Primary Patient-reported Outcome Measure Research Articles

Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Effect of thoracolumbar fascia injury on reported outcomes after percutaneous vertebroplasty.

Thoracolumbar fascia injury is often associated with poor early pain relief after percutaneous vertebroplasty (PVP). This study will evaluate the effects of thoracolumbar fascia injury on early pain relief and time to get out of bed after PVP. A total of 132 patients treated with PVP for osteoporotic vertebral compression fractures (OVCF) were included and divided into injured group (52 cases) and non-injured group (80 cases) according to the existence of thoracolumbar fascia injury. Before surgery, 1 day, 3 days, 1 week, 1 month, and 3 months after surgery, and at the last follow-up, the primary patient-reported outcome measures (PROMs) were the visual analogue scale (VAS) of pain while rolling over and standing, and the secondary PROMs was the Oswestry disability index (ODI). Meanwhile, the achieved rate of minimal clinically important differences (MCID) and patient acceptable symptom states (PASS) of the above measures in both groups was evaluated at the last follow-up. Except for the postoperative 3 months and the last follow-up, there were statistically significant differences in VAS-standing and ODI between the two groups at other time points after surgery (P < 0.05), and the non-injured group was significantly better than the injured group. At the last follow-up, there was no statistically significant difference in the MCID and PASS achievement rates of the above measures between the two groups (P > 0.05). In addition, the proportion of patients who got out of bed 1 and 3 days after surgery in the non-injury group was significantly higher than that in the injury group (P = 0.000 for both). Thoracolumbar fascia injury significantly affected early pain relief and extended time of getting out of bed after PVP. Attention should be paid to preoperative evaluation of thoracolumbar fascial injury in order to better predict the postoperative efficacy of PVP.

Patient-Reported Outcome Measures following Coblation Nucleoplasty for Cervical Discogenic Dizziness

Background: There is little research in the literature comparing the efficacy of coblation nucleoplasty with conservative treatment in the treatment of cervical discogenic dizziness and reporting the achieved rate of minimal clinically important differences (MCID) and patient acceptable symptom state (PASS) after surgery. This retrospective study aims to explore the patient-reported outcome measures (PROM) following coblation nucleoplasty for cervical discogenic dizziness and to compare the therapeutic effect of coblation nucleoplasty with prolonged conservative treatment. Methods: Sixty-one patients with cervical discogenic dizziness and a positive intradiscal diagnostic test eligible for single-level cervical coblation nucleoplasty were included in the study. Among these 61 patients, 40 patients underwent cervical coblation nucleoplasty, while the remaining 21 patients refused surgery and received continued conservative treatment. The primary PROMs were the intensity and frequency of dizziness and secondary PROMs were related to the neck disability index (NDI) and visual analog scale (VAS) for neck pain (VAS-neck) during a 12-month follow-up period. Moreover, the achieved rate of MCID and PASS in both groups was assessed 12 months after surgery. Results: Dizziness intensity, dizziness frequency, VAS-neck score, and NDI score were significantly improved from the baseline at all follow-up time points in both treatment groups, except for showing no significant improvement in dizziness frequency in the conservative treatment group at 6 and 12 months after surgery. However, at each follow-up time point, the above indexes were lower in the surgery group than in the conservative treatment group. In addition, the achieved rates for PASS and MCID in all indexes in the surgery group were significantly higher than those in the conservative treatment group at 12 months after surgery. Conclusions: Cervical coblation nucleoplasty significantly improved the intensity and frequency of dizziness, neck pain, and NDI in patients with cervical discogenic dizziness, and the results were superior to those from prolonged conservative treatment. Meanwhile, cervical coblation nucleoplasty is a good choice for patients with chronic neck pain and refractory cervical discogenic dizziness who have not demonstrated the indications for open surgery and have not responded well to conservative treatment.

