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Implementing PROMS for elective surgery patients: feasibility, response rate, degree of recovery and patient acceptability

Abstract

Background

Patient reported outcome measures (PROMs) engage patients in co-evaluation of their health and wellbeing outcomes. This study aimed to determine the feasibility, response rate, degree of recovery and patient acceptability of a PROM survey for elective surgery.

Methods

We sampled patients with a broad range of elective surgeries from four major Australian hospitals to evaluate (1) feasibility of the technology used to implement the PROMs across geographically dispersed sites, (2) response rates for automated short message service (SMS) versus email survey delivery formats, (3) the degree of recovery at one and four weeks post-surgery as measured by the Quality of Recovery 15 Item PROM (QoR-15), and (4) patient acceptability of PROMS based on survey and focus group results. Feasibility and acceptability recommendations were then co-designed with stakeholders, based on the data.

Results

Over three months there were 5985 surveys responses from 20,052 surveys (30% response rate). Feasibility testing revealed minor and infrequent technical difficulties in automated email and SMS administration of PROMs prior to surgery. The response rate for the QoR-15 was 34.8% (n = 3108/8919) for SMS and 25.8% (n = 2877/11,133) for email. Mean QoR-15 scores were 122.1 (SD 25.2; n = 1021); 113.1 (SD 27.7; n = 1906) and 123.4 (SD 26.84; n = 1051) for pre-surgery and one and four weeks post-surgery, respectively. One week after surgery, 825 of the 1906 responses (43%) exceeded 122.6 (pre-surgery average), and at four weeks post-surgery, 676 of the 1051 responses (64%) exceeded 122.6 (pre-surgery average). The PROM survey was highly acceptable with 76% (n = 2830/3739) of patients rating 8/10 or above for acceptability. Fourteen patient driven recommendations were then co-developed.

Conclusion

Administering PROMS electronically for elective surgery hospital patients was feasible, acceptable and discriminated changes in surgical recovery over time. Patient co-design and involvement provided innovative and practical solutions to implementation and new recommendations for implementation.

Trial Registration and Ethical Approval ACTRN12621000298819 (Phase I and II) and ACTRN12621000969864 (Phase III). Ethics approval has been obtained from La Trobe University (Australia) Human Research Ethics Committee (HEC20479).

Key points

Patient reported outcome measures (PROMs) help to engage patients in understanding their health and wellbeing outcomes. This study aimed to determine how patients feel about completing a PROM survey before and after elective surgery, and to develop a set of recommendations on how to roll out the survey, based on patient feedback. We found that implementing an electronic PROM survey before and after elective surgery was relatively easy to do and was well accepted by patients. Consumer feedback throughout the project enabled co-design of innovative and practical solutions to PROM survey administration.

Introduction

Patient reported outcome measures (PROMS) provide information on patient perceptions of their own health and wellbeing, including in response to interventions such as elective surgery [1,2,3]. By engaging patients in co-evaluation of their responses to surgery, health professionals and administrators can implement patient-informed, co-produced policies, procedures and interventions [4, 5]. Prior to large scale implementation of PROMS across hospitals globally, it is important to understand PROM feasibility, acceptability and outcomes from a surgical patient perspective [6, 7].

Feasibility refers to the ease of treatment implementation, practicality, integration, demand and acceptability [8]. In the context of receiving a PROM survey, each of the constructs are key. For example, the burden of a survey refers to the effort required to participate at different time points, coherence is the extent to which the patient understands the survey, and the self-efficacy refers to patient confidence that they can complete the survey correctly [9]. Acceptability from the patient perspective is particularly important for PROM surveys, as patient response rate, a key outcome of PROM implementation, acts as a surrogate for acceptability [10]. Acceptability is described as the extent to which the people who provide or receive an intervention view it as appropriate, effective and helpful [9]. It also incorporates elements of burden, coherence, ethics, opportunity cost and self-efficacy [9].

This current PROM study for elective surgery patients is a part of a larger research program designed to develop Australian ePROM implementation recommendations, called ‘AusPROM’, with a detailed protocol previously published [11]. In summary, the AusPROM research program contains a number of phased studies that embed patient and staff co-design into the implementation process, through an iterative process, and this included the identification of barriers and facilitators from the patient and staff perspective.

In the current study we sampled patients having a broad range of elective surgeries from four major Australian hospitals, aiming to evaluate (1) technical feasibility of the technology used to implement the PROMs across geographically dispersed sites, (2) response rates for automated short message service (SMS) versus email survey delivery, (3) the degree of recovery at one and four weeks post-surgery (Quality of Recovery 15 Item PROM; QoR-15) [12, 13], and (4) patient acceptability based on survey and focus group results. The patient surveys and focus group were designed to enable patient co-design in the development of the broader AusPROM recommendations, through the development of a set of patient-driven recommendations.

Methods

This study has been reported according to the CONSORT statement: extension to randomised pilot and feasibility trials [14] in “Appendix 1”. As noted in the aims, the current study reports on four distinct areas from this broader research program including technical feasibility, response rate, degree of recovery and patient acceptability.

