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OBJECTIVES: To understand individual prescribing and associated costs in patients managed with the Edinburgh Pain Assessment and management Tool (EPAT). METHODS: The EPAT study was a two-arm parallel group cluster randomised (1:1) trial, including 19 UK cancer centres. Study outcome assessments, including pain levels, analgesia and non-pharmacological and anaesthetic interventions, collected at baseline, 3-5 days and, if applicable, 7-10 days after admission. Costs calculated for inpatient length of stay (LoS), medications and complex pain interventions. Analysis accounted for the clustered nature of the trial design. In this post-hoc analysis, healthcare utilisation and costs are presented descriptively. PARTICIPANTS: 10 centres randomised to EPAT (487 patients) and 9 (449 patients) to usual care (UC). MAIN OUTCOME MEASURES: Pharmacological and non-pharmacological management, complex pain interventions, length of hospital stay and costs related to these outcomes. RESULTS: The mean per patient hospital cost was £3866 with EPAT and £4194 with UC, reflecting a mean LoS of 2.9 days and 3.1 days, respectively. Costs were lower for non-opioids, Non-steroidal anti-inflammatories (NSAIDs) and opioids but slightly higher for adjuvants with EPAT than with UC. The mean per-patient opioid costs were £17.90 (EPAT) and £25.80 (UC). Mean per patient costs of all medication were £36 (EPAT) and £40 (UC).Complex pain intervention costs were £117 with EPAT per patient and £90 with UC. Overall mean cost per patient was £4018.3 (95% CI 3698.9 to 4337.8) with EPAT and £4323.8 (95% CI 4060.0 to 4587.7) with UC. CONCLUSIONS: EPAT facilitated personalised medicine and may result in less opioids, more specific treatments, improved pain outcomes and cost savings.
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Dor do Câncer , Custos de Cuidados de Saúde , Humanos , Analgésicos Opioides/uso terapêutico , Dor do Câncer/diagnóstico , Dor do Câncer/terapia , Hospitalização , Tempo de Internação , Manejo da Dor , Medição da DorRESUMO
BACKGROUND: Traumatic brain injury (TBI) is a major cause of disability and death in young adults worldwide. It results in around 1 million hospital admissions annually in the European Union (EU), causes a majority of the 50,000 deaths from road traffic accidents and leaves a further ≈10,000 people severely disabled. OBJECTIVE: The Eurotherm3235 Trial was a pragmatic trial examining the effectiveness of hypothermia (32-35 °C) to reduce raised intracranial pressure (ICP) following severe TBI and reduce morbidity and mortality 6 months after TBI. DESIGN: An international, multicentre, randomised controlled trial. SETTING: Specialist neurological critical care units. PARTICIPANTS: We included adult participants following TBI. Eligible patients had ICP monitoring in place with an ICP of > 20 mmHg despite first-line treatments. Participants were randomised to receive standard care with the addition of hypothermia (32-35 °C) or standard care alone. Online randomisation and the use of an electronic case report form (CRF) ensured concealment of random treatment allocation. It was not possible to blind local investigators to allocation as it was obvious which participants were receiving hypothermia. We collected information on how well the participant had recovered 6 months after injury. This information was provided either by the participant themself (if they were able) and/or a person close to them by completing the Glasgow Outcome Scale - Extended (GOSE) questionnaire. Telephone follow-up was carried out by a blinded independent clinician. INTERVENTIONS: The primary intervention to reduce ICP in the hypothermia group after randomisation was induction of hypothermia. Core temperature was initially reduced to 35 °C and decreased incrementally to a lower limit of 32 °C if necessary to maintain ICP at < 20 mmHg. Rewarming began after 48 hours if ICP remained controlled. Participants in the standard-care group received usual care at that centre, but without hypothermia. MAIN OUTCOME MEASURES: The primary outcome measure was the GOSE [range 1 (dead) to 8 (upper good recovery)] at 6 months after the injury as assessed by an independent collaborator, blind to the intervention. A priori subgroup analysis tested the relationship between minimisation factors including being aged < 45 years, having a post-resuscitation Glasgow Coma Scale (GCS) motor score of < 2 on admission, having a time from injury of < 12 hours and patient outcome. RESULTS: We enrolled 387 patients from 47 centres in 18 countries. The trial was closed to recruitment following concerns raised by the Data and Safety Monitoring Committee in October 2014. On an intention-to-treat basis, 195 participants were randomised to hypothermia treatment and 192 to standard care. Regarding participant outcome, there was a higher mortality rate and poorer functional recovery at 6 months in the hypothermia group. The adjusted common odds ratio (OR) for the primary statistical analysis of the GOSE was 1.54 [95% confidence interval (CI) 1.03 to 2.31]; when the GOSE was dichotomised the OR was 1.74 (95% CI 1.09 to 2.77). Both results favoured standard care alone. In this pragmatic study, we did not collect data on adverse events. Data on serious adverse events (SAEs) were collected but were subject to reporting bias, with most SAEs being reported in the hypothermia group. CONCLUSIONS: In participants following TBI and with an ICP of > 20 mmHg, titrated therapeutic hypothermia successfully reduced ICP but led to a higher mortality rate and worse functional outcome. LIMITATIONS: Inability to blind treatment allocation as it was obvious which participants were randomised to the hypothermia group; there was biased recording of SAEs in the hypothermia group. We now believe that more adequately powered clinical trials of common therapies used to reduce ICP, such as hypertonic therapy, barbiturates and hyperventilation, are required to assess their potential benefits and risks to patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34555414. 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. 45. See the NIHR Journals Library website for further project information. The European Society of Intensive Care Medicine supported the pilot phase of this trial.
