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OBJECTIVES: To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement. DESIGN: Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study. SETTING: Two National Health Service (NHS) secondary care hospitals in England and Wales. PARTICIPANTS: Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0-28 on the Sleep Condition Indicator questionnaire. INTERVENTION: The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals. OUTCOME MEASURES: The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients. RESULTS: Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable. CONCLUSIONS: This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible. TRIAL REGISTRATION NUMBER: ISRCTN14233189.
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Artroplastia do Joelho , Adulto , Humanos , Terapia Comportamental , Análise Custo-Benefício , Inglaterra , Estudos de Viabilidade , Inquéritos e Questionários , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVES: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. DESIGN: Pragmatic, parallel group, open label, randomised controlled trial. SETTING: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. PARTICIPANTS: 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). INTERVENTIONS: A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. MAIN OUTCOME MEASURES: The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. RESULTS: The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; 1.4). CONCLUSIONS: At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN10956306.
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Qualidade de Vida , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Análise Custo-Benefício , Ontário , Anos de Vida Ajustados por Qualidade de Vida , SuéciaRESUMO
INTRODUCTION: Knee replacements are highly successful for many people, but if a knee replacement fails, revision surgery is generally required. Surgeons and patients may choose from a range of implant components and combinations that make up knee replacement constructs, all with potential implications for how long a knee replacement will last. To inform surgeon and patient decisions, a comprehensive synthesis of data from randomised controlled trials is needed to evaluate the effects of different knee replacement implants on overall construct survival. Due to limited follow-up in trials, joint registry analyses are also needed to assess the long-term survival of constructs. Finally, economic modelling can identify cost-effective knee replacement constructs for different patient groups. METHODS AND ANALYSIS: In this protocol, we describe systematic reviews and network meta-analyses to synthesise evidence on the effectiveness of knee replacement constructs used in total and unicompartmental knee replacement and analyses of two national joint registries to assess long-term outcomes. Knee replacement constructs are defined by bearing materials and mobility, constraint, fixation and patella resurfacing. For men and women in different age groups, we will compare the lifetime cost-effectiveness of knee replacement constructs. ETHICS AND DISSEMINATION: Systematic reviews are secondary analyses of published data with no ethical approval required. We will design a common joint registry analysis plan and provide registry representatives with information for submission to research or ethics committees. The project has been assessed by the National Health Service (NHS) REC committee and does not require ethical review.Study findings will be disseminated to clinicians, researchers and administrators through open access articles, presentations and websites. Specific UK-based groups will be informed of results including National Institute for Health Research and National Institute for Health and Care Excellence, as well as international orthopaedic associations and charities. Effective dissemination to patients will be guided by our patient-public involvement group and include written lay summaries and infographics. PROSPERO REGISTRATION NUMBER: CRD42019134059 and CRD42019138015.
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Artroplastia do Joelho , Medicina Estatal , Teorema de Bayes , Análise Custo-Benefício , Feminino , Humanos , Masculino , Metanálise como Assunto , Metanálise em Rede , Sistema de RegistrosRESUMO
OBJECTIVE: To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR). METHODS: In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively. RESULTS: The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported. CONCLUSION: Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.
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Artroplastia do Joelho/reabilitação , Modalidades de Fisioterapia , Idoso , Feminino , Processos Grupais , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Prosthetic implants used in total hip replacements (THR) have a range of bearing surface combinations (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, and metal-on-metal), head sizes (small [<36 mm in diameter] and large [≥36 mm in diameter]), and fixation techniques (cemented, uncemented, hybrid, and reverse hybrid). These can influence prosthesis survival, patients' quality of life, and healthcare costs. OBJECTIVES: To compare the lifetime cost-effectiveness of implants for patients of different age and sex profiles. METHODS: We developed a Markov model to compare the cost-effectiveness of various implants against small-head cemented metal-on-polyethylene implants. The probability that patients required 1 or more revision surgeries was estimated from analyses of more than 1 million patients in the UK and Swedish hip joint registries, for men and women younger than 55, 55 to 64, 65 to 74, 75 to 84, and 85 years and older. Implant and healthcare costs were estimated from local procurement prices, national tariffs, and the literature. Quality-adjusted life-years were calculated using published utility estimates for patients undergoing THR in the United Kingdom. RESULTS: Small-head cemented metal-on-polyethylene implants were the most cost-effective for men and women older than 65 years. These findings were robust to sensitivity analyses. Small-head cemented ceramic-on-polyethylene implants were most cost-effective in men and women younger than 65 years, but these results were more uncertain. CONCLUSIONS: The older the patient group, the more likely that the cheapest implants, small-head cemented metal-on-polyethylene implants, were cost-effective. We found no evidence that uncemented, hybrid, or reverse hybrid implants were the most cost-effective option for any patient group. Our findings can influence clinical practice and procurement decisions for healthcare payers worldwide.
