Evidence map›Paper›PMID 30343489›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2019

Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial.

A S Adams, J A Schmittdiel, A Altschuler, E A Bayliss, R Neugebauer, L Ma, W Dyer, J Clark, B Cook, D Willyoung and 10 more

Registry-linked trialAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02056431 (Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy), which is not on this map. Cited by 3 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02056431 nacompletednot on this map

Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy

TypeinterventionalSponsorKaiser PermanenteRan2014 to 2016Enrolled1,270ConditionsDiabetic Peripheral NeuropathyArmsIVR Intervention Group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

A S AdamsKaiser Permanente Division of Research, Oakland, CA.ORCID 0000-0002-0146-4996
J A SchmittdielKaiser Permanente Division of Research, Oakland, CA.
A AltschulerKaiser Permanente Division of Research, Oakland, CA.
E A BaylissKaiser Permanente Colorado Institute for Health Research, Denver, CO.
R NeugebauerKaiser Permanente Division of Research, Oakland, CA.
L MaKaiser Permanente Division of Research, Oakland, CA.
W DyerKaiser Permanente Division of Research, Oakland, CA.
J ClarkKaiser Permanente Division of Research, Oakland, CA.
B CookKaiser Permanente Division of Research, Oakland, CA.
D WillyoungKaiser Permanente Division of Research, Oakland, CA.
M JaffeKaiser Permanente South San Francisco Medical Center, South San Francisco, CA.
J D YoungKaiser Permanente Oakland Medical Center, Oakland, CA.
E KimKaiser Permanente Oakland Medical Center, Oakland, CA.
J M BoggsKaiser Permanente Colorado Institute for Health Research, Denver, CO.
L A ProsserUniversity of Michigan, School of Public Health, Ann Arbor, MI.
E WittenbergHarvard School of Public Health, Boston, MA.
B CallaghanUniversity of Michigan, Michigan Medicine, Neurology Clinic, Ann Arbor, MI, USA.
M ShainlineKaiser Permanente Colorado Institute for Health Research, Denver, CO.
R M HipplerKaiser Permanente Division of Research, Oakland, CA.
R W GrantKaiser Permanente Division of Research, Oakland, CA.

Funding

Translational Research Core - Health Engagement & Action Translational (HEAT)P30DK092924 · NIDDK · KAISER FOUNDATION RESEARCH INSTITUTE · PI Alyce Sophia Adams, HILARY Kessler SELIGMAN · 2011 to 2026
$9.2M
Multi-Component Behavioral Intervention for Complex Patients with CVD RiskR01HL117939 · NHLBI · KAISER FOUNDATION RESEARCH INSTITUTE · PI GRANT, RICHARD W · 2014 to 2018
$3.4M
Pre-Visit Prioritization for Complex Primary Care Patients with DiabetesR01DK099108 · NIDDK · KAISER FOUNDATION RESEARCH INSTITUTE · PI GRANT, RICHARD W · 2013 to 2017
$3.0M
The Impact of the Metabolic Syndrome on NeuropathyK23NS079417 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CALLAGHAN, BRIAN CHRISTOPHER · 2013 to 2017
$939k
National Institute for Diabetes, Digestive and Kidney Diseases K24DK109144National Institute for Diabetes, Digestive and Kidney Diseases R01DK099108NCCDPHP CDC HHS U58 DP002641NHLBI NIH HHS R01 HL117939NIDDK NIH HHS P30 DK092924NIDDK NIH HHS R01 DK099108NINDS NIH HHS K23 NS079417
6 · The paper itself

Abstract

aimsTo evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy.

methodsWe conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g. pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment.

resultsSome 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 participants (93%) completed follow-up (619 control, 560 intervention). Quality of life scores (intervention: 0.658 ± 0.094; control: 0.653 ± 0.092) and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: -0.002 (95% CI -0.01, 0.01), P = 0.623; pain: 0.295 (-0.75, 1.34), P = 0.579; sleep disruption: 0.342 (-0.18, 0.86), P = 0.196; lower extremity functioning: -0.079 (-1.27, 1.11), P = 0.896; depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes.

conclusionsAutomated telephone monitoring and feedback alone were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy.

trial registrationClinicalTrials.gov (NCT02056431).

Indexed as

Primary Health CareQuality of LifeAgedCluster AnalysisDiabetic NeuropathiesFemaleHumansMaleMiddle AgedMonitoring, PhysiologicOutcome Assessment, Health CarePractice Patterns, Physicians'

Identifiers

PMID30343489
PMCPMC7236318

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.