important issue in chronic disease management and an indicator of patients' ability to self-manage their condition and treatment. Some drug-dispensing and drug-delivery devices have been designed to support patients' medication-taking behavior by including dose-memory and combined dose-memory and dose-reminder functions, which electronically store, and visually display dose-history information, enabling the patient to review, monitor, and/or be actively reminded about their medication doses. Purpose: This literature review explored the role and impact of these devices on patients' treatment adherence, confidence with, and self-management of their condition and treatment. Materials and methods: A search of MEDLINE, Embase, and PsycINFO was performed to identify articles published in English from 2003-2013 that studied the effect of devices with dose-memory and combined dose-memory and dose-reminder functions on treatment adherence and users' (patients, health care professionals [HCPs], and caregivers) confidence, self-management behavior, and attitudes. Results: The database searches yielded 940 abstracts from which 13 articles met the inclusion criteria and were retained. Devices with dose-memory and combined dose-memory and dose-reminder functions were found to improve self-reported and electronically monitored treatment adherence in chronic conditions such as asthma, diabetes, and HIV. The ability of the devices to provide dose-history information and active medication reminders was considered valuable in disease management by patients, caregivers, and HCPs. The devices were found to enhance patients' confidence in, and motivation to manage their medication and condition, and help reduce forgotten or incorrect medication dosing. Conclusion: The incorporation of dose-memory and combined dose-memory and dose-reminder functions in drug-delivery devices can improve patients' adherence, confidence, and self-management behavior. They can target non-intentional barriers to adherence and can provide a means of improving disease control and clinical outcomes, thereby offering clinical and economic value. This review highlights the importance of conducting further qualitative and quantitative research to further understand the value and impact of these types of devices on patients' long-term adherence to, and self-management of treatment. © 2014 Hall et al.

Humphrey L.,Adelphi Values | Kulich K.,Novartis | Deschaseaux C.,Novartis | Blackburn S.,Adelphi Values | And 2 more authors.
Health and Quality of Life Outcomes | Year: 2013

Background: A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver's life. Following initial development, the next stage was to evaluate caregivers' understanding of the questionnaire items and their conceptual relevance.Methods: To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a " think aloud" exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers' understanding, interpretation and the relevance of the instructions, items, response scales and recall period.Results: Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD = 10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period.Conclusions: The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample. © 2013 Humphrey et al.; licensee BioMed Central Ltd.

Bonner N.,Adelphi Values | Abetz L.,Adelphi Values | Meunier J.,Mapi Consultancy | Sikirica M.,Bayer AG | Mathai S.C.,Johns Hopkins University
Health and Quality of Life Outcomes | Year: 2013

Background: The Living with Pulmonary Hypertension questionnaire (LPH) was adapted from the Minnesota Living with Heart Failure Questionnaire for use in patients with pulmonary arterial hypertension (PAH). Study objectives were to confirm the face and content validity, to assess the structure and psychometric properties, and provide guidance for the interpretation of the LPH. Methods: A qualitative interview study was conducted with PAH patients in the US (n=12), Germany (n=14) and France (n=12) to evaluate the face and content validity of the LPH. Psychometric validation was performed using blinded data from a double blind, Phase III, clinical trial (n=196). Validation analyses were performed on baseline and week 12 (visit 6/last visit) data and included evaluation of: item response distributions, quality of completion, construct validity, reliability, clinical validity and responsiveness. Analyses to provide an estimation of the Minimal Important Difference (MID) for the LPH scores were performed. Results:Cognitive debriefing interviews with 38 PAH patients indicated that the most commonly reported PAH symptoms and impacts are covered by LPH items. Patients found the LPH questionnaire relevant and comprehensive to their experience. Some suggestions were made to enhance the face validity of the LPH. The content validity of the questionnaire was supported. Results of the psychometric validation analyses (n=190) indicated that the LPH Emotional and Physical scores met the criteria for convergent and discriminant validity; for the total score all but two items met the test for item convergent validity. Internal consistency reliability was demonstrated by Cronbach's alpha values of >0.70 for all LPH scores. The LPH Physical and Total scores discriminated between World Health Organisation (WHO) Functional classes and 6 Minute walk test distances, indicating clinical validity and were also responsive to change in clinical severity, as measured by change in WHO functional class and Borg CR 10 Scale. Further investigation is required to confirm the responsiveness of the Emotional score. Estimation of MID using distribution-based methods indicated a change of 3 points for the sub-scales and 7 for the total score to be clinically meaningful.Conclusion: The LPH is a valid and reliable instrument that meets FDA criteria. © 2013 Bonner et al.; licensee BioMed Central Ltd.

