Evaluation Of Patient-reported Outcome Measures Research Articles

Palliative single-level selective dorsal rhizotomy for children with spastic cerebral palsy Gross Motor Function Classification System level IV and V: a case series and systematic review of the literature.

Single-level selective dorsal rhizotomy (SDR), typically indicated for ambulatory patients, is a controversial topic for severe spastic cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level IV or V. The objective of this case series and systematic literature review was to outline the indication and outcome of palliative SDR for nonambulatory patients with CP and GMFCS level IV and V, focusing on improvement of spasticity and of patient and caregiver reported quality of life assessment. A retrospective case series of patients with CP and GMFCS level IV or V who underwent single-level SDR at the authors' institution is presented. Furthermore, two databases (PubMed and Embase) were searched and a systematic review with a search string based on the terms "selective dorsal rhizotomy," "cerebral palsy," and "outcome" was conducted. The primary outcome was the reduction of spasticity based on the modified Ashworth scale (MAS). Secondary outcomes were change on the Gross Motor Function Measure-66 (GMFM-66), evaluation of patient-reported outcome measures (PROMs), surgical morbidity, and mortality. Eleven consecutive children under the age of 25 years undergoing palliative single-level SDR were included. All patients showed a reduction in MAS score (mean 1.09 ± 0.66 points) and no surgical morbidity and mortality occurred. For the systematic review results from our case series, in addition to 4 reports, 274 total patients were included. Reduction of spasticity based on MAS score was noted in all studies (mean range 1.09-3.2 points). Furthermore, in 2 studies spasticity of the upper extremities showed a MAS score reduction as well (range 1.7-2.8 points). The GMFM-66 score improved in 72% of the patients, while bladder function improved in 78% of the patients. Based on the PROMs, 92% of the patients/caregivers were satisfied with the outcome and their quality of life after the procedure. Two wound infections (2.7%) and one CSF leak (1.3%) occurred, while no surgery-related deaths were described. This analysis showed an improvement in spasticity, daily care, and comfort for patients with CP and GMFCS levels IV and V. Larger cohorts analyzing the outcome of palliative single-level SDR, based on the MAS, GMFM-66, and PROMs, are still needed and should be the focus of future studies. Systematic review registration no.: CRD42024495762 (https://www.crd.york.ac.uk/prospero/).

Supportive and palliative care needs in advanced non-malignant liver disease: systematic review

Advanced cirrhosis confers a significant symptom burden and has a 50% 2-year mortality rate in those with decompensated disease. There is increasing demand for supportive and palliative care (SAPC) for...

Evaluation of Patient-Reported Outcome Measures (PROMs) Associated With the Acceleration of Canine Retraction by Piezosurgery in Comparison With Low-Level Laser Therapy: A Three-Arm Randomized Controlled Clinical Trial.

Background and objectives Recently, both surgical and non-surgical interventions have gained popularity in accelerating orthodontic tooth movement, but there is no randomized controlled trial (RCT) comparing both modalities in terms of patient-reported outcome measures (PROMs) during maxillary canine retraction. Therefore, this trial aimed to assess the PROMs associated with either low-level laser therapy (LLLT) or piezocision-assisted acceleration in the context of maxillary canine retraction. Materials and methods This was a single-blinded, single-center, three-arm RCT. A total of 54 patients (12 males, 42 females, mean age 20.65 ± 2.85) whose treatment needed upper-first-premolar extraction to facilitate canine retraction were enrolled and randomly divided into three groups: piezocision group (PG), LLLT group (LLLTG), and the control group (CG). Standardized questionnaires using a visual analog scale were distributed to patients at five assessment times: 1 (T1), 3 (T2), 7 (T3), 14 (T4), and 28 days following the canine retraction initiation (T5). The patients' pain, discomfort, swelling, chewing difficulty, satisfaction, and acceptance were recorded. Results Regarding pain and discomfort, the levels were significantly lower in the LLLTG during the first two weeks of canine retraction compared to the other two groups (p<0.017). At the same time, these levels were significantly greater in the PG than the CG in the first week of canine retraction (p<0.017). Patients in the PG had a "mild to moderate" perception of swelling at T1 and T2, which was significantly different than that of the other two groups (p<0.001). Regarding chewing difficulty, the levels in the LLLTG were significantly lower than those in PG at the first three assessment times (p<0.017). Patients' satisfaction with canine speed was significantly greater in the intervention groups compared to the CG (p<0.001). In contrast, no statistically significant differences were found between the three groups regarding satisfaction with gum appearance surrounding the canine (p=0.061) and acceptance (p=0.125). Conclusion The LLLT-assisted canine retraction was associated with significantly lower negative patient-reported outcomes during the first two weeks of retraction than piezocision-assisted retraction. However, the levels of pain and discomfort were significantly greater in the piezocision-assisted retraction group than those in the conventional canine retraction group, which in turn were greater than those with the LLLT-assisted canine retraction group during the first week of retraction. Patient satisfaction and acceptance were high with both piezocision and LLLT interventions.