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Lesões Encefálicas Traumáticas/terapia , Hipotermia Induzida/economia , Hipotermia Induzida/métodos , Pressão Intracraniana/fisiologia , Adolescente , Adulto , Fatores Etários , Idoso , Lesões Encefálicas Traumáticas/epidemiologia , Lesões Encefálicas Traumáticas/mortalidade , Criança , Pré-Escolar , Análise Custo-Benefício , Feminino , Escala de Resultado de Glasgow , Humanos , Hipotermia Induzida/mortalidade , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Pneumonia Associada à Ventilação Mecânica/epidemiologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , Avaliação da Tecnologia Biomédica , Tempo para o Tratamento , Adulto JovemRESUMO
Purpose Pain is suboptimally managed in patients with cancer. We aimed to compare the effect of a policy of adding a clinician-delivered bedside pain assessment and management tool (Edinburgh Pain Assessment and management Tool [EPAT]) to usual care (UC) versus UC alone on pain outcomes. Patients and Methods In a two-arm, parallel group, cluster randomized (1:1) trial, we observed pain outcomes in 19 cancer centers in the United Kingdom and then randomly assigned the centers to either implement EPAT or to continue UC. The primary outcome was change in the percentage of study participants in each center with a clinically significant (≥ 2 point) improvement in worst pain (using the Brief Pain Inventory Short Form) from admission to 3 to 5 days after admission. Secondary outcomes included quality of analgesic prescribing and opioid-related adverse effects. Results Ten centers were randomly assigned to EPAT, and nine were assigned to UC. We enrolled 1,921 patients and obtained outcome data from 93% (n = 1,795). Participants (mean age, 60 years; 49% women) had a variety of cancer types. For centers randomly assigned to EPAT, the percentage of participants with a clinically significant improvement in worst pain increased from 47.7% to 54.1%, and for those randomly assigned to continue UC, this percentage decreased from 50.6% to 46.4%. The absolute difference was 10.7% (95% CI, 0.2% to 21.1%; P = .046) and it increased to 15.4% (95% CI, 5.8% to 25.0%; P = .004) when two centers that failed to implement EPAT were excluded. EPAT centers had greater improvements in prescribing practice and in the Brief Pain Inventory Short Form pain subscale score. Other pain and distress outcomes and opioid adverse effects did not differ between EPAT and UC. Conclusion A systematic integrated approach improves pain outcomes for inpatients in cancer centers without increasing opioid adverse effects.
