Perioperative interventions for smoking cessation in hip and knee arthroplasty for osteoarthritis and other non-traumatic diseases

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the benefits and harms of perioperative smoking cessation interventions on outcomes and complications after knee or hip replacement.

Background

Description of the condition

Total knee and hip arthroplasty (TKA and THA) are very common surgeries performed in patients who suffer from pain and functional limitation due to symptomatic arthritis, when medical management has failed. These surgeries are usually elective, and are associated with excellent outcomes including significant improvement in function, quality of life and reduction in pain severity (Ethgen 2004; Kane 2005). Some people fail to improve dramatically after THA/TKA; this may be related to the presence of several non-modifiable and modifiable risk factors, such as obesity, comorbidity and depression (Brander 2003; Brander 2007; Santaguida 2008; Singh 2008; Singh 2009; Singh 2010a; Singh 2010b). One common risk factor in this arena that is receiving increasing attention is smoking (Singh 2011a), which is a modifiable risk factor.

Description of the intervention

Smoking is a modifiable risk factor. A variety of smoking cessation interventions that include behavioral and pharmacological components have been examined for improving the quit rates in smokers (Annonymous 1996; Carmody 2008; Prochazka 1992; Prochazka 1998; Prochazka 2004; Simon 2003). Smoking cessation programs have been implemented in surgical populations (Quraishi 2006, Sorenson 2007, Villebro 2008, Wolfenden 2008). Although challenges to smoking cessation exist (CDC 1990), these programs can be implemented. Smoking cessation can have a positive impact on postoperative complications (Yamashita 2004).

How the intervention might work

Smoking cessation interventions include behavioral modification or pharmacological interventions (including nicotine replacement therapy), or both. These interventions help to reduce the symptoms of nicotine withdrawal, and thus improve the quit rates in people attempting to quit smoking. Decreasing the exposure to nicotine decreases the detrimental effect of current smoking on intra- and postoperative complications. Several short-term post-arthroplasty complications have been linked to current smoking, such as surgical site infections, pneumonia, stroke and one-year mortality (Singh 2011a). In addition, a systematic review showed that current smokers were significantly more likely to have postoperative complications and death compared to nonsmokers (Singh 2011b). Smoking cessation in the perioperative period is likely to decrease the risk of some of these complications compared to active smoking in the perioperative period.

Why it is important to do this review

Smoking is a modifiable risk factor for these elective surgeries. Knee and hip replacements are very common surgeries worldwide; in the USA alone, one-million procedures are performed per year (Kurtz 2007). If evidence supports the hypothesis that perioperative smoking cessation decreases post-operative complications, interventions to modify this risk in the pre- or post-operative period can be implemented. Although a Cochrane review on preoperative smoking cessation in surgical patients exists (Thomsen 2010), that review included all surgeries in its analyses. Since THA and TKA are almost always elective surgeries, and the recovery period - as well as complications - after THA or TKA are different from several other surgeries, it is prudent to perform a Cochrane review to assess smoking cessation interventions that is limited to this population.

Objectives

To assess the benefits and harms of perioperative smoking cessation interventions on outcomes and complications after knee or hip replacement.

Methods

Criteria for considering studies for this review

Types of studies

Randomized controlled trials (RCTs), and controlled clinical trials (CCTs) that have assessed perioperative smoking cessation interventions in patients undergoing knee or hip arthroplasty for osteoarthritis and other non-traumatic diseases will be considered for inclusion if they are published in full. Abstracts will not be included.

Types of participants

Adult smokers (aged 16 or older) planning to undergo knee or hip arthroplasty.

Types of interventions

Pre-operative smoking cessation interventions compared to no intervention, usual care or another pre-operative cessation intervention for which a RCT or CCT exists, will be considered for inclusion.

Types of outcome measures

Primary outcomes

We will assess the following primary outcomes.

  • Wound complications - superficial and deep.

  • Revision or reoperation rate.

  • Any postoperative complication within 30-days of the surgery: if the authors do not specify the time-frame and present complications for the inpatient stay rather than for 30-days, we will use the inpatient stay data, understanding that stays are usually shorter than 30-days, and most often, 4-7 days.

  • Venous thromboembolism.

  • Death.

  • Function: as assessed by validated outcome measures such as the Western Ontario McMaster Osteoarthritis Index (WOMAC), Oxford knee score, Oxford hip score, Hip disability and Osteoarthritis Outcome Score (HOOS), knee disability and Osteoarthritis Outcome Score HOOS (KOOS), Hospital for Special Surgery (HSS) score, Harris Hip Score (HHS), American Knee Society (AKS) score etc.

