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1.
Trauma Violence Abuse ; 24(2): 1001-1015, 2023 04.
Article in English | MEDLINE | ID: mdl-35107333

ABSTRACT

It is well known that victims of intimate partner violence experience numerous barriers to leaving abusive relationships. For ethnic minority and immigrant women these barriers are significantly exacerbated. This metasynthesis explored barriers to help-seeking as experienced by Black, Asian, minority ethnic and immigrant women with experience of intimate partner violence. A review of worldwide literature published in English in peer-reviewed journals on this topic from 2000 to July 2020 produced 2597 relevant articles. After removing duplicates and applying the exclusion criteria, a total of 47 articles were selected for inclusion in the review. The synthesis found that these women faced additional barriers as a result of institutional racism, immigration laws, culture and religion, and issues of cultural competence, and lack of diversity within frontline services. Such barriers, from a range of formal and informal resources, services and other mechanisms of support, served to exacerbate feelings of fear, threat, isolation and powerlessness. The barriers were also further weaponised by perpetrators in order to extend their reign of terror and control. As a result, women were caught in a double-bind - stay in an abusive relationship or face further threats and consequences if they attempted to leave. Whilst our search criteria focused on barriers to help-seeking, many of the papers included in our synthesis also explored facilitators to help-seeking, which are included in our findings and overwhelmingly relate to informal support from females.


Subject(s)
Emigrants and Immigrants , Intimate Partner Violence , Spouse Abuse , Female , Humans , Minority Groups , Ethnicity , Qualitative Research
2.
J Interpers Violence ; 38(9-10): 6275-6297, 2023 05.
Article in English | MEDLINE | ID: mdl-36373601

ABSTRACT

Intimate partner violence causes significant, long-lasting harm to almost one-third (27%) of the world's population of women. Even when women leave abusive relationships, some men continue to exercise control over their ex-partners through psychological control, threats, violence, stalking, and other forms of harassment. In this qualitative study, 52 purposively sampled women who self-identified as victims or survivors of intimate partner violence (IPV) from male partners were interviewed. Data were analyzed with a theoretically informed thematic analysis, supported by Nvivo® software. We found that leaving a violent relationship was a long-term process fraught with difficulty and ongoing risks of psychological harm. The concept of Continuous Traumatic Stress (CTS), first developed to understand the impact of state-sponsored violence and war, was found to be a particularly useful tool for the analysis of the impact of post-separation abuse. Additionally, CTS encourages researchers and practitioners to think anew about resilience-centered approaches to improving protection and access to justice for female victims.


Subject(s)
Intimate Partner Violence , Stalking , Humans , Female , Male , Intimate Partner Violence/psychology , Violence , Qualitative Research , Employment
3.
Qual Health Res ; 30(1): 88-104, 2020 01.
Article in English | MEDLINE | ID: mdl-31729937

ABSTRACT

Coronary heart disease (CHD) has no cure, and patients with myocardial infarction are at high risk for further cardiac events. Health education is a key driver for patients' understanding and motivation for lifestyle change, but little is known about patients' experience of such education. In this review, we aimed to explore how patients with CHD experience health education and in particular risk communication. A total of 2,221 articles were identified through a systematic search in five databases. 40 articles were included and synthesized using thematic analysis. Findings show that both "what" was communicated, and "the way" it was communicated, had the potential to influence patients' engagement with lifestyle changes. Communication about the potential of lifestyle change to reduce future risk was largely missing causing uncertainty, anxiety, and, for some, disengagement with lifestyle change. Recommendations for ways to improve health education and risk communication are discussed to inform international practice.


Subject(s)
Communication , Coronary Disease/psychology , Patient Education as Topic , Physician-Patient Relations , Cardiovascular Diseases/psychology , Health Education , Humans , Life Style , Patients , Qualitative Research , Risk
4.
Int J Nurs Stud ; 86: 60-73, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29966826