Philp I.,South Warwickshire Foundation National Health Service Trust | Brainin M.,Danube University Krems | Walker M.F.,University of Nottingham | Ward A.B.,Staffordshire University | And 3 more authors.
Journal of Stroke and Cerebrovascular Diseases | Year: 2013

Background: Long-term care for stroke survivors is fragmented and lacks an evidence-based, easy-to-use tool to identify persistent long-term problems among stroke survivors and streamline referral for treatment. We sought to develop a poststroke checklist (PSC) to help health care professionals identify poststroke problems amenable to treatment and subsequent referral. Methods: An instrument development team, supported by measurement experts, international stroke experts, and poststroke care stakeholders, was created to develop a long-term PSC. A list of long-term poststroke problem areas was generated by an international, multidisciplinary group of stroke experts, the Global Stroke Community Advisory Panel. Using Delphi methods, a consensus was reached on which problem areas on the list were most important and relevant to include in a PSC. The instrument development team concurrently created the actual checklist, which provided example language about how to ask about poststroke problem areas and linked patient responses to a specific referral process. Results: Eleven long-term poststroke problem areas were rated highly and consistently among stroke experts participating in the Delphi process (n = 12): secondary prevention, activities of daily living, mobility, spasticity, pain, incontinence, communication, mood, cognition, life after stroke, and relationship with caregiver. These problem areas were included in the long-term PSC. Conclusions: The PSC was developed to be a brief and easy-to-use tool, intended to facilitate a standardized approach for health care providers to identify long-term problems in stroke survivors and to facilitate appropriate referrals for treatment. © 2013 by National Stroke Association.

Morimoto .,Hyogo College of Medicine | Crawford B.,Adelphi Values | Wada K.,Adelphi Values | Ueda S.,University of Ryukyus
Journal of Cardiology | Year: 2015

Background: This study was designed to compare efficacy and safety among novel oral anticoagulants (NOACs), which have not been directly compared in randomized control trials to date. Method: We performed network meta-analyses of randomized control trials in preventing thromboembolic events and major bleeding in patients with atrial fibrillation. PubMed, Embase, and the Cochrane Database of Systematic Reviews for published studies and various registries of clinical trials for unpublished studies were searched for 2002-2013. All phase III randomized controlled trials (RCTs) of NOACs (apixaban, edoxaban, dabigatran, rivaroxaban), idraparinux, and ximelagatran were reviewed. Results: A systematic literature search identified nine phase III RCTs for primary analyses. The efficacy of each NOAC was similar with respect to our primary composite endpoint following adjustment for open label designs [odds ratios (ORs) versus vitamin K antagonists: apixaban 0.79; dabigatran 150 mg 0.77; edoxaban 60 mg 0.87; rivaroxaban 0.86] except for dabigatran 110 mg and edoxaban 30 mg. Apixaban and edoxaban 30 mg and 60 mg had significantly fewer major bleeding events than dabigatran 150 mg, ricvaroxaban, and vitamin K antagonists. All NOACs were similar in reducing secondary endpoints with the exception of dabigatran 110 mg and 150 mg which were associated with a significantly greater incidence of myocardial infarction compared to apixaban, edoxaban 60 mg, and rivaroxaban. Conclusions: Our indirect comparison with adjustment for study design suggests that the efficacy of the examined NOACs is similar across drugs, but that some differences in safety and risk of myocardial infarction exist, and that open label study designs appear to overestimate safety and treatment efficacy. Differences in study design should be taken into account in the interpretation of results from RCTs of NOACs. © 2015 Japanese College of Cardiology.

