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1.
Health Technol Assess ; 24(49): 1-130, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33043881

RESUMO

BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. PARTICIPANTS: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist. RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581. 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. 24, No. 49. See the NIHR Journals Library website for further project information.


Sciatica is pain that spreads into the leg because of a trapped nerve in the lower back. It can be a very painful condition that affects everyday life and ability to work. People with sciatica usually see their general practitioner first; if they do not get better over time, they may be referred to a physiotherapist or, eventually, to a spinal specialist. It is difficult to know which sciatica patient will do well without much treatment and who might need to see a physiotherapist or spinal specialist sooner. Stratified care is an approach aiming to help decide, early on, which patients need to see which health professionals. It has previously been shown to be helpful for patients with lower-back pain. In a trial of 476 patients with sciatica a stratified care model was tested to see if it led to faster improvements in sciatica-related leg pain, when compared with usual care. Adults seeing their general practitioner with sciatica were invited to attend a research clinic. Those willing to take part were randomly assigned to stratified care or usual care. Patients in the stratified care arm were referred either to physiotherapy for a short or a longer course of treatment, or to undergo magnetic resonance imaging and see a spinal specialist with the magnetic resonance imaging results within 4 weeks. Pain, function and quality-of-life data were collected over 12 months using text messages and questionnaires. Although patients in the stratified care arm improved slightly more quickly (2 weeks, on average), we did not find convincing evidence that stratified care led to better results than usual care. On average, most patients in both trial arms improved in a similar way over 12 months. The stratified care model tested in this trial did not lead to faster recovery for patients with sciatica than usual care.


Assuntos
Padrões de Prática Médica , Atenção Primária à Saúde , Ciática/terapia , Adulto , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modalidades de Fisioterapia , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica , Resultado do Tratamento , País de Gales
2.
Lancet Rheumatol ; 2(7): e401-e411, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32617529

RESUMO

BACKGROUND: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. METHODS: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. FINDINGS: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. INTERPRETATION: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. FUNDING: National Institute for Health Research.

3.
Rheumatol Adv Pract ; 2(2): rky018, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30506022

RESUMO

OBJECTIVES: Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. METHODS: A trial-based cost-utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. RESULTS: The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £-62.10 to £562.60; TEA-UC: £141.80, 95% CI: £-135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: -0.015, 95% CI: -0.057 to 0.026; TEA-UC: -0.003, 95% CI: -0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability <40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups. CONCLUSION: This is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 93634563. TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at http://www.biomedcentral.com/1471-2474/15/254 doi: 10.1186/1471-2474-15-254.

4.
Lancet ; 392(10156): 1423-1433, 2018 10 20.
Artigo em Inglês | MEDLINE | ID: mdl-30343858

RESUMO

BACKGROUND: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. METHODS: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. FINDINGS: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference -0·32; 95% CI -0·48 to -0·16; p=0·0001). No adverse events were reported. INTERPRETATION: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. FUNDING: Arthritis Research UK.


Assuntos
Anti-Inflamatórios/administração & dosagem , Síndrome do Túnel Carpal/terapia , Injeções , Metilprednisolona/análogos & derivados , Contenções , Adulto , Idoso , Síndrome do Túnel Carpal/economia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Metilprednisolona/administração & dosagem , Acetato de Metilprednisolona , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento
5.
Trials ; 19(1): 408, 2018 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-30064491

RESUMO

BACKGROUND: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. METHODS: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. RESULTS: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. CONCLUSIONS: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.


Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Término Precoce de Ensaios Clínicos , Modalidades de Fisioterapia , Ciática/tratamento farmacológico , Adalimumab/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Terapia Combinada , Contratos , Avaliação da Deficiência , Término Precoce de Ensaios Clínicos/economia , Humanos , Injeções Subcutâneas , Medição da Dor , Seleção de Pacientes , Modalidades de Fisioterapia/efeitos adversos , Apoio à Pesquisa como Assunto , Ciática/diagnóstico , Ciática/imunologia , Ciática/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Fator de Necrose Tumoral alfa/imunologia , Reino Unido
6.
Arthritis Care Res (Hoboken) ; 70(12): 1787-1794, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29609205

