{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:36Z","timestamp":1772168976519,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/hrbopenres.13661.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T00:00:00Z","timestamp":1692576000000}}],"reference-count":40,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T00:00:00Z","timestamp":1692576000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001590","name":"Health Research Board","doi-asserted-by":"publisher","award":["DIFA-2020-012"],"award-info":[{"award-number":["DIFA-2020-012"]}],"id":[{"id":"10.13039\/501100001590","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["hrbopenresearch.org"],"crossmark-restriction":false},"short-container-title":["HRB Open Res"],"abstract":"<ns3:p>\n                    <ns3:bold>Background:<\/ns3:bold>\n                    Hypertension is one of the most important risk factors for stroke and heart disease. Recent international guidelines have stated that\n                    <ns3:italic>'poor adherence to treatment \u2013 in addition to physician inertia - is the most important cause of poor blood pressure control'.<\/ns3:italic>\n                    The MaxImising Adherence, Minimising Inertia (MIAMI) intervention, which has been developed using a systematic, theoretical, user-centred approach, aims to support general practitioners (GPs) and people with hypertension to maximise medication use, through the facilitation of adequate information exchange within consultations about long-term antihypertensive medication use and adherence skill development. The aim of the MIAMI pilot cluster randomised controlled trial (RCT) is to gather and analyse feasibility data to allow us to (1) refine the intervention, and (2) determine the feasibility of a definitive RCT.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Methods:<\/ns3:bold>\n                    GP practices (n = 6) will be recruited and randomised to the intervention arm (n = 3) or usual care control arm (n = 3). Each practice will recruit 10 patient participants. For a patient to be eligible they must have a diagnosis of hypertension, be on two or more anti-hypertensive medications, must not be achieving recommended blood pressure levels, \u00a0and be over the age of 65 years. Participants in the intervention arm will meet their GP and receive the MIAMI intervention twice over three months. Quantitative data collection will take place at baseline and three month follow up. A pilot health economic analysis and a qualitative sub-study will also be incorporated into the study.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Discussion:<\/ns3:bold>\n                    This pilot cluster RCT of the MIAMI intervention will allow us to gather valuable acceptability and feasibility data to further refine the intervention so it optimally designed for both GP and patient use. In particular, the qualitative component will provide an insight into GP and patient experiences of using the intervention.\n                  <\/ns3:p>","DOI":"10.12688\/hrbopenres.13661.2","type":"journal-article","created":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T08:10:13Z","timestamp":1692605413000},"page":"6","update-policy":"https:\/\/doi.org\/10.12688\/hrbopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Supporting GPs and people with hypertension to maximise medication use to control blood pressure: Protocol for a pilot cluster RCT of the MIAMI intervention"],"prefix":"10.12688","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1452-6145","authenticated-orcid":false,"given":"Eimear","family":"Morrissey","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Murphy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Murphy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise","family":"O'Grady","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Molly","family":"Byrne","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7778-2002","authenticated-orcid":false,"given":"Monica","family":"Casey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eamon","family":"Dolan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sinead","family":"Duane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8761-0519","authenticated-orcid":false,"given":"Hannah","family":"Durand","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paddy","family":"Gillespie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Hayes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5532-3830","authenticated-orcid":false,"given":"Anna","family":"Hobbins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Hynes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T22:40:12Z","timestamp":1715035212000},"score":1,"resource":{"primary":{"URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,21]]},"references-count":40,"URL":"https:\/\/doi.org\/10.12688\/hrbopenres.13661.2","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/hrbopenres.15086.r37038","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/hrbopenres.15086.r38415","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/hrbopenres.15086.r37038","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/hrbopenres.15086.r38415","asserted-by":"object"}]},"ISSN":["2515-4826"],"issn-type":[{"value":"2515-4826","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,21]]},"assertion":[{"value":"Indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/hrbopenres.14939.r34045, Buna Bhandari, University of New South Wales, Sydney, New South Wales, 10 Jul 2023, version 1, 1 approved with reservations","URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v1#referee-response-34045","order":0,"name":"referee-response-34045","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Eimear Morrissey<\/b>; \n<i>Posted: 08 Aug 2023<\/i>; \n<i>This is an interesting study to address the non-adherence to antihypertensive medication and prevent further complications. I have added some comments for the improvement of the quality of the article.<\/i>  We thank the reviewer for taking the time to review our manuscript. The comments have been very useful and we have added our responses below.  \n<i>Objectives need revision, e.g. objectives 2,3, and 5 do not require \u201cto collect quantitative and qualitative data\u201d. Author can directly write \u201cto assess the feasibility outcomes\u201d and how those objectives will be assessed, \u201cData collection process\u201d can be detailed in the methods section. Rather it\u2019s better to mention what are those feasibility outcomes if possible.<\/i>  We have revised the framing of objectives 2, 3 and 5 in line with this suggestion and agree that the description of objectives is now clearer.  \n<i>The protocol should be registered in a clinical trial registry such as ISRCTN, and the registration number should be provided in the paper. I noticed it is under process, so please provide the number once registered.<\/i>  As noted, the ISRCTN registration was underway when this manuscript was submitted. Registration has been completed and the registration number is ISRCTN85009436. This has been updated in the manuscript (under section heading \u2018Aims of the MIAMI cluster pilot RCT).  \n<i>Methods - please provide little details about the characteristics of the study cluster. In addition, it\u2019s not compulsory to have power calculation for the sample size in the pilot study, but it is worth mentioning how those 6 clusters and 10 participants in each cluster were decided. Please also specify whether these 10 include only patients or patients and GPs. There is a mismatch in the information provided in the manuscript.<\/i>  We have added a description of the cluster (under section heading \u2018Sample size calculations\u2019) As mentioned in the manuscript, the number of clusters chosen was governed by pragmatism and to provide a diverse sample (urban and rural practices) from the population of clusters from which data in the definitive trial will be sampled. Our study statistician has estimated that for any future definitive trial, the population mean systolic clinic BP from this sample will be accurate to within +\/- 7 mmHg and the estimated population standard deviation to within 4 units. However, we are very aware that significant caution is required in applying such figures from pilot to definitive trials, and for this reason consider these estimates to be for illustration only. The ten participants per cluster in this case refer to patient participants. This is stated in the \u2018sample size calculations\u2019 section. The number of GP participants in each cluster will be dependent on practice size.  \n<i>I am not clear why the acceptability interview with the control arm is needed; what were the objectives of this interview? Please specify.<\/i>  The objectives of these interviews are to explore the acceptability of being allocated to the \u2018usual care\u2019 arm of a pilot RCT in this context. This is an important aspect to explore, as previous research has shown that study participants can sometimes misunderstand clinical equipoise, and express a preference for intervention arm allocation\n<sup>1<\/sup>.&nbsp; These interviews will add important data to the assessment of the overall acceptability of conducting a pilot RCT in primary care in Ireland. 1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Houghton C, Dowling M, Meskell P, et al. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. \n<i>Cochrane Database Syst Rev<\/i>. 2020;(10). &nbsp;  \n<i>Table 2 provides details about the MIAMI intervention, which is clear. However, the author has indicated in the background that Behavior change and Collective Intelligence methodologies were used to design the intervention, so it is unclear how those models\/theories were used and how the intervention was designed. Though the author plans to discuss that in a separate paper, it is very important to provide some details about the intervention design process (MIAMI booklet, Computer guide development etc.) &nbsp;to ensure the robustness and comprehensiveness of this intervention.<\/i>  As the reviewer has noted, we plan to outline the full development process of the MIAMI intervention in a separate paper, which is currently nearing completion. However, we agree that it is useful to include some detail here and we have added this (under section heading\u2019 Introduction\u2019; final paragraph).  \n<i>Please provide more details about the SWAT, as it is unclear how the participants will be randomized, whether they will be randomized within each cluster or not. In addition, which objectives of this pilot trial will lead to this SWAT? Need more clarification about the approach; it is confusing to the reader.<\/i>  Thank you for highlighting this, we have now restructured and added more detail to the SWAT section and believe it is much clearer (under section heading \u2018Study within a trial (SWAT)\u2019).","URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2#referee-comment-3538","order":1,"name":"referee-comment-3538","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/hrbopenres.15086.r37038, Sarah J Billups, University of Colorado Health, Aurora, Colorado, 27 Nov 2023, version 2, indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2#referee-response-37038","order":2,"name":"referee-response-37038","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/hrbopenres.15086.r38415, Peter Knapp, University of York, York, England, 07 May 2024, version 2, indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/6-6\/v2#referee-response-38415","order":3,"name":"referee-response-38415","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Health Research Board [HRB-DIFA-2020-012]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}