xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987280</url>
    </required_header>
    <id_info>
      <org_study_id>40350</org_study_id>
      <nct_id>NCT05987280</nct_id>
    </id_info>
    <brief_title>Core Outcome Set for Pharmacist-led Interventions in CKD</brief_title>
    <acronym>COSP-KD</acronym>
    <official_title>Development of a Core Outcome Set for Pharmacist-led Interventions in Chronic Kidney Disease: a Protocol for a Survey and e-Delphi Consensus Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Leicester</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background Chronic kidney disease (CKD) is a progressive condition characterised by a gradual&#xD;
        reduction in kidney function and structure over time. CKD is a risk factor for other&#xD;
        morbidity, where it not only increases the likelihood of all-cause and cardiovascular&#xD;
        mortality, but also can have a detrimental impact on quality of life. Whilst several&#xD;
        systematic reviews have demonstrated the benefits of interventions delivered by pharmacists,&#xD;
        there is significant variability in terms of the outcomes reported and an inconsistency with&#xD;
        the measures used (e.g., medication adherence is often assessed using different outcome&#xD;
        measures). The large heterogeneity of outcomes reported and the measures used in randomised&#xD;
        controlled trials investigating the impact interventions involving pharmacists have on CKD&#xD;
        patients makes it difficult to interpret findings and make comparisons between interventions&#xD;
        have. This ultimately affects the quality of research and limits the ability to synthesize&#xD;
        evidence, particularly in meta-analyses. Issues around inconsistent outcome reporting could&#xD;
        be addressed with the development and application of agreed standardised sets of outcomes.&#xD;
        Indeed, the significant range of outcomes in the CKD pharmacy literature led the authors in&#xD;
        Raiisi et al., to state that further research is required to establish a core outcome set&#xD;
        (COS) in CKD, in relation to pharmacy practice. COS are a collection of outcomes that are&#xD;
        standardised and agreed upon, in which as a minimum, they should be measured and reported in&#xD;
        all trials for a particular clinical topic. They are of importance as input is provided from&#xD;
        a variety of stakeholders such as patients, researchers, family members, carers, and&#xD;
        healthcare professionals, in which relevant outcomes are more likely to be identified, as&#xD;
        well as helping reduce reporting bias and heterogeneity in the research literature. Currently&#xD;
        no pharmacy-specific COS exists for interventions conducted in CKD.&#xD;
  &#xD;
        Aims The overall objective is to develop a COS for clinical trials evaluating the efficacy or&#xD;
        effectiveness of pharmacist-led interventions (i.e., interventions provided to patients are&#xD;
        either pharmacist-led or involve their input) in people with CKD. The aim of Phase 1 is to&#xD;
        conduct an online survey to explore outcomes of importance to stakeholders. The outcomes&#xD;
        identified in Phase 1 will lead into a subsequent Delphi process to develop a COS (Phase 2).&#xD;
  &#xD;
        Methods&#xD;
  &#xD;
        Phase 1&#xD;
  &#xD;
        The investigators aim to use an online survey to collect data from participants. The&#xD;
        questions in this survey can be found in the attached documentation. It is estimated that&#xD;
        this survey will take 10 minutes to complete. The first part of the survey asks questions&#xD;
        about the participant including what stakeholder group best describes them. The second part&#xD;
        asks them about what outcomes are important in pharmacy research and in the management of&#xD;
        kidney disease.&#xD;
  &#xD;
        Phase 2 The outcomes generated in this survey will be supplemented by outcomes identified in&#xD;
        an ongoing systematic review performed by the research group. The investigators will take&#xD;
        this long-list of outcomes and aim to reach a consensus on a COS using a 2-round Delphi&#xD;
        process. The Delphi process is a structured process used for forming a consensus, where&#xD;
        stakeholder groups provide their opinions in an iterative approach for answering questions&#xD;
        over several rounds.&#xD;
  &#xD;
        This will also take place using surveys online and the investigators will submit an ethical&#xD;
        amendment for each round with the questions and outcomes we will be seeking consensus on. In&#xD;
        each Delphi round, participants will be asked to rate the importance of outcomes for&#xD;
        inclusion or exclusion. Between each round, excluded outcomes will be removed.&#xD;
  &#xD;
        Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who&#xD;
        scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the&#xD;
        COS.&#xD;
  &#xD;
        Following the Delphi survey, the investigators will conduct a consensus day. A sample of&#xD;
        participants will be invited to discuss the findings and reach a consensus on the final COS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Generation of longlist of outcomes</measure>
      <time_frame>8 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Delphi Round 1</measure>
      <time_frame>4 weeks</time_frame>
      <description>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.&#xD;
  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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Delphi Round 2</measure>
      <time_frame>4 weeks</time_frame>
      <description>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&#xD;
  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.&#xD;
  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.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Phase 1</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase 2</arm_group_label>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>eDelphi method</intervention_name>
      <description>eDelphi method</description>
      <arm_group_label>Phase 1</arm_group_label>
      <arm_group_label>Phase 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The stakeholders that will be invited to participate in this survey include: 1) pharmacists&#xD;
          involved in the care of kidney patients and non-renal pharmacists; 2) researchers involved&#xD;
          in CKD and pharmacy research; 3) nurses and physicians involved in CKD management; 4)&#xD;
          people living with kidney disease; and 5) their carers and/or family members.&#xD;
  &#xD;
          It is likely that participants will not fit into distinct homogeneous groups; for example,&#xD;
          researchers may also be registered pharmacists. Participants will answer questions relevant&#xD;
          to their group. All participants over the age of 18 will be invited to take part in the&#xD;
          survey&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
          The stakeholders that will be invited to participate in this survey include: 1)&#xD;
          self-defined pharmacists involved in the care of kidney patients and non-renal pharmacists;&#xD;
          2) self-defined researchers involved in CKD and pharmacy research; 3) self-defined nurses&#xD;
          and physicians involved in CKD management; 4) self-defined people living with kidney&#xD;
          disease; and 5) their carers and/or family members.&#xD;
  &#xD;
          It is likely that participants will not fit into distinct homogeneous groups; for example,&#xD;
          researchers may also be registered pharmacists. Participants will answer questions relevant&#xD;
          to their group. All participants over the age of 18 will be invited to take part in the&#xD;
          survey&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          Any participants not self-defined as one of the above five groups.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Thomas Wilkinson, PhD</last_name>
      <phone>07538494193</phone>
      <email>tjw26@le.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ashkon Ardavani</last_name>
      <phone>07927307013</phone>
      <email>aa1305@leicester.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Thomas Wilkinson</name>
        <address>
          <city>Leicester</city>
          <state>Leicestershire</state>
          <zip>LE1 7RH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Wilkinson</last_name>
        <phone>07538494193</phone>
        <email>tjw26@leicester.ac.uk</email>
      </contact>
      <contact_backup>
        <email>tjw26@leicester.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Thomas Wilkinson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacy</keyword>
    <keyword>Pharmacist</keyword>
    <keyword>Kidney disease</keyword>
    <keyword>Core outcome set</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987280
  org study id: 40350
  nct id: NCT05987280
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Other
  time perspective: Prospective
  measure: Generation of longlist of outcomes
  time frame: 8 weeks
  description: 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.
  measure: Delphi Round 1
  time frame: 4 weeks
  description: 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.
  measure: Delphi Round 2
  time frame: 4 weeks
  description: 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.
  arm group label: Phase 1
  description: 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.
  arm group label: Phase 2
  description: 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.
  intervention type: Other
  intervention name: eDelphi method
  description: eDelphi method
  arm group label: Phase 1
  arm group label: Phase 2
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Thomas Wilkinson, PhD
  phone: 07538494193
  email: tjw26@le.ac.uk
  last name: Ashkon Ardavani
  phone: 07927307013
  email: aa1305@leicester.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic