Study conduct strategies to minimise the problem of missing PRO data
| Category | Topic | Specific recommendation | N recommendations* | Potential drawbacks | Source/s: first author (year). Full citations are provided as Online Supplementary Appendix C |
|---|---|---|---|---|---|
| Administration procedures | Approach all participants | All 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.) | 11 | None | Bernhard, Peterson (1998), Fairclough (2010), Hopwood (1998), Bakitas (2009), McMillan (2003), Revicki (2005), Young, de Haes (1999), Aaronson (1990), Moynihan (1998) |
| Assistance completing PRO measures | Prespecify types/levels of assistance that may be provided to participants | 5 | None | Fayers (1997), Kaasa (2002), Revicki (2005), Young, de Haes (1999), Fairclough (2010) | |
| Offer assistance to participants who need it | 11 | Requires additional staff time | Aaronson (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 provided | 1 | None | Blazeby (2003) | ||
| Nominate who should provide assistance to participants | 3 | Requires additional time and resources | Cella (1995), Revicki (2005), Young, de Haes (1999) | ||
| Be organised | Ensure sufficient questionnaires available for use | 1 | None | Moynihan (1998) | |
| Prepare for upcoming assessments (have questionnaires ready) | 6 | None | Vantongelen (1989), Cella (1995), Coates (1998), Moinpour (1989), Revicki (2005), Young, de Haes (1999) | ||
| Prepare to handle potential problems | 1 | None | Revicki (2005) | ||
| Track when PRO assessments due | 5 | None | Cella (1994), Cella (1995), Young, de Haes (1999) | ||
| Checking | Checking for missed PRO items | 29 | None | Calvert (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) | 2 | None | Davies (1994), Poy (1993) | ||
| Ensure patients receive questionnaires (particularly when the patients complete questionnaires outside of clinic) | 1 | None | Kaasa (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 sheet | 1 | None | Moinpour (1998) | |
| Recording levels of assistance | 6 | Requires additional time and resources to collect | Fayers (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) | 39 | Requires additional time and resources to collect | Fairclough (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 assessments | Alternative 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’) | 17 | Requires 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 assessments | 18 | Requires additional staff time and resources | Cella (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) | 8 | May be difficult to offer a quiet place to complete questionnaires in busy clinic environment | Calvert (2004), Hurny (1992), Jansen (2013), Moynihan (1998), Sadura (1992), Sherman (2005), Young, de Haes (1999) | ||
| Returning questionnaires | Specify procedures for returning questionnaires | 1 | None | Poulter (1997) | |
| Time of completion | Standardise time of completion (eg, first thing when the patient arrives at the clinic) | 2 | None | Bernhard, Cella (1998), Fayers (1997) | |
| Before seeing clinician (many sources recommended PROs should be completed before the participants have their appointment with their clinician) | 4 | Requires 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 methods | Adhere to PRO assessment schedule | 2 | None | Moinpour (1998), Poulter (1997) | |
| Use standard administration methods | 5 | None | Cella (1995), Chassany (2002), Movsas (2003), Movsas (2004), Revicki (2005) | ||
| Standardise methods (eg, by developing written guidance) | 13 | Time and minimal costs involved initially | Bernhard, 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 participant | On completion of questionnaire (face-to-face) | 6 | None | Calvert (2004), Kyte (2013), Meyers (2003), Sherman (2005), Steinhauser (2006), Young, de Haes (1999) | |
| Thank you letters | 3 | Requires additional time and resources | Steinhauser (2006), Fallowfield (1998), Poulter (1997) | ||
| Train staff | – | – | See ‘Train staff’ category | ||
| Participant education and engagement | Confidentiality | Be mindful of sensitive PRO data (ensure participants understand it will be kept confidential) | 2 | None | Cella (1994), Sherman (2005) |
| Discuss family involvement (participants may not wish to disclose certain information if they believe family members may see the data) | 1 | None | Sherman (2005) | ||
| Inform participants that PRO data are kept confidential | 6 | None | Calvert (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) | 1 | Prevents site staff from being able to check for any missing items | Fallowfield (1998) | ||
| Strategies for continued participant engagement | Site staff should offer to answer participant questions | 3 | None | Calvert (2004), Fayers (1997), Hurny (1992) | |
| Awareness of culturally sensitive issues | 1 | None | Bernhard, 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.) | 1 | May not be possible/feasible for all studies | Cella (1995) | ||
| Build rapport with participants | 4 | None | Blazeby (2003), Steinhauser (2006) | ||
| Educate participants about PROs (importance of PROs, how PRO data are used, how to complete PROs) | 5 | Requires staff time and commitment—depending on the comprehensiveness of education offered | Basch (2012), Fairclough (2010), Gotay (2005), Huntington (2005), Kaasa (1998) | ||
| Provide clear/simple instructions for completion of PRO assessments | 5 | None | Bernhard, 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) | 2 | None | Fayers (1997), Hopwood (1998) | ||
| Ensure participants understand (PRO assessment/how to complete questionnaires, etc) | 8 | Requires 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 participants | 4 | Risk of drop out may be difficult to predict in some samples. | Little, D’Agostino (2012), Senturia (1998),Sprague (2003) | ||
| Maintain contact with participants | 4 | Requires staff time, resources and commitment | Hellard (2001), Kleinpell-Nowell (2000), Senturia (1998), Wisniewski (2006) | ||
| Send participants PRO assessment reminders | 16 | Requires staff time, resources and commitment | Altman (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 required | 1 | Requires staff time, resources and commitment | Fairclough (2010) | ||
| Provide encouragement to participants when completing PROs | 4 | Requires staff time, resources and commitment | Basch (2012), Bernhard, Cella (1998), Little, Cohen (2012), Revicki (2005) | ||
| Explain reason for multiple PRO assessments | 4 | None | Bernhard, Peterson (1998), Calvert (2004), Hurny (1992), Sprague (2003) | ||
| Explain and remind participants of importance of PROs | 11 | None | Fayers (1997), Kyte (2013), Taphoorn (2010), Wilcox (2001), Calvert (2004), Cella (1995), Chassany (2002), Conroy (2003), Hellard (2001), Sherman (2005) | ||
| Update participants on trial/study progress | 6 | Requires staff time, resources and commitment | Cella (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 answers | 1 | None | Young T, de Haes (1999) | |
| Inform participants that assistance is available if needed | 1 | None | Young T, de Haes (1999) | ||
| Explain commitment involved for the PRO study | 7 | None | Bernhard, Cella (1998), Blazeby (2003), Hurny (1992), Sherman (2005), Sprague (2003), Young, de Haes (1999) | ||
| Explain PRO assessment during informed consent process | 5 | None | Fallowfield (1998), Fayers (1997), Hopwood (1998), Movsas (2003), Moynihan (1998) | ||
| Explain importance of PRO assessment | 14 | None | Bernhard, 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 data | 5 | None | Bernhard, Peterson (1998), Little, Cohen (2012), Young T, de Haes (1999), Kleinpell-Nowell (2000), Revicki (2005) | ||
| Explain that participation is voluntary | 1 | None | Sherman (2005) | ||
| Language translations available (participants may feel more confident using an alternative language translation that the default language offered) | 1 | None | Young T, de Haes (1999) | ||
| Ensure participant understands | 3 | None | Ganz (1988), Young, de Haes (1999) | ||
| Participants can take information sheets home. | 3 | None | Fayers (1997), Land (2007) | ||
| Recruitment method | Face-to-face recruitment | 2 | None | Jansen (2013) | |
| Follow the recruitment protocol | 1 | None | Senturia (1998) | ||
| Less aggressive recruitment methods may be more effective than more assertive methods. | 2 | May result in reduced recruitment. Recruitment method should not be aggressive, not lax. | Hellard (2001), Kaasa (1998) | ||
| Participant records | Obtain contact details at registration | Alternate contact (a close relative or friend who you can contact in case the participant cannot be reached) | 5 | Some 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 details | 1 | Participant 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 records | 3 | None | Cella (1995), Moinpour (1990), Senturia (1998) | ||
| Update participant records | Check 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.) | 2 | Must be handled carefully if participants’ relatives are contacted, and may require formal approval if participants’ GPs are contacted | Fallowfield (1998), Hopwood (1996) | |
