Table 3

Study conduct strategies to minimise the problem of missing PRO data

CategoryTopicSpecific recommendationN recommendations*Potential drawbacksSource/s: first author (year). Full citations are provided as Online Supplementary Appendix C
Administration proceduresApproach all participantsAll participants involved in the PRO study should be approached to complete scheduled PRO assessments, including those who are very ill (Site staff should not make any decisions about who is able to complete PROs as this may lead to selection bias. The decision is the participant’s.)11NoneBernhard, Peterson (1998), Fairclough (2010), Hopwood (1998), Bakitas (2009), McMillan (2003), Revicki (2005), Young, de Haes (1999), Aaronson (1990), Moynihan (1998)
Assistance completing PRO measuresPrespecify types/levels of assistance that may be provided to participants5NoneFayers (1997), Kaasa (2002), Revicki (2005), Young, de Haes (1999), Fairclough (2010)
Offer assistance to participants who need it11Requires additional staff timeAaronson (1990), Bernhard, Peterson (1998), Fayers (1997), Friedman (1998), Hurny (1992), Jordhoy (2010), Bakitas(2009), Macefield (2013), Repetto (2001), Young, de Haes (1999)
Record levels of assistance provided1NoneBlazeby (2003)
Nominate who should provide assistance to participants3Requires additional time and resourcesCella (1995), Revicki (2005), Young, de Haes (1999)
Be organisedEnsure sufficient questionnaires available for use1NoneMoynihan (1998)
Prepare for upcoming assessments (have questionnaires ready)6NoneVantongelen (1989), Cella (1995), Coates (1998), Moinpour (1989), Revicki (2005), Young, de Haes (1999)
Prepare to handle potential problems1NoneRevicki (2005)
Track when PRO assessments due5NoneCella (1994), Cella (1995), Young, de Haes (1999)
CheckingChecking for missed PRO items29NoneCalvert (2004), Cella (1994), Cella (1995), Chassany (2002), Davies (1994), Fallowfield (1998), Fayers (1997), Fowler (1996), Friedman (1998), Ganz (1988), Hayden (1993), Hopwood (1998), Kleinpell-Nowell (2000), Kyte (2013), Moinpour (1990), Moinpour (1998), Movsas (2003), Movsas (2004), Revicki (2005), Taphoorn (2010), Wisniewski (2006), Young, de Haes (1999)
Checking source data (data entry; when entering questionnaire data into database)2NoneDavies (1994), Poy (1993)
Ensure patients receive questionnaires (particularly when the patients complete questionnaires outside of clinic)1NoneKaasa (1998)
PRO completion cover sheet (a form on which site staff can record whether PROs were completed and if not completed, the possible reason why)Importance of cover sheet1NoneMoinpour (1998)
Recording levels of assistance6Requires additional time and resources to collectFayers (1997), Fairclough (2010), Fayers (1997), Moinpour (1998), Hopwood (1998), Revicki (2005)
  Standardised reasons for missing data (possible reasons for non-completion of PROs may be listed on a cover sheet for the convenience of site staff and for ease of data collection)39Requires additional time and resources to collectFairclough (2010), Fayers (1997), Moinpour (1998), Hopwood (1998), Revicki (2005), Bell (2014), Bernhard, Cella (1998), Blazeby (2003), Calvert (2004), Curran (1998), Fairclough (2010), Fallowfield (1998), Fayers (1997), Hahn (1998), Hao (2010), Kiebert (1998), Kleinpell-Nowell (2000), Land (2007), Little, Cohen (2012), Luo (2008), Moinpour (1990), Moinpour (1998), Revicki (2005), Simes (1998), Taphoorn (2010), Walker (2003), Wisniewski (2006), Young, de Haes (1999)
Reasons for missing PRO data may not be easy to determine in some cases.