Study design

We used a mixed-methods design to test the technical feasibility, response rate, degree of recovery and patient acceptability of electronic PROMS.

Patient co-design

To improve acceptability, usability and uptake, patient feedback and co-design were embedded throughout the study [4]. This included a patient co-designing and co-authoring the project from its concept (VR); patients completing acceptability questions alongside the PROM survey; as well as a patient focus group to further explore PROM survey acceptability and patient driven recommendations for ongoing PROM implementation [4, 5].

Participants

Survey participants were patients who had elective surgery in four hospitals in Australia. Inclusion criteria were adults aged 18+, having either elective day-surgery or elective surgery requiring an overnight hospital admission. Exclusion criteria included a pregnancy related procedure or an investigative procedure (see “Appendix 2” for full list of excluded procedures). Consent was via an opt-in consent tick-box prior to commencing the survey. The pre-test surveys were distributed through one hospital in New South Wales, Australia. The pilot site surveys were distributed through four of the health services 29 hospitals which provide elective surgery. The four pilot sites were selected based on a sample of convenience and were located in New South Wales, Queensland and Victoria, Australia. Three of the four hospitals had an emergency department and all four were located in metropolitan areas.

Across the health service, there are hospital specific consumer groups. The consumers are generally past patients from the health service. The patient focus group participants were members of the hospital specific consumer groups (i.e., not current patients). Individuals were approached through the Quality Manager, based on a request from the Corporate Consumer Consultant (Chairperson of the Healthscope National Consumer Advisory Council). The sample of convenience aimed to obtain a mix of past patients across the different states and territories of Australia. Inclusion criteria were adults 18+ who were members of the hospital specific consumer groups. There were no exclusion criteria. Written informed consent was required prior to participation in the focus group.

Intervention and study instrument

The intervention was the administration of the PROM survey, based on the QoR-15 tool, the week prior to surgery, and one and four weeks post-surgery. The QoR-15 was derived from the Quality of Recovery 40 item (QoR-40) tool [12]. It has 15 items each rated on a 11-point scale from 0 to 10, with a maximum score of 150 The QoR-15 has reported good validity, reliability and responsiveness and is brief to administer (< 3 min) [12, 15]. The QoR-15 can be used pre-surgery, 24 h post-surgery, as well as from weeks to months post-surgery, as a measure of change over time [13, 16, 17], supporting this studies use of the QoR-15 the week prior to surgery, and one and four weeks post-surgery. The minimal clinical important difference of the QoR-15 is 8.0 [16].

With permission from the QoR-15 author [13], questions 7 and 8 of the QoR-15 tool were modified for the pre-surgery surveys as they were designed for the post-surgery period. Questions 7 was modified from “Getting support from hospital doctors and nurses” to “Getting support from Health Professionals”, and Question 8 was modified from “Able to return to work or usual home activities” to “Able to participate in work or usual home activities”.

The QoR-15 tool was chosen due to its valid use pre and post-surgery, the short completion time and its applicability across most surgery types [13, 18,19,20], enabling the health service to implement one consistent and inclusive tool. In addition, the individual items within the tool can be used to isolate the more difficult areas of recovery post-surgery, and enable the health service to target these areas to improve care and recovery.

Outcomes

  1. (i)

    Technical feasibility of the technology used to implement the PROMs across geographically dispersed sites

Outputs and outcomes for the PROM pre-pilot surveys included development of agreed list of surgical procedures to be excluded from the survey distribution list, as well as observations of the differences between the pre-surgery and the post-surgery survey distribution lists.

  1. (ii)

    Response rates for automated short message service (SMS) versus email survey delivery

Response rate for SMS and email survey invitations were reported separately and combined for the pre-surgery, one week post-surgery and four weeks post-surgery surveys. In addition, at the four sites, separate to the PROM survey, was a long-standing Patient Experience survey. As a part of PROM feasibility testing, we examined if the introduction of the PROM survey impacted the response rate of the Patient Experience survey. To test this, the Patient Experience response rates were reviewed across the four sites during the PROM study.

  1. (iii)

    Degree of recovery at one and four weeks post-surgery as measured by the QoR-15

The PROM survey, focussed on the QoR-15, was administered electronically pre-surgery, one week post-surgery and four weeks post-surgery. Patients were independently invited to participate in a survey at each time point. This was because someone included in the pre-surgery survey may have been excluded in the post-surgery survey if the planned surgery changed and was one of the excluded surgery types.

  1. (iv)

    Patient acceptability based on survey and focus group results (quantitative and qualitative acceptability questions)

Outcomes for patient acceptability, via survey questions and the patient focus group, include a survey question “Based on the different aspects of acceptability which are important to you, how do you rate the acceptability of the survey just completed?” measuring of acceptability based on a 0–10 Likert scale (0 = Not acceptable, 10 = Highly acceptable), and an open-ended question asking “Can you please note which aspects of acceptability are important to you? And, how we could modify the survey to be more acceptable to you (or if it is ok just the way it is)?”. In addition, there was a focus group for further qualitative data on acceptability.