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Dor do Câncer/terapia , Manejo da Dor/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos/uso terapêutico , Feminino , Humanos , Pacientes Internados , Masculino , Pessoa de Meia-Idade , Medição da Dor , Resultado do Tratamento , Reino UnidoRESUMO
RATIONALE: Survivors of critical illness experience significant morbidity, but the impact of surviving the intensive care unit (ICU) has not been quantified comprehensively at a population level. OBJECTIVES: To identify factors associated with increased hospital resource use and to ascertain whether ICU admission was associated with increased mortality and resource use. METHODS: Matched cohort study and pre/post-analysis using national linked data registries with complete population coverage. The population consisted of patients admitted to all adult general ICUs during 2005 and surviving to hospital discharge, identified from the Scottish Intensive Care Society Audit Group registry, matched (1:1) with similar hospital control subjects. Five-year outcomes included mortality and hospital resource use. Confounder adjustment was based on multivariable regression and pre/post within-individual analyses. MEASUREMENTS AND MAIN RESULTS: Of 7,656 ICU patients, 5,259 survived to hospital discharge (5,215 [99.2%] matched to hospital control subjects). Factors present before ICU admission (comorbidities/pre-ICU hospitalizations) were stronger predictors of hospital resource use than acute illness factors. In the 5 years after the initial hospital discharge, compared with hospital control subjects, the ICU cohort had higher mortality (32.3% vs. 22.7%; hazard ratio, 1.33; 95% confidence interval, 1.22-1.46; P < 0.001), used more hospital resources (mean hospital admission rate, 4.8 vs. 3.3/person/5 yr), and had 51% higher mean 5-year hospital costs ($25,608 vs. $16,913/patient). Increased resource use persisted after confounder adjustment (P < 0.001) and using pre/post-analyses (P < 0.001). Excess resource use and mortality were greatest for younger patients without significant comorbidity. CONCLUSIONS: This complete, national study demonstrates that ICU survivorship is associated with higher 5-year mortality and hospital resource use than hospital control subjects, representing a substantial burden on individuals, caregivers, and society.
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Cuidados Críticos/economia , Cuidados Críticos/estatística & dados numéricos , Estado Terminal/economia , Estado Terminal/mortalidade , Custos Hospitalares/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Estudos de Coortes , Feminino , Humanos , Unidades de Terapia Intensiva/economia , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Sistema de Registros , Escócia/epidemiologia , Fatores Sexuais , Sobreviventes/estatística & dados numéricosRESUMO
OBJECTIVES: Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers. STUDY DESIGN AND SETTING: Web-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)-registered CTUs. RESULTS: Twenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing. CONCLUSION: There is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.
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Ensaios Clínicos como Assunto/economia , Apoio Financeiro , Disseminação de Informação/métodos , Confidencialidade , Humanos , Política Organizacional , Projetos de Pesquisa , Inquéritos e Questionários , Reino UnidoRESUMO
BACKGROUND: The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998. METHODS: An expert panel (n = 7) was convened comprising statisticians, clinicians and trial methodologists with prior TSC experience. Twelve questions about the role and responsibilities of the TSC were discussed by the panel at two full-day meetings. Each meeting was transcribed in full and the discussions were summarised. RESULTS: The expert panel reached agreement on the role of the TSC, to which it was accountable, the membership, the definition of independence, and the experience and training needed. The management of ethical issues, difficult/complex situations and issues the TSC should not ask the DMC to make recommendations on were more difficult to discuss without specific examples, but support existed for further work to help share issues and to provide appropriate training for TSC members. Additional topics discussed, which had not been identified by previous work relating to the DMCs but were pertinent to the role of the TSC, included the following: review of data sharing requests, indemnity, lifespan of the TSC, general TSC administration, and the roles of both the Funder and the Sponsor. CONCLUSIONS: This paper presents recommendations that will contribute to the revision and update of the MRC TSC terms of reference. Uncertainty remains in some areas due to the absence of real-life examples; future guidance on these issues would benefit from a repository of case studies. Notably, the role of a patient and public involvement (PPI) contributor was not discussed, and further work is warranted to explore the role of a PPI contributor in independent trial oversight.