Kitchen H.,Adelphi Values | Rofail D.,Adelphi Values | Heron L.,Adelphi Values | Sacco P.,Novartis
Advances in Therapy | Year: 2012

Introduction: Nearly every individual with schizophrenia is affected by cognitive decline. The aim of this literature review was to: (a) describe the humanistic burden of cognitive impairment associated with schizophrenia (CIAS); (b) develop a conceptual model that depicts the signs and symptoms of CIAS along with key concepts important to patients; and (c) consider the adequacy of potential patient-reported outcome (PRO) instruments for assessing future treatments. Methods: The following electronic databases were searched for articles published between January 1999 and November 2009 related to CIAS and PROs, or cost of illness: Medline; Embase; PsycINFO; the Health Economic Evaluation Database; and the National Health Service Economic Evaluation Database and Health Technology Assessment databases at the Centre for Reviews and Dissemination, University of York. Results: The literature search revealed 3950 abstracts, of which 101 articles were reviewed in detail. Cognitive functions affected include memory, attention/concentration, problem solving, learning, executive function, processing speed, and social cognition. Cognitive impairment impacts the ability of individuals to carry out activities of daily living, work productively, function socially, and adhere to treatment. These effects have economic ramifications through increased direct and indirect costs associated with the treatment of schizophrenia. The literature revealed 39 PRO instruments that have been used to assess functioning. However, no single instrument captures all key concepts of importance to patients with schizophrenia. Conclusion: The significant burden from CIAS for patients and society has implications for designing future treatments and health strategies to improve functional outcomes. © 2012 Springer Healthcare.

Charlesworth B.,Adelphi Values | Pilling C.,Adelphi Values | Chadwick P.,Salford Royal Foundation Trust | Butcher M.,Northern Devon Healthcare Trust
ClinicoEconomics and Outcomes Research | Year: 2014

Background: Dressings are the mainstay of wound care management; however, adherence of the dressing to the wound or periwound skin is common and can lead to dressing-related pain and trauma. Dressing-related trauma is recognized as a clinical and economic burden to patients and health care providers. This study was conducted to garner expert opinion on clinical sequelae and resource use associated with dressing-related trauma in a UK setting. Methods: This was an exploratory study with two phases: qualitative pilot interviews with six wound care specialists to explore dressing-related trauma concepts, sequelae, and resource utilization; and online quantitative research with 30 wound care specialists to validate and quantify the concepts, sequelae, and resource utilization explored in the first phase of the study. Data were collected on mean health care professional time, material costs, pharmaceutical costs, and inpatient management per sequela occurrence until resolution. Data were analyzed to give total costs per sequela and concept occurrence. Results: The results demonstrate that dressing-related trauma is a clinically relevant concept. The main types of dressing-related trauma concepts included skin reactions, adherence to the wound, skin stripping, maceration, drying, and plugging of the wound. These were the foundation for a number of clinical sequelae, including wound enlargement, increased exudate, bleeding, infection, pain, itching/excoriation, edema, dermatitis, inflammation, and anxiety. Mean total costs range from £56 to £175 for the complete onward management of each occurrence of the six main concepts. Conclusion: These results provide insight into the hidden costs of dressing-related trauma in a UK setting. This research successfully conceptualized dressing-related trauma, identified associated clinical sequelae, and quantified resource utilization associated with a typical occurrence of each trauma concept. Further research is warranted into dressing-related trauma and the associated costs. © 2014 Charlesworth et al.

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