Image1_Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.jpeg

IntroductionA multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies.MethodsA constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed.ResultsParticipants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named “the Ideal Scenario” was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture.ConclusionNovel explanatory theory is proposed with relevance for Implementation Science. The “Ideal Scenario” is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.</p

Image2_Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.jpeg

IntroductionA multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies.MethodsA constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed.ResultsParticipants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named “the Ideal Scenario” was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture.ConclusionNovel explanatory theory is proposed with relevance for Implementation Science. The “Ideal Scenario” is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.</p

Datasheet1_Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.docx

IntroductionA multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies.MethodsA constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed.ResultsParticipants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named “the Ideal Scenario” was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture.ConclusionNovel explanatory theory is proposed with relevance for Implementation Science. The “Ideal Scenario” is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.</p

Individual PWV results (m/sec) in each group at baseline, 12 weeks and 12 months (9-month follow-up).

<p><b>(A)</b> UC group (n = 20), <b>(B)</b> AT group (n = 12), and <b>(C)</b> RT group (n = 10).</p

Individual PWV results (m/sec) in each group at baseline, 12 weeks and 12 months (9-month follow-up).

<p><b>(A)</b> UC group (n = 20), <b>(B)</b> AT group (n = 12), and <b>(C)</b> RT group (n = 10).</p

CONSORT flow diagram.

<p>Demonstrating flow of participants throughout the study at baseline, 12 weeks, 12 months (9-month follow-up), and those included in final analysis.</p

Measurement properties of performance-based measures to assess physical function in chronic kidney disease: recommendations from a COSMIN systematic review

Background There is wide heterogeneity in physical function tests available for clinical and research use, hindering our ability to synthesize evidence. The aim of this review was to identify and evaluate physical function measures that could be recommended for standardized use in chronic kidney disease (CKD). Methods MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL, Scopus and Web of Science were searched from inception to March 2022, identifying studies that evaluated a clinimetric property (validity, reliability, measurement error and/or responsiveness) of an objectively measured performance-based physical function outcomes using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) based recommendations. Studies with individuals of all ages and of any stage of CKD were included. Results In total, 50 studies with 21 315 participants were included. Clinimetric properties were reported for 22 different physical function tests. The short physical performance battery (SPPB), Timed-up-and-go (TUG) test and Sit-to-stand tests (STS-5 and STS-60) had favorable properties to support their use in CKD and should be integrated into routine use. However, the majority of studies were conducted in the hemodialysis population, and very few provided information regarding validity or reliability. Conclusion The SPPB demonstrated the highest quality of evidence for reliability, measurement error and construct validity amongst transplant, CKD and dialysis patients. This review is an important step towards standardizing a core outcome set of tools to measure physical function in research and clinical settings for the CKD population.</p

Long-term outcomes at 9-month follow-up-, and results of 9-month follow-up ANCOVA analysis.

<p>Long-term outcomes at 9-month follow-up-, and results of 9-month follow-up ANCOVA analysis.</p

Participant baseline demographics and 9-month follow-up outcomes.

<p>Participant baseline demographics and 9-month follow-up outcomes.</p

Individual relative VO2peak values (ml/min/kg) in each group at baseline, 12 weeks and 12 months (9-month follow-up).

<p><b>(A)</b> UC group (n = 20), <b>(B)</b> AT group (n = 9), and <b>(C)</b> RT group (n = 8).</p