Surgical interventions for the rheumatoid shoulder
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective of this review is to assess beneficial and harmful effects of all forms of surgical treatment in the management of the rheumatoid shoulder.
Background
Rheumatoid arthritis (RA) is a chronic systemic disease that afflicts between 0.3% and 0.8% of the general population (Bone 2005). RA often starts with inflammation in the small joints of the hands and feet. However, debut in the shoulder joint has been reported in approximately 20% of the patients (Olofsson 2003), and it is estimated that between 80 and 90% of the RA patients with more than 15 years disease duration are severely affected in the shoulders (Petersson 1986).
Shoulder pain and functional limitations can severely limit performance and activities of daily living, even when the patients have a well‐functioning elbow and hand. A pain free and flexible shoulder is therefore essential for independent functioning for rheumatic patients. In early stages of shoulder joint involvement, synovectomy of the glenohumeral joint might be a treatment option. Since RA, unlike other shoulder conditions, is usually progressive and the destructive disease process causes irreversible bony erosions and the joints become structurally deformed, arthroplasties may be considered as the only beneficial treatment option. However, even if arthroplasties are potentially highly beneficial procedures, there might also be some possibility of harm associated with this treatment.
To our knowledge there are few systematic reviews of surgical interventions for rheumatic shoulders. A literature review undertaken by the Swedish Council on Technology Assessment in Health Care indicates that synovectomies and arthroplasties in the shoulder are associated with pain reduction (SBU 1998) but the report concluded that the methods are evaluated largely on the basis of accepted clinical practice and uncontrolled studies, and that scientific methods in the field can be improved substantially.
Objectives
The objective of this review is to assess beneficial and harmful effects of all forms of surgical treatment in the management of the rheumatoid shoulder.
Methods
Criteria for considering studies for this review
Types of studies
Included studies must have the primary aim of evaluating beneficial or harmful effects of surgical procedures for the rheumatoid shoulder.
Three main categories of study designs will be included:
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Experimental studies with randomly assigned interventions (RCTs), i.e. randomised or quasi‐randomised studies (alternate allocation, case record numbers, dates of birth etc.).
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Controlled before and after studies (CBAs), i.e. comparative observational studies where the intervention groups are not defined by the investigators, i.e. cohort studies and case‐control studies.
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Non‐comparative studies, i.e. case‐series. However, this study design will only be considered for the assessment of harmful effects.
Types of participants
We will include trials with male and female participants, between 16 and 80 years of age, who have:
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RA according to the 1987 American College of Rheumatology (ACR) criteria or other acceptable diagnostic criteria. Studies including other related diagnoses, such as osteoarthritis, will only be included if data can be extracted for the RA‐group separately.
Trials including patients with (primary) osteoporosis or traumatic fractures will be excluded.
Types of interventions
All forms of surgical treatment in the management of the rheumatoid shoulder will be considered.
In comparative studies, all control interventions will be eligible, including no treatment (including placebo) and any other therapy (including different surgical interventions).
Types of outcome measures
The main outcomes of interest are:
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Shoulder function
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Shoulder pain.
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Active shoulder range of motion
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General functional abilities
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Health‐related quality of life
Other outcomes that are important for patients or others, such as patient satisfaction, overall improvement, general well being will also be considered. Only outcomes assessed with validated instruments will be considered.
Surgical interventions for rheumatic shoulders can be considered as potentially highly beneficial, but there are also some safety concerns related to surgery. A special emphasis will therefore be given to unintended effects in this review. The most known complications following surgical procedures, such as loosening, infections, neurological injuries and others will be collected and reported in the review.
Search methods for identification of studies
Relevant studies will be identified by electronically searching in the following databases:
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The Cochrane Musculoskeletal Review Group's Specialized Register (to August 2006)
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The Cochrane Central Register of Controlled Trials (CENTRAL) (to August 2006)
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MEDLINE (1966 to August 2006)
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EMBASE (1980 to August 2006)
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SCISEARCH (1987 to August 2006)
The following search strategy was used for MEDLINE: Appendix 1.
A similar process will be used for the other databases.
Studies will also be identified by:
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Scanning the reference lists of retrieved reports
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Personal contact with the authors of included articles
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Search of abstracts published in relevant Conference Proceedings (for example ERASS).
Data collection and analysis
Two reviewers will independently assess all citations, and any study that either reviewer consider potentially relevant will be retrieved.
Two reviewers will independently assess the relevance of all retrieved articles that are considered potentially relevant using the inclusion criteria specified above. Disagreements will be resolved by discussion. A third reviewer will be consulted for any disagreements that could not be resolved. The number and reasons for disagreements will be recorded. Studies for which there are disagreements or initial uncertainty about being excluded are listed in the excluded studies table with the reasons for exclusion recorded.
Methodological quality
Two reviewers will independently assess the validity of the included studies by employing a set of specific methodological criteria for each main category of study designs:
For RCT's the following criteria recommended in the Cochrane Handbook (Higgins 2005) will be used:
Concealment of allocation
A. Adequate concealment ‐ Allocation of participants to different groups was not known until the point of allocation (e.g. sequentially numbered, sealed, opaque envelopes; onsite computer system with locked, unreadable files)
B. Unclear concealment (e.g. stating only that a list or table was used)
C. Inadequate concealment ‐ Transparent before allocation (e.g. alternation; case record numbers; dates of birth or days of the week)
D. Not used ‐ clear that allocation concealment was not used
Outcome assessment
MET: Assessor unaware of the assigned treatment when collecting outcome measures
UNCLEAR: Blinding of assessor not reported and cannot be verified by contacting investigators
NOT MET: Assessor aware of the assigned treatment when collecting outcome measures.
Co‐intervention
MET: Interventions other than the intervention of interest avoided, controlled or used similarly across comparison groups.
UNCLEAR: Use of interventions other than the intervention of interest not reported and cannot be verified by contacting the investigators
NOT MET: Dissimilar use of interventions other than the intervention of interest across comparison groups, i. e. differences in the care provided to the participants in the comparison groups other than the intervention under investigation.
Blinding of provider or patient
MET: The patient or the provider was blinded for the intervention. We will note if one or both.
UNCLEAR: Blinding not reported
NOT MET: The patient and the provider were not blinded for the intervention.
Losses to follow up
MET: Losses to follow up less or equal than 20% and equally distributed between comparison groups
UNCLEAR: Losses to follow up not reported
NOT MET: Losses to follow up greater than 20% or not equally distributed between comparison groups
Intention‐to‐treat
MET: Intention to treat analysis performed or possible with data provided
UNCLEAR: Intention to treat not reported, and cannot be verified by contacting the investigators
NOT MET: Intention to treat analyses not done and not possible for reviewers to calculate independently.
For Controlled Before and After studies the Newcastle‐Ottawa Scale will be used.
There are separate checklists for cohort‐studies and case control studies, but for both designs there is four items related to selection, one item related to comparability and three items related to exposure. The manuals and scales are presented in detail and are available at:
http://www.ohri.ca/programs/clinical_epidemiology/oxford.htm
For Non‐Comparative studies (Case‐series) assessing adverse effects the following six criteria suggested byCRD 2001will be used:
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Is the study based on a representative sample selected from a relevant population?
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Are the criteria for inclusion explicit?
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Did all individuals enter the survey at a similar point in their disease progression?
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Was follow‐up long enough for important events to occur?
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Were outcomes assessed using objective criteria or was blinding used?
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If comparisons of sub‐series are being made, was there sufficient description of the series and the distribution of prognostic factors?
Data Extraction
Two reviewers will independently extract data from the full text report using a specially designed and pilot tested data extraction form. Discrepancies will be resolved by consensus. If the article doesn't contain data on characteristics of methodological issues, the study population or necessary data for statistical analyses, letters will be sent to the investigators to collect missing data.
Analyses
Included studies will be stratified in sub‐categories according to:
‐ Type of intervention (synovectomies, arthroplasties etc.).
‐ Type of study design (RCTs, observational comparative studies, non‐comparative studies).
‐ Different stages of the disease and if possible, relate those to the surgical treatment.
It is likely that included studies will compare a variety of interventions and employ a variety of outcome measures at different time points, comparisons and subgroup analysis will therefore be performed as appropriate.
For dichotomous outcomes we will calculate an overall relative risk (with 95% CI). Weighted mean difference will be calculated for continuous outcomes with identical instruments (with 95% CI). Standard mean difference will be calculated if the outcome measure instruments are similar, but not identical across studies. Both random effects model and fixed effect model will be used.