RESUMO

OBJECTIVE: To investigate the cost-effectiveness (cost-utility) of introducing general practitioner screening for anxiety and depression in patients consulting for osteoarthritis (OA). METHODS: A cluster-randomized trial-based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting for OA compared to usual care (screening for pain intensity) was undertaken over a 12-month period from a UK National Health Service and societal perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were estimated, and cost-effectiveness acceptability curves controlling for cluster-level data were constructed. The base-case analysis used the net benefit regressions approach. The 2-stage nonparametric sampling technique was explored in a sensitivity analysis. RESULTS: The base-case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY differential -0.029 [95% confidence interval -0.062, 0.003]). In the base-case analyses, general practitioner screening for anxiety and depression was unlikely to be a cost-effective option (probability <5% at £20,000/QALY). Similar results were observed in all sensitivity analyses. CONCLUSION: Prompting general practitioners to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost-effective. Further research is needed to explore clinically effective and cost-effective models of managing anxiety and depression in patients presenting with clinical OA.


Assuntos
Ansiedade/diagnóstico , Ansiedade/economia , Depressão/diagnóstico , Depressão/economia , Medicina Geral/economia , Custos de Cuidados de Saúde , Osteoartrite/diagnóstico , Osteoartrite/economia , Questionário de Saúde do Paciente/economia , Idoso , Ansiedade/psicologia , Ansiedade/terapia , Comorbidade , Análise Custo-Benefício , Depressão/psicologia , Depressão/terapia , Feminino , Humanos , Masculino , Osteoartrite/psicologia , Osteoartrite/terapia , Valor Preditivo dos Testes , Prognóstico , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal/economia , Fatores de Tempo , Reino Unido
7.
Pain ; 159(1): 128-138, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28976423

RESUMO

Musculoskeletal pain is a common cause of work absence, and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service into primary care to provide occupational support. Six general practices were randomised; patients were eligible if they were consulting their general practitioner with musculoskeletal pain and were employed and struggling at work or absent from work <6 months. Practices in the intervention arm could refer patients to a vocational advisor embedded within the practice providing a case-managed stepwise intervention addressing obstacles to working. The primary outcome was number of days off work, over 4 months. Participants in the intervention arm (n = 158) had fewer days work absence compared with the control arm (n = 180) (mean 9.3 [SD 21·7] vs 14·4 [SD 27·7]) days, incidence rate ratio 0·51 (95% confidence interval 0·26, 0·99), P = 0·048). The net societal benefit of the intervention compared with best care was £733: £748 gain (work absence) vs £15 loss (health care costs). The addition of a vocational advice service to best current primary care for patients consulting with musculoskeletal pain led to reduced absence and cost savings for society. If a similar early intervention to the one tested in this trial was implemented widely, it could potentially reduce days absent over 12 months by 16%, equating to an overall societal cost saving of approximately £500 million (US $6 billion) and requiring an investment of only £10 million.


Assuntos
Emprego , Custos de Cuidados de Saúde , Dor Musculoesquelética/economia , Atenção Primária à Saúde/economia , Orientação Vocacional , Adulto , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento
8.
Health Technol Assess ; 21(60): 1-180, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-29063827

RESUMO

BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. DESIGN: Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. SETTING: Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. PARTICIPANTS: Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. INTERVENTIONS: After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. MAIN OUTCOME MEASURES: Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. SAMPLE SIZE: To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t-test and 80% retention rate, 332 participants would have needed to be recruited. ANALYSIS PLAN: The primary effectiveness analysis would have been linear mixed models for repeated measures to measure the effects of time and group allocation. An internal pilot study would have involved the first 50 participants recruited across all centres. The primary economic analysis would have been a cost-utility analysis. RESULTS: The internal pilot study was discontinued as a result of low recruitment after eight participants were recruited from two out of six sites. One site withdrew from the study before recruitment started, one site did not complete contract negotiations and two sites signed contracts shortly before trial closure. In the two sites that did recruit participants, recruitment was slow. This was partly because of operational issues, but also because of a low rate of uptake from potential participants. LIMITATIONS: Although large numbers of invitations were sent to potential participants, identified by retrospective searches of general practitioner (GP) records, there was a low rate of uptake. Two sites planned to recruit participants during GP consultations but opened too late to recruit any participants. CONCLUSION: The main failure was attributable to problems with contracts. Because of this we were not able to complete the internal pilot or to test all of the different methods for primary care recruitment we had planned. A trial of biological therapy in patients with sciatica still needs to be done, but would require a clearer contracting process, qualitative research to ensure that patients would be willing to participate, and simpler recruitment methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14569274. 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. 21, No. 60. See the NIHR Journals Library website for further project information.


Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Injeções Subcutâneas , Seleção de Pacientes , Modalidades de Fisioterapia , Ciática/tratamento farmacológico , Análise Custo-Benefício , Humanos , Projetos Piloto , Resultado do Tratamento
9.
BMC Musculoskelet Disord ; 18(1): 172, 2017 04 26.
Artigo em Inglês | MEDLINE | ID: mdl-28441971

RESUMO

BACKGROUND: Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. METHODS/DESIGN: Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. DISCUSSION: This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. TRIAL REGISTRATION: ISRCTN75449581 , date: 20.11.2014.


Assuntos
Análise Custo-Benefício/métodos , Modalidades de Fisioterapia/economia , Ciática/economia , Ciática/reabilitação , Feminino , Humanos , Masculino , Projetos Piloto , Medicina de Precisão/economia , Medicina de Precisão/métodos , Ciática/diagnóstico , Método Simples-Cego
10.
BMJ Open ; 7(3): e012987, 2017 03 12.
Artigo em Inglês | MEDLINE | ID: mdl-28286331

RESUMO

INTRODUCTION: Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow. SETTING: A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK. OBJECTIVES: Investigate feasibility of a main RCT. PARTICIPANTS: Adult patients registered in participating practices and consulting with a musculoskeletal problem. INTERVENTIONS: 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway. OUTCOMES: Process outcomes and exploratory analyses of clinical and cost outcomes. DATA COLLECTION: Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records. BLINDING: The study statistician and research nurses were blinded to practice allocation. RESULTS: Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was -0.28 (95% CI -1.35 to 0.79) and at 12 months 0.12 (95% CI -1.27 to 1.51). CONCLUSIONS: A full RCT is feasible and will provide trial evidence about the clinical and cost-effectiveness of patient direct access to physiotherapy. TRIAL REGISTRATION NUMBER: ISRCTN23378642.


Assuntos
Clínicos Gerais , Acessibilidade aos Serviços de Saúde , Dor Musculoesquelética/terapia , Modalidades de Fisioterapia , Medicina Física e Reabilitação , Atenção Primária à Saúde , Encaminhamento e Consulta , Adulto , Análise Custo-Benefício , Feminino , Medicina Geral , Humanos , Masculino , Doenças Musculoesqueléticas/terapia , Projetos Piloto , Padrões de Prática Médica , Projetos de Pesquisa , Medicina Estatal , Inquéritos e Questionários , Reino Unido
11.
BMC Musculoskelet Disord ; 17(1): 415, 2016 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-27716159

RESUMO

BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. METHOD/DESIGN: A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. DISCUSSION: The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions. TRIAL REGISTRATION: Trial registration: EudraCT 2013-001435-48 (registered 05/06/2013), ClinicalTrials.gov NCT02038452 (registered 16/1/2014), and Current Controlled Trials ISRCTN09392969 (retrospectively registered 01/05/2014).


Assuntos
Síndrome do Túnel Carpal/terapia , Análise Custo-Benefício , Glucocorticoides/uso terapêutico , Metilprednisolona/análogos & derivados , Contenções/economia , Adulto , Síndrome do Túnel Carpal/economia , Glucocorticoides/administração & dosagem , Glucocorticoides/economia , Mãos , Humanos , Injeções , Metilprednisolona/administração & dosagem , Metilprednisolona/economia , Metilprednisolona/uso terapêutico , Acetato de Metilprednisolona , Satisfação do Paciente , Atenção Primária à Saúde/métodos , Inquéritos e Questionários , Resultado do Tratamento
12.
BMJ Open ; 6(10): e011735, 2016 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-27733409

RESUMO

OBJECTIVES: To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). DESIGN: Prospective cohort study. SETTING: Single musculoskeletal CATS at the primary-secondary care interface. PARTICIPANTS: 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. OUTCOME MEASURES: Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. RESULTS: Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3-6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. CONCLUSIONS: While most patients are appropriate for a 'one-stop shop' model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity.