ABSTRACT

BACKGROUND: Mechanical ventilation is a routine intervention for the critically ill but patients' experiences of this intervention are largely hidden from clinicians. A comprehensive understanding of Intensive Care Units survivors' accounts is required to provide health professionals with evidence about the patients' experience to deliver patient-centred care. OBJECTIVES: To synthesise qualitative findings from international studies to understand Intensive Care Unit survivors' experiences of mechanical ventilation, clarify the components of patient-centred care from the patient perspective and understand what can be done by health professionals to improve care processes. DESIGN: A meta-ethnography of qualitative evidence following ENTREQ recommendations for reporting systematic reviews. DATA SOURCES: Eight databases (MEDLINE, AMED, CINAHL, PsychINFO, Scopus, WileyOnline, PubMed Central, TRIP) were systematically searched using a piloted strategy described in a published protocol. Searches were completed on 31.8.16 and no date restrictions were placed. Searches were updated on 25.4.17. REVIEW METHODS: Two researchers independently reviewed studies against pre-determined inclusion criteria to assess their eligibility. Studies were included if they reported on the adult patient experience of mechanical ventilation and used qualitative data collection and analysis methods. All included studies were quality appraised. Participant quotes and concepts, described within the categories and themes of published studies, were extracted by one reviewer and coded by two reviewers. A process of constant comparison, which is central to meta-ethnography, facilitated the re-interpretation of data by a team of researchers to generate the final qualitative synthesis. The Enhancing Transparency in Reporting the Synthesis of Qualitative (ENTREQ) statement was used to ensure that all synthesis stages were comprehensively reported. RESULTS: Findings from 38 studies, with 608 participants, informed a patient-centred trajectory model; three overlapping stages; alienation, hidden work and recovery characterised the experiences of mechanical ventilation survivors. Health professionals could positively influence the patient experience by promoting 'trust' and being vigilant so that patients felt 'safe'. Care provision that promoted 'personalisation' helped participants to retain their identity as unique human beings. CONCLUSIONS: For the first time the pooling of qualitative findings from international studies, using meta-ethnography, has provided a patient-centred model of mechanical ventilation survivors' experiences of their care processes. Patients may actively engage or passively endure the treatment burden associated with mechanical ventilation.


Subject(s)
Critical Care , Respiration, Artificial/psychology , Survivors/psychology , Anthropology, Cultural , Humans
5.
Health Psychol Rev ; 12(4): 405-418, 2018 12.
Article in English | MEDLINE | ID: mdl-29932851

ABSTRACT

This article explores the potential of complex adaptive systems (CAS) theory to inform behaviour change research. A CAS describes a collection of heterogeneous agents interacting within a particular context, adapting to each other's actions. In practical terms, this implies that behaviour change is (1) socially and culturally situated; (2) highly sensitive to small baseline differences in individuals, groups, and intervention components; and (3) determined by multiple components interacting 'chaotically'. Two approaches to studying CAS are briefly reviewed. Agent-based modelling is a computer simulation technique that allows researchers to investigate 'what if' questions in a virtual environment. Applied qualitative research techniques, on the other hand, offer a way to examine what happens when an intervention is pursued in real-time, and to identify the sorts of rules and assumptions governing social action. Although these represent very different approaches to complexity, there may be scope for mixing these methods - for example, by grounding models in insights derived from qualitative fieldwork. Finally, I will argue that the concept of CAS offers one opportunity to gain a deepened understanding of health-related practices, and to examine the social psychological processes that produce health-promoting or damaging actions.


Subject(s)
Health Behavior , Health Promotion/methods , Cognition , Computer Simulation , Delivery of Health Care/organization & administration , Humans , Interpersonal Relations , Social Behavior , Social Networking
6.
Int J Environ Health Res ; 28(3): 293-305, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29699406

ABSTRACT

The objective of this review was to scope the literature on nature-based interventions that could be conducted in institutional settings where people reside full-time for care or rehabilitation purposes. Systematic searches were conducted across CINAHL, Medline, Criminal Justice Abstracts, PsycINFO, Scopus, Social Care Online and Cochrane CENTRAL. A total of 85 studies (reported in 86 articles) were included. Four intervention modalities were identified: Gardening/therapeutic horticulture; animal-assisted therapies; care farming and virtual reality-based simulations of natural environments. The interventions were conducted across a range of settings, including inpatient wards, care homes, prisons and women's shelters. Generally, favourable impacts were seen across intervention types, although the reported effects varied widely. There is a growing body of literature on nature-based interventions that could be applied to a variety of institutional settings. Within most intervention types, there is sufficient research data available to perform full systematic reviews. Recommendations for future systematic reviews are offered.


