175. Discrepancy in patient-reported pain using the numeric pain scale and a percentage change to quantify treatment effectiveness after pain injections

Abstract BACKGROUND: Outcomes studies use patient-reported outcome (PRO) measurements to assess treatment effectiveness, but can lack direct clinical meaning. Minimum clinically important difference (MCID) calculation provides a point estimate of the critical threshold needed to achieve clinically relevant treatment effectiveness. MCID remains uninvestigated for microvascular decompression (MVD), a common surgical procedure for trigeminal neuralgia. OBJECTIVE: We aimed to determine MCID for the most commonly used PRO measures of pain after MVD: Visual Analog Scale (VAS) and Barrow Neurological Institute Pain Scale (BNI-PS). METHODS: Sixty consecutive patients with classic trigeminal neuralgia who decided to undergo MVD by a single surgeon were prospectively assessed with VAS and BNI-PS preoperatively and 2 years postoperatively. Three anchors were used to assign each patient's outcome. We then used 3 well-established, anchor-based methods to calculate MCID. RESULTS: Patients experienced significant improvement in both VAS (9.9 vs 2.0, P < .001) and BNI-PS (5.0 vs 1.9, P < .001) after MVD. The area under the receiver-operating characteristic curve was greater for BNI-PS than for VAS for all 3 anchors, indicating that BNI-PS is probably better suited for calculating MCID. The 3 MCID calculation methods generated a range of MCID values for each of the PROs (VAS: 1.40-8.87, BNI-PS: 0.95-3.26). CONCLUSION: MVD-specific MCID is highly variable based on calculation technique. Some of these calculations appear to either overestimate or underestimate the patients' preoperative expectations. When the different MCID methods are averaged, the results are clinically appropriate and consistent with preoperative expectations. The average MCID for VAS is 6.25 and for BNI-PS is 2.44.

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Preoperative Opioid Use in Patients Undergoing Common Hand Surgeries

Hand ◽

10.1177/1558944720974122 ◽

2021 ◽

pp. 155894472097412

Author(s):

Ali Aneizi ◽

Dominique Gelmann ◽

Dominic J. Ventimiglia ◽

Patrick M. J. Sajak ◽

Vidushan Nadarajah ◽

...

Keyword(s):

Outcome Measures ◽

Hand Surgery ◽

Patient Characteristics ◽

Patient Reported Outcome Measures ◽

Pain Scale ◽

Patient Reported Outcome ◽

Measurement Information ◽

Opioid Use ◽

Patient Reported ◽

Opioid Users

Background: The objectives of this study were to determine the baseline patient characteristics associated with preoperative opioid use and to establish whether preoperative opioid use is associated with baseline patient-reported outcome measures in patients undergoing common hand surgeries. Methods: Patients undergoing common hand surgeries from 2015 to 2018 were retrospectively reviewed from a prospective orthopedic registry at a single academic institution. Medical records were reviewed to determine whether patients were opioid users versus nonusers. On enrollment in the registry, patients completed 6 Patient-Reported Outcomes Measurement Information System (PROMIS) domains (Physical Function, Pain Interference, Fatigue, Social Satisfaction, Anxiety, and Depression), the Brief Michigan Hand Questionnaire (BMHQ), a surgical expectations questionnaire, and Numeric Pain Scale (NPS). Statistical analysis included multivariable regression to determine whether preoperative opioid use was associated with patient characteristics and preoperative scores on patient-reported outcome measures. Results: After controlling for covariates, an analysis of 353 patients (opioid users, n = 122; nonusers, n = 231) showed that preoperative opioid use was associated with higher American Society of Anesthesiologists class (odds ratio [OR], 2.88), current smoking (OR, 1.91), and lower body mass index (OR, 0.95). Preoperative opioid use was also associated with significantly worse baseline PROMIS scores across 6 domains, lower BMHQ scores, and NPS hand scores. Conclusions: Preoperative opioid use is common in hand surgery patients with a rate of 35%. Preoperative opioid use is associated with multiple baseline patient characteristics and is predictive of worse baseline scores on patient-reported outcome measures. Future studies should determine whether such associations persist in the postoperative setting between opioid users and nonusers.

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Which patient-reported outcomes do rheumatology patients find important to track digitally? A real-world longitudinal study in ArthritisPower

Arthritis Research & Therapy ◽

10.1186/s13075-021-02430-0 ◽

2021 ◽

Vol 23 (1) ◽

Author(s):

W. Benjamin Nowell ◽

Kelly Gavigan ◽

Carol L. Kannowski ◽

Zhihong Cai ◽

Theresa Hunter ◽

...