An Evaluation of Patient-reported Outcome Measures and Minimal Clinically Important Difference Usage in Hand Surgery.

This study was designed to examine the current use of patient-reported outcome measures (PROMs) and minimal clinically important difference (MCID) calculations in the hand surgery literature in an effort to standardize their use for research purposes. A systematic review of the hand surgery literature was conducted. All nonshoulder upper extremity articles utilizing PROMs were compared between different journals, different surgical indications, and differing usage. MCID values were reported, and calculation methods assessed. In total, 4677 articles were reviewed, and 410 met the inclusion criteria of containing at least one PROM. Of the 410 articles reporting PROMs, 148 also mentioned an associated MCID. Of the articles that mentioned MCIDs, 14 calculated MCID values based on their specific clinical populations, whereas the remainder referenced prior studies. An estimated 35 different PROMs were reported in the study period; 95 different MCID values were referenced from 65 unique articles. There are many different PROMs currently being used in hand surgery clinical reports. The reported MCIDs from their related PROMs are from multiple different sources and calculated by different methods. The lack of standardization in the hand surgery literature makes interpretation of studies utilizing PROMs difficult. There is a need for a standardized method of calculating MCID values and applying these values to established PROMs for nonshoulder upper extremity conditions.

Challenging the Status Quo: Debunking the Necessity of 5-Year to 10-Year Patient-Reported Outcome Measures in Total Hip and Knee Arthroplasties

BackgroundIn the current shift toward value-based healthcare, patient-reported outcome measures (PROMs) have become essential to assess the effectiveness of medical interventions. However, elucidation of the optimal timeframe for PROMs evaluation remains crucial. This study aimed to (1) determine the proportion of patients who experienced clinically meaningful improvements in PROMs scores at each follow-up visit after total hip arthroplasty (THA) and total knee arthroplasty (TKA) and (2) calculate and apply the clinical relevance ratio (CRR) for these long-term PROM collections postoperatively. MethodsA total of 12 independent studies reporting THA (n = 8 studies) and TKA (n = 4 studies) postoperative PROM data with up to 10 years of follow-up in Europe or the United States were aggregated. A distribution-based minimal clinically important difference threshold and CRR were used to determine which patients had clinically meaningful improvements in PROMs at 1, 5, and 10 years. ResultsThe proportion of patients who had clinically meaningful improvements in PROM scores stabilized after 1 year following both THA and TKA. Overall, the CRR decreased over time for all PROMs, with the CRR beginning to decrease at 1-year follow-up, bringing into question the robustness and clinical relevance of long-term PROMs data. ConclusionsThe present study challenges the utility of requiring PROMs with a minimum follow-up of 2 years for THA and TKA. Research efforts should be focused on registries evaluating implant survivorship at longer-term follow-up, while PROMs should be better assessed up to 1-year follow-up. Reconsidering the long-term PROMs assessment would lead to more efficient and cost-effective research in orthopedic outcomes, without compromising data quality.