Subject(s)
Animal Assisted Therapy , Farms , Gardening , Virtual Reality Exposure Therapy , Hospitals , Humans , Laboratories , Nursing Homes , Prisons , Rehabilitation Centers
7.
Br J Health Psychol ; 22(4): 786-804, 2017 11.
Article in English | MEDLINE | ID: mdl-28628736

ABSTRACT

OBJECTIVES: To understand the perceived benefits and drawbacks of a mild cognitive impairment (MCI) diagnosis from the perspective of those living with the label. METHODS: Participants were included if they had recently (within 6 months) received a MCI diagnosis. We also recruited close family members to gain their perspectives. Each was interviewed separately with a semi-structured topic guide covering three areas: (1) experience of cognitive impairments and changes in the individual; (2) impact of cognitive impairment(s) on daily activities and social relationships; and (3) experience of the diagnosis process and living with the label. Transcribed interviews were stored in Nvivo® . Grounded theory procedures of memo writing, open coding, constant comparison, and focused coding were used to derive conceptual themes. RESULTS: Eighteen dyads were interviewed. The overarching themes surrounding diagnosis benefits and drawbacks were as follows: (1) emotional impact of the diagnosis; (2) practical benefits and limitations of the diagnosis, in terms of (a) understanding one's symptoms and (b) access to clinical support. Although participants were glad to have clinical support in place, they expressed frustration at the lack of clarity, and the lack of available treatments for MCI. Consequently, living with MCI can be characterized as an ambivalent experience. CONCLUSION: As a clinical label, MCI appears to have little explanatory power for people living with cognitive difficulties. Work is needed to clarify how clinicians and patients communicate about MCI, and how people can be helped to live well with the label. Despite an emerging body of prognostic studies, people with MCI are likely to continue living with significant uncertainty. Statement of contribution What is already known on this subject? Mild cognitive impairment is a state of cognitive decline between normal cognitive ageing and dementia. This clinical category has been an important domain of academic debate over recent years. From a clinical perspective, diagnosing MCI is a helpful way to enable communication between health professionals, and a diagnosis can be important for patients in need of support and education. However, diagnosis can be fraught with difficulties, while patients have reported significant uncertainty about the label. This study aimed to examine the perceived benefits and drawbacks of receiving a MCI diagnosis. What does this study add? The emotional impact of a MCI diagnosis is complex and raised conflicting and fluctuating emotions in our participants' accounts - most notably worry and relief. Participants were glad to have clinical support available to call on; however, they were frustrated at the lack of 'treatments' available for MCI and were often anxious to slow any cognitive decline down Health psychologists will have an important role to play in understanding and improving clinical communication about MCI.


Subject(s)
Alzheimer Disease/diagnosis , Cognitive Dysfunction/diagnosis , Diagnosis, Differential , Aged , Aged, 80 and over , Anxiety , Family , Female , Humans , Interviews as Topic , Male , Middle Aged , Qualitative Research
8.
Acta Haematol ; 136(1): 23-42, 2016.
Article in English | MEDLINE | ID: mdl-27160308

ABSTRACT

INTRODUCTION: Multiple studies show that transfusion independence (TI) in myelodysplastic syndrome (MDS) has a positive impact on overall survival (OS). To assess this, a systematic review and meta-analysis of the association between TI and OS in patients with MDS was conducted (PROSPERO ID: CRD42014007264). METHODS: Comprehensive searches of 5 key bibliographic databases were conducted and supplemented with additional search techniques. Included were studies that had recruited adults aged >18 years with MDS and had examined the impact of transfusion status on OS. RESULTS: Fifty-five studies (89 citations) were included. The vast majority reported a statistically significant hazard ratio (HR) for OS in favor of TI patients or in patients who acquired TI after treatment. A random-effects meta-analysis was conducted. Patients classed as TI at baseline showed a 59% decrease in the risk of death compared with transfusion-dependent (TD) patients [HR 0.41; 95% credible interval (CrI) 0.29-0.56], and this effect did not appear to interact significantly with illness severity (interaction coefficient HR 1.38; 95% CrI 0.62-3.41). A meta-analysis of studies where patients acquired TI was not possible, but those studies consistently reported a survival benefit for those who acquired TI. CONCLUSION: The findings revealed a 59% pooled reduction in mortality among TI patients when compared with TD patients.