The patient survey and focus group results were used to help develop patient driven recommendations for ongoing PROM implementation. It is noted that this study only reports on the patient perspective and that similar work was completed for the staff perspective and this has been reported separately.

The theoretical framework chosen to support the selection and implementation of PROMs was the “PROM cycle” [21]. The PROM cycle has four main phases [21]. The first is “goal” setting, to determine the objective for PROM implementation; the second phase is “selection” and testing of the appropriate PROM; the third identifies the “indicator” which includes the steps of defining and testing the quality indicator; and the fourth is “use” and involves the steps of implementing and evaluating the PROM [21]. Feasibility studies such as the current investigation are vitally important during phases two and three of the PROM-cycle, to test the PROM and confirm quality indicators to show successful implementation.

Sample size

The PROM pre-pilot surveys aimed to invite up to 100 participants, the survey implementation at four pilot sites aimed to invite up to 2700 participants, and both were based on a sample of convenience. Based on a previous national survey response rate across the same heath service of 37% [22], the PROM survey response rate was also expected to be between 30–40%. The patient focus group aimed for up to 10 participants, and was conducted after the survey results were analysed to ensure the themes which emerged in the survey, were explored in the focus group.

Statistical analysis

Results from the PROM pre-pilot surveys are reported descriptively. Results for the PROM survey implementation at four pilot sites are reported as a number and percentage for the response rate, and as a mean and standard deviation for the QoR-15 scores pre and post-surgery. Pre-surgery QoR-15 scores were compared to post-surgery scores using independent t-tests reporting the mean difference and confidence interval. A chi-square statistic was used to determine if there was a difference between proportion within age groups, proportion female, and proportion of day surgery versus overnight surgery between pre-surgery, one week post-surgery and four week post-surgery groups. Responses are reported separately for day surgery, overnight surgery and for combined day/overnight surgery, as a number of the surgeons perform surgery which requires both day and overnight admissions, and this reporting structure will ensure aggregate results are meaningful to the surgeons. Statistical significance was assumed at p < 0.05 and SPSS [23] was used for the analysis.

Qualitative results for patient acceptability, via survey questions and the patient focus group, were analysed using a content analysis and then themed according to the seven constructs of the theoretical framework of acceptability (TFA) [9]. The constructs were based on affective attitude: surgical patient feelings about the survey; burden: the effort required by the patient to participate; and perceived effectiveness: perception by the patient that the survey is likely to achieve its purpose. In addition there was ethicality: the surveys “fit” with individual value systems; intervention coherence: extent to which the patient understands the survey; opportunity costs: extent to which benefits or values of the patient must be given up to engage in the survey; and self-efficacy: patients confidence that they can complete the survey correctly [9]. These themed qualitative results were then critically reviewed by the research team to derive feasibility and acceptability recommendations from the patient perspective.

Results

  1. (i)

    Technical feasibility of the technology used to implement the PROMs across geographically dispersed sites

In April 2021, the pre-pilot survey used email to invite 80 patients to participate over the pre-pilot period. While all 80 received the pre-surgery survey, only 67 received the post-surgery surveys. Patient survey distribution lists included for the pre-surgery survey and the post-surgery survey differed because of late additions or cancellations prior to surgery, and intra-operative changes to the planned surgery, for example a patients would be excluded from the pre-surgery PROM survey distribution list if they had an investigative procedure planned, however, if this extended to an interventional procedure, they would be added to the post-surgery survey distribution list. A list of surgical procedures which were excluded has been detailed in “Appendix 2”.

The pre-surgery survey had 26 responses (response rate 32.5%, n = 26/80). The one and four weeks post-surgery surveys each had 15 responses (response rate 22.4%, n = 15/67). The technical feasibility testing on the pre-pilot survey resulted in a robust party automated/party manual process being developed for the identification of the pre-surgery PROM survey distribution list for PROM survey implementation at four pilot sites, compared to the fully automated post-surgery PROM survey distribution list.

  1. (ii)

    Response rates for automated short message service (SMS) versus email survey delivery

Between April 2021 and July 2021, there were 5985 surveys responses (response rate 29.8%, n = 5985/20,052) and these were distributed across the pre-surgery survey (response rate 44.5%, n = 1756/3944), the one-week post-surgery survey (response rate 33.3%, n = 2682/8054) and the four weeks post-surgery survey (response rate 19.2%, n = 1547/8054).

Two sites used SMS and two sites used email to invite patients to participate. The response rate for SMS was 34.8% (n = 3108/8919) and the median time to complete the survey was 2 min and 10 s and the response rate for email was 25.8% (n = 2877/11,133) and the median time to complete the survey was 2 min and 29 s (Table 1).

Table 1 Response rate

At the four sites, separate to the PROM survey, was a long standing Patient Experience survey. As a part of PROM feasibility testing, we examined if the introduction of the PROM survey impacted the response rate of the Patient Experience survey. To test this, the Patient Experience response rates were reviewed and these remained consistent across the four sites during the PROM study with a response rate ranging from 29.9 to 31.5% prior to introducing the PROM survey (October to December 202), and a rate ranging from 29.4 to 31.7% during PROM survey introduction (April to June 2021; Table 2).

