Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)
Weldring, Theresa; Smith, Sheree M.S.
2013-01-01
In recent years, there has been an increased focus on placing patients at the center of health care research and evaluating clinical care in order to improve their experience and ensure that research is both robust and of maximum value for the use of medicinal products, therapy, or health services. This paper provides an overview of patients’ involvement in clinical research and service evaluation along with its benefits and limitations. We describe and discuss patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), including the trends in current research. Both the patient-reported experiences measures (PREMs) and patient and public involvement (PPI) initiative for including patients in the research processes are also outlined. PROs provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received. PROMs are tools and/or instruments used to report PROs. Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety. This reflects the ongoing health service commitment of involving patients and the public within the wider context of the development and evaluation of health care service delivery and quality improvement. PMID:25114561
Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures
Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.
2013-01-01
Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562
Korus, Lisa J; Cypel, Tatiana; Zhong, Toni; Wu, Albert W
2015-03-01
Patient-reported outcomes provide an invaluable tool in the assessment of outcomes in plastic surgery. Traditionally, patient-reported outcomes have consisted of either generic or ad hoc measures; however, more recently, there has been interest in formally constructed and validated questionnaires that are specifically designed for a particular patient population. The purpose of this systematic review was to determine whether generic measures still have a role in the evaluation of breast reconstruction outcomes, given the recent popularity and push for use of specific measures. A systematic review was performed to identify all articles using patient-reported outcomes in the assessment of postmastectomy breast reconstruction. Frequency of use was tabulated and the most frequently used tools were assessed for success of use, using criteria described previously by the Medical Outcomes Trust. To date, the most frequently used measures are still generic measures. The 36-Item Short-Form Health Survey was the most frequently used and most successfully applied showing evidence of responsiveness in multiple settings. Other measures such as the Hospital Anxiety and Depression Scale, the Hopwood Body Image Scale, and the Rosenberg Self-Esteem Scale were able to show responsiveness in certain settings but lacked evidence as universal tools for the assessment of outcomes in reconstructive breast surgery. Despite the recent advent of measures designed specifically to assess patient-reported outcomes in the breast reconstruction population, there still appears to be a role for the use of generic instruments. Many of these tools would benefit from undergoing formal validation in the breast reconstruction population.
Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.
Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L
2018-01-29
Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.
Garcia, Sofia F; Cella, David; Clauser, Steven B; Flynn, Kathryn E; Lad, Thomas; Lai, Jin-Shei; Reeve, Bryce B; Smith, Ashley Wilder; Stone, Arthur A; Weinfurt, Kevin
2007-11-10
Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.
Patient reported outcome measures in septorhinoplasty surgery.
Biggs, T C; Fraser, L R; Ward, M J; Sunkaraneni, V S; Harries, P G; Salib, R J
2015-01-01
Surgical procedures incorporating a cosmetic element such as septorhinoplasty and otoplasty are currently under threat in the National Health Service (NHS) as they are deemed to be procedures of 'limited clinical benefit' by many primary care providers. Patient reported outcome measures (PROMs), which assess the quality of care delivered from the patients' perspective, are becoming increasingly important in documenting the effectiveness of such procedures. The Rhinoplasty Outcomes Evaluation (ROE) questionnaire, a validated PROM tool, was used to assess patient satisfaction in 141 patients undergoing septorhinoplasty surgery over a 90-month period at the University Hospital Southampton NHS Foundation Trust. Overall, 100 patients with a mean follow-up period of 36 months completed the study. The mean ROE score was 73.3%. In addition, 75% of patients questioned were happy with the final result of their operation and 83% would undergo the procedure again if required. These benefits occurred irrespective of age, sex and primary versus revision surgery, and were maintained for up to 71 months following surgery. This study has shown that patients are generally satisfied with their functional and cosmetic outcomes following septorhinoplasty surgery. These results help support the case for septorhinoplasty surgery to continue being funded as an NHS procedure.
When do patient-reported outcome measures inform readmission risk?
Hinami, Keiki; Smith, Jennifer; Deamant, Catherine D; DuBeshter, Kayle; Trick, William E
2015-05-01
To characterize changes in patient-reported outcome measures from hospital discharge to assess when they best inform risk of utilization as defined by readmissions or emergency department use. Patients discharged from an urban safety-net hospital. Longitudinal cohort study. We serially administered the Memorial Symptom Assessment Scale (MSAS) and the PROMIS Global Health short form assessing General Self-Rated Health (GSRH), Global Physical (GPH), and Mental (GMH) Health at 0, 30, 90, and 180 days from hospital discharge. Time to first utilization from each survey was plotted by dichotomizing our sample on each patient-reported measure, and equivalence of the time-to-event curves was assessed using the log-rank test. Cox proportional hazard models were used to control for available covariates including prior utilization during the study, Charlson score, age, gender, and race/ethnicity. We assessed each measure's effect on the fit of the predictive models using the likelihood ratio test. We recruited 196 patients, of whom 100%, 98%, 90%, and 88% completed each respective survey wave. Participants' mean age was 52 years, 51% were women, 60% were non-Hispanic black, and 21% completed the questionnaires in Spanish. In-hospital assessments revealed high symptom burden and poor health status. In-hospital assessments of GMH and GSRH predicted 14-day reutilization, whereas posthospitalization assessments of MSAS and GPH predicted subsequent utilizations. Each measure selectively improved predictive model fit. Routine measurement of patient-reported outcomes can help identify patients at higher risk for utilizations. At different time points, MSAS, GPH, GMH, and GSRH all informed utilization risk. © 2015 Society of Hospital Medicine.
Patient-reported outcome measures in burning mouth syndrome - a review of the literature.
Ni Riordain, R; McCreary, C
2013-04-01
Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved. © 2012 John Wiley & Sons A/S.
Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva
2018-05-09
We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of
Wu, Albert W; Kharrazi, Hadi; Boulware, L Ebony; Snyder, Claire F
2013-08-01
This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient centeredness and digitization. We pose the question, "What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?" We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; and the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. Copyright © 2013 Elsevier Inc. All rights reserved.
Review of patient-reported outcome measures in chronic hepatitis C
2012-01-01
Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to
Heald, Alison E; Fudman, Edward J; Anklesaria, Pervin; Mease, Philip J
2010-05-01
To assess the validity, responsiveness, and reliability of single-joint outcome measures for determining target joint (TJ) response in patients with inflammatory arthritis. Patient-reported outcomes (PRO), consisting of responses to single questions about TJ global status on a 100-mm visual analog scale (VAS; TJ global score), function on a 100-mm VAS (TJ function score), and pain on a 5-point Likert scale (TJ pain score) were piloted in 66 inflammatory arthritis subjects in a phase 1/2 clinical study of an intraarticular gene transfer agent and compared to physical examination measures (TJ swelling, TJ tenderness) and validated function questionnaires (Disabilities of the Arm, Shoulder and Hand scale, Rheumatoid Arthritis Outcome Score, and the Health Assessment Questionnaire). Construct validity was assessed by evaluating the correlation between the single-joint outcome measures and validated function questionnaires using Spearman's rank correlation. Responsiveness or sensitivity to change was assessed through calculating effect size and standardized response means (SRM). Reliability of physical examination measures was assessed by determining interobserver agreement. The single-joint PRO were highly correlated with each other and correlated well with validated functional measures. The TJ global score exhibited modest effect size and modest SRM that correlated well with the patient's assessment of response on a 100-mm VAS. Physical examination measures exhibited high interrater reliability, but correlated less well with validated functional measures and the patient's assessment of response. Single-joint PRO, particularly the TJ global score, are simple to administer and demonstrate construct validity and responsiveness in patients with inflammatory arthritis. (ClinicalTrials.gov identifier NCT00126724).
Patient-reported outcome measures in arthroplasty registries
Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill
2016-01-01
The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175
Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G
2014-12-01
This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.
Wu, Albert W.; Kharrazi, Hadi; Boulware, L. Ebony; Snyder, Claire F.
2013-01-01
Objective This paper presents the current state of patient-reported outcome measures, and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Study Design and Setting Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient-centeredness and digitization. We pose the question: “What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?” Results We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. Conclusion The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other e-health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. PMID:23849145
Bolink, S A A N; Grimm, B; Heyligers, I C
2015-12-01
Outcome assessment of total knee arthroplasty (TKA) by subjective patient reported outcome measures (PROMs) may not fully capture the functional (dis-)abilities of relevance. Objective performance-based outcome measures could provide distinct information. An ambulant inertial measurement unit (IMU) allows kinematic assessment of physical performance and could potentially be used for routine follow-up. To investigate the responsiveness of IMU measures in patients following TKA and compare outcomes with conventional PROMs. Patients with end stage knee OA (n=20, m/f=7/13; age=67.4 standard deviation 7.7 years) were measured preoperatively and one year postoperatively. IMU measures were derived during gait, sit-stand transfers and block step-up transfers. PROMs were assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Society Score (KSS). Responsiveness was calculated by the effect size, correlations were calculated with Spearman's rho correlation coefficient. One year after TKA, patients performed significantly better at gait, sit-to-stand transfers and block step-up transfers. Measures of time and kinematic IMU measures demonstrated significant improvements postoperatively for each performance-based test. The largest improvement was found in block step-up transfers (effect size=0.56-1.20). WOMAC function score and KSS function score demonstrated moderate correlations (Spearman's rho=0.45-0.74) with some of the physical performance-based measures pre- and postoperatively. To characterize the changes in physical function after TKA, PROMs could be supplemented by performance-based measures, assessing function during different activities and allowing kinematic characterization with an ambulant IMU. Copyright © 2015 Elsevier B.V. All rights reserved.
Patient-Reported Outcome Measures for Hand and Wrist Trauma
Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim
2016-01-01
Background: Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. Methods: A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. Results: The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. Conclusions: The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology. PMID:27418884
Use of patient-reported outcome measures in foot and ankle research.
Hunt, Kenneth J; Hurwit, Daniel
2013-08-21
In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will
Patient-reported outcomes in obsessive-compulsive disorder
Subramaniam, Mythily; Soh, Pauline; Ong, Clarissa; Esmond Seow, Lee Seng; Picco, Louisa; Vaingankar, Janhavi Ajit; Chong, Siow Ann
2014-01-01
The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures. PMID:25152661
Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.
Keays, Melise A; Starke, Nathan; Lee, Simon C; Bernstein, Ira; Snodgrass, Warren T; Bush, Nicol C
2016-04-01
Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical
van Dulmen, Simone A; van der Wees, Philip J; Bart Staal, J; Braspenning, J C C; Nijhuis-van der Sanden, Maria W G
2017-03-01
Routine use of patient reported outcome measures (PROMs) may provide an effective way of monitoring patient valued outcomes. In this study we explored (1) the current use of PROMs; (2) to what extent the goals correspond with the selected PROMs; (3) the health outcomes based on PROMs. Observational clinical cohort study. Dutch primary care physiotherapy practices (n=43). Patients (n=299) with neck pain or low back pain. The number of PROMs used per patient were calculated. The International Classification of Functioning, Disability and Health was used to map the patients' goals and the percentages of PROMS selected that match the domains of the goals were calculated. Health outcomes were assessed using two approaches for estimating the minimal clinically important difference (MCID). Repeated measurements with the Visual Analogue Scale, the Patient Specific Complaints questionnaire, the Quebec Back Pain Disability Scale, or the Neck Disability Index were completed by more than 60% of the patients. The PROMs used matched in 46% of the cases with goals for pain improvement, and in 43% with goals set at activity/participation level. The mean differences between baseline and follow up scores for all PROMs were statistically significant. Improvements of patients based on MCID varied from 57% to 90%. PROMs were used in the majority of the patients, showed improved health outcomes and fitted moderately with goals. The results of this study can be used for future research assessing the routine use of outcome measurements with PROMs. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
2012-01-01
Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare
Patterson, Brendan M; Orvets, Nathan D; Aleem, Alexander W; Keener, Jay D; Calfee, Ryan P; Nixon, Devon C; Chamberlain, Aaron M
2018-06-01
The Patient-Reported Outcomes Measurement Information System (PROMIS) is being used to assess outcomes in many patient populations despite limited validation. The purpose of this study was to investigate the relationship between American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test (SST) scores and PROMIS Physical Function (PF) and Upper Extremity (UE) function scores collected preoperatively in patients undergoing rotator cuff repair. This cross-sectional study analyzed 164 consecutive patients undergoing arthroscopic rotator cuff repair. Study inclusion required preoperative completion of the ASES and SST evaluations, as well as the PROMIS PF, UE, and Pain Interference computerized adaptive tests. Descriptive statistics were produced, and Pearson correlation coefficients were calculated between each of the outcome measures. Average PROMIS UE scores indicated greater impairment than PROMIS PF scores (34 vs 44). Three percent of patients reached the PROMIS UE ceiling score of 56. PROMIS PF scores demonstrated a weak correlation with ASES scores (r = 0.43, P < .001) and a moderate correlation with SST scores (r = 0.51, P < .001). PROMIS UE scores demonstrated a moderate correlation with both ASES scores (r = 0.59, P < .001) and SST scores (r = 0.62, P < .001). PROMIS Pain Interference scores demonstrated weak negative correlations with both ASES scores (r = -0.43, P < .001) and SST scores (r = -0.41, P < .001). Patients answered fewer questions on average using the PROMIS PF and UE instruments as compared with the ASES and SST instruments. PROMIS UE scores indicate greater impairment and demonstrate a stronger correlation with the legacy shoulder scores than PROMIS PF scores in patients with symptomatic rotator cuff tears. PROMIS computerized adaptive tests allow for more efficient patient-reported outcome data collection compared with traditional outcome scores. Copyright © 2018 Journal of Shoulder and
Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick
2017-01-01
Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how
Shapiro, Danielle N; Waljee, Jennifer; Ranganathan, Kavitha; Buchman, Steven; Warschausky, Seth
2015-06-01
Children with craniofacial anomalies are at risk for social exclusion, bullying, and psychological symptoms, all of which are associated with poor developmental and health outcomes. The National Institutes of Health-developed Patient Reported Outcomes Measurement Information System instruments may be useful tools for monitoring psychosocial functioning in clinical settings and for integrating patient and parent perspectives. The current study included 74 children (50 percent male) with craniofacial anomalies recruited through a multidisciplinary clinic. The authors obtained child self-report and parent-proxy ratings of depression, anxiety, and peer relationship quality using National Institutes of Health Patient Reported Outcomes Measurement Information System instruments. The authors compared sample means to Patient Reported Outcomes Measurement Information System instruments norms and analyzed the reliability of parents' and children's reporting of psychosocial variables. All reliability statistics were satisfactory (α values ranging from 0.74 to 0.96) and sample standard deviations were similar to those obtained in a general population, suggesting that Patient Reported Outcomes Measurement Information System instruments are reliable among children with craniofacial anomalies. In general, children and parents did not report unusual levels of psychological distress; however, they did report poorer peer relationship quality relative to normed data, a trend that was particularly pronounced among boys. National Institutes of Health Patient Reported Outcomes Measurement Information System instruments are efficient and accurate tools for monitoring psychosocial adjustment among children with craniofacial anomalies. It may be especially important to monitor social functioning, particularly among boys.
Patient-reported outcome measures in arthroplasty registries
Bohm, Eric; Franklin, Patricia; Lyman, Stephen; Denissen, Geke; Dawson, Jill; Dunn, Jennifer; Eresian Chenok, Kate; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Lübbeke, Anne
2016-01-01
Abstract — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or
Patient-reported outcomes in borderline personality disorder.
Hasler, Gregor; Hopwood, Christopher J; Jacob, Gitta A; Brändle, Laura S; Schulte-Vels, Thomas
2014-06-01
Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes.
The importance of patient-reported outcome measures in reconstructive urology.
Jackson, Matthew J; N'Dow, James; Pickard, Rob
2010-11-01
Patient-reported outcome measures (PROMs) are now recognised as the most appropriate instruments to assess the effectiveness of healthcare interventions from the patient's perspective. The purpose of this review was to identify recent publications describing the use of PROMs following reconstructive urological surgery. A wide systematic search identified only three original articles published in the last 2 years that prospectively assessed effectiveness using a patient-completed condition-specific or generic health-related quality of life (HRQoL) instrument. These publications illustrate the need to administer PROMs at a postoperative interval relevant to the anticipated recovery phase of individual procedures. They also highlight the difference in responsiveness of generic HRQoL instruments to symptomatic improvement between straightforward conditions such as pelviureteric junction obstruction and complex multidimensional conditions such as meningomyelocele. PROMs uptake and awareness is increasing in reconstructive urology but more work is required to demonstrate the effectiveness of surgical procedures for patients and healthcare funders alike. Healthcare policy-makers now rely on these measures to determine whether specific treatments are worth financing and to compare outcomes between institutions.
Patient-reported outcomes in borderline personality disorder
Hasler, Gregor; Hopwood, Christopher J.; Jacob, Gitta A.; Brändle, Laura S.; Schulte-Vels, Thomas
2014-01-01
Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes. PMID:25152662
Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G
2012-10-01
Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.
Eckstein, Donna A; Wu, Rebecca L; Akinbiyi, Takintope; Silver, Lester; Taub, Peter J
2011-11-01
Patient-reported outcomes in cleft lip and palate treatment are critical for patient care. Traditional surgical outcomes focused on objective measures, such as photographs, anatomic measurements, morbidity, and mortality. Although these remain important, they leave many questions unanswered. Surveys that include aesthetics, speech, functionality, self-image, and quality of life provide more thorough outcomes assessment. It is vital that reliable, valid, and comprehensive questionnaires are available to craniofacial surgeons. The authors performed a literature review to identify questionnaires validated in cleft lip and palate patients. Qualifying instruments were assessed for adherence to guidelines for development and validation by the scientific advisory committee and for content. The authors identified 44 measures used in cleft lip and palate studies. After 15 ad hoc questionnaires, eight generic instruments, 11 psychiatric instruments, and one non-English language questionnaire were excluded, nine measures remained. Of these, four were never validated in the cleft population. Analysis revealed one craniofacial-specific measure (Youth Quality of Life-Facial Differences), two voice-related measures (Patient Voice-Related Quality of Life and Cleft Audit Protocol for Speech-Augmented), and two oral health-related measures (Child Oral Health Impact Profile and Child Oral Health Quality of Life). The Youth Quality of Life-Facial Differences, Child Oral Health Impact Profile, and Child Oral Health Quality of Life questionnaires were sufficiently validated. None was created specifically for clefts, resulting in content limitations. There is a lack of comprehensive, valid, and reliable questionnaires for cleft lip and palate surgery. For thorough assessment of satisfaction, further research to develop and validate cleft lip and palate surgery-specific instruments is needed.
Patient reported outcome measures in male incontinence surgery.
Tran, M G B; Yip, J; Uveili, K; Biers, S M; Thiruchelvam, N
2014-10-01
Patient reported outcome measures (PROMs) were used to evaluate outcomes of the artificial urinary sphincter (AUS) and the AdVance™ (American Medical Systems, Minnetonka, MN, US) male sling system (AVMS) for the symptomatic management of male stress urinary incontinence. All male patients with stress urinary incontinence referred to our specialist clinic over a two-year period completed the ICIQ-UI SF (International Consultation on Incontinence Questionnaire on Urinary Incontinence Short Form) and the ICIQ-MLUTS LF (International Consultation on Incontinence Questionnaire on Male Lower Urinary Tract Symptoms Long Form) at consultation as well as at subsequent follow-up appointments. The Wilcoxon signed-rank test for non-parametric paired data was used for pre and postoperative comparisons. The chi-squared test was used for categorical variables. Thirty-seven patients (forty surgical cases) completed a preoperative and at least one follow-up questionnaire. There was a statistically significant improvement in PROMs postoperatively, regardless of mode of surgery (p<0.01). Analysis of the ICIQ-MLUTS LF showed that patients with higher preoperative scores (>25) had greater improvement with an AUS than with the AVMS (p<0.01). This prospective study shows that completion and collection of PROMs as part of routine clinical practice is achievable and useful in the assessment of male stress incontinence surgery. PROMs are important instruments to assess effectiveness of healthcare intervention and they are useful adjuncts in surgical studies.
Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial.
Claessen, Femke M A P; Mellema, Jos J; Stoop, Nicky; Lubberts, Bart; Ring, David; Poolman, Rudolf W
2016-01-01
Patient-reported outcome measures (PROMs) are influenced by psychosocial factors, but it is unknown whether we can influence PROM scores by modifying the mindset of the patient. We assessed whether priming affects scores on PROMs. In all, 168 patients with musculoskeletal illness participated in this double-blinded, randomized, controlled, parallel study between July 2014 and October 2014 in a level I trauma center. Inclusion criteria were patients aged 18 years or older with English fluency and literacy and the ability to provide informed consent. Priming was performed by means of the Pain Catastrophizing Scale (PCS). The patients were randomized (1:1:1) into 3 groups: intervention group I was negatively primed with the original PCS; intervention group II was positively primed with a positively phrased PCS group; and control group III was not primed. Assessments were performed using PROMs on the domain of physical function, depression, and pain. Bivariate and multivariable regression analyses were conducted. The intervention and control groups were well balanced in demographic and condition-specific characteristics. The positive PCS was independently associated with higher PROM scores in the physical function domain (Patient-Reported Outcome Measurement Information System Upper Extremity Function: coefficient = 4.7, partial R(2) = 0.042; CI: 1.2-8.2; p < 0.010). Patients primed with a positively phrased version of the PCS reported less functional disability as compared with patients who were either negatively primed or not primed at all. This suggests that by influencing the mindset, PROMs can be influenced, resulting in better outcome if positively primed. Level 1 therapeutic study. NCT02209259. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform.
Squitieri, Lee; Bozic, Kevin J; Pusic, Andrea L
2017-06-01
The U.S. health care system is currently experiencing profound change. Pressure to improve the quality of patient care and control costs have caused a rapid shift from traditional volume-driven fee-for-service reimbursement to value-based payment models. Under the 2015 Medicare Access and Children's Health Insurance Program Reauthorization Act, providers will be evaluated on the basis of quality and cost efficiency and ultimately receive adjusted reimbursement as per their performance. Although current performance metrics do not incorporate patient-reported outcome measures (PROMs), many wonder whether and how PROMs will eventually fit into value-based payment reform. On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders across all health care disciplines to discuss the potential role of PROs in value-based health care reform. The purpose of this article was to summarize the findings from this conference in the context of recent literature and guidelines to inform implementation of PROs in value-based payment models. Recommendations for evaluating key perspectives and measurement goals are made to facilitate appropriate use of PROMs to best benefit and amplify the voice of our patients. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
LC-PROM: Validation of a patient reported outcomes measure for liver cirrhosis patients.
Zhang, Ying; Yang, Yuanyuan; Lv, Jing; Zhang, Yanbo
2016-05-10
The aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to the Patient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity to fill gaps in this field. A conceptual framework was developed and a preliminary item pool developed through literature review and interviews of 10 patients with liver cirrhosis. With the preliminary items, we performed a pilot survey that included a cognitive test with patients and interviews with experts; the focus was on content and language of the scale. In the item selection stage, seven statistical methods including discrete trends method, discrimination analysis, exploratory factor analysis, Cronbach's α coefficient, correlation coefficient, test-retest reliability, Item-Response Theory were applied to survey data from 200 subjects (150 liver cirrhosis patients and 50 controls). This produced the preliminary Liver Cirrhosis Patient-reported Outcome Measure (LC-PROM). In the next stage, we conducted the survey with 620 subjects (500 patients and 120 controls) to validate reliability, validity and acceptability of this scale. The 55 items and 13 dimensions addressed four domains: physical, psychological, social, and therapeutic. Cronbach's α coefficients were 0.921 for the total scale; the confirmatory factor analysis, t-tests and ANOVA supported scale validity; the model fit index as Root Mean Square Error of Approximation (RMSEA), Root Mean Square Residual (RMR), Normed Fit Index (NFI), Non-Normed Fit Index (NNFI), Comparative Fit Index (CFI) and Incremental Fit Index (IFI) met the criterion generally. The acceptance ratio and response rate indicated good feasibility. This study developed an accurate and stable patient-reported outcome scale of liver cirrhosis, which is able to evaluate clinical effects effectively, is helpful to patients in recognizing their health condition, and contributes to clinical decision making both for patients and
Methods for interpreting change over time in patient-reported outcome measures.
Wyrwich, K W; Norquist, J M; Lenderking, W R; Acaster, S
2013-04-01
Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.
Checklist to operationalize measurement characteristics of patient-reported outcome measures.
Francis, David O; McPheeters, Melissa L; Noud, Meaghan; Penson, David F; Feurer, Irene D
2016-08-02
The purpose of this study was to advance a checklist of evaluative criteria designed to assess patient-reported outcome (PRO) measures' developmental measurement properties and applicability, which can be used by systematic reviewers, researchers, and clinicians with a varied range of expertise in psychometric measure development methodology. A directed literature search was performed to identify original studies, textbooks, consensus guidelines, and published reports that propose criteria for assessing the quality of PRO measures. Recommendations from these sources were iteratively distilled into a checklist of key attributes. Preliminary items underwent evaluation through 24 cognitive interviews with clinicians and quantitative researchers. Six measurement theory methodological novices independently applied the final checklist to assess six PRO measures encompassing a variety of methods, applications, and clinical constructs. Agreement between novice and expert scores was assessed. The distillation process yielded an 18-item checklist with six domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation. With minimal instruction, good agreement in checklist item ratings was achieved between quantitative researchers with expertise in measurement theory and less experienced clinicians (mean kappa 0.70; range 0.66-0.87). We present a simplified checklist that can help guide systematic reviewers, researchers, and clinicians with varied measurement theory expertise to evaluate the strengths and weakness of candidate PRO measures' developmental properties and the appropriateness for specific applications.
Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel
2017-05-01
While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.
The PU-PROM: A patient-reported outcome measure for peptic ulcer disease.
Liu, Na; Lv, Jing; Liu, Jinchun; Zhang, Yanbo
2017-12-01
Patient-reported outcome measure (PROM) conceived to enable description of treatment-related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient-centred peptic ulcer patient-reported outcome measure (PU-PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility. To develop a conceptual framework and item pool for the PU-PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure. The final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate. The peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical
Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.
Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan
2013-12-01
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such
Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley
2012-08-01
Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than
Tran, K; Zomer, S; Chadder, J; Earle, C; Fung, S; Liu, J; Louzado, C; Rahal, R; Moxam, R Shaw; Green, E
2018-04-01
Patient-reported outcomes measures (proms) are an important component of the shift from disease-centred to person-centred care. In oncology, proms describe the effects of cancer and its treatment from the patient perspective and ideally enable patients to communicate to their providers the physical symptoms and psychosocial concerns that are most relevant to them. The Edmonton Symptom Assessment System-revised (esas-r) is a commonly used and validated tool in Canada to assess symptoms related to cancer. Here, we describe the extent to which patient-reported outcome programs have been implemented in Canada and the severity of symptoms causing distress for patients with cancer. As of April 2017, 8 of 10 provinces had implemented the esas-r to assess patient-reported outcomes. Data capture methods, the proportion of cancer treatment sites that have implemented the esas-r, and the time and frequency of screening vary from province to province. From October 2016 to March 2017 in the 8 reporting provinces, 88.0% of cancer patients were screened for symptoms. Of patients who reported having symptoms, 44.3% reported depression, with 15.5% reporting moderate-to-high levels; 50.0% reported pain, with 18.6% reporting moderate-to-high levels; 56.2% reported anxiety, with 20.4% reporting moderate-to-high levels; and 75.1% reported fatigue, with 34.4% reporting moderate-to-high levels. There are some notable areas in which the implementation of proms could be improved in Canada. Findings point to a need to increase the number of cancer treatment sites that screen all patients for symptoms; to standardize when and how frequently patients are screened across the country; to screen patients for symptoms during all phases of their cancer journey, not just during treatment; and to assess whether giving cancer care providers real-time patient-reported outcomes data has led to appropriate interventions that reduce the symptom burden and improve patient outcomes. Continued measurement
Patient-Reported Outcome Measures (PROM) as A Preoperative Assessment Tool.