Assuntos
Procedimentos Clínicos/organização & administração , Atenção à Saúde/organização & administração , Doenças Musculoesqueléticas/terapia , Atenção Primária à Saúde/organização & administração , Qualidade da Assistência à Saúde/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Autorrelato , Adolescente , Adulto , Análise Custo-Benefício , Estudos Transversais , Feminino , Humanos , Masculino , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Qualidade da Assistência à Saúde/tendências , Encaminhamento e Consulta/tendências , Reino Unido/epidemiologia , Adulto Jovem
13.
PLoS One ; 10(8): e0135460, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26317528

RESUMO

BACKGROUND: The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)-consisting of a GP consultation followed by information and advice on exercises-with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation. METHODS AND FINDINGS: Adults with new diagnosis of tennis elbow were recruited from 38 general practices in the UK, and randomly allocated to PCM (n = 120) or PCM plus TENS (n = 121). Outcomes included reduction in pain intensity and quality-adjusted-life-years (QALYs) based on the EQ5D and SF6D. Two economic perspectives were evaluated: (i) healthcare-inclusive of NHS and private health costs for the tennis elbow; (ii) societal-healthcare costs plus productivity losses through work absenteeism. Mean outcome and cost differences between the groups were evaluated using a multiple imputed dataset as the base case evaluation, with uncertainty represented in cost-effectiveness planes and through probabilistic cost-effectiveness acceptability curves). Incremental healthcare cost was £33 (95%CI -40, 106) and societal cost £65 (95%CI -307, 176) for PCM plus TENS. Mean differences in outcome were: 0.11 (95%CI -0.13, 0.35) for change in pain (0-10 pain scale); -0.015 (95%CI -0.058, 0.029) for QALYEQ5D; 0.007 (95%CI -0.022, 0.035) for QALYSF6D (higher score differences denote greater benefit for PCM plus TENS). The ICER (incremental cost effectiveness ratio) for the main evaluation of mean difference in societal cost (£) relative to mean difference in pain outcome was -582 (95%CI -8666, 8113). However, incremental ICERs show differences in cost-effectiveness of additional TENS, according to the outcome being evaluated. CONCLUSION: Our findings do not provide evidence for or against the cost-effectiveness of TENS as an adjunct to primary care management of tennis elbow.


Assuntos
Análise Custo-Benefício , Atenção Primária à Saúde , Cotovelo de Tenista/terapia , Estimulação Elétrica Nervosa Transcutânea , Absenteísmo , Gerenciamento Clínico , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Atenção Primária à Saúde/economia , Estimulação Elétrica Nervosa Transcutânea/economia , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do Tratamento , Reino Unido
14.
PLoS One ; 10(4): e0120042, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25849594

RESUMO

OBJECTIVE: Osteoarthritis pain has become a leading cause of decreased productivity and work disability in older workers, a major concern in primary care. How osteoarthritis pain leads to decreased productivity at work is unclear; the aim of this study was to elucidate causal mechanisms and thus identify potential opportunities for intervention. METHODS: Population-based prospective cohort study of primary care consulters with osteoarthritis. Path analysis was used to test proposed mechanisms by examining the association between pain at baseline, and onset of work productivity loss at three years for mediation by physical limitation, depression, poor sleep and poor coping mechanisms. RESULTS: High pain intensity was associated with onset of work productivity loss (Adjusted Odds Ratio 2.5; 95%CI 1.3, 4.8). About half of the effect of pain on work productivity was a direct effect, and half was mediated by the impact of pain on physical function. Depression, poor sleep quality and poor coping did not mediate the association between high pain intensity and onset of work productivity loss. CONCLUSIONS: As pain is a major cause of work productivity loss, results suggest that decreasing pain should be a major focus. However, successfully improving function may have an indirect effect by decreasing the impact of pain on work productivity, especially important as significant pain reduction is often difficult to achieve. Although depression, sleep problems, and coping strategies may be directly related to work productivity loss, addressing these issues may not have much effect on the significant impact of pain on work productivity.