Evaluation of patient-reported outcome measures in burn-specific tools: A systematic review

IntroductionPatient-reported outcome measures (PROMs) are now well-established tools to evaluate the quality of patient-centred care. Due to the multi-faceted and multi-disciplinary nature of the practice of burn care, as well as the range of significant potential sequelae, PROM’s should form a fundamental component of burn quality improvement programs. We aim to 1. Explore biological, psychological, and social considerations that are currently listed in burn-specific PROM tools, as well as their efficacy, 2. Evaluate biological, psychological, and social factors that are considered in new burn-specific PROM tools or those under development, and 3. Identify any opportunities with respect to burn-specific PROM tools, in order to inform future investigation in this area. MethodsA search was performed of MEDLINE (Ovid), EMBASE, CINAHL, and the Cochrane Library databases. Two independent reviewers screened article titles/abstracts and then the full texts using Covidence. All studies were graded independently according to the Quality Rating Scheme for Studies and Other Evidences. ResultsThe initial search yielded 552 references. Based on ab initio inclusion and exclusion criteria, 133 full-text studies were assessed for eligibility, and 21 articles were ultimately included in the systematic review. Due to study heterogeneity, a qualitative synthesis was conducted. Existing burn-specific PROMs covered a range of biological, psychological, and social factors affecting adult and paediatric patients with burn injury, but several studies required additional PROMs for a thorough evaluation. Burn-specific PROM tools under development are poised to fill this deficit. ConclusionMajor burn injuries are a unique form of trauma, requiring coordinated management that considers numerous factors not relevant to other patient populations. Further research is necessary to validate existing burn-specific PROM tools and to develop more comprehensive burn-specific PROM measures that more comprehensively incorporate the bio-psycho-social model of health.

Evaluation of Patient-Reported Outcome Measures in Patients Receiving Bio-Integrative Screws for Lisfranc Injuries: A Case Series Study

Category: Midfoot/Forefoot; Midfoot/Forefoot Introduction/Purpose: Lisfranc injury consists of a spectrum of injuries affecting the tarsometatarsal joint. Various fixation methods are used to treat Lisfranc injuries and each show different outcomes. Metal implants have been used for open reduction and internal fixation (ORIF) of Lisfranc injuries routinely. However, other than the complications in these patients, such as non- anatomical reduction, implant loosening, breakage, and arthrosis, most of these patients will undergo a second surgery for implant removal. Using bio-degradable and bio-integrative materials in these implants reduces the need for these re-operations; however, whether other complications reported for metal implants occur by using bio-integrative materials has yet to be proven. The aim of our study is to assess patient-reported outcome measures (PROMs) and complications in patients received bio-integrative screws for Lisfranc fixation. Methods: The inclusion criteria were 1) ≥ 18 years old, and 2) had ORIF for Lisfranc injury using bio-integrative (OSSIOfiber ™) screws. The patients’ charts were reviewed, and the variables were gathered, including the type of injury, pain score, and PROMs. The questionnaires used to evaluate PROMs were Patient-Reported Outcome Measurement Information System (PROMIS) surveys for physical function, pain interference, pain intensity, and depression. We also reported the average scores for these PROMs among a randomly sampled population of patients who had ORIF with metal screws for Lisfranc injuries for comparison (n=12). Results: We recruited 12 patients for this study. The minimum follow-up time of the patients in this study was three months. Out of 12 patients, 1 patient showed non-union. The mean (SD) PROMIS scores for physical function, pain interference, pain intensity, and depression were 43.9 (14.9), 56.1 (13.9), 45.9 (10.1), and 43.5 (4.9) in patients who received bio-integrative screws, respectively. In the sampled population treated with metal screws, these PROMs were 42.1 (9.5), 55 (10.1), 46.4 (8.1), and 44.4 (6.4) for physical function, pain interference, pain intensity, and depression, respectively. No significant difference was observed between the two groups regarding physical function (P=0.72), pain interference (P0.82), pain intensity (P=0.88), and depression (P=0.69). Conclusion: The current report showed promising patient-reported outcomes after Lisfranc ORIF with bio-integrative screws. However, longer term follow-ups, as well as comparison with a larger population for both types of instruments, bio-integrative and metal, will shed light on the pros and cons of both materials. Moreover, cost-effective studies are highly suggested to assess the usefulness of these implants against their costs for the healthcare system and the patients.

Evaluation of patient-reported outcome measures for on-demand treatment of hereditary angioedema attacks anddesign of KONFIDENT, a phase 3 trial of sebetralstat.