Kim, Sunghye; Duncan, Pamela W; Groban, Leanne; Segal, Hannah; Abbott, Rica Moonyeen; Williamson, Jeff D
2017-11-28
undergoing elective surgery who might have subtle physical, social, or psychological deficits or challenges, otherwise missed upon routine evaluation. Patient Reported Outcome Measures (PROMs) can be used to effectively and efficiently collect these factors in the preoperative period, thereby identifying areas that can be intervened preemptively. (Partially Funded by the National Institute on Aging and the Wake Forest University Claude D. Pepper Older Americans Independence Center.).
Malhotra, Aneil; Banning, Adrian P; Jenkinson, Crispin
2010-01-01
Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making. Design Systematic review. Data sources Medline and Embase. Study selection Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008. Results Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients. Conclusions Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This
Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju
2018-03-01
This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in
An Introduction to Item Response Theory for Patient-Reported Outcome Measurement
Nguyen, Tam H.; Han, Hae-Ra; Kim, Miyong T.
2015-01-01
The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured. PMID:24403095
An introduction to item response theory for patient-reported outcome measurement.
Nguyen, Tam H; Han, Hae-Ra; Kim, Miyong T; Chan, Kitty S
2014-01-01
The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured.
Patient Reported Outcome Measure of Spiritual Care as Delivered by Chaplains.
Snowden, Austyn; Telfer, Iain
2017-01-01
Chaplains are employed by health organizations around the world to support patients in recognizing and addressing their spiritual needs. There is currently no generalizable measure of the impact of these interventions and so the clinical and strategic worth of chaplaincy is difficult to articulate. This article introduces the Scottish PROM, an original five-item patient reported outcome measure constructed specifically to address this gap. It describes the validation process from its conceptual grounding in the spiritual care literature through face and content validity cycles. It shows that the Scottish PROM is internally consistent and unidimensional. Responses to the Scottish PROM show strong convergent validity with responses to the Warwick and Edinburgh Mental Well-Being Scale, a generic well-being scale often used as a proxy for spiritual well-being. In summary, the Scottish PROM is fit for purpose. It measures the outcomes of spiritual care as delivered by chaplains in this study. This novel project introduces an essential and original breakthrough; the possibility of generalizable international chaplaincy research.
Goldsmith, Elizabeth S; Taylor, Brent C; Greer, Nancy; Murdoch, Maureen; MacDonald, Roderick; McKenzie, Lauren; Rosebush, Christina E; Wilt, Timothy J
2018-05-01
Developing successful interventions for chronic musculoskeletal pain requires valid, responsive, and reliable outcome measures. The Minneapolis VA Evidence-based Synthesis Program completed a focused evidence review on key psychometric properties of 17 self-report measures of pain severity and pain-related functional impairment suitable for clinical research on chronic musculoskeletal pain. Pain experts of the VA Pain Measurement Outcomes Workgroup identified 17 pain measures to undergo systematic review. In addition to a MEDLINE search on these 17 measures (1/2000-1/2017), we hand-searched (without publication date limits) the reference lists of all included studies, prior systematic reviews, and-when available-Web sites dedicated to each measure (PROSPERO registration CRD42017056610). Our primary outcome was the measure's minimal important difference (MID). Secondary outcomes included responsiveness, validity, and test-retest reliability. Outcomes were synthesized through evidence mapping and qualitative comparison. Of 1635 abstracts identified, 331 articles underwent full-text review, and 43 met inclusion criteria. Five measures (Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Bodily Pain Scale (SF-36 BPS), Numeric Rating Scale (NRS), and Visual Analog Scale (VAS)) had data reported on MID, responsiveness, validity, and test-retest reliability. Seven measures had data reported on three of the four psychometric outcomes. Eight measures had reported MIDs, though estimation methods differed substantially and often were not clinically anchored. In this focused evidence review, the most evidence on key psychometric properties in chronic musculoskeletal pain populations was found for the ODI, RMDQ, SF-36 BPS, NRS, and VAS. Key limitations in the field include substantial variation in methods of estimating psychometric properties, defining chronic musculoskeletal pain, and reporting patient demographics. Registered in the PROSPERO
Antunes, Bárbara; Harding, Richard; Higginson, Irene J
2014-02-01
Many patient-reported outcome measures have been developed in the past two decades, playing an increasingly important role in palliative care. However, their routine use in practice has been slow and difficult to implement. To systematically identify facilitators and barriers to the implementation of patient-reported outcome measures in different palliative care settings for routine practice, and to generate evidence-based recommendations, to inform the implementation process in clinical practice. Systematic literature review and narrative synthesis. Medline, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, Embase and British Nursing Index were systematically searched from 1985. Hand searching of reference lists for all included articles and relevant review articles was performed. A total of 3863 articles were screened. Of these, 31 articles met the inclusion criteria. First, data were integrated in the main themes: facilitators, barriers and lessons learned. Second, each main theme was grouped into either five or six categories. Finally, recommendations for implementation on outcome measures at management, health-care professional and patient levels were generated for three different points in time: preparation, implementation and assessment/improvement. Successful implementation of patient-reported outcome measures should be tailored by identifying and addressing potential barriers according to setting. Having a coordinator throughout the implementation process seems to be key. Ongoing cognitive and emotional processes of each individual should be taken into consideration during changes. The educational component prior to the implementation is crucial. This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making.
An introduction to patient-reported outcome measures (PROMs) in physiotherapy.
Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C
2015-06-01
The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
Middleton, Robert; Beard, David J; Price, Andrew J; Hopewell, Sally
2017-01-01
Objective Meniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears. Design A systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments. Data sources A search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017). Eligibility criteria for selecting studies Development and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included. Results 11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity. Conclusion For patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears. PROSPERO registration number CRD42017056847. PMID:29030413
Spiekermann, Christoph; Amler, Susanne; Rudack, Claudia; Stenner, Markus
2018-06-01
The patient's satisfaction with the esthetic result is a major criterion of success in septorhinoplasty. However, the idea of esthetic perfection varies greatly and primarily depends on subjective perception. Hence, patient-reported instruments are important and necessary to assess the outcome in septorhinoplasty. To analyze the potential of the visual analog scale (VAS) as a patient-reported outcome measure in septorhinoplasty, the perception of the nasal appearance was assessed by a VAS pre- and postoperatively in 213 patients undergoing septorhinoplasty. Furthermore, in this prospective study, the patients' satisfaction concerning the procedure's result was analyzed using a five-point Likert scale. Females had lower preoperative VAS scores but a higher increase compared to males. Patients with lower initial VAS scores showed a higher improvement in the VAS score postoperatively compared to patients with higher initial VAS scores. Satisfaction with the result depends on the increase in the VAS score value. The VAS scale is a short and comprehensible tool to assess patients' perception of nasal appearance preoperatively and represents an appropriate instrument to assess the esthetic patient-reported outcome in septorhinoplasty.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Talaei-Khoei, Mojtaba; Riklin, Eric; Merker, Vanessa L; Sheridan, Monica R; Jordan, Justin T; Plotkin, Scott R; Vranceanu, Ana-Maria
2017-01-01
The patient reported outcomes measurement information system (PROMIS) provides clinicians and researchers access to reliable, validated measures of physical, mental, and social well-being. The use of PROMIS can facilitate comparisons among clinical subpopulations and with the U.S. general population. We report on the first study using PROMIS measures in patients with neurofibromatosis (NF). Eighty-six adult patients (mean age = 44; 55% female; 87% white; 50% NF1, 41% NF2 and 9% schwannomatosis) completed a battery of PROMIS computerized adaptive tests (CATs). Across all PROMIS instruments, mean scores for each CAT were between 48.97 and 52.60, which is within ±0.5 SD of the U.S. general population norms. However, scores were distributed across a broad range for each PROMIS measure (±3 SDs). Clinically meaningful scores (defined >1 SD impairment) were observed in 20% (pain interference), 17% (pain behavior), 16% (physical function), 16% (anxiety), 16% (depression), 15% (satisfaction with social roles), 13% (fatigue), 6% (anger), and 5% (satisfaction with discretionary social activities) of the sample. All PROMIS measures were highly interrelated in bivariate analysis (P ≤ .001). There were no differences in PROMIS scores by disease type (NF1, NF2 and schwannomatosis), or self reported learning disabilities, or compared with the US population. Scores suggest a broad continuum of symptoms and functioning in patients with NF that is not affected by NF type, as well as interrelation among the physical and psychosocial domains as measured by PROMIS. PROMIS measures may be useful in clinical practice to monitor changes in symptoms and functioning over time, as well as in clinical trials to determine patient reported changes during drug and psychosocial clinical trials.
Newell, Dave; Diment, Emily; Bolton, Jenni E
2016-01-01
The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.
ERIC Educational Resources Information Center
Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.
2017-01-01
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…
Measurement tools and outcome measures used in transitional patient safety; a systematic review.
van Melle, Marije A; van Stel, Henk F; Poldervaart, Judith M; de Wit, Niek J; Zwart, Dorien L M
2018-01-01
Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed. To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety. The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23). Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on
Improving Outcomes in Patients with CRC: The Role of Patient Reported Outcomes—An ESDO Report
Van Cutsem, Eric; De Gramont, Aimery; Henning, Geoffrey; Rougier, Philippe; Bonnetain, Franck; Seufferlein, Thomas
2017-01-01
Colorectal cancer is one of the most commonly diagnosed cancers worldwide and nearly half of patients will develop metastatic disease at some point during the course of their disease. The goal of anticancer therapy in this context is to extend survival, while trying to maximise the patient’s health-related quality of life. To this end, we need to understand how to incorporate patient-reported outcomes into clinical trials and routine practice to accurately assess if treatment strategies are providing clinical benefit for the patient. This review reflects the proceedings of a 2016 European Society of Digestive Oncology workshop, where the authors discussed the use of patient-reported outcomes to measure health-related quality of life when evaluating treatment during the management of colorectal cancer. A summary of the challenges associated with implementing patient-reported outcomes in clinical trials is provided, as well as a review of the current clinical evidence surrounding patient-reported outcomes in metastatic colorectal cancer. PMID:28587143
Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie
Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing
Kocks, Jan Willem H; van den Berg, Jan Willem K; Kerstjens, Huib AM; Uil, Steven M; Vonk, Judith M; de Jong, Ynze P; Tsiligianni, Ioanna G; van der Molen, Thys
2013-01-01
Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. PMID:23766644
Wolpert, Miranda; Ford, Tamsin; Trustam, Emma; Law, Duncan; Deighton, Jessica; Flannery, Halina; Fugard, Andrew J B; Fugard, Rew J B
2012-04-01
There is increasing emphasis on use of patient-reported outcome measures (PROMs) in mental health but little research on the best approach, especially where there are multiple perspectives. To present emerging findings from both standardized and idiographic child-, parent- and clinician-rated outcomes in child and adolescent mental health services (CAMHS) and consider their correlations. Outcomes were collected in CAMHS across the UK. These comprised idiographic measures (goal-based outcomes) and standardized measures (practitioner-rated Children's Global Assessment Scale; child- and parent-rated Strengths and Difficulties Questionnaire). There was reliable positive change from the beginning of treatment to later follow-up according to all informants. Standardized clinician function report was correlated with standardized child difficulty report (r = - 0.26), standardized parent report (r = - 0.28) and idiographic joint client-determined goals (r = 0.38) in the expected directions. These results suggest that routine outcome monitoring is feasible, and suggest the possibility of using jointly agreed idiographic measures alongside particular perspectives on outcome as part of a PROMs approach.
Development and validation of a patient-reported outcome measure for stroke patients.
Luo, Yanhong; Yang, Jie; Zhang, Yanbo
2015-05-08
Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke
Patient reported outcomes and patient empowerment in clinical genetics services.
McAllister, M; Dearing, A
2015-08-01
Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS. © 2014 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J
2017-08-01
The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient
Malhotra, Karan; Buraimoh, Olatunbosun; Thornton, James; Cullen, Nicholas; Singh, Dishan; Goldberg, Andrew J
2016-06-20
To determine whether an entirely electronic system can be used to capture both patient-reported outcomes (electronic Patient-Reported Outcome Measures, ePROMs) as well as clinician-validated diagnostic and complexity data in an elective surgical orthopaedic outpatient setting. To examine patients' experience of this system and factors impacting their experience. Retrospective analysis of prospectively collected data. Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. All patients were invited to complete ePROMs prior to attending their outpatient appointment. At their appointment, those patients who had not completed ePROMs were offered the opportunity to complete it on a tablet device with technical support. Matched diagnostic and complexity data were captured by the treating consultant during the appointment. Capture rates of patient-reported and clinician-reported data. All information and technology (IT) failures, language and disability barriers were captured. Patients were asked to rate their experience of using ePROMs. The scoring systems used included EQ-5D-5L, the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Visual Analogue Scale (VAS) pain score. Out of 2534 new patients, 2176 (85.9%) completed ePROMs, of whom 1090 (50.09%) completed ePROMs at home/work prior to their appointment. 31.5% used a mobile (smartphone/tablet) device. Clinician-reported data were captured on 2491 patients (98.3%). The mean patient experience score of using Patient-Reported Outcome Measures (PROMs) was 8.55±1.85 out of 10 and 666 patients (30.61%) left comments. Of patients leaving comments, 214 (32.13%) felt ePROMs did not adequately capture their symptoms and these patients had significantly lower patient experience scores (p<0.001). This study demonstrates the successful implementation of technology into a service improvement programme
Jones, Laura L; Calvert, Melanie; Moiemen, Naiem; Deeks, Jonathan J; Bishop, Jonathan; Kinghorn, Philip; Mathers, Jonathan
2017-12-01
Pressure garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients' health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial
Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.
Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken
2017-07-21
There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P <0.01). The r 2 ranged from 0.11 (PROMIS fatigue) to 0.56 (SIS-16). Change in scores occurred in 51% with mRS and 35% with SIS-16. There was lower agreement and less ability to discriminate change in mRS than in SIS-16 with change in the other measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
Sawatzky, Richard; Chan, Eric K H; Zumbo, Bruno D; Ahmed, Sara; Bartlett, Susan J; Bingham, Clifton O; Gardner, William; Jutai, Jeffrey; Kuspinar, Ayse; Sajobi, Tolulope; Lix, Lisa M
2017-09-01
Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.
Wahl, Elizabeth; Yazdany, Jinoos
2016-01-01
Summary Use of Patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing healthcare quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. We first explore other countries’ experiences collecting and evaluating national PRO data to assess quality of care. We describe the current use of PROs as quality measures in rheumatology, and frame an agenda for future work supporting development of meaningful quality measures based on PROs. PMID:27133495
Ju, Angela; Unruh, Mark; Davison, Sara; Dapueto, Juan; Dew, Mary Amanda; Fluck, Richard; Germain, Michael; Jassal, Sarbjit V; Obrador, Gregorio; O'Donoghue, Donal; Josephson, Michelle A; Craig, Jonathan C; Viecelli, Andrea; O'Lone, Emma; Hanson, Camilla S; Manns, Braden; Sautenet, Benedicte; Howell, Martin; Reddy, Bharathi; Wilkie, Caroline; Rutherford, Claudia; Tong, Allison
2018-03-15
Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
McNamara, Robert L; Spatz, Erica S; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S; Sadwin, Lawrence; Schoeberl, Mark; Shahian, David; Weston, Clive; Yeh, Robert; Lewin, Jack
2015-05-19
Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.
ERIC Educational Resources Information Center
Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David
2011-01-01
The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS[R]). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and…
Hand therapist use of patient report outcome (PRO) in practice: a survey study.
Valdes, Kristin; MacDermid, Joy; Algar, Lori; Connors, Brian; Cyr, Lisa M; Dickmann, Sharon; Lucado, Ann M; Naughton, Nancy
2014-01-01
The purpose of this survey was to gain greater insight into hand therapists' use of Patient Report Outcome (PRO) measures. An 11-question survey that evaluated therapists' perceptions, preferences, and patterns of use of patient report outcome measures was sent to members of ASHT. A total of 633 ASHT members participated in the survey study. A large majority of participants (92%) responded affirmatively to using a PRO measure in practice. The DASH was reported as the most frequently used measure (90%). The majority of therapists (84%) discuss the results of the outcome measurement score with their patients. Of the participants who use more than one outcome measure, 44% report that this allows them to better establish their patient's functional and physical limitations. The findings in this study suggest that a large percentage of hand therapists are currently including a PRO measure in their hand therapy practice. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.
Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.
Hunter, Robert; Cameron, Rosie; Norrie, John
2009-02-01
The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine
Mason, Samantha J; Catto, James Wf; Downing, Amy; Bottomley, Sarah E; Glaser, Adam W; Wright, Penny
2018-05-03
Patient Reported Outcome Measures (PROMs) are important tools used to understand patient focused outcomes from care. Various PROMs have been developed for patients with Bladder Cancer (BC), although the disease's heterogeneity makes selection difficult. Accurate measurement of Health Related Quality of Life (HRQL) can only be achieved if the PROM chosen is 'fit for purpose' (i.e. psychometrically sound). Systematic reviews of psychometric properties are useful for selecting the best PROM for a specific purpose. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) developed a checklist to improve the selection of health measurement instruments as part of a review process. Our aims were to undertake a systematic review, using the COSMIN criteria, to assess the quality of studies that report the psychometric properties of PROMs used with people with BC and determine the psychometric quality of these PROMs. An electronic search of seven databases including PubMed, MEDLINE and EMBASE (PROSPERO reference CRD42016051974) was undertaken to identify English language publications, published between January 1990 and September 2017 that evaluated psychometric properties of PROMs used in BC research. Two researchers independently screened abstracts and selected full text papers. Studies were rated on methodological quality using the COSMIN checklist. Overall, 4,663 records were screened and 23 studies, reporting outcomes in 3,568 patients, were evaluated using the COSMIN checklist. Most PROMs had limited information reported about their psychometric properties. Studies reporting on the Bladder Cancer Index (BCI) and Functional Assessment of Cancer Therapy Vanderbilt Cystectomy Index (FACT-VCI) provided the most detail and these PROMs could be evaluated on the most COSMIN properties. Based on the available evidence, no existing PROM stands out as the most appropriate to measure HRQL in BC populations. This is due to two factors; (i) the
Patel, Nishant; Brown, Robert D; Sarkissian, Carl; De, Shubha; Monga, Manoj
2017-01-01
With a high rate of recurrence, urolithiasis is a chronic disease that impacts quality of life. The Patient Reported Outcomes Measurement Information System is an NIH validated questionnaire to assess patient quality of life. We evaluated the impact of urolithiasis on quality of life using the NIH-sponsored PROMIS-43 questionnaire. Patients reporting to the kidney stone clinic were interviewed to collect information on stone history and demographic information and were asked to complete the PROMIS-43 questionnaire. Quality of life scores were analyzed using gender and age matched groups for the general US population. Statistical comparisons were made based on demographic information and patient stone history. Statistical significance was P<0.05. 103 patients completed the survey. 36% of respondents were male, the average age of the group was 52 years old, with 58% primary income earners, and 35% primary caregivers. 7% had never passed a stone or had a procedure while 17% passed 10 or more stones in their lifetime. Overall, pain and physical function were worse in patients with urolithiasis. Primary income earners had better quality of life while primary caregivers and those with other chronic medical conditions were worse. Patients on dietary and medical therapy had better quality of life scores. Urolithiasis patients subjectively have worse pain and physical function than the general population. The impact of pain on quality of life was greatest in those patients who had more stone episodes, underscoring the importance of preventive measures. Stone prevention measures improve quality of life. Copyright® by the International Brazilian Journal of Urology.
[Patient-reported and patient-weighted outcomes in ophthalmology].
Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M
2010-03-01
Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences.
Garrow, Adam P; Yorke, Janelle; Khan, Naimat; Vestbo, Jørgen; Singh, Dave; Tyson, Sarah
2015-01-01
Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.
Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam
2011-08-01
The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.
An International Standard Set of Patient-Centered Outcome Measures After Stroke.
Salinas, Joel; Sprinkhuizen, Sara M; Ackerson, Teri; Bernhardt, Julie; Davie, Charlie; George, Mary G; Gething, Stephanie; Kelly, Adam G; Lindsay, Patrice; Liu, Liping; Martins, Sheila C O; Morgan, Louise; Norrving, Bo; Ribbers, Gerard M; Silver, Frank L; Smith, Eric E; Williams, Linda S; Schwamm, Lee H
2016-01-01
Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. © 2015 The Authors.
Png, Kelly; Kwan, Yu Heng; Leung, Ying Ying; Phang, Jie Kie; Lau, Jia Qi; Lim, Ka Keat; Chew, Eng Hui; Low, Lian Leng; Tan, Chuen Seng; Thumboo, Julian; Fong, Warren; Østbye, Truls
2018-03-21
This systematic review aimed to identify studies investigating measurement properties of patient reported outcome measures (PROMs) for spondyloarthritis (SpA), and to evaluate their methodological quality and level of evidence relating to the measurement properties of PROMs. This systematic review was guided by the preferred reporting items for systematic review and meta-analysis (PRISMA). Articles published before 30 June 2017 were retrieved from PubMed ® , Embase ® , and PsychINFO ® (Ovid). Methodological quality and level of evidence were evaluated according to recommendations from the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). We identified 60 unique PROMs from 125 studies in 39 countries. Twenty-one PROMs were validated for two or more SpA subtypes. The literature examined hypothesis testing (82.4%) most frequently followed by reliability (60.0%). A percentage of 77.7% and 42.7% of studies that assessed PROMs for hypothesis testing and reliability, respectively had "fair" or better methodological quality. Among the PROMs identified, 41.7% were studied in ankylosing spondylitis (AS) only and 23.3% were studied in psoriatic arthritis (PsA) only. The more extensively assessed PROMs included the ankylosing spondylitis quality of life (ASQoL) and bath ankylosing spondylitis functional index (BASFI) for ankylosing spondylitis, and the psoriatic arthritis quality of life questionnaire (VITACORA-19) for psoriatic arthritis. This study identified 60 unique PROMs through a systematic review and synthesized evidence of the measurement properties of the PROMs. There is a lack of validation of PROMs for use across SpA subtypes. Future studies may consider validating PROMs for use across different SpA subtypes. Copyright © 2018 Elsevier Inc. All rights reserved.
Cook, Karon F; Kallen, Michael A; Buckenmaier, Chester; Flynn, Diane M; Hanling, Steven R; Collins, Teresa S; Joltes, Kristin; Kwon, Kyung; Medina-Torne, Sheila; Nahavandi, Parisa; Suen, Joshua; Gershon, Richard
2017-07-01
In 2009, the Army Pain Management Task Force was chartered. On the basis of their findings, the Department of Defense recommended a comprehensive pain management strategy that included development of a standardized pain assessment system that would collect patient-reported outcomes data to inform the patient-provider clinical encounter. The result was the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The purpose of this study was to assess the validity and response burden of the patient-reported outcome measures in PASTOR. Data for analyses were collected from 681 individuals who completed PASTOR at baseline and follow-up as part of their routine clinical care. The survey tool included self-report measures of pain severity and pain interference (measured using the National Institutes of Health Patient-Reported Outcome Measurement Information System [PROMIS] and the Defense and Veterans Pain Rating scale). PROMIS measures of pain correlates also were administered. Validation analyses included estimation of score associations among measures, comparison of scores of known groups, responsiveness, ceiling and floor effects, and response burden. Results of psychometric testing provided substantial evidence for the validity of PASTOR self-report measures in this population. Expected associations among scores largely supported the concurrent validity of the measures. Scores effectively distinguished among respondents on the basis of their self-reported impressions of general health. PROMIS measures were administered using computer adaptive testing and each, on average, required less than 1 minute to administer. Statistical and graphical analyses demonstrated the responsiveness of PASTOR measures over time. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.
Bryant, Elizabeth; Murtagh, Shemane; Finucane, Laura; McCrum, Carol; Mercer, Christopher; Smith, Toby; Canby, Guy; Rowe, David A; Moore, Ann P
2018-05-11
In response for the need of a freely available, stand-alone, validated outcome measure for use within musculoskeletal (MSK) physiotherapy practice, sensitive enough to measure clinical effectiveness, we developed an MSK patient reported outcome measure. This study examined the validity and reliability of the newly developed Brighton musculoskeletal Patient-Reported Outcome Measure (BmPROM) within physiotherapy outpatient settings. Two hundred twenty-four patients attending physiotherapy outpatient departments in South East England with an MSK condition participated in this study. The BmPROM was assessed for user friendliness (rated feedback, N = 224), reliability (internal consistency and test-retest reliability, n = 42), validity (internal and external construct validity, N = 224), and responsiveness (internal, n = 25). Exploratory factor analysis indicated that a two-factor model provides a good fit to the data. Factors were representative of "Functionality" and "Wellbeing". Correlations observed between the BmPROM and SF-36 domains provided evidence of convergent validity. Reliability results indicated that both subscales were internally consistent with alphas above the acceptable limits for both "Functionality" (α = .85, 95% CI [.81, .88]) and 'Wellbeing' (α = .80, 95% CI [.75, .84]). Test-retest analyses (n = 42) demonstrated a high degree of reliability between "Functionality" (ICC = .84; 95% CI [.72, .91]) and "Wellbeing" scores (ICC = .84; 95% CI [.72, .91]). Further examination of test-retest reliability through the Bland-Altman analysis demonstrated that the difference between "Functionality" and "Wellbeing" test scores did not vary as a function of absolute test score. Large treatment effect sizes were found for both subscales (Functionality d = 1.10; Wellbeing 1.03). The BmPROM is a reliable and valid outcome measure for use in evaluating physiotherapy treatment of MSK conditions. Copyright © 2018 John Wiley & Sons, Ltd.
