Table 2 Final set of recommendations for PROMs inclusions in CQRs

RATIONALE

MI

DI

1.1

Purpose of collecting PROMs

1.1.1

In registries PROMs may be collected for a variety of purposes, such as:

- to promote patient engagement in their treatment including measuring relevant symptoms/adverse events/treatment outcomes and monitoring changes over time;

- to inform patient's choice of treatment or access to quality of care;

- to measure quality of care and patient outcomes in the real world;

- to facilitate shared decision making between clinician and patient, and to support patient centred care;

- to inform models of care;

- to support health service improvements by identifying variation in care;

- to identify subgroups of patients with persistent adverse outcomes indicative of increased risk of procedure/treatment/device failure;

- to identify patients with the greatest need to support the allocation of healthcare resources;

- to measure burden of disease;

- to support post-marketing surveillance activities;

- to guide the specialist community to determine best practice.

8

0.54

1.1.2

PROMs may be useful as a measure of positive outcomes such as pain relief and improved function and as a marker of risk for negative outcomes such as persistent pain or reduced function.

8

0.49

1.1.3

Use of PROMs should be driven by outcomes capable of contributing to improving patient care that can be met through patient reporting. Consensus of key objectives should occur before the design stage.

8

0.49

1.2

Stakeholders

1.2.1

Stakeholders with an interest in PROMs may include patients/consumers, clinicians, funders, insurers, health services, Departments of Health/Government, policy makers, academics and/or others with relevant expertise/experience.

7

0.75

1.2.2

Stakeholders should assist in the development of a PROMs framework encompassing the aim, purpose, scope, and infrastructure, selection of the PROM and data collection strategies.

7

0.37

1.2.3

Different stakeholders may identify various primary goals for use of the PROMs (Please see 1.1.1 for further details).

7

0.74

SETTING

2.1

Implementation

2.1.1

Registries should develop a holistic framework to define and guide PROMs implementation (e.g. who, when, where, what and how), to identify and address potential barriers for implementation (e.g. patient recruitment, patient language, operational, cultural, resourcing, cost, expertise, appropriate instruments) and to allocate appropriate resources and expertise.

7

0.42

2.1.2

Consideration should be given to piloting PROMs implementation before the full rollout to assess feasibility from the patient, clinician and/or system perspective.

9

0.49

2.2

Population and sample size

2.2.1

It may be a cost-effective strategy to target populations within the registry that are most in need and establishing where PROMs can be most usefully applied, e.g. recurrence following removal of a high-risk cancer.

7

1.50

2.2.2

When selecting a baseline PROM, consideration should be given to a screening process to identify the eligible population prior to the intervention.

7

0.72

2.2.3

Administration of baseline PROMs should include an assessment prior to an intervention where possible, and to provide a reference to PROMs assessments post intervention.

8

0.84

2.2.4

Depending on the purpose of data collection, PROMs may be collected from the whole population or a particular sample population.

8

0.33

ETHICS

3.1

Patient consent

3.1.1

Information about the PROMs should be provided to participants using a method approved by an ethics committee. This information should include the benefits and risks of participation, and the process of withdrawal from participation.

8

0.75

3.1.2

Depending on the jurisdiction and institutional ethics review, PROMs may require an opt-in or opt-out approach.

8

0.33

INSTRUMENTS

4.1

Consumer engagement

4.1.1

Patients should be involved in setting PROMs objectives and instrument choice, including the development and validation of new instruments, as well as use of PROMs data.

7

0.75

4.1.2

Response rates may be optimised by providing patients with information on how data will be used and the goals/aims for PROMs.

7

0.56

4.1.3

PROMs data collection should consider instrument type and mode of administration for patients with special needs or disabilities.

7

0.54

4.1.4

PROMs data collection should consider patient preferences for providing PROMs responses, including multiple modes of administration, if possible.

7

0.87

4.2

New/Existing

4.2.1

PROMs selection should commence with a literature review to identify the range and frequency of use of existing validated instruments associated with the device/procedure/diagnosis/treatment. PROMs selection should meet the purpose of implementation and reflect the identified outcome of interest.

8

0.75

4.2.2

Any PROM selected may be an existing and validated tool, an abbreviated or amended version of an existing tool, or a new tool developed within the registry space, if existing tools are not available or adaptable.

7

0.74

4.2.3

New and abbreviated PROMs need to be evaluated for validity before being used to measure and report on outcomes.

8

0.51

4.2.4

PROMs with a clear scoring system should be used to maximise ease of use, administration and capacity to capture poor outcomes, if needed.

7

0.65

4.2.5

PROMs may be translated into multiple languages depending on the availability of validated translated versions and the cost of implementation.

7

0.45

4.2.6

A PROM response scale should consider a variety of response options (e.g. very dissatisfied, dissatisfied, neutral, satisfied, and very satisfied) to enable clear interpretation.

7

0.53

4.2.7

PROMs selection should be based on recommendations by experts in the field including patients with lived experience of the disease/condition, instrument reliability and validity, global standards (e.g. ICHOM or ISOQOL), completion time, costs and patient burden.

7

0.75

4.3

Generic/Specific

4.3.1

Registries should consider using item banks (e.g. PROMIS, PROQOLID, EUROQOL, etc.), to access items that are individually validated and can be mixed and matched according to the overall purpose of PROM implementation.

7

0.51

4.3.2

Registries should consider using both general and specific PROMs. Generic PROMs such as SF-12 and EQ-5D may be useful in a registry setting for global health, research and policy purposes to compare against outcomes from other populations or healthcare interventions, and over time. Disease-/condition-/procedure-specific PROMs have greater clinical utility related to particular conditions, treatments and procedures.