Hereditary angioedema (HAE) with C1-inhibitor deficiency (HAE-C1-INH) is characterized by recurrent, debilitating episodes of swelling. Sebetralstat, an investigational oral plasma kallikrein inhibitor, demonstrated promising efficacy for on-demand treatment of HAE-C1-INH in a phase 2 trial. We describe the multipronged approach informing the design of KONFIDENT, a phase 3 randomized, placebo-controlled, three-way crossover trial evaluating the efficacy and safety of sebetralstat in patients aged ≥12years with HAE-C1-INH. To determine an optimal endpoint to measure the beginning of symptom relief in KONFIDENT, we engaged patients with HAE on clinical outcome measures and subsequently conducted analyses of phase 2 outcomes. Sample size was determined via a simulation-based approach using phase 2 data. Patient interviews revealed a strong preference (71%) for the Patient Global Impression of Change (PGI-C) over other measures and indicated a rating of "A Little Better" as a clinically meaningful milestone. In phase 2, a rating of "A Little Better" demonstrated agreement with attack severity improvement and resolution on the Patient Global Impression of Severity and had better sensitivity than "Better." Simulations indicated that 84 patients completing treatment would ensure at least 90% power for assessing the primary endpoint of time to beginning of symptom relief defined as a PGI-C rating of at least "A Little Better" for two time points in a row. Patient feedback and phase 2 data support PGI-C as the primary outcome measure in the phase 3 KONFIDENT trial evaluating sebetralstat, which has the potential to be the first oral on-demand treatment for HAE-C1-INH attacks.

Two-stage revision in periprosthetic joint infection of the hip using a new intraoperatively molded articulating spacer design

PurposeThe treatment of periprosthetic joint infection (PJI) after total hip arthroplasty (THA) is still under debate. Two-stage exchange arthroplasty is the most common surgical procedure performed. This study analyzed a new functional articulating hip spacer called "Spaceflex" regarding the mechanical-related complications, the recurrent/persistent infection during the interval period, the overall infection-free survivorship after reimplantation, the overall complication/reoperation after reimplantation and the evaluation of patient-reported outcome measures (PROMs) at three intervals of time: before the first stage, during the interval period, and at the final follow-up after reimplantation. MethodsA consecutive series of 56 patients with chronic hip PJI undergoing two-stage prosthetic revision using a new intraoperatively molded articulating hip spacer design implanted by the same experienced surgeons was examined from January 2017 to December 2021. The demographic and clinical characteristics of the included patients were analyzed. Specifically, PROMs before the first stage, during the interval period, and at the final follow-up after reimplantation and complications reported during the interval period and after reimplantation were examined. ResultsThe new functional articulating hip spacer was characterized by a low mechanical complication rate (5.8%) and an overall two-stage procedure success rate of 90.6% at the last follow-up. PROMs improved with the spacer during the interval period and at the final follow-up. Furthermore, the reinfection rate was in line with other case series with different spacer designs. Finally, low postoperative complication rates after reimplantation have been demonstrated. ConclusionsTwo-stage revision performed with a modular articulating spacer allows patients to preserve satisfactory functional and quality-of-life outcomes in the postoperative period, with a low risk of mechanical complications and without increasing the reinfection rate.

41. Patient Reported Outcome Measures (PROMs) in Zygomatic Fracture Surgery – What do patients want?

Whilst patient safety and clinical effectiveness are intrinsic to the traditional measurement of successful healthcare, Patient Reported Outcome Measures (PROMs) are increasingly being advocated as an important tool to uphold patient-centric care in the NHS. The aim of this study is to complete the first evaluation of PROMs in patients receiving surgical management of zygomatic fractures.

Redefining Disability: Patient-Reported Outcome Measures After Minor Stroke and Transient Ischemic Attack.

Long-term outcome assessment patients with stroke is not fully captured by usual clinical scales such as the modified Rankin Scale (mRS). Patient-reported outcome measures (PROMs) are standardized and validated assessments that consider clinical outcomes from the patient perspective. We aim to analyze the added value of PROMs in patients with transient ischemic attack and minor stroke. We included consecutive patients with minor stroke or transient ischemic attack (National Institutes of Health Stroke Scale score 0-5) from April 2020 to October 2021 that participated in the PROMs-through-App program (NORA, NoraHealth Barcelona Spain). Clinician and self-evaluated outcomes were assessed at 90 days: clinician-evaluated mRS, self-reported mRS, the 10-item patient-reported outcome measures questionnaire global health survey (v1.2), Hospital Anxiety and Depression Scale, and the Fatigue Assessment Scale. We evaluated the acceptability (response rate), reliability (internal consistency), and construct validity (correlation with mRS and between scales) of each questionnaire. We included 355 patients in the analysis, response rate was patient-reported outcome measures questionnaire 71.3% (253), Hospital Anxiety and Depression Scale 70.7% (251), Fatigue Assessment Scale 71.8% (255), and self-assessed mRS 66.8% (237). PROMS internal consistency was good or excellent, while agreement between clinician and self-reported mRS was fair (k=0.34). Rate of abnormal PROMS scores were as follows (all responders versus clinician-reported mRS score 0-2): patient-reported outcome measures questionnaire mental health (43.1% versus 36.3%), physical health (48.6% versus 43.6%); Hospital Anxiety and Depression Scale-anxiety (21.9% versus 17.7%) and depression (17.1% versus 13.3%); and Fatigue Assessment Scale (40.8% versus 36.4%). PROMs scores correlated with clinician and self-reported mRS at 90 days. Evaluation of PROMs using a mobile-app-based communication system is a reliable and valid strategy to assess the outcome of patients from their perspective after a mild stroke or transient ischemic attack.

Patient-reported outcomes and morbidity after head and neck reconstructions: An evaluation of fibular and scapular free flaps

BackgroundFibular (FFF) and scapular free flaps (SFF) are versatile tissue transfers for head and neck reconstruction. However, their relative morbidity has been sparsely studied. The primary goal of this study was to evaluate the morbidity and patient-reported outcome measures of these two reconstructive options. Materials and MethodsCase series of patients from 2017 to 2020 who underwent a FFF or SFF for head and neck ablation. Demographic and surgical outcome measures, such as Charlson Comorbidity Index (CCI), anesthetic time, donor site morbidity, and perioperative morbidity score (POMs) were extracted. Patients were contacted to complete the Decision Regret Scale (DRS), University of Washington Quality of Life (UW-QoL), Oral Health Impact-14, and limb specific functional outcome measures. Statistical analyses included a linear regression. ResultsIn total, 97 FFF (mean age 58.5, 62.9% male) and 55 SFF (mean age 64.8, 63.6% male) were included. Total surgical time was higher in the SFF group (p < 0.05) and they had more comorbidities (p < 0.01). SFF patients had lower POM scores on post-operative day three (p < 0.05) while FFF patients scored better on the UW-QoL Physical Domain (p < 0.01). The DRS for both groups (FFF mean DRS 22.7, SFF mean DRS 19.2) was similar. When adjusted for patient morbidity, however, the SFF group had less decisional regret (p < 0.05). ConclusionThis is the largest comprehensive evaluation of patient-reported outcome measures for FFF and SFFs. SFFs required longer surgical times but had less early morbidity than FFFs. Patients who underwent either reconstructions reported mild decisional regret, proving these are generally well tolerated procedures.

Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis.

With the widespread of surgically-assisted orthodontic acceleration, the analysis of patient-reported outcome measures (PROMs) has become very important to assure patient acceptance and satisfaction before adopting any acceleration procedure. This review aimed to critically appraise the available evidence regarding the levels of pain, discomfort, functional impairments, and other patient-reported outcome measures during surgically-assisted acceleration of orthodontic treatment compared with the traditional non-accelerated treatment. Eight electronic bibliographic databases were searched from January 1990 till May 2022. A manual search of the selected orthodontic journals was also undertaken. Randomized controlled trials (RCTs) were included in this systematic review on patients undergoing orthodontic treatment with one group subjected to an acceleration procedure. Cochrane's risk of bias tool (RoB2 tool) was used to assess the risk of bias of the included RCTs. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines were used to assess the overall quality of the evidence. Thirteen RCTs were included in this review (333 patients), and only minimally invasive surgically-assisted acceleration studies were included. Two RCTs were included in the quantitative synthesis of data. After the first day of surgical intervention, the levels of pain and discomfort ranged from mild to moderate in the surgical groups (mean values ranged from 0.8 to 6.8), while it was mild in the control groups. However, on the seventh day after the surgical intervention, the levels of pain, discomfort, swelling, and functional impairments were almost similar between groups. According to the GRADE, the quality of evidence supporting these findings ranged from low to very low. All surgical interventions were minimally invasive. There was very low to low evidence that acceleration caused mild to moderate pain and discomfort on the first day after the surgical intervention and disappeared completely at one week following surgery. Functional impairments were found within acceptable limits immediately and in the short-term follow-up. More high-quality randomized controlled clinical trials are needed to establish good evidence in this field. The protocol of this systematic review was registered in PROSPERO database (CRD42021274481) during the first stages of this review.