Assuntos
Comitês Consultivos/normas , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Ensaios Clínicos como Assunto/normas , Membro de Comitê , Papel Profissional , Projetos de Pesquisa/normas , Pesquisadores/normas , Comitês Consultivos/economia , Comitês Consultivos/ética , Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/ética , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/estatística & dados numéricos , Conflito de Interesses , Consenso , Interpretação Estatística de Dados , Humanos , Projetos de Pesquisa/estatística & dados numéricos , Pesquisadores/economia , Pesquisadores/ética , Apoio à Pesquisa como Assunto/normas , Inquéritos e QuestionáriosRESUMO
BACKGROUND: In patients with traumatic brain injury, hypothermia can reduce intracranial hypertension. The benefit of hypothermia on functional outcome is unclear. METHODS: We randomly assigned adults with an intracranial pressure of more than 20 mm Hg despite stage 1 treatments (including mechanical ventilation and sedation management) to standard care (control group) or hypothermia (32 to 35°C) plus standard care. In the control group, stage 2 treatments (e.g., osmotherapy) were added as needed to control intracranial pressure. In the hypothermia group, stage 2 treatments were added only if hypothermia failed to control intracranial pressure. In both groups, stage 3 treatments (barbiturates and decompressive craniectomy) were used if all stage 2 treatments failed to control intracranial pressure. The primary outcome was the score on the Extended Glasgow Outcome Scale (GOS-E; range, 1 to 8, with lower scores indicating a worse functional outcome) at 6 months. The treatment effect was estimated with ordinal logistic regression adjusted for prespecified prognostic factors and expressed as a common odds ratio (with an odds ratio <1.0 favoring hypothermia). RESULTS: We enrolled 387 patients at 47 centers in 18 countries from November 2009 through October 2014, at which time recruitment was suspended owing to safety concerns. Stage 3 treatments were required to control intracranial pressure in 54% of the patients in the control group and in 44% of the patients in the hypothermia group. The adjusted common odds ratio for the GOS-E score was 1.53 (95% confidence interval, 1.02 to 2.30; P=0.04), indicating a worse outcome in the hypothermia group than in the control group. A favorable outcome (GOS-E score of 5 to 8, indicating moderate disability or good recovery) occurred in 26% of the patients in the hypothermia group and in 37% of the patients in the control group (P=0.03). CONCLUSIONS: In patients with an intracranial pressure of more than 20 mm Hg after traumatic brain injury, therapeutic hypothermia plus standard care to reduce intracranial pressure did not result in outcomes better than those with standard care alone. (Funded by the National Institute for Health Research Health Technology Assessment program; Current Controlled Trials number, ISRCTN34555414.).
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Lesões Encefálicas/complicações , Hipotermia Induzida , Hipertensão Intracraniana/terapia , Adulto , Pressão Arterial/fisiologia , Barbitúricos/uso terapêutico , Lesões Encefálicas/mortalidade , Lesões Encefálicas/fisiopatologia , Lesões Encefálicas/terapia , Terapia Combinada , Craniectomia Descompressiva , Humanos , Unidades de Terapia Intensiva , Análise de Intenção de Tratamento , Hipertensão Intracraniana/etiologia , Pressão Intracraniana/fisiologia , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
BACKGROUND: Annual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence. OBJECTIVES: We undertook a systematic review of individual patient data (IPD) to identify the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes. DATA SOURCES: Studies were identified from searches of MEDLINE and EMBASE. REVIEW METHODS: The electronic search strategies for MEDLINE and EMBASE databases created during an aggregate systematic review of predictive factors for foot ulceration in diabetes were updated and rerun to January 2013. One reviewer applied the IPD review eligibility criteria to the full-text articles of the studies identified in our literature search and also to all studies excluded from our aggregate systematic review to ensure that we did not miss eligible IPD. A second reviewer applied the eligibility criteria to a 10% random sample of the abstract search yield to check that no relevant material was missed. This review includes exposure variables (risk factors) only from individuals who were free of foot ulceration at the time of study entry and who had a diagnosis of diabetes mellitus (either type 1 or type 2). The outcome variable was incident ulceration. RESULTS: Our search identified 16 cohort studies and we obtained anonymised IPD for 10. These data were collected from more than 16,000 people with diabetes worldwide and reanalysed by us. One data set was kept for independent validation. The data sets contributing IPD covered a range of temporal, geographical and clinical settings. We therefore selected random-effects meta-analysis, which assumes not that all the estimates from each study are estimates of the same underlying true value, but rather that the estimates belong to the same distribution. We selected candidate variables for meta-analysis using specific criteria. After univariate meta-analyses, the most clinically important predictors were identified by an international steering committee for inclusion in the primary, multivariable meta-analysis. Age, sex, duration of diabetes, monofilaments and pulses were considered most prognostically important. Meta-analyses based on data from the entire IPD population found that an inability to feel a 10-g monofilament [odds ratio (OR) 3.184, 95% confidence interval (CI) 2.654 to 3.82], at least one absent pedal pulse (OR 1.968, 95% CI 1.624 to 2.386), a longer duration of a diagnosis of diabetes (OR 1.024, 95% CI 1.011 to 1.036) and a previous history of ulceration (OR 6.589, 95% CI 2.488 to 17.45) were all predictive of risk. Female sex was protective (OR 0.743, 95% CI 0.598 to 0.922). LIMITATIONS: It was not possible to perform a meta-analysis using a one-step approach because we were unable to procure copies of one of the data sets and instead accessed data via Safe Haven. CONCLUSIONS: The findings from this review identify risk assessment procedures that can reliably inform national and international diabetes clinical guideline foot risk assessment procedures. The evidence from a large sample of patients in worldwide settings show that the use of a 10-g monofilament or one absent pedal pulse will identify those at moderate or intermediate risk of foot ulceration, and a history of foot ulcers or lower-extremity amputation is sufficient to identify those at high risk. We propose the development of a clinical prediction rule (CPR) from our existing model using the following predictor variables: insensitivity to a 10-g monofilament, absent pedal pulses and a history of ulceration or lower-extremities amputations. This CPR could replace the many tests, signs and symptoms that patients currently have measured using equipment that is either costly or difficult to use. STUDY REGISTRATION: This study is registered as PROSPERO CRD42011001841. FUNDING: The National Institute for Health Research Health Technology Assessment programme.
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Pé Diabético/diagnóstico , Medição de Risco , Humanos , Valor Preditivo dos Testes , Prognóstico , Fatores de RiscoRESUMO
IMPORTANCE: Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. OBJECTIVE: To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. DESIGN, SETTING, AND PARTICIPANTS: A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. INTERVENTIONS: During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. MAIN OUTCOMES AND MEASURES: The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). RESULTS: Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, -0.2 [95% CI, -1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, -0.1 [95% CI, -3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, -3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. CONCLUSIONS AND RELEVANCE: Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN09412438.
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Hospitalização , Reabilitação/métodos , Idoso , Cuidados Críticos , Feminino , Gestão da Informação em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Modalidades de Fisioterapia , Avaliação de Processos em Cuidados de Saúde , Estudos ProspectivosRESUMO
BACKGROUND: Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes. METHODS/DESIGN: The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either 'intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445.
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Artroplastia do Joelho/reabilitação , Articulação do Joelho/cirurgia , Modalidades de Fisioterapia , Projetos de Pesquisa , Artroplastia do Joelho/economia , Fenômenos Biomecânicos , Protocolos Clínicos , Análise Custo-Benefício , Avaliação da Deficiência , Custos de Cuidados de Saúde , Humanos , Articulação do Joelho/fisiopatologia , Medição da Dor , Satisfação do Paciente , Seleção de Pacientes , Modalidades de Fisioterapia/economia , Estudos Prospectivos , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Reino UnidoRESUMO
OBJECTIVES: Intensive care survivors continue to experience significant morbidity following acute hospital discharge, but healthcare costs associated with this ongoing morbidity are poorly described. As the demand for intensive care increases, understanding the magnitude of postacute hospital healthcare costs is of increasing relevance to clinicians and healthcare planners. We undertook a systematic review of the literature reporting major healthcare resource use by intensive care survivors following discharge from the hospital and identified factors associated with increased resource use. DATA SOURCES: Seven electronic databases (1990 to August 2012), conference proceedings, and reference lists were searched. STUDY SELECTION: Studies published in English were included that reported postacute hospital discharge healthcare resource use at the individual level for survivors of intensive care. DATA EXTRACTION: Two reviewers screened abstracts and one abstracted data using standardized templates. Study quality was assessed using recognized appraisal methods specific to economic evaluation, epidemiological studies, and randomized trials. DATA SYNTHESIS: From 4,909 articles, 18 articles representing 14 cohorts fulfilled inclusion criteria. There was substantial variation in methodology, especially the resource categories included in the studies. Following standardization to a common currency and year, variation in cost of resource use was evident (range 2011 US $18,847-$148,454 for year 1 postdischarge). Studies undertaken within the United States reported the highest costs; those in the United Kingdom reported substantially lower costs. Factors associated with increased resource use included increasing age, comorbidities, organ dysfunction score, and previous resource use. CONCLUSIONS: Wide variation in methodological approaches limited study comparability and external validity of findings. We found substantial variation in the cost of resource use, especially among countries. Careful description of patient cohorts and healthcare systems is required to maximize generalizability. We give recommendations for a more standardized approach to improve design and reporting of future studies.