Chronic low back pain: a prospective study with 4 to 15 years follow-up after a multidisciplinary biopsychosocial rehabilitation program

BackgroundMultidisciplinary biopsychosocial rehabilitation (MBR) in patients with chronic low back pain (CLBP) is superior to less intensive treatments for at least one year, but the long-term course of the disease is largely unknown. The primary aim of this study was to describe the long-term course of an MBR in relation to pain, disability, and quality of life from the beginning of an MBR to between 4 to 15 years after participation. The secondary aim was to explore the long-term course of an MBR in relation to physiological outcomes of functioning.MethodsThis was a observational study conducted at a university hospital. The cohort consisted of participants of a 3-week, CLBP-specific MBR program between August 2001 and January 2013. The North American Spine Society questionnaire (NASS) pain and disability scale was the primary patient -reported outcome measure (PROM). The NASS neurogenic symptoms scale and the Short-Form 36 (SF-36) health survey were secondary PROMs. Patients were assessed before entry to the MBR (T0), at entry (T1), at discharge (T2) and 4 to 15 years after discharge (T3). Effects were quantified by effect size (ES). Score differences were tested for significance using parametric or non-parametric tests and linear mixed models.ResultsOf 299 consecutive patients from the MBR program, 229 could be contacted. Of these, 84 declined participation, five did not meet the inclusion criteria, and 26 had incomplete data. Thus, 114 patients were included. The mean follow-up time was 9.2 years. At T3, patients exhibited beneficial effects for NASS pain and disability with a moderate ES (ES = 0.63; p < 0.001). The NASS neurogenic symptoms scale was stable. The SF-36 scales showed an improvement in the bodily pain domain (ES = 1.02; p < 0.001), but no significant changes for physical functioning, physical role, general health, vitality, social functioning, emotional role, or mental health. The physical health component summary was improved (ES = 0.40, p = 0.002), and the mental health summary was unchanged. The linear mixed model analysis confirmed improvements in pain and disability between T1 and T3 (p = 0.010).ConclusionsThe results of this study suggest that there is a long-term benefit of MBR participation in patients with CLBP.

Conservative interventions and clinical outcome measures used in the perioperative rehabilitation of breast cancer patients undergoing mastectomy: a scoping review

BackgroundMastectomy is the first-line treatment approach for more than 90% of breast cancer patients. The numerous physical impairments associated with this surgical procedure negatively impact the patient’s quality of life. To date, rehabilitation resources available for breast cancer patients undergoing mastectomy within the institutions affiliated to the Centre intégré universitaire de soins de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS-MCQ) are lacking and do not always seem to reflect the particularities of breast cancer care pathways. The purpose of this review was to identify and describe the conservative interventions and the clinical outcome measures used in the perioperative physical rehabilitation of women with breast cancer who are awaiting or have undergone mastectomy. We also aimed to report on the barriers and facilitators to study participation and completion.MethodsMEDLINE, CINAHL, and the Cochrane Library were searched from inception to January 2021, and we updated the search on July 11, 2022. We included peer-reviewed English and French literature with quantitative designs, describing conservative interventions and clinical outcome measures used within rehabilitation programs designed for women who were awaiting or had undergone mastectomy. Paired reviewers independently reviewed all citations and articles using a two-phase screening process and independently extracted the data.ResultsOf the 6080 articles identified, 57 met the inclusion criteria. Most interventions were multimodal, which combined exercise with patient education, manual therapy, and/or lymphatic drainage. The most frequently used objective measures of physical function were shoulder range of motion, muscle strength, and signs of lymphedema. In contrast, the primary patient-reported outcome measures were quality of life, shoulder function, and pain. Undergoing another breast surgery, death, and cancer recurrence were the most reported barriers to study completion.ConclusionThis scoping review reports on the heterogeneity and wide range of conservative interventions and clinical outcome measures used in the physical rehabilitation of breast cancer patients who had undergone or were scheduled to undergo mastectomy. Tailoring interventions to breast cancer patients’ needs and promoting outpatient rehabilitation interventions appear to be better suited to the particularities of breast cancer care pathways. Further research is needed to better identify barriers and facilitators to study participation and completion.

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial.

The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making.

Comparing the responsiveness of a generic and a musculoskeletal specific functional outcome measure in orthopaedic patients with operative fixation of pelvic ring, acetabulum, or tibia fractures: a comparison between single injury and multiply injured patients.