| Update participant contact details | 6 | Requires time and resources | Kleinpell-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) | 1 | None | Meyers (2003) | ||
| Quality assurance | Central monitoring for PROs | Central office monitors compliance | 4 | Requires planning and resources to implement | Bernhard, Cella (1998), Hayden (1993), Kiebert (1998), Land (2007) |
| Appoint a central PRO coordinator/QA officer | 12 | Requires additional resources | Bell (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) | 27 | Requires 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 time | Basch (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) | ||
| Communication | Central 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). | 1 | Requires real-time compliance monitoring, which requires time, commitment and resources of central and site staff | Sprague (2003) | |
| Discuss the role of site staff in responding to participants’ medical needs | 1 | None | Sherman (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). | 14 | Requires real-time compliance monitoring, which requires time and resources of central staff | Bernhard, 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) | 3 | Time commitment | Bernhard, Gusset (1998), Hopwood (1998) | ||
| Importance of regular communication between research team | 20 | Requires time and resources | Bernhard, 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) | 6 | Requires time and resources | Cella (1994), Land (2007), Moinpour (1989), Osoba (1996), Sprague (2003), Wisniewski (2006) | ||
| Share strategies for successful PRO compliance | 3 | None | Bernhard, Peterson (1998), Calvert (2004), Kleinpell-Nowell (2000) | ||
| Schedule when reports are due for the sites to communicate with the central office | 1 | None | Cella (1995) | ||
| Reward high performing sites/staff | Document methods of success (regarding high PRO completion rates) | 1 | None | Stewart (1992) | |
| Offer financial incentives to sites for high completion rates | 5 | Costs involved | Little, 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) | 4 | Costs involved | Basch (2012), Bernhard, Cella (1998), Cella (1995), Hurny (1992) | ||
| Offer National Cancer Institute (NCI, USA) credit as incentive | 2 | Costs involved | Land (2007) | ||
| Offer non-financial incentives | 1 | Costs involved | Little, D’Agostino (2012) | ||
| Site coordinator authorship as incentive | 1 | Costs involved | Moinpour (1998) | ||
| Thank you letters to site staff | 1 | Time and costs involved | Land (2007) | ||
| Travel support to high performing site staff as incentive | 2 | Costs involved | Hahn (1998) | ||
| Poorly performing sites | Intervene in poorly performing sites (ie, with additional training, discussion about support needed to improve completion rates, etc) | 4 | Requires real-time compliance monitoring, and time and resources to implement interventions | Bernhard, Gusset (1998), Hahn (1998), Hahn (1998), Land (2007) | |
| Introduce incentives if improvement is seen at poorly performing sites | 1 | Costs 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) | 5 | May reduce morale at that site if not handled appropriately | Bernhard, Cella (1998), Hayden (1993), Land (2007), Moinpour (1998) | ||
| Terminate recruitment at poorly performing sites | 2 | May reduce number of patients eligible for recruitment | Fayers (1997), Poy (1993) | ||
| QA should be in place to promote high completion rates | – | 10 | Requires commitment and resources to implement | Bell (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 rates | 1 | Requires real-time compliance monitoring, which requires central staff time and resources | Land (2007) | ||
| Site-level monitoring | Sites should be prepared for regulator inspections | 1 | Requires time and commitment of site and central staff | Poy (1993) | |
| Sites should also monitor their own compliance rates | 1 | Requires time and resources | Hahn (1998) | ||
| Support for sites/staff | Offer ongoing training to site staff | 4 | Time and costs involved | Cella (1994), Cella (1995), Hahn (1998), Revicki (2005) | |
| Send site staff reminders (for upcoming/overdue PRO assessments) | 32 | Requires time and resources | Basch (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 coordinator | Appoint a site coordinator—an individual at each site responsible for PRO administration for the study | 34 | Costs involved | Beitz (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.) | 1 | Costs involved | Scott (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.) | 3 | Requires additional resources to ensure back-up coordinator is adequately trained and informed about the PRO study | Calvert (2004), Fayers (1997), Revicki (2005) | ||
| Characteristics of site coordinator | Committed to the study | 2 | None | Blazeby (2003), Larkin (2012), Moinpour (1998) | |
| Site staff should be accommodating/flexible | 7 | The flexibility of site staff is limited by their individual schedules and the resources available at the site | Senturia (1998), Sherman (2005), Sprague (2003) | ||
| Interpersonal skills | 1 | Interpersonal skills cannot always be taught | Bernhard, 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) | 1 | May be difficult to recruit multilingual site coordinators | Bernhard, Peterson (1998) | ||
| Positive attitude | 8 | Difficult 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 implementation | Commitment to the PRO study—required of the entire trial team, specifically: | Central office staff | 1 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Osoba (2007) |
| Physicians | 2 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Hurny (1992), Vantongelen (1989) | ||
| Multidisciplinary support | 2 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Poy (1993) | ||
| Site coordinators | 3 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Larkin (2012), Hayden (1993) | ||
| Participants | 1 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Hayden (1993) | ||
| Sponsor | 1 | May require some education about the value and importance of complete PRO data—which may require additional time and resources | Poy (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) | 2 | May require additional time and resources | Hahn (1998), Osoba (1992) | ||
| Support the site staff | Offer support to sites/staff (eg, psychological support, bereavement counselling) | 6 | Requires time and resources | Wilcox (2001), Sherman (2005), Steinhauser (2006) | |
| Minimise institution burden | 6 | None | Aaronson (1990), Young, de Haes (1999) | ||
| Offer a flexible working environment for site staff | 1 | Needs to be negotiated within the needs of the PRO study | Steinhauser (2006) | ||
| Reward site staff for their work | 2 | Needs to be negotiated within the resources of the study | Steinhauser (2006) | ||
| Train staff | Train site staff | Training for site coordinators is needed | 27 | Requires time and resources | Basch (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. | 15 | Requires time and resources | Bernhard, 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 future | 3 | Requires central monitoring to identify poorly performing sites+time/resources to implement training | Fayers (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) | 5 | Requires time and resources | Bernhard, 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) | 1 | Requires time and resources | Cella (1995) | ||
| Good clinical practice/good research practice | 1 | Requires time and resources | Poy (1993) | ||
| Informed consent (PRO issues to discuss at consent stage) | 2 | Requires time and resources | Little, Cohen (2012), Wisniewski (2006) | ||
| Missing PRO data/importance of compliance | 6 | Requires time and resources | Fairclough (2010), Little, Cohen (2012), Luo (2008), Meyer (2009), Moinpour (1998), Young T, de Haes (1999) | ||
| Purpose/importance of PRO assessments | 12 | Requires time and resources | Calvert (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) | 8 | Requires time and resources | Bernhard, Peterson (1998), Chassany (2002), Friedman (1998), Hayden (1993), Hurny (1992), Moinpour (1989), Sadura (1992), Sloan (2007) | ||
| Format of training | Informational newsletters (as an additional training format) | 1 | Requires time and resources | Moinpour (1989) | |
| Pilot study as a training exercise in administering PROs and addressing common problems | 1 | Requires time, costs and resources | Cella (1994) | ||
| Video training (format) | 3 | Requires time and resources | Bernhard, Cella (1998), Hayden (1993), Revicki (2005) | ||
| Timing of training | Requisite training for site coordinators (All site coordinators should receive training about PROs before they can work on studies with PROs.) | 4 | Requires time and resources | Moinpour (1990), Sadura (1992), Wisniewski (2006) | |
| Training at the start-up presentation (which can address study-specific PRO issues as well as general PRO issues) | 2 | Requires time and resources | Fallowfield (1998), Fairclough (2010) | ||
| Train clinician investigators | 6 | Requires time and resources | Hahn (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.