Subject(s)
Blood Transfusion , Myelodysplastic Syndromes , Humans , Platelet Transfusion
9.
Eur Respir J ; 47(3): 751-68, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26846832

ABSTRACT

The aim of this review was to evaluate the clinical effectiveness of fractional exhaled nitric oxide (FeNO) measured in a clinical setting for the management of asthma in adults.13 electronic databases were searched and studies were selected against predefined inclusion criteria. Quality assessment was conducted using QUADAS-2. Class effect meta-analyses were performed.Six studies were included. Despite high levels of heterogeneity in multiple study characteristics, exploratory class effect meta-analyses were conducted. Four studies reported a wider definition of exacerbation rates (major or severe exacerbation) with a pooled rate ratio of 0.80 (95% CI 0.63-1.02). Two studies reported rates of severe exacerbations (requiring oral corticosteroid use) with a pooled rate ratio of 0.89 (95% CI 0.43-1.72). Inhaled corticosteroid use was reported by four studies, with a pooled standardised mean difference of -0.24 (95% CI -0.56-0.07). No statistically significant differences for health-related quality of life or asthma control were found.FeNO guided management showed no statistically significant benefit in terms of severe exacerbations or inhaled corticosteroid use, but showed a statistically significant reduction in exacerbations of any severity. However, further research is warranted to clearly define which management protocols (including cut-off points) offer best efficacy and which patient groups would benefit the most.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Anti-Asthmatic Agents/therapeutic use , Asthma/drug therapy , Nitric Oxide/analysis , Adult , Asthma/diagnosis , Biomarkers/analysis , Breath Tests , Disease Management , Disease Progression , Exhalation , Humans , Quality of Life , Randomized Controlled Trials as Topic
10.
Health Technol Assess ; 19(82): 1-330, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26484874