7

0.89

4.3.3

More than one instrument may be required to meet the objective(s) of the PROMs data collection.

8

0.75

4.3.4

The number of instruments used and the number of items included in a specific PROMs data collection tool should be minimised without losing the essential constructs/domains related to the output of interest (especially for registries with large populations in order to maximise a response rate).

8

0.49

ADMINISTRATION

5.1

Timing and Frequency

5.1.1

Based on discipline-specific clinical best practice and evidence, PROMs should be administered at various time points (e.g. baseline, single or multiple).

8

0.81

5.1.2

The length of PROM data collection tools and numbers of data collection points should consider patient and administrative burden.

8

0.49

5.1.3

PROMs data collection should consider patient’s burden in relation to the number and timing of reminders and the mode of administration.

7

0.75

5.1.4

Processes should be developed to avoid sending follow-up PROMs to deceased patients or patients who have withdrawn their informed consent.

9

0.29

5.2

Modes and Methods

5.2.1

PROMs data collection plan should outline the mode(s) of administration (e.g. paper, telephone, electronic, other) and setting (e.g., clinic, home, other).

7

0.75

5.2.2

PROMs may be administered via multiple methods to increase response rate.

7

0.94

5.2.3

Evaluation of the PROMs program should be undertaken periodically and include feedback from patients, clinicians and other stakeholders.

8

0.42

5.2.4

Mode of PROMs administration should take into consideration patient factors, such as the age, gender and digital literacy.

7

0.75

5.2.5

Computer adaptive testing systems should be considered to minimise patient’s time and data entry burden.

7

0.75

5.2.6

PROMs collection at the moment of contact with a clinician/service encourages patient participation and maximises capture of complete data.

7

0.78

DATA MANAGEMENT

6.1

Entry and Quality checks

6.1.1

PROMs data management should consider issues of data security, information governance, and availability of technology for data collection.

9

0.59

6.1.2

Data management protocols should include plans for data entry, coding, security, and storage, including any related processes to promote data quality (e.g. double data entry, range checks for data values, etc.)

8

0.54

6.1.3

Registries should provide data management protocols and training to assist staff in PROMs administration, data collection and data entry.

8

0.41

6.2

IT design/Storage

6.2.1

PROMs IT modules should be designed to support PROM completion e.g. send regular email or phone reminders, validation checks for missing data prior to submission, store the completed data with the date of completion.

7

0.64

6.2.2

PROMs IT modules should be able to calculate PROM scores and to extract data from the database.

7

0.81

6.2.3

Appropriate strategy should be developed for managing missing PROMs data (e.g. missing items vs. non-response).

7

0.51

STATISTICAL METHODS

7.1

PROMs Analysis

7.1.1

Biostatisticians and/or epidemiologists should be involved in processing and reporting PROMs data.

8

0.33

7.1.2

Statistical methods used for PROMs data analysis should be clearly described.

8

0.33

7.1.3

The volume, nature, and management of missing PROMs data should be described (e.g. approach to imputation and sensitivity analyses).

8

0.61

7.1.4

Clinical or sociodemographic differences between respondent and non-respondent populations should be reported to help explain possible variation in PROMs findings.

8

0.50

7.1.5

When a PROM is a primary outcome of interest, both baseline and follow-up information should be reported.

8

0.88

7.1.6

Risk adjustment should be undertaken to control for the role of confounding and case mix in PROMs data analysis, and adjustment for confounding and case-mix factors should be guided by causal knowledge.

7

0.67

7.1.7

Confounding and case-mix factors may be adjusted (1) in the design (e.g., restriction or matching techniques such as propensity or radius) or (2) in the analysis (e.g., inverse probability weighting, stratification, restriction).

7

0.79

7.1.8

Real-time analyses can provide PROMS data for shared decision-making in clinical practice.

7

0.65

FEEDBACK AND REPORTING

8.1

Dissemination

8.1.1

The reporting of PROMs results should highlight the benefit of improving care for existing and/or future patients. Output should be published in a range of formats to reach a broad range of stakeholders.

8

0.48

8.1.2

PROMs outputs should be reported as aggregated data that maintains confidentiality of participants. It may be used to compare patient group results against the entire cohort, or used for comparative purposes including benchmarking outcomes, such as variation between two sites or jurisdictions.

8

0.49

8.1.3

PROMs data should be reported at the individual level (e.g. scores and changes in responses) only to the patient and/or to the patient's treating clinician/team. These data should be presented in a readily understandable format for the patient.

8

0.75

8.1.4

PROMs data can be shared through publications distributed directly to stakeholders, in research journals, and at conferences and forums. Audiences include all interested stakeholders, including clinicians and patients, to inform outcomes at the health service level, and funders and service providers, to inform policy and practice.

7

0.67

8.1.5

When using PROMs data for benchmarking purposes, disclosure or anonymity of centres/sites should be agreed on prior to publication.

7.5

0.56

8.2

Access and data sharing

8.2.1

De-identified case-level data should be available for research purposes.

8

0.27

8.2.2

To encourage participation in PROMs collection and provide opportunities to maximise use of data, clinicians should have access to their patients’ PROMs data.

7

0.61

8.2.3

PROMs data sharing should be in accordance with privacy legislation and the registry data access policy.

9

0.24

8.3

Timing and Frequency

8.3.1

Timing and frequency of the PROMs reports should be determined in advance and be in line with the data analysis plan.

7

0.72