Teresi, Jeanne A; Jones, Richard N
2016-01-01
The purpose of this article is to introduce the methods used and challenges confronted by the authors of this two-part series of articles describing the results of analyses of measurement equivalence of the short form scales from the Patient Reported Outcomes Measurement Information System ® (PROMIS ® ). Qualitative and quantitative approaches used to examine differential item functioning (DIF) are reviewed briefly. Qualitative methods focused on generation of DIF hypotheses. The basic quantitative approaches used all rely on a latent variable model, and examine parameters either derived directly from item response theory (IRT) or from structural equation models (SEM). A key methods focus of these articles is to describe state-of-the art approaches to examination of measurement equivalence in eight domains: physical health, pain, fatigue, sleep, depression, anxiety, cognition, and social function. These articles represent the first time that DIF has been examined systematically in the PROMIS short form measures, particularly among ethnically diverse groups. This is also the first set of analyses to examine the performance of PROMIS short forms in patients with cancer. Latent variable model state-of-the-art methods for examining measurement equivalence are introduced briefly in this paper to orient readers to the approaches adopted in this set of papers. Several methodological challenges underlying (DIF-free) anchor item selection and model assumption violations are presented as a backdrop for the articles in this two-part series on measurement equivalence of PROMIS measures.
Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin
2018-04-01
An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.
AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.
2018-03-01
Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that
Broderick, Joan E.; Schneider, Stefan; Junghaenel, Doerte U.; Schwartz, Joseph E.; Stone, Arthur A.
2013-01-01
Objective Evaluation of known group validity, ecological validity, and test-retest reliability of four domain instruments from the Patient Reported Outcomes Measurement System (PROMIS) in osteoarthritis (OA) patients. Methods Recruitment of an osteoarthritis sample and a comparison general population (GP) through an Internet survey panel. Pain intensity, pain interference, physical functioning, and fatigue were assessed for 4 consecutive weeks with PROMIS short forms on a daily basis and compared with same-domain Computer Adaptive Test (CAT) instruments that use a 7-day recall. Known group validity (comparison of OA and GP), ecological validity (comparison of aggregated daily measures with CATs), and test-retest reliability were evaluated. Results The recruited samples matched (age, sex, race, ethnicity) the demographic characteristics of the U.S. sample for arthritis and the 2009 Census for the GP. Compliance with repeated measurements was excellent: > 95%. Known group validity for CATs was demonstrated with large effect sizes (pain intensity: 1.42, pain interference: 1.25, and fatigue: .85). Ecological validity was also established through high correlations between aggregated daily measures and weekly CATs (≥ .86). Test-retest validity (7-day) was very good (≥ .80). Conclusion PROMIS CAT instruments demonstrated known group and ecological validity in a comparison of osteoarthritis patients with a general population sample. Adequate test-retest reliability was also observed. These data provide encouraging initial data on the utility of these PROMIS instruments for clinical and research outcomes in osteoarthritis patients. PMID:23592494
Equivalence of electronic and paper-based patient-reported outcome measures.
Campbell, Niloufar; Ali, Faraz; Finlay, Andrew Y; Salek, Sam S
2015-08-01
Electronic formats (ePROs) of paper-based patient-reported outcomes (PROs) should be validated before they can be reliably used. This review aimed to examine studies investigating measurement equivalence between ePROs and their paper originals to identify methodologies used and to determine the extent of such validation. Three databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROs with their validated paper-based originals, with regard to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time. Fifty-five studies investigating 79 instruments met the inclusion criteria. 53 % of the 79 instruments studied were condition specific. Several instruments, such as the SF-36, were reported in more than one publication. The most frequently reported formats for ePROs were Web-based versions. In 78 % of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Of the 30 publications that provided preference data, 87 % found that overall participants preferred the electronic format. When examining equivalence between paper and electronic versions of PROs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of ePROs.
Kotronoulas, Grigorios; Kearney, Nora; Maguire, Roma; Harrow, Alison; Di Domenico, David; Croy, Suzanne; MacGillivray, Stephen
2014-05-10
The systematic use of patient-reported outcome measures (PROMs) has been advocated as an effective way to standardize cancer practice. Yet, the question of whether PROMs can lead to actual improvements in the quality of patient care remains under debate. This review examined whether inclusion of PROM in routine clinical practice is associated with improvements in patient outcomes, processes of care, and health service outcomes during active anticancer treatment. A systematic review of five electronic databases (Medline, EMBASE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], PsycINFO, and Psychology and Behavioral Sciences Collection [PBSC]) was conducted from database inception to May 2012 to locate randomized and nonrandomized controlled trials of patients receiving active anticancer treatment or supportive care irrespective of type of cancer. Based on prespecified eligibility criteria, we included 26 articles that reported on 24 unique controlled trials. Wide variability in the design and use of interventions delivered, outcomes evaluated, and cancer- and modality-specific context was apparent. Health service outcomes were only scarcely included as end points. Overall, the number of statistically significant findings were limited and PROMs' intervention effect sizes were predominantly small-to-moderate. The routine use of PROMs increases the frequency of discussion of patient outcomes during consultations. In some studies, PROMs are associated with improved symptom control, increased supportive care measures, and patient satisfaction. Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health services usage.
Teresi, Jeanne A.; Jones, Richard N.
2017-01-01
The purpose of this article is to introduce the methods used and challenges confronted by the authors of this two-part series of articles describing the results of analyses of measurement equivalence of the short form scales from the Patient Reported Outcomes Measurement Information System® (PROMIS®). Qualitative and quantitative approaches used to examine differential item functioning (DIF) are reviewed briefly. Qualitative methods focused on generation of DIF hypotheses. The basic quantitative approaches used all rely on a latent variable model, and examine parameters either derived directly from item response theory (IRT) or from structural equation models (SEM). A key methods focus of these articles is to describe state-of-the art approaches to examination of measurement equivalence in eight domains: physical health, pain, fatigue, sleep, depression, anxiety, cognition, and social function. These articles represent the first time that DIF has been examined systematically in the PROMIS short form measures, particularly among ethnically diverse groups. This is also the first set of analyses to examine the performance of PROMIS short forms in patients with cancer. Latent variable model state-of-the-art methods for examining measurement equivalence are introduced briefly in this paper to orient readers to the approaches adopted in this set of papers. Several methodological challenges underlying (DIF-free) anchor item selection and model assumption violations are presented as a backdrop for the articles in this two-part series on measurement equivalence of PROMIS measures. PMID:28983448
Patient-reported outcomes in drug development for hematology.
Acquadro, Catherine; Regnault, Antoine
2015-01-01
Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs. © 2015 by The American Society of Hematology. All rights reserved.
Katzan, Irene L; Lapin, Brittany
2018-01-01
The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score <2 versus ≥2. There was moderate internal reliability (ordinal α, 0.82-0.88) and marginal model fit for the 2-factor solution for component scores (root mean square error of approximation, 0.11). Convergent validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P <0.001 for all). There was excellent discrimination for all PROMIS GH items and component scores across modified Rankin Scale levels. Good responsiveness (effect size, >0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings
Santana, Maria-Jose; Feeny, David
2014-06-01
The inclusion of patient-reported outcome measures (PROMs) in the routine clinical care of chronically ill patients has the potential to add valuable information about the impact of the disease and its treatment and promotes effective patient self-management in which patients become more active participants in their own care. PROMs provide clinicians with timely information on patients' symptoms as well as functional and emotional status. PROMs are a useful tool for enhancing patient-clinician communication. We develop a conceptual framework describing the potential effects of the use of PROMs in chronic care management. The framework summarizes insights from the methods for evaluating the clinical effectiveness and methods for the health technology assessment of diagnostic technologies and results from the relevant studies. The framework describes potential effects, from proximal to distal, including communication (patient-clinician, patient-relative, clinician-clinician, and clinician-relative), engaging patients in shared clinical decision making, patient management (clinician management and patient self-management), and patient outcomes. Important potential effects also include enhancement in patient activation as well as improvements in clinician and patient satisfaction, and patient adherence to recommended treatment. Previous frameworks have described patient-physician communication, patient satisfaction, and health outcomes. Our framework adds unique domains, including patient engagement, patient activation, shared clinical decision making, and patient self-management. The framework can be used as a tool to guide the development of interventions to improve chronic care management through the use of PROMs.
Patient Expectations and Patient-Reported Outcomes in Surgery: A Systematic Review
Waljee, Jennifer; McGlinn, Evan P.; Sears, Erika Davis; Chung, Kevin C.
2014-01-01
Background Recent events in healthcare reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) following surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs. Methods We performed a search of the literature published prior to November 1, 2012. Articles were included in the review if 1) primary data were presented 2) patient expectations regarding a surgical procedure were measured 3) PROs were measured, and 4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into five subgroups: satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality. Results From the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 (47%) studies, and poorer PROs for 9 (15%) studies. Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative QOL. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations. Conclusions Patient expectations are inconsistently correlated with PROs following surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policy
Wysham, Nicholas G; Abernethy, Amy P; Cox, Christopher E
2014-10-01
Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.
Wörner, Tobias; Sigurðsson, Haraldur B; Pålsson, Anders; Kostogiannis, Ioannis; Ageberg, Eva
2017-01-01
This study aimed to evaluate patient-reported outcomes as well as lower extremity and trunk muscle function in patients with long-standing hip and groin pain, in comparison with matched, healthy controls. It was hypothesized that patients with long-standing hip and groin pain would report more deficiency on the Copenhagen Hip and Groin Outcome Score (HAGOS) and have worse outcomes on performance-based measures than healthy controls. Nineteen patients with long-standing hip and groin pain and 19 healthy, activity level-, age-, gender-, and weight-matched controls were assessed with the HAGOS for self-reported outcomes, and a parallel squat (w/kg), single-leg triple jump (cm), single-leg rise (n), barbell roll-out (% of height), and plank test (s) for performance-based measures. Independent sample t test was performed to assess between-group differences. The paired t test was used to analyse between-limb differences in unilateral performance tasks. The patients had worse scores than the controls in all HAGOS subscales (p ≤ 0.001), while no statistically significant differences were observed for any performance measure between groups or between symptomatic and non-symptomatic limbs. Despite significant self-reported functional limitations on the HAGOS, there were no significant differences between groups in performance-based strength or power measures. The results of this study highlight the need to identify performance-based measures, sensitive to functional deficiencies in patients with long-standing hip and groin pain in order to complement the clinical picture obtained by patient-reported outcomes such as the HAGOS. III.
Patient Reported Outcomes Measurement Information System in Children with Crohn’s Disease
Arvanitis, Marina; DeWalt, Darren A.; Martin, Christopher F.; Long, Millie D.; Chen, Wenli; Jaeger, Beth; Sandler, Robert S.; Kappelman, Michael D.
2016-01-01
Objectives To assess the criterion validity and responsiveness of Patient Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn’s disease. Study design We recruited children, ages 9 to 17, with Crohn’s disease and their parents from the web-based Crohn’s and Colitis Foundation of America Kids & Teens Study cohort. Upon entry into the cohort and 6 months later, children self-reported Crohn’s disease activity, health-related quality of life and PROMIS domains of pain interference, anxiety, depression, fatigue and peer relationships. Results Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn’s disease activity (per Short Crohn’s disease Activity Index, p<0.005 for all), Crohn’s disease activity in the prior 6 months (per Manitoba Index, p<0.01 for all) and health related quality of life (per IMPACT-35, p<0.001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn’s disease activity reported improved PROMIS scores, and those with worsened Crohn’s disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn’s disease activity reported less improvement (p=0.07). Conclusions PROMIS scores were significantly associated with known groups of Crohn’s disease activity in a linear and clinically meaningful manner, and responded to change in Crohn’s disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS. PMID:27157449
Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus
2017-08-01
Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.
Harris, Nathaniel; Eudy, Amanda; Clowse, Megan
2018-06-15
While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
A systematic review of patient-reported outcome measures in clinical vestibular research
Fong, Eric; Li, Carol; Aslakson, Rebecca; Agrawal, Yuri
2014-01-01
Objective To identify the most commonly-used patient-reported outcome (PRO) measures in clinical vestibular research, and assess their test characteristics and applicability to study age-related vestibular loss (ARVL) in clinical trials. Data Sources We performed a systematic review of the PubMed, CINAHL, and PsycINFO databases from 1950 to August 13, 2013. Study Selection PRO measures were defined as outcomes that capture the subjective experience of the patient, such as symptoms, functional status, health perceptions, and quality of life. Two independent reviewers selected studies that used PRO measures in clinical vestibular research. Disparities were resolved with consensus between the reviewers. Of 2260 articles initially found on literature search, 255 full-text articles were retrieved for assessment. One-hundred and four studies met inclusion criteria for data collection. Data Extraction PRO measures were identified by two independent reviewers. The four most commonly used PROs were evaluated for their applicability to the condition of ARVL. Specifically, for these four PROs, data were collected pertaining to instrument test-retest reliability, item domains, and target population of the instrument. Data Synthesis A total of 50 PRO instruments were identified. The four most frequently utilized PROs were the Dizziness Handicap Inventory (DHI), the Activities-specific Balance Confidence (ABC) scale, the Vertigo Symptom Scale (VSS), and the Visual Analogue Scale (VAS). Of these four PROs, three were validated for use in patients with vestibular disease, and one was validated in community-dwelling older individuals with balance impairments. Items across the four PROs were categorized into three domains based on the International Classification of Functioning, Disability and Health: Activity, Participation, and Body Functions and Structures. Conclusions None of the most commonly-used PRO instruments were validated for use in community-dwelling older adults
U.S. Dental School Deans' Views on the Value of Patient-Reported Outcome Measures in Dentistry.
Rosen, Evan B; Donoff, R Bruce; Riedy, Christine A
2016-06-01
There has historically been limited development and utilization of patient-reported outcome measures (PROMs) in clinical dentistry. However, in recent years PROMs have been recognized by other health care fields as valuable in the comprehensive assessment of patient outcomes. The aim of this study was to survey deans of U.S. dental schools to better understand their vision for the role of PROMs in the field of dentistry. A 13-question online survey was emailed to the deans of the 64 accredited U.S. dental schools at the time to gather their opinions about the value of patient-reported outcomes in dentistry. The survey consisted of questions in 12 domains such as treatment planning, perceived success/complications of surgery, identification/management of dental pain, psychological and oral function, and insurance payment/reimbursement. Of the 64 deans, 33 responses were received (51.5% response rate), but three surveys were excluded due to incomplete answers, resulting in a final response rate of 46.8%. All respondents reported there was value in utilization of PROMs for understanding a patient's satisfaction of a procedure, a patient's perceived success of dental surgery, identifying dental pain, and managing dental pain. However, there was disagreement among the respondents about utilization of PROMs for the purpose of determining insurance payment and/or reimbursement. Additional steps should be taken to develop clinically appropriate PROMs for dentistry and to determine the appropriate situations in which to use dental PROMs. This study suggests that PROMs should be incorporated into dental school curricula as they will likely play a role in future comprehensive treatment assessment.
The medial tibial stress syndrome score: a new patient-reported outcome measure.
Winters, Marinus; Moen, Maarten H; Zimmermann, Wessel O; Lindeboom, Robert; Weir, Adam; Backx, Frank Jg; Bakker, Eric Wp
2016-10-01
At present, there is no validated patient-reported outcome measure (PROM) for patients with medial tibial stress syndrome (MTSS). Our aim was to select and validate previously generated items and create a valid, reliable and responsive PROM for patients with MTSS: the MTSS score. A prospective cohort study was performed in multiple sports medicine, physiotherapy and military facilities in the Netherlands. Participants with MTSS filled out the previously generated items for the MTSS score on 3 occasions. From previously generated items, we selected the best items. We assessed the MTSS score for its validity, reliability and responsiveness. The MTSS score was filled out by 133 participants with MTSS. Factor analysis showed the MTSS score to exhibit a single-factor structure with acceptable internal consistency (α=0.58) and good test-retest reliability (intraclass correlation coefficient=0.81). The MTSS score ranges from 0 to 10 points. The smallest detectable change in our sample was 0.69 at the group level and 4.80 at the individual level. Construct validity analysis showed significant moderate-to-large correlations (r=0.34-0.52, p<0.01). Responsiveness of the MTSS score was confirmed by a significant relation with the global perceived effect scale (β=-0.288, R(2)=0.21, p<0.001). The MTSS score is a valid, reliable and responsive PROM to measure the severity of MTSS. It is designed to evaluate treatment outcomes in clinical studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J
2018-05-01
Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to
Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio
2016-12-01
The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Alvey, James; Palmer, Simon; Otter, Simon
2012-01-01
Measuring the outcome of surgical intervention is an integral part of modern-day healthcare provision. The increasing requirement to monitor patient-reported outcomes highlights the need for patients to be able to read and understand health outcomes questionnaires. The present study compared the readability of 2 commonly used, validated, foot surgery outcome questionnaires (the Foot Health Status Questionnaire and the Manchester-Oxford Foot Questionnaire) using the Flesch Reading Ease score and the Flesch-Kincaid grade level score. The Manchester-Oxford Foot Questionnaire had a significantly greater (p < .003) score for reading ease and a significantly lower reading grade score (p < .005) than the Foot Health Status Questionnaire. These findings suggest the Manchester-Oxford Foot Questionnaire is a more suitable instrument in terms of readability and comprehension for a greater proportion of the population undergoing hallux valgus surgery. Copyright © 2012 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.
Peeters, Geeske; Barker, Anna L; Talevski, Jason; Ackerman, Ilana; Ayton, Darshini R; Reid, Christopher; Evans, Sue M; Stoelwinder, Johannes U; McNeil, John J
2018-05-01
Patient-reported outcome measures (PROMs) capture health information from the patient's perspective that can be used when weighing up benefits, risks and costs of treatment. This is important for elective procedures such as those for coronary revascularisation. Patients should be involved in the development of PROMs to accurately capture outcomes that are important for the patient. The aims of this review are to identify if patients were involved in the development of cardiovascular-specific PROMs used for assessing outcomes from elective coronary revascularisation, and to explore what methods were used to capture patient perspectives. PROMs for evaluating outcomes from elective coronary revascularisation were identified from a previous review and an updated systematic search. The studies describing the development of the PROMs were reviewed for information on patient input in their conceptual and/or item development. 24 PROMs were identified from a previous review and three additional PROMs were identified from the updated search. Full texts were obtained for 26 of the 27 PROMs. The 26 studies (11 multidimensional, 15 unidimensional) were reviewed. Only nine studies reported developing PROMs using patient input. For eight PROMs, the inclusion of patient input could not be judged due to insufficient information in the full text. Only nine of the 26 reviewed PROMs used in elective coronary revascularisation reported involving patients in their conceptual and/or item development, while patient input was unclear for eight PROMs. These findings suggest that the patient's perspective is often overlooked or poorly described in the development of PROMs.
Fagundes, Christopher P; Shi, Qiuling; Vaporciyan, Ara A; Rice, David C; Popat, Keyuri U; Cleeland, Charles S; Wang, Xin Shelley
2015-09-01
Measuring patient-reported outcomes (PROs) has become increasingly important for assessing quality of care and guiding patient management. However, PROs have yet to be integrated with traditional clinical outcomes (such as length of hospital stay), to evaluate perioperative care. This study aimed to use longitudinal PRO assessments to define the postoperative symptom recovery trajectory in patients undergoing thoracic surgery for lung cancer. Newly diagnosed patients (N = 60) with stage I or II non-small cell lung cancer who underwent either standard open thoracotomy or video-assisted thoracoscopic surgery lobectomy reported multiple symptoms from before surgery to 3 months after surgery, using the MD Anderson Symptom Inventory. We conducted Kaplan-Meier analyses to determine when symptoms returned to presurgical levels and to mild-severity levels during recovery. The most-severe postoperative symptoms were fatigue, pain, shortness of breath, disturbed sleep, and drowsiness. The median time to return to mild symptom severity for these 5 symptoms was shorter than the time to return to baseline severity, with fatigue taking longer. Recovery from pain occurred more quickly for patients who underwent lobectomy versus thoracotomy (8 vs 18 days, respectively; P = .022). Patients who had poor preoperative performance status or comorbidities reported higher postoperative pain (all P < .05). Assessing symptoms from the patient's perspective throughout the postoperative recovery period is an effective strategy for evaluating perioperative care. This study demonstrates that the MD Anderson Symptom Inventory is a sensitive tool for detecting symptomatic recovery, with an expected relationship among surgery type, preoperative performance status, and comorbid conditions. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Hung, Man; Nickisch, Florian; Beals, Timothy C; Greene, Tom; Clegg, Daniel O; Saltzman, Charles L
2012-08-01
Accurately measuring, reporting and comparing outcomes is essential for improving health care delivery. Current challenges with available health status scales include patient fatigue, floor/ceiling effects and validity/reliability. This study compared Patient Reported Outcomes Measurement Information System (PROMIS)-based Lower Extremity Physical Function Computerized Adaptive Test (LE CAT) and two legacy scales -the Foot and Function Index (FFI) and the sport module from the Foot and Ankle Ability Measure (spFAAM) -for 287 patients scheduled for elective foot and ankle surgery. We documented the time required by patients to complete the instrument, instrument precision, and the extent to which each instrument covered the full range of physical functioning across the patient sample. Average time of test administration: 66 seconds for LE CAT, 130 seconds for spFAAM and 239 seconds for FFI. All three instruments were fairly precise at intermediate physical functioning levels (i.e., Standard Error of Measurement < 0.35), were relatively less precise at the higher trait levels and the LE CAT maintained precision in the lower range while the spFAAM and FFI's had decreased precision. The LE CAT had less floor/ceiling effects than the FFI and the spFAAM. The LE CAT showed considerable advantage compared to legacy scales for measuring patient-reported outcomes in orthopaedic patients with foot and ankle problems. A paradigm shift to broader use of PROMIS-based CATs should be considered to improve precision and reduce patient burden with patient-reported outcome measuremen foot and ankle patients.
Kahn, Timothy L; Soheili, Aydin; Schwarzkopf, Ran
2013-12-01
Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes. Using cohort data from the Osteoarthritis Initiative, we studied 172 patients who underwent TKA. For each patient, we compiled pre- and postoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scores. Radiographs were measured for knee joint angles, femorotibial angles, anatomical lateral distal femoral angles, and anatomical medial proximal tibial angles; Kellgren and Lawrence (KL) grades were assigned to each compartment of the knee. All studied measurements were compared to WOMAC outcomes. Preoperative WOMAC disability, pain, and total scores were positively associated with postoperative WOMAC total scores (P = .010, P = .010, and P = .009, respectively) and were associated with improvement in WOMAC total scores (P < .001, P < .001, and P < .001, respectively). For radiographic measurements, preoperative joint angles were positively associated with improvements in postoperative WOMAC total scores (P = .044). Combined KL grades (medial and lateral compartments) were negatively correlated with postoperative WOMAC disability and pain scores (P = .045 and P = .044) and were positively correlated with improvements in WOMAC total scores (P = .001). All preoperative WOMAC scores demonstrated positive associations with postoperative WOMAC scores, while among the preoperative radiographic measurements only combined KL grades and joint angles showed any correlation with postoperative WOMAC scores. Higher preoperative KL grades and joint angles were associated with better (lower) postoperative WOMAC scores, demonstrating an
Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R.; Sherry, David D.; Mara, Constance A.; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan
2015-01-01
The Patient Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of seven PROMIS domains for the assessment of children (ages 8-18) with chronic pain – Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function and Peer Relationships. PROMIS measures were administered at the initial visit and two follow-up visits at an outpatient chronic pain clinic (CPC; N=82) and at an intensive amplified pain day-treatment program (AMP; N= 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding “legacy” measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and AMP samples. Longitudinal growth models showed that PROMIS Pain Interference, Anxiety, Depression, Mobility, Upper Extremity and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All seven PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research. PMID:26447704
Kroll, Thilo; Wyke, Sally; Jahagirdar, Deepa; Ritchie, Karen
2014-10-01
Patient-reported outcome measures have received increasing attention with regard to ensuring quality improvement across the health service. However, there is a risk that people with disabilities and low literacy are systematically excluded from the development of these measures as well as their application in clinical practice. This editorial highlights some of these risks and the potential consequences of exclusion for these groups. © 2012 John Wiley & Sons Ltd.
Mills, Kelly A; Mari, Zoltan; Pontone, Gregory M; Pantelyat, Alexander; Zhang, Angela; Yoritomo, Nadine; Powers, Emma; Brandt, Jason; Dawson, Ted M; Rosenthal, Liana S
2016-12-01
In Parkinson's disease, the association between objective and patient-reported measures of cognitive dysfunction is unknown and highly relevant to research and clinical care. To determine which cognitive domain-specific Montreal Cognitive Assessment (MoCA) subscores are most strongly associated with patient-reported cognitive impairment on question 1 (Q1) of the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). We analyzed data from 759 PD participants and 481 persons without PD with in a retrospective, cross sectional analysis using data from the NINDS Parkinson's Disease Biomarkers Program (PDBP), a longitudinal, multicenter biomarker study. The relationship between a patient-reported cognitive rating (MDS-UPDRS q1.1) and objective cognitive assessments (MoCA) was assessed using multinomial logistic regression modeling and the outcomes reported as conditional odds ratios (cOR's) representing the relative odds of a participant reporting cognitive impairment that is "slight" versus "normal" on MDS-UPDRSq1.1 for a one unit increase in a MoCA sub-score, adjusted for age and education. In PD participants, changes in visuospatial-executive performance and memory had the most significant impact on subjective cognitive impairment. A 1-point increase in visuospatial-executive function decreased the chance of reporting a MDS-UPDRS Q1 score of "slight" versus "normal" by a factor of 0.686 (p < 0.001) and each 1 point improvement in delayed recall decreased the odds of reporting "slight" cognitive impairment by a factor of 0.836 (p < 0.001). Conversion from a PD patient's report of "normal" to "slight" cognitive impairment may be associated with changes in visuospatial-executive dysfunction and memory more than other cognitive domains. Copyright © 2016 Elsevier Ltd. All rights reserved.
Boody, Barrett S; Bhatt, Surabhi; Mazmudar, Aditya S; Hsu, Wellington K; Rothrock, Nan E; Patel, Alpesh A
2018-03-01
OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. METHODS The legacy outcome measures Neck Disability Index (NDI) and SF-12 were used as comparisons with PROMIS measures. PROMIS CATs, NDI-10, and SF-12 measures were administered prospectively to 59 consecutive tertiary hospital patients who were treated surgically for degenerative cervical spine disorders. A subscore of NDI-5 was calculated from NDI-10 by eliminating the lifting, headaches, pain intensity, reading, and driving sections and multiplying the final score by 4. Assessments were administered preoperatively (baseline) and postoperatively at 6 weeks and 3 months. Patients presenting for revision surgery, tumor, infection, or trauma were excluded. Participants completed the measures in Assessment Center, an online data collection tool accessed by using a secure login and password on a tablet computer. Subgroup analysis was also performed based on a primary diagnosis of either cervical radiculopathy or cervical myelopathy. RESULTS Convergent validity for PROMIS CATs was supported with multiple statistically significant correlations with the existing legacy measures, NDI and SF-12, at baseline. Furthermore, PROMIS CATs demonstrated known-group validity and identified clinically significant improvements in all measures after surgical intervention. In the cervical radiculopathy and myelopathic cohorts, the PROMIS measures demonstrated similar responsiveness to the
Dirven, Linda; Armstrong, Terri S; Blakeley, Jaishri O; Brown, Paul D; Grant, Robin; Jalali, Rakesh; Leeper, Heather; Mendoza, Tito; Nayak, Lakshmi; Reijneveld, Jaap C; Le Rhun, Emilie; Walbert, Tobias; Weller, Michael; Wen, Patrick Y; Taphoorn, Martin J B
2018-03-01
The Response Assessment in Neuro-Oncology-Patient-Reported Outcome (RANO-PRO) working group is an international multidisciplinary collaboration that provides guidance on the use of patient-reported outcome (PRO) measures in clinical trials and practice for adult patients with brain tumours. Findings from both PROs and traditional outcome measures, such as survival, and clinical or radiological response, are essential to inform the research community, policy makers, physicians, and patients in the treatment decision-making process. Previous initiatives in oncology have focused on guidelines concerning the collection, analysis, interpretation, and reporting of PRO data. However, we recommend the application of appropriate PRO instruments, with respect to its content and measurement properties (ie, research question, content validity, and other measurement properties), in brain tumour research. PROs should be well defined and reliable to generate high-quality evidence, and our recommendations on the use of specific PRO measures could help to improve the quality of PRO evidence derived from neuro-oncological studies, and might add a new dimension in how the value of therapeutics is assessed in patients with brain tumours. In this Policy Review, we present the RANO-PRO working plan for the use of PROs in adults with brain tumours. Copyright © 2018 Elsevier Ltd. All rights reserved.
