DF_PTvisits
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DF_PTvisits

DF_PTvisits — Scheduling and status of all cycles & visits in the visit map

Synopsis

DF_PTvisits {study} [-itime {[[e#] | [l#] | [o#] | [oU]...] [[done] | [notdone]]}] [ [-i #, #-#] | [-c #, #-#] ]
[-v #, #-#] [-vtype {[X] | [P] | [B] | [O] | [S] | [T] | [W] | [F] | [E] | [A] | [R] | [r]...}] [-vtime {[e#] | [l#] | [o#] | [oU]...}]
[-cneed {[all] | [[[unknown] | [required] | [next] | [optional] | [excluded]...]]}] [-cdone {[all] | [[[notdone] | [overdue] | [inprogress] | [terminate] | [abort]...]]}]
[-vneed {[all] | [[[unknown] | [required] | [next] | [optional] | [excluded]...]]}] [-vdone {[all] | [[[notdone] | [overdue] | [received] | [terminate] | [abort]...]]}]
[-tag {[[all] | [[[lost] | [mvp] | [etp] | [CT] | [CV] | [overdue]...]]] [[e#] | [l#] | [o#] | [oU]...] [[sday] | [cday]]}] [-fmt fmt] [-pg rows cols 0|1]

Description

This report shows visit scheduling and status information for subjects and visits meeting the specified selection criteria. The report output appears as illustrated in the following example. 

DF_PTvisits: Visit status & schedule. DFstudy 245. Mar 20,2016 11:35   PAGE 35

      1064 0:SCREENING (required) -terminated 03/09/07
      1064    91 X Screen #1          0  0  rD ~03/08/31   
      1064    92 X Screen #2          7  0  rT  03/09/07   
      1064 
      1064 1:IN-STUDY VISITS (required)
      1064    51 P Pre-entry         -2  0  rD ~03/09/11   
      1064     0 B Baseline           0  0  rD  03/09/13
      1064     1 O QOL form           -  -  rD  03/09/13   CV1r
      1064    61 r Lab Test           -  -  x.             CV2x
      1064     3 S Month 3           91  5  rL                   
      1064     6 S Month 6          183  5  n* ~04/03/14   DOD=6
      1064     9 S Month 9          274  5  r. ~04/06/13   
      1064    12 T Month 12         365  5  r. ~04/09/12   
      1064    81 E Early Term         -  -  o.             
      1064   210 R Clinical Eval      0  0  r. ~04/09/12   
      1064   211 R Patient Eval      30  0  ?.             
      1064 
      1064 2:REPORTS (end)
      1064    80 A Death Report       -  -  o.
      1064   101 O AE Report #01      -  -  o.

The output for each subject is displayed as a block of records beginning with the subject ID (1064 in the example above).

Cycle Records.  Each cycle begins with a record showing the cycle number, label, type, conditions that affect cycle requirement (if any), and the cycle termination date (if it has terminated). The termination date may also identify an abort date that precedes the scheduled cycle start date. If the cycle requirement is affected by a conditional cycle map entry the condition number and action is displayed using the following format: 

CC# (required | optional | excluded)

where # is the condition number determined by the order in which the conditions are defined in the conditional cycle map.

Visit Records.  Each visit starts with the visit number, the single letter visit type acronym, visit label, visit scheduled due day, and the overdue allowance, all of which come from the study visit map. For optional visits, which cannot be scheduled, due day and overdue allowance appear as - (dash). These visit map specifications are followed by visit status and scheduling information in the following order:

  1. visit need.  A single letter tag indicates whether the visit is required:

    r = required
    o = optional
    x = excluded
    n = next required visit
    ? = requirement not yet known

  2. visit status.  A single letter tag indicates whether the visit has been completed:

    D = visit done
    T = visit done and cycle terminates at this visit
    A = visit done and all cycles terminate at this visit
    L = visit is recorded as missed
    . = visit has not been received and is not yet overdue
    * = visit has not been received and is overdue

  3. visit date.  If the visit has been received and the visit date is known the visit date is shown. If the visit has not been received, or has been received but the visit date is unknown, the scheduled visit date is show with a ~ (tilde) prefix.

Visit Tags.  After the visit date additional information may be displayed:

  1. days overdue.  If the visit is overdue, and it is possible to compute the number of days overdue, the tag DOD=# shows the number of days the visit is overdue (i.e. current report date minus the scheduled due date for the visit). If the visit is overdue but the dates needed to calculate the visit due date are unavailable, the tag overdue is shown. The above tags appear by default, but can be altered using the -tag option to only tag those visits known to be overdue by a specified number of days, or more.

  2. conditions met.  The following tags identify visits affected by conditions specified in the conditional visit and termination maps:

    CV#[rox] = conditional visit map entry # and action, where r=required, o=optional, and x=excluded
    CT# = conditional termination map entry #

  3. special plates received.  The following tags identify special plates which were received and may affect subsequent scheduling:

    ETP# = early termination plate # was received at this visit
    MVP# = missed visit plate # was received at this visit

  4. study day.  It is possible to display the day on which visits were performed or are scheduled to be performed using the -tag option with either cday or sday (only one is allowed). When these options are used, the day appears as the first tag to the right of the visit date. With the cday option study day is computed for each subject from each cycle baseline visit. With the sday option study day is computed from the baseline of the first visit received.

  5. off-schedule.  Using the -tag option it is possible to tag visits that were performed off-schedule by a specified number of days, or more. The tags have the following format:

    S-# = visit was performed early by # days
    S+# = visit was performed late by # days

Options

The options for this report are grouped into 4 categories. Subject and visit selection options determine which subjects and visits are included in the report, visit tag options determine which information tags are displayed, and the formatting options allow limited control over the report output format. By default all subjects enrolled in the trial and all visits defined in the visit map are included in the report. If more than one subject and/or visit selection option is specified, only those subjects and visits that meet all of the selection criteria are included in the report.

Subject Selection Options

-itime e# l# o# oU done|notdone

select the subjects to include based upon one or more of the criteria:

e#: select subjects with 1+ visits early by # days or more
l#: select subjects with 1+ visits late by # days or more
o#: select subjects with 1+ visits overdue by # days or more
oU: select subjects with 1+ visits overdue, duration unknown
done: select subjects with no remaining scheduled or overdue visits
notdone: select subjects with one or more required but not yet received visits

-i #, #-#

select subjects by subject ID

-c #, #-#

select subjects by site ID

Visit Selection Options

-v #, #-#

select by visit number

-vtype list

select by visit type where list may contain any combination of the visit type characters from the list X, P, B, O, S, T, W, F, E, A, R, and r.

-vtime e# l# o# oU

select visits performed early or late by # days or more, or overdue by # days or more, or overdue by an unknown duration

e#: select visits early by # days or more
l#: select visits late by # days or more
o#: select visits overdue by # days or more
oU: select visits overdue, duration unknown

-cneed list

select cycles by their need where list may contain any combination of the keywords: unknown, required, next, optional, excluded. [5]

Each cycle is classified as belonging to only one of these categories. Thus option required does not include next. To list all required cycles, including the next scheduled cycle for each subject, you must specify both, i.e. -cneed required next.

-cdone list

select cycles by their status where list may contain any combination of the keywords: notdone, overdue, inprogress, terminate, abort.

Each cycle is classified as belonging to only one of these categories. Do not be confused by the common English interpretation of these words. For example, option notdone does not include overdue, and option terminate does not include abort. To list all cycles that are not done, including those that are overdue, you must specify both, i.e. -cdone notdone overdue. And to list all cycles that have ended in either a cycle termination or an abort you must specify both, i.e. -cdone terminate abort.

-vneed list

select visits by their need where list may contain any combination of the keywords: unknown, required, next, optional, excluded.

Each visit is classified as belonging to only one of these categories. Thus option required does not include next. To list all required visits, including the next scheduled visit, you must specify both, i.e. -vneed required next.

-vdone list

select visits by their status where list may contain any combination of the keywords: notdone, overdue, missed, received, terminate, abort.

Each visit is classified as belonging to only one of these categories. Do not be confused by the common English interpretation of these words. For example, option notdone does not include overdue, and option received does not include terminate or abort. Visits registered as missed might be considered not done or done depending on you whether you mean that the visit never occurred or that it is no longer expected. Thus, to list all visits that are not done, including those that are overdue, you must specify both, i.e. -vdone notdone overdue, and if you want to include visits that have been recorded as missed the specification will be -vdone notdone overdue missed. Similarly, to list all visits that have arrived in the database you must specify -vdone received terminate abort.

Visit Tag Options

-tag all|[lost mvp etp CT CV overdue] e# l# o# sday|cday

For each visit that is output include the following information, which is selected by including the listed keyword:

missed: all required plates are registered as missed
mvp: visits with a missed visit notification plate
etp: visits with an early termination plate
CT: visits on which a conditional termination occurred
CV: visits affected by a conditional visit map entry
overdue: visits currently overdue
all: all of lost, mvp, etp, CT, CV, and overdue (this is the default)
e#: tag visits early by # days or more
l#: tag visits late by # days or more
o#: tag visits overdue by # days or more
sday: show days since arrival of first valid Visit Date
cday: show days since cycle baseline date

Output Format Options

-pg rows columns 0|1

set page length, width and one subject/page option. The default is 57 lines by 80 columns and 0 = one page/subject option is turned off.

-fmt fmt

set output format. The -fmt option can be used to change the output format used for each visit. The format statement follows awk/C syntax. The default output format for each visit is: 

"%10d %5d(1) %s(2) %-15.15s %4s %2s  %2s %-11.11s(3) %s"

(1)

Print number right justified in 5 spaces (but more if required).

(2)

Print string right justified, in as many spaces as required.

(3)

Print string, left justified in exactly 11 spaces (truncate if >11).

Note that there is one specification for each of the 9 output columns: Subject ID, visit#, visit type, visit label, due day, overdue allowance, visit need&status, visit date, and the visit tags. Also note that the entire format string must be enclosed in single or double quotes.

Examples

Example 2.37. Select subjects from sites 40-44 for whom any visit was performed early or late by 10+ days, or with a visit currently overdue by 30+ days, or with a visit overdue by an unknown duration

-c 40-44 -itime e10 l10 o30 oU

Example 2.38. Show visits 101-199 for subjects who have completed all follow-up

-itime done -v 101-199

Example 2.39. Show baseline, scheduled follow-up and termination visits only

-vtype BST

Example 2.40. Show cycles that are not expected but which nonetheless are in progress or have been completed

-cneed excl -cdone inpr term abort

Example 2.41. Show all info tags including study day

-tag all sday

Limitations

  1. The input for DF_PTvisits comes from summary file DFX_schedule (created by DF_QCupdate). Thus, the output will reflect the status of subject follow-up as of the most recent execution of DF_QCupdate, and will not contain any changes that have occurred since then.

  2. Visit requirements and scheduling are not fixed and may change during the trial. The requirement for each cycle and visit, and the scheduled due dates may change for each subject due to: new database conditions triggered at follow-up visits, corrections to the data values that trigger conditions, corrections to the dates recorded for baseline or termination dates, or to visits used to schedule subsequent visits.

See Also

DF_QCupdate
DF_PTschedule

[5] Only the first 3 characters of each keyword are significant. For example, -cneed required next and -cneed req nex are equivalent and will select the next required cycle, plus all other required cycles, whether they have been completed or not. This applies to the keywords supplied for any of the -cneed, -cdone, -vneed, and -vdone options.

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