Dual-mobility versus Fixed-bearing in Primary Total Hip Arthroplasty: Outcome Comparison.

PurposeUse of dual mobility (DM) articulations can reduce the risk of instability in both primary and revision total hip arthroplasty (THA). Knowledge regarding the impact of this design on patient-reported outcome measures (PROMs) is limited. This study aims to compare clinical outcomes between DM and fixed bearing (FB) prostheses following primary THA.Materials and MethodsAll patients who underwent primary THA between 2011-2021 were reviewed retrospectively. Patients were separated into three cohorts: FB vs monoblock-D vs modular-DM. An evaluation of PROMs including HOOS, JR, and FJS-12, as well as discharge-disposition, 90-day readmissions, and revisions rates was performed. Propensity-score matching was performed to limit significant demographic differences, while ANOVA and chi-squared test were used for comparison of outcomes.ResultsOf the 15,184 patients identified, 14,652 patients (96.5%) had a FB, 185 patients (1.2%) had a monoblock-DM, and 347 patients (2.3%) had a modular-DM prosthesis. After propensity-score matching, a total of 447 patients were matched comparison. There was no statistical difference in the 90-day readmission (P=0.584), revision rate (P=0.265), and 90-day readmission (P=0.365) and revision rate due to dislocation (P=0.365) between the cohorts. Discharge disposition was also non-significant (P=0.124). There was no statistical difference in FJS-12 scores at 3-months (P=0.820), 1-year (P=0.982), and 2-years (P=0.608) between the groups.ConclusionDM bearings yield PROMs similar to those of FB implants in patients undergoing primary THA. Although DM implants are utilized more often in patients at higher-risk for instability, we suggest that similar patient satisfaction may be attained while achieving similar dislocation rates.

Evaluating the development, woman-centricity and psychometric properties of maternity patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs): A systematic review protocol

IntroductionWoman-centred care is the right of every woman receiving maternity care, irrespective of where care is being received and who is providing care. This protocol describes a planned systematic review...

Evaluation of Patient-Reported Outcome Measures of Positive Psychosocial Constructs in Children and Adolescent/Young Adults with Cancer: A Systematic Review of Measurement Properties.

Introduction: Children, adolescents, and young adults with cancer are a vulnerable population in whom improvements in psycho-oncology care would be valuable. We previously published a scoping review exploring what is known about positive psychological constructs in this population. A key finding was that evidence-based patient-reported outcome measures (PROMs) were needed to standardize psycho-oncology research. Methods: We undertook a systematic review of measurement properties focused on PROMs in the pediatric and adolescent/young adults (AYAs) with cancer populations. We searched for PROMs that measured at least 1 of 15 previously identified, key positive constructs. This systematic review followed COSMIN guidelines, considered the gold standard manual for systematic reviews of measurement properties. Results: We identified 20 (22 if proxy reports are counted separately) unique PROMs that met inclusion criteria. Of those, only five were recommended for use given the current evidence. The remainder may be used if no alternative exists. Only eight PROMs had any evidence of content validity, considered the most important psychometric property by COSMIN. Many studies were at risk of bias owing to incomplete or suboptimal methods. Discussion: Five PROMs are considered reliable for the pediatric and AYA with cancer populations. A number of PROMs require additional research to ensure their items and instructions are comprehensive, relevant, and comprehensible to children and AYAs. Given the overall lack of research, this review may be considered a starting point for the future refinement of a core set of PROMs to measure positive psychological constructs.

Evaluating quality in acute care using patient reported outcome measures: a scoping review

The aim of this scoping review is to identify patient reported outcome measures (PROMs) in acute care settings, assess their psychometric properties and provide recommendations for their use in daily practice. We performed a search in the PubMed database to identify publications concerning PROMs in an acute care setting. The COSMIN checklist was used to assess the psychometric properties of the reported PROMs. We found 1407 publications and included 14 articles, describing 15 measures. Most publications provided limited information on psychometric properties. Three generic PROMs were deemed of adequate quality for use in acute care. We recommend future development and evaluation of PROMs focussing on acute care to further evaluate and improve the quality of acute care.