Assuntos
Absenteísmo , Consultores/estatística & dados numéricos , Eficiência , Osteoartrite/fisiopatologia , Dor/complicações , Atenção Primária à Saúde/estatística & dados numéricos , Avaliação da Capacidade de Trabalho , Adaptação Psicológica , Adulto , Idoso , Depressão/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite/psicologia , Dor/fisiopatologia , Dor/psicologia , Estudos Prospectivos , Encaminhamento e Consulta , Fatores Socioeconômicos
15.
Spine (Phila Pa 1976) ; 40(6): 405-14, 2015 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-25599287

RESUMO

STUDY DESIGN: Within-study cost-utility analysis. OBJECTIVE: To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within risk-defined patient subgroups (that is, patients at low, medium, and high risk of persistent disabling pain). SUMMARY OF BACKGROUND DATA: Individual-level data collected alongside a prospective, sequential comparison of separate patient cohorts with 6-month follow-up. METHODS: Adopting a cost-utility framework, the base case analysis estimated the incremental LBP-related health care cost per additional quality-adjusted life year (QALY) by risk subgroup. QALYs were constructed from responses to the 3-level EQ-5D, a preference-based health-related quality of life instrument. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative methodological approaches, including a complete case analysis, the incorporation of non-back pain-related health care use and estimation of societal costs relating to work absence. RESULTS: Stratified care was a dominant treatment strategy compared with usual care for patients at high risk, with mean health care cost savings of £124 and an incremental QALY estimate of 0.023. The likelihood that stratified care provides a cost-effective use of resources for patients at low and medium risk is no greater than 60% irrespective of a decision makers' willingness-to-pay for additional QALYs. Patients at medium and high risk of persistent disability in paid employment at 6-month follow-up reported, on average, 6 fewer days of LBP-related work absence in the stratified care cohort compared with usual care (associated societal cost savings per employed patient of £736 and £652, respectively). CONCLUSION: At the observed level of adherence to screening tool recommendations for matched treatments, stratified care for LBP is cost-effective for patients at high risk of persistent disabling LBP only. LEVEL OF EVIDENCE: 2.


Assuntos
Dor Lombar/terapia , Manejo da Dor/economia , Manejo da Dor/métodos , Atenção Primária à Saúde/economia , Atenção Primária à Saúde/métodos , Adulto , Análise Custo-Benefício , Feminino , Humanos , Masculino , Estudos Prospectivos , Qualidade de Vida
16.
Rheumatology (Oxford) ; 54(5): 876-83, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25339642

RESUMO

OBJECTIVES: Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. METHODS: A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. RESULTS: Mean costs (QALYs) were £58.46 (s.d. 0.662) for leaflet and advice, £92.12 (s.d. 0.659) for joint protection, £64.51 (s.d. 0.681) for hand exercises and £112.38 (s.d. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. CONCLUSION: This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option.


Assuntos
Análise Custo-Benefício/métodos , Articulação da Mão , Osteoartrite/terapia , Modalidades de Fisioterapia/economia , Equipamentos de Proteção/economia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Análise de Regressão , Medicina Estatal , Resultado do Tratamento , Reino Unido
17.
BMJ Open ; 4(9): e005221, 2014 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-25190616

RESUMO

OBJECTIVE: To describe the prevalence of expected work limitations (EWL) prior to future retirement age in osteoarthritis consulters, and the associated health, sociodemographic and workplace factors. DESIGN: Population-based prospective cohort study. SETTING: General practices in Staffordshire, England. PARTICIPANTS: 297 working adults aged 50-65, who had consulted primary care for osteoarthritis. OUTCOME: EWL was defined using a single question, "Do you think joint pain will limit your ability to work before you reach 69 years old?" RESULTS: 51 (17.2%) indicated that joint pain would not limit their ability to work until 69, 79 (26.6%) indicated EWL and 167 (56.2%) did not know if joint pain would limit work before 69. In bivariate analysis, physical function (OR 0.93; 95% CI 0.91 to 0.96), depression (4.51; 1.81 to 11.3), cognitive symptom (3.84; 1.81 to 8.18), current smoker (2.75; 1.02 to 7.38), age (0.69; 0.58 to 0.82), physically demanding job (3.18; 1.50 to 6.72), no opportunities to retrain (3.01; 1.29 to 7.05) and work dissatisfaction (3.69; 1.43 to 9.49) were associated with EWL. The final multivariate model included physical function and age. CONCLUSIONS: Only one in five osteoarthritis consulters expected that joint pain would not limit their work participation before 69 years of age. Given the expectation for people to work until they are older, the results highlight the increasing need for clinicians to include work participation in their consultation and implement strategies to address work loss/limitation. Targeting pain-related functional limitation and effective communication with employers to manage workplace issues could reduce EWL.


Assuntos
Osteoartrite/diagnóstico , Avaliação da Capacidade de Trabalho , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde , Estudos Prospectivos , Fatores Socioeconômicos
18.
Implement Sci ; 9: 95, 2014 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-25209897

RESUMO

BACKGROUND: There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. DESIGN: A mixed methods study with a nested cluster randomised controlled trial. METHOD: This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive 'whole-system' evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations. DISCUSSION: The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance. TRIAL REGISTRATION: ISRCTN number: ISRCTN06984617.


Assuntos
Medicina Geral/métodos , Fidelidade a Diretrizes , Osteoartrite/terapia , Guias de Prática Clínica como Assunto , Idoso , Protocolos Clínicos , Análise por Conglomerados , Análise Custo-Benefício , Educação Médica Continuada/economia , Estudos de Viabilidade , Feminino , Grupos Focais , Medicina Geral/educação , Pessoal de Saúde/educação , Implementação de Plano de Saúde , Humanos , Entrevista Psicológica , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Osteoartrite/economia , Equipe de Assistência ao Paciente , Satisfação do Paciente , Simulação de Paciente , Encaminhamento e Consulta/economia , Inquéritos e Questionários , Resultado do Tratamento , Reino Unido
19.
BMC Musculoskelet Disord ; 15: 254, 2014 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-25064573

RESUMO

BACKGROUND: Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. METHODS/DESIGN: Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. DISCUSSION: This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. TRIAL REGISTRATION ISRCTN: ISRCTN93634563.


Assuntos
Terapia por Exercício/economia , Terapia por Exercício/métodos , Custos de Cuidados de Saúde , Articulação do Joelho/fisiopatologia , Osteoartrite do Joelho/terapia , Projetos de Pesquisa , Fatores Etários , Protocolos Clínicos , Análise Custo-Benefício , Avaliação da Deficiência , Humanos , Pessoa de Meia-Idade , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/economia , Osteoartrite do Joelho/fisiopatologia , Cooperação do Paciente , Recuperação de Função Fisiológica , Medicina Estatal , Fatores de Tempo , Resultado do Tratamento , Reino Unido
20.
BMC Musculoskelet Disord ; 15: 232, 2014 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-25012813

RESUMO

BACKGROUND: Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. METHODS/DESIGN: This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. DISCUSSION: This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52269669.


Assuntos
Aconselhamento , Dor Musculoesquelética/terapia , Doenças Profissionais/terapia , Serviços de Saúde do Trabalhador , Atenção Primária à Saúde , Projetos de Pesquisa , Absenteísmo , Administração de Caso , Protocolos Clínicos , Análise Custo-Benefício , Aconselhamento/economia , Inglaterra , Medicina Geral , Custos de Cuidados de Saúde , Humanos , Dor Musculoesquelética/diagnóstico , Dor Musculoesquelética/economia , Doenças Profissionais/diagnóstico , Doenças Profissionais/economia , Serviços de Saúde do Trabalhador/economia , Atenção Primária à Saúde/economia , Anos de Vida Ajustados por Qualidade de Vida , Licença Médica , Fatores de Tempo , Resultado do Tratamento
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