Skinner, M W; Chai-Adisaksopha, C; Curtis, R; Frick, N; Nichol, M; Noone, D; O'Mahony, B; Page, D; Stonebraker, J S; Iorio, A
2018-01-01
The interest of health care agencies, private payers and policy makers for patient-reported outcomes (PRO) is continuously increasing. There is a substantial need to improve capacity to collect and interpret relevant PRO data to support implementation of patient-centered research and optimal care in haemophilia. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project aims to develop a patient-led research network, to develop a standardized questionnaire to gather patient-reported outcomes and to perform a feasibility study of implementing the PROBE questionnaire. A pilot questionnaire was developed using focus group methodology. Content and face validity were assessed by a pool of persons living with haemophilia (PWH) and content experts through interactive workshops. The PROBE questionnaire was translated with the forward-backward approach. PROBE recruited national haemophilia patient non-governmental organizations (NGOs) to administer the questionnaire to people with and without haemophilia. PROBE measured the time to complete the questionnaire and gathered feedback on its content and clarity; staff time and cost required to implement the questionnaire were also collected. The PROBE questionnaire is comprised of four major sections (demographic data, general health problems, haemophilia-related health problems and health-related quality of life using EQ-5D-5L and EQ-VAS). Seventeen NGOs participated in the pilot study of the PROBE Project, recruiting 656 participants. Of these, 71% completed the questionnaire within 15 min, and all participants completed within 30 min. The median total staff and volunteer time required for the NGOs to carry out the study within their country was 9 h (range 2 to 40 h). NGO costs ranged from $22.00 to $543.00 USD per country, with printing and postage being the most commonly reported expenditures. The PROBE questionnaire assesses patient-important reported outcomes in PWH and control participants, with a
Peters, Rinne M; van Beers, Loes W A H; van Steenbergen, Liza N; Wolkenfelt, Julius; Ettema, Harmen B; Ten Have, Bas L E F; Rijk, Paul C; Stevens, Martin; Bulstra, Sjoerd K; Poolman, Rudolf W; Zijlstra, Wierd P
2018-06-01
Patient-reported outcome measures (PROMs) are used to evaluate the outcome of total hip arthroplasty (THA). We determined the effect of surgical approach on PROMs after primary THA. All primary THAs, with registered preoperative and 3 months postoperative PROMs were selected from the Dutch Arthroplasty Register. Based on surgical approach, 4 groups were discerned: (direct) anterior, anterolateral, direct lateral, and posterolateral approaches. The following PROMs were recorded: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS); Oxford Hip Score; EQ-5D index score; EQ-5D thermometer; and Numeric Rating Scale measuring pain, both active and in rest. The difference between preoperative and postoperative scores was calculated (delta-PROM) and used as primary outcome measure. Multivariable linear regression analysis was performed for comparisons. Cohen's d was calculated as measure of effect size. All examined 4 approaches resulted in a significant increase of PROMs after primary THA in the Netherlands (n = 12,274). The anterior and posterolateral approaches were associated with significantly more improvement in HOOS-PS scores compared with the anterolateral and direct lateral approaches. Furthermore, the posterolateral and anterior approaches showed greater improvement on Numeric Rating Scale pain scores compared with the anterolateral approach. No relevant differences in delta-PROM were seen between the anterior and posterolateral surgical approaches. Anterior and posterolateral surgical approaches showed more improvement in self-reported physical functioning (HOOS-PS) compared with anterolateral and direct lateral approaches in patients receiving a primary THA. However, clinical differences were only small. Copyright © 2018 Elsevier Inc. All rights reserved.
2013-01-01
Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network. PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making. The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item
Alonso, Jordi; Bartlett, Susan J; Rose, Matthias; Aaronson, Neil K; Chaplin, John E; Efficace, Fabio; Leplège, Alain; Lu, Aiping; Tulsky, David S; Raat, Hein; Ravens-Sieberer, Ulrike; Revicki, Dennis; Terwee, Caroline B; Valderas, Jose M; Cella, David; Forrest, Christopher B
2013-12-20
Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item
Mathias, Susan D; Berry, Pamela; Pascoe, Katie; de Vries, Jane; Askanase, Anca D; Colwell, Hilary H; Chang, David J
2017-03-01
The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care. Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ). A second cohort of patients with SLE participated in combined concept elicitation/cognitive debriefing interviews, after which the LSQ was revised. Fourteen patients completed concept elicitation interviews: 93% were female, 57% were white, and 85% had moderate/severe SLE. Current treatments included hydroxychloroquine (93%), steroids (79%), and belimumab (57%), and 43% were biologic naive. Patients were generally satisfied with their treatment and medical care; however, they were dissatisfied with treatment adverse effects and the number of available treatment options. Cognitive debriefing interviews (n = 8) demonstrated that the LSQ was comprehensive, clear, and relevant; therefore, only minor revisions were made to the questionnaire. The LSQ assesses satisfaction with current SLE treatments (25 items), medical care (11 items), and insurance coverage (3 items). The draft LSQ was evaluated in 195 adults with SLE. Fifty-eight percent of patients reported that they were "somewhat satisfied" with their SLE treatment. The LSQ has been developed to assess treatment satisfaction among patients with SLE. Following further testing to support its validity and reliability, it will provide a useful tool to facilitate assessment of satisfaction with treatments for SLE and help inform treatment decisions.
Merriwether, Ericka N; Rakel, Barbara A; Zimmerman, Miriam B; Dailey, Dana L; Vance, Carol G T; Darghosian, Leon; Golchha, Meenakshi; Geasland, Katherine M; Chimenti, Ruth; Crofford, Leslie J; Sluka, Kathleen A
2017-08-01
The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Dual site, university-based outpatient clinics. Women aged 20 to 67 years diagnosed with fibromyalgia. Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P < 0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (r = -0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (r = -0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were r = -0.65 for 'physical function,' r = -0.63 for 'global,' and r = -0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
Kyte, Derek; Cockwell, Paul; Marshall, Tom; Gheorghe, Adrian; Keeley, Thomas; Slade, Anita; Calvert, Melanie
2017-01-01
Background Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM. Results The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients. Conclusions We suggest considering the
Sadiqi, Said; Lehr, A Mechteld; Post, Marcel W; Jacobs, Wilco C H; Aarabi, Bizhan; Chapman, Jens R; Dunn, Robert N; Dvorak, Marcel F; Fehlings, Michael G; Rajasekaran, S; Vialle, Luiz R; Vaccaro, Alexander R; Oner, F Cumhur
2016-08-01
There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. The study used a formal decision-making and consensus process. The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. Combining the results of the preparatory studies, the
Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
Donovan, J L; Hamdy, F C; Lane, J A; Mason, M; Metcalfe, C; Walsh, E; Blazeby, J M; Peters, T J; Holding, P; Bonnington, S; Lennon, T; Bradshaw, L; Cooper, D; Herbert, P; Howson, J; Jones, A; Lyons, N; Salter, E; Thompson, P; Tidball, S; Blaikie, J; Gray, C; Bollina, P; Catto, J; Doble, A; Doherty, A; Gillatt, D; Kockelbergh, R; Kynaston, H; Paul, A; Powell, P; Prescott, S; Rosario, D J; Rowe, E; Davis, M; Turner, E L; Martin, R M; Neal, D E
2016-10-13
Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general
Shah, Nina; Shi, Qiuling; Giralt, Sergio; Williams, Loretta; Bashir, Qaiser; Qazilbash, Muzaffar; Champlin, Richard E; Cleeland, Charles S; Wang, Xin Shelley
2018-04-01
We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p < 0.01). Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p < 0.0001). Finally, the PRO demonstrated significant construct validity for measuring functioning status with MDASI-walking against ECOG-PS as the anchor (AUC = 0.77, 95% CI 0.60-0.94, p = 0.003). The PRO of MDASI-walking interference is a valid physical functioning measure, correlating with an objective functional measure (6MWT) in MM patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.
Xiong, David D; Ye, Wenda; Xiao, Roy; Miller, Jacob A; Mroz, Thomas E; Steinmetz, Michael P; Nagel, Sean J; Machado, Andre G
2018-05-22
Prior studies have shown that patient-reported allergies can be prognostic of poorer postoperative outcomes. To investigate the correlation between self-reported allergies and outcomes after cervical or lumbar spine surgery. Retrospective cohort study at a single tertiary-care institution. All patients undergoing cervical or lumbar spine surgery from 2009-2014. The primary outcome measure was change in the EuroQol-5 Dimensions (EQ-5D) following surgery. Secondary outcomes included change in the Pain Disability Questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ-9), achieving the minimal clinically important difference (MCID) in these measures, as well as cost of admission. Prior to and following surgery, EQ-5D, PDQ, and PHQ-9 were recorded for patients with available data. Paired student's t-tests were used to compare change in these measures following surgery. Multivariable linear and logistic regression were used to assess the relationship between the log transformation of the total number of allergies and outcomes. 592 cervical patients and 4,465 lumbar patients were included. The median number of reported allergies was two. The EQ-5D index increased from 0.539 to 0.703 for cervical patients and from 0.530 to 0.676 for lumbar patients (p<0.01 for both). Patients experienced significant pain improvement by the PDQ (80.1 to 58.2 for cervical patients, 79.4 to 58.1 for lumbar patients; p<0.01). Using multivariable logistic regression, the log transformation of number of allergies predicted significantly higher odds of achieving the PDQ MCID (OR = 2.09, 95% CI 1.05-4.15, p=0.02 for cervical patients; OR = 1.30, 95% CI 1.03-1.68, p=0.03 for lumbar patients). However, this relationship was not durable for patients with follow-up exceeding 1 year. The log transformation of number of allergies for lumbar patients predicted significantly increased cost of admission (β=$3,597, p<0.01) and trended towards significance among cervical patients (β=$1,842, p=0
The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.
Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L
2017-02-01
Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.
Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A; Tugwell, Peter S; Guillemin, Francis
2015-12-01
The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.
Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J.; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G.; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A.; Tugwell, Peter S.; Guillemin, Francis
2016-01-01
Objective The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. Methods The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Results Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Conclusion Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures. PMID:26077410
Eisen, Susan V; Bottonari, Kathryn A; Glickman, Mark E; Spiro, Avron; Schultz, Mark R; Herz, Lawrence; Rosenheck, Robert; Rofman, Ethan S
2011-04-01
Research on patient-centered care supports use of patient/consumer self-report measures in monitoring health outcomes. This study examined the incremental value of self-report mental health measures relative to a clinician-rated measure in predicting functional outcomes among mental health service recipients. Participants (n = 446) completed the Behavior and Symptom Identification Scale, the Brief Symptom Inventory, and the Veterans/Rand Short Form-36 at enrollment in the study (T1) and 3 months later (T2). Global Assessment of Functioning (GAF) ratings, mental health service utilization, and psychiatric diagnoses were obtained from administrative data files. Controlling for demographic and clinical variables, results indicated that improvement based on the self-report measures significantly predicted one or more functional outcomes (i.e., decreased likelihood of post-enrollment psychiatric hospitalization and increased likelihood of paid employment), above and beyond the predictive value of the GAF. Inclusion of self-report measures may be a useful addition to performance measurement efforts.
Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim
2016-03-01
Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology.
Thewlis, Dominic; Fraysse, Francois; Callary, Stuart A; Verghese, Viju Daniel; Jones, Claire F; Findlay, David M; Atkins, Gerald J; Rickman, Mark; Solomon, Lucian B
2017-07-01
Tibial plateau fractures are complex and the current evidence for postoperative rehabilitation is weak, especially related to the recommended postoperative weight bearing. The primary aim of this study was to investigate if loading in the first 12 weeks of recovery is associated with patient reported outcome measures at 26 and 52 weeks postoperative. We hypothesized that there would be no association between loading and patient reported outcome measures. Seventeen patients, with a minimum of 52-week follow-up following fragment-specific open reduction and internal fixation for tibial plateau fracture, were selected for this retrospective analysis. Postoperatively, patients were advised to load their limb to a maximum of 20kg during the first 6 weeks. Loading data were collected during walking using force platforms. A ratio of limb loading (affected to unaffected) was calculated at 2, 6 and 12 weeks postoperative. Knee Injury and Osteoarthritis Scores were collected at 6, 12, 26 and 52 weeks postoperative. The association between loading ratios and patient reported outcomes were investigated. Compliance with weight bearing recommendations and changes in the patient reported outcome measures are described. Fracture reduction and migration were assessed on plain radiographs. No fractures demonstrated any measurable postoperative migration at 52 weeks. Significant improvements were seen in all patient reported outcome measures over the first 52 weeks, despite poor adherence to postoperative weight bearing restrictions. There were no associations between weight bearing ratio and patient reported outcomes at 52 weeks postoperative. Significant associations were identified between the loading ratio at 2 weeks and knee-related quality of life at six months (R 2 =0.392), and between the loading ratio at 6 weeks combined with injury severity and knee-related quality of life at 26 weeks (R 2 =0.441). In summary, weight bearing as tolerated does not negatively affect the
Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.
2017-01-01
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. PMID:28030869
Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Keeley, Thomas; Gheorghe, Adrian; Calvert, Melanie
2016-10-12
Chronic kidney disease (CKD) is associated with symptoms that can significantly reduce the quality of life (QoL) of patients. Patient-reported outcome measures (PROMs) may facilitate the assessment of the impact of disease and treatment on the QoL, from a patient perspective. PROMs can be used in research and routine clinical practice. A systematic review of studies evaluating the measurement properties of PROMs in adults with CKD will be conducted. MEDLINE, EMBASE, PsycINFO and CINAHL Plus will be systematically searched from inception. Hand searching of reference lists and citations of included studies will be carried out. 2 reviewers will independently screen the titles and abstracts of all the studies retrieved during the systematic search to determine their eligibility. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist will be used to appraise the methodological quality of the selected studies following the full-text review. Data on the study population, questionnaire characteristics and measurement properties will be extracted from the selected papers. Finally, a narrative synthesis of extracted data will be undertaken. Ethical permissions are not required for this study as data from published research articles will be used. Findings will be disseminated through publication in a peer-reviewed journal and presented at conferences. This systematic review will provide a comprehensive assessment of the measurement properties of PROMs currently available for use in adult patients with CKD and present evidence which may inform the selection of measures for use in research and clinical practice. CRD42016035554. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Singisetti, Kiran; Muthumayandi, Karthikeyan; Abual-Rub, Zaid; Weir, David
2015-11-01
Navigation technique for total knee replacement has been shown to improve accuracy of prosthesis alignment in several studies. The purpose was to compare the patient-reported outcome measures in primary total knee replacement (TKR) using navigation versus conventional surgical technique at 1- and 2-year follow-up. A retrospective review of prospectively collected patient-reported outcome data for 351 consecutively performed primary TKR was included in the study. The study group (N = 113) included patients who had Triathlon TKR using articular surface mounted (ASM Stryker) navigation technique and control group (N = 238) included patients who had Triathlon TKR using conventional jig. In addition to the WOMAC (Western Ontario and McMaster University Osteoarthritis Index) and SF-36 (Medical Outcomes Trust Short Form-36), a short self-report questionnaire evaluating the level of satisfaction, quality of life and whether patients would undergo knee replacement again. WOMAC: no significant difference between the groups was noted in mean WOMAC pain, function and stiffness scores at 1- and 2-year follow-up. SF-36: no significant difference between the groups was seen except in the physical function component of score at 1 year (p = 0.019). Navigation group mean 56.78 (CI 51.06-62.5) versus conventional group mean 48.34 (44.68-52.01) but this difference was not observed at 2-year follow-up. The overall patient-reported outcome scores improved after total knee replacement but appear to be comparable in both groups at 1- and 2-year follow-up.
Snyder, Claire F.; Jensen, Roxanne E.; Segal, Jodi B.; Wu, Albert W.
2013-01-01
Patient-centered outcomes research (PCOR) aims to improve care quality and patient outcomes by providing information that patients, clinicians, and family members need regarding treatment alternatives, and emphasizing patient input to inform the research process. PCOR capitalizes on available data sources and generates new evidence to provide timely and relevant information and can be conducted using prospective data collection, disease registries, electronic medical records, aggregated results from prior research, and administrative claims. Given PCOR’s emphasis on the patient perspective, methods to incorporate patient-reported outcomes (PROs) are critical. PROs are defined by the U.S. Food & Drug Administration as “Any report coming directly from patients… about a health condition and its treatment.” However, PROs have not routinely been collected in a way that facilitates their use in PCOR. Electronic medical records, disease registries, and administrative data have only rarely collected, or been linked to, PROs. Recent technological developments facilitate the electronic collection of PROs and linkage of PRO data, offering new opportunities for putting the patient perspective in PCOR. This paper describes the importance of and methods for using PROs for PCOR. We (1) define PROs; (2) identify how PROs can be used in PCOR, and the critical role of electronic data methods for facilitating the use of PRO data in PCOR; (3) outline the challenges and key unanswered questions that need to be addressed for the routine use of PROs in PCOR; and (4) discuss policy and research interventions to accelerate the integration of PROs with clinical data. PMID:23774513
Greene, Meridith E; Rolfson, Ola; Nemes, Szilard; Gordon, Max; Malchau, Henrik; Garellick, Göran
2014-06-01
Age, sex, and medical comorbidities may be associated with differences in patient-reported outcome scores after THA. Highest level of education may be a surrogate for socioeconomic status, but the degree to which this is associated with patient-reported outcomes after THA is not known. We investigated the national Swedish Hip Arthroplasty Register for the association of education attainment on patient-reported outcomes 1 year after THA; specifically, we evaluated level of education attainment against health-related quality of life (HRQoL), pain reduction, and satisfaction with treatment 1 year after THA. All THAs for osteoarthritis performed from 2005 through 2007 with complete patient-reported outcome measures (representing 49% of the THAs performed for this diagnosis) were selected from the Swedish Hip Arthroplasty Register. These cases were merged with national databases containing education attainment, marital status, and comorbidities (n = 11,464; mean age of patients, 64 years). The patient-reported outcome measure protocol included the HRQoL measure EuroQol five-dimension scale (EQ-5D), a VAS for pain, the Charnley classification survey, and a VAS addressing THA satisfaction. Linear regression analyses determined the association of preoperative patient factors with patient-reported outcomes. High education attainment was associated with higher HRQoL (EQ-5D index ß(high) = 0.03 ± 0.01; EQ VAS ß(high) = 2.6 ± 0.5) after THA, whereas those with low and medium education were at risk for lower HRQoL. High education was associated with less pain after treatment (ß(high) = -3.3 ± 0.05). Individuals with low or medium education were at risk for less satisfaction with THA (p < 0.001). Our results suggest clinicians should support patients with low and medium education to a greater extent. Identification of patients who will benefit most from THA and educating those at risk for poorer outcomes, like patients with low and medium education, ultimately may improve
Osborne, Candice Lee; Kauvar, David Seth
2017-10-17
The purpose of this study was to link, classify and describe the content of peripheral arterial disease (PAD)-specific patient-reported outcome measures using the International Classification of Functioning. The results were then analyzed to determine if these assessments provide clinicians and researchers with a comprehensive understanding of the lived experience of patients with PAD. Each meaningful concept in identified PAD assessments was linked to the International Classification of Functioning, Disability and Health to determine included and excluded content areas. An overall perspective was assigned to each assessment item. Inter-rater reliability was established using a kappa statistic. The body functions component is most frequently addressed overall followed by the activities and participation component. International Classification of Functioning chapter and category distribution vary greatly between assessments and no assessment comprehensively examines community participation and relationships. The majority of the assessment items are of the health status-disability and quality of life perspectives. The results of this study suggest the need for the development of a comprehensive PAD assessment that includes a more even distribution of International Classification of Functioning topics and subtopics. A more comprehensive assessment would better capture the lived experience of this patient population. Implications for Rehabilitation A better understanding of the data collected using the current peripheral arterial disease-specific patient-reported outcome measures may contribute to the development of more comprehensive assessment tools that will ultimately lead to improved patient care. This study contributes to the preliminary foundation for the development of a peripheral arterial disease International Classification of Functioning, Disability and Health Core Set. Clinicians and researchers interested in using peripheral arterial disease
Reducing Barriers to Patient-Reported Outcome Measures for People With Cognitive Impairments.
Kramer, Jessica M; Schwartz, Ariel
2017-08-01
The field of rehabilitation has increasingly called for the use of patient-reported outcome measures (PROMs) in research and practice. Given that many rehabilitation patients present with conditions associated with cognitive impairments, it is imperative to reduce barriers to PROM use for this population. The purpose of this article is to develop a comprehensive understanding of cognitive accessibility that can prospectively inform the design of PROMs. We put forth the following definition of cognitive accessibility for PROMs: cognitive accessibility is present when assessment design anticipates respondent variability in cognitive abilities and, to the greatest extent possible, reduces cognitive demands and/or supports cognitive processes to enable respondents with a range of cognitive abilities to interpret and respond to assessment items as intended. Our operationalization of cognitive accessibility in measurement in the field of rehabilitation is informed by 2 assumptions: (1) cognitive accessibility results from an interaction between the individual's capacities and the demands of the assessment and assessment context, and (2) individuals with cognitive impairments have the right to be involved in decisions about their lives, including health care decisions. This article proposes 3 design features that can be optimized for cognitive accessibility: content, layout, and administration procedures. We end with a discussion of next steps that the field of rehabilitation measurement can undertake to advance our understanding of cognitive accessibility. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Patient-Reported Outcomes and Return to Activity After Peroneus Brevis Repair.
Steginsky, Brian; Riley, Aimee; Lucas, Douglas E; Philbin, Terrence M; Berlet, Gregory C
2016-02-01
There is limited data on functional outcomes after primary repair of partial peroneal tendon tears. Previous reports have been limited by small cohorts, duration of follow-up, and often included both tenodesis and primary repair. The purpose of this study was to report the functional outcomes and return to activity in the largest cohort to date with partial peroneal tendon tears treated with primary repair. A chart review identified all patients who underwent primary repair of the peroneus brevis tendon from 2008 to 2012. Demographic data, magnetic resonance imaging findings, and postoperative complications were reviewed. Patients were asked to complete a follow-up questionnaire, Foot and Ankle Ability Measure (FAAM), and Foot Function Index (FFI). There were 201 patients who underwent primary repair of the peroneus brevis tendon. The average age at time of operation was 44.3 years. Seventy-one patients returned the follow-up questionnaires with an average follow-up of 4.6 years. Fifty-two patients completed the FFI questionnaire preoperatively and postoperatively. Fifty-nine patients (83.1%) reported a return to regular exercise and sports at final follow-up. At 1 year postoperatively, 76.5% of patients returned to the same preinjury activities, and 62.3% returned to the same level of preinjury activity. Furthermore, 85.9% of patients were satisfied with their outcome, and 91.4% of patients reported they would choose to undergo the same procedure again. The mean FAAM score was 85.2 at follow-up. The mean preoperative and postoperative FFI score was 41.1 and 12.2, respectively. There was a significant improvement in the FFI score of 28.9 after primary peroneus brevis tendon repair (P < .001). Primary repair of peroneus brevis tendon provided consistent improvement in functional outcomes in the majority of patients, as measured by a validated scoring system, the FFI. FAAM scores demonstrated good function compared to historical controls. The majority of patients
Coco, Laura; Colina, Sonia; Atcherson, Samuel R.
2017-01-01
Purpose The purpose of this study was to examine the readability level of the Spanish versions of several audiology- and otolaryngology-related patient-reported outcome measures (PROMs) and include a readability analysis of 2 translation approaches when available—the published version and a “functionalist” version—using a team-based collaborative approach including community members. Method Readability levels were calculated using the Fry Graph adapted for Spanish, as well as the Fernandez-Huerta and the Spaulding formulae for several commonly used audiology- and otolaryngology-related PROMs. Results Readability calculations agreed with previous studies analyzing audiology-related PROMs in English and demonstrated many Spanish-language PROMs were beyond the 5th grade reading level suggested for health-related materials written for the average population. In addition, the functionalist versions of the PROMs yielded lower grade-level (improved) readability levels than the published versions. Conclusion Our results suggest many of the Spanish-language PROMs evaluated here are beyond the recommended readability levels and may be influenced by the approach to translation. Moreover, improved readability may be possible using a functionalist approach to translation. Future analysis of the suitability of outcome measures and the quality of their translations should move beyond readability and include an evaluation of the individual's comprehension of the written text. PMID:28892821
Lansdown, Drew A; Kunze, Kyle; Ukwuani, Gift; Waterman, Brian R; Nho, Shane J
2018-06-01
The specific influence of preoperative and postoperative radiographic measurements on patient-reported outcome measures after hip arthroscopy for femoroacetabular impingement (FAI) remains unclear. To investigate the relationship between radiographic measurements and 2-year outcomes after hip arthroscopy for the treatment of FAI. Case series; Level of evidence, 4. A clinical registry of patients undergoing primary hip arthroscopy for FAI between January 1, 2012, and December 31, 2014, was queried. Outcome measures included the Hip Outcome Score (HOS) Activities of Daily Living (ADL), HOS Sport-Specific Subscale (SSS), modified Harris Hip Score (mHHS), and visual analog scale (VAS) for pain and satisfaction. Preoperative and postoperative radiographic measurements were recorded. Univariate analysis was conducted to identify relationships between all radiographic and demographic variables and outcome scores. A multivariate regression analysis, controlling for demographic factors, was used to identify independent associations between radiographic measurements on plain radiographs and patient-reported outcomes. The authors identified 707 patients who underwent primary hip arthroscopic management for FAI who were included for analysis. Two-year outcome surveys were completed for 78% to 84% of patients. The mean age of the patients was 33.2 ± 12.3 years, and 64.4% of the patients (n = 456) were female. The mean anteroposterior (AP) alpha angle decreased by 34.3° ( P < .0001), false profile alpha angle by 25.2° ( P < .0001), Dunn lateral alpha angle by 28.9° ( P < .0001), lateral center edge angle by 2.6° ( P < .0001), and anterior center edge angle by 3.4° ( P < .0001). The HOS-ADL score increased from 65.7 ± 18.7 preoperatively to 85.9 ± 16.7 postoperatively ( P < .0001), HOS-SSS increased from 43.4 ± 23.1 to 72.6 ± 27.2 ( P < .0001), and mHHS increased from 57.7 ± 14.0 to 79.1 ± 17.2 ( P < .0001). With multivariate analysis, independent predictors of the
Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David
2011-01-01
The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately −1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items. PMID:21697139
Pilkonis, Paul A; Choi, Seung W; Reise, Steven P; Stover, Angela M; Riley, William T; Cella, David
2011-09-01
The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately -1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items.