Missed assessmentsAlternative mode of administration (if participants miss a PRO assessment, contact the participant to capture the data using an alternative mode. Also see table 2 ‘Mode of administration’)17Requires additional staff time and resources. Potential for bias based on setting of completion (systematic differences between modes, particularly if one mode is interview administered, and the other is completed by patient66)Basch (2014) Calvert (2004), Cella (1995), Fairclough (2010), Fowler (1996), Hopwood (1996), Hurny (1992), Kleinpell-Nowell (2000), Land (2007), Moinpour (1990), Revicki (2005), Stewart (1992), Walker (2003), Revicki (2005)
Following up missed assessments18Requires additional staff time and resourcesCella (1994), Cella (1995),Conroy (2003), Fowler (1996), Hopwood (1998), Huntington (2005), Kleinpell-Nowell (2000), Movsas (2003), Movsas (2004), Sherman (2005), Sprague (2003), Sprangers (2002), Taphoorn (2010), Wisniewski (2006), Young, de Haes (1999)
Specify place of PRO completion (eg, quiet spot in the clinic)8May be difficult to offer a quiet place to complete questionnaires in busy clinic environmentCalvert (2004), Hurny (1992), Jansen (2013), Moynihan (1998), Sadura (1992), Sherman (2005), Young, de Haes (1999)
Returning questionnairesSpecify procedures for returning questionnaires1NonePoulter (1997)
Time of completionStandardise time of completion (eg, first thing when the patient arrives at the clinic)2NoneBernhard, Cella (1998), Fayers (1997)
Before seeing clinician (many sources recommended PROs should be completed before the participants have their appointment with their clinician)4Requires advanced planning and potential negotiation with clinician to ensure PRO assessment is complete prior to the clinic appointment. Difficulties may arise if scheduled PRO assessments do not align with clinic visits.Fayers (1997), Sprague (2003), Young, de Haes (1999), Hopwood (1998)
Standardised methodsAdhere to PRO assessment schedule2NoneMoinpour (1998), Poulter (1997)
Use standard administration methods5NoneCella (1995), Chassany (2002), Movsas (2003), Movsas (2004), Revicki (2005)
Standardise methods (eg, by developing written guidance)13Time and minimal costs involved initiallyBernhard, Gusset (1998), Cella (1995), Chassany (2002), Fayers (1997), Gheorghe (2014), Hopwood (1998), Moinpour (1998), Movsas (2003), Movsas (2004), Osoba (2007), Poy (1993), Revicki (2005), Sadura (1992)
Thank the participantOn completion of questionnaire (face-to-face)6NoneCalvert (2004), Kyte (2013), Meyers (2003), Sherman (2005), Steinhauser (2006), Young, de Haes (1999)
Thank you letters3Requires additional time and resourcesSteinhauser (2006), Fallowfield (1998), Poulter (1997)
Train staffSee ‘Train staff’ category
Participant education and engagementConfidentialityBe mindful of sensitive PRO data (ensure participants understand it will be kept confidential)2NoneCella (1994), Sherman (2005)
Discuss family involvement (participants may not wish to disclose certain information if they believe family members may see the data)1NoneSherman (2005)
Inform participants that PRO data are kept confidential6NoneCalvert (2004), Fallowfield (1998), Movsas (2003), Sherman (2005), Simes (1998), Young, de Haes (1999)
Sealed envelopes (allow participants to self-seal so they are assured of the confidentiality of data)1Prevents site staff from being able to check for any missing itemsFallowfield (1998)
Strategies for continued participant engagementSite staff should offer to answer participant questions3NoneCalvert (2004), Fayers (1997), Hurny (1992)
Awareness of culturally sensitive issues1NoneBernhard, Cella (1998)
Match staff to participant cultural group (Some participants may build rapport more easily if they liaise with a coordinator from the same cultural group.)1May not be possible/feasible for all studiesCella (1995)
Build rapport with participants4NoneBlazeby (2003), Steinhauser (2006)
Educate participants about PROs (importance of PROs, how PRO data are used, how to complete PROs)5Requires staff time and commitment—depending on the comprehensiveness of education offeredBasch (2012), Fairclough (2010), Gotay (2005), Huntington (2005), Kaasa (1998)
Provide clear/simple instructions for completion of PRO assessments5NoneBernhard, Peterson (1998), Calvert (2004), Chassany (2002), Hurny (1992), Revicki (2005)
Encourage participants to ask for questionnaire when they are due (in case site staff forget)2NoneFayers (1997), Hopwood (1998)