Objectives:This study compares the responsiveness, or the ability to detect clinical change in a disease, between the generic Short Form-36 (SF-36) and musculoskeletal specific Short Musculoskeletal Functional Assessment (SMFA) patient-reported outcome measures (PROMs) in the orthopaedic trauma population. Stratified analysis was performed to compare whether responsiveness differs between patients with single or multiple orthopaedic injuries.Design:Prospective case series.Setting:Level 1 Trauma Center.Patients:A total of 659 patients with orthopaedic trauma injuries to the pelvis, acetabulum, or tibia were included for analysis. There were 485 patients with a single isolated injury and 174 patients with multiple orthopaedic injuries.Intervention:None.Main Outcome Measurements:Responsiveness was calculated through the standard response mean (SRM), the proportion meeting a minimal clinically important difference, and floor and ceiling effects.Results:Between baseline and 6 months the magnitude of the SRM for SF-36 was consistently greater than that of SMFA in patients with single (P < .01) and multiple injuries (P < .01). Between 6 and 12 months, there were no differences in SRM across all cohorts. The proportion of patients who achieved minimal clinically important difference was consistently higher when assessed with SF-36 compared with SMFA between baseline and 6 months (81.8% vs 68.1%, P < .0001) and between 6 and 12 months (63.3% vs 55.4%, P = .01).A ceiling effect was only observed at baseline for the SMFA with 16.6% of patients achieving the maximal level of functioning detectable. No floor effects were seen in either PROM.Conclusion:This study demonstrates that SF-36 has superior responsiveness versus SMFA in both polytrauma and isolated injury patients and supports the collection of SF-36 as the primary PROM in prospective orthopaedic trauma studies irrespective of whether the patient has an isolated injury or multiple injuries.

Hip Arthroscopy for Femoroacetabular Impingement in Adolescents: 10-Year Patient-Reported Outcomes

Background: Previous studies have demonstrated hip arthroscopy to be an effective treatment for femoroacetabular impingement (FAI) in individuals 18 years of age and older. Long-term outcome data in the adolescent population, however, are limited. Purpose: To report 10-year outcomes after hip arthroscopy in adolescents with symptomatic FAI. Study Design: Case series; Level of evidence, 4. Methods: Prospectively collected data were analyzed on adolescent patients younger than 18 years of age who had hip arthroscopy between March 2005 and 2009 with a minimum 10-year follow-up. Patients were included if they were diagnosed with symptomatic FAI and an associated labral tear that was treated with repair. Patients were excluded if they had previous hip procedures, acetabular dysplasia (lateral center-edge angle, <20°), avascular necrosis, previous hip fracture or dislocation, or Legg-Calve-Perthes disease, or refused to participate. The primary patient-reported outcome measure was the Hip Outcome Score (HOS) Activities of Daily Living (ADL) subscale. In addition, the HOS—Sport, modified Harris Hip Score (mHHS), 12-Item Short Form Health Survey (SF-12), and patient satisfaction were collected. Failure was defined as patients having to undergo revision arthroscopy. Results: There were 60 patients (70 hips) who met inclusion criteria and had a 10-year follow-up. The mean age of the cohort was 16 ± 1.2 years, with 21 male and 49 female hips. Seven hips (10%) required revision hip arthroscopy. All revisions occurred in female patients and were associated with global laxity as well as longer duration of symptoms before time of surgery. At a mean follow-up of 12 years (range, 10-14 years), patients who did not undergo revision surgery had significant improvements from preoperatively to postoperatively in HOS-ADL (from 64 to 92; P < .01), HOS–Sport (from 40 to 86; P < .01), mHHS (from 56 to 88; P < .01), and SF-12 Physical Component Summary (from 41 to 54; P < .01). The median patient satisfaction was 10 out of 10 (very satisfied). Conclusion: Hip arthroscopy for FAI with labral repair resulted in excellent patient-reported outcomes and satisfaction at a minimum of 10 years of follow-up. There was a 10% rate of revision surgery, which was associated with global laxity and longer duration of symptoms before surgery, which should be considered in patient selection.

Real-World Effectiveness of Physical Therapy for Common Neck Pain Diagnoses: A Multivariate Analysis of 1554 Patients.

Retrospective cohort study (Level of evidence-3). The objective of this study was to investigate the real-life effectiveness of physical therapy (PT) for patients initially presenting with common neck pain diagnoses. Neck pain is a common cause of morbidity and a leading cause of disability in the United States. PT is prescribed as a first-line treatment for the vast majority of patients with neck pain; however, there is limited literature supporting the effectiveness of these treatments. A total of 1554 patients enrolled in PT for the nonoperative treatment of neck pain were included in the study. Three primary patient-reported outcome (PRO) measures [neck disability index (NDI), resting numeric pain rating scale (NPRS), and activity NPRS] were recorded before and at conclusion of therapy. Improvement was noted if patients met a threshold value for a minimal clinically important difference (MCID). Bivariate analysis using a χ test and multiple logistic regression analysis were performed to determine risk factors predictive of treatment failure. About 40.5% of patients achieved MCID for NDI with an average change of -6.31 points. For resting NPRS and activity NPRS scores, 50.6% and 52.1% of patients achieved MCID with an average change of -1.93 and -2.36, respectively. After multiple logistic regression analysis, worker's compensation status was found to be an independent predictor for treatment failure in all groups; whereas, Medicare status was found predictive of achieving MCID in the activity NPRS group. We observed that up to half of the patients analyzed met the minimum criteria for improvement in neck pain with respect to the PRO measures, suggesting that real-life effectiveness of PT for common neck pain diagnoses may approach 50%.

Superior Clinical Outcomes with Capsular Closure versus Non-Closure in Patients Undergoing Arthroscopic Hip Labral Repair

Objectives:Controversy still exists on closing the capsule following hip arthroscopy. It is unclear if capsular closure at the end of hip arthroscopy results in better clinical outcomes compared to non-closure. The purpose of this study was to compare the clinical outcomes in patients who had a closed capsule to those without a closed capsule following hip arthroscopic labral repair by a single surgeon.Methods:Patients who did not have capsular closure were identified by reviewing arthroscopy video (non-closure group). Fifty consecutive patients without capsular closure were matched with fifty patients who had capsular closure. All patients underwent primary hip arthroscopy and labral repair. The primary patient-reported outcome measure was Hip Outcome Score(HOS)-ADL. Secondary outcome measures included the modified Harris hip score(MHHS), HOS-Sport, WOMAC, general health, and patient satisfaction with outcome. Patients with lateral center edge angle less than 25º were excluded.Results:There were 23 females and 27 males with an average age of 36 years (range:14 to 77) in each group. The average lateral center edge angle was 34º (range, 27 to 48) in both groups. The alpha angle was 68º (range, 40 to 134) in the non-closure group and 70º (range, 41 to 98) in the closure group. No patient had microfractures at the time of surgery. The average follow-up time was 5 years (non-closure group range: 3-10; closure group range 3-9). Eight patients (16%) in the non-closure group required total hip arthroplasty(THA), while 4 patients (8%) in the closure group required THA. Six patients in the non-closure group and 3 patients in the closure group required revision hip arthroscopy. Of those patients who did not require revision or THA, there was a significant difference in the HOS ADL score and the secondary outcome measures (see table). Capsular closure resulted in superior clinical outcomes compared to non-closure.Conclusion:There were twice as many conversion to THA and twice as many hip arthroscopy revisions in patients undergoing hip arthroscopic labral repair without capsular closure compared to those with closure. In addition, the closure group showed significantly higher outcomes scores compared to the non-closure at 5-year follow-up time.Mid-term follow-up outcome scores in closure and non-closure groupOutcome scoreWithout closureWith closurep valueSF12 PCS50.0 SD 1054.2 SD 5.90.04SF12MCS50.9 SD 9.754.3 SD 7.30.11HOS ADL83.9 SD 1490.4 SD 8.80.02HOS SPORT72.4 SD 2686 SD 180.006WOMAC11.6 SD 16.27.1 SD 8.40.067Modified Harris Hip Score81.5 SD 16.690.1 SD 110.016Patient Satisfaction with Outcome (median, range)9.5 (1 to 10)10 (3 to 10)ns