Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study

Froud, Robert; Fawkes, Carol; Foss, Jonathan G. K.; Underwood, Martin; Carnes, Dawn

doi:10.2196/jmir.9828

Cited by 21 publications

(15 citation statements)

References 94 publications

(138 reference statements)

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“…We will ask the patients to estimate the intensity of their neck pain (NRS-NP) and arm pain (NRS-AP) using a standard internet-based Numeric Rating Scale (eNRS)15 at baseline, and at 1 week, 1 month and 6 months after the surgery (table 2). We will use an 11-unit NRS scale ranging from 0 (no pain) to 10 (extreme pain).…”

Section: Methodsmentioning

confidence: 99%

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Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

investigators

Lönnrot²,

Taimela³

et al. 2019

BMJ Open

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IntroductionAlthough a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients’ perception of symptom relief and their ability to return to normal daily activities and work.Methods and analysisThis is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1–3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6–8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom’s criteria), patient’s satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.Ethics and disseminationThe study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.Trial registration number NCT03979443.

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Section: Methodsmentioning

confidence: 99%

“…We will use an 11-unit NRS scale ranging from 0 (no pain) to 10 (extreme pain). We will consider two points as the MID 15…”

Section: Methodsmentioning

confidence: 99%

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

investigators

Lönnrot²,

Taimela³

et al. 2019

BMJ Open

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“…Für chronischen Kreuzschmerz werden MCIDs von 2 [30] bis 4,6 [26] berichtet. Diagnosen-und methodenübergreifend liegen die MCID-Werte für mit numerischen Ratingskalen gemessenem Rückenschmerz zwischen 1 [18,31] und 4,6 [26], mit einem Schwerpunkt bei 2 Punkten [25,27,28,31,32] bzw. 30 % [5,28,32].…”

Section: Roc-kurven-analyseunclassified

Clinical Relevance of Changes in Pain Intensity in Patients with Specific Back Pain

Haase¹,

Kladny²

2021

Z Orthop Unfall

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Background Pain intensity is frequently measured on the 11-point numerical pain rating scale (NRS-PI), ranging from 0 (no pain) to 10 points (worst imaginable pain). However, it is difficult to interpret the clinical importance of changes from baseline to endpoint on this instrument. Objectives To estimate the minimal detectable change (MDC) and the minimal clinically important difference (MCID) for average pain intensity in patients with specific back pain. Materials and Methods Data on 1232 subjects with specific back pain from a German hospital were included in this study. A score combining the patientʼs (PGIC) and the physicianʼs global impression of change (CGIC) over the in-patient length of stay was used as an external criterion. A priori, we considered the score value “slightly improved” as the MCID. MDC was calculated using the standard error of measurement (SEM) and the standard deviation (SD) of the sample. MCID was estimated by the mean value of PI-NRS change in patients who self-assess as “slightly improved”, and by sensitivity/specificity analyses, computed by the receiver operating characteristic method (ROC). Results MDC was 1.77. The MCS and ROC methods consistently showed an MCID of 2 for the total sample. Both methods showed the dependence of the MCID on the initial pain: 1 for mild to moderate pain at baseline (1 – 4 NRS points), 2 for moderate to severe pain (5 – 7) and 3 – 4 for very severe to extreme pain (8 – 10). For patients with lumbosacral intervertebral disc disorders and patients in the acute phase (duration of pain < 6 weeks), the ROC method resulted in a higher limit than the MCS method. Conclusions In order to facilitate the interpretation of changes and to take into account the patientʼs perspective, the global assessment of the success of treatment should be used as an anchor criterion. In addition to dealing with pain measurement, function-related and psychosocial aspects of pain symptoms should be kept in mind.

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“…The pilot testing of the app involved three separate data collection streams to assess the feasibility of using the app, its responsiveness, and test-retest reliability of the PROMs [28]. Volunteer osteopaths recruited patients on a consecutive basis.…”

Section: Prom App Pilot Testingmentioning

confidence: 99%

Patient reported outcomes in a large cohort of patients receiving osteopathic care in the United Kingdom

Fawkes

Carnes

2021

PLoS ONE

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Objective The use of Patient Reported Outcome Measures (PROMs) to evaluate care is being advocated increasingly in clinical settings. Electronic data capture is both resource and environmentally friendly and convenient. This purpose of this study was to test and implement a nationwide system to collect routine PROM data from osteopathic patients using a web and mobile app. Methods A prospective study design was used to monitor outcomes of care for patients attending osteopathic clinics. Demographic and service data were collected, the primary outcomes were the Bournemouth Questionnaire and a Global Rating of Change score. Data concerning patients’ satisfaction and experience of care were collected also. Data were collected at baseline, one week, and six weeks post-treatment. Results A total of 1721 patients completed the PROM app questionnaire. The majority (65.8%) of patients who used the PROM app were between 40 and 69 years old with 11% being 70 years and over. At baseline 39.8% of patients reported they’d had their symptoms for 13 weeks or more. Low back pain was the most common symptom (55.8%). Patients reported high scores for both satisfaction and experience of osteopathic care: 88.1% were very satisfied at six weeks post-baseline and 93.5% reported very good experience at six weeks post-baseline. Data from the Global Rating of Change scale indicated that at one week post-baseline 89.1% of patients reported some measure of improvement, and at six weeks this figure rose to 92.8%. The mean sum score for the Bournemouth Questionnaire went from 30.8 at baseline to 13.3 at six weeks post-baseline. This represented a significant and clinically meaningful positive change score of 56.8%. Conclusion The app was well-completed and the data very encouraging. These data will help to form the basis for standards of care for patients attending osteopathic practices.

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Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study

Cited by 21 publications

References 94 publications

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

Clinical Relevance of Changes in Pain Intensity in Patients with Specific Back Pain

Patient reported outcomes in a large cohort of patients receiving osteopathic care in the United Kingdom

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