Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure

Brod, Meryl; Blum, Steven I.; Bushnell, Donald M.; Ramasamy, Abhilasha

doi:10.1007/s11136-015-1037-0

Cited by 14 publications

(10 citation statements)

References 39 publications

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“…PRO is a modern scientific approach widely used in evaluating outcomes of clinical trials based on patient-centered evidence [31-33]. PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else [34].…”

Section: Methodsmentioning

confidence: 99%

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

et al. 2019

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Background: This study aimed to explore the effectiveness of acupuncture combined with tuina therapy in patients with migraine. Methods: A prospective, randomized controlled assessor-blind clinical trial was performed between January 2017 and May 2018, and 135 patients were assigned into acupuncture combined with tuina (A), acupuncture (B), and control (flunarizine hydrochloride) (C) groups, each with 45 patients. Treatments were performed for 12 weeks and a 4-week follow-up. Frequency of attacks, severity of pain, duration of migraine, associated symptoms, patient-reported outcome (PRO) scores, and frequency of analgesic consumption were assessed. Results: The total effective rate was 95.6, 88.9, and 75.6% for group A, B, and C, respectively, with a significant reduction in attack frequency, severity of pain, duration of migraine, and associated symptoms at post-treatment and follow-up compared to pre-treatment. The PRO scores and frequency of analgesic consumption were significantly improved (group A, p < 0.01; groups B and C, p < 0.05). The differences in pre-/post-treatment and in pre-treatment/follow-up in groups A and B were significantly improved compared to group C (A vs. C, p < 0.01; B vs. C, A vs. B, p < 0.05). No significant adverse events occurred. Conclusion: Acupuncture combined with tuina could significantly increase the therapeutic effect of acupuncture in migraine treatment.

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Section: Methodsmentioning

confidence: 99%

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

et al. 2019

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“…Third, we wanted to validate both sets of information using psychometric and Rasch data analysis. 27,28 This would allow for consideration of methods for online and repeated registration of parents’ concerns and assessment data to provide better support and services and for creation of methods of repeated follow-up on purposely improved interventions.…”

Section: Discussionmentioning

confidence: 99%

Parents’ Expressions of Concerns and Hopes for the Future and Their Concomitant Assessments of Disability in Their Children

Illum

Bonderup

Gradel

2018

Clin Med Insights Pediatr

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Aim:To assess parents’ ability to express their concerns and hopes for the future in their children with disability and assess their children’s disability as well as to analyse these data for consistency.Method:Parents of 162 children with spina bifida, spinal muscular atrophy, muscular disorders, cerebral palsy, visual impairment, hearing impairment, mental disability, or disability following brain tumours were asked to freely express their concerns and hopes for the future and to assess disability in their own children by employing a set of 26 International Classification of Functioning, Disability and Health, Children and Youth Version (ICF-CY) body function (b) codes and activity and participation (d) codes. A grounded theory approach was employed to systematize parents’ expressions of concerns and hopes; then, parents scored qualifiers on a 5-step qualitative Likert scale. Parents assessed their children’s disability in the same way using the ICF-CY 5-step qualifier scale.Results:Altogether, 119 parents freely expressed their concerns and hopes, and 101 of them also assessed their children’s disability using the 26 ICF-CY codes. A total of 475 expressions of concern and hopes (issues) were expressed and categorized into 34 areas of concern and hopes (subsections). The most frequently mentioned issues were education; understanding, goodwill, and communication between parents; and community support. Qualitative data on both 5-step qualifier scales showed good reliability. Rasch analysis maps on concerns and hopes for children as well as on the ICF-CY assessment demonstrated good alignment and a clinically relevant progression from the least to the most disabled children.Conclusion:Parents can express valid and reliable data on their concerns and hopes for the future and can reliably assess disability in their own children.

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“…The duration of each attack refers to the time from migraine onset to vanish, if the patient goes to sleep in pain, the time of vanishing is when he wakes up. Patient reported outcome (PRO) is a modern scientific approach widely used in evaluating outcomes of clinical trials based on patient centred evidence [ 23 – 25 ]. A PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

Zhengtian Capsule versus flunarizine in patients with migraine: a multi-center, double-blind, double-dummy, randomized controlled, non-inferior clinical trial

Cao

Han

Lin

et al. 2016

BMC Complement Altern Med

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BackgroundThe primary objective of this study was to assess whether Zhengtian Capsule was non-inferior to flunarizine in efficacy and safety profile for prevention of migraine in adults.MethodsThis was a double-dummy, double-blind, multicenter, positive drug (flunarizine), parallel randomized controlled, non-inferior clinical trial. Patients (n = 360) were randomized in a 1:1 to receive either Zhengtian Capsule or flunarizine, including 12 weeks’ intervention and 4 weeks’ follow-up. The primary outcome measure was responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period). The secondary outcome measures included migraine attack frequency, the number of migraine days, pain evaluated by visual analogue scale (VAS) score, duration of migraine attacks, the times of using analgesics, patient-reported outcome (PRO) measure of migraine and the scores of short-form 36 Health Survey Scale (SF-36). Weight variation in both groups was also evaluated. Adverse events were monitored throughout the trial.ResultsZhengtian Capsule was non-inferior to flunarizine in responder rate at week 12 and follow-up period (P = 0.002, P < 0.001). There was fewer migraine days in Zhengtian Capsule group at follow-up period compared with flunarizine (P = 0.001). For the total duration of migraine attacks, there was significant group difference at week 4 which favored the control group (P = 0.009). For the total score of PRO scale, there was statistical difference between the two groups at follow-up period (P = 0.021). There were also group differences between the two groups in the dimensions of somatization symptoms at week 4 (P = 0.022) and functional status at week 12 and follow-up period (P < 0.001, P < 0.001). However, there were no significant differences between the two groups in migraine attack frequency, VAS scores reduction, consumption of acute pain drugs and the dimension scores of SF-36 at any time interval of the treatment period (P > 0.05). No severe adverse events occurred in the trial. Flunarizine was found associated with a weight gain.ConclusionZhengtian Capsule was non-inferior to flunarizine with regard to the primary endpoint. In addition, it could reduce migraine days and improve the functional status and somatization symptoms of migraine patients with good safety profile.Trial registrationThis trial was registered at Chinese Clinical Trial Register (ChiCTR), ChiCTR-TRC-13004412.

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Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure

Abstract: CE and psychometric results provide evidence that the final, 18-item DPNPI is a reliable and valid PRO measure of disease impacts and treatment for DPNP. Further validation work should include responsiveness assessment.

Cited by 14 publications

References 39 publications

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

The Effectiveness of Acupuncture Combined with Tuina Therapy in Patients with Migraine

Parents’ Expressions of Concerns and Hopes for the Future and Their Concomitant Assessments of Disability in Their Children

Zhengtian Capsule versus flunarizine in patients with migraine: a multi-center, double-blind, double-dummy, randomized controlled, non-inferior clinical trial

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