ABSTRACT

BACKGROUND: High fractions of exhaled nitric oxide (FeNO) in the breath of patients with symptoms of asthma are correlated with high levels of eosinophils and indicate that a patient is likely to respond to inhaled corticosteroids. This may have a role in the diagnosis and management of asthma. OBJECTIVE: To assess the diagnostic accuracy, clinical effectiveness and cost-effectiveness of the hand-held electrochemical devices NIOX MINO(®) (Aerocrine, Solna, Sweden), NIOX VERO(®) (Aerocrine) and NObreath(®) (Bedfont Scientific, Maidstone, UK) for the diagnosis and management of asthma. DATA SOURCES: Systematic searches were carried out between March 2013 and April 2013 from database inception. Databases searched included MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Science Citation Index Expanded and Conference Proceedings Citation Index - Science. Trial registers such as ClinicalTrials.gov and the metaRegister of Controlled Trials were also searched in March 2013. All searches were updated in September 2013. REVIEW METHODS: A rapid review was conducted to assess the equivalence of hand-held and chemiluminescent FeNO monitors. Systematic reviews of diagnostic accuracy and management efficacy were conducted. A systematic review of economic analyses was also conducted and two de novo health economic models were developed. All three reviews were undertaken according to robust high-quality methodology. RESULTS: The rapid review (27 studies) found varying levels of agreement between monitors (Bland-Altman 95% limits of agreement up to ±10 parts per billion), with better agreement at lower FeNO values. Correlation was good (generally r > 0.9). The diagnostic accuracy review identified 22 studies in adults (all ages) and four in children. No studies used NObreath or NIOX VERO and seven used NIOX MINO. Estimates of diagnostic accuracy varied widely. FeNO used in combination with another test altered diagnostic accuracy only slightly. High levels of heterogeneity precluded meta-analysis. Limited observations included that FeNO may be more reliable and useful as a rule-in than as a rule-out test; lower cut-off values in children and in smokers may be appropriate; and FeNO may be less reliable in the elderly. The management review identified five randomised controlled trials in adults, one in pregnant asthmatics and seven in children. Despite clinical heterogeneity, exacerbation rates were lower in all studies but not generally statistically significantly so. Effects on inhaled corticosteroid (ICS) use were inconsistent, possibly because of differences in management protocols, differential effectiveness in adults and children and differences in population severity. One UK diagnostic model and one management model were identified. Aerocrine also submitted diagnostic and management models. All had significant limitations including short time horizons and the selective use of efficacy evidence. The de novo diagnostic model suggested that the expected difference in quality-adjusted life-year (QALY) gains between diagnostic options is likely to be very small. Airway hyper-responsiveness by methacholine challenge test is expected to produce the greatest QALY gain but with an expected incremental cost-effectiveness ratio (ICER) compared with FeNO (NObreath) in combination with bronchodilator reversibility of £1.125M per QALY gained. All remaining options are expected to be dominated. The de novo management model indicates that the ICER of guidelines plus FeNO monitoring using NObreath compared with guidelines alone in children is expected to be approximately £45,200 per QALY gained. Within the adult subgroup, FeNO monitoring using NObreath compared with guidelines alone is expected to have an ICER of approximately £2100 per QALY gained. The results are particularly sensitive to assumptions regarding changes in ICS use over time, the number of nurse visits for FeNO monitoring and duration of effect. CONCLUSIONS: Limitations of the evidence base impose considerable uncertainty on all analyses. Equivalence of devices was assumed but not assured. Evidence for diagnosis is difficult to interpret in the context of inserting FeNO monitoring into a diagnostic pathway. Evidence for management is also inconclusive, but largely consistent with FeNO monitoring resulting in fewer exacerbations, with a small or zero reduction in ICS use in adults and a possible increased ICS use in children or patients with more severe asthma. It is unclear which specific management protocol is likely to be most effective. The economic analysis indicates that FeNO monitoring could have value in diagnostic and management settings. The diagnostic model indicates that FeNO monitoring plus bronchodilator reversibility dominates many other diagnostic tests. FeNO-guided management has the potential to be cost-effective, although this is largely dependent on the duration of effect. The conclusions drawn from both models require strong technical value judgements with respect to several aspects of the decision problem in which little or no empirical evidence exists. There are many potential directions for further work, including investigations into which management protocol is best and long-term follow-up in both diagnosis and management studies. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013004149. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Asthma/drug therapy , Breath Tests , Luminescent Measurements/economics , Nitric Oxide/analysis , Adrenal Cortex Hormones/economics , Asthma/economics , Breath Tests/instrumentation , Cost-Benefit Analysis , Disease Management , Humans , Luminescent Measurements/instrumentation , Models, Economic , Quality-Adjusted Life Years , Technology Assessment, Biomedical
11.
Gerontologist ; 55(5): 892-912, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26315317

ABSTRACT

PURPOSE OF THE STUDY: Mild Cognitive Impairment (MCI) is a diagnosis proposed to describe an intermediate state between normal cognitive aging and dementia. MCI has been criticised for its conceptual fuzziness, its ambiguous relationship to dementia, and the tension it creates between medical and sociological understandings of "normal aging". DESIGN AND METHODS: We examined the published qualitative literature on experiences of being diagnosed and living with MCI using metasynthesis as the methodological framework. RESULTS: Two overarching conceptual themes were developed. The first, MCI and myself-in-time, showed that a diagnosis of MCI could profoundly affect a person's understanding of their place in the world. This impact appears to be mediated by multiple factors including a person's social support networks, which daily activities are affected, and subjective interpretations of the meaning of MCI. The second theme, Living with Ambiguity, describes the difficulties people experienced in making sense of their diagnosis. Uncertainty arose, in part, from lack of clarity and consistency in the information received by people with MCI, including whether they are even told MCI is the diagnosis. IMPLICATIONS: We conclude by suggesting an ethical tension is always at play when a MCI diagnosis is made. Specifically, earlier support and services afforded by a diagnosis may come at the expense of a person's anxiety about the future, with continued uncertainty about how his or her concerns and needs can be addressed.


