In the practice of healthcare, patient-reported outcomes (PROs) and PRO measures (PROMs) are used as an attempt to observe the changes in complex clinical situations. They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect. For any PROM to be usable in health care, we need it to be reliable, encapsulating the points of interest with the potential to detect any real change. Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview, and this allows the physician and patient to have a meaningful conversation as well as a customized plan for each patient. Having mentioned the rationale and the benefits of PROMs, understanding the quantification process is crucial before embarking on management decisions. A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition. There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences. This article details the various quantification metrics used to evaluate the treatment effect using PROMs, their limitations and the scope of usage and implementation in clinical practice.

• Patient-reported outcome measures
• Treatment effect
• Minimal clinical important difference
• Patient-accepted symptom state
• Minimum detectable change
• Orthopedics

• Corticosteroid
• Platelet-rich plasma
• Randomised controlled trial
• Regenerative medicine
• de Quervain tenosynovitis

• Humans
• Platelet-Rich Plasma
• De Quervain Disease/therapy
• Male
• Female
• Adult
• Middle Aged
• Prospective Studies
• Young Adult
• Pain Measurement
• Triamcinolone Acetonide/therapeutic use
• Triamcinolone Acetonide/administration & dosage
• Adolescent
• Glucocorticoids/therapeutic use
• Glucocorticoids/administration & dosage
• Ultrasonography, Interventional
• Treatment Outcome

• 8-Foot up-and-Go
• Body fat
• Fall accident
• Fractures
• Osteoporosis

• Humans
• Accidental Falls
• Aged
• Female
• Male
• Postural Balance/physiology
• Osteoporosis/physiopathology
• Osteoporosis/diagnosis
• Aged, 80 and over
• Walking/physiology
• Geriatric Assessment/methods
• Physical Functional Performance
• Pain Measurement/methods
• Case-Control Studies

• 124404 TrygFonden
• 18-4708 Det Obelske Familiefond
• Dansk Oplysnings Forbund
• Aalborg University

• Musculoskeletal pain
• acupuncture
• disability
• dry needling
• injection

• Humans
• Acupuncture Therapy/methods
• Anesthetics, Local
• Botulinum Toxins, Type A
• Cortisone
• Musculoskeletal Pain
• Randomized Controlled Trials as Topic
• Rheumatic Diseases

• functionality
• manual lymphatic drainage
• randomized controlled trial
• rheumatoid arthritis

• Function
• Knee osteoarthritis
• Low-level laser therapy
• Pain
• Pulsed electromagnetic field therapy

• Humans
• Low-Level Light Therapy/methods
• Osteoarthritis, Knee/diagnosis
• Osteoarthritis, Knee/therapy
• Treatment Outcome
• Electromagnetic Fields
• Laser Therapy
• Pain

• knee osteoarthrosis
• long term effects
• pain
• posturography
• quality of life
• surgery

• hemodialysis
• hemodialysis access
• music
• pain
• single-blind method

• Humans
• Music
• Single-Blind Method
• Pain/etiology
• Pain/prevention & control
• Renal Dialysis/adverse effects
• Anxiety/etiology
• Anxiety/prevention & control
• Catheterization/adverse effects

• Terumo Foundation for Life Sciences and Arts

• Arthroscopy
• Fibrosis
• Patient reported outcomes
• Total knee arthroplasty
• Total knee replacement
• Unexplained pain

• injection
• intra-articular
• knee
• mesenchymal stem cells
• osteoarthritis

• TENS
• clinical trial
• knee osteoarthritis
• opioids
• pain management

The onset of rheumatic disease affects each patient differently and may impact quality of life with progression. We investigated the relationship between patient-reported outcome measure (PROM) scores and organ damage in patients with recent-onset systemic lupus erythematosus (SLE) and those with early rheumatoid arthritis (RA). Patients with recent-onset SLE without prior organ damage from the Clinical Lupus Register in Northeastern Gothia and patients with early RA from the observational 2nd Timely Interventions in Early RA study, Sweden, were included. Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index (SDI) was used to assess organ damage. PROM (visual analog scale [VAS]: pain, fatigue, well-being, Health Assessment Questionnaire, and EQ-5D-3L) scores were captured at months 0, 6, 12, 24, 36, 48, and 60 after diagnosis. Statistical tests included Pearson correlation coefficients and t-tests. Forty-one patients with recent-onset SLE and 522 with early RA were included. Numerical differences were seen in age and sex. PROMs were worse for patients with RA versus SLE but improved by month 6 following diagnosis, while SLE PROMs remained stable. The incidence of organ damage in SLE was 13.6 per 100 patient-years. SDI significantly correlated with EQ-5D-3L (− 0.48, P = 0.003), VAS fatigue (0.44, P = 0.009), and well-being (0.41, P = 0.01) at month 24. As illustrated, the complexity of disease burden in patients with SLE is clear and may result from disease-related multiorgan system effects and slower symptom resolution compared with RA. This underscores the need for improved multiprofessional interventions to manage all aspects of SLE.