Keyword(s):

Physical Function ◽

Lupus Erythematosus ◽

Patient Reported Outcomes ◽

Treatment Effectiveness ◽

Time Window ◽

Joint Stiffness ◽

Summary Score ◽

Longitudinal Tracking ◽

Patient Reported

Abstract Background Patient-reported outcomes (PROs) are increasingly used to track symptoms and to assess disease activity, quality of life, and treatment effectiveness. It is therefore important to understand which PROs patients with rheumatic and musculoskeletal disease consider most important to track for disease management. Methods Adult US patients within the ArthritisPower registry with ankylosing spondylitis, fibromyalgia syndrome, osteoarthritis, osteoporosis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus were invited to select between 3 and 10 PRO symptom measures they felt were important to digitally track for their condition via the ArthritisPower app. Over the next 3 months, participants (pts) were given the option to continue tracking their previously selected measures or to remove/add measures at 3 subsequent monthly time points (month [m] 1, m2, m3). At m3, pts prioritized up to 5 measures. Measures were rank-ordered, summed, and weighted based on pts rating to produce a summary score for each PRO measure. Results Among pts who completed initial selection of PRO assessments at baseline (N = 253), 140 pts confirmed or changed PRO selections across m1–3 within the specified monthly time window (28 days ± 7). PROs ranked as most important for tracking were PROMIS Fatigue, Physical Function, Pain Intensity, Pain Interference, Duration of Morning Joint Stiffness, and Sleep Disturbance. Patient’s preferences regarding the importance of these PROs were stable over time. Conclusion The symptoms that rheumatology patients prioritized for longitudinal tracking using a smartphone app were fatigue, physical function, pain, and morning joint stiffness.

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Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2020-102238 ◽

2021 ◽

pp. rapm-2020-102238

Author(s):

Jonathan M Hagedorn ◽

Timothy R Deer ◽

Nicholas C Canzanello ◽

Stephen M Covington ◽

Darrell R Schroeder ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Stimulation ◽

Rating Scale ◽

Numeric Rating Scale ◽

Pain Scale ◽

Concordance Correlation ◽

Percentage Improvement ◽

Patient Reported ◽

The Mean ◽

Numeric Rating

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

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A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

Bone & Joint Open ◽

10.1302/2046-3758.16.bjo-2020-0014.r1 ◽

2020 ◽

Vol 1 (6) ◽

pp. 214-221 ◽

Cited By ~ 2

Author(s):

Juul Achten ◽

Ruth Knight ◽

Susan J. Dutton ◽

Matthew L. Costa ◽

James Mason ◽

...

Keyword(s):

Distal Radius ◽

Scientific Evidence ◽

Pain Scale ◽

Current Treatment ◽

Measurement Information ◽

Equivalence Trial ◽

School Absence ◽

Patient Reported ◽

Patient Will

Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.

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A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder

Trials ◽

10.1186/s13063-019-3995-y ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 2

Author(s):

Brittany B. Dennis ◽

Nitika Sanger ◽

Monica Bawor ◽

Leen Naji ◽

Carolyn Plater ◽

...

Keyword(s):

Clinical Trials ◽

Addiction Treatment ◽

Treatment Effectiveness ◽

Methadone Treatment ◽

Population Level ◽

Opioid Addiction ◽

Complex Nature ◽

Opioid Use ◽

Structured Interviews ◽

Patient Reported

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials. Conclusions There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. Trial registration PROSPERO, CRD42013006507.

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Effect of intervention on a quality measure of pain management at Medstar Washington Cancer Institute.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.30_suppl.218 ◽

2014 ◽

Vol 32 (30_suppl) ◽

pp. 218-218

Author(s):

Vishal Navnitray Ranpura ◽

Puja Chokshi ◽

Charan Yerasi ◽

Sundeep Agrawal ◽

Lynne Wood ◽

...