Table 2 PROM survey impact on the previously implemented Patient Experience questionnaire

While patient characteristics were similar for those who completed the pre-surgery survey, compared to the one week post-surgery survey, compared to the four weeks post-surgery, based on a chi-square statistic the proportion of patients in each of the age brackets did significantly differ between the groups (p < 0.01), however the difference between proportion female, and proportion of day surgery versus overnight surgery, did not significantly differ (p > 0.05), (Table 3).

  1. (iii)

    Degree of recovery at one and four weeks post-surgery as measured by the Quality of Recovery 15 Item PROM (QoR-15)

Table 3 Patient characteristics for the pre-surgery survey, and the one and four weeks post-surgery surveys

Across the four pilot sites there were 489 different surgeons who had patients complete a PROM survey, with each surgeon having an average of 3.50 (SD 5.68) patients complete the pre-surgery survey, 6.44 (SD 7.54) patients complete the 1 week post-surgery survey and 4.32 (SD 4.50) patients complete the 4 weeks post-surgery survey.

For combined overnight and day admissions, prior to surgery, the mean QoR-15 score was 122.69 (SD 25.23; n = 1021), one week post-surgery it was 113.08 (SD 27.74; n = 1906) and 4 weeks post-surgery it was 123.39 (SD 26.84; n = 1051). While there was a significant difference in the score from pre-surgery to one week following surgery, and again from one and four weeks post-surgery, there was no significant difference between QoR-15 scores pre-surgery and four weeks post-surgery. At one-week post-surgery, 825 of the 1,906 responses (43%) exceeded 122.6 (pre-surgery average), and at four weeks post-surgery, 676 of the 1,051 responses (64%) exceeded 122.6 (pre-surgery average). When this was separated into the subgroups of day admissions and overnight admissions, the findings were similar (Table 4; Fig. 1).

  1. (iv)

    Patient acceptability based on survey and focus group results (quantitative and qualitative acceptability questions)

Table 4 QoR-15 scores
Fig. 1
figure 1

Overall PROM response on the QoR-15 prior to surgery and one and four weeks following surgery

During the first, second and third surveys, there were 3739 responses to the survey question rating acceptability, 76% (n = 2830/3739) rated 8/10 or above for acceptability where 10/10 indicated highly acceptable (Fig. 2).

Fig. 2
figure 2

Patient rating for PROM survey acceptability

In the PROM survey, 1877 (31%) patients provided a breadth of additional comments regarding patient acceptability and 4108 (69%) did not. Comments were spread across the pre-surgery surgery (n = 507, 27%), the one week post-surgery survey (n = 863, 46%) and the four week post-surgery survey (n = 507, 27%). The single patient focus group (n = 8 participants) had representation from NT, SA, NSW, ACT and Victoria, and explored patient acceptability of introducing a PROM survey (focus group interview guide; “Appendix 3”).

COVID-19 response during pilot data collection

It is noted that the COVID-19 pandemic had an impact on the study during the final weeks of data collection. This involved stopping the pre-surgery survey at two sites (New South Wales) two weeks earlier than planned (completing 10 weeks of the 12 weeks of planned data collection), due to the manual steps associated with the pre-surgery survey to remove participants with excluded surgery types. This was defined as a project “Red Phase”—refer to “Appendix 4” for details related to the “COVID-19 contingency plan”. The one week and four weeks post-surgery surveys were not impacted.

Feasibility and acceptability patient recommendations

To provide structure, the patient recommendations have been presented under the 4-Phases of the PROM cycle as well as the 7-domains of patient acceptability for receiving a health service, in the following Text Box.

Discusssion

This authorship team has completed a research program which resulted in the development of Australian ePROM implementation recommendations, called ‘AusPROM’ [11, 24]. The current study represents the consumer voice and brings patient co-design into the AusPROM recommendation development process. Patients articulated how they felt about completing a PROM survey before and after elective surgery, and co-designed a set of “patient driven” recommendations on how to roll out the survey. These “patient driven” recommendations provided innovative and practical solutions regarding how the survey could be rolled out. These recommendations have been a key driver in a Delphi technique that was used to confirm the final set of AusPROM recommendations [24].

The current study found that implementing PROMS electronically for elective surgery hospital patients was technically feasible and did not require additional infrastructure. In agreement with a 2022 systematic review of global studies by Sokas [25] hospital patients found participating in the ePROM acceptable before and after their surgery, and achieved a similar response rate to other long term hospital surveys. Based on the general direction of the results, for this elective surgery group of patients the PROM discriminated change in the patients surgical recovery over time, with a full recovery for most patients by four-weeks.

Despite being conducted in the height of the COVID-19 pandemic, this comprehensive analysis had almost 6,000 survey responses. It showed favourable responses for implementing PROMS, which is consistent with PROMS implementation in other diagnostic categories such oncology [26] and total knee replacement [27], as well as across broader patient populations [25, 28]. Feasibility testing revealed minor and infrequent technical difficulties in automated SMS or email administration of the PROM prior to surgery. The QoR-15 response rate was higher for SMS compared to email. From the week prior to surgery to the week immediately after elective surgery, patients experienced reduction in this patient-centred outcome and this was reversed by four weeks post-surgery. From the patient perspective, the PROM survey was highly acceptable with 76% of patients rating 8/10 or above for acceptability.

When considering all online devices, such as smart phones and computers, email invitations and SMS invitations to survey participation have a similar response rate, however, when only considering the smart phone response rate, the SMS yields a higher response rate [29, 30]. This finding was consistent for the current study where the SMS response rate (36%) exceeded the email response rate (25%).

The average quality of recovery score in the current study, measured through the QoR-15 tool, prior to elective surgery was 123 out of a possible 150 (n = 1021). This pre-surgery score was consistent with other patient cohorts undergoing mixed surgery types with similar pre-surgery scores of 123 (n = 127) [12] and 125 (n = 363) [31], yet higher than a patient cohort undergoing hip replacement with a score of 114 (n = 115) [32]. Post-operatively, the average quality of recovery score in the current study dipped to 113 (n = 1906) the week after surgery then returned to 123 (n = 1051) 4 weeks after surgery, indicating that based on the general direction of the results, the PROM discriminated change in the patients surgical recovery over time, consistent with the literature [12, 31]. When the cohort was separated into the subgroups of day admissions and overnight admissions, the findings were similar. It is possible that this data set does not represent the final status of recovery after surgery, as further gains may have been achieved after the 4 week post-surgery time point.

Patient acceptability of the current PROM survey was high, based on quantitative and qualitative acceptability questions within the survey and a patient focus group. In comparison, a small number of systematic reviews have concluded that there is either some evidence that PROMs are acceptable to the patients affected by cancer or cystic fibrosis [33, 34], or that there is a paucity in the literature to conclude that PROMs are (or are not) acceptable to the patients affected by chronic fatigue syndrome, a hip fracture or kidney disease [35,36,37].

It has been described as wrong to seek patient feedback in healthcare and then not use this information to influence clinical practice [38]. From the onset, the current study intended to use patient feedback to guide innovative and practical solutions to shape co-design. The themed qualitative results, which developed the 14 feasibility and acceptability recommendations from the patient perspective, will provide a patient voice to the next stage of this research program where the final “AusPROM” Recommendations [11, 24] will be developed. Patient recommendations included defined roles and responsibilities for the nursing, medical, administrative and management staff in relation to the PROM survey process. However, it is unknown if these views would have differed prior to the impact on staff demands due to the COVID-19 pandemic.

Limitations to this study included an end point of 4 week post-surgery which may not have reported the final status of recovery after surgery, excluding any non-electronic modes of survey distribution, as well as the impact of COVID-19 during the final weeks of data collection. The study was conducted in Australia and it is not known whether similar results would be obtained in other regions of the world or for different cultures or case-mixes, or in health services with different technology systems.

Conclusion

Implementing PROMS electronically for elective surgery hospital patients was feasible, acceptable and showed changes in outcome over time. Patient involvement facilitated innovative and practical solutions to implementation and the formulation of recommendations.

Availability of data materials

The named authors on this protocol will have access to the final trial dataset. Individual patient level data will not be available for sharing at the conclusion of this study.

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Acknowledgements

This project conducted as a part of the Healthscope ARCH (www.latrobe.edu.au/she/arch) and is a collaboration between Healthscope and La Trobe University Australia.

Vincent Rovtar—Patient-Author.

Funding

This study was funded by Healthscope Australia.

Author information

Authors and Affiliations

Authors

Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by MEM, AH and NKB. The first draft of the manuscript was written by NKB and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Meg E. Morris.

Ethics declarations

Ethics approval and consent to participate

Trial registration ACTRN12621000298819 (Phase I and II) and ACTRN12621000969864 (Phase III). Ethics approval has been obtained from La Trobe University (Australia) Human Research Ethics Committee (HEC20479). Patient survey participants provided written consent via a tick box, prior to commencing the PROM survey. Patient focus group participants provided written informed consent prior to the focus group.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Appendices

Appendix 1

CONSORT statement: extension to randomised pilot and feasibility trials

Section/topic and item no

Extension for pilot trials

Note where reported

Title and abstract

  

1a

Identification as a pilot or feasibility randomised trial in the title

Title

1b

Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials)

Abstract

Introduction

  

Background and objectives:

  

2a

Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial

Introduction

2b

Specific objectives or research questions for pilot trial

Introduction

Methods

  

Trial design:

  

3a

Description of pilot trial design (such as parallel, factorial) including allocation ratio

Methods

3b

Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons

Methods

Participants:

  

4a

Eligibility criteria for participants

Methods

4b

Settings and locations where the data were collected

Methods

4c

How participants were identified and consented

Methods

Interventions:

  

5

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Methods

Outcomes:

  

6a

Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed

Methods

6b

Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons

N/A

6c

If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial

N/A

Sample size:

  

7a

Rationale for numbers in the pilot trial

Methods

7b

When applicable, explanation of any interim analyses and stopping guidelines

N/A

Randomisation:

  

Sequence generation:

  

8a

Method used to generate the random allocation sequence

N/A

8b

Type of randomisation(s); details of any restriction (such as blocking and block size)

N/A

Allocation concealment mechanism:

  

9

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

N/A

Implementation:

  

10

Who generated the random allocation sequence, enrolled participants, and assigned participants to interventions

N/A

Blinding:

  

11a

If done, who was blinded after assignment to interventions (eg, participants, care providers, those assessing outcomes) and how

N/A

Analytical methods:

  

12a

Methods used to address each pilot trial objective whether qualitative or quantitative

Methods

Results

  

Participant flow (a diagram is strongly recommended):

  

13a

For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly assigned, received intended treatment, and were assessed for each objective

Results

13b

For each group, losses and exclusions after randomisation, together with reasons

N/A

Recruitment:

  

14a

Dates defining the periods of recruitment and follow-up

Results

14b

Why the pilot trial ended or was stopped

N/A

Baseline data:

  

15

A table showing baseline demographic and clinical characteristics for each group

Results

Numbers analysed:

  

16

For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomised group

Results

Outcomes and estimation:

  

17a

For each objective, results including expressions of uncertainty (such as 95% confidence interval) for any estimates. If relevant, these results should be by randomised group

Results

Ancillary analyses:

  

18

Results of any other analyses performed that could be used to inform the future definitive trial

Results

Harms:

  

19

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

N/A

19a

If relevant, other important unintended consequences

N/A

Discussion

  

Limitations:

  

20

Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility

Discussion

Generalisability:

  

21

Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies

Discussion

Interpretation:

  

22

Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and considering other relevant evidence

Discussion

22a

Implications for progression from pilot to future definitive trial, including any proposed amendments

Discussion

Other information

  

Registration:

  

23

Registration number for pilot trial and name of trial registry

Title page

Protocol:

  

24

Where the pilot trial protocol can be accessed, if available

Methods

Funding:

  

25

Sources of funding and other support (such as supply of drugs), role of funders

Discussion

26

Ethical approval or approval by research review committee, confirmed with reference number

Methods

Appendix 2

A list of surgical procedures which were excluded from the survey distribution list