Ensure participants understand (PRO assessment/how to complete questionnaires, etc)8Requires staff time,Moinpour (1990), Moinpour (1998), Muller-Buh (2011), Poulter (1997), Revicki (2005)
Collect information about participants at risk of dropping out and use that information to intervene, or implement intensive follow-up strategies for these participants4Risk of drop out may be difficult to predict in some samples.Little, D’Agostino (2012), Senturia (1998),Sprague (2003)
Maintain contact with participants4Requires staff time, resources and commitmentHellard (2001), Kleinpell-Nowell (2000), Senturia (1998), Wisniewski (2006)
Send participants PRO assessment reminders16Requires staff time, resources and commitmentAltman (1993), Basch (2012), Bell (2014), Bernhard, Cella (1994), Cella (1995), Cella (1998), Fallowfield (1998), Jansen (2013), Kleinpell-Nowell (2000), Land (2007), Revicki (2005), Sherman (2005), Sprague (2003), Wisniewski (2006)
Provide assistance to participants when required1Requires staff time, resources and commitmentFairclough (2010)
Provide encouragement to participants when completing PROs4Requires staff time, resources and commitmentBasch (2012), Bernhard, Cella (1998), Little, Cohen (2012), Revicki (2005)
Explain reason for multiple PRO assessments4NoneBernhard, Peterson (1998), Calvert (2004), Hurny (1992), Sprague (2003)
Explain and remind participants of importance of PROs11NoneFayers (1997), Kyte (2013), Taphoorn (2010), Wilcox (2001), Calvert (2004), Cella (1995), Chassany (2002), Conroy (2003), Hellard (2001), Sherman (2005)
Update participants on trial/study progress6Requires staff time, resources and commitmentCella (1995), Hellard (2001), Little, Cohen (2012), Sadura (1992)
Informed consent (ensure these aspects of PRO study are addressed)Instruct participants to answer honestly/no right or wrong answers1NoneYoung T, de Haes (1999)
Inform participants that assistance is available if needed1NoneYoung T, de Haes (1999)
Explain commitment involved for the PRO study7NoneBernhard, Cella (1998), Blazeby (2003), Hurny (1992), Sherman (2005), Sprague (2003), Young, de Haes (1999)
Explain PRO assessment during informed consent process5NoneFallowfield (1998), Fayers (1997), Hopwood (1998), Movsas (2003), Moynihan (1998)
Explain importance of PRO assessment14NoneBernhard, Cella (1998), Conroy (2003), Fairclough (2010), Fayers (1997), Friedman (1998), Hurny (1992), Kleinpell-Nowell (2000), Blazeby (2003), Revicki (2005),Taphoorn (2010), Walker (2003), Young, de Haes (1999)
Explain importance of complete PRO data5NoneBernhard, Peterson (1998), Little, Cohen (2012), Young T, de Haes (1999), Kleinpell-Nowell (2000), Revicki (2005)
Explain that participation is voluntary1NoneSherman (2005)
Language translations available (participants may feel more confident using an alternative language translation that the default language offered)1NoneYoung T, de Haes (1999)
Ensure participant understands3NoneGanz (1988), Young, de Haes (1999)
Participants can take information sheets home.3NoneFayers (1997), Land (2007)
Recruitment methodFace-to-face recruitment2NoneJansen (2013)
Follow the recruitment protocol1NoneSenturia (1998)
Less aggressive recruitment methods may be more effective than more assertive methods.2May result in reduced recruitment. Recruitment method should not be aggressive, not lax.Hellard (2001), Kaasa (1998)
Participant recordsObtain contact details at registrationAlternate contact (a close relative or friend who you can contact in case the participant cannot be reached)5Some participants may not have a trusted friend/relative to nominate as alternate contact. Alternate contact person will need to provide consent to be contacted—which may be difficult to obtain and/or implement.Kleinpell-Nowell (2000), Senturia (1998), Sherman (2005)
Obtain complete participant contact details1Participant contact details may change during the course of the study; therefore, contact details should be checked regularly.Sprague (2003)
Specify procedures for checking and updating participant records3NoneCella (1995), Moinpour (1990), Senturia (1998)
Update participant recordsCheck if participant is alive (It may be distressing for friends/family members if study reminder letters are posted to participants home after they have died. This situation can be avoided by contacting the participant's doctor for updates on the participant’s condition.)2Must be handled carefully if participants’ relatives are contacted, and may require formal approval if participants’ GPs are contactedFallowfield (1998), Hopwood (1996)