  • Pain: as assessed as mean pain by visual analog scale (VAS), numeric rating scale (NRS), semi-quantitative or a four-level ordinal scale (none, mild, moderate, severe) or similar scale and dichotomous measures, i.e. participant-reported pain relief of 30% or greater; and pain relief of 50% or greater.

Secondary outcomes
  • Success rate of smoking cessation in the pre- and post-operative period.

  • Cardiopulmonary: composite of pulmonary (pneumonia, pneumothorax, others) and cardiac complications (myocardial infarction, cardiac arrest, arrhythmia, malignant hypertension).

  • Loosening of aseptic implant.

  • Implant dislocation.

  • Septic arthritis.

  • Re-intubation.

  • Length of stay in intensive care unit.

  • Patient satisfaction.

All outcomes will be expressed as a percentage of the participants randomized (intention-to-treat analysis).

All time-points will be included. For the main analyses, we will include observations at the last time point. We will include other, shorter time-points, since the effect of smoking cessation may differ for immediate versus later complications. These analyses may add additional information.

Search methods for identification of studies

Electronic searches

We will search the following databases for randomized or controlled clinical trials as detailed in Appendix 1:

  • Tobacco Addiction Group’s specialized register

  • The Cochrane Central Register of Controlled Trials (CENTRAL), via The Cochrane Library, Wiley InterScience (www.thecochranelibrary.com) most recent issue;

  • OVID MEDLINE, 1966 to present;

  • CINAHL (via EBSCOHost), 1982 to present;

  • EMBASE 1980 to present;

  • Dissertations and Theses via ProQuest 1861 to present;

  • Scopus up to present;

  • A Pubmed-related articles search will be conducted on included studies, with no date restriction.

There will be no language restrictions.  Non-English articles will be translated. We will not include any abstracts in this review.

Searching other resources

We will search clinical trials.gov and the World Health Organization (WHO) trial registry portal. We will also search the reference lists of included trials to identify any studies missed by the search.

Data collection and analysis

Selection of studies

We will select studies based on the inclusion criteria outlined in the Criteria for considering studies for this review section. Two review authors (NK, AB) will review potential studies independently and assess whether or not they should be included. Disagreements between the two review authors will be resolved by consensus. Any unresolved issues will be referred to an arbiter (JS).

Data extraction and management

Two review authors (AB, NK) will independently extract data from the included trials in an Excel sheet or a similar format, including information on population of study, number of centers, types of intervention, primary and secondary outcomes, number of participants randomized per arm and analyses performed in the original studies. We will extract mean, standard deviation and number of participants for continuous outcomes for control and intervention groups; for categorical outcomes, we will abstract the number of events. The data will be gathered using standardized extraction methods. If more information is needed, we will contact the studies' authors. We will use data based on intention-to-treat analysis, when possible.

If trials report more than one measure for an outcome :

  • for pain, we will use a hierarchy of 11 levels:

    • pain overall (global pain);

    • pain on walking;

    • WOMAC pain subscale;

    • pain on activities other than walking;

    • WOMAC global scale;

    • Lequesne osteoarthritis index global score;

    • other algofunctional scale;

    • patient’s global assessment;

    • physician’s global assessment;

    • other outcome;

    • no continuous outcome reported.

When more than one is reported, we will take the highest on the list – for example choose global pain over WOMAC pain subscale.

  • for physical function, we will choose a continuous scale over an ordinal scale, and use a hierarchy of eight levels;

    • global disability score;

    • walking disability;

    • WOMAC disability subscore;

    • composite disability scores other than WOMAC;

    • disability other than walking;

    • WOMAC global scale;

    • Lequesne osteoarthritis index global score;

    • other algofunctional scale.

When more than one is reported, we will take the highest on the list.

  • if both final values and change from baseline values are reported for the same outcome, we will extract the final values;

  • if both unadjusted and adjusted values for the same outcome are reported, we plan to extract the adjusted values; and,

  • if data are analyzed based on an intention-to-treat (ITT) sample and another sample (e.g. per-protocol, as-treated), we plan to extract ITT sample values for both benefits and harms.

  • if there are multiple time points, we will abstract the data for three time-frames: (a) short-term: less than three months after the surgery; (b) intermediate-term: three to six months after the surgery; and (c) long-term: more than six months after the surgery.