Selecting, implementing and evaluating patient-reported outcome measures for routine clinical use in cancer: the Cancer Care Ontario approach

BackgroundThe use of Patient-Reported Outcome Measures (PROMs) in routine clinical care can help ensure symptoms are identified, acknowledged and addressed. In 2007, the provincial cancer agency, Cancer Care Ontario, began to implement routine symptom screening with the Edmonton Symptom Assessment System (ESAS) for ambulatory cancer patients. Having had a decade of experience with ESAS, the program developed a strategic interest in implementing new and/or additional measures. This article describes the development of a streamlined PROM selection and implementation evaluation process with core considerations.MethodsDevelopment of the PROM selection and implementation evaluation process involved analysis of quantitative and qualitative data as well as consensus building through a multi-stakeholder workshop. Core PROM selection considerations were developed through a literature scan, review and refinement by a panel of methodological experts and patient advisors, and testing via a test case. Core PROM implementation evaluation considerations were developed through analysis of PROM evaluation frameworks, and review and refinement by a committee of provincial implementation leads.ResultsCore PROM selection considerations were identified under three overarching themes: symptom coverage, usability and psychometric properties. The symptom coverage category assesses each PROM to determine how well the PROM items address the most prevalent and burdensome symptoms in the target patient population. The usability category aims to assess each measure on characteristics key to successful implementation in the clinical setting. The psychometric properties category assesses each PROM to ensure the data collected is credible, meaningful and interpretable. A scoring system was developed to rate PROM performance by assigning a grade of “weak”, “average” or “good” for each category. The process results in a summary matrix which illustrates the overall assessment of each PROM. Implementation evaluation considerations were identified under three overarching concepts: acceptability, outcomes, and sustainability. A consensus building exercise resulted in the further identification of patient, provider, and clinic specific indicators for each consideration.ConclusionTo address the need for a systematic, evidence-based approach to selection, implementation and evaluation of PROMs in the clinical setting, Cancer Care Ontario defined a process with embedded core considerations to facilitate decision-making and encourage standardization.

Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial.

BackgroundIn the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health.ObjectiveThis study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D.MethodsPatients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health.ResultsA total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study.ConclusionsOur pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention.Trial RegistrationClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Selecting Patient-Reported Outcome Measures to Contribute to Primary Care Performance Measurement: a Mixed Methods Approach.

New models of primary care include patient-reported outcome measures (PROMs) to promote patient-centered care. PROMs provide information on patient functional status and well-being, can be used to enhance care quality, and are proposed for use in assessing performance. Our objective was to identify a short list of candidate PROMs for use in primary care practice and to serve as a basis for performance measures (PMs). We used qualitative and quantitative methods to identify relevant patient-reported outcome (PRO) domains for use in performance measurement (PRO-PM) and their associated PROMs. We collected data from key informant groups: patients (n = 13; one-on-one and group interviews; concept saturation analysis), clinical thought leaders (n = 9; group discussions; thematic analysis), primary care practices representatives (n = 37; six focus groups; thematic analysis), and primary care payer representatives (n = 10; 12-question survey; frequencies of responses). We merged the key informant group information with findings from environmental literature scans. We conducted a targeted evidence review of measurement properties for candidate PROMs. We used a scoping review and key informant groups to identify PROM evaluation criteria, which were linked to the National Quality Forum measure evaluation criteria. We developed a de novo schema to score candidate PROMs against our criteria. We identified four PRO domains and 10 candidate PROMs: 3 for depressive symptoms, 2 for physical function, 3 for self-efficacy, 2 for ability to participate. Five PROMs met ≥ 70% of the evidence criteria for three PRO domains: PHQ-9 or PROMIS Depression (depression), PF-10 or PROMIS-PF (physical functioning), and PROMIS Self-Efficacy for Managing Treatments and Medications (self-efficacy). The PROMIS Ability to Participate in Social Roles and Activities met 68% of our criteria and might be considered for inclusion. Existing evidence and key informant data identified 5 candidate PROMs to use in primary care. These instruments can be used to develop PRO-PMs.