PROSPERO International prospective register of systematic reviews Closed reduction methods for acute anterior shoulder dislocation [Cochrane Protocol] Kanthan Theivendran, Raj Thakrar, Subodh Deshmukh, Kerry Dwan Citation Kanthan Theivendran, Raj Thakrar, Subodh Deshmukh, Kerry Dwan. Closed reduction methods for acute anterior shoulder dislocation [Cochrane Protocol]. PROSPERO 2015:CRD42015017735 Available from http://www.crd.york.ac.uk/prospero_rebranding/display_record.asp?id=crd42015017735 Review question(s) To compare the effects of different methods of closed reduction of acute anterior shoulder dislocation. Searches We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (in The Cochrane Library, current issue), MEDLINE (1946 to present) and EMBASE (1980 to present). We will also search the World Health Organization International Clinical Trials Registry platform and Current Controlled Trials to identify ongoing and recently completed trials. We will apply no restrictions based on language or publication status. In MEDLINE (Ovid Online), we will combine a subject-specific strategy with a modified version of the of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (sensitivity-maximising version) (Lefebvre 2011). Search strategies for MEDLINE, The Cochrane Library and EMBASE can be found in Appendix 1. [in the full protocol on the Cochrane Library] We will check reference lists of articles. We will also attempt to contact researchers in the field for information on existing or ongoing trials. We will search specific proceedings of shoulder and elbow surgery meetings and conferences from the following sources: British Elbow and Shoulder Society (2001 onwards); American Orthopaedic Trauma Association (1996 onwards); The Bone and Joint Journal Orthopaedic Proceedings (2001 onwards) and American Shoulder and Elbow Society (2005 onwards). Electronic searches We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (in The Cochrane Library, current issue), MEDLINE (1946 to present) and EMBASE (1980 to present). We will also search the World Health Organization International Clinical Trials Registry platform and Current Controlled Trials to identify ongoing and recently completed trials. We will apply no restrictions based on language or publication status. In MEDLINE (Ovid Online), we will combine a subject-specific strategy with a modified version of the of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (sensitivity-maximising version) (Lefebvre 2011). Search strategies for MEDLINE, The Cochrane Library and EMBASE can be found in Appendix 1. [in the full protocol on the Cochrane Library] Searching other resources We will check reference lists of articles. We will also attempt to contact researchers in the field for information on existing or ongoing trials. We will search specific proceedings of shoulder and elbow surgery meetings and conferences from the following sources: British Elbow and Shoulder Society (2001 onwards); American Orthopaedic Trauma Association (1996 onwards); The Bone and Joint Journal Orthopaedic Proceedings (2001 onwards) and American Shoulder and Elbow Society (2005 onwards). Types of study to be included Page: 1 / 6
Randomised controlled trials and quasi-randomised (using a method of allocating participants to a treatment that is not strictly random, e.g. by hospital number) controlled trials evaluating closed reduction methods for acute anterior shoulder dislocation. Condition or domain being studied The Cochrane Bone, Joint and Muscle Trauma Group Participants/ population People who have an acute anterior shoulder dislocation that is considered suitable by the trial investigators for reduction by closed methods (non-surgical procedure). This can be a primary or first-time dislocation or a redislocation. Closed reduction can take place in any setting. Ideally, the acute anterior shoulder dislocation should have been confirmed by physical examination and radiography or other imaging technique. Where trials do not specify their method of diagnosis or base their diagnosis on physical examination alone, we will consider the potential for misdiagnosis, such as a missed proximal humeral fracture. We will exclude trials focusing on people with fracturedislocations of the proximal humerus. Although we will not exclude trials including patients presenting more that 24 hours after injury, we anticipate that most trials will exclude these late presentations as they are generally treated in theatre. Intervention(s), exposure(s) Various methods (manipulative manoeuvres) of closed reduction of anterior shoulder dislocation have been described. We aim to compare different methods of putting the shoulder joint back into its normal position (reduction) without the need for surgery. We will group reduction techniques according to their principal mode of action: tractioncountertraction, leverage and scapular manipulation. We plan the following comparisons based on the principal modes of action. Leverage versus traction-countertraction Scapular manipulation versus traction-countertraction Scapular manipulation versus leverage When comparing techniques with similar modes of action, the control comparison will be the older or more established of the methods used. Comparator(s)/ control Specified above. Outcome(s) Primary outcomes Reduction success. We will define this as a successful reduction after up to two attempts with the same technique, without requiring a major change in analgesia or anaesthesia. We will collect other definitions of reduction success used by study authors under the secondary outcome 'reduction failure'. Pain scores (visual analogue scale) measured during the procedure. Complications: for example, early complications can include fractures of the proximal humerus and nerve injuries; complete failure requiring general anaesthesia, surgery or both. Secondary outcomes 'Reduction failure' (lack of success) as defined by study authors. This could include a change in technique, more than two attempts at reduction and complete failure. Patient satisfaction with intervention. Number of attempts at reduction. Page: 2 / 6