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Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Unidades de Terapia Intensiva , Sobreviventes , Fatores Etários , Comorbidade , Humanos , Escores de Disfunção Orgânica , Alta do Paciente , Respiração Artificial/estatística & dados numéricosRESUMO
BACKGROUND: Venous thromboembolism (VTE) is a common and important complication of stroke. The CLOTS 3 trial aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression (IPC) in immobile stroke patients reduces the risk of proximal deep vein thrombosis (DVT). METHODS/DESIGN: The CLOTS 3 trial is a multicenter, parallel group trial with centralized randomization (minimization) to ensure allocation concealment. The protocol has been published (Trials 2012, 13:26) and is available in full at: http://www.clotstrial.com. Between December 2008 and September 2012, 105 centers in the UK recruited 2,876 immobile stroke patients within the first 3 days of their hospital admission. Patients were allocated to best medical care or best medical care plus IPC. Ultrasonographers performed a compression Doppler ultrasound scan to detect DVT in each treatment group at 7 to 10 days and 25 to 30 days. The primary outcome cluster includes symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either scan. Patients will be followed up by postal or telephone questionnaire at 6 months from randomization to detect later symptomatic DVT and pulmonary embolism (PE), and to measure functional outcome (Oxford Handicap Scale) and quality of life (EQ-5D-3L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has more than 90% power to detect a 4% absolute difference (12% versus 8%) in risk of the primary outcome and includes a health economic analysis.Follow-up will be completed in April 2013 and the results reported in May 2013. In this update, we describe the statistical analysis plan. TRIAL REGISTRATION: ISRCTN: ISRCTN93529999.
Assuntos
Veia Femoral , Dispositivos de Compressão Pneumática Intermitente , Modelos Estatísticos , Veia Poplítea , Reabilitação do Acidente Vascular Cerebral , Trombose Venosa/prevenção & controle , Repouso em Cama , Custos e Análise de Custo , Interpretação Estatística de Dados , Veia Femoral/diagnóstico por imagem , Custos de Cuidados de Saúde , Humanos , Dispositivos de Compressão Pneumática Intermitente/economia , Veia Poplítea/diagnóstico por imagem , Valor Preditivo dos Testes , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/economia , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler , Reino Unido , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/economia , Trombose Venosa/etiologiaRESUMO
INTRODUCTION: Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. METHODS AND ANALYSIS: The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. ETHICS AND DISSEMINATION: Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. TRIAL REGISTRATION: The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.
RESUMO
BACKGROUND: Long-term evaluation of cardiothoracic surgical outcomes is a major goal of The Society of Thoracic Surgeons (STS). Linking the STS Database to the Social Security Death Master File (SSDMF) allows for the verification of "life status." This study demonstrates the feasibility of linking the STS Database to the SSDMF and examines longitudinal survival after cardiac operations. METHODS: For all operations in the STS Adult Cardiac Surgery Database performed in 2008 in patients with an available Social Security Number, the SSDMF was searched for a matching Social Security Number. Survival probabilities at 30 days and 1 year were estimated for nine common operations. RESULTS: A Social Security Number was available for 101,188 patients undergoing isolated coronary artery bypass grafting, 12,336 patients undergoing isolated aortic valve replacement, and 6,085 patients undergoing isolated mitral valve operations. One-year survival for isolated coronary artery bypass grafting was 88.9% (6,529 of 7,344) with all vein grafts, 95.2% (84,696 of 88,966) with a single mammary artery graft, 97.4% (4,422 of 4,540) with bilateral mammary artery grafts, and 95.6% (7,543 of 7,890) with all arterial grafts. One-year survival was 92.4% (11,398 of 12,336) for isolated aortic valve replacement (95.6% [2,109 of 2,206] with mechanical prosthesis and 91.7% [9,289 of 10,130] with biologic prosthesis), 86.5% (2,312 of 2,674) for isolated mitral valve replacement (91.7% [923 of 1,006] with mechanical prosthesis and 83.3% [1,389 of 1,668] with biologic prosthesis), and 96.0% (3,275 of 3,411) for isolated mitral valve repair. CONCLUSIONS: Successful linkage to the SSDMF has substantially increased the power of the STS Database. These longitudinal survival data from this large multi-institutional study provide reassurance about the durability and long-term benefits of cardiac operations and constitute a contemporary benchmark for survival after cardiac operations.