Regardt, Malin; Basharat, Pari; Christopher-Stine, Lisa; Sarver, Catherine; Björn, Anita; Lundberg, Ingrid E; Wook Song, Yeong; Bingham, Clifton O; Alexanderson, Helene
2015-12-01
The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis. Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM). Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable. The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.
Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny
2013-01-01
Background Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. Objective This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Methods Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. Results ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both P<.001). Most non-consenters (71.1%, 234/329) cited information technology reasons (ie, difficulty using a computer). Questionnaires were fully or partially completed by 85.1% (541/636) of invited participants at T1 (80 questions total), 70.0% (442/631) at T2 (102-108 questions), and 66.3% (414/624) at T3 (148-154 questions), and fully completed at all three time-points by 57.6% (344/597) of participants. Reminders (mainly via email) effectively prompted responses. The PROs were successfully linked with cancer registry data for 100% of patients (N=636). Participant feedback
Psychometric properties of carer-reported outcome measures in palliative care: A systematic review
Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele
2016-01-01
Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683
Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures.
van Bekkum, Marlies L; van Munster, Barbara C; Thunnissen, Peter L M; Smorenburg, Carolien H; Hamaker, Marije E
2015-01-01
The elderly comprise the majority of patients newly diagnosed with cancer. Despite this, little evidence-based data are available on the care of the growing number of older patients with cancer. The objective of the current study was to evaluate the characteristics and outcome measures of current clinical trials on palliative chemotherapy in elderly patients. Fourteen international clinical trials registries were searched using the terms "cancer" and "elderly" to identify clinical palliative chemotherapy trials designed specifically for patients aged 70+ years. From the trial protocol, data were extracted on trial characteristics and outcome measures. Of 127 trials, 81% formulated one or more stringent criteria with respect to organ function; 32% excluded patients with WHO performance status (PS) 2 and 83% with PS3. Functional outcomes, health care utilisation, cognitive function after treatment, and quality of life were reported in 6%, 3%, 6%, and 31% of trials, respectively. In only 16% of trials on palliative cancer treatment, a geriatric assessment was performed at baseline. Although recent years have seen a growing evidence base regarding fit older patients, our study suggests a lack of representative cohorts of older patients and patient-centred outcome measures in current palliative treatment trials for the elderly. Research addressing alternative outcome measures, including quality of life and impact of therapy on general functioning, cognition, and preservation of independence, and incorporation of a geriatric assessment are needed to provide elderly patients with cancer and their treating physicians with realistic information about palliative chemotherapy. Copyright © 2014 Elsevier Inc. All rights reserved.
Update on Outcome Measure Development for Large Vessel Vasculitis: Report from OMERACT 12
Aydin, Sibel Zehra; Direskeneli, Haner; Sreih, Antoine; Alibaz-Oner, Fatma; Gul, Ahmet; Kamali, Sevil; Hatemi, Gulen; Kermani, Tanaz; Mackie, Sarah L.; Mahr, Alfred; Meara, Alexa; Milman, Nataliya; Nugent, Heidi; Robson, Joanna; Tomasson, Gunnar; Merkel, Peter A.
2015-01-01
Objective The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group’s research agenda. Methods The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group’s LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients’ perspectives and that patients have input into the research agenda and process. Results The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. Conclusion The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. PMID:26077399
Ashley, Laura; Jones, Helen; Forman, David; Newsham, Alex; Brown, Julia; Downing, Amy; Velikova, Galina; Wright, Penny
2011-10-26
Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs) is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service. Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups), within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore if and how they relate to disease, treatment and
Albach, Carlos Augusto; Wagland, Richard; Hunt, Katherine J
2018-04-01
This systematic review (1) identifies the current generic and cancer-related patient-reported outcome measures (PROMs) that have been cross-culturally adapted to Brazilian Portuguese and applied to cancer patients and (2) critically evaluates their cross-cultural adaptation (CCA) and measurement properties. Seven databases were searched for articles regarding the translation and evaluation of measurement properties of generic and cancer-related PROMs cross-culturally adapted to Brazilian Portuguese that are applied in adult (≥18 years old) cancer patients. The methodological quality of included studies was assessed using the COSMIN checklist. The bibliographic search retrieved 1674 hits, of which seven studies analysing eight instruments were included in this review. Data on the interpretability of scores were poorly reported. Overall, the quality of the CCA process was inconsistent throughout the studies. None of the included studies performed a cross-cultural validation. The evidence concerning the quality of measurement properties is limited by poor or fair methodological quality. Moreover, limited information regarding measurement properties was provided within the included papers. This review aids the selection process of Brazilian Portuguese PROMs for use in cancer patients. After acknowledging the methodological caveats and strengths of each tool, our opinion is that for quality of life and symptoms assessment the adapted FACT-G version and the ESAS could be recommended, respectively. Future research should rely on the already accepted standards of CCA and validation studies.
Sales, Célia Md; Neves, Inês Td; Alves, Paula G; Ashworth, Mark
2017-11-22
There is increasing interest in individualized patient-reported outcome measures (I-PROMS), where patients themselves indicate the specific problems they want to address in therapy and these problems are used as items within the outcome measurement tool. This paper examined the extent to which 279 items reported in an I-PROM (PSYCHLOPS) added qualitative information which was not captured by two well-established outcome measures (CORE-OM and PHQ-9). Comparison of items was only conducted for patients scoring above the "caseness" threshold on the standardized measures. 107 patients were participating in therapy within addiction and general psychiatric clinical settings. Almost every patient (95%) reported at least one item whose content was not covered by PHQ-9, and 71% reported at least one item not covered by CORE-OM. Results demonstrate the relevance of individualized outcome assessment for capturing data describing the issues of greatest concern to patients, as nomothetic measures do not always seem to capture the whole story. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.
2014-01-01
Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients’ expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process. PMID:24499454
Welch, Lisa C; Trudeau, Jeremiah J; Silverstein, Steven M; Sand, Michael; Henderson, David C; Rosen, Raymond C
2017-01-01
Cognitive impairment is a serious, often distressing aspect of schizophrenia that affects patients' day-to-day lives. Although several interview-based instruments exist to assess cognitive functioning, a reliable measure developed based on the experiences of patients facing cognitive difficulties is needed to complement the objective performance-based assessments. The present article describes the initial development of a patient-reported outcome (PRO) measure to assess the subjective experience of cognitive impairment among patients with schizophrenia, the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). The phases of development included the construction of a conceptual model based on the existing knowledge and two sets of qualitative interviews with patients: 1) concept elicitation interviews to ensure face and content validity from the perspective of people with schizophrenia and 2) cognitive debriefing of the initial item pool. Input from experts was elicited throughout the process. The initial conceptual model included seven domains. The results from concept elicitation interviews (n=80) supported these domains but yielded substantive changes to concepts within domains and to terminology. Based on these results, an initial pool of 53 items was developed to reflect the most common descriptions and languages used by the study participants. Cognitive debriefing interviews (n=22) resulted in the removal of 18 items and modification of 22 other items. The remaining 35 items represented 23 concepts within six domains plus two items assessing bother. The draft PRO measure is currently undergoing psychometric testing as a precursor to broad-based clinical and research use.
Lindeboom, Jerome A; van Wijk, Arjen J
2010-04-01
Flapless implant surgery is considered to offer advantages over the traditional flap access approach. There may be minimized bleeding, decreased surgical times and minimal patient discomfort. Controlled studies comparing patient outcome variables to support these assumptions, however, are lacking. The objective of this clinical study was to compare patient outcome variables using flapless and flapped implant surgical techniques. From January 2008 to October 2008, 16 consecutive patients with edentulous maxillas were included in the study. Patients were randomly allocated to either implant placement with a flapless procedure (eight patients, mean age 54.6 + or - 2.9 years) or surgery with a conventional flap procedure (eight patients, mean age 58.7 + or - 7.2 years). All implants were placed using a Nobel guide CT-guided surgical template. Outcome measures were the Dutch version of the Impact of Event Scale-Revised (IES-R), dental anxiety using the s-DAI and oral health-related quality of life (OHIP-14). Ninety-six implants were successfully placed. All implants were placed as two-phase implants and the after-implant placement dentures were adapted. No differences could be shown between conditions on dental anxiety (s-DAI), emotional impact (IES-R), anxiety, procedure duration or technical difficulty, although the flapless group did score consistently higher. The flap procedure group reported less impact on quality of life and included more patients who reported feeling no pain at all during placement. Differences found in the patient outcome variables do suggest that patients in the flapless implant group had to endure more than patients in the flap group.
Tetar, Shyama; Bakker, Roosje; Jeulink, Marloes; Slotman, Ben J.; Oei, Swie; Haasbeek, Cornelis; De Jong, Karel; Senan, Suresh; Lagerwaard, Frank
2018-01-01
Purpose Magnetic resonance imaging-guided radiation therapy (MRgRT) requires patient positioning within the MR bore and prolonged MR imaging during delivery, both of which are new in radiation oncology. Patient tolerance of MRgRT was prospectively evaluated using patient-reported outcome questionnaires (PRO-Q). Methods Our MRgRT procedure involves daily high-resolution MR scanning, limited re-contouring, daily plan re-optimization, quality assurance (QA), and gated delivery. Patients with claustrophobia are excluded. Mean fraction duration was 45 and 60 minutes for stereotactic treatments during free-breathing and breath-hold, respectively. Patient-controlled video-feedback was used for breath-hold delivery. PRO-Qs collected in the first 150 patients treated included questions on MR-related complaints and also evaluated aspects of active participation. Results Almost one-third of patients (29%) scored at least one PRO-Q item on MR-related complaints as ‘moderate’ or ‘very much’, with noise, feeling cold, and paresthesia being the most frequently scored in this way. Considerable anxiety was reported by 5%, but no medication was required for this in any patient. Patient participation in video feedback for breath-hold delivery was appreciated by the majority of patients, all of whom completed the procedure. Only 5% of patients considered treatment duration to be unacceptably long. Conclusion Despite the lengthy MRgRT procedure, outcomes of PRO-Q indicate that it was well-tolerated by patients. PMID:29719739
Gewandter, Jennifer S.; Dale, William; Magnuson, Allison; Pandya, Chintan; Heckler, Charles E.; Lemelman, Tatyana; Roussel, Breton; Ifthikhar, Rafa; Dolan, James; Noyes, Katia; Mohile, Supriya G.
2015-01-01
Objective In older patients with cancer, we aimed to investigate associations between a patient-reported outcome measure for sarcopenia (SarcoPRO) and the Short Physical Performance Battery (SPPB), self-reported falls, and limitations in instrumental activities of daily living (IADLs). Materials and Methods Assessments were conducted as part of the initial evaluation of older, often frail, patients with cancer seen in the Specialized Oncology Care and Research in the Elderly (SOCARE) clinic. Univariate associations were evaluated using Spearman’s correlation and Wilcoxon sign ranked tests. Logistic regressions were used to identify associations of clinical factors and SarcoPRO scores or SPPB scores with falls and IADL limitations. Results In total, 174 older patients with cancer were evaluated. A moderate correlation was found between the SarcoPRO and the SPPB (ρ = 0.62). After adjusting for multiple clinical factors, neither the SarcoPRO nor the SPPB were associated with falls. In contrast, both higher SarcoPRO (i.e., worse) and lower SPPB (i.e., worse) scores were associated with limitations in IADLs (Odds ratio for one unit change in predictor: SarcoPRO: 1.06, p<0.0001; SPPB: 0.71, p = 0.003, respectively). Models using the SarcoPRO and SPPB explained similar amounts of variability in association with IADL limitations (AUC: 0.88 vs 0.87, respectively). Conclusions The SarcoPRO was moderately associated with the SPPB, an objective measure of physical performance, and was associated with limitations in IADLs. Thus, older patients with cancer who present with IADL limitations should be screened for sarcopenia. The SarcoPRO shows promise as a measure for screening as well as outcome assessment for research on sarcopenia. PMID:26365897
Dowling, N Maritza; Bolt, Daniel M; Deng, Sien; Li, Chenxi
2016-05-26
Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. A
Cappelleri, Joseph C.; Lundy, J. Jason; Hays, Ron D.
2014-01-01
Introduction The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. Methods We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Conclusion Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures. PMID:24811753
Horodniceanu, Erica G; Bal, Vasudha; Dhatt, Harman; Carter, John A; Huang, Vicky; Lasch, Kathryn
2017-06-23
Compliance, palatability, gastrointestinal (GI) symptom, and treatment satisfaction patient- and observer-reported outcome (PRO, ObsRO) measures were developed/modified for patients with transfusion-dependent anemias or myelodysplastic syndrome (MDS) requiring iron chelation therapy (ICT). This qualitative cross-sectional observational study used grounded theory data collection and analysis methods and followed PRO/ObsRO development industry guidance. Patients and caregivers of patients with transfusion-dependent anemias or MDS were individually interviewed face-to-face to cognitively debrief the Compliance, Palatability, GI Symptom Diary, and Modified Satisfaction with Iron Chelation Therapy (SICT) instruments presented electronically. Interviews were conducted in sets. Interviews began open-endedly to spontaneously elicit ICT experiences. Item modifications were debriefed during the later interviews. Interviews were audio recorded, transcribed, and coded. Data was analyzed using ATLAS.ti qualitative research software. Twenty-one interviews were completed (Set 1: 5 patients, 6 caregivers; Set 2: 6 patients, 4 caregivers) in 6 US cities. Mean age was 43 years for patients and 9 years for children of caregivers. Conditions requiring ICT use across groups included transfusion-dependent anemias (85.7%) and MDS (14.3%). Concepts spontaneously reported were consistent with instruments debriefed. Interview analysis resulted in PRO and ObsRO versions of each instrument: Compliance (2 items), Palatability (4 items), GI Symptom Diary (6 items), and Modified SICT (PRO = 13, ObsRO = 17 items). Qualitative research data from cognitive interviews supports the content validity and relevance of the instruments developed/modified. Quantitative validation of these PRO and ObsRO measures is needed testing for validity, reliability, and responsiveness for future research use with new formulations of oral ICT.
Whose quality of life? Ethical implications in patient-reported health outcome measurement.
Hagell, Peter; Reimer, Jan; Nyberg, Per
2009-06-01
Patient-reported health status questionnaires intend to assess illness and therapy from the patients' perspective. To provide fair and valid assessments, they should be equally relevant to major subsets of respondents. Furthermore, disease-specific measures are assumed to be perceived as more relevant than generic ones. This study assessed these assumptions among people with Parkinson's disease. Cross-sectional data from 202 people with Parkinson's disease (54% men; mean age, 70) were analyzed regarding patient-rated relevance and predictors of patient-rated poor relevance of two generic [the 36-item Short Form Health Survey (SF-36) and Nottingham Health Profile (NHP)] and one disease-specific [Parkinson's Disease Questionnaire (PDQ-39)] health status questionnaire. There were no differences in relevance ratings across the questionnaires. Poorer overall quality of life [odds ratio (OR), 2.459] and mental health (OR, 1.023) were associated with poorer patient-rated relevance of the SF-36, and higher age was associated with poorer patient-rated relevance of the PDQ-39 (OR, 1.040). No significant predictors were found for the NHP. The PDQ-39 failed to meet the assumption that disease-specific scales are more relevant than generic ones. Nevertheless, the most important implication of this study is an ethical one. Because the relevance of the SF-36 and PDQ-39 is perceived as poorer by those who fare least well and by older people, these scales may not reflect the perspectives of these groups. This challenges bioethical principles and threatens scientific validity. Perceived relevance of patient-centered outcomes needs to be considered, or the voice of vulnerable groups may be silenced, fair inferences prohibited, and opportunities for improved care lost.
Patient-reported outcome assessment and objective evaluation of chemotherapy-induced alopecia.
Komen, Manon M C; van den Hurk, Corina J G; Nortier, Johan W R; van der Ploeg, T; Smorenburg, Carolien H; van der Hoeven, Jacobus J M
2018-04-01
Alopecia is one of the most distressing side effects of chemotherapy. Evaluating and comparing the efficacy of potential therapies to prevent chemotherapy-induced alopecia (CIA) has been complicated by the lack of a standardized measurement for hair loss. In this study we investigated the correlation between patient-reported outcome assessments and quantitative measurement with the hair check to assess CIA in clinical practice. Scalp cooling efficacy was evaluated by patients by World Health Organisation (WHO) of CIA, Visual Analogue Scale (VAS) and wig use. The Hair Check was used to determine the amount of hair (in mm 2 ) per unit of scalp skin area (in cm 2 ) (Hair Mass Index, HMI). CIA was also evaluated by doctors, nurses and hairdressers. Baseline HMI was not predictive for hair loss. HMI declined throughout all chemotherapy cycles, which was not reflected by patient-reported measures. HMI correlated with patient-reported hair quantity before the start of the therapy, but not with WHO and/or VAS during therapy. Patient's opinion correlated moderately with the opinion of doctors and nurses (ρ = 0.50-0.56 respectively), but strongly with hair dressers (ρ = 0.70). The Hair check is suitable to quantify the amount of hair loss and could complement research on refining outcome of scalp cooling, but the patient's opinion should be considered as the best method to assess hair loss in clinical practice. Trialregister.nl NTR number 3082. Copyright © 2018 Elsevier Ltd. All rights reserved.
PatientViewpoint: a website for patient-reported outcomes assessment.
Snyder, Claire F; Jensen, Roxanne; Courtin, S Orion; Wu, Albert W
2009-09-01
To develop a prototype website to collect patient-reported outcomes in outpatient clinical oncology and link the data with the electronic medical record (EMR). A multidisciplinary Research Network, including experts in outcomes research, clinical oncology, nursing, social work, information technology, EMRs, behavioral science, decision science, clinical trials, law, and a cancer survivor, was formed to design the prototype website. The Research Network developed the initial website specifications, elicited feedback from patients (n = 20) and clinicians (n = 7), constructed the website, and conducted usability testing (n = 10). Clinicians reported that the website could improve clinical practice if it was not burdensome and were most interested in tracking change over time. Patients were interested in using the website because of the potential to facilitate communication with their clinicians. Patients emphasized the importance of short and simple surveys and a user-friendly interface. The PatientView-oint website was designed to meet these specifications. Usability testing suggested that patients had few problems accessing and using the site. Preliminary reports from clinicians and patients suggest that a website to collect PROs and link them with the EMR could help improve the quality of cancer care. Further pilot-testing will evaluate the use, usefulness, and acceptability of PatientViewpoint.
Training clinicians in how to use patient-reported outcome measures in routine clinical practice.
Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina
2015-07-01
Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians
Fiore, Julio F; Figueiredo, Sabrina; Balvardi, Saba; Lee, Lawrence; Nauche, Bénédicte; Landry, Tara; Mayo, Nancy E; Feldman, Liane S
2018-04-01
To appraise the level of evidence supporting the measurement properties of patient-reported outcome measures (PROMs) in the context of postoperative recovery after abdominal surgery. There is growing interest in using PROMs to support value-based care in abdominal surgery; however, to draw valid conclusions regarding patient-reported outcomes data, PROMs with robust measurement properties are required. Eight databases (MEDLINE, EMBASE, Biosis, PsycINFO, The Cochrane Library, CINAHL, Scopus, Web of Science) were searched for studies focused on the measurement properties of PROMs in the context of recovery after abdominal surgery. The methodological quality of individual studies was evaluated using the consensus-based COSMIN checklist. Evidence supporting the measurement properties of each PROM was synthetized according to standardized criteria and compared against the International Society of Quality of Life Research minimum standards for the selection of PROMs for outcomes research. We identified 35 studies evaluating 22 PROMs [12 focused on nonspecific surgical populations (55%), 4 focused on abdominal surgery (18%), and 6 generic PROMs (27%)]. The great majority of the studies (74%) received only poor or fair quality ratings. Measurement properties of PROMs were predominantly supported by limited or unknown evidence. None of the PROMs fulfilled International Society of Quality of Life Research's minimum standards, hindering specific recommendations. There is very limited evidence supporting the measurement properties of existing PROMs used in the context of recovery after abdominal surgery. This precludes the use of these PROMs to support value-based surgical care. Further research is required to bridge this major knowledge gap. International Prospective Register of Systematic Reviews (PROSPERO): CRD42014014349.
Quittner, Alexandra L; Marciel, Kristen K; Salathe, Matthias A; O'Donnell, Anne E; Gotfried, Mark H; Ilowite, Jonathan S; Metersky, Mark L; Flume, Patrick A; Lewis, Sandra A; McKevitt, Matthew; Montgomery, A Bruce; O'Riordan, Thomas G; Barker, Alan F
2014-08-01
The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first disease-specific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented. Reviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N = 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N = 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N = 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1). Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. This interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming. ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.
Rinkel, R N P M; Verdonck-de Leeuw, I M; de Bree, R; Aaronson, N K; Leemans, C R
2015-04-01
The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3 months, 38 patients (21 males, 17 females; mean age 54 years) were included who visited the outpatient clinic for follow-up care 6-155 months after surgical treatment (n = 14) or combined surgery and radiotherapy (n = 24) for oral (n = 21) or oropharyngeal cancer (n = 17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.
Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean
2012-12-01
Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.
Griffiths, C; Armstrong-James, L; White, P; Rumsey, N; Pleat, J; Harcourt, D
2015-03-01
Patient reported outcome measures (PROMs) can identify important information about patient needs and therapeutic progress. The aim of this review was to identify the PROMs that are being used in child and adolescent burn care and to determine the quality of such scales. Computerised and manual bibliographic searches of Medline, Social Sciences Index, Cinahl, Psychinfo, Psycharticles, AMED, and HAPI, were used to identify English-language articles using English-language PROMs from January 2001 to March 2013. The psychometric quality of the PROMs was assessed. 23 studies met the entry criteria and identified 32 different PROMs (31 generic, 1 burns-specific). Overall, the psychometric quality of the PROMs was low; only two generic scales (the Perceived Stigmatisation Questionnaire and the Social Comfort Scale) and only one burns-specific scale (the Children Burn Outcomes Questionnaire for children aged 5-18) had psychometric evidence relevant to this population. The majority of PROMs did not have psychometric evidence for their use with child or adolescent burn patients. To appropriately identify the needs and treatment progress of child and adolescent burn patients, new burns-specific PROMs need to be developed and validated to reflect issues that are of importance to this population. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.
Strategies to use tablet computers for collection of electronic patient-reported outcomes.
Schick-Makaroff, Kara; Molzahn, Anita
2015-01-22
Mobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues. The issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design. Although use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.
Li, Kuan-Yi; Lin, Keh-Chung; Wang, Tien-Ni; Wu, Ching-Yi; Huang, Yan-Hua; Ouyang, Pei
2012-01-01
This investigation examined the demographic characteristics along with 3 measures of motor function in determining outcomes in activities of daily living (ADL) after distributed constraint-induced therapy (dCIT). The study recruited 69 stroke patients who received 3 weeks of dCIT for 2 hours daily, 5 days a week. The self-reported outcome measures for daily function were the Motor Activity Log (MAL) including the amount of use (AOU) and quality of movement (QOM), Nottingham Extended Activities of Daily Living Questionnaire (NEADL), and the Stroke Impact Scale (SIS). Age, sex, onset, side of stroke, Fugl-Meyer assessment (FMA), Wolf Motor Function Test (WMFT), and Action Research Arm Test (ARAT) were the potential predictors. The ARAT grasp-grip-pinch score was the most dominant predictor for MAL-AOU and NEADL (P< 0.05), and the ARAT total score for the subscore of the ADL/instrumental ADL section of the SIS (P< 0.05). The FMA wrist-hand score was a significant predictor for MAL-QOM (P< 0.05). Age was the only demographic factor that significantly predicted NEADL performance (P< 0.05). Among the 3 commonly used measures of motor function after stroke, ARAT was the strongest determinant in predicting MAL-AOU, MAL-QOM, and SIS-ADL/instrumental ADL after dCIT.
Aguiar, Isabella de Carvalho; Veiga, Daniela Francescato; Marques, Thaline Figueiredo; Novo, Neil Ferreira; Sabino Neto, Miguel; Ferreira, Lydia Masako
2017-02-01
The purpose of this study was to assess patient-reported outcomes of breast reconstruction with implants, using the BREAST-Q, in the late postoperative period. A total of 114 women previously operated due to breast cancer, in the late postoperative period (range 6-24 months) were enrolled in this cross-sectional study, and were allocated to either the mastectomy group (MG, n = 57) or reconstruction group (RG, n = 57). Patients in MG and RG, respectively, completed the Brazilian versions of Mastectomy and Reconstruction Modules of the BREAST-Q. The mean age of patients was 46.6 and 44.3 years in MG and RG, respectively. All patients underwent chemotherapy and 6% and 11% of patients underwent radiotherapy in MG and RG, respectively. Patients in the RG reported higher satisfaction with surgical outcome (P < 0.0001). However, no significant between-group differences were found in physical and sexual well-being, or satisfaction with the plastic surgeon, medical team, and office staff. Breast reconstruction with implants increased patient satisfaction with the surgical outcome, but did not influence patients' physical and sexual well-being or their satisfaction with the treatment received. Copyright © 2016 Elsevier Ltd. All rights reserved.
Patient-reported allergies cause inferior outcomes after total knee arthroplasty.
Hinarejos, Pedro; Ferrer, Tulia; Leal, Joan; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan Carles
2016-10-01
The main objective of this study was to analyse the outcomes after total knee arthroplasty (TKA) of a group of patients with at least one self-reported allergy and a group of patients without reported allergies. We hypothesized there is a significant negative influence on clinical outcome scores after TKA in patients with self-reported allergies. Four-hundred and seventy-five patients who had undergone TKA were analysed preoperatively and 1 year after surgery. The WOMAC, KSS and SF-36 scores were obtained. The patients' Yesavage depression questionnaire score was also recorded. The scores of the 330 (69.5 %) patients without self-reported allergies were compared to the scores of the 145 (30.5 %) patients with at least one self-reported allergy in the medical record. Preoperative scores were similar in both groups. The WOMAC post-operative scores (23.6 vs 20.4; p = 0.037) and the KSS-Knee score (91.1 vs 87.6; p = 0.027) were worse in the group of patients with self-reported allergies than in the group without allergies. The scores from the Yesavage depression questionnaire and in the SF-36 were similar in both groups. Patients with at least one self-reported allergy have worse post-operative outcomes in terms of the WOMAC and KSS-Knee scores after TKA than patients without allergies. These poor outcomes do not seem to be related to depression. Therefore, more research is needed to explain them. Reported allergies could be considered a prognostic factor and used when counselling TKA patients. I.
Alkhaffaf, Bilal; Glenny, Anne-Marie; Blazeby, Jane M; Williamson, Paula; Bruce, Iain A
2017-08-09
Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.
