Integrating routine clinical interventions with single-case methodology: Parallels, differences and bridging strategies

2019 ◽  
Vol 21 (1) ◽  
pp. 99-109
Author(s):  
Robyn L. Tate ◽  
Michael Perdices ◽  
Donna Wakim
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Treatment Effectiveness ◽  
Single Case ◽  
Controlled Trial ◽  
Routine Clinical Practice ◽  
Case Methods ◽  
Case Methodology ◽  
Randomised Controlled ◽  
Building Practice

AbstractClinical practice offers the opportunity for the clinician to be a scientist-practitioner in the workplace. This, in turn, facilitates building practice-based evidence. But this can only occur if the effects of the interventions are objectively and systematically evaluated. To this end, single-case methodology is a valuable tool to implement an intervention in a scientifically rigorous manner and gather data on treatment effectiveness. It is possible to incorporate single-case methods into routine clinical practice by using a few simple strategies. This paper examines the ways in which single-case methodology departs from (a) routine clinical practice and (b) the familiar between-groups research design, such as the randomised controlled trial. It presents five practical strategies that will bridge the gap between routine clinical practice and single-case methodology. The Model for Assessing Treatment Effect is described as providing context for and a framework to self-evaluate the scientific rigour in clinical practice and benchmark service delivery.

scholarly journals Promoting Early Presentation of Breast Cancer in Older Women: Implementing an Evidence-Based Intervention in Routine Clinical Practice

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Lindsay J. L. Forbes ◽  
Alice S. Forster ◽  
Rachael H. Dodd ◽  
Lorraine Tucker ◽  
Rachel Laming ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Older Women ◽  
Breast Screening ◽  
Controlled Trial ◽  
Routine Clinical Practice ◽  
Cancer Awareness ◽  
Breast Cancer Awareness ◽  
Randomised Controlled

Background. Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age~70, in the English National Health Service Breast Screening Programme.Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered.Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2).Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women.

scholarly journals Thresholds for clinically important deterioration versus improvement in COPD health status: results from a randomised controlled trial in pulmonary rehabilitation and an observational study during routine clinical practice

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025776 ◽  
Author(s):  
Harma Johanna Alma ◽  
Corina de Jong ◽  
Danijel Jelusic ◽  
Michael Wittmann ◽  
Michael Schuler ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Health Status ◽  
Randomised Controlled Trial ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Routine Clinical Practice ◽  
Observational Research ◽  
Chronic Obstructive ◽  
Global Rating ◽  
Randomised Controlled

ObjectivesChronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires.Design and settingData were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2).ParticipantsPatients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis.Primary outcomesThe COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George’s Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds.ResultsIn total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from −3.78 to −1.53 (CAT), from −0.50 to −0.19 (CCQ), and from −9.20 to −2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from −5.02 to −3.29 vs 3.89 to 8.14 (CAT), from −0.90 to −0.72 vs 0.42 to 1.23 (CCQ), and from −15.85 to −13.63 vs 7.46 to 9.30 (SGRQ).ConclusionsMCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings.Trial registration numberRoutine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.

Translation of Randomised Controlled Trial Findings into Clinical Practice: Comparison of Olanzapine and Valproate in the EMBLEM Study

2009 ◽  
Vol 42 (04) ◽  
pp. 145-152 ◽  
Author(s):  
D. Novick ◽  
A. Gonzalez-Pinto ◽  
J. M. Haro ◽  
J. Bertsch ◽  
C. Reed ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals International feasibility trial on the use of an interactive mobile health platform for cardiac rehabilitation: protocol of the Diversity 1 study

2019 ◽  
Vol 26 (1) ◽  
pp. e100042
Author(s):  
Manuel Cruz Gonzalez-Garcia ◽  
Farhad Fatehi ◽  
Martijn Scherrenberg ◽  
Robin Henriksson ◽  
Adrian Maciejewski ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Mobile Health ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Rehabilitation Protocol ◽  
Research Organisation ◽  
Home Based ◽  
Randomised Controlled

IntroductionThe implementation of home-based cardiac rehabilitation has demonstrated potential to increase patient participation, but the content and the delivering of the programmes varies across countries. The objective of this study is to investigate whether an Australian-validated mobile health (mHealth) platform for cardiac rehabilitation will be accepted and adopted irrespectively from the existing organisational and contextual factors in five different European countries.Methods and analysisThis international multicentre feasibility study will use surveys, preliminary observations and analysis to evaluate the use and the user’s perceptions (satisfaction) of a validated mHealth platform in different contextual settings.Ethics and disseminationThis study protocol has been approved by the Australian research organisation CSIRO and the respective ethical committees of the European sites. The dissemination of this trial will serve as a ground for the further implementation of an international large randomised controlled trial which will contribute to an effective global introduction of mHealth into daily clinical practice.

scholarly journals Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 390 (10109) ◽  
pp. 2247-2255 ◽  
Author(s):  
Ashley Woodcock ◽  
Jørgen Vestbo ◽  
Nawar Diar Bakerly ◽  
John New ◽  
J Martin Gibson ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Fluticasone Furoate ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled

scholarly journals METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuanyuan Wang ◽  
Andrew J. Teichtahl ◽  
Graeme Jones ◽  
Helen I. Keen ◽  
Catherine L. Hill ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Trial Registration ◽  
Positive Trial ◽  
Hand Osteoarthritis ◽  
Double Blind ◽  
Structural Progression ◽  
Randomised Controlled

Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124

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