Feasibility of a Practical Clinical Trial for Asthma Conducted in Primary Care

Hahn, David L.; Plane, Mary Beth

doi:10.3122/jabfm.17.3.190

Cited by 9 publications

(7 citation statements)

References 9 publications

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“…At the start of the trial, and at 3-mo follow-up, participants also completed a quality-of-life questionnaire using a validated scale. The primary objective of this trial was to investigate the feasibility of running an asthma trial in the primary care setting, and in using IVR telephone systems to collect the outcome data, reported in [ 13 ]. In this paper, the asthma outcomes are reported.…”

mentioning

confidence: 99%

Secondary Outcomes of a Pilot Randomized Trial of Azithromycin Treatment for Asthma

et al. 2006

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Objectives:The respiratory pathogen Chlamydia pneumoniae (C. pneumoniae) produces acute and chronic lung infections and is associated with asthma. Evidence for effectiveness of antichlamydial antibiotics in asthma is limited. The primary objective of this pilot study was to investigate the feasibility of performing an asthma clinical trial in practice settings where most asthma is encountered and managed. The secondary objectives were to investigate (1) whether azithromycin treatment would affect any asthma outcomes and (2) whether C. pneumoniae serology would be related to outcomes. This report presents the secondary results.Design:Randomized, placebo-controlled, blinded (participants, physicians, study personnel, data analysts), allocation-concealed parallel group clinical trial.Setting:Community-based health-care settings located in four states and one Canadian province.Participants:Adults with stable, persistent asthma.Interventions:Azithromycin (six weekly doses) or identical matching placebo, plus usual community care.Outcome Measures:Juniper Asthma Quality of Life Questionnaire (Juniper AQLQ), symptom, and medication changes from baseline (pretreatment) to 3 mo posttreatment (follow-up); C. pneumoniae IgG and IgA antibodies at baseline and follow-up.Results:Juniper AQLQ improved by 0.25 (95% confidence interval; −0.3, 0.8) units, overall asthma symptoms improved by 0.68 (0.1, 1.3) units, and rescue inhaler use decreased by 0.59 (−0.5, 1.6) daily administrations in azithromycin-treated compared to placebo-treated participants. Baseline IgA antibodies were positively associated with worsening overall asthma symptoms at follow-up (p = 0.04), but IgG was not (p = 0.63). Overall asthma symptom improvement attributable to azithromycin was 28% in high IgA participants versus 12% in low IgA participants (p for interaction = 0.27).Conclusions:Azithromycin did not improve Juniper AQLQ but appeared to improve overall asthma symptoms. Larger community-based trials of antichlamydial antibiotics for asthma are warranted.

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confidence: 99%

Secondary Outcomes of a Pilot Randomized Trial of Azithromycin Treatment for Asthma

et al. 2006

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“…GPs recognise the need to improve evidence-based medicine in primary care, but their lack of participation in clinical trials is also evident. [21][22][23] GPs report the lack of support staff for research as being a major barrier to participation in RCTs. However, use of a clinical research nurse requires a change in the study strategy.…”

Section: Discussionmentioning

confidence: 99%

Randomised studies in general practice: how to integrate the electronic patient record

Mosis

Koes²,

Dieleman³

et al. 2005

Journal of Innovation in Health Informatics

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The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet.The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the computer randomises the patients. Follow-up is documented by normal routine care in the EPR.Although the randomised database study has many methodological advantages, it has never been tested. Our software system is meant as a tool to implement and facilitate evaluation of the randomised database approach.

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“…Practical clinical trials try to account for this potential limitation of RCTs by including a broad, representative sample from a variety of community-based settings to generate relevant evidence-based information. 6,7 The primary benefit to the use of practical clinical trials is that they ultimately yield data that are more relevant to clinicians and decision-makers. 6 Perhaps the biggest analytical challenge in telehealth research when a RCT is not feasible or acceptable-especially in studies with underserved populations and low resource settings-is that patients may be selected for the program in a nonrandom, nonexperimental manner.…”

Section: Randomized Controlled Trials In Telehealthmentioning

confidence: 99%

Recommendations for Research Design of Telehealth Studies

Chumbler

Kobb²,

Brennan³

et al. 2008

Telemedicine and e-Health

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Properly designed randomized controlled trials (RCTs) are the gold standard to use when examining the effectiveness of telehealth interventions on clinical outcomes. Some published telehealth studies have employed well-designed RCTs. However, such methods are not always feasible and practical in particular settings. This white paper addresses not only the need for properly designed RCTs, but also offers alternative research designs, such as quasi-experimental designs, and statistical techniques that can be employed to rigorously assess the effectiveness of telehealth studies. This paper further offers design and measurement recommendations aimed at and relevant to administrative decision-makers, policymakers, and practicing clinicians.

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Feasibility of a Practical Clinical Trial for Asthma Conducted in Primary Care

Cited by 9 publications

References 9 publications

Secondary Outcomes of a Pilot Randomized Trial of Azithromycin Treatment for Asthma

Secondary Outcomes of a Pilot Randomized Trial of Azithromycin Treatment for Asthma

Randomised studies in general practice: how to integrate the electronic patient record

Recommendations for Research Design of Telehealth Studies

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