Patchick, Emma L; Horne, Maria; Woodward-Nutt, Kate; Vail, Andy; Bowen, Audrey
2015-12-01
Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials. Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems. Qualitative semi-structured interviews in participants' homes. Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke. Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure. Participants identified important impacts of their 'invisible' cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like 'bothered' and 'frustration' were often used. The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers. © 2014 John Wiley & Sons Ltd.
Camuso, Natasha; Bajaj, Prerna; Dudgeon, Deborah; Mitera, Gunita
2016-08-01
Tools to collect patient-reported outcome measures (PROMs) are frequently used in the healthcare setting to collect information that is most meaningful to patients. Due to discordance among how patients and healthcare providers rank symptoms that are considered most meaningful to the patient, engagement of patients in the development of PROMs is extremely important. This review aimed to identify studies that described how patients are involved in the item generation stage of cancer-specific PROM tools developed for cancer patients. A literature search was conducted using keywords relevant to PROMs, cancer, and patient engagement. A manual search of relevant reference lists was also conducted. Inclusion criteria stipulated that publications must describe patient engagement in the item generation stage of development of cancer-specific PROM tools. Results were excluded if they were duplicate findings or non-English. The initial search yielded 230 publications. After removal of duplicates and review of publications, 6 were deemed relevant. Fourteen additional publications were retrieved through a manual search of references from relevant publications. A total of 13 unique PROM tools that included patient input in item generation were identified. The most common method of patient engagement was through qualitative interviews or focus groups. Despite recommendations from international groups and the emphasized importance of incorporating patient feedback in all stages of development of PROMs, few unique tools have incorporated patient input in item generation of cancer-specific tools. Moving forward, a framework of best practices on how to best engage patients in developing PROMs is warranted to support high-quality patient-centered care.
The French-Canadian validation of a disease-specific, patient-reported outcome measure for lupus.
Bourré-Tessier, J; Clarke, A E; Kosinski, M; Mikolaitis-Preuss, R A; Bernatsky, S; Block, J A; Jolly, M
2014-12-01
The objective of this paper is to perform the cross-cultural validation of the French version of the LupusPRO, a disease-targeted patient-reported outcome measure, among systemic lupus erythematosus (SLE) patients in Canada. The French version of the LupusPRO and the MOS SF-36 were administered; demographic, clinical and serological characteristics were obtained. Disease activity (SELENA-SLEDAI and the Lupus Foundation of America definition of flare) and damage (SLICC/ACR SDI) were assessed. Physician disease activity and damage assessments were ascertained using visual analog scales. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity, damage or health status) and known group validity were tested. A total of 99 French-Canadian SLE patients participated (97% women, mean (SD) age 45.2 (14.5) years). The median (IQR) SELENA-SLEDAI and SDI were 3.5 (6.0) and 1.0 (2.0), respectively. The ICR of the LupusPRO domains ranged from 0.81 to 0.93 (except for lupus symptoms, procreation and coping), while TRT ranged from 0.72 to 0.95. Convergent and discriminant validity, criterion validity and known group validity against disease activity, damage and health status measures were observed. Confirmatory factor analysis showed a good fit. The LupusPRO has fair psychometric properties among French-Canadian patients with SLE. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
Teresi, Jeanne A.; Ramirez, Mildred; Lai, Jin-Shei; Silver, Stephanie
2009-01-01
Examination of the equivalence of measures involves several levels, including conceptual equivalence of meaning, as well as quantitative tests of differential item functioning (DIF). The purpose of this review is to examine DIF in patient-reported outcomes. Reviewed were measures of self-reported depression, quality of life (QoL) and general health. Most measures of depression contained large amounts of DIF, and the impact of DIF at the scale level was typically sizeable. The studies of QoL and health measures identified a moderate amount of DIF; however, many of these studies examined only one type of DIF (uniform). Relative to DIF analyses of depression measures, less analysis of the impact of DIF on QoL and health measures was performed, and the authors of these analyses generally did not recommend remedial action, with one notable exception. While these studies represent good beginning efforts to examine measurement equivalence in patient-reported outcome measures, more cross-validation work is required using other (often larger) samples of different ethnic and language groups, as well as other methods that permit more extensive analyses of the type of DIF, together with magnitude and impact. PMID:20165561
Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study
Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira
2017-01-01
Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive
Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.
2017-01-01
Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia
2013-01-01
Background Despite growing interest and urges by leading experts for the routine collection of patient reported outcome (PRO) measures in all general care patients, and in particular cancer patients, there has not been an updated comprehensive review of the evidence regarding the impact of adopting such a strategy on patients, service providers and organisations in an oncologic setting. Methods Based on a critical analysis of the three most recent systematic reviews, the current systematic review developed a six-method strategy in searching and reviewing the most relevant quantitative studies between January 2000 and October 2011 using a set of pre-determined inclusion criteria and theory-based outcome indicators. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to rate the quality and importance of the identified publications, and the synthesis of the evidence was conducted. Results The 27 identified studies showed strong evidence that the well-implemented PROs improved patient-provider communication and patient satisfaction. There was also growing evidence that it improved the monitoring of treatment response and the detection of unrecognised problems. However, there was a weak or non-existent evidence-base regarding the impact on changes to patient management and improved health outcomes, changes to patient health behaviour, the effectiveness of quality improvement of organisations, and on transparency, accountability, public reporting activities, and performance of the health care system. Conclusions Despite the existence of significant gaps in the evidence-base, there is growing evidence in support of routine PRO collection in enabling better and patient-centred care in cancer settings. PMID:23758898
Tadić, V; Rahi, J S
2017-01-01
The purpose of this article is to summarise methodological challenges and opportunities in the development and application of patient reported outcome measures (PROMs) for the rare and complex population of children with visually impairing disorders. Following a literature review on development and application of PROMs in children in general, including those with disabilities and or/chronic condition, we identified and discuss here 5 key issues that are specific to children with visual impairment: (1) the conflation between theoretically distinct vision-related constructs and outcomes, (2) the importance of developmentally appropriate approaches to design and application of PROMs, (3) feasibility of standard questionnaire formats and administration for children with different levels of visual impairment, (4) feasibility and nature of self-reporting by visually impaired children, and (5) epidemiological, statistical and ethical considerations. There is an established need for vision-specific age-appropriate PROMs for use in paediatric ophthalmology, but there are significant practical and methodological challenges in developing and applying appropriate measures. Further understanding of the characteristics and needs of visually impaired children as questionnaire respondents is necessary for development of quality PROMs and their meaningful application in clinical practice and research. PMID:28085146
Updating the OMERACT filter: implications for patient-reported outcomes.
Kirwan, John R; Bartlett, Susan J; Beaton, Dorcas E; Boers, Maarten; Bosworth, Ailsa; Brooks, Peter M; Choy, Ernest; de Wit, Maarten; Guillemin, Francis; Hewlett, Sarah; Kvien, Tore K; Landewé, Robert B; Leong, Amye L; Lyddiatt, Anne; March, Lyn; May, James; Montie, Pamela Lesley; Nikaï, Enkeleida; Richards, Pam; Voshaar, Marieke M J H; Smeets, Wilma; Strand, Vibeke; Tugwell, Peter; Gossec, Laure
2014-05-01
At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied. Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved. Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons. Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.
Letchford, Robert; Sparkes, Valerie; van Deursen, Robert W M
2015-06-01
A return to pre injury activity participation remains a common but often elusive goal following ACL injury. Investigations to improve our understanding of participation restrictions are limited by inconsistent use of insufficiently investigated measurement tools. The aim of this study was to follow the consensus based standards for the selection of health measurement instruments (COSMIN) guideline to provide a comparative evaluation of four patient reported outcomes (PROMs) on the basis of measurement properties. This will inform recommendations for measuring participation of ACL injured subjects, particularly in the United Kingdom (UK) National Health Service (NHS). Thirteen criteria were compiled from the COSMIN guideline. These included reliability, measurement error, content validity, construct validity, responsiveness and interpretability. Data from 51 subjects collected as part of a longitudinal observational study of recovery over the first year following ACLR was used in the analysis. Of the thirteen criteria, the required standard was met in 11 for Tegner, 11 for International Knee Documentation Committee (IKDC), 6 for Cincinnati Sports Activity Scale (CSAS) and 6 for Marx. The two weaknesses identified for the Tegner are more easily compensated for during interpretation than those in the IKDC; for this reason the Tegner is the recommended PROM. The Tegner activity rating scale performed consistently well in respect of all measurement properties in this sample, with clear benefits over the other PROMs. The measurement properties presented should be used to inform implementation and interpretation of this outcome measure in clinical practice and research. Level II prospective study. Copyright © 2015 Elsevier B.V. All rights reserved.
Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.
Berlowitz, Dan R; Foy, Capri G; Kazis, Lewis E; Bolin, Linda P; Conroy, Molly B; Fitzpatrick, Peter; Gure, Tanya R; Kimmel, Paul L; Kirchner, Kent; Morisky, Donald E; Newman, Jill; Olney, Christine; Oparil, Suzanne; Pajewski, Nicholas M; Powell, James; Ramsey, Thomas; Simmons, Debra L; Snyder, Joni; Supiano, Mark A; Weiner, Daniel E; Whittle, Jeff
2017-08-24
The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment
The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.
Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret
2016-01-01
Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS ® initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS ® initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs. 1 Incorporating PROMIS ® outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS ® initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or web
The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.
Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret
2016-09-01
Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS ® initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS ® initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs. 1 Incorporating PROMIS ® outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS ® initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or web
[Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].
Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J
2018-02-01
The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.
Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B
2015-09-01
An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to
Neale, Joanne; Vitoratou, Silia; Finch, Emily; Lennon, Paul; Mitcheson, Luke; Panebianco, Daria; Rose, Diana; Strang, John; Wykes, Til; Marsden, John
2016-08-01
Patient Reported Outcome Measures (PROMs) assess health status and health-related quality of life from the patient/service user perspective. Our study aimed to: i. develop a PROM for recovery from drug and alcohol dependence that has good face and content validity, acceptability and usability for people in recovery; ii. evaluate the psychometric properties and factorial structure of the new PROM ('SURE'). Item development included Delphi groups, focus groups, and service user feedback on draft versions of the new measure. A 30-item beta version was completed by 575 service users (461 in person [IP] and 114 online [OL]). Analyses comprised rating scale evaluation, assessment of psychometric properties, factorial structure, and differential item functioning. The beta measure had good face and content validity. Nine items were removed due to low stability, low factor loading, low construct validity or high complexity. The remaining 21 items were re-scaled (Rasch model analyses). Exploratory and confirmatory factor analyses revealed 5 factors: substance use, material resources, outlook on life, self-care, and relationships. The MIMIC model indicated 95% metric invariance across the IP and OL samples, and 100% metric invariance for gender. Internal consistency and test-retest reliability were granted. The 5 factors correlated positively with the corresponding WHOQOL-BREF and ARC subscales and score differences between participant sub-groups confirmed discriminative validity. 'SURE' is a psychometrically valid, quick and easy-to-complete outcome measure, developed with unprecedented input from people in recovery. It can be used alongside, or instead of, existing outcome tools. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.
Khanna, Puja; Agarwal, Nikhil; Khanna, Dinesh; Hays, Ron D.; Chang, Lin; Bolus, Roger; Melmed, Gil; Whitman, Cynthia B.; Kaplan, Robert M.; Ogawa, Rikke; Snyder, Bradley; Spiegel, Brennan M.R.
2014-01-01
OBJECTIVES Because gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse—the GI-PRO database. METHODS Using a protocol developed by the NIH Patient-Reported Outcome Measurement Information System (PROMIS®), we performed a systematic review to identify English-language GI PROs. We abstracted PRO items and developed an online searchable item database. We categorized symptoms into content “bins” to evaluate a framework for GI symptom reporting. Finally, we assigned a score for the methodological quality of each PRO represented in the published literature (0–20 range; higher indicates better). RESULTS We reviewed 15,697 titles (κ > 0.6 for title and abstract selection), from which we identified 126 PROs. Review of the PROs revealed eight GI symptom “bins”: (i) abdominal pain, (ii) bloat/gas, (iii) diarrhea, (iv) constipation, (v) bowel incontinence/soilage, (vi) heartburn/reflux, (vii) swallowing, and (viii) nausea/vomiting. In addition to these symptoms, the PROs covered four psychosocial domains: (i) behaviors, (ii) cognitions, (iii) emotions, and (iv) psychosocial impact. The quality scores were generally low (mean 8.88±4.19; 0 (min)−20 (max)). In addition, 51% did not include patient input in developing the PRO, and 41% provided no information on score interpretation. CONCLUSIONS GI PROs cover a wide range of biopsychosocial symptoms. Although plentiful, GI PROs are limited by low methodological quality. Our online PRO library (www.researchcore.org/gipro/) can help in selecting PROs for clinical and research purposes. PMID:24343547
Romero, Melissa M; Flood, Lisa Sue; Gasiewicz, Nanci K; Rovin, Richard; Conklin, Samantha
2015-12-01
At present there is a lack of well-validated surveys used to measure quality of life in patients with malignant brain tumors and their caregivers. The main objective of this pilot study was to validate the National Institutes of Health Patient-Reported Outcomes Measurement Information System (NIH PROMIS) survey for use as a quality-of-life measure in this population. This article presents the rationale for using the NIH PROMIS instrument as a quality-of-life measure for patients with malignant brain tumors and their caregivers. Copyright © 2015 Elsevier Inc. All rights reserved.
Taylor, Fiona; Higgins, Sophie; Carson, Robyn T; Eremenco, Sonya; Foley, Catherine; Lacy, Brian E; Parkman, Henry P; Reasner, David S; Shields, Alan L; Tack, Jan; Talley, Nicholas J
2018-01-01
Objectives: The Functional Dyspepsia Symptom Diary (FDSD) was developed to address the lack of symptom-focused, patient-reported outcome (PRO) measures designed for use in functional dyspepsia (FD) patients and meeting Food and Drug Administration recommendations for PRO instrument development. Methods: Concept elicitation interviews were conducted with FD participants to identify symptoms important and relevant to FD patients. A preliminary version of the FDSD was constructed, then completed by FD participants on an electronic device in cognitive interviews to evaluate the readability, comprehensibility, relevance, and comprehensiveness of the FDSD, and to preliminarily evaluate its measurement properties. Results: During concept elicitation interviews, 45 participants spontaneously reported 19 symptom concepts. Of those, seven symptoms were selected for assessment by the eight-item FDSD. Cognitive interviews with 57 participants confirmed that participants were able to comprehend and provide meaningful responses to the FDSD, and that the handheld electronic FDSD format was suitable for use in the target population. Scores of the FDSD were well-distributed among response options, item discrimination indices suggested that the FDSD items differentiate among patients with varying degrees of FD severity, and inter-item correlations suggested that no items of the FDSD were capturing redundant information. Internal consistency estimates (0.87) and construct-related validity estimates using known-groups methods were within acceptable ranges. Conclusions: The FDSD is a content-valid PRO measure, with preliminary psychometric evidence providing support for the FDSD’s items and total score. Further psychometric evaluations are recommended to more fully test the FDSD’s score performance and other measurement properties in the target patient population. PMID:28925989
Herrington, Lee
2014-01-01
Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that
Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation.
Abel, Gregory A; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y; Odejide, Oreofe O; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert
2016-08-01
Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days after their first autologous or allogeneic HCT at 3 high-volume centers. We assessed decreases in household income; difficulty with HCT-related costs, such as need to relocate or travel; and 2 types of hardship: hardship_1 (reporting 1 or 2 of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month) and "hardship_2" (reporting all 3). Patient-reported stress was measured with the Perceived Stress Scale-4, and 7-point scales were provided for perceptions of overall quality of life (QOL) and health. In total, 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline after HCT, 56% reported hardship_1, and 15% reported hardship_2. In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (odds ratio, 6.9; 95% confidence interval, 3.8 to 12.3). Hardship_1 was associated with QOL below the median (odds ratio, 2.9; 95% confidence interval, 1.7 to 4.9), health status below the median (odds ratio, 2.2; 95% confidence interval, 1.3 to 3.6), and stress above the median (odds ratio, 2.1; 95% confidence interval, 1.3 to 3.5). In this sizable cohort of HCT patients, financial hardship was prevalent and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship-especially those that ameliorate HCT-specific costs-are likely to improve patient-reported outcomes. Copyright © 2016
Rapport, Frances L; Boisvert, Isabelle; McMahon, Catherine M; Hutchings, Hayley A
2017-01-01
Introduction In the UK, it is estimated that a disabling hearing loss (HL) affects 1 in 6 people. HL has functional, economic and social-emotional consequences for affected individuals. Intervention for HL focuses on improving access to the auditory signal using hearing aids or cochlear implants. However, even if sounds are audible and speech is understood, individuals with HL often report increased effort when listening. Listening effort (LE) may be measured using self-reported measures such as patient-reported outcome measures (PROMs). PROMs are validated questionnaires completed by patients to measure their perceptions of their own functional status and well-being. When selecting a PROM for use in research or clinical practice, it is necessary to appraise the evidence of a PROM’s acceptability to patients, validity, responsiveness and reliability. Methods and analysis A systematic review of studies evaluating the measurement properties of PROMs available to measure LE in HL will be undertaken. MEDLINE, EMBASE, CINAHL, PsychINFO and Web of Science will be searched electronically. Reference lists of included studies, key journals and the grey literature will be hand-searched to identify further studies for inclusion. Two reviewers will independently complete title, abstract and full-text screening to determine study eligibility. Data on the characteristics of each study and each PROM will be extracted. Methodological quality of the included studies will be appraised using the COnsensus-based Standards for the selection of health Measurement INstruments, the quality of included PROMs appraised and the credibility of the evidence assessed. A narrative synthesis will summarise extracted data. Ethics and dissemination Ethical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals, conference presentations and the lead author’s doctoral dissertation. Findings may inform the
Stambough, Jeffrey B; Xiong, Ao; Baca, Geneva R; Wu, Ningying; Callaghan, John J; Clohisy, John C
2016-02-01
In a new health care economy, there is an emerging need to understand and quantify predictors of total hip arthroplasty (THA) outcomes. We investigated the association between preoperative radiographic disease (as measured quantitatively by joint space width [JSW]) and patient-reported function, activity, pain, and quality of life after THA. We retrospectively analyzed 146 patients (146 hips) 55 years or younger with a diagnosis of osteoarthritis who underwent cementless THA between January 2009 and December 2010. Preoperative pelvic radiographs were measured by 1 author blinded to clinical outcomes to establish JSW, defined as the shortest distance between the femoral head margin and the superolateral weight-bearing portion of the acetabulum. The JSW value was treated as a continuous variable when applied to statistical modeling. The relationship between the JSW and the improvement of clinical outcome was examined via a general linear modeling approach with adjustments for patients' age, body mass index, and sex. We identified an inverse relationship between preoperative JSW and improvements in functional, activity, pain, and quality of life. We found that, as JSW decreased by 1 mm, the outcome measure improvements were modified Harris Hip Score of 6.3 (p<0.001); SF-12 physical: 2.1 (p=0.027); WOMAC-pain: 4.8 (p=0.01); and UCLA Activity: 0.44 (p=0.02). Our results demonstrate that patients with greater preoperative joint space have less predictable improvement in terms of function, pain relief, and activity. These findings suggest that THA in young patients with a JSW less than 1.5 to 2 mm provides more predictable improvements in pain and functional outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.
Patient-reported outcomes and diabetes technology: a systematic review of the literature.
Rubin, Richard R; Peyrot, Mark
2010-08-01
Advanced diabetes technology should have benefits not only in terms of clinical outcomes, but also in terms of patient-reported outcomes. The objective of this paper is to review the methodology and findings of studies that assessed the effects of diabetes technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and integrated CSII/CGM on patientreported outcomes. The existing literature in pediatric and adult patients is limited, so there is no conclusive evidence that use of CSII, CGM, or integrated CSII/CGM systems produce improved patient-reported outcomes, but most studies provide evidence that these technologies yield some patient-reported outcomes advantages, and few indicate any disadvantages. We expect that more robust studies in the future will provide further evidence regarding the impact of these technologies for patient-reported outcomes, including general health-related quality-of-life, diabetesspecific quality-of-life, treatment satisfaction, and treatment preference.
Defining Outcome Measures for Psoriasis: The IDEOM Report from the GRAPPA 2016 Annual Meeting.
Callis Duffin, Kristina; Gottlieb, Alice B; Merola, Joseph F; Latella, John; Garg, Amit; Armstrong, April W
2017-05-01
The International Dermatology Outcome Measures (IDEOM) psoriasis working group was established to develop core domains and measurements sets for psoriasis clinical trials and ultimately clinical practice. At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, the IDEOM psoriasis group presented an overview of its progress toward developing this psoriasis core domain set. First, it summarized the February 2016 meeting of all involved with the IDEOM, highlighting patient and payer perspectives on outcome measures. Second, the group presented an overview of the consensus process for developing the core domain set for psoriasis, including previous literature reviews, nominal group exercises, and meeting discussions. Future plans include the development of working groups to review candidate measures for at least 2 of the domains, including primary pathophysiologic manifestations and patient-reported outcomes, and Delphi surveys to gain consensus on the final psoriasis core domain set.
Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation
Abel, Gregory A.; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y.; Odejide, Oreofe O.; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert
2016-01-01
Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients, nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days post first autologous or allogeneic HCT at three high-volume centers. We assessed decreases in household income, difficulty with HCT-related costs such as need to relocate or travel, and two types of hardship: “hardship_1” (reporting one or two of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month), and “hardship_2” (reporting all three). Patient-reported stress was measured with the Perceived Stress Scale (PSS-4), and seven-point scales were provided for perceptions of overall quality of life (QOL) and health. 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline post-HCT, 56% reported “hardship_1” and 15% “hardship 2.” In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (OR 6.9 [3.8, 12.3]). “Hardship_1” was associated with QOL below the median (OR 2.9 [1.7, 4.9]), health status below the median (OR 2.2 [1.3, 3.6]), and stress above the median (OR 2.1 [1.3, 3.5]). In this sizable cohort of HCT patients, financial hardship was prevalent, and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship—especially those that ameliorate HCT-specific costs—are likely to improve patient-reported outcomes. PMID:27184627
Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O
2017-05-01
Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We
Yarlas, Aaron; Yen, Linnette; Hodgkins, Paul
2015-03-01
Ulcerative colitis (UC) is associated with impaired health-related quality of life (HRQL) and work-related outcomes (WRO). This analysis examined correspondences among measures of HRQL and WRO in patients with UC, as well as the magnitude of each measure's responsiveness to disease activity and treatment. An open-label, prospective trial of delayed-release mesalamine tablets formulated with MMX(®) technology included 8 weeks of treatment for patients with active mild-to-moderate UC (n = 137) and 12 months of maintenance treatment for patients with quiescent UC (n = 206). Spearman correlations (ρ) measured inter-domain associations across measures of generic HRQL [12-item Short-Form Health Survey (SF-12v2)], disease-specific HRQL [Short Inflammatory Bowel Disease Questionnaire (SIBDQ)], and disease-specific WRO [Work Productivity and Activity Impairment for Specific Health Problems (WPAI:SHP)]. Responsiveness to disease activity and treatment was assessed for each instrument. Changes in scores from baseline to week 8 were moderately correlated across all instrument domains: 65 of 80 (81 %) between-instrument inter-domain correlations were of moderate magnitude (0.30 < ρ < 0.70), with an average magnitude of 0.42 [95 % confidence interval (CI) 0.38-0.46]. Associations between symptom measures were stronger for SIBDQ (|average ρ| = 0.41; 95 % CI 0.34-0.48) and WPAI:SHP (0.40; 0.30-0.47) than SF-12v2 (0.30; 0.27-0.34). SIBDQ was most sensitive to treatment [effect size (d z ) for change from baseline to week 8 = 0.62; 95 % CI 0.35-0.89], followed by WPAI:SHP (d z = 0.43; 0.32-0.54) and SF-12v2 (d z = 0.33; 0.27-0.39). While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment, all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment.
Haywood, K L; Collin, S M; Crawley, E
2014-11-01
Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) in children is characterized by persistent or recurrent debilitating fatigue which results in a substantial reduction in activity. There is a growing interest in the use of questionnaires, or patient-reported outcome measures (PROMs), to assess how patients function and feel in relation to their health and associated healthcare. However, guidance for PROM selection for children with CFS/ME does not exist. We reviewed the quality and acceptability of PROMs used with children with CFS/ME to inform recommendations for practice. We conducted a systematic review of PROMs completed by children with CFS/ME. The quality of the evaluative studies and the reviewed measures were assessed against recommended criteria using an appraisal framework and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. We sought evidence of measurement (reliability, validity, responsiveness, interpretability, data quality) and practical properties (acceptability, relevance, feasibility). Sixteen articles were included in the review, providing evidence of reliability and/or validity for 13 PROMs. Of these, five were child-specific (one health-related quality-of-life; four emotional well-being) and eight were not (four emotional well-being, three fatigue-specific; and one generic). All measures had limited evidence of measurement properties and no evidence of practical properties. Recommendations for patient-reported assessment are difficult to make because of limited evidence of the quality and acceptability of PROMs for children with CFS/ME. The appraisal method highlighted significant methodological and quality issues which must be addressed in future research. There is a lack of qualitative evidence describing the outcomes of healthcare that are important to children with CFS/ME, and the relevance or appropriateness of available measures. Future PROM development and evaluation in
Watt, Torquil; Barbesino, Giuseppe; Bjorner, Jakob Bue; Bonnema, Steen Joop; Bukvic, Branka; Drummond, Russell; Groenvold, Mogens; Hegedüs, Laszlo; Kantzer, Valeska; Lasch, Kathryn E; Marcocci, Claudio; Mishra, Anjali; Netea-Maier, Romana; Ekker, Merel; Paunovic, Ivan; Quinn, Terence J; Rasmussen, Åse Krogh; Russell, Audrey; Sabaretnam, Mayilvaganan; Smit, Johannes; Törring, Ove; Zivaljevic, Vladan; Feldt-Rasmussen, Ulla
2015-03-01
Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in
Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W; Abernethy, April; Duffin, Kristina Callis; Bhushan, Reva; Garg, Amit; Merola, Joseph F; Maccarone, Mara; Christensen, Robin
2015-02-01
As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Patient-reported Outcomes of Tarsal Coalitions Treated With Surgical Excision.