Item

Description

Item

Description

Item

Description

11,333

Caloric test of labyrin

16,633

PROCEDURE ON MULTIPLE PRE

49,342

HIP REVISION TOTAL REPLAC

11,336

Simultaneous bithermal ca

16,636

Procedure on multiple pre

49,345

HIP REVISION TOTAL REPLAC

11,339

Electronystagmography

18,262

ILIO-INGUINAL ILIOHYPOGAS

49,346

HIP REVISION ARTHROPLASTY

114

Removal of calculus. fir

30,569

ENDOSCOPIC EXAMINATION OF

49,515

KNEE REMOVAL OF PROSTHESI

115

Removal of calculus. sub

32,030

RECTOSIGMOIDECTOMY—HART

49,517

KNEE HEMIARTHROPLASTY OF

11,500

Bronchospirometry

32,072

SIGMOIDOSCOPIC EXAMINATIO

49,518

KNEE TOTAL REPLACEMENT AR

11,503

Measurement of: (a) the m

32,075

SIGMOIDOSCOPIC EXAMINATIO

49,519

KNEE TOTAL REPLACEMENT AR

11,505

Measurement of spirometry

32,078

SIGMOIDOSCOPIC EXAMINATIO

49,521

KNEE TOTAL REPLACEMENT AR

11,506

Measurement of respirator

32,081

SIGMOIDOSCOPIC EXAMINATIO

49,524

KNEE TOTAL REPLACEMENT AR

11,507

Measurement of spirometry

32,084

Sigmoidoscopy or colonoscopy

49,527

KNEE TOTAL REPLACEMENT AR

11,508

Maximal symptom&#8209;lim

32,087

Endoscopic examination of

49,530

KNEE TOTAL REPLACEMENT AR

11,600

BLOOD PRESSURE MONITORING

32,088

Fibreoptic colonoscopy ex

49,533

KNEE TOTAL REPLACEMENT AR

11,602

Investigation of venous r

32,089

Endoscopic examination of

49,534

KNEE PATELLO-FEMORAL JOIN

11,604

Plethysmographic assessment

32,090

FIBREOPTIC COLONOSCOPY -

49,536

KNEE REPAIR OR RECONSTRUC

11,605

Infrared photoplethysmogr

32,093

FIBREOPTIC COLONOSCOPY -

49,539

KNEE RECONSTRUCTIVE SURGE

11,610

Measurement of ankle

32,095

ENDOSCOPIC EXAMINATION OF

49,542

KNEE RECONSTRUCTIVE SURGE

11,611

Measurement of wrist

32,222

Endoscopic examination of

49,545

KNEE REVISION ARTHRODESIS

11,612

Exercise study

32222P

Endoscopic exam of the co

49,548

KNEE REVISION OF PATELLO-

11,722

Implanted ECG loop record

32,223

Colonoscopy Applicable On

49,551

KNEE REVISION OF PROCEDUR

11,728

Implanted loop recording

32223P

Col with Polyp Applicable

49,554

KNEE REVISION OF TOTAL RE

11,820

Capsule endoscopy

32,224

Endoscopic examination of

49,557

KNEE DIAGNOSTIC ARTHROSCO

12,210

Overnight paediatric investigation

32224P

Endoscopic exam of the co

50,353

HIP SPICA INITIAL APPLICA

12,213

Overnight paediatric investigation

32,225

Endoscopic examination of

50,616

SCOLIOSIS IN A CHILD OR A

12,215

Overnight paediatric investigation

32225P

Endoscopic exam of the co

50,620

SCOLIOSIS IN A CHILD OR A

12,217

Overnight paediatric investigation

32,226

Endoscopic examination of

50,624

SCOLIOSIS IN A CHILD OR A

13,200

Assisted reproductive ser

32226P

Endoscopic exam of the co

50,628

SCOLIOSIS IN A CHILD OR A

13,203

Ovulation monitoring serv

32,227

Endoscopic examination of

50,636

SCOLIOSIS IN A CHILD OR A

13,206

Assisted reproductive ser

32,228

Colonoscopy Applicable On

50,640

SCOLIOSIS IN A CHILD OR A

13,209

Planning and management o

32228P

Colonoscopy with polyp Ap

55,118

HEART 2 DIMENSIONAL REAL

13,212

OOCYTE RETRIEVAL BY ANY M

35,643

EVACUATION OF THE CONTENT

55,700

Pelvis or abdomen, pregnancy

13,215

TRANSFER OF EMBRYOS OR BO

35,674

ULTRASOUND GUIDED NEEDLIN

55,703

Pelvis or abdomen, pregnancy

13,218

PREPARATION AND TRANSFER

35,676

ECTOPIC PREGNANCY REMOVAL

55,704

Pelvis or abdomen, pregnancy

13,221

Preparation of semen for

35,677

ECTOPIC PREGNANCY REMOVAL

55,705

Pelvis or abdomen, pregnancy

13,251

Intracytoplasmic sperm in

35,678

ECTOPIC PREGNANCY LAPAROS

55,706

Pelvis or abdomen, pregnancy

135A

Consultant paediatrician,

36,504

RIGID CYSTOSCOPY using bl

55,707

Pelvis or abdomen, pregnancy

164A

Professional attendance f

36,505

RIGID CYSTOSCOPY using bl

55,708

Pelvis or abdomen, pregnancy

16,500

Antenatal attendance

36,507

RIGID CYSTOSCOPY using bl

55,709

Pelvis or abdomen, pregnancy

16,501

External cephalic version

36,508

RIGID CYSTOSCOPY using bl

55,712

Pelvis or abdomen, pregnancy

16,502

Polyhydramnios, unstable

36,812

CYSTOSCOPY WITH URETHROSC

55,715

Pelvis or abdomen, pregnancy

16,504

Treatment of habitual mis

36,860

ENDOSCOPIC EXAMINATION OF

55,718

Pelvis or abdomen, pregnancy

16,505

Threatened abortion

38,218

SELECTIVE CORONARY ANGIOG

55,721

Pelvis or abdomen, pregnancy

16,508

Pregnancy complicated by

38,285

IMPLANTABLE EGG LOOP RECO

55,723

Pelvis or abdomen, pregnancy

16,509

Preeclampsia, eclampsia o

38,286

IMPLANTABLE EGG LOOP RECO

55,725

Pelvis or abdomen, pregnancy

16,511

CERVIX PURSE STRING LIGAT

38,288

Implantable loop recorder

55,759

Pelvis or abdomen, pregnancy

16,512

CERVIX REMOVAL OF PURSE S

47,540

HIP SPICA OR SHOULDER SPI

55,762

pelvis or abdomen, pregnancy

16,514

Antenatal cardiotocograph

48,912

SHOULDER ARTHROTOMY OF AN

55,764

pelvis or abdomen, pregnancy

16,515

MANAGEMENT OF VAGINAL DEL

48,915

SHOULDER HEMI-ARTHROPLAST

55,766

Pelvis or abdomen, pregnancy

16,518

Management of labour

48,918

SHOULDER TOTAL REPLACEMEN

55,768

Pelvis or abdomen, pregnancy

16,519

MANAGEMENT OF LABOUR AND

48,921

SHOULDER TOTAL REPLACEMEN

55,770

pelvis or abdomen, pregnancy

16519L

MANAGEMENT OF LABOUR AND

48,924

SHOULDER TOTAL REPLACEMEN

55,772

Pelvis or abdomen, pregnancy

16,520

CAESAREAN SECTION AND POS

48,927

SHOULDER PROSTHESIS REMOV

55,774

Pelvis or abdomen, pregnancy

16,522

MANAGEMENT OF LABOUR AND

48,933

SHOULDER STABILISATION PR

55,816

Hip or groin, 1 or both s

16,525

Management of second trim

48,936

SHOULDER SYNOVECTOMY OF A

55,818

Hip or groin, 1 or both s

16,530

Management of pregnancy l

48,939

SHOULDER ARTHRODESIS OF A

55,820

Paediatric hip examination

16,531

Management of pregnancy l

48,942

SHOULDER ARTHRODESIS OF I

55,822

Paediatric hip examination

16,564

EVACUATION OF RETAINED PR

48,954

SHOULDER ARTHROSCOPIC TOT

55,852

Paediatric spine, spinal

16,567

MANAGEMENT OF POSTPARTUM

48,960

SHOULDER RECONSTRUCTION O

55,854

Paediatric spine, spinal

16,570

ACUTE INVERSION OF THE UT

49,303

HIP ARTHROTOMY OF INCLUDI

57,522

Knee NR K

16,571

CERVIX REPAIR OF EXTENSIV

49,306

HIP—ARTHRODESIS OF ANAE

57,523

Knee R K

16,573

THIRD DEGREE TEAR INVOLVI

49,309

HIP ARTHRECTOMY OR EXCISI

57,537

Knee NR NK

16,590

Planning and management o

49,312

HIP ARTHRECTOMY OR EXCISI

57,540

Knee R NK

16,600

Amniocentesis, diagnostic

49,315

HIP ARTHROPLASTY OF UNIPO

57,700

Shoulder or scapula (NR

16,603

Chorionic villus sampling

49,318

HIP TOTAL REPLACEMENT ART

57,703

Shoulder or scapula (R)

16,606

FETAL BLOOD SAMPLING USIN

49,319

HIP TOTAL REPLACEMENT OF

57,712

Hip joint (R)

16,609

FETAL INTRAVASCULAR BLOOD

49,321

HIP TOTAL REPLACEMENT ART

66,750

Quantitation, in pregnancy

16,612

FETAL INTRAPERITONEAL BLO

49,324

HIP TOTAL REPLACEMENT ART

66,751

Quantitation, in pregnancy

16,615

FETAL INTRAPERITONEAL BLO

49,327

HIP TOTAL REPLACEMENT ART

73,806

Pregnancy test by 1 or more

16,618

AMNIOCENTESIS THERAPEUTIC

49,330

HIP TOTAL REPLACEMENT ART

D10009

Paediatric Dentistry

16,621

AMNIOINFUSION FOR DIAGNOS

49,333

HIP TOTAL REPLACEMENT ART

T049

Procedure Only Paediatric

16,624

FETAL FLUID FILLED CAVITY

49,336

HIP TREATMENT OF A FRACTU

  

16,627

FETO-AMNIOTIC SHUNT INSER

49,339

HIP REVISION TOTAL REPLAC

  

Appendix 3

Focus group interview guide

figure a
figure b

Appendix 4

COVID-19 response during pilot data collection

The last two weeks of pilot data collection was impacted at the two sites in New South Wales due to a wave of COVID-19 community infections. Due to this, there was an amendment to the study protocol. The amendment included the addition of a “COVID-19 contingency plan”. The following explanation was provided to the Human Research Ethics Committee:

Due to the global COVID-19 pandemic, states and territories within Australia may experience a “lockdown” over a period of time following a COVID-19 outbreak. Pending on the state or territory, and the specific government rules and regulations in place at the time, elective surgery across public and private health may be impacted. The following risk based approach will guide the patient survey distribution for the AusPROM study over such periods of lockdown: “During period of COVID-19 lockdown, hospitals will be managed on a state-by-state basis. Hospitals will be categorised as Green / Amber / Red pending on the specific COVID-19 lockdown rules and regulations in place at the time. A detailed log will be kept to reflect any occasions of lockdown and the categorisation in place.”

  • Green

    • No change to surveys 1 (pre-surgery), 2 (post-surgery) or 3 (post-surgery)

  • Amber

    • No change to surveys 2 (post-surgery) and 3 (post-surgery), however 1 (pre-surgery) will be managed differently

    • Survey 1 (pre-surgery) will undergo a process agreed to by the General Manger and the Director of Nursing, together with the National Manager Patient Reported Experience and Outcomes

      • Pending on the situation, it is likely that this will involve a process of automating a list of patients who have confirmed surgery on a more frequent basis, to account for the likelihood of cancellations

      • This many include a more conservative approach to survey distribution, where patients with a “likelihood” of having surgery cancelled, being removed from the Survey 1 distribution list (noting they will be picked up for Survey 2 and 3 if they do in fact have the elective surgery)

  • Red

    • No change to surveys 2 (post-surgery) and 3 (post-surgery), however survey 1 (pre-surgery) will be stopped due to the human demands associated with the party automated / party manual process

As such, due to the COVID-19 pandemic, the two sites in NSW entered a “Red Phase” during the final 2 weeks of data collection. This involved no change to surveys 2 (post-surgery) or 3 (post-surgery), however survey 1 (pre-surgery) was stopped due to the human demands associated with the party automated/party manual process.

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Brusco, N.K., Atkinson, V., Woods, J. et al. Implementing PROMS for elective surgery patients: feasibility, response rate, degree of recovery and patient acceptability. J Patient Rep Outcomes 6, 73 (2022). https://doi.org/10.1186/s41687-022-00483-6

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