Single-Patient Drug Trial Methodology for Allergic Rhinitis

Reitberg, Donald P.; Rio, Eve Del; Weiss, Sidney L; Rebell, Gerbert; Zaias, Nardo

doi:10.1345/aph.1c031

Cited by 6 publications

(3 citation statements)

References 7 publications

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“…Participating clinicians included 21 general internists, 21 family physicians, 2 Veterans Affairs pain specialty physicians practicing in close association with primary care, 1 nurse practitioner, 2 physician assistants, and 1 clinical pharmacist. Of the participating clinicians, 60% (n = 29) were recruited from UC Davis, the mean (SD) age was 44 (10) years; the mean (SD) time in practice was 12.5 (9.5) years, and 50% (n = 24) were female. Clinicians received a small participation incentive (ie, $100 gift card for each patient completing the 6-month follow-up).…”

Section: Setting and Participantsmentioning

confidence: 99%

“…Additionally, n-of-1 trials are most appropriate for chronic stable diseases and for treatments with rapid onset and minimal carryover following treatment switching . Although used in diverse conditions, n-of-1 trials have not been widely adopted, in part because they have been perceived by clinicians and patients as requiring too much time and effort …”

Section: Introductionmentioning

confidence: 99%

“…2,3 Additionally, n-of-1 trials are most appropriate for chronic stable diseases and for treatments with rapid onset and minimal carryover following treatment switching. 4 Although used in diverse conditions, [5][6][7][8][9][10][11][12] n-of-1 trials have not been widely adopted, in part because they have been perceived by clinicians and patients as requiring too much time and effort. 13 Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, emotional distress, and work absenteeism.…”

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confidence: 99%

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Effect of Mobile Device–Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain

et al. 2018

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IMPORTANCE Individually designed single-patient multi-crossover (n-of-1) trials can facilitate tailoring of treatments directed at various conditions, including chronic musculoskeletal pain (CMSP) but are potentially burdensome, which may limit uptake in research and practice.OBJECTIVES To determine whether patients randomized to participate in an n-of-1 trial supported by a mobile health (mHealth) app would experience less pain and improved global health, adherence, satisfaction, and shared decision making compared with patients assigned to usual care. DESIGN, SETTING, AND PARTICIPANTSThis randomized clinical trial compared participation in an individualized, mHealth-supported n-of-1 trial vs usual care. The participating 215 patients had CMSP for at least 6 weeks, had a smartphone or tablet with a data plan, were enrolled in northern California from July 2014 through July 2016, and were followed for up to 1 year by 48 clinicians in academic, community, Veterans Affairs, and military settings.INTERVENTIONS Intervention patients met with their clinicians and used a desktop interface to select treatments and trial parameters for an n-of-1 trial comparing 2 pain-management regimens. The mHealth app provided reminders to take designated treatments on assigned days and to upload responses to daily questions on pain and treatment-associated adverse effects. Control patients received care as usual. MAIN OUTCOMES AND MEASURESThe primary outcome was change in the PROMIS (Patient-Reported Outcomes Measurement Information System) pain-related interference 8-item short-form scale (full scale range, 41-78) from baseline to 6 months. Secondary outcomes included patient-reported pain intensity, overall health, analgesic adherence, trust in clinician, satisfaction with care, medication-related shared decision making, and, for the n-of-1 group only, participant engagement and experience. RESULTS Among 215 patients (108 randomized to the n-of-1 intervention and 107 to control), 102 (47%) were women, and the mean (SD) age was 55.5 (11.1) years. At the 6-month follow-up, pain interference was reduced in both groups, though there was no difference between the intervention and control groups (−1.36 points; 95% CI, −2.91 to 0.19 points; P = .09). There were no advantages in secondary outcomes for intervention patients vs control patients except for higher medication-related shared decision making at 6 months (between-group difference, 11.9 points; 95% CI, 2.6-21.2 points; P = .01). Among patients assigned to the n-of-1 group, 88% (n = 86) affirmed that the mHealth app could help people like them manage their pain. CONCLUSIONS AND RELEVANCEIn this population of patients with CMSP, mHealth-supported n-of-1 trials were feasible and associated with a satisfactory user experience, but n-of-1 trial participation did not significantly improve pain interference at 6 months vs usual care.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02116621

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Section: Setting and Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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confidence: 99%

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Effect of Mobile Device–Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain

et al. 2018

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Opt–e–scrip, Inc.

Huser

Swartz

2010

Entrepreneurship Theory and Practice

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Opt-e-scrip, Inc., has developed a patented test for determining the efficacy of drugs in individual patients so that doctors can prescribe the drug that really works for each person. In addition, test results show that older, less expensive drugs are often as or more efficacious than the newer, expensive drugs pushed by manufacturers. It, thus, benefits physicians, patients, and drug benefit payers. However, the company has had difficulty entering the market, given its complexity and their lack of resources. The test remains a product in search of an application and a customer willing to pay for its usage.

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Advances in Single-Patient Trials for Drug Treatment Optimization and Risk Management

Reitberg¹,

Weiss²,

Rio³

2005

Drug Information J

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Experts in evidence-based medicine consider single-patient trials or "n-of-I" studies to be the highest fanm of evidence for making individual patient drug treatment decisions. Singlepatient trial-baed risk management programs for chronic care drugs with recognized s a f e risks would improve risk/benefit ly more reliably identifung individual patients who do not receive benefit and/or who experience undue short-term adverse events. f i e widespread use of single-patient trials would also generate a continuously expanding database of prospectively documented flectiveness and s a f e outcomes that would support population and subgroup risk/benefit assessments, leading to improved prescribing information.

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Single-Patient Drug Trial Methodology for Allergic Rhinitis

Abstract: The allergic rhinitis SPT proved to be acceptable to patients, feasible to administer, and reproducible. It can statistically discriminate effectiveness and adverse events, serving as a useful, prognostic tool in community practice.

Cited by 6 publications

References 7 publications

Effect of Mobile Device–Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain

Effect of Mobile Device–Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain

Opt–e–scrip, Inc.

Advances in Single-Patient Trials for Drug Treatment Optimization and Risk Management

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