Mahan, Susan T; Spencer, Samantha A; Vezeridis, Peter S; Kasser, James R
2015-09-01
There are little patient-reported data on functional outcomes of tarsal coalition resection in children and adolescents. The purpose of this study is to evaluate the medium-term (>2 y) outcomes in patients who have had surgical excision of their symptomatic tarsal coalition and to compare patient-based outcomes in patients who have calcaneonavicular (CN) coalitions to those with talocalcaneal (TC) coalitions. A billing query was conducted to identify patients who had surgical excision of their tarsal coalition between 2003 and 2008. Eligible patients were mailed questionnaires consisting of a modified American Orthopaedic Foot and Ankle Society (AOFAS) score and the University of California at Los Angeles (UCLA) activity scale. Patients were also specifically asked if their activity level was limited by their foot pain. Only patients who returned questionnaires were included. Demographics and diagnostic images were reviewed. A nonresponder analysis was completed. Complications such as infection and reoperation were reported. Sixty-three patients (22 females, 41 males) who returned questionnaires were included in the analysis. Twenty-four patients had bilateral surgery. TC coalitions were present in 20 patients (32%); CN coalitions were present in 43 patients (68%).Overall, mean modified AOFAS score was 88.3 and mean UCLA activity score was 8.33 at an average of 4.62 years after surgery. Patients who had TC coalitions had similar modified AOFAS scores (88.4) and UCLA activity scores (8.4) when compared with those with CN coalitions (88.0 and 8.3, both not significant).Of the 73% (46/63) patients who reported that their activity levels were not limited by their foot pain, the mean AOFAS score was 93.9 and the mean UCLA activity score was 8.9; 32 of these were CN and 14 were TC coalitions. Of the 27% (17/63) patients who reported that their activity levels were limited by their foot pain, the mean AOFAS score was 72.9 and the mean UCLA activity score was 6.9; 11 of
2013-01-01
Background Relative validity (RV), a ratio of ANOVA F-statistics, is often used to compare the validity of patient-reported outcome (PRO) measures. We used the bootstrap to establish the statistical significance of the RV and to identify key factors affecting its significance. Methods Based on responses from 453 chronic kidney disease (CKD) patients to 16 CKD-specific and generic PRO measures, RVs were computed to determine how well each measure discriminated across clinically-defined groups of patients compared to the most discriminating (reference) measure. Statistical significance of RV was quantified by the 95% bootstrap confidence interval. Simulations examined the effects of sample size, denominator F-statistic, correlation between comparator and reference measures, and number of bootstrap replicates. Results The statistical significance of the RV increased as the magnitude of denominator F-statistic increased or as the correlation between comparator and reference measures increased. A denominator F-statistic of 57 conveyed sufficient power (80%) to detect an RV of 0.6 for two measures correlated at r = 0.7. Larger denominator F-statistics or higher correlations provided greater power. Larger sample size with a fixed denominator F-statistic or more bootstrap replicates (beyond 500) had minimal impact. Conclusions The bootstrap is valuable for establishing the statistical significance of RV estimates. A reasonably large denominator F-statistic (F > 57) is required for adequate power when using the RV to compare the validity of measures with small or moderate correlations (r < 0.7). Substantially greater power can be achieved when comparing measures of a very high correlation (r > 0.9). PMID:23721463
Harle, Christopher A; Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried Of; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W
2016-01-01
In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Morel, Thomas; Cano, Stefan J
2017-11-02
Our ability to evaluate outcomes which genuinely reflect patients' unmet needs, hopes and concerns is of pivotal importance. However, much current clinical research and practice falls short of this objective by selecting outcome measures which do not capture patient value to the fullest. In this Opinion, we discuss Patient-Centered Outcomes Measures (PCOMs), which have the potential to systematically incorporate patient perspectives to measure those outcomes that matter most to patients. We argue for greater multi-stakeholder collaboration to develop PCOMs, with rare disease patients and families at the center. Beyond advancing the science of patient input, PCOMs are powerful tools to translate care or observed treatment benefit into an 'interpretable' measure of patient benefit, and thereby help demonstrate clinical effectiveness. We propose mixed methods psychometric research as the best route to deliver fit-for-purpose PCOMs in rare diseases, as this methodology brings together qualitative and quantitative research methods in tandem with the explicit aim to efficiently utilise data from small samples. And, whether one opts to develop a brand-new PCOM or to select or adapt an existing outcome measure for use in a rare disease, the anchors remain the same: patients, their daily experience of the rare disease, their preferences, core concepts and values. Ultimately, existing value frameworks, registries, and outcomes-based contracts largely fall short of consistently measuring the full range of outcomes that matter to patients. We argue that greater use of PCOMs in rare diseases would enable a fast track to Patient-Centered Care.
Adogwa, Owoicho; Elsamadicy, Aladine A; Cheng, Joseph; Bagley, Carlos
2016-03-01
Longitudinally following patients requires a full-time employee (FTE)-dependent data inflow infrastructure. There are efforts to capture patient-reported outcomes (PROs) by the use of non-FTE-dependent methodologies. In this study, we set out to assess the reliability of PRO data captured via FTE-dependent compared with non-FTE-dependent methodologies. A total of 119 adult patients (65 men) who underwent 1-and 2-level lumbar fusions at Duke University Medical Center were enrolled in this prospective study. Enrollment criteria included available demographic, clinical, and PRO data. All patients completed 2 sets of questionnaires--the first a phone interviews and the second a self-survey. There was at least a 2-week period between the phone interviews and self-survey. Questionnaires included the Oswestry Disability Index (ODI), the visual analog scale for back pain (VAS-BP), and the visual analog scale for leg pain (VAS-LP). Repeated-measures analysis of variance was used to compare the reliability of baseline PRO data captured. A total of 39.49% of patients were smokers, 21.00% had diabetes, and 11.76% had coronary artery disease; 26.89% reported history of anxiety disorder, and 28.57% reported history of depression. A total of 97.47% of patients had a high-school diploma or General Education Development, and 49.57% attained a 4-year college degree or postgraduate degree. We observed a high correlation between baseline PRO data captured between FTE-dependent versus non-FTE dependent methodologies (ODI: r = -0.89, VAS-BP: r = 0.74, VAS-LP: r = 0.70). There was no difference in PROs of baseline pain and functional disability between FTE-dependent and non-FTE-dependent methodologies: baseline ODI (FTE-dependent: 47.73 ± 16.77 [mean ± SD] vs. non-FTE-dependent: 45.81 ± 12.11, P = 0.39), VAS-LP (FTE-dependent: 6.13 ± 2.78 vs. non-FTE-dependent: 6.46 ± 2.79, P = 0.36) and VAS-BP (FTE-dependent: 6.33 ± 2.90 vs. non-FTE-dependent: 6.53 ± 2.48, P = 0.57). Our study
Korst, Lisa M; Fridman, Moshe; Saeb, Samia; Greene, Naomi; Fink, Arlene; Gregory, Kimberly D
2018-05-24
To develop a conceptual framework and preliminary item bank for childbirth-specific patient-reported outcome (PRO) domains. Women, who were U.S. residents, ≥18 years old, and ≥20 weeks pregnant, were surveyed regarding their childbirth values and preferences (V&P) using online panels. Using community-based research techniques and Patient-Reported Outcomes Management Information System (PROMIS ® ) methodology, we conducted a comprehensive literature review to identify self-reported survey items regarding patient-reported V&P and childbirth experiences and outcomes (PROs). The V&P/PRO domains were validated by focus groups. We conducted a cross-sectional observational study and fitted a multivariable logistic regression model to each V&P item to describe "who" wanted each item. We identified 5,880 V&P/PRO items that mapped to 19 domains and 58 subdomains. We present results for the 2,250 survey respondents who anticipated a vaginal delivery in a hospital. Wide variation existed regarding each V&P item, and personal characteristics, such as maternal confidence and ability to cope well with pain, were frequent predictors in the models. The resulting preliminary item bank consisted of 60 key personal characteristics and 63 V&P/PROs. The conceptual framework and preliminary (PROMIS ® ) item bank presented here provide a foundation for the development of childbirth-specific V&P/PROs. © Health Research and Educational Trust.
Kuhn, John E
2016-01-01
The concept of measuring the outcomes of treatment in health care was promoted by Ernest Amory Codman in the early 1900s, but, until recently, his ideas were generally ignored. The forces that have advanced outcome measurement to the forefront of health care include the shift in payers for health care from the patient to large insurance companies or government agencies, the movement toward assessing the care of populations not individuals, and the effort to find value (or cost-effective treatments) amid rising healthcare costs. No ideal method exists to measure outcomes, and the information gathered depends on the reason the outcome information is required. Outcome measures used in research are best able to answer research questions. The methods for assessing physician and hospital performance include process measures, patient-experience measures, structure measures, and measures used to assess the outcomes of treatment. The methods used to assess performance should be validated, be reliable, and reflect a patient's perception of the treatment results. The healthcare industry must measure outcomes to identify which treatments are most effective and provide the most benefit to patients.
Bae, Woo Kyun; Kwon, Jihyun; Lee, Hyun Woo; Lee, Sang-Cheol; Song, Eun-Kee; Shim, Hyeok; Ryu, Keun Ho; Song, Jemin; Seo, Sungbo; Yang, Yaewon; Park, Jong-Hyock; Lee, Ki Hyeong; Han, Hye Sook
2018-05-07
There is growing interest in integrating electronic patient-reported outcome (PRO) measures into routine oncology practice for symptom monitoring. Here, we evaluated the feasibility and accessibility of electronic PRO measures using a smartphone (PRO-SMART) for cancer patients receiving routine chemotherapy. The proposed PRO-SMART application obtains daily personal health record (PHR) data from cancer patients via a smartphone. An analysis report of cumulative PHR data is provided to the clinician in a format suitable for upload to electronic medical records (EMRs). Cancer outpatients who had received at least two cycles of chemotherapy and who were scheduled for two more cycles were enrolled. Between February 2015 and December 2016, 111 patients were screened and 101 of these were included. One-hundred patients used PRO-SMART at least once and were included in the final analysis (90.1% overall accessibility among all screened patients). The number of symptomatic adverse events (AEs) related to chemotherapy recorded in EMRs (mean ± standard deviation [SD]) increased from 0.92 ± 0.80 to 2.26 ± 1.80 (P < 0.001), and grading of AEs increased from 0.81 ± 0.69 to 1.00 ± 0.62 (P = 0.029). After using PRO-SMART, the numeric rating scale for pain (mean ± SD) increased from 0.20 ± 0.72 to 0.99 ± 1.55 (P < 0.001). A patient-reported questionnaire revealed that 64.2% of patients found it useful and 83% found it easy to use. This study suggests that the proposed PRO-SMART is feasible and accessible for assessment of symptomatic AEs in cancer patients receiving chemotherapy for a prospective randomized trial.
Ellis, Robert J; Cho, Yeoungjee; Del Vecchio, Sharon J; McStea, Megan; Morais, Christudas; Coombes, Jeff S; Wood, Simon T; Gobe, Glenda C; Francis, Ross S
2018-05-01
Most practice decisions relevant to preserving kidney function in patients managed surgically for kidney tumours are driven by observational studies. A wide range of outcome measures are used in these studies, which reduces comparability and increases the risk of reporting bias. To comprehensively and succinctly describe the outcomes used to evaluate kidney function in studies evaluating surgical management of kidney tumours. Electronic search of the PubMed database was conducted to identify studies with at least one measure of kidney function in patients managed surgically for kidney tumours, published between January 2000 and September 2017. Abstracts were initially screened for eligibility. Full texts of articles were then evaluated in more detail for inclusion. A narrative synthesis of the evidence was conducted. A total of 312 studies, involving 127905 participants, were included in this review. Most were retrospective (n=274) studies and conducted in a single centre (n=264). Overall, 78 unique outcome measures were identified, which were grouped into six outcome categories. Absolute postoperative kidney function (n=187), relative kidney function (n=181), and postoperative chronic kidney disease (n=131) were most frequently reported. Kidney function was predominantly quantified using estimated glomerular filtration rate or creatinine clearance (n=255), most using the modification of diet in renal disease equation (n=182). Only 70 studies provided rationale for specific outcome measures used. There is significant variability in the reporting and quantification of kidney function in studies evaluating patients managed surgically for kidney tumours. A standardised approach to measuring and reporting kidney function will increase the effectiveness of outcomes reported and improve relevance of research findings within a clinical context. Although we know that the removal of a kidney can reduce kidney function, clinical significance of various approaches is a matter
Patient-reported outcomes of occipitocervical and atlantoaxial fusions in children.
Vedantam, Aditya; Hansen, Daniel; Briceño, Valentina; Brayton, Alison; Jea, Andrew
2017-01-01
OBJECTIVE There is limited literature on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) outcomes in pediatric patients undergoing surgery for craniovertebral junction pathology. The aim of the present study was to assess surgical and quality of life outcomes in children who had undergone occipitocervical or atlantoaxial fusion. METHODS The authors retrospectively reviewed the demographics, procedural data, and outcomes of 77 consecutive pediatric patients who underwent posterior occipitocervical or atlantoaxial fusion between 2008 and 2015 at Texas Children's Hospital. Outcome measures (collected at last follow-up) included mortality, neurological improvement, complications, Scoliosis Research Society Outcomes Measure-22 (SRS-22) score, SF-36 score, Neck Disability Index (NDI), and Pediatric Quality of Life Inventory (PedsQL). Multivariate linear regression analysis was performed to identify factors affecting PROs and HRQOL scores at follow-up. RESULTS The average age in this series was 10.6 ± 4.5 years. The median follow-up was 13.9 months (range 0.5-121.5 months). Sixty-three patients (81.8%) were treated with occipitocervical fusion, and 14 patients (18.1%) were treated with atlantoaxial fusion. The American Spinal Injury Association (ASIA) grade at discharge was unchanged in 73 patients (94.8%). The average PRO metrics at the time of last follow-up were as follows: SRS-22 score, 4.2 ± 0.8; NDI, 3.0 ± 2.6; the parent's PedsQL (ParentPedsQL) score, 69.6 ± 22.7, and child's PedsQL score, 75.5 ± 18.7. Multivariate linear regression analysis revealed that older age at surgery was significantly associated with lower SRS-22 scores at follow-up (B = -0.06, p = 0.03), and the presence of comorbidities was associated with poorer ParentPedsQL scores at follow-up (B = -19.68, p = 0.03). CONCLUSIONS This study indicates that occipitocervical and atlantoaxial fusions in children preserve neurological function and are associated with
Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic
Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P.; Hsu, John; Cole, Andrew J.; Schwamm, Lee H.
2016-01-01
Objective: To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. Methods: We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Results: Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p < 0.01), married (51.5% vs 47.9%, p < 0.01), and seen in general neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p < 0.01) and more likely to report English as their preferred language (50.1% vs 38.4%, p < 0.01). Participating patients had a mean physical health T score of 28.7 (SD 15) and mental health T score of 33 (SD 15), which were 3 and 2 SD worse than the average for the US general population, respectively. Mean T scores in every category of the mRS were different from every other category (n = 232, p < 0.01). Patient Reported Outcomes Measurement Information System-10 T scores were linearly associated with QOLIE-10 scores (n = 202, p < 0.01) Conclusions: Systematic digital collection of PROMs is feasible. Differences among survey participants and nonparticipants highlight the need to develop multilingual measurement tools that may improve collection from vulnerable populations. PMID:27815405
Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.
Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H
2016-12-06
To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p < 0.01), married (51.5% vs 47.9%, p < 0.01), and seen in general neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p < 0.01) and more likely to report English as their preferred language (50.1% vs 38.4%, p < 0.01). Participating patients had a mean physical health T score of 28.7 (SD 15) and mental health T score of 33 (SD 15), which were 3 and 2 SD worse than the average for the US general population, respectively. Mean T scores in every category of the mRS were different from every other category (n = 232, p < 0.01). Patient Reported Outcomes Measurement Information System-10 T scores were linearly associated with QOLIE-10 scores (n = 202, p < 0.01) CONCLUSIONS: Systematic digital collection of PROMs is feasible. Differences among survey participants and nonparticipants highlight the need to develop multilingual measurement tools that may improve collection from vulnerable populations. © 2016 American Academy of Neurology.
Building a Patient-Reported Outcome Metric Database: One Hospital's Experience.
Rana, Adam J
2016-06-01
A number of provisions exist within the Patient Protection and Affordable Care Act that focus on improving the delivery of health care in the United States, including quality of care. From a total joint arthroplasty perspective, the issue of quality increasingly refers to quantifying patient-reported outcome metrics (PROMs). This article describes one hospital's experience in building and maintaining an electronic PROM database for a practice of 6 board-certified orthopedic surgeons. The surgeons advocated to and worked with the hospital to contract with a joint registry database company and hire a research assistant. They implemented a standardized process for all surgical patients to fill out patient-reported outcome questionnaires at designated intervals. To date, the group has collected patient-reported outcome metric data for >4500 cases. The data are frequently used in different venues at the hospital including orthopedic quality metric and research meetings. In addition, the results were used to develop an annual outcome report. The annual report is given to patients and primary care providers, and portions of it are being used in discussions with insurance carriers. Building an electronic database to collect PROMs is a group undertaking and requires a physician champion. A considerable amount of work needs to be done up front to make its introduction a success. Once established, a PROM database can provide a significant amount of information and data that can be effectively used in multiple capacities. Copyright © 2016 Elsevier Inc. All rights reserved.
Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A
2010-12-01
Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.
Kleijn, Gitta; Post, Lenneke; Witte, Birgit I.; Bohlmeijer, Ernst T.; Westerhof, Gerben J.; Cuijpers, Pim; Verdonck-de Leeuw, Irma M.
2016-01-01
Purpose To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS)) on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences) and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness) among cancer patients. Methods Cancer patients (n = 164) completed patient reported outcome measures on ego-integrity and despair (NEIS), psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57) or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107)). Confirmatory Factor Analysis was used to assess construct validity. Cronbach’s alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety. Results The majority of all items (94.5%) of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items) and Despair (4 items) had acceptable internal consistency (Cronbach’s alpha .72 and .61, respectively). The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001) with quality of life (r = -.29), distress (r = .44), anxiety (r = .47) and depression (r = .32). Conclusion The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients. PMID:27195750
Haskell, Andrew; Kim, Todd
2018-05-01
The authors describe a method of collecting patient-reported outcomes (PROs) using computerized adaptive tests (CATs) in a high-volume orthopedic surgery practice with limited resources and no research coordinator. Patient-Reported Outcomes Measurement Information System CATs were collected prospectively for all clinic patients using a tablet and recorded in the electronic medical record. Scores were compared with validated national norms using single-variable t tests. Linear regression was used to assess age effects. Preoperative and postoperative pain scales were compared using paired t tests. In total, 4,524 CATs were administered during 10,719 visits (42%), reaching 70% as more tablets were introduced. Completing the CATs required 157 seconds. Older patients took more time than younger ones ( P < .05). Compared with normalized t scores of 50 ± 10 for the US population, pain intensity was 48.0 (95% confidence interval [CI], 47.8-48.2), pain interference 58.9 (95% CI, 58.6-59.1), physical function 40.1 (95% CI, 39.9-40.3), global physical health 43.4 (95% CI, 41.9-44.9), and global mental health 41.1 (95% CI, 40.89-41.4) ( P < .05 for all). Age had a small effect on all domains ( P < .05). Approximately 20 patients would be required to demonstrate a 15% change for a 2-tailed, paired study with α = 0.05 and 80% power. After surgery, pain intensity improved from 51.9 ± 8.2 to 44.1 ± 8.5, pain interference improved from 62.5 ± 6.9 to 55.7 ± 8.4, and physical function improved from 37.3 ± 8.9 to 41.5 ± 7.9 ( P < .05 for all). Using tablets to administer CATs and entering the data in the electronic medical record for later retrieval was an effective technique to collect PROs. An adequate number of tablets are needed for acceptable completion rates. Modest sample size requirements for comparative studies highlight the potential of these tools and techniques. Level II, Prospective Comparative Study.
Elad, Sharon; Ranna, Vinisha; Ariyawardana, Anura; Correa, Maria Elvira Pizzigatti; Tilly, Vanessa; Nair, Raj G; Rouleau, Tanya; Logan, Richard M; Pinto, Andres; Charette, Veronica; Saunders, Debbie P; Jensen, Siri Beier
2017-02-01
To review the literature for outcome measures for oral viral infections in cancer patients. A secondary aim was to update the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of oral viral infections in cancer patients. Databases were searched for articles published in the English language, 1981-2013. Studies that met the eligibility criteria were reviewed systematically. The data about the outcome measures were classified according to the aim of the study: prevention, treatment, or non-interventional. The results of interventional studies were compared to the 2010 MASCC/ISOO publication. Multiple clinical and laboratory tests were used to measure oral viral infections, with great variability between studies. Most of the studies were about Herpes Simplex Virus (HSV). The outcome measure that was most commonly used was the presence of HSV infection diagnosed based on a combination of suggestive clinical presentation with a positive laboratory result. HSV culture was the most commonly reported laboratory outcome measure. Acyclovir and valacyclovir were consistently reported to be efficacious in the management of oral herpetic infections. No new data on the quality of life and economic aspects was found. Considering the variability in outcome measures reported to assess oral herpetic infections the researcher should select carefully the appropriate measures based on the objective of the study. Acyclovir and valacyclovir are effective in the management of oral herpetic infections in patients receiving treatment for cancer. Studies on newer anti-viral drugs may be useful to address the issue of anti-viral resistance.
Bingham, Clifton O.; Bartlett, Susan J.; Merkel, Peter A.; Mielenz, Thelma J.; Pilkonis, Paul A.; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K.
2016-01-01
Purpose The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes, and in particular, the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Methods Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects’ experiences. Results Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. Conclusions The PCORI Pilot Projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders. PMID:26914103
Bingham, Clifton O; Bartlett, Susan J; Merkel, Peter A; Mielenz, Thelma J; Pilkonis, Paul A; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K
2016-08-01
The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes and, in particular the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects' experiences. Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. The PCORI pilot projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders.
A brief Patient-Reported Outcomes Quality of Life (PROQOL) instrument to improve patient care.
Ridgeway, Jennifer L; Beebe, Timothy J; Chute, Christopher G; Eton, David T; Hart, Lacey A; Frost, Marlene H; Jensen, Daniel; Montori, Victor M; Smith, John G; Smith, Steven A; Tan, Angelina D; Yost, Kathleen J; Ziegenfuss, Jeanette Y; Sloan, Jeff A
2013-11-01
Jeff Sloan and colleagues describe the development of the Patient-Reported Outcomes Quality of Life (PROQOL) instrument, which captures and stores patient-recorded outcomes in the medical record for patients with diabetes. Please see later in the article for the Editors' Summary.
Fuller, Garth; Bolus, Roger; Whitman, Cynthia; Talley, Jennifer; Erder, M Haim; Joseph, Alain; Silberg, Debra G; Spiegel, Brennan
2017-03-01
Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010). To develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders. We prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial. During the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders. Analysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an
Hotchen, Andrew J; Demetriou, Charis; Edwards, Dennis; Melton, Joel T K
2018-06-13
The presentation and clinical course of mucoid degeneration of the anterior cruciate ligament (MD-ACL) are poorly documented within the literature. Subsequently, it is under-diagnosed and the optimal management strategy remains ill-defined. Here, we characterize the syndrome associated with MD-ACL and compare the natural clinical course with the outcomes of arthroscopic management. Thirty-one patients with radiological features of MD-ACL over a 2-year period had their clinical notes retrospectively reviewed. Seven patients underwent arthroscopic debridement of the ACL for MD. These were followed up for a minimum of 2 years and an average of 2.8 years from surgery. The remainder were managed conservatively ( n = 24) and were followed up for a minimum of 2 years and an average of 4.0 years. The notch width index (NWI) and associated pathology was noted. Primary outcome measures were presence of knee pain and use of analgesia. Secondary outcome measures were the Oxford and Lysholm knee scores. The most commonly reported symptoms were posterior knee pain (77.4%) and limitation of terminal flexion (58.1%). All patients who underwent arthroscopic debridement were pain and analgesia free at follow-up. Of the patients who did not undergo arthroscopic surgery, three patients had knee replacement surgery and three were lost to follow-up. The remaining patients, 14/18 (77.8%), reported knee pain and regular analgesia use at follow-up, which was significantly more than the arthroscopic debridement group ( p < 0.01). The knee scores were significantly better in the arthroscopic debridement group at follow-up (Oxford knee score: 45 vs 34; Lysholm: 92 vs 67; p < 0.01). Furthermore, the postoperative improvement in the Oxford knee and Lysholm scores compared with preoperatively was 12.1 and 31.8 points, respectively ( p < 0.01). The NWI was increased in patients with mild-to-severe osteoarthritis (0.266 vs 0.273; p < 0.05). MD-ACL should be considered in
Kaat, Aaron J; Schalet, Benjamin D; Rutsohn, Joshua; Jensen, Roxanne E; Cella, David
2018-01-01
Measuring patient-reported outcomes (PROs) is becoming an integral component of quality improvement initiatives, clinical care, and research studies in cancer, including comparative effectiveness research. However, the number of PROs limits comparability across studies. Herein, the authors attempted to link the Functional Assessment of Cancer Therapy-General Physical Well-Being (FACT-G PWB) subscale with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) calibrated item bank. The also sought to augment a subset of the conceptually most similar FACT-G PWB items with PROMIS PF items to improve the linking. Baseline data from 5506 participants in the Measuring Your Health (MY-Health) study were used to identify the optimal items for linking FACT-G PWB with PROMIS PF. A mixed methods approach identified the optimal items for creating the 5-item FACT/PROMIS-PF5 scale. Both the linked and augmented relationships were cross-validated using the follow-up MY-Health data. A 5-item FACT-G PWB item subset was found to be optimal for linking with PROMIS PF. In addition, a 2-item subset, including only items that were conceptually very similar to the PROMIS item bank content, were augmented with 3 PROMIS PF items. This new FACT/PROMIS-PF5 provided superior score recovery. The PROMIS PF metric allows for the evaluation of the extent to which similar questionnaires can be linked and therefore expressed on the same metric. These results allow for the aggregation of existing data and provide an optimal measure for future studies wishing to use the FACT yet also report on the PROMIS PF metric. Cancer 2018;124:153-60. © 2017 American Cancer Society. © 2017 American Cancer Society.
Burke, Jeanmarie R
2014-09-01
The purpose of this study was to test the utility of Patient-Reported Outcomes Measurement Information System (PROMIS) as a resource for collecting data on patient-reported outcomes (PRO) within academic health centers at a chiropractic college; and, to describe changes in PRO following pragmatic chiropractic care incorporating instrument-assisted soft tissue mobilization (IASTM) on pain symptoms. This was a pre-post intervention design without a control group (case series) involving 25 patients (14 females and 11 males; 40.5 ± 16.39 years, range 20-70 years) who completed their chiropractic care and their baseline and post-treatment pain assessments. The pragmatic chiropractic care intervention included both spinal manipulation and IASTM to treat pain symptoms. PRO's were collected using PROMIS to measure pain behavior, pain interference and pain intensity. The average pre-post assessment interval was 33 ± 22.5 days (95% CI, 23-42 days). The durations of treatments ranged from one week to 10 weeks. The median number of IASTM treatments was six. Pre-post decreases in T-scores for pain behavior and pain interference were 55.5 to 48.4 and 57.7 to 48.4, respectively (P < .05). Only 12 patients had a baseline T-score for pain intensity greater than 50. The pre-post decrease in pain intensity T-scores for these 12 patients was from 53.4 to 40.9. Within the limitations of a case series design, these data provide initial evidence on the utility of PROMIS instruments for clinical and research outcomes in chiropractic patients.
