Regional analgesia for improvement of long‐term functional outcome after elective large joint replacement
Appendices
Appendix 1. MEDLINE search strategy via OvidSP
1. Analgesia/ or exp Analgesia, Epidural/ or (regional adj3 analg*).ti,ab. or (analg* and rehabilitat*).mp.
2. exp Arthroplasty, Replacement, Hip/ or exp Arthroplasty, Replacement, Knee/ or exp Arthroplasty, Replacement/ or exp Arthroplasty, Replacement, Shoulder/ or "Range of Motion, Articular"/ or ((joint* or arthroplasty or arthritic or shoulder or hip or knee) adj3 replac*).af. or (joint* and replac* and (surg* or procedur* or operat*)).mp. or (joint* and (long or short) and (flexibility or mobility or functionality)).mp. or (articular adj3 (range or motion)).mp.
3. 1 and 2
4. ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab.) not (animals not (humans and animals)).sh.
5. 3 and 4
Appendix 2. Data Collection Form
Study Selection, Quality Assessment & Data Extraction Form
Person Extracting Data: AA/ GS/MHA/HS
| ID # | First author | Journal/Conference Proceedings etc | Year | PMID/Identifier unpublished |
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Study eligibility
| Intervention | Non Regional Comparator | Functionality |
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Regional / No / Unclear |
Yes / No / Unclear |
Movement / No / Unclear |
| Do not proceed if any of the above answers are ‘No’. If study to be included in ‘Excluded studies’ section of the review, record below the information/reason to be inserted into ‘Table of excluded studies’. Done: |
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Freehand space for comments on study design and treatment:
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References to trial
Check other references identified in searches. If there are further references to this trial link the papers now & list below. All references to a trial should be linked under one Study ID in RevMan.
| Code each paper | ID# | Author(s) | Journal/Conference Proceedings etc | Year | PMID/ Identifier |
| A |
| The paper listed above |
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| B |
| Further papers |
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| C |
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Participants and trial characteristics
| Trial characteristics |
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| Further details | |
| Single centre / multicentre |
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| Country / Countries |
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| Trial design
| Randomized Yes No Controlled Yes No Placebo Alternative Treatment Cross‐Over Parallel Prospective Retrospective Groups: 1 2 3 More ‐‐‐‐
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| Participant characteristics | |
| Further details |
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| Total Hip replacement Total shoulder replacement Total Knee Replacement Other |
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| @ screening/enrolment: @ randomization: @ endpoint: |
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| Age (mean, SD) | Each group all patients |
| Paediatric Population % | 0 |
| Sex of participants (men/women) | Exp Control |
| Inclusion Criteria |
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| Exclusion Criteria |
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| Co‐morbidities |
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| Intervention | |
| Regional Nerve Block | Epidural Femoral Block Interscalene other |
| Active Ingredient | Ropivicaine Bupivicaine Other |
| Describe the Regional Technique administered |
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| Comparator | |
| Comparator | Placebo General Anesthesia Describe : ____________ |
| Comments |
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| Outcomes | |
| Follow up period(s) | Pre First@___ second@___ third@____ forth@____ |
| Outcome(s) | Dichotomous Continuous Ordinal Responder data Primary: Secondary: |
Methodological quality
Free Text Comments:
| Selection bias/Allocation of intervention | |
| State here method used to generate allocation and reasons for grading | Bias |
| Allocation is clearly described. An accepted randomized method is used. Randomization is done at appropriate time point. Detail: _________________________________________________________ | Low‐risk |
| High‐risk | |
| Unclear | |
| Performance bias/Concealment of allocation Process used to prevent foreknowledge of group assignment in a RCT, which should be seen as distinct from blinding | |
| State here method used to conceal allocation and reasons for | Bias (circle) |
| Concealment of allocation is explained. Provider and patients are unaware of allocation throughout treatment/observation period, respectively. Detail: ___________________________________________________________ | Low‐risk |
| High‐risk | |
| Unclear | |
| Detection bias/Blinding | Bias likely | ||
| Person responsible for participants care | High‐risk / Low‐risk / Unclear | ||
| Participant | High‐risk / Low‐risk / Unclear | ||
| Outcome assessor | High‐risk / Low‐risk / Unclear | ||
| Other (please specify) _____________________ | High‐risk / Low‐risk / Unclear | ||
| Comments: | |||
| Attrition bias/Intention‐to‐treat An intention‐to‐treat (ITT) analysis is one in which all the participants in a trial are analysed according to the intervention to which they were allocated, whether they received it or not. | |
| Loss to follow up? | reported reported as none uncertain/not reported not applicable |
| ITT Analysis? | reported not reported no uncertain/not reported not applicable |
| PP Analysis? | reported not reported uncertain/not reported not applicable |
| Were withdrawals described? | Yes No not clear
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| How were lost patients/withdraw accounted for: | Last observation carried forward information collected at end of study uncertain/not reported excluded |
| Comments |
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| Bias likely | High‐risk / Low‐risk / Unclear |
| Selective Reporting Did the study authors report the primary outcomes or is the reported significant outcome a secondary outcome, while the primary outcome of the study was negative. | |
| Primary outcome stated | Prior to study begin, e.g. in protocol After completion of study, e.g. in publication |
| Outcome was the primary outcome of the reported study | Yes Unclear No |
| Conflict of Interest and Sponsors Is there a statement on potential conflict of interests or sponsors and did these have an undue influence on the analysis of the data | |
| Conflict of interest | Statement on COI Yes No |
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| No indication of relevant COI Unclear Possible conflict of interest apparent |
| Sponsors | No report on sponsors Unclear information on sponsor Sponsor reported and detailed information |
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| Possible undue influence apparent Unclear Undue sponsor influence unlikely |
Data extraction
Primary Outcome:
Responder Data
| Table 1: Responder data @ _ weeks/months
| Treatment Group | Comparison Group | Third Group | Total |
| Number randomized
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| Number analysed ITT
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| Number analysed PP
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Dichotomous Data not reported
| Table 1: Comparison @ _ weeks/months
| Treatment Group | Comparison Group | Third Group | Total |
| Number randomized
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| Number analysed ITT
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| Number analysed PP
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| Table 2: Comparison @ _ weeks/months
| Treatment Group | Comparison Group | Third Group | Total |
| Number randomized
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| Number analysed ITT
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| Number analysed PP
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Other outcomes: not reported
| Outcome/Instrument
| Treatment Group Value (+/‐SD) | Comparison Group Value (+/‐SD) | Between Group Comparison Absolute difference, confidence interval [] and P value |
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Withdrawals and adverse events (report number of patients)
not reported
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| Treatment Group | Comparison Group |
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Any adverse event not reported |
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Withdrawals due to adverse events |
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Withdrawals due to any reason |
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| Comments: | ||
| Other information which you feel is relevant to the results Indicate if: any data were obtained from the primary author; if results were estimated from graphs etc; or calculated by you using a formula (this should be stated and the formula given). In general if results not reported in paper(s) are obtained this should be made clear here to be cited in review. |
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Authors contacted once/twice by email &letter Response Yes/No
| Free text space for writing actions such as contact with study authors and changes
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References to other trials/data
Are there any references to published or unpublished data in this article?
| Code each paper | Author(s) | Journal/Conference Proceedings, etc. | Year | PMID/Identifier | Published |
| A |
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| Yes/No |
| B |
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| Yes/No |
| C |
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| Yes/No |
| D |
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| Yes/No |