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Artroplastia de Quadril/economia , Artroplastia de Quadril/instrumentação , Tomada de Decisão Clínica/métodos , Análise Custo-Benefício/métodos , Prótese de Quadril/economia , Desenho de Prótese/economia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese/métodos , Suécia/epidemiologia , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. METHODS: This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. DISCUSSION: If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. TRIAL REGISTRATION: ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.
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Artroplastia do Joelho/efeitos adversos , Dor Crônica/terapia , Procedimentos Clínicos , Manejo da Dor , Dor Pós-Operatória/terapia , Artroplastia do Joelho/economia , Dor Crônica/diagnóstico , Dor Crônica/economia , Dor Crônica/etiologia , Análise Custo-Benefício , Procedimentos Clínicos/economia , Custos de Cuidados de Saúde , Humanos , Estudos Multicêntricos como Assunto , Manejo da Dor/economia , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/economia , Dor Pós-Operatória/etiologia , Projetos Piloto , Ensaios Clínicos Pragmáticos como Assunto , Atenção Secundária à Saúde , Fatores de Tempo , Resultado do Tratamento , Reino UnidoRESUMO
BACKGROUND: Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable. METHODS: In line with the UK Medical Research Council's recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders. RESULTS: Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial. CONCLUSIONS: This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.
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Artralgia/terapia , Artroplastia do Joelho/efeitos adversos , Dor Crônica/terapia , Procedimentos Clínicos , Avaliação de Processos e Resultados em Cuidados de Saúde , Manejo da Dor/métodos , Artralgia/diagnóstico , Artralgia/etiologia , Dor Crônica/diagnóstico , Dor Crônica/etiologia , Consenso , Estudos de Viabilidade , Humanos , Medição da Dor , Aceitação pelo Paciente de Cuidados de Saúde , Fatores de Risco , Participação dos Interessados , Resultado do TratamentoRESUMO
Objective To compare the survival of different implant combinations for primary total hip replacement (THR). Design Systematic review and network meta-analysis. Data sources Medline, Embase, The Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register.Review methods Published randomised controlled trials comparing different implant combinations. Implant combinations were defined by bearing surface materials (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or metal-on-metal), head size (large ≥36 mm or small <36 mm), and fixation technique (cemented, uncemented, hybrid, or reverse hybrid). Our reference implant combination was metal-on-polyethylene (not highly cross linked), small head, and cemented. The primary outcome was revision surgery at 0-2 years and 2-10 years after primary THR. The secondary outcome was the Harris hip score reported by clinicians.Results 77 studies were included in the systematic review, and 15 studies (3177 hips) in the network meta-analysis for revision. There was no evidence that the risk of revision surgery was reduced by other implant combinations compared with the reference implant combination. Although estimates are imprecise, metal-on-metal, small head, cemented implants (hazard ratio 4.4, 95% credible interval 1.6 to 16.6) and resurfacing (12.1, 2.1 to 120.3) increase the risk of revision at 0-2 years after primary THR compared with the reference implant combination. Similar results were observed for the 2-10 years period. 31 studies (2888 patients) were included in the analysis of Harris hip score. No implant combination had a better score than the reference implant combination.Conclusions Newer implant combinations were not found to be better than the reference implant combination (metal-on-polyethylene (not highly cross linked), small head, cemented) in terms of risk of revision surgery or Harris hip score. Metal-on-metal, small head, cemented implants and resurfacing increased the risk of revision surgery compared with the reference implant combination. The results were consistent with observational evidence and were replicated in sensitivity analysis but were limited by poor reporting across studies.Systematic review registration PROSPERO CRD42015019435.
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Artroplastia de Quadril/instrumentação , Prótese de Quadril , Metanálise em Rede , Falha de Prótese , Reoperação/estatística & dados numéricos , Adulto , Idoso , Cerâmica , Feminino , Humanos , Masculino , Próteses Articulares Metal-Metal , Pessoa de Meia-Idade , Polietilenos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
An RCN position statement issued this month confirms the college's ongoing commitment to supporting nurses, midwives and healthcare workers to better understand the complexities that surround domestic abuse.
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Violência Doméstica , Papel do Profissional de Enfermagem , Violência Doméstica/prevenção & controle , Humanos , Reino UnidoRESUMO
As A&E attendances rise, the British Red Cross has declared a 'humanitarian crisis'.