Assuntos
Procedimentos Cirúrgicos Cardíacos/mortalidade , Causas de Morte , Bases de Dados Factuais , Previdência Social/estatística & dados numéricos , Sociedades Médicas , Adulto , Idoso , Valva Aórtica/cirurgia , Benchmarking , Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária/estatística & dados numéricos , Coleta de Dados , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Análise de Sobrevida , Procedimentos Cirúrgicos Torácicos/mortalidade , Procedimentos Cirúrgicos Torácicos/estatística & dados numéricos , Estados Unidos/epidemiologiaAssuntos
Educação de Pós-Graduação em Medicina/normas , Erros Médicos , Qualidade da Assistência à Saúde , Cirurgia Torácica/educação , Competência Clínica , Atenção à Saúde/normas , Humanos , Erros Médicos/efeitos adversos , Erros Médicos/economia , Erros Médicos/mortalidade , Erros Médicos/prevenção & controleRESUMO
OBJECTIVE: To determine whether a higher score on Item 9 of the Patient Health Questionnaire-9 (range zero to three) was more likely to indicate suicidality as determined at subsequent clinical interview in cancer outpatients. METHOD: Analysis of anonymized data (with ethical approval) obtained from the routine clinical administration of self-report questionnaires and telephone interviews to patients attending a cancer centre in the UK. RESULTS: Complete data were available on 330 patients. Those with higher scores on the item were more likely to be suicidal at interview. However, a substantial number of those (54/235; 23%) who scored only one on the item were also found to be suicidal. CONCLUSIONS: A higher score on Item 9 of the PHQ-9 indicates a greater likelihood that the patient is suicidal. However, even patients who score only 1 may be suicidal and consequently also require further assessment.
Assuntos
Inquéritos Epidemiológicos , Programas de Rastreamento/métodos , Neoplasias/epidemiologia , Neoplasias/psicologia , Tentativa de Suicídio/psicologia , Tentativa de Suicídio/estatística & dados numéricos , Inquéritos e Questionários , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Adulto JovemRESUMO
OBJECTIVE: Accurate and consistent outcome assessment is essential to randomized clinical trials. We aimed to explore observer variation in the assessment of outcome in a recently completed trial of dexanabinol in head injury and to consider steps to reduce such variation. METHODS: Eight hundred sixty-one patients with severe traumatic brain injury who were admitted to 86 centers were included in a multicenter, placebo-controlled, Phase III trial. Outcome was assessed at 3 and 6 months postinjury using the extended Glasgow Outcome Scale; standardized assessment was facilitated by the use of a structured interview. Before initiation of trial centers, outcome ratings were obtained for sample cases to establish initial levels of agreement. Training sessions in outcome assessment were held, and problems in assigning outcome were investigated. During the trial, a process of central review was established to monitor performance. Interobserver variation was analyzed using the kappa statistic. RESULTS: Substantial observer variation was found in the rating of sample cases (weighted kappa, 0.72; confidence interval, 0.68-0.75) and in assigning outcome based on completed structured interviews (weighted kappa, 0.61; confidence interval, 0.57-0.64). In the early stages of the trial, a relatively large number of discrepancies (29-37%) were identified on central review. This number declined as the trial progressed and coincided with investigator training and feedback from central review. Centers with higher enrollment rates showed better performance. CONCLUSION: Observer variation in outcome assessment is a significant problem for head injury trials. Consistency can be improved by standardizing procedures, training assessors, and monitoring the quality of assessments and providing feedback to interviewers.
Assuntos
Lesões Encefálicas/diagnóstico , Lesões Encefálicas/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Medição de Risco/métodos , Adolescente , Adulto , Idoso , Lesões Encefálicas/terapia , Feminino , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Prognóstico , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
BACKGROUND: The efficacy and safety of uterine-artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. METHODS: We conducted a randomized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids. The primary outcome was quality of life at 1 year of follow-up, as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). RESULTS: Patients were randomly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolization group had a shorter median duration of hospitalization than the surgical group (1 day vs. 5 days, P<0.001) and a shorter time before returning to work (P<0.001). At 1 year, symptom scores were better in the surgical group (P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolization group (12%) and 10 in the surgical group (20%) (P=0.22), mostly related to the intervention. Ten patients in the embolization group (9%) required repeated embolization or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolization group (13%) required hospitalization, 3 of them for major adverse events and 11 for reintervention for treatment failure. CONCLUSIONS: In women with symptomatic fibroids, the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients. (ISRCTN.org number, ISRCTN23023665 [controlled-trials.com].)