Subsequent recurrence of dislocation, preferably assessed at one year or more. Long-term shoulder function assessed using validated patient-reported outcome measures such as the Oxford Shoulder Instability Score (Dawson 1999) and Western Ontario Shoulder Instability Score (WOSI) (Kirkley 1998), preferably assessed at one year. Duration of reduction procedure (time taken to put the shoulder back into joint from start of closed reduction procedure). Data extraction, (selection and coding) Selection of studies Two review authors (KT and RT) will independently examine the titles and abstracts of articles identified via the search for potentially eligible trials. After obtaining the full texts of these trials, where possible, the same two authors will then independently perform study selection based on our inclusion criteria. Any disagreement will be discussed and, if necessary, a third author (SD) will arbitrate. Where necessary, we will attempt to contact trial authors for clarification of study methods. Data extraction and management Two review authors (KT and RT) will independently extract data from each included trial using a piloted data extraction form. We will resolve any differences in data extraction by consensus, and by referring back to the original article. When necessary, we will seek information from the study authors. Disagreement will be resolved by discussion and, where necessary, in consultation with a third review author (SD). Risk of bias (quality) assessment Assessment of risk bias in included studies Two review authors (RT and KD) will independently assess the risk of bias of the included studies using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). We will assess the following domains: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; completeness of outcome data; selective reporting and other bias. We will attempt to locate trial registrations of included trials in trial registries; this will include the UK National Research Register (NRR) Archive, where appropriate. We will consider two sources of other bias: that from major imbalances in baseline characteristics (age, time from injury, primary or recurrent dislocations) and additional performance bias arising from differences in the level of experience of the care providers with the methods of reduction under test. We will judge each of these domains as being at low risk of bias, high risk of bias or unclear risk of bias (either lack of information or uncertainty over the potential for bias). Disagreement will be resolved by discussion and, where necessary, in consultation with a third review author (SD). Strategy for data synthesis Data synthesis When considered appropriate, we will pool results of comparable groups of trials using both fixed-effect and randomeffects models. The choice of the model to report will be guided by careful consideration of the extent of heterogeneity and whether it can be explained, in addition to other factors, such as the number and size of included studies. We will use 95% CIs throughout. We will consider not pooling data where there is considerable heterogeneity (I² > 75%) that cannot be explained by the diversity of methodological or clinical features among trials. Where it is inappropriate to pool data, we will still present trial data in the analyses or tables for illustrative purposes and will report these in the text. Assessment of heterogeneity We will assess clinical heterogeneity within all comparisons of all included trials. We will assess statistical heterogeneity by visual inspection of graphs (e.g. forest plots) and calculation of the I² statistic, which provides an estimate of the percentage of variability due to heterogeneity rather than to chance alone. We will judge there to be 'considerable heterogeneity' if the I² estimate is 75% or more (Higgins 2003; Higgins 2011). Assessment of reporting biases We will investigate the possibility of publication bias by constructing a funnel plot if there are data from more than 10 trials. Page: 3 / 6
Sensitivity analysis Where possible, we plan to conduct sensitivity analyses examining various aspects of trial and review methodology. These will include examining the effects of: excluding trials at high or unclear risk of bias, such as selection bias arising from the lack of allocation concealment; excluding trials only reported in conference abstracts; excluding trials with unit of analyses problems related to the inclusion of participants with bilateral dislocations; the choice of statistical model for pooling (fixed-effect versus random-effects); missing data. Assessing the quality of the evidence We will use the GRADE approach to assess the quality of evidence related to each of the primary outcomes listed in Types of outcome measures (Higgins 2011; see section 12.2). Where there are sufficient data, we will summarise the results for the main comparisons described in Types of interventions in 'Summary of findings' tables. Analysis of subgroups or subsets Where data allow, we will analyse variations of similar techniques or methods of reduction. If possible, and where relevant, we will conduct the following subgroup analyses: participants with first time versus recurrent dislocation; age range: less than 30 years, older than 30 years (Hovelius 2008); athletes versus non-athletes; the use/type of anaesthesia/sedation (including sedation, intra-articular anaesthetic and intravenous analgesia). The age ranges have been chosen to reflect those reported in an important long-term study by Hovelius 2008, highlighting the higher chances of recurrence of dislocation in the younger age category. We will investigate whether the results of subgroups are significantly different by inspecting the overlap of confidence intervals and performing the test for subgroup differences available in Review Manager 5.2 (RevMan 2012). Dissemination plans This is a Cochrane review and will be published in full online in the Cochrane Database of Systematic Reviews (CDSR), which is a core component of The Cochrane Library. Contact details for further information Kanthan Theivendran k.theivendran@nhs.net Organisational affiliation of the review The Cochrane Collaboration http://www.cochrane.org/ Review team Mr Kanthan Theivendran, University Hospital Birmingham NHS Foundation Trust Mr Raj Thakrar, The Royal Orthopaedic Hospital NHS Foundation Trust Mr Subodh Deshmukh, The Royal Orthopaedic Hospital NHS Foundation Trust Dr Kerry Dwan, University of Liverpool Anticipated or actual start date 15 March 2014 Page: 4 / 6
Anticipated completion date 15 March 2016 Funding sources/sponsors University Hospital Birmingham, Royal Orthopaedic Hospital, Birmingham Conflicts of interest Kanthan Theivendran: none known Raj R Thakrar: none known Subodh C Deshmukh: none known Kerry Dwan: none known Other registration details This is a protocol for a Cochrane review, full details are available on The Cochrane Library. Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Humans; Manipulation, Orthopedic; Reconstructive Surgical Procedures; Shoulder Dislocation Stage of review Ongoing Date of registration in PROSPERO 24 March 2015 Date of publication of this revision 24 March 2015 DOI 10.15124/CRD42015017735 Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes No Formal screening of search results against eligibility criteria No No Data extraction No No Risk of bias (quality) assessment No No Data analysis No No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, Page: 5 / 6
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