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Serviços Médicos de Emergência/organização & administração , Medicina Estatal/organização & administração , Humanos , Reino UnidoRESUMO
Despite planning and public well-being campaigns, the health of the population continues to deteriorate due to lifestyle-related conditions such as diabetes, obesity, smoking-related bronchitis, and alcohol and drug misuse.
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Promoção da Saúde , Inglaterra , Medicina EstatalRESUMO
Despite planning and public well-being campaigns, the health of the population continues to deteriorate due to lifestyle-related conditions such as diabetes, obesity, smoking-related bronchitis, and alcohol and drug misuse.
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Consumo de Bebidas Alcoólicas/prevenção & controle , Diabetes Mellitus/prevenção & controle , Promoção da Saúde/métodos , Obesidade/prevenção & controle , Autonomia Pessoal , Autocuidado/métodos , Prevenção do Hábito de Fumar , Humanos , Fatores de Risco , Reino UnidoRESUMO
The launch of RCNi Nurse Awards 2017 is a lovely reminder of this fantastic event in 2015, when I became nurse of the year for supporting victims of domestic abuse. The story continues, as I sit waiting to do an interview with ITV about domestic abuse, keeping the conversation going.
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Valid points on the need for nursing students to be able to competently detect and assess victims of intimate partner violence were made in Artur Dalfó Pibernat's letter in May's issue of Emergency Nurse magazine.
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BACKGROUND: Primary total knee replacement is a common operation that is performed to provide pain relief and restore functional ability. Inpatient physiotherapy is routinely provided after surgery to enhance recovery prior to hospital discharge. However, international variation exists in the provision of outpatient physiotherapy after hospital discharge. While evidence indicates that outpatient physiotherapy can improve short-term function, the longer term benefits are unknown. The aim of this randomised controlled trial is to evaluate the long-term clinical effectiveness and cost-effectiveness of a 6-week group-based outpatient physiotherapy intervention following knee replacement. METHODS/DESIGN: Two hundred and fifty-six patients waiting for knee replacement because of osteoarthritis will be recruited from two orthopaedic centres. Participants randomised to the usual-care group (n = 128) will be given a booklet about exercise and referred for physiotherapy if deemed appropriate by the clinical care team. The intervention group (n = 128) will receive the same usual care and additionally be invited to attend a group-based outpatient physiotherapy class starting 6 weeks after surgery. The 1-hour class will be run on a weekly basis over 6 weeks and will involve task-orientated and individualised exercises. The primary outcome will be the Lower Extremity Functional Scale at 12 months post-operative. Secondary outcomes include: quality of life, knee pain and function, depression, anxiety and satisfaction. Data collection will be by questionnaire prior to surgery and 3, 6 and 12 months after surgery and will include a resource-use questionnaire to enable a trial-based economic evaluation. Trial participation and satisfaction with the classes will be evaluated through structured telephone interviews. The primary statistical and economic analyses will be conducted on an intention-to-treat basis with and without imputation of missing data. The primary economic result will estimate the incremental cost per quality-adjusted life year gained from this intervention from a National Health Services (NHS) and personal social services perspective. DISCUSSION: This research aims to benefit patients and the NHS by providing evidence on the long-term effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement. If the intervention is found to be effective and cost-effective, implementation into clinical practice could lead to improvement in patients' outcomes and improved health care resource efficiency. TRIAL REGISTRATION: ISRCTN32087234 , registered on 11 February 2015.
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Assistência Ambulatorial/economia , Artroplastia do Joelho/economia , Custos de Cuidados de Saúde , Articulação do Joelho/cirurgia , Osteoartrite do Joelho/economia , Osteoartrite do Joelho/cirurgia , Modalidades de Fisioterapia/economia , Artroplastia do Joelho/efeitos adversos , Protocolos Clínicos , Análise Custo-Benefício , Inglaterra , Humanos , Articulação do Joelho/fisiopatologia , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/fisiopatologia , Satisfação do Paciente , Modalidades de Fisioterapia/efeitos adversos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Recuperação de Função Fisiológica , Projetos de Pesquisa , Medicina Estatal/economia , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
It was with some concern that I learned of the proposals for nursing roles to be expanded (news, May 18) as part of an initiative to supplement care delivered previously by junior doctors.
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Recursos Humanos de Enfermagem Hospitalar/provisão & distribuição , Admissão e Escalonamento de Pessoal , Carga de Trabalho , Educação Continuada em Enfermagem , Humanos , Corpo Clínico Hospitalar , Recursos Humanos de Enfermagem Hospitalar/educação , Reino UnidoRESUMO
BACKGROUND: Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. METHODS/DESIGN: INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. DISCUSSION: INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies. Results from the INFORM trial will also benefit clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness. TRIAL REGISTRATION: Current controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.