Core Outcome Set for Pharmacist-led Interventions in CKD (COSP-KD)

August 2, 2023 updated by: University of Leicester

Development of a Core Outcome Set for Pharmacist-led Interventions in Chronic Kidney Disease: a Protocol for a Survey and e-Delphi Consensus Study

Background Chronic kidney disease (CKD) is a progressive condition characterised by a gradual reduction in kidney function and structure over time. CKD is a risk factor for other morbidity, where it not only increases the likelihood of all-cause and cardiovascular mortality, but also can have a detrimental impact on quality of life. Whilst several systematic reviews have demonstrated the benefits of interventions delivered by pharmacists, there is significant variability in terms of the outcomes reported and an inconsistency with the measures used (e.g., medication adherence is often assessed using different outcome measures). The large heterogeneity of outcomes reported and the measures used in randomised controlled trials investigating the impact interventions involving pharmacists have on CKD patients makes it difficult to interpret findings and make comparisons between interventions have. This ultimately affects the quality of research and limits the ability to synthesize evidence, particularly in meta-analyses. Issues around inconsistent outcome reporting could be addressed with the development and application of agreed standardised sets of outcomes. Indeed, the significant range of outcomes in the CKD pharmacy literature led the authors in Raiisi et al., to state that further research is required to establish a core outcome set (COS) in CKD, in relation to pharmacy practice. COS are a collection of outcomes that are standardised and agreed upon, in which as a minimum, they should be measured and reported in all trials for a particular clinical topic. They are of importance as input is provided from a variety of stakeholders such as patients, researchers, family members, carers, and healthcare professionals, in which relevant outcomes are more likely to be identified, as well as helping reduce reporting bias and heterogeneity in the research literature. Currently no pharmacy-specific COS exists for interventions conducted in CKD.

Aims The overall objective is to develop a COS for clinical trials evaluating the efficacy or effectiveness of pharmacist-led interventions (i.e., interventions provided to patients are either pharmacist-led or involve their input) in people with CKD. The aim of Phase 1 is to conduct an online survey to explore outcomes of importance to stakeholders. The outcomes identified in Phase 1 will lead into a subsequent Delphi process to develop a COS (Phase 2).

Methods

Phase 1

The investigators aim to use an online survey to collect data from participants. The questions in this survey can be found in the attached documentation. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease.

Phase 2 The outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review performed by the research group. The investigators will take this long-list of outcomes and aim to reach a consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.

This will also take place using surveys online and the investigators will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed.

Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.

Following the Delphi survey, the investigators will conduct a consensus day. A sample of participants will be invited to discuss the findings and reach a consensus on the final COS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thomas Wilkinson, PhD
  • Phone Number: 07538494193
  • Email: tjw26@le.ac.uk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The stakeholders that will be invited to participate in this survey include: 1) pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) researchers involved in CKD and pharmacy research; 3) nurses and physicians involved in CKD management; 4) people living with kidney disease; and 5) their carers and/or family members.

It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey

Description

Inclusion criteria:

The stakeholders that will be invited to participate in this survey include: 1) self-defined pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) self-defined researchers involved in CKD and pharmacy research; 3) self-defined nurses and physicians involved in CKD management; 4) self-defined people living with kidney disease; and 5) their carers and/or family members.

It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey

Exclusion criteria:

Any participants not self-defined as one of the above five groups.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1
We aim to use an online survey to collect data from participants. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease.
Other: eDelphi method
eDelphi method
Phase 2

The outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review being performed by our group. We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.

This will also take place using surveys online and we will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed. Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
Other: eDelphi method
eDelphi method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generation of longlist of outcomes
Time Frame: 8 weeks
The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease. Outcomes suggested by the participants will be entered into a 'longlist' of outcomes for Phase 2.
8 weeks
Delphi Round 1
Time Frame: 4 weeks

We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.

In Delphi round 1, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale.
4 weeks
Delphi Round 2
Time Frame: 4 weeks

Between Rounds 1 and 2, excluded outcomes will be removed. Included outcomes are defined as those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree

In Delphi round 2, participants will be asked to rate the importance of remaining outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale.

Final included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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