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.

scholarly journals Findings of a feasibility study of pre-operative pulmonary rehabilitation to reduce post-operative pulmonary complications in people with chronic obstructive pulmonary disease scheduled for major abdominal surgery

2019 ◽  
Author(s):  
Lucy L Marlow ◽  
Angeline HY Lee ◽  
Emma Hedley ◽  
Michael P Grocott ◽  
Michael C Steiner ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Abdominal Surgery ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Pulmonary Complications ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled ◽  
Surgical Pathway

AbstractBackgroundPatients with chronic obstructive pulmonary disease (COPD) are at increased risk of complications and death following surgery. Pulmonary complications are particularly prominent. Pulmonary rehabilitation is a course of physical exercise and education that helps people with COPD manage their condition. Although proven to improve health outcomes in patients with stable COPD, it has never been formally tested as a pre-surgical intervention in patients scheduled for non-cardiothoracic surgery. If a beneficial effect were to be demonstrated, pulmonary rehabilitation for pre-surgical patients with COPD might be rapidly implemented across the National Health Service, as pulmonary rehabilitation courses are already well established across much of the United Kingdom (UK).MethodsWe performed a feasibility study to test study procedures and barriers to identification and recruitment to a randomised controlled trial testing whether pulmonary rehabilitation, delivered before major abdominal surgery in a population of people with COPD, would reduce the incidence of post-operative pulmonary complications. This study was run in two UK centres (Oxford and Newcastle upon Tyne).ResultsWe determined that a full randomised controlled trial would not be feasible, due to failure to identify and recruit participants. We identified an unmet need to identify more effectively patients with COPD earlier in the surgical pathway. Service evaluations suggested that barriers to identification and recruitment would likely be the same across other UK hospitals.ConclusionsAlthough pulmonary rehabilitation is a potentially beneficial intervention to prevent post-operative pulmonary complications, a randomised controlled trial is unlikely to recruit sufficient participants to answer our study question conclusively at the present time, when spirometry is not automatically conducted in all patients planned for surgery. As pulmonary rehabilitation is a recommended treatment for all people with COPD, alternative study methods combined with earlier identification of candidate patients in the surgical pathway should be considered.Trial registrationISRCTN 29696295, http://www.isrctn.com/ISRCTN29696295, registered 31st August 2017

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 Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study)

2020 ◽  
Vol 7 (1) ◽  
pp. e000548
Author(s):  
Derrick Lopez ◽  
Nola Cecins ◽  
Joanne Cockram ◽  
Anna Collins ◽  
Holly Landers ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled ◽  
Maintenance Programme

IntroductionPulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.Methods and analysisThe ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.Ethics and disseminationApproval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.Clinical trial registrationANZCTR 12618000933257

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