Subject(s)
Activities of Daily Living/psychology , Aging/psychology , Cognitive Dysfunction/diagnosis , Dementia/psychology , Memory , Aged, 80 and over , Cognition , Cognitive Dysfunction/psychology , Female , Health Knowledge, Attitudes, Practice , Humans , Male , Qualitative Research , Quality of Life/psychology , Social Support
12.
Int J Lang Commun Disord ; 50(4): 416-35, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25630911

ABSTRACT

BACKGROUND: Children's and adolescent's speech and language difficulties (SaLD) can affect various domains of quality of life (QoL), and speech and language therapy interventions are critical to improving QoL. Systematically measuring QoL outcomes in this population is highly complex due to factors such as heterogeneity in impairments and differing targets during intervention. However, measurements of QoL are increasingly required by healthcare commissioners and policy-makers to inform resource allocation. AIMS: To review the use of QoL measures in research involving children (age ≤ 18 years) with SaLD. METHODS & PROCEDURES: A systematic review was undertaken. A systematic search across various databases was performed. Information on the methodological details of each relevant study, along with descriptions of the QoL measures employed, were extracted into standardized data extraction forms. Findings were discussed in a narrative synthesis. OUTCOMES & RESULTS: Twenty-one relevant studies were identified that deal with a range of subpopulations of children with SaLD. For the most part, generic QoL measures were used, although there was little convergence on the type of QoL measures employed throughout the literature. Five studies utilized preference-based QoL measures, including the 16D/17D, HUI3, EQ-5D and QWB-SA. Of these measures, the HUI3 demonstrated the most promising discriminant validity, although the preference weights for this measure were generated with adults. CONCLUSIONS & IMPLICATIONS: QoL among children with SaLD is not yet being captured in a systematic way. The HUI3 measure appears to show some promise for generating relevant preference-based QoL estimates, although further testing of the measure is required.


Subject(s)
Language Development Disorders/diagnosis , Language Development Disorders/psychology , Quality of Life/psychology , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Language Development Disorders/therapy , Language Therapy , Male , Speech Therapy
13.
Health Psychol ; 34(4): 407-16, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25197985

ABSTRACT

OBJECTIVES: This article aims to elaborate chronotope disruption--a changed relation to time and space--as a sensitizing concept for understanding chronic illness narratives. METHODS: Sixteen men and 16 women with Type 2 diabetes were purposefully sampled. Each was interviewed about his or her experience of diabetes self-management using the biographical-narrative interview method. Transcripts were inspected for key moments defined as emotionally laden stories relevant to the purpose of the research. We present dialogically inflected discursive analysis of exemplar extracts. RESULTS: The analysis demonstrates how the concept of chronotope disruption helps identify, and understand, important aspects of patients' chronic illness narratives. First, we investigate how medical advice can conflict with embodied experience and how progressive bodily deterioration can provoke a reevaluation of past illness (self-mis)management. Second, the increasing temporal and spatial intrusion of chronic illness into participants' lives is examined. Finally, we focus on the masquerade of health as an attempt to manage, hide, or deny that one is physically challenged. CONCLUSIONS: Chronotope disruption offers a useful sensitizing concept for approaching chronic illness narratives and around which to organize analytical insights and to develop practice. Chronotope analysis fills an important gap in the science through compensating current health sciences' focus on rationality, cognition, and prospective time (prediction) with a patient-oriented focus on emotionality, embodiment, and retrospective time (nostalgia). Chronotope disruption could be used to develop practice by gaining empathic understanding of patients' life-worlds and provides a tool to examine how new technologies change the way in which the chronically ill have "being" in the world.


Subject(s)
Chronobiology Phenomena , Diabetes Mellitus, Type 2/psychology , Narration , Self Care/psychology , Aged , Aged, 80 and over , Chronic Disease , Diabetes Mellitus, Type 2/therapy , Female , Humans , Male , Middle Aged , Prospective Studies , Retrospective Studies , Self Care/methods , Time Factors
14.
Health Technol Assess ; 18(17): 1-290, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24650687

ABSTRACT

BACKGROUND: Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection. OBJECTIVES: To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales. DATA SOURCES: A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data. REVIEW METHODS: Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report. RESULTS: A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs. LIMITATIONS: Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make. CONCLUSION: For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA. STUDY REGISTRATION: This study was registered as PROSPERO number CRD42011001822. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Kyphoplasty/economics , Osteoporotic Fractures/surgery , Spinal Fractures/surgery , Vertebroplasty/economics , Back Pain/etiology , Bone Cements , Cost-Benefit Analysis , England , Fractures, Compression , Humans , Kyphoplasty/methods , Quality of Life , Randomized Controlled Trials as Topic , Recovery of Function , Technology Assessment, Biomedical , Vertebroplasty/methods
15.
BMJ Open ; 3(9): e003250, 2013 Sep 18.
Article in English | MEDLINE | ID: mdl-24048626

ABSTRACT

OBJECTIVES: To estimate the cost-effectiveness of remote monitoring strategies versus usual care for adults recently discharged after a heart failure (HF) exacerbation. DESIGN: Decision analysis modelling of cost-effectiveness using secondary data sources. SETTING: Acute hospitals in the UK. PATIENTS: Patients recently discharged (within 28 days) after a HF exacerbation. INTERVENTIONS: Structured telephone support (STS) via human to machine (STS HM) interface, (2) STS via human to human (STS HH) contact and (3) home telemonitoring (TM), compared with (4) usual care. MAIN OUTCOME MEASURES: The incremental cost per quality-adjusted life year (QALY) gained by each strategy compared to the next most effective alternative and the probability of each strategy being cost-effective at varying willingness to pay per QALY gained. RESULTS: TM was the most cost-effective strategy in the scenario using these base case costs. Compared with usual care, TM had an estimated incremental cost effectiveness ratio (ICER) of £11 873/QALY, whereas STS HH had an ICER of £228 035/QALY against TM. STS HM was dominated by usual care. Threshold analysis suggested that the monthly cost of TM has to be higher than £390 to have an ICER greater than £20 000/QALY against STS HH. Scenario analyses performed using higher costs of usual care, higher costs of STS HH and lower costs of TM do not substantially change the conclusions. CONCLUSIONS: Cost-effectiveness analyses suggest that TM was an optimal strategy in most scenarios, but there is considerable uncertainty in relation to clear descriptions of the interventions and robust estimation of costs.

16.
Heart ; 99(23): 1717-26, 2013 Dec.
Article in English | MEDLINE | ID: mdl-23680885

ABSTRACT

CONTEXT: Readmission to hospital for heart failure is common after recent discharge. Remote monitoring (RM) strategies have the potential to deliver specialised care and management and may be one way to meet the growing needs of the heart failure population. OBJECTIVE: To determine whether RM strategies improve outcomes for adults who have been recently discharged (<28 days) following an unplanned admission due to heart failure. STUDY DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Fourteen electronic databases (including MEDLINE, EMBASE and PsycINFO) were searched to January 2012, and supplemented by hand-searching relevant articles. STUDY SELECTION: All randomised-controlled trials (RCTs) or observational cohort studies with a contemporaneous control group were included. RM interventions included home telemonitoring (TM) (including implanted monitoring devices) with medical support provided during office hours or 24/7 and structured telephone support (STS) programmes delivered via human-to-human contact (HH) or human-to-machine interface (HM). DATA EXTRACTION: Data were extracted and validity was assessed independently by two reviewers. RESULTS: Twenty-one RCTs that enrolled 6317 patients were identified (11 studies evaluated STS (10 of which were HH, while 1 was HM), 9 studies assessed TM, and 1 study assessed both STS and TM). No trial of implanted monitoring devices met the inclusion criteria. Compared with usual care, although not reaching statitistical significance, RM trended to reduce all-cause mortality for STS HH (HR: 0.77, 95% credible interval (CrI): 0.55, 1.08), TM during office hours (HR: 0.76, 95% CrI: 0.49, 1.18) and TM24/7 (HR: 0.49, 95% CrI: 0.20, 1.18). Exclusion of one trial that provided better-than-usual support to the control group rendered each of the above comparisons statistically significant. No beneficial effect on mortality was observed with STS HM. Reductions were also observed in all-cause hospitalisations for TM interventions but not for STS interventions. Care packages generally improved health-related quality-of-life and were acceptable to patients. CONCLUSIONS: STS HH and TM with medical support provided during office hours showed beneficial trends, particularly in reducing all-cause mortality for recently discharged patients with heart failure. Where 'usual' care is less good, the impact of RM is likely to be greater.


Subject(s)
Heart Failure/rehabilitation , Monitoring, Ambulatory/methods , Cause of Death , Heart Failure/mortality , Hospitalization/statistics & numerical data , Humans , Observational Studies as Topic , Patient Satisfaction , Quality of Life , Randomized Controlled Trials as Topic
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