• Patient-reported outcome measures
• Quality of life
• Recent onset of disease
• Rheumatoid arthritis
• Systemic lupus erythematosus

• Mediterranean diet
• anti-inflammatory diet
• arthralgia
• ketogenic diet
• pain
• rheumatoid arthritis
• vegan diet
• vegetarian diet

With the availability of effective treatment with targeted synthetic and biologic disease-modifying anti-rheumatic drugs (ts/bDMARDs) for psoriatic arthritis (PsA), it is crucial to identify predictors of access to this treatment since disease onset. We retrospectively enrolled patients with peripheral PsA, assessed in an early arthritis clinic from 2005 to 2020. The main baseline demographic, clinical and ultrasonographic (assessment of bilateral wrist and metacarpophalangeal joints) features were evaluated through descriptive statistics and tested as predictors by univariate and multivariate Cox models. The outcome of interest was the indication for ts/bDMARDs within 2 years from diagnosis. We included 238 patients with PsA, with a mean (sd) age of 51.04 (13.98) years; 90 (37.8%) were male, and the median (IQR) symptom duration was 6.12 (3.29–12.25) months. In univariate analyses, C-reactive protein (RR, 95% CI 1.204 (1.065,1.362)), Visual Analogue Scale (VAS) pain (1.027 (1.005,1.048)), the number of tender joints on 28 joints (1.087 (1.025, 1.153)), and a synovial power Doppler (PD) score > 1 (3.63 (1.307, 10.08)) emerged as significant predictors. C-reactive protein, VAS pain and PD confirmed their predictive value also in multivariate models. These results provide preliminary evidence on the features that might characterize patients with early peripheral PsA requiring more intensive monitoring and treatment escalation.

• disease-modifying anti-rheumatic drugs
• early arthritis
• predictors
• psoriatic arthritis

• PROM
• Visco-supplementation
• ankle arthritis
• hyaluronic acid
• injection

• Analgesia, Epidural
• Analgesics, Opioid
• Anesthetics, Local
• Humans
• Kenya
• Laparotomy/adverse effects
• Pain, Postoperative/drug therapy
• Pain, Postoperative/prevention & control
• Single-Blind Method

Background: The magnitude and duration of conditioned pain modulation (CPM) likely depends on the nature and intensity of the conditioning stimulus (CS).

Aims: The aim of this study was to measure the effect of CS intensity on the duration of CPM hypoalgesia.

Methods: In this single-blind, nonrandomized, repeated measures study, we assessed CPM hypoalgesia in 20 healthy participants following cold pressor tests (CPT) at 7°C and 12°C. The test stimulus, a 60-s heat stimulation, was administered before the CPT and immediately after, and again at 5-min intervals until participants’ pain scores returned to pre-CS levels. Two hypoalgesia thresholds were used to establish return to pre-CS level: within −10/100 of baseline and within −20/100 of baseline.

Results: CPM hypoalgesia, when defined as a reduction in pain levels >10/100, did not last longer following the more intense 7°C CPT compared to the 12°C CPT (32 min vs. 20 min, respectively; P = 0.06); similar results were obtained when CPM hypoalgesia was defined as a reduction in pain levels of >20/100 (16 min following the 7°C CPT vs. 9 min following the 12°C CPT; P = 0.33). The duration of CPM hypoalgesia was significantly longer when the 10/100 threshold was used compared to the 20/100 threshold, regardless of CPT temperature (P = 0.008 for the 12°C CPT; P < 0.001 for the 7°C CPT).

Conclusions: The more intense CS did not induce CPM hypoalgesia of longer duration compared to the less intense CS. The choice of threshold for what constitutes CPM hypoalgesia did have a significant effect on the results.

• cold pressor test
• conditioned pain modulation
• descending inhibition
• pain
• pain modulation

• cytokine
• growth factor
• hyaluronic acid
• osteoarthritis
• platelet-rich plasma

• rotator cuff
• strain elastography
• supraspinatus tendon
• tendinopathy
• tendon change
• training
• ultrasound

• allogeneic
• human adipose-derived mesenchymal progenitor cells
• intra-articular injection
• knee osteoarthritis
• magnetic resonance imaging
• mesenchymal stem cells

• Amyotrophic lateral sclerosis
• Rasch
• TONiC
• interval level measurement
• quality of life

• MR/R024804/1 Medical Research Council
• YOUNG/JAN15/929-794 Motor Neurone Disease Association

• Depression
• Depressive symptoms
• Knowledge synthesis
• Low back pain
• Systematic review

• Adult
• Depression/complications
• Humans
• Low Back Pain/complications
• Low Back Pain/psychology
• Low Back Pain/therapy
• Radiculopathy/complications
• Radiculopathy/psychology
• Radiculopathy/therapy
• Treatment Outcome
• Systematic Reviews as Topic

• Kinesiotaping
• Knee
• Osteoarthritis
• Rehabilitation

This study aimed to determine the effects of kinesiotape (KT) on pain, range of motion, and functional status in patients with osteoarthritis of the knee. In this randomized controlled trial, patients with knee osteoarthritis, based on American College of Rheumatology criteria, and Kellgren-Lawrence grade 2 or 3 criteria were selected. Visual analogue scale and active range of motion were the primary outcome measures. Timed Up and Go test and 6-min walk test, were the secondary outcome measures. Evaluation was performed at baseline (T0), after 1 hr (T1), and after 72 hr (T2). We recruited 27 patients with osteoarthritis (age, 57.33±8.72 years; 63% female; body mass index, 29.7±4.3 kg/m²) who were randomly assigned into KT or sham-KT groups. There was a significant group by time interaction for the visual analogue scale (P< 0.001, η²=0.593), active range of motion (flexion) (P<0.001, η²=0.492), active range of motion (extension) (P<0.001, η²=0.351), 6-min walk test (P<0.001, η²=0.568), and Timed Up and Go test (P=0.026, η²=0.136). Between-group comparisons revealed significant differences between KT and sham-KT in visual analogue scale and Timed Up and Go test in T1 and T2 assessments, with changes in knee flexion (P<0.002) and extension active range of motion (P<0.010) and 6-min walk test (P<0.044) at 72-hr posttreatment. This study showed that, 1 hr of KT is an effective treatment for decreasing pain and improving active range of motion and physical function at a 72-hr follow-up in patients with osteoarthritis.

• Kinesiotape
• Knee pain
• Osteoarthritis
• Range of motion

Feasibility and pilot studies are recommended prior to embarking on large-scale costly confirmatory trials. The objectives were to determine the feasibility of conducting a cluster randomized controlled trial (C-RCT) to evaluate a complex knowledge translation (KT) intervention to improve the management of people with neck pain, and to identify challenges and potential solutions to conducting a fully powered C-RCT in the chiropractic setting.

Pilot C-RCT involving a nationally representative sample of chiropractors and patients. We invited 400 chiropractors and 150 patients to participate. Clinicians were randomized to receive either an online theory-based KT educational and brief action plan (BAP) intervention (intervention group) or a copy of a clinical practice guideline (control group). Study-related challenges were ascertained via mid-study phone interviews and end-of-study feedback questionnaires. Analyses focused on descriptive estimates of likely recruitment, retention, and adherence rates, and documentation of potential barriers.

In total, 47 chiropractors (12%) agreed to participate and were randomized after resampling. Fifteen withdrew from the study, leaving a total of 32 (8%) participants. Eleven chiropractors in the intervention group completed the webinars and e-learning modules, two partially completed them and three did not register. Participating chiropractors recruited a total of 29 patients. Sixty-three percent (n = 7) of intervention and 56% (n = 10) of control group patients completed all outcome measures at both baseline and 3-months follow-up, attended follow-up visits and performed home exercises. Patients in the intervention group reported significant reductions in pain (mean 1.6, 95% CI 0.26–2.94, P = 0.027) and disability scores (9.8, 95% CI 3.68–15.91, P = 0.033) from baseline to 3-month follow-up. Key barriers to participation reported by chiropractors included lack of time, difficulties in recruiting patients, problems with the administration of study questionnaires, concern that the clinician-patient relationship might be jeopardized, and lack of assistance from office staff. Over half (55%) of the respondents in the intervention group encountered some difficulty registering or completing the educational modules.

Recruitment of clinicians and patients for a trial of a complex intervention can be challenging, and retention of participants after enrolment may be low. Future trials of this nature likely require multiple recruitment strategies to achieve desired sample sizes. Moreover, time-constraint issues are perceived particularly by clinicians as a major barrier to both study enrolment before, and protocol adherence during, their actual participation in a trial.

The study was registered at, NCT02483091, on 17th June 2015.

The online version of this article (10.1186/s12998-019-0253-z) contains supplementary material, which is available to authorized users.

