Data on several endpoints and risk-of-bias from a systematic review of studies on tiotropium in patients with chronic obstructive pulmonary disease (COPD).

dat.karner2014

Format

The data frame contains the following columns:

studycharacterpublication identifier (first author and publication year)
yearnumericpublication year
durationfactorstudy duration (\(<1\) year vs. \(\geq 1\) year)
inhalerfactortype of inhaler investigated (“dry powder” or “soft mist”)
baseline.agenumericmean age at baseline
baseline.malesnumericproportion of males among study participants
baseline.fev1numericmean FEV1 at baseline (L)
baseline.fev1ppnumericmean FEV1 (percent of predicted) at baseline
baseline.pyrnumericmean number of pack-years (smoking history)
tiotropium.totalnumerictotal number of patients in the treatment group
tiotropium.exanumericnumber of patients with \(\geq 1\) exacerbation in the treatment group
tiotropium.sexanumericnumber of patients with \(\geq 1\) severe exacerbation in the treatment group
tiotropium.hospinumericnumber of patients with \(\geq 1\) hospitalization (all-cause) in the treatment group
tiotropium.deathsnumericnumber of deaths in the treatment group
tiotropium.saenumericnumber of patients with \(\geq 1\) serious adverse event (non-fatal) in the treatment group
tiotropium.dropoutnumericnumber of withdrawals in the treatment group
placebo.totalnumerictotal number of patients in the control group
placebo.exanumericnumber of patients with \(\geq 1\) exacerbation in the control group
placebo.sexanumericnumber of patients with \(\geq 1\) severe exacerbation in the control group
placebo.hospinumericnumber of patients with \(\geq 1\) hospitalization (all-cause) in the control group
placebo.deathsnumericnumber of deaths in the control group
placebo.saenumericnumber of patients with \(\geq 1\) serious adverse event (non-fatal) in the control group
placebo.dropoutnumericnumber of withdrawals in the control group
sgrq.md, sgrq.senumericmean difference and associated standard error for St. George's respiratory questionnaire (SGRQ) total score
fev1.md, fev1.senumericmean difference and associated standard error for forced expiratory volume in 1 second (FEV1, mL)
rob.randfactorrandom sequence generation (selection bias)
rob.allocfactorallocation concealment (selection bias)
rob.perffactorblinding of participants and personnel (performance bias)
rob.detfactorblinding of outcome assessment (detection bias)
rob.attfactorincomplete outcome data (attrition bias)
rob.repfactorselective reporting bias (reporting bias)

Details

Chronic obstructive pulmonary disease (COPD) is a chronic and progressive condition characterized by recurrent exacerbation phases. Various treatment options are available, aimed at both providing relief during an acute exacerbation, and at delaying overall disease progression. A common drug used in the management of COPD is tiotropium, a long-acting muscarinic antagonist (LAMA), which is administered via an inhaler device.

Karner et al. (2014) conducted a systematic review in order to evaluate the evidence on the effects of tiotropium in comparison to placebo. 22 placebo-controlled studies were found, and a range of endpoints and subgroups were considered. The data reproduced here relate to analyses 1.1, 1.9, 1.14, 1.15, 1.19, 1.26, 1.27, and 1.28 in the original investigation. The risk-of-bias assessments were shown in Fig. 2. A number of study-level covariables are also provided.

Source

Karner, C., Chong, J., & Poole, P. (2014). Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews, 7, CD009285. https://doi.org/10.1002/14651858.cd009285.pub3

Author

Christian Röver, christian.roever@med.uni-goettingen.d

Concepts

medicine, pulmonology, odds ratios, raw mean differences, meta-regression, risk-of-bias