Zerillo, Jessica A; Schouwenburg, Maartje G; van Bommel, Annelotte C M; Stowell, Caleb; Lippa, Jacob; Bauer, Donna; Berger, Ann M; Boland, Gilles; Borras, Josep M; Buss, Mary K; Cima, Robert; Van Cutsem, Eric; van Duyn, Eino B; Finlayson, Samuel R G; Hung-Chun Cheng, Skye; Langelotz, Corinna; Lloyd, John; Lynch, Andrew C; Mamon, Harvey J; McAllister, Pamela K; Minsky, Bruce D; Ngeow, Joanne; Abu Hassan, Muhammad R; Ryan, Kim; Shankaran, Veena; Upton, Melissa P; Zalcberg, John; van de Velde, Cornelis J; Tollenaar, Rob
2017-05-01
Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM's working group in colorectal cancer. The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.
Patient-reported outcomes in idiopathic pulmonary fibrosis research.
Swigris, Jeffrey J; Fairclough, Diane
2012-08-01
Patient-reported outcomes (PROs) include questionnaires or surveys that ask patients for their perceptions about things like symptoms they are experiencing or quality of life. For incurable, morbid, life-shortening conditions like idiopathic pulmonary fibrosis (IPF), PROs are particularly germane: They elucidate for clinicians and researchers what it is like for patients to live with such a disease, and they may detect important treatment effects not captured by other metrics (eg, pulmonary physiology). However, a relative paucity of research on PROs in IPF has left significant knowledge gaps in this area and contributed to the timidity investigators have about using PROs as prominent outcomes in IPF drug trials. Additional research on existing instruments is needed to establish or bolster their basic psychometric properties in IPF. When PROs are used as end points in therapeutic trials, analyzing PRO response data can be challenging, but these challenges can be overcome with a transparent, thoughtful, and sophisticated statistical approach. In this article, we discuss some of the basics of PRO assessment, existing knowledge gaps in IPF-related PRO research, and the potential usefulness of using PROs in IPF trials and conclude by offering specific recommendations for an approach to analyzing repeated-measures PRO data from IPF trials.
Street, Andrew; Gomes, Manuel; Bojke, Chris
2015-01-01
Summary Objective The best practice tariff for hip and knee replacement in the English National Health Service (NHS) rewards providers based on improvements in patient-reported outcome measures (PROMs) collected before and after surgery. Providers only receive a bonus if at least 50% of their patients complete the preoperative questionnaire. We determined how many providers failed to meet this threshold prior to the policy introduction and assessed longitudinal stability of participation rates. Design Retrospective observational study using data from Hospital Episode Statistics and the national PROM programme from April 2009 to March 2012. We calculated participation rates based on either (a) all PROM records or (b) only those that could be linked to inpatient records; constructed confidence intervals around rates to account for sampling variation; applied precision weighting to allow for volume; and applied risk adjustment. Setting NHS hospitals and private providers in England. Participants NHS patients undergoing elective unilateral hip and knee replacement surgery. Main outcome measures Number of providers with participation rates statistically significantly below 50%. Results Crude rates identified many providers that failed to achieve the 50% threshold but there were substantially fewer after adjusting for uncertainty and precision. While important, risk adjustment required restricting the analysis to linked data. Year-on-year correlation between provider participation rates was moderate. Conclusions Participation rates have improved over time and only a small number of providers now fall below the threshold, but administering preoperative questionnaires remains problematic in some providers. We recommend that participation rates are based on linked data and take into account sampling variation. PMID:25827906
Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin
2017-01-01
This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.
Patients reported outcome post-cochlear implantation: how severe is their dizziness?
Zawawi, Faisal; Alobaid, Faisal; Leroux, Tony; Zeitouni, Anthony G
2014-01-01
The reported prevalence of vestibular dysfunction after cochlear implantation (CI) is varies between different scientific papers. The aim of this study is to determine the reported post-implantation outcome in terms of dizziness, and to measure its impact on quality of life using the Dizziness handicap inventory (DHI). This was a prospective questionnaire based study of postoperative cochlear implant patients. The questionnaire assessed the type and onset of dizziness in addition to the DHI. 122 patients were recruited in this study, which is the largest sample size in the literature reported so far. Dizziness was evident in 45.9% of the population post-CI and in 27% pre-CI. The commonest subtype of the dizziness was unsteadiness followed by lightheadedness. The dizziness was mild in most of the patients. Although mild, dizziness is a common complaint post-cochlear implantation. An understanding of symptoms helps counsel patients preoperatively.
Moonesinghe, Suneetha Ramani; Walker, Eleanor Mary Kate; Bell, Madeline
2015-01-01
Patient satisfaction is an important metric of health-care quality. Accidental awareness under general anaesthesia (AAGA) is a serious complication of anaesthesia care which may go unrecognised in the immediate perioperative period but leads to long-term psychological harm for affected patients. The SNAP-1 study aimed to measure patient satisfaction with anaesthesia care and the incidence of AAGA, reported on direct questioning within 24 h of surgery, in a large multicentre cohort. A secondary aim of SNAP-1 was to test the effectiveness of a new network of Quality Audit and Research Coordinators in NHS anaesthetic departments, to achieve widespread study participation and high patient recruitment rates. This manuscript describes the study methodology. SNAP-1 was a prospective observational cohort study. The study protocol was approved by the National Research Ethics Service. All UK NHS hospitals with anaesthetic departments were invited to participate. Adult patients undergoing any type of non-obstetric surgery were recruited in participating hospitals on 13th and 14th May 2014. Demographic data were collected by anaesthetists providing perioperative care. Patients were then approached within 24 h of surgery to complete two questionnaires-the Bauer patient satisfaction questionnaire (to measure patient reported outcome) and the modified Brice questionnaire (to detect possible accidental awareness). Completion of postoperative questionnaires was taken as evidence of implied consent. Results were recorded on a standard patient case report form, and local investigators entered anonymised data into an electronic database for later analysis by the core research team. Preliminary analyses indicate that over 15,000 patients were recruited across the UK, making SNAP-1 the largest NIHR portfolio-adopted study in anaesthesia to date. Both descriptive and analytic epidemiological analyses will be used to answer specific questions about the patient perception of anaesthesia
Patient-reported outcomes to support medical product labeling claims: FDA perspective.
Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L
2007-01-01
This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.
Perez, Jorge L; Mosher, Zachary A; Watson, Shawna L; Sheppard, Evan D; Brabston, Eugene W; McGwin, Gerald; Ponce, Brent A
2017-08-01
Patient-reported outcome measures (PROMs) are increasingly used to quantify patients' perceptions of functional ability. The American Medical Association and NIH suggest patient materials be written at or below 6th to 8th grade reading levels, respectively, yet one recent study asserts that few PROMs comply with these recommendations, and suggests that the majority of PROMs are written at too high of a reading level for self-administered patient use. Notably, this study was limited in its use of only one readability algorithm, although there is no commonly accepted, standard readability algorithm for healthcare-related materials. Our study, using multiple readability equations and heeding equal weight to each, hopes to yield a broader, all-encompassing estimate of readability, thereby offering a more accurate assessment of the readability of orthopaedic PROMS. (1) What proportion of orthopaedic-related PROMs and orthopaedic-related portions of the NIH Patient Reported Outcomes Measurement Information System (PROMIS ® ) are written at or below the 6th and 8th grade levels? (2) Is there a correlation between the number of questions in the PROM and reading level? (3) Using systematic edits based on guidelines from the Centers for Medicare and Medicaid Services, what proportion of PROMs achieved American Medical Association and NIH-recommended reading levels? Eighty-six (86) independent, orthopaedic and general wellness PROMs, drawn from commonly referenced orthopaedic websites and prior studies, were chosen for analysis. Additionally, owing to their increasing use in orthopaedics, four relevant short forms, and 11 adult, physical health question banks from the PROMIS ® , were included for analysis. All documents were analyzed for reading grade levels using 19 unique readability algorithms. Descriptive statistics were performed using SPSS Version 22.0. The majority of the independent PROMs (64 of 86; 74%) were written at or below the 6th grade level, with 81 of 86
Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F
2015-01-01
Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.
Patel, Alpesh A; Dodwad, Shah-Nawaz M; Boody, Barrett S; Bhatt, Surabhi; Savage, Jason W; Hsu, Wellington K; Rothrock, Nan E
2018-03-19
Prospective, cohort study. Demonstrate validity of PROMIS physical function, pain interference, and pain behavior computer adaptive tests (CATs) in surgically treated lumbar stenosis patients. There has been increasing attention given to patient reported outcomes associated with spinal interventions. Historical patient outcome measures have inadequate validation, demonstrate floor/ceiling effects, and infrequently used due to time constraints. PROMIS is an adaptive, responsive NIH assessment tool that measures patient-reported health status. 98 consecutive patients were surgically treated for lumbar spinal stenosis and were assessed using PROMIS CATs, ODI, ZCQ and SF-12. Prior lumbar surgery, history of scoliosis, cancer, trauma, or infection were excluded. Completion time, preoperative assessment, 6 week and 3 month postoperative scores were collected. At baseline, 49%, 79%, and 81% of patients had PROMIS PB, PI, and PF scores greater than 1 SD worse than the general population. 50.6% were categorized as severely disabled, crippled, or bed bound by ODI. PROMIS CATs demonstrated convergent validity through moderate to high correlations with legacy measures (r = 0.35-0.73). PROMIS CATs demonstrated known groups validity when stratified by ODI levels of disability. ODI improvements of at least 10 points on average had changes in PROMIS scores in the expected direction (PI = -12.98, PB = -9.74, PF = 7.53). PROMIS CATs demonstrated comparable responsiveness to change when evaluated against legacy measures. PROMIS PB and PI decreased 6.66 and 9.62 and PROMIS PF increased 6.8 points between baseline and 3-months post-op (p < 0.001). Completion time for the PROMIS CATs (2.6 minutes) compares favorably to ODI, ZCQ, and SF-12 scores (3.1, 3.6, and 3.0 minutes). PROMIS CATs demonstrate convergent validity, known groups validity, and responsiveness for surgically treated patients with lumbar stenosis to detect change over time and are more efficient than
Kwan, Bethany M; Sills, Marion R; Graham, Deborah; Hamer, Mika K; Fairclough, Diane L; Hammermeister, K E; Kaiser, Alicyn; de Jesus Diaz-Perez, Maria; Schilling, Lisa M
2016-01-01
Patient-reported outcome (PRO) measures offer value for clinicians and researchers, although priorities and value propositions can conflict. PRO implementation in clinical practice may benefit from stakeholder engagement methods to align research and clinical practice stakeholder perspectives. The objective is to demonstrate the use of stakeholder engagement in PRO implementation. Engaged stakeholders represented researchers and clinical practice representatives from the SAFTINet practice-based research network (PBRN). A stakeholder engagement process involving iterative analysis, deliberation, and decision making guided implementation of a medication adherence PRO measure (the Medication Adherence Survey [MAS]) for patients with hypertension and/or hyperlipidemia. Over 9 months, 40 of 45 practices (89%) implemented the MAS, collecting 3,247 surveys (mean = 72, median = 30, range: 0 - 416). Facilitators included: an electronic health record (EHR) with readily modifiable templates; existing staff, tools and workflows in which the MAS could be integrated (e.g., health risk appraisals, hypertension-specific visits, care coordinators); and engaged leadership and quality improvement teams. Stakeholder engagement appeared useful for promoting PRO measure implementation in clinical practice, in a way that met the needs of both researchers and clinical practice stakeholders. Limitations of this approach and opportunities for improving the PRO data collection infrastructure in PBRNs are discussed. © Copyright 2016 by the American Board of Family Medicine.
Chalmers, J R; Simpson, E; Apfelbacher, C J; Thomas, K S; von Kobyletzki, L; Schmitt, J; Singh, J A; Svensson, Å; Williams, H C; Abuabara, K; Aoki, V; Ardeleanu, M; Awici-Rasmussen, M; Barbarot, S; Berents, T L; Block, J; Bragg, A; Burton, T; Bjerring Clemmensen, K K; Creswell-Melville, A; Dinesen, M; Drucker, A; Eckert, L; Flohr, C; Garg, M; Gerbens, L A A; Graff, A L B; Hanifin, J; Heinl, D; Humphreys, R; Ishii, H A; Kataoka, Y; Leshem, Y A; Marquort, B; Massuel, M-A; Merhand, S; Mizutani, H; Murota, H; Murrell, D F; Nakahara, T; Nasr, I; Nograles, K; Ohya, Y; Osterloh, I; Pander, J; Prinsen, C; Purkins, L; Ridd, M; Sach, T; Schuttelaar, M-L A; Shindo, S; Smirnova, J; Sulzer, A; Synnøve Gjerde, E; Takaoka, R; Vestby Talmo, H; Tauber, M; Torchet, F; Volke, A; Wahlgren, C-F; Weidinger, S; Weisshaar, E; Wollenberg, A; Yamaga, K; Zhao, C Y; Spuls, P I
2016-07-01
This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British
Van Der Wees, Philip J; Nijhuis-Van Der Sanden, Maria W G; Ayanian, John Z; Black, Nick; Westert, Gert P; Schneider, Eric C
2014-12-01
Policy Points: The patient-reported outcome (PRO) is a standardized method for measuring patients' views of their health status. Our international study showed that experts in clinical practice and performance measurement supported the integrated collection of PRO data for use in both clinical care and performance measurement. The measurement of PROs to support patient-provider decisions and the use of PRO performance measures to evaluate health care providers have developed both separately and in parallel. The use of PROs would benefit from a shared vision by health care providers, purchasers of care, and patients regarding the aims and purposes of the various applications; and the establishment of trust among stakeholders concerning the prudent use of PRO performance measures. Patient-reported outcomes (PROs) can play an important role in patient-centered health care by focusing on the patient's health goals guiding therapeutic decisions. When aggregated, PROs also can be used for other purposes, including comparative effectiveness research, practice improvement, assessment of the performance of clinicians and organizations, and as a metric for value-based payments. The feasibility of integrating the use of PROs for these various purposes on a wide scale has not yet been demonstrated. Our study was conducted to inform policymakers of prudent next steps for implementing PROs in clinical practice and performance measurement programs in order to maximize their impact on the quality of health care. We conducted a qualitative study, interviewing 58 experts and leaders from 37 organizations (response rate: 88%) in the United States, England, and the Netherlands. Respondents included clinical practitioners (n = 30), measure developers (n = 11), and leaders of performance measurement programs (n = 17). We used a qualitative content analysis to assess current strategies for applying PROs in clinical practice and performance measurement and to identify barriers to and
Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.
2016-01-01
Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344
Self-efficacy as a predictor of patient-reported outcomes in adults with congenital heart disease.
Thomet, Corina; Moons, Philip; Schwerzmann, Markus; Apers, Silke; Luyckx, Koen; Oechslin, Erwin N; Kovacs, Adrienne H
2018-04-01
Self-efficacy is a known predictor of patient-reported outcomes in individuals with acquired diseases. With an overall objective of better understanding patient-reported outcomes in adults with congenital heart disease, this study aimed to: (i) assess self-efficacy in adults with congenital heart disease, (ii) explore potential demographic and medical correlates of self-efficacy and (iii) determine whether self-efficacy explains additional variance in patient-reported outcomes above and beyond known predictors. As part of a large cross-sectional international multi-site study (APPROACH-IS), we enrolled 454 adults (median age 32 years, range: 18-81) with congenital heart disease in two tertiary care centres in Canada and Switzerland. Self-efficacy was measured using the General Self-Efficacy (GSE) scale, which produces a total score ranging from 10 to 40. Variance in the following patient-reported outcomes was assessed: perceived health status, psychological functioning, health behaviours and quality of life. Hierarchical multivariable linear regression analysis was performed. Patients' mean GSE score was 30.1 ± 3.3 (range: 10-40). Lower GSE was associated with female sex ( p = 0.025), not having a job ( p = 0.001) and poorer functional class ( p = 0.048). GSE positively predicted health status and quality of life, and negatively predicted symptoms of anxiety and depression, with an additional explained variance up to 13.6%. No associations between self-efficacy and health behaviours were found. GSE adds considerably to our understanding of patient-reported outcomes in adults with congenital heart disease. Given that self-efficacy is a modifiable psychosocial factor, it may be an important focus for interventions targeting congenital heart disease patients' well-being.
Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B
2017-01-01
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of
Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients
Winterstein, Andrew P.; McGuine, Timothy A.; Carr, Kathleen E.; Hetzel, Scott J.
2013-01-01
Background: Knee injury among young, active female patients remains a public health issue. Clinicians are called upon to pay greater attention to patient-oriented outcomes to evaluate the impact of these injuries. Little agreement exists on which outcome measures are best, and clinicians cite several barriers to their use. Single Assessment Numerical Evaluation (SANE) may provide meaningful outcome information while lessening the time burden associated with other patient-oriented measures. Hypothesis: The SANE and International Knee Documentation Committee (IKDC) scores would be strongly correlated in a cohort of young active female patients with knee injuries from preinjury through 1-year follow-up and that a minimal clinically important difference (MCID) could be calculated for the SANE score. Study Design: Observational prospective cohort. Methods: Two hundred sixty-three subjects completed SANE and IKDC at preinjury by recall, time of injury, and 3, 6, and 12 months postinjury. Pearson correlation coefficients were used to assess the association between SANE and IKDC. Repeated-measures analysis of variance was used to determine differences in SANE and IKDC over time. MCID was calculated for SANE using IKDC MCID as an anchor. Results: Moderate to strong correlations were seen between SANE and IKDC (0.65-0.83). SANE, on average, was 2.7 (95% confidence interval, 1.5-3.9; P < 0.00) units greater than IKDC over all time points. MCID for the SANE was calculated as 7 for a 6-month follow-up and 19 for a 12-month follow-up. Conclusion: SANE scores were moderately to strongly correlated to IKDC scores across all time points. Reported MCID values for the SANE should be utilized to measure meaningful changes over time for young, active female patients with knee injuries. Clinical Relevance: Providing clinicians with patient-oriented outcome measures that can be obtained with little clinician and patient burden may allow for greater acceptance and use of outcome measures
2010-01-01
Background Patient-reported outcomes are increasingly seen as complementary to biomedical measures. However, their prognostic importance has yet to be established, particularly in female long-term myocardial infarction (MI) survivors. We aimed to determine whether 10-year survival in older women after MI relates to patient-reported outcomes, and to compare their survival with that of the general female population. Methods We included all women aged 60-80 years suffering MI during 1992-1997, and treated at one university hospital in Norway. In 1998, 145 (60% of those alive) completed a questionnaire package including socio-demographics, the Sense of Coherence Scale (SOC-29), the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) and an item on positive effects of illness. Clinical information was based on self-reports and hospital medical records data. We obtained complete data on vital status. Results The all-cause mortality rate during the 1998-2008 follow-up of all patients was 41%. In adjusted analysis, the conventional predictors s-creatinine (HR 1.26 per 10% increase) and left ventricular ejection fraction below 30% (HR 27.38), as well as patient-reported outcomes like living alone (HR 6.24), dissatisfaction with self-rated health (HR 6.26), impaired psychological quality of life (HR 0.60 per 10 points difference), and experience of positive effects of illness (HR 6.30), predicted all-cause death. Major adverse cardiac and cerebral events were also significantly associated with both conventional predictors and patient-reported outcomes. Sense of coherence did not predict adverse events. Finally, 10-year survival was not significantly different from that of the general female population. Conclusion Patient-reported outcomes have long-term prognostic importance, and should be taken into account when planning aftercare of low-risk older female MI patients. PMID:21108810
Norekvål, Tone M; Fridlund, Bengt; Rokne, Berit; Segadal, Leidulf; Wentzel-Larsen, Tore; Nordrehaug, Jan Erik
2010-11-25
Patient-reported outcomes are increasingly seen as complementary to biomedical measures. However, their prognostic importance has yet to be established, particularly in female long-term myocardial infarction (MI) survivors. We aimed to determine whether 10-year survival in older women after MI relates to patient-reported outcomes, and to compare their survival with that of the general female population. We included all women aged 60-80 years suffering MI during 1992-1997, and treated at one university hospital in Norway. In 1998, 145 (60% of those alive) completed a questionnaire package including socio-demographics, the Sense of Coherence Scale (SOC-29), the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) and an item on positive effects of illness. Clinical information was based on self-reports and hospital medical records data. We obtained complete data on vital status. The all-cause mortality rate during the 1998-2008 follow-up of all patients was 41%. In adjusted analysis, the conventional predictors s-creatinine (HR 1.26 per 10% increase) and left ventricular ejection fraction below 30% (HR 27.38), as well as patient-reported outcomes like living alone (HR 6.24), dissatisfaction with self-rated health (HR 6.26), impaired psychological quality of life (HR 0.60 per 10 points difference), and experience of positive effects of illness (HR 6.30), predicted all-cause death. Major adverse cardiac and cerebral events were also significantly associated with both conventional predictors and patient-reported outcomes. Sense of coherence did not predict adverse events. Finally, 10-year survival was not significantly different from that of the general female population. Patient-reported outcomes have long-term prognostic importance, and should be taken into account when planning aftercare of low-risk older female MI patients.
Hatt, Sarah R; Leske, David A; Wernimont, Suzanne M; Birch, Eileen E; Holmes, Jonathan M
2017-03-01
A rating scale is a critical component of patient-reported outcome instrument design, but the optimal rating scale format for pediatric use has not been investigated. We compared rating scale performance when administering potential questionnaire items to children with eye disorders and their parents. Three commonly used rating scales were evaluated: frequency (never, sometimes, often, always), severity (not at all, a little, some, a lot), and difficulty (not difficult, a little difficult, difficult, very difficult). Ten patient-derived items were formatted for each rating scale, and rating scale testing order was randomized. Both child and parent were asked to comment on any problems with, or a preference for, a particular scale. Any confusion about options or inability to answer was recorded. Twenty-one children, aged 5-17 years, with strabismus, amblyopia, or refractive error were recruited, each with one of their parents. Of the first 10 children, 4 (40%) had problems using the difficulty scale, compared with 1 (10%) using frequency, and none using severity. The difficulty scale was modified, replacing the word "difficult" with "hard." Eleven additional children (plus parents) then completed all 3 questionnaires. No children had problems using any scale. Four (36%) parents had problems using the difficulty ("hard") scale and 1 (9%) with frequency. Regarding preference, 6 (55%) of 11 children and 5 (50%) of 10 parents preferred using the frequency scale. Children and parents found the frequency scale and question format to be the most easily understood. Children and parents also expressed preference for the frequency scale, compared with the difficulty and severity scales. We recommend frequency rating scales for patient-reported outcome measures in pediatric populations.
Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction.
Santosa, Katherine B; Qi, Ji; Kim, Hyungjin M; Hamill, Jennifer B; Wilkins, Edwin G; Pusic, Andrea L
2018-06-20
Previous outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process. To determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery. Patients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up. Procedure type (ie, implant vs autologous tissue reconstruction). The primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life. Of the 2013 women in the study (mean [SD] age, 48.1 [10.5] years for the group that underwent implant-based reconstruction and 51.6 [8.7] years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients
Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC
2014-01-01
Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient-reported
Usefulness of Patients-Reported Outcomes in Rheumatoid Arthritis Focus Group
Amaya-Amaya, Jenny; Botello-Corzo, Diana; Calixto, Omar-Javier; Calderón-Rojas, Rolando; Domínguez, Aura-Maria; Cruz-Tapias, Paola; Montoya-Ortiz, Gladis; Mantilla, Ruben-Dario; Anaya, Juan-Manuel; Rojas-Villarraga, Adriana
2012-01-01
Objective. Patient-reported outcomes (PROs) have become an essential part of the assessment of patients with rheumatoid arthritis (RA). We aimed to evaluate the agreement and correlation between PROs and the physician's measurements. Methods. This was a cross-sectional analytical study in which 135 patients with RA were clinically evaluated during two different sessions of focus group interviews. Rheumatologist recorded 28 swollen (SJCs) and tender joint counts (TJCs). The patients filled out the PROs instruments (MDHAQ, RADAI, RAPID3, 4, and 5 and self-report articular index (SAI) diagram for pain and joint swelling). DAS28 was calculated (C-reactive protein). An adjusted multiple lineal regression model was done (DAS28 as dependent variable). Results. Highly significant agreements were found between SJC and TJC registered by the physician and patient. There was moderate correlation between DAS28 with patient SJC (r = 0.52), patient TJC (r = 0.55), RADAI (r = 0.56), RAPID3 (r = 0.52), RAPID4 (r = 0.56), RAPID5 (r = 0.66), and VAS-Global (r = 0.51). Likewise, we found moderate to high correlations between CDAI and SDAI with all variable measurements done by the patients. The resulting predictive equation was DAS28(CRP) = 2.02 + 0.037 × RAPID4 + 0.042× patient SJC. Conclusion. PROs applied in focus groups interview are a useful tool for managing patients with RA regardless of gender, educational level, and duration of disease. PMID:23097701
Cowan, Renee A; Suidan, Rudy S; Andikyan, Vaagn; Rezk, Youssef A; Einstein, M Heather; Chang, Kaity; Carter, Jeanne; Zivanovic, Oliver; Jewell, Elizabeth J; Abu-Rustum, Nadeem R; Basch, Ethan; Chi, Dennis S
2016-11-01
We previously reported on the feasibility of a Web-based system to capture patient-reported outcomes (PROs) in the immediate postoperative period. The purpose of this study was to update the experience of these patients and assess patient and provider satisfaction and feedback regarding the system. This is a prospective cohort study of patients scheduled to undergo laparotomy for presumed gynecologic malignancy. Patients completed a Web-based Symptom Tracking and Reporting (STAR) questionnaire preoperatively and weekly during a 6-week postoperative period. Email alerts were sent to study nurses when concerning patient responses were entered. The patient and the nurse assessments of STAR's usefulness were measured via an exit survey. The study enrolled 96 eligible patients. Of these, 71 patients (74%) completed at least four of seven total sessions. Of the patients who completed the exit satisfaction survey, 98% found STAR easy to use; 84% found it useful; and 82% would recommend it to other patients. Despite positive feedback from patients, clinical personnel found that the STAR system increased their current workload without enhancing patient care. Application of an electronic program for PROs in those recovering from major gynecologic cancer surgery is feasible, and acceptable to most patients. While most clinicians did not find STAR clinically helpful, the majority of patients reported a positive experience with the system and would recommend its use. The program helped many patients feel more empowered in their postoperative recovery. Copyright © 2016 Elsevier Inc. All rights reserved.
Lavoie Smith, Ellen M.; Haupt, Rylie; Kelly, James P.; Lee, Deborah; Kanzawa-Lee, Grace; Knoerl, Robert; Bridges, Celia; Alberti, Paola; Prasertsri, Nusara; Donohoe, Clare
2018-01-01
Purpose/Objectives To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). Research Approach Cross-sectional, prospective, qualitative design. Setting Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. Participants 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. Methodologic Approach Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument. Findings Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. Interpretation Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. Implications for Nursing Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure. PMID:28820525
Terwee, C B; Roorda, L D; de Vet, H C W; Dekker, J; Westhovens, R; van Leeuwen, J; Cella, D; Correia, H; Arnold, B; Perez, B; Boers, M
2014-08-01
The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children that has the potential to be more valid, reliable and responsive than existing PROMs. The PROMIS items can be administered in short forms or, more efficiently, