A Mixed Methods Study of Cross-sectoral Rehabilitation Intervention for Patients with Intermittent Claudication Versus Usual Care for Patients in Non-operative Management. -The Cipic Rehab Study

Abstract Introduction: Intermittent claudication (IC) caused by Peripheral Artery Disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behavior. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this paper is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients’ post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation. Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with intermittent claudication. The study will describe how to monitor and improve rehabilitations programme for patients with intermittent claudication in a real-world setting. Mixed method strategies can allow for both exploration and generalization in the same study, but the research design is a complex intervention and any effects found can not be awarded a specific component.

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Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management. - The CIPIC Rehab study: study protocol for a randomised controlled trial

10.21203/rs.2.12578/v2 ◽

2019 ◽

Author(s):

Maj Siercke ◽

Lise Pyndt Jørgensen ◽

Malene Missel ◽

Lau Caspar Thygesen ◽

Pernille Peppercorn Blach ◽

...

Keyword(s):

Cardiac Rehabilitation ◽

Usual Care ◽

Intermittent Claudication ◽

Mixed Method ◽

Operative Management ◽

Treadmill Walking ◽

Rehabilitation Programme ◽

Walking Distance ◽

Walking Test ◽

Non Operative Management

Abstract Introduction: Intermittent claudication (IC) caused by Peripheral Artery Disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behavior. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this paper is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients’ post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation. Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with intermittent claudication. The study will describe how to monitor and improve rehabilitations programme for patients with intermittent claudication in a real-world setting. Mixed method strategies can allow for both exploration and generalization in the same study, but the research design is a complex intervention and any effects found can not be awarded a specific component.

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Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

10.31487/j.jicoa.2021.04.01.sup ◽

2021 ◽

Author(s):

Maj Siercke ◽

Sanne Pagh Moller ◽

Lau Caspar Thygesen ◽

Henrik Sillesen ◽

Dorthe Overgaard

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Clinical Trial ◽

Mixed Methods ◽

Usual Care ◽

Randomized Clinical Trial ◽

Intermittent Claudication ◽

Walking Distance ◽

Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

Journal of Integrative Cardiology Open Access ◽

10.31487/j.jicoa.2021.04.01 ◽

2021 ◽

pp. 1-13

Author(s):

Maj Siercke ◽

Sanne Pagh Moller ◽

Lau Caspar Thygesen ◽

Henrik Sillesen ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Clinical Trial ◽

Mixed Methods ◽

Usual Care ◽

Randomized Clinical Trial ◽

Intermittent Claudication ◽

Walking Distance ◽

Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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Management of treatment-resistant depression in primary care: a mixed-methods study

British Journal of General Practice ◽

10.3399/bjgp18x699053 ◽

2018 ◽

Vol 68 (675) ◽

pp. e673-e681 ◽

Cited By ~ 4

Author(s):

Nicola Wiles ◽

Abigail Taylor ◽

Nicholas Turner ◽

Maria Barnes ◽

John Campbell ◽

...

Keyword(s):

Primary Care ◽

Mixed Methods ◽

Usual Care ◽

Antidepressant Medication ◽

Mixed Methods Study ◽

Active Management ◽

Treatment Resistant Depression ◽

Treatment Resistant ◽

Resistant Depression ◽

Medication Changes

BackgroundNon-response to antidepressant medication is common in primary care. Little is known about how GPs manage patients with depression that does not respond to medication.AimTo describe usual care for primary care patients with treatment-resistant depression (TRD).Design and settingMixed-methods study using data from a UK primary care multicentre randomised controlled trial.MethodIn total, 235 patients with TRD randomised to continue with usual GP care were followed up at 3-month intervals for a year. Self-report data were collected on antidepressant medication, number of GP visits, and other treatments received. In addition, 14 semi-structured face-to-face interviews were conducted with a purposive sample after the 6-month follow-up and analysed thematically.ResultsMost patients continued on the same dose of a single antidepressant between baseline and 3 months (n = 147/186 at 3 months, 79% (95% confidence interval [CI] = 73 to 85%)). Figures were similar for later follow-ups (for example, 9–12 months: 72% (95% CI = 63 to 79%). Medication changes (increasing dose; switching to a different antidepressant; adding a second antidepressant) were uncommon. Participants described usual care mainly as taking antidepressants, with consultations focused on other (physical) health concerns. Few accessed other treatments or were referred to secondary care.ConclusionUsual care in patients with TRD mainly entailed taking antidepressants, and medication changes were uncommon. The high prevalence of physical and psychological comorbidity means that, when these patients consult, their depression may not be discussed. Strategies are needed to ensure the active management of this large group of patients whose depression does not respond to antidepressant medication.

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Determining Emotional Tone and Verbal Behavior in Patients With Tinnitus and Hyperacusis: An Exploratory Mixed-Methods Study

American Journal of Audiology ◽

10.1044/2019_aja-18-0136 ◽

2019 ◽

Vol 28 (3) ◽

pp. 660-672

Author(s):

Suzanne H. Kimball ◽

Toby Hamilton ◽

Erin Benear ◽

Jonathan Baldwin

Keyword(s):

Mixed Methods ◽

Verbal Behavior ◽

Coping Strategies ◽

Mixed Methods Study ◽

Self Report ◽

Anxiety And Depression ◽

Negative Consequences ◽

Emotional Tone ◽

Explanatory Mixed Methods ◽

Quantitative Results

Purpose The purpose of this study was to evaluate the emotional tone and verbal behavior of social media users who self-identified as having tinnitus and/or hyperacusis that caused self-described negative consequences on daily life or health. Research Design and Method An explanatory mixed-methods design was utilized. Two hundred “initial” and 200 “reply” Facebook posts were collected from members of a tinnitus group and a hyperacusis group. Data were analyzed via the LIWC 2015 software program and compared to typical bloggers. As this was an explanatory mixed-methods study, we used qualitative thematic analyses to explain, interpret, and illustrate the quantitative results. Results Overall, quantitative results indicated lower overall emotional tone for all categories (tinnitus and hyperacusis, initial and reply), which was mostly influenced by higher negative emotion. Higher levels of authenticity or truth were found in the hyperacusis sample but not in the tinnitus sample. Lower levels of clout (social standing) were indicated in all groups, and a lower level of analytical thinking style (concepts and complex categories rather than narratives) was found in the hyperacusis sample. Additional analysis of the language indicated higher levels of sadness and anxiety in all groups and lower levels of anger, particularly for initial replies. These data support prior findings indicating higher levels of anxiety and depression in this patient population based on the actual words in blog posts and not from self-report questionnaires. Qualitative results identified 3 major themes from both the tinnitus and hyperacusis texts: suffering, negative emotional tone, and coping strategies. Conclusions Results from this study suggest support for the predominant clinical view that patients with tinnitus and hyperacusis have higher levels of anxiety and depression than the general population. The extent of the suffering described and patterns of coping strategies suggest clinical practice patterns and the need for research in implementing improved practice plans.

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