Update participant contact details6Requires time and resourcesKleinpell-Nowell (2000), Little, Cohen (2012), Little, D’Agostino (2012), Meyers (2003), Young, de Haes (1999)
Record successful strategies for contacting participants (so that these strategies may be used for future study contact)1NoneMeyers (2003)
Quality assuranceCentral monitoring for PROsCentral office monitors compliance4Requires planning and resources to implementBernhard, Cella (1998), Hayden (1993), Kiebert (1998), Land (2007)
Appoint a central PRO coordinator/QA officer12Requires additional resourcesBell (2014), Bernhard, Cella (1998), Cella (1994), Cella (1995), Fallowfield (1998), Hahn (1998), Hurny (1992), Land (2007), Moinpour (1990), Poy (1993), Simes (1998), Sloan (2007)
Real-time monitoring of PRO completion (enables prompt intervention if PRO assessments are missed)27Requires time, commitment and resources of site and central monitoring staff. Requires input from database developers and statisticians from set-up phase. Difficult to implement for multisite trials due to delays in obtaining PRO forms from sites, and differences between patients in recruitment timeBasch (2012), Basch (2014), Bernhard, Cella (1998), Bernhard, Gusset (1998), Bernhard, Peterson (1998), Ganz (2007), Hayden (1993), Huntington (2005), Kyte (2013), Little, Cohen (2012), Movsas (2003), Poy (1993), Revicki (2005), Siddiqui (2014), Sprague (2003), Walker (2003), Wilcox (2001), Wisniewski (2006), Young, de Haes (1999)
CommunicationCentral monitors should discuss participants who withdraw with site staff (this may identify potential issues with site management and potential strategies for avoiding problems in future).1Requires real-time compliance monitoring, which requires time, commitment and resources of central and site staffSprague (2003)
Discuss the role of site staff in responding to participants’ medical needs1NoneSherman (2005)
Central office should send feedback reports to sites on PRO compliance and reasons for missing PRO data (this may assist sites to recognise problematic patterns in missing data, and to work towards rectifying such issues).14Requires real-time compliance monitoring, which requires time and resources of central staffBernhard, Peterson (1998), Bernhard, Cella (1998), Land (2007), Friedman (1998), Hahn (1998), Hurny (1992), Senturia (1998), Wilcox (2001), Young, de Haes (1999), Young, Maher (1999)
Sites should send feedback to central office (problems, participant feedback, etc, which may be able to be addressed through discussion, in future protocol amendments or in future studies)3Time commitmentBernhard, Gusset (1998), Hopwood (1998)
Importance of regular communication between research team20Requires time and resourcesBernhard, Peterson (1998), Calvert (2004), Cella (1994), Cella (1995), Hayden (1993), Land (2007), Moinpour (1998), Moynihan (1998), Osoba (1992), Poy (1993), Wisniewski (2006), Young, de Haes (1999)
Regular meetings (a forum for communication between the research team)6Requires time and resourcesCella (1994), Land (2007), Moinpour (1989), Osoba (1996), Sprague (2003), Wisniewski (2006)
Share strategies for successful PRO compliance3NoneBernhard, Peterson (1998), Calvert (2004), Kleinpell-Nowell (2000)
Schedule when reports are due for the sites to communicate with the central office1NoneCella (1995)
Reward high performing sites/staffDocument methods of success (regarding high PRO completion rates)1NoneStewart (1992)
Offer financial incentives to sites for high completion rates5Costs involvedLittle, D’Agostino (2012), Ganz (2007), Little, Cohen (2012), Aaronson (1990), Bernhard, Gusset (1998)
Offer incentives to sites for high completion rates (type of incentive unspecified)4Costs involvedBasch (2012), Bernhard, Cella (1998), Cella (1995), Hurny (1992)
Offer National Cancer Institute (NCI, USA) credit as incentive2Costs involvedLand (2007)
Offer non-financial incentives1Costs involvedLittle, D’Agostino (2012)
Site coordinator authorship as incentive1Costs involvedMoinpour (1998)
Thank you letters to site staff1Time and costs involvedLand (2007)
Travel support to high performing site staff as incentive2Costs involvedHahn (1998)
Poorly performing sitesIntervene in poorly performing sites (ie, with additional training, discussion about support needed to improve completion rates, etc)4Requires real-time compliance monitoring, and time and resources to implement interventionsBernhard, Gusset (1998), Hahn (1998), Hahn (1998), Land (2007)
Introduce incentives if improvement is seen at poorly performing sites1Costs involved. Need to be introduced before compliance rates fall too low.Cella (1994)
Penalise sites for poor compliance (eg, eliminate opportunity for future recruitment/involvement in future trials)5May reduce morale at that site if not handled appropriatelyBernhard, Cella (1998), Hayden (1993), Land (2007), Moinpour (1998)
Terminate recruitment at poorly performing sites2May reduce number of patients eligible for recruitmentFayers (1997), Poy (1993)
QA should be in place to promote high completion rates10Requires commitment and resources to implementBell (2014), Bernhard, Cella (1998), Bernhard, Peterson (1998), Cella (1995), Moinpour (1989), Moinpour (1998), Osoba (2007), Poy (1993), Revicki (2005)
Rate site's performance and assess against benchmark compliance rates1Requires real-time compliance monitoring, which requires central staff time and resourcesLand (2007)
Site-level monitoringSites should be prepared for regulator inspections1Requires time and commitment of site and central staffPoy (1993)
Sites should also monitor their own compliance rates1Requires time and resourcesHahn (1998)
Support for sites/staffOffer ongoing training to site staff4Time and costs involvedCella (1994), Cella (1995), Hahn (1998), Revicki (2005)
Send site staff reminders (for upcoming/overdue PRO assessments)32Requires time and resourcesBasch (2012), Bernhard, Cella (1998), Bernhard, Peterson (1998), Cella (1994), Cella (1995), Fairclough (2010), Hahn (1998), Hayden (1993), Hurny (1992), Land (2007), Moinpour (1989), Moinpour (1998), Osoba (1992), Poulter (1997), Revicki (2005), Sadura (1992), Siddiqui (2014), Simes (1998), Vantongelen (1989)
Site coordinatorAppoint a site coordinator—an individual at each site responsible for PRO administration for the study34Costs involvedBeitz (1996), Bernhard, Cella (1998), Bernhard, Peterson (1998), Blazeby (2003), Calvert (2004), Cella (1994), Cella (1995), Conroy (2003), Fallowfield (1998), Fayers (1997), Ganz (1988), Gotay (2005), Hahn (1998), Hayden (1993), Hopwood (1998), Hurny (1992), Kaasa (1992), Kyte (2013), Moinpour (1989), Moinpour (1990), Muller-Buh (2011), Poulter (1997), Revicki (2005), Stewart (1992), Young, de Haes (1999)
Roving coordinator (Rural/remote centres may have too few participants to warrant appointing a dedicated site coordinator. Instead a roving coordinator may be responsible for several such sites.)1Costs involvedScott (2004)
May be difficult to implement if rural centres are geographically distant, and if participants have similar PRO assessment schedules
Nominate a back-up site coordinator (If a primary site coordinator is absent, this individual will take responsibility for the trial.)3Requires additional resources to ensure back-up coordinator is adequately trained and informed about the PRO studyCalvert (2004), Fayers (1997), Revicki (2005)
Characteristics of site coordinatorCommitted to the study2NoneBlazeby (2003), Larkin (2012), Moinpour (1998)
Site staff should be accommodating/flexible7The flexibility of site staff is limited by their individual schedules and the resources available at the siteSenturia (1998), Sherman (2005), Sprague (2003)
Interpersonal skills1Interpersonal skills cannot always be taughtBernhard, Cella (1998)
Languages spoken (if the site has participants from multiple language backgrounds, it may be crucial to employ a coordinator who can speak these language/s)1May be difficult to recruit multilingual site coordinatorsBernhard, Peterson (1998)
Positive attitude8Difficult to train staff to have a positive attitude. Ascertaining and intervening in such problems may be difficult to implement.Bernhard, Cella (1998), Fairclough (2010), Kaasa (1992), Larkin (2012), Revicki (2005), Scott (2004), Sherman (2005)
Team involved in study implementationCommitment to the PRO study—required of the entire trial team, specifically:Central office staff1May require some education about the value and importance of complete PRO data—which may require additional time and resourcesOsoba (2007)
Physicians2May require some education about the value and importance of complete PRO data—which may require additional time and resourcesHurny (1992), Vantongelen (1989)
Multidisciplinary support2May require some education about the value and importance of complete PRO data—which may require additional time and resourcesPoy (1993)
Site coordinators3May require some education about the value and importance of complete PRO data—which may require additional time and resourcesLarkin (2012), Hayden (1993)
Participants1May require some education about the value and importance of complete PRO data—which may require additional time and resourcesHayden (1993)