Assessment of risk of bias in included studies

Two review authors (AB, NK) will independently assess the risk of bias in the included studies, using the Cochrane Collaboration recommendations of assessing risk of bias. They will evaluate each study for the following: (1) selection bias: allocation concealment, random sequence generation; (2) performance bias: blinding in the studies (of participants, caregivers); (3) detection bias: blinding of outcome assessors; (4) attrition bias: incomplete outcome data; (5) reporting bias: selective outcome reporting; and (6) other sources of bias not covered in other domains of bias above, such as source of funding (pharmaceutical or device company), selective data presentation and selective reporting of subgroups (Higgins 2011).  They will rate each criterion as 'low risk of bias', 'high risk of bias', or 'unclear' (either lack of information or uncertainty over the potential for bias) for each included study.

Measures of treatment effect

For dichotomous outcomes, we will calculate the relative risk and 95% confidence interval. For rare events (i.e. less than 10%), we will use the Peto odds ratio. We will calculate mean differences and 95% confidence intervals for reporting continuous outcomes. When comparing data that measure the same construct but use varying construct measures; for example, trials that use different scales (construct measure) to measure pain (same construct), standardized mean differences will be used to address issues related to data using different scales of measurement. In cases where median scores are reported instead of mean scores, we will substitute median for the mean.

Unit of analysis issues

Individual participants will be the unit of analysis. In cases where outcomes are presented by events or joints, rather than participants, we will use the data from the joints. Since simultaneous bilateral arthroplasty is very uncommon (less than 5%), the effect of combining these data will be minimal. However, we will also perform sensitivity analyses by limiting analyses only to patient-level data and compare results to those obtained using all data. For the 'Summary of findings' tables, the background risk will be based only on patient-level data.

Dealing with missing data

No imputation for missing data will be done.

Assessment of heterogeneity

We will examine the forest plots to look for evidence of heterogeneity and calculate the I2 statistic to quantify heterogeneity. As recommended in the Cochrane handbook, an I2 of 0% to 40% might not be important, 30% to 60% may represent moderate heterogeneity, 50% to 90% may represent substantial heterogeneity; and 75% to 100% represents considerable heterogeneity (Deeks 2011). If heterogeneity (I2 > 50%) is detected, we will look for reasons for it by examining participant and trial characteristics of included studies, and it will be noted and discussed. The main analyses will be based on all included trials.

Assessment of reporting biases

We will assess reporting biases and other biases associated with small sample sizes for the primary outcomes by means of a funnel plot. The funnel plot is a scatter plot of with treatment effect on the x-axis and the study sample size on its y-axis. If considerable asymmetry is observed in the funnel plot, we will conclude that reporting bias exists.

Data synthesis

We will use the risk ratio or rate ratio (RR) as a measure of the association between smoking cessation interventions and selected outcomes (Schünemann 2011a). We will apply random-effects, rather than fixed-effect models to estimate pooled RRs in order to take into account the heterogeneity, however small, of the risk estimates and, therefore, to be more conservative. Sensitivity analyses will be done by using the fixed-effect model and we will note whether the interpretation change between random- and fixed-effect models; and present random- and fixed-ffects in text and as separate tables, as needed.

Subgroup analysis and investigation of heterogeneity

The planned sub-analyses will include the following, if data are available:

  • knee versus hip, versus ankle, versus shoulder replacement;

  • successful quitters versus unsuccessful quitters;

  • according to effect on outcome at various time-points after surgery: (a) short-term: less than three months after the surgery; (b) intermediate-term: three to six months after the surgery; (c) long-term: more than six months after the surgery;

  • according to gender: men versus women;

  • according to ethnicity/race: white versus African-American versus others

Sensitivity analysis

Following the criteria mentioned in the 'Assessment of risk of bias in included studies' section above, we will assess for bias due to allocation concealment, blinding and pharmacological funding by performing sensitivity analyses wherever possible. We will also perform sensitivity analyses, by limiting analyses only to patient-level data and excluding joint-level data.

'Summary of findings' table

We will complete a 'Summary of findings' table in Review Manager 5 (RevMan) in order to communicate the key outcomes of the review (RevMan 2013; Schünemann 2011b). We will use GRADE software to provide an overall grading of the quality of the evidence. The number needed to treat for an additional beneficial outcome (NNTB) or the number needed to treat for an additional harmful outcome (NNTH), absolute risk difference (risk difference between intervention and control groups), and relative risk difference (intervention group - control group risk divided by the risk in the control group, expressed as percent) will be added to the 'Summary of findings' table. For continuous outcomes, we will calculate the absolute difference using the mean difference (benefit). Then, as needed, we will convert standardized mean differences (SMDs) to odds ratios to derive numbers needed to treat to cause one additional beneficial treatment response (NNTB), and numbers needed to treat to cause one additional adverse outcome (NNTH) (Chinn 2000). The inverse of the absolute risk difference, which is the absolute difference between risk in the treatment group and risk in the control group, will be used to calculate the NNTB or the NNTH, using the Cates calculator Visual Rx (Cates 2008; available at www.nntonline.net).