Keyword(s):

Quality Improvement ◽

Pain Scale ◽

Quality Improvement Project ◽

Administrative Staff ◽

Improvement Project ◽

Pareto Chart ◽

Numeric Pain Scale ◽

American Society ◽

Oncology Practice ◽

Pain Documentation

218 Background: Appropriate cancer pain documentation is one of the quality indicators in American Society of Clinical Oncology (ASCO)’s Quality Oncology Practice Initiative (QOPI). Medstar Washington Cancer Institute (MWCI) has participated in QOPI since 2008. Documentation of plan of care for moderate/severe pain defined as a pain score of ≥4 on a numeric pain scale was 69%, (compared to QOPI aggregate of 79%) during the fall 2011 round which led to a quality improvement project with an aim of ≥ 90%. Methods: MWCI created a team of physicians, nurses and administrative staff. We attended ASCO’s quality training workshop from October 2013 to March 2014 for guidance. We implemented a Plan Do Study Act (PDSA) methodology for our quality improvement project. We created a process map, cause and effect diagram and Pareto chart based on survey of physicians citing common reasons for lack of documented plan of care for pain. Results: Baseline rate of documented plan of care for pain control in November 2013 was 70%. In January 2014, we implemented action plans to increase the awareness of pain documentation (Electronic Health Record (HER) trigger for pain ≥ 4, fellows and mid level education and faculty consensus on documenting management for pain unrelated to cancer). After intervention, the pain documentation rate was improved to 90.2% (Table). Conclusions: After one cycle of PDSA, we achieved our goal of pain documentation rate. In order to sustain our project, we will continue to monitor the pain documentation rate quarterly in 2014 and continue the process of education and orientation to new staff as well rotating residents and fellows. [Table: see text]

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Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

Journal of Speech Language and Hearing Research ◽

10.1044/2016_jslhr-s-16-0022 ◽

2017 ◽

Vol 60 (1) ◽

pp. 62-88 ◽

Cited By ~ 27

Author(s):

David O. Francis ◽

James J. Daniero ◽

Kristen L. Hovis ◽

Nila Sathe ◽

Barbara Jacobson ◽

...

Keyword(s):

Systematic Review ◽

Treatment Effectiveness ◽

A Priori ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Exclusion Criteria ◽

Patient Reported ◽

Development And Validation ◽

Key Terms

Purpose The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications.

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A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

Bone & Joint Open ◽

10.1302/2633-1462.16.bjo-2020-0014.r1 ◽

2020 ◽

Vol 1 (6) ◽

pp. 214-221 ◽

Cited By ~ 3

Author(s):

Juul Achten ◽

Ruth Knight ◽

Susan J. Dutton ◽

Matthew L. Costa ◽

James Mason ◽

...

Keyword(s):

Distal Radius ◽

Scientific Evidence ◽

Pain Scale ◽

Current Treatment ◽

Measurement Information ◽

Equivalence Trial ◽

School Absence ◽

Patient Reported ◽

Patient Will

Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.

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The treatment of coccydynia in adolescents

Bone & Joint Open ◽

10.1302/2046-3758.15.bjo-2020-0017 ◽

2020 ◽

Vol 1 (5) ◽

pp. 115-120

Author(s):

Ante Matti Kalstad ◽

Rainer Günter Knobloch ◽

Vilhjalmur Finsen

Keyword(s):

Pain Scale ◽

Adult Patients ◽

Injection Therapy ◽

Control Group ◽

Treatment Results ◽

Results Of Treatment ◽

Adolescent Patients ◽

Numeric Pain Scale ◽

One Year

Aims To determine if the results of treatment of adolescents with coccydynia are similar to those found in adults. Adult patients with coccydynia may benefit from injection therapy or operative treatment. There is little data evaluating treatment results in adolescents. We have treated adolescent patients similarly to adults and compared the outcomes. Methods Overall, 32 adolescents with coccydynia were treated at our institution during a seven-year period; 28 responded to final follow-up questionnaires after a minimum of one year, 14 had been treated with only injection therapy, and 14 had been operated with coccygectomy. We collected data with regards to pain while sitting, leaning forward, rising from a sitting position, during defecation, while walking or jogging, and while travelling in trains, planes, or automobiles. Pain at follow-up was registered on a numeric pain scale. Each adolescent was then matched to adult patients, and results compared in a case control fashion. The treatment was considered successful if respondents were either completely well or much better at final follow-up after one to seven years. Results Out of the 28 treated adolescents, 14 were regarded as successfully treated. Seven were somewhat better, and the remaining seven were unchanged. In the adult control group the corresponding number was 15 successfully treated, eight patients were somewhat better, and five were unchanged. Six of the 14 successfully treated adolescents had been operated. There were no significant differences between the groups in the various registered domains, or on numeric pain scale. Conclusion Treatment results in adolescent patients seem similar to those in adults. The long-term success rate of injection therapy is low. In case of injection treatment failure, operation may be considered, also in adolescents.

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