• Adherence
• Chiropractic
• Feasibility studies
• Interviews
• Knowledge translation
• Multifaceted intervention
• Pilot projects
• Randomized controlled trial
• Recruitment
• Retention

• Exercise
• Knee Joint
• Patellofemoral Pain Syndrome
• Physical Therapy Modalities
• Postural Balance

• Activities of Daily Living
• Arthralgia/therapy
• Cost-Benefit Analysis
• Exercise Therapy/adverse effects
• Exercise Therapy/economics
• Exercise Therapy/methods
• Humans
• Ontario
• Osteoarthritis, Knee/therapy
• Quality of Life
• Technology Assessment, Biomedical

This study was aimed to investigate the effect of localized vibration on sensory thresholds in mice and humans using a novel quantitative method.

The sensory thresholds of 7-week-old male C57BL/6J mice were measured with four sine-wave electrostimulation frequencies (5, 50, 250, and 2,000 Hz) before and after applying 2-minute vibration to the plantar side of the foot in mice. In human participants (16 males and 16 females; mean age, 21.0±0.8 years), the sensory threshold was measured at 50 Hz before and after applying 2-minute and 5-minute vibrations to the dorsal side of the foot.

Application of a 2-minute vibration at either the ipsilateral or contralateral side modulated the sensory thresholds elicited by a 5- or 50-Hz right electrostimulation in mice. In human participants, application of a 5-minute vibration at either the ipsilateral or contralateral side modulated the sensory threshold elicited by 50-Hz right electrostimulation, but had no effect on local skin temperature. These results suggest that the right side of pain-related Aδ fibers (50 Hz) or C fibers (5 Hz) was modulated by the localized ipsilateral or contralateral side of vibratory stimuli, respectively, in mice and humans.

The ability of contralateral vibration to modify the right sensory thresholds suggests possible involvement of the central nervous system in vibratory modulation.

• central modulation
• electrostimulation
• sensory threshold
• vibration

• Exparel
• liposomal bupivacaine
• pain control
• periarticular injection
• ropivacaine
• total knee arthroplasty

• disability
• health-related quality of life
• questionnaires
• rehabilitation

• hip
• knee
• postoperative pain
• total joint arthroplasty
• visual analog scale

• amyotrophic lateral sclerosis
• motor neurone disease
• patient reported outcome measures
• quality of life
• spasticity

• Chronic pain
• Methodology
• Minimum clinically important difference
• Pain
• Pain assessment
• Systematic review

• Dysmenorrhea
• Endometriosis
• Minimal important difference
• Pain
• Quality of life
• VAS-scale

• Adult
• Anesthetics, Local/therapeutic use
• Dysmenorrhea/drug therapy
• Dysmenorrhea/etiology
• Endometriosis/complications
• Female
• Humans
• Lidocaine/therapeutic use
• Minimal Clinically Important Difference
• Pain Measurement
• Pelvic Pain/drug therapy
• Pelvic Pain/etiology
• Prospective Studies
• Quality of Life
• Surveys and Questionnaires

The early post-operative course after hip arthroscopy for femoroacetabular impingement syndrome has not been thoroughly characterized or correlated to factors that may influence recovery. The aim of this study was to report on early pain, function and attitudes towards rehabilitation and to determine predictors of early recovery after hip arthroscopy. Sixty-two patients reported pre-operative pain, iHOT-12 (hip functional score), psychological status and other baseline characteristics. Pain, iHOT-12, hip flexion and several other outcomes were measured through 6 weeks post-operative. Baseline characteristics were correlated with outcomes using univariate and multivariable models. Pain relief started on post-operative day 1 and consistently improved throughout the 6 weeks of follow-up. The average patient’s pain was reduced from a pre-operative level of 5/10 to 2/10 by 6 weeks post-operative. Similarly, iHOT-12 improved from 33/100 to 57/100 whereas hip flexion increased by 9° by 6 weeks post-operative. At 2 weeks post-operative, pre-operative anti-inflammatory usage was associated with greater improvement in pain and swelling; pre-operative opioid usage with poorer patient-reported helpfulness of and adherence to rehabilitation; and higher ASA (American Society of Anesthesiologists) score and lower procedure time with improvement of the pre-operative pain complaint. At 6 weeks, greater depression was associated with lower post-operative pain reduction but greater pre-operative pain complaint improvement. Continuous passive motion usage was associated with increased hip flexion. Pain improved from pre-operative by Day 1 after hip arthroscopy, and early functional improvements were seen by 6 weeks post-operative. Pre-operative anti-inflammatory and opioid usage, depression, race, ASA score, procedure time and continuous passive motion usage were significantly associated with study outcomes.

• TL1 TR001116 NCATS NIH HHS

• Analgesia
• TENS
• chronic low back pain
• physiotherapy