Acknowledgements

We thank Louise Falzon and Tamara Rader for assistance with performing the literature search.

Appendices

Appendix 1. Appendix 1

Ovid MEDLINE(R)

 

1. exp Arthroplasty/

2. exp Joint Prosthesis/

3. exp "Prostheses and Implants"/

4. Knee/

5. exp Knee Joint/

6. or/1-3

7. 4 or 5

8. 6 and 7

9. Arthroplasty, Replacement, Knee/

10. Knee Prosthesis/

11. (tka or tkr).tw.

12. (knee$ adj (replace$ or arthroplast$ or prosthe$ or endoprosthe$ or implant$)).tw.

13. or/8-12

14. Hip/

15. Hip Joint/

16. 14 or 15

17. 6 and 16

18. Arthroplasty, Replacement, Hip/

19. (tha or thr).tw.

20. (hip$ adj (replace$ or arthroplast$ or prosthe$ or endoprosthe$ or implant$)).tw.

21. or/17-20

22. 13 or 21

23. exp Smoking/

24. exp Tobacco/

25. "Tobacco Use Disorder"/

26. (smok$ or tobacco or pipe or cigar$ or cigarette$).tw.

27. or/23-26

28. (cessation or cease$ or withdraw$ or stop$ or quit$ or intervention$).tw.

29. 27 and 28

30. exp "Tobacco Use Cessation"/

31. 29 or 30

32. 22 and 31

 

Ovid EMBASE

 

1. exp arthroplasty/

2. exp joint prosthesis/

3. prosthesis/

4. exp implant/

5. or/1-4

6. exp knee/

7. 5 and 6

8. exp knee arthroplasty/

9. (tka or tkr).tw.

10. (knee$ adj (replace$ or arthroplast$ or prosthe$ or endoprosthe$ or implant$)).tw.

11. or/7-10

12. hip/

13. 5 and 12

14. exp hip arthroplasty/

15. (tha or thr).tw.

16. (hip$ adj (replace$ or arthroplast$ or prosthe$ or endoprosthe$ or implant$)).tw.

17. or/13-16

18. 11 or 17

19. exp smoking/

20. tobacco/

21. tobacco dependence/

22. (smok$ or tobacco or pipe or cigar$ or cigarette$).tw.

23. or/19-22

24. (cessation or cease$ or withdraw$ or stop$ or quit$ or intervention$).tw.

25. 23 and 24

26. smoking cessation/

27. 25 or 26

28. 18 and 27

 

CINAHL via EBSCOHost

 

S36 S23 and S35

S35 S32 or S33 or S34

S34 (MH "Smoking Cessation Programs")

S33 (MH "Smoking Cessation")

S32 (S29 or S30) and (S28 and S31)

S31 S29 or S30

S30 AB cessation or AB cease* or AB withdraw* or AB stop* or AB quit* or AB intervention*

S29 TI cessation or TI cease* or TI withdraw* or TI stop* or TI quit* or TI intervention*

S28 S24 or S25 or S26 or S27

S27 ab smok* or ab tobacco or ab pipe* or ab cigar* or ab cigarette*

S26 ti smok* or ti tobacco or ti pipe* or ti cigar* or ti cigarette*

S25 (MH "Tobacco+")

S24 (MH "Smoking+")

S23 S13 or S22

S22 S17 or S18 or S19 or S20 or S21

S21 S6 and S16

S20 ab hip* replace* or ab hip* arthroplast* or ab hip* prosthe* or ab hip* endoprosthe* or ab hip* implant*

S19 ti hip* replace* or ti hip* arthroplast* or ti hip* prosthe* or ti hip* endoprosthe* or ti hip* implant*

S18 ti tha or ti thr or ab tha or ab thr

S17 (MH "Arthroplasty, Replacement, Hip")

S16 S14 or S15

S15 (MH "Hip Joint")

S14 (MH "Hip")

S13 S8 or S9 or S10 or S11 or S12

S12 ab knee* replace* or ab knee* arthroplast* or ab knee* prosthe* or ab knee* endoprosthe* or ab knee* implant*

S11 ti knee* replace* or ti knee* arthroplast* or ti knee* prosthe* or ti knee* endoprosthe* or ti knee* implant*

S10 ti tka or ti tkr or ab tka or ab tkr

S9 (MH "Arthroplasty, Replacement, Knee")

S8 S6 and S7

S7 S4 or S5

S6 S1 or S2 or S3

S5 (MH "Knee Joint+")

S4 (MH "Knee")

S3 (MH "Prostheses and Implants+")

S2 (MH "Joint Prosthesis")

S1 (MH "Arthroplasty+")

 

The Cochrane Library (via Wiley InterScience)

 

#1           MeSH descriptor Arthroplasty explode all trees

#2           MeSH descriptor Joint Prosthesis explode all trees

#3           MeSH descriptor Prostheses and Implants explode all trees

#4           MeSH descriptor Knee explode all trees

#5           MeSH descriptor Knee Joint explode all trees

#6           (#1 OR #2 OR #3)

#7           (#4 OR #5)

#8           (#6 AND #7)

#9           MeSH descriptor Arthroplasty, Replacement, Knee explode all trees

#10         MeSH descriptor Knee Prosthesis explode all trees

#11         (tka or tkr):ti,ab

#12         (knee* next (replace* or arthroplast* or prosthe* or endoprosthe* or implant*)):ti,ab

#13         (#8 OR #9 OR #10 OR #11 OR #12)

#14         MeSH descriptor Hip explode all trees

#15         MeSH descriptor Hip Joint explode all trees

#16         (#14 OR #15)

#17         (#6 AND #16)

#18         MeSH descriptor Arthroplasty, Replacement, Hip explode all trees

#19         (tha or thr):ti,ab

#20         (hip* next (replace* or arthroplast* or prosthe* or endoprosthe* or implant*)):ti,ab

#21         (#17 OR #18 OR #19 OR #20)

#22         (#13 AND #21)

#23         MeSH descriptor Smoking explode all trees

#24         MeSH descriptor Tobacco explode all trees

#25         MeSH descriptor Tobacco Use Disorder explode all trees

#26         (smok* or tobacco or pipe* or cigar* or cigarette*):ti,ab

#27         (#23 OR #24 OR #25 OR #26)

#28         (cessation or cease* or withdraw* or stop* or quit* or intervention*):ti,ab

#29         (#27 AND #28)

#30         MeSH descriptor Tobacco Use Cessation explode all trees

#31         (#29 OR #30)

#32         (#22 AND #31)

 

Scopus

 

#6 #3 AND #4 AND #5

#5 (cessation or cease* or withdraw* or stop* or quit* or intervention*) in Article Title, Abstract, Keywords

#4 TITLE-ABS-KEY(smok* OR tobacco OR pipe* OR cigar* OR cigarette*) in Article Title, Abstract, Keywords

#3 #1 OR #2

#2 TITLE-ABS-KEY(tha OR thr OR hip* replace* OR hip* arthroplast* OR hip* prosthe* OR hip* endoprosthe* OR hip* implant*) in Article Title, Abstract, Keywords

#1 TITLE-ABS-KEY(tka OR tkr OR knee* replace* OR knee* arthroplast* OR knee* prosthe* OR knee* endoprosthe* OR knee* implant*) in Article Title, Abstract, Keywords

 

ProQuest Dissertation Abstracts

 

1 tkr OR tka OR knee* replace* OR knee* arthroplast* OR knee* prosthe* OR knee* endoprosthe* OR knee* implant* in Citation/Abstract

2 thr OR tha ORhip* replace* OR hip* arthroplast* OR hip* prosthe* OR hip* endoprosthe* OR hip* implant* in Citation/Abstract

3 1 OR 2

4 smok* OR tobacco OR pipe* OR cigar* OR cigarette in Citation/Abstract

5 smok* OR tobacco OR pipe* OR cigar* OR cigarette* in Citation/Abstract

6 3 AND 4 AND 5

 

What's new

DateEventDescription
19 August 2013AmendedSpecialized Group register added to list of electronic databases.

Contributions of authors

JAS conceived the topic, prepared and submitted title registration, prepared and submitted the protocol.

AB and NK reviewed the protocol.

Declarations of interest

JAS has received research and/or travel grants from Takeda and Savient; and consultant fees from Savient, Takeda, Ardea, Regeneron, Allergan, URL pharmaceuticals and Novartis.

AB and NK have no conflicts of interest.

Sources of support

Internal sources

  • Birmingham VA Medical Center, Not specified.

    This work is supported by the use of facilities and resources of the Birmingham VA Medical Center

External sources

  • None, Not specified.

    No external support was obtained for this study

Ancillary