Examples

dat.karner2014
#>             study year         duration    inhaler baseline.age baseline.males baseline.fev1
#> 1    Bateman2010a 2010 1 year or longer  soft mist           65           0.78          1.10
#> 2    Bateman2010b 2010 1 year or longer  soft mist           65           0.74          1.06
#> 3        Beeh2006 2006     up to 1 year dry powder           62           0.76          1.30
#> 4    Brusasco2003 2003     up to 1 year dry powder           64           0.77          1.10
#> 5    Casaburi2002 2002 1 year or longer dry powder           65           0.64          1.00
#> 6        Chan2007 2007 1 year or longer dry powder           67           0.60          0.97
#> 7      Cooper2010 2010 1 year or longer dry powder           65           0.77          1.10
#> 8     Covelli2005 2005     up to 1 year dry powder           65             NA          1.00
#> 9      Dusser2006 2006 1 year or longer dry powder           65           0.88          1.40
#> 10    Freeman2007 2007     up to 1 year dry powder           65             NA          1.30
#> 11  Johansson2008 2008     up to 1 year dry powder           62             NA          2.10
#> 12  Magnussen2008 2008     up to 1 year dry powder           60           0.61          1.50
#> 13      Moita2008 2008     up to 1 year dry powder           64           0.95          1.20
#> 14    NCT00144326 2005     up to 1 year dry powder           63           0.78          1.30
#> 15 Niewoehner2005 2005     up to 1 year dry powder           68           0.98          1.00
#> 16     Powrie2007 2007 1 year or longer dry powder           66             NA          1.30
#> 17        Sun2007 2007     up to 1 year dry powder           62             NA          1.30
#> 18    Tashkin2008 2008 1 year or longer dry powder           65           0.75          1.10
#> 19     Tonnel2008 2008     up to 1 year dry powder           64           0.86          1.40
#> 20   Trooster2011 2011     up to 1 year dry powder           62           0.69          2.00
#> 21  Verkindre2006 2006     up to 1 year dry powder           60           0.94          1.10
#> 22    Voshaar2008 2008     up to 1 year  soft mist           64           0.70          1.10
#>    baseline.fev1pp baseline.pyr tiotropium.total tiotropium.exa tiotropium.sexa tiotropium.hospi
#> 1               40           45             1989            685             161              304
#> 2               38           48             1337            495              78              198
#> 3               45           36             1236            180              29               55
#> 4               39           43              402            129              48               48
#> 5               39           NA              550            198              30               90
#> 6               39           51              608            268              51              105
#> 7               38           52              260            112              21               57
#> 8               39           66              100              9               2                5
#> 9               48           43              500            213              28               88
#> 10              49           37              200             19               2                7
#> 11              73           31              107              2               0                3
#> 12              53           34              228             13               4                9
#> 13              NA           NA              147              6               1                5
#> 14              46           NA              123             11               2                6
#> 15              36           68              914            255              64               NA
#> 16              50           55               69             30               2               15
#> 17              47           NA               30              0               0               NA
#> 18              39           49             2987           2001             759             1369
#> 19              44           44              266            101              11               40
#> 20              66           NA              238             11              NA               NA
#> 21              35           44               46             10               0                2
#> 22              52           52              360             43               2               11
#>    tiotropium.deaths tiotropium.sae tiotropium.dropout placebo.total placebo.exa placebo.sexa
#> 1                 52            342                318          2002         842          198
#> 2                 34            233                251           653         288           44
#> 3                  2             63                218           403          80            7
#> 4                  1             37                 62           400         156           90
#> 5                  7             99                103           371         156           35
#> 6                 13            108                135           305         125           19
#> 7                  6             63                 66           259         102           16
#> 8                  0              5                 10            96          12            1
#> 9                  7             86                117           510         272           33
#> 10                 1              6                 18           195          35            1
#> 11                 0              3                  2           117           4            0
#> 12                 0             10                  5           244          26            0
#> 13                 2              4                 11           164           6            1
#> 14                 0              6                 10           127          12            0
#> 15                22            140                149           915         296           87
#> 16                 1             15                 21            73          47            3
#> 17                 0              0                  0            30           2            2
#> 18               381           1541               1099          3006        2049          811
#> 19                 3             42                 39           288         130            8
#> 20                 0             10                 27           219          24           NA
#> 21                 0              2                  1            54           8            3
#> 22                 2             12                 34           181          21            0
#>    placebo.hospi placebo.deaths placebo.sae placebo.dropout sgrq.md sgrq.se fev1.md fev1.se rob.rand
#> 1            318             38         336             373   -2.90    0.49     101      10      low
#> 2             99             10         110             205   -3.65    0.59     141       6      low
#> 3             17              2          22              90      NA      NA      79      17      low
#> 4             90              5          52             103   -2.70    0.99     120       7      low
#> 5             64              7          78             103   -3.44    0.92     150      14      low
#> 6             39              2          42              84   -2.79    0.97     100      20      low
#> 7             52              6          59              96   -4.03    1.50      75      27      low
#> 8              5              0           5              17      NA      NA     184      37      low
#> 9             93              8          96             147      NA      NA     120      20      low
#> 10            10              4          10              33      NA      NA      60      23      low
#> 11             1              1           1               4      NA      NA     119      32      low
#> 12             3              2           5              11      NA      NA      98      23      low
#> 13             3              0           3              11      NA      NA     102      31      low
#> 14             4              0           4              15      NA      NA      70      56      low
#> 15            NA             19         137             245      NA      NA     100      13      low
#> 16            13              2          11              21      NA      NA     190      88      low
#> 17            NA              0           0               3      NA      NA     209      54      low
#> 18          1357            411        1509            1358   -2.28    0.38     107       7      low
#> 19            34              6          38              74   -4.18    1.27     104      34      low
#> 20            NA              0          11              21      NA      NA     166      29      low
#> 21             6              0           6               9   -6.50    2.90     110      42      low
#> 22             5              0           5              22      NA      NA     134      19      low
#>    rob.alloc rob.perf rob.det rob.att rob.rep
#> 1        low      low     low     low     low
#> 2        low      low     low    high     low
#> 3        low      low     low unclear     low
#> 4        low      low     low unclear     low
#> 5        low      low     low unclear     low
#> 6        low      low     low unclear     low
#> 7        low      low     low    high     low
#> 8        low      low     low unclear unclear
#> 9        low      low     low unclear     low
#> 10       low      low     low unclear     low
#> 11       low      low     low     low     low
#> 12       low      low     low     low     low
#> 13       low      low     low     low     low
#> 14       low      low     low     low     low
#> 15       low      low     low unclear     low
#> 16       low      low     low unclear     low
#> 17   unclear      low unclear     low     low
#> 18       low      low     low    high     low
#> 19       low      low     low unclear     low
#> 20       low      low     low     low     low
#> 21       low      low     low unclear     low
#> 22       low      low     low     low     low

library(metafor)
library(bayesmeta)

# compute effect sizes (log odds ratios) from exacerbation count data
# (using the "metafor" package's "escalc()" function)
karner.exa <- escalc(measure="OR",
                     ai=tiotropium.exa, n1i=tiotropium.total,
                     ci=placebo.exa,    n2i=placebo.total,
                     slab=study, data=dat.karner2014)

# show forest plot
forestplot(karner.exa, title="exacerbation",
           exponentiate=TRUE, xlog=TRUE,
           xlab="odds ratio")


# derive St. George's Respiratory Questionnaire (SGRQ) effect sizes
# (change in SGRQ score)
karner.sgrq <- escalc(measure="MD",
                      yi=sgrq.md, sei=sgrq.se,
                      slab=study, data=dat.karner2014,
                      subset=is.finite(dat.karner2014$sgrq.md))

# show forest plot
forestplot(karner.sgrq, title="SGRQ", xlab="mean difference")