Heterogeneity will be tested by applying a chi‐square test and I‐squared test. If the I‐squared test shows a value greater than 50%, we consider this to indicate a substantial heterogeneity, and a random effects model will be used and causes of heterogeneity will be explored (Higgins 2005).
In order to assess the robustness of conclusions to quality of data and clinical heterogeneity, sensitivity analyses will be performed in terms of studies of different levels of methodological quality, differences in sub‐types of interventions, and differences in participant characteristics.
If the nature of the included studies do not allow for pooling of results (clinically or statistically) a narrative (qualitative) summary from studies will be used to present the results.
For unintended effects (results from the non‐comparative studies), the frequency of complications at each follow up point will be presented.
Clinical relevance
Clinical relevance tables will be compiled under additional tables to improve the readability of the review. For dichotomous outcomes, the weighted absolute risk difference will be calculated using the risk difference (RD) statistic in RevMan. RR‐1 calculates the weighted relative percent change. The number needed to treat (NNT) will be calculated from the control group event rate (unless the population event rate is known) and the relative risk using the Visual Rx NNT calculator (Cates 2004).
Continuous outcome tables will also be presented under additional tables. Weighted absolute change will be calculated from the weighted mean difference (WMD) statistic in RevMan when trials using the same scale are pooled. For outcomes pooled on different scales, the standardized mean difference (SMD) is multiplied by the baseline standard deviation in the control group to obtain the weighted absolute change. Relative percent change from baseline will be calculated as the absolute benefit divided by the baseline mean of the control group. NNT is calculated using the Wells calculator software available at the CMSG editorial office. The minimal clinically important difference (MCID) for each outcome will be determined for input into the calculator. (CMSG 2006). According to the Philadelphia Panel an improvement at 15% relative to a control group can be considered clinically relevant (Philadelphia 2001).
Grading of evidence
The quality of evidence will be assessed according to a systematic and explicit method (GRADE 2004). In order to indicate the extent to which one can be confident that an estimate of effect is correct, judgments about the quality of evidence will be made for each comparison and outcome. These judgments will consider study design (RCT, quasi RCT or observational study), study quality (detailed study design and execution), consistency of results (similarity of estimates of effect across studies) and directness (the extent to which people, interventions and outcome measures are similar to those of interest). The following definitions in grading the quality of evidence for each outcome will be used.
High: further research is very unlikely to change our confidence in the estimate of effect.
Moderate: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low: further research is very likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Very low: any estimate of effect is very uncertain.
In addition, we will use the grading system described in the 2004 book Evidence‐based Rheumatology (Tugwell 2004) and recommended by the Musculoskeletal Group:
Platinum:
To achieve the platinum level of evidence, a published systematic review that has at least two individual controlled trials each satisfying the following is required:
·Sample sizes of at least 50 per group ‐ if these do not find a statistically significant difference, they are adequately powered for a 20% relative difference in the relevant outcome.
·Blinding of patients and assessors for outcomes.
·Handling of withdrawals >80% follow up (imputations based on methods such as Last Observation Carried Forward (LOCF) are acceptable).
·Concealment of treatment allocation.
Gold:
The gold level of evidence requires at least one randomised clinical trial meeting all of the following criteria for the major outcome(s) as reported:
·Sample sizes of at least 50 per group ‐ if these do not find a statistically significant difference, they are adequately powered for a 20% relative difference in the relevant outcome.
·Blinding of patients and assessors for outcomes.
·Handling of withdrawals > 80% follow up (imputations based on methods such as LOCF are acceptable).
·Concealment of treatment allocation.
Silver:
The silver level of evidence requires a randomised trial that does not meet the above criteria for gold or platinum ranking or evidence from at least one study of non‐randomised cohorts that did and did not receive the therapy, or evidence from at least one high quality case‐control study. A randomised trial with a 'head‐to‐head' comparison of agents would be considered silver level ranking unless a reference were provided to a comparison of one of the agents to placebo showing at least a 20% relative difference.
Bronze:
The bronze ranking is requires at least one high quality case series without controls (including simple before/after studies in which patients act as their own control) or a conclusion derived from expert opinion based on clinical experience without reference to any of the foregoing (for example, argument from physiology, bench research or first principles).