Sponsor1May require some education about the value and importance of complete PRO data—which may require additional time and resourcesPoy (1993)
PRO Committee (group of PRO experts involved with a trials group who liaise with and advise trial investigators about PRO research. Committees may review PRO aspects of protocols or may be represented on trial teams69)2May require additional time and resourcesHahn (1998), Osoba (1992)
Support the site staffOffer support to sites/staff (eg, psychological support, bereavement counselling)6Requires time and resourcesWilcox (2001), Sherman (2005), Steinhauser (2006)
Minimise institution burden6NoneAaronson (1990), Young, de Haes (1999)
Offer a flexible working environment for site staff1Needs to be negotiated within the needs of the PRO studySteinhauser (2006)
Reward site staff for their work2Needs to be negotiated within the resources of the studySteinhauser (2006)
Train staffTrain site staffTraining for site coordinators is needed27Requires time and resourcesBasch (2012), Bernhard, Cella (1998), Bernhard, Gusset (1998), Bernhard, Peterson (1998), Cella (1995), Fairclough (2010), Ganz (2007), Gotay (2005), Hahn (1998), Hopwood (1998), Huntington (2005), Hurny (1992), Movsas (2003), Movsas (2004), Moynihan (1998), Osoba (1996), Poulter (1997), Poy (1993), Revicki (2005), Sherman (2005), Vantongelen (1989), Walker (2003)
Booster/ongoing training should also be offered, particularly if the trial/study runs over many years and staff changeover is expected.15Requires time and resourcesBernhard, Cella (1998), Bernhard, Peterson (1998), Cella (1994), Cella (1995), Hahn (1998), Larkin (2012), Moinpour (1998), Revicki (2005), Wilcox (2001), Wisniewski (2006), Young, de Haes (1999), Young, Maher (1999)
Poorly performing sites—additional training should be offered to help improve compliance rates in future3Requires central monitoring to identify poorly performing sites+time/resources to implement trainingFayers (1997), Hopwood (1998), Poy (1993)
Content of training for trial staff—the following issues related to PROs should be addressed: Communication skills (particularly for site coordinators—good communication skills are essential for ensuring the PRO study is explained to participants, ensuring participants’ questions are answered, and for building rapport)5Requires time and resourcesBernhard, Peterson (1998), Moynihan (1998), Poy (1993), Wilcox (2001)
Data cannot be retrieved later (this point should be made at training so that staff understand the importance of adhering to PRO assessment time windows)1Requires time and resourcesCella (1995)
Good clinical practice/good research practice1Requires time and resourcesPoy (1993)
Informed consent (PRO issues to discuss at consent stage)2Requires time and resourcesLittle, Cohen (2012), Wisniewski (2006)
Missing PRO data/importance of compliance6Requires time and resourcesFairclough (2010), Little, Cohen (2012), Luo (2008), Meyer (2009), Moinpour (1998), Young T, de Haes (1999)
Purpose/importance of PRO assessments12Requires time and resourcesCalvert (2004), Cella (1994), Cella (1995), Hahn (1998), Hopwood (1998), Little, D’Agostino (2012), Moinpour (1998), Poulter (1997), Taphoorn (2010), Walker (2003), Young, de Haes (1999), Young, Maher (1999)
Standardised procedures (importance of using standardised methods to administer PROs to minimise risk of bias)8Requires time and resourcesBernhard, Peterson (1998), Chassany (2002), Friedman (1998), Hayden (1993), Hurny (1992), Moinpour (1989), Sadura (1992), Sloan (2007)
Format of trainingInformational newsletters (as an additional training format)1Requires time and resourcesMoinpour (1989)
Pilot study as a training exercise in administering PROs and addressing common problems1Requires time, costs and resourcesCella (1994)
Video training (format)3Requires time and resourcesBernhard, Cella (1998), Hayden (1993), Revicki (2005)
Timing of trainingRequisite training for site coordinators (All site coordinators should receive training about PROs before they can work on studies with PROs.)4Requires time and resourcesMoinpour (1990), Sadura (1992), Wisniewski (2006)
Training at the start-up presentation (which can address study-specific PRO issues as well as general PRO issues)2Requires time and resourcesFallowfield (1998), Fairclough (2010)
Train clinician investigators6Requires time and resourcesHahn (1998), Aaronson (1990), Poy (1993), Young, de Haes (1999)
  • *Some sources may have provided a recommendation more than once.

  • GP, general practitioner; PRO, patient-reported outcome; QA, quality assurance.