Details of HTA project
Last updated: 1 February 2012 - Next update due: 8 February 2012
Research type: |
Secondary Research (e.g. systematic review) |
Project title: |
Management of frozen shoulder: a systematic review and decision analytic model |
Project ref: |
09/13/02 |
Cost: |
£192,073 |
Chief Investigator : |
Dr Catriona McDaid, Research Fellow, Centre for Reviews and Dissemination, University of York |
Start Date: |
March 2010 |
Estimated date of publication in HTA journal series: |
April 2012. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
Frozen shoulder is a very painful condition in which movement of the shoulder becomes severely restricted. The condition starts with an increasing stiffness and loss of motion of the shoulder and considerable pain when moving, especially at night. This is thought to be a result of inflammation and swelling in the shoulder joint (capsule) with a resulting contraction of the shoulder joint capsule. Although pain does decrease within four to 12 months, the stiffness and restriction of movement remains. Generally the condition does resolve within one to three and a half years but during that time many daily activities such as dressing can be very difficult and the condition also impacts on working life, leisure and general quality of life. It is most common amongst people in their 50's and it is estimated that it affects between 2% and 5% of the general population. There are several treatment options available. Most commonly used are "watchful waiting" which involves explaining the condition to the patient and advising being active within pain limits, physical therapies such as mobilisation by a physiotherapist, acupuncture, steroid injections, mobilisation of the shoulder joint while under general anaesthesia, arthrographic distension (injection of saline or other solution to expand the shoulder capsule and free up the joint) and capsular release (a surgical procedure to release contracted tissue). Although less invasive treatment options are generally tried first, there is uncertainty about which are the most effective and at what stage of the condition they should be provided. There are previous systematic reviews evaluating some of these individual treatments. Unlike previous reviews that have focused on single treatments, the proposed research will take a broader perspective and examine overall management of the condition. The project will investigate what treatments are effective and provide the best value for money. This will involve (1) conducting a systematic review, to provide a rigorous and comprehensive summary of all the available evidence, while using standard methods to reduce error and bias in the conclusions and (2) developing a decision analytic model which, in addition to taking into account the effectiveness of the treatments and their impact on quality of life, will also be based on the best available data on costs of the different treatment options. Patient-assessed pain intensity, functional status (including disability and quality of life) and time to recovery will be the main outcomes of interest. The findings of the project will be disseminated through a report to the NIHR HTA programme, a non-technical summary of the findings and recommendations, which will be circulated to relevant healthcare professionals and professional and patient groups, and through the submission of papers to conferences and relevant clinical peer reviewed journals. A multidisciplinary team has been assembled that provides both methodological and clinical expertise. The team has extensive experience in systematic review methods, health economics, information science (to ensure that the search for evidence on effects and costs of treatments is as comprehensive as possible), clinical trials and dissemination of findings of research to a range of audiences. The clinical expertise on the team reflects key clinical groups that are involved in management of frozen shoulder: physiotherapy, general practice and orthopaedic surgery. The project will be based at the Centre for Reviews and Dissemination (CRD) at the University of York in conjunction with colleagues from Department of Health Sciences and Centre for Health Economics (CHE). The collaborative links between these departments are long established. CRD and CHE are one of the technology assessment groups that undertake systematic reviews and economic modelling for the NIHR National Collaborating Centre for Health Technology Assessment and National Institute for Health and Clinical Excellence (NICE). They have several years experience working together undertaking assessments of interventions used in the NHS. The quality of research produced by this group was highlighted in the 2008 Research Assessment Exercise (RAE). The University of York was ranked joint top for health services research in the UK based on a combined submission from Department of Health Sciences, CHE and CRD. The applicants will draw upon the wider expertise of this group, where necessary. The project will be large and complex given the number of different treatments identified in the commissioning brief. It will be undertaken over a 12 month period. The amount of time involved in undertaking the review, and therefore the costs, has been calculated based on preliminary literature searches, as well as previous experience of conducting systematic reviews and developing decision analytic models. To minimise error and bias it is good practice that at least two researchers undertake the systematic review and we have costed for two researchers each at 60% full time equivalent (FTE) over the life of the project. For the economic model we have costed one economist at 40% who will undertake the majority of the work with assistance from a junior economist at 20% FTE who will assist in sifting the literature, identifying data on costs and inputting and checking data. Supervision will be provided at 30% FTE by the lead applicant given the size and complexity of the project as well as the large team. Supervision and methodological advice will also be provided by a senior economist at 5% FTE. The remaining costs are mainly related to the clinical and methodological advisors to the project and the costs of literature searching. Telephone conferencing will be used for most meetings but we have requested costs for three face-to-face meetings of the team. |
Project Abstract: |
Search Strategy: A database of published and unpublished literature on the effectiveness and cost-effectiveness of the interventions will be assembled. Electronic sources will include MEDLINE, EMBASE, CINAHL PEDro DARE, NHS EED and the Cochrane Library and they will be searched without language restrictions. Review of effectiveness: Studies of patients with iodiopathic frozen shoulder undergoing physical therapies, steroid injection, arthrographic distension, manipulation under anaesthesia, arthrographic distension or capsular release will be included in the review. The approach of 'watchful waiting' will also be included. The primary outcomes of interest will be patient-assessed pain intensity, functional status (including disability scales and generic quality of life measures such as SF36) and time to recovery. RCTs will be included where available. In the absence of such evidence, other study designs will be considered. Two researchers will independently screen studies for inclusion. Data extraction and quality assessment will be undertaken by one researcher and checked by a second. A narrative, tabular and graphical summary of key study characteristics, results and quality assessment will be provided. Where appropriate, meta-analysis will be undertaken. Cost-effectiveness: A systematic review of the cost-effectiveness literature will also be undertaken. Evaluations will be included provided they compare two or more relevant alternatives, with costs and outcomes examined separately for each. Quality will be assessed and a summary of the findings will be used to inform the development of a decision model. The decision model will estimate the cost-effectiveness of the different interventions for frozen shoulder with health benefits expressed in terms of quality of life years (QALYs). The model will map patients' care pathways for the alternative therapies and will be reviewed by a range of clinical experts to ensure that the pathways are clinically meaningful. Based on the evidence synthesis, recommendations for clinical practice and future research will be made. |
Project Protocol: |
Project protocol (pdf format, 160 kbytes) |
URL of this page: |
http://www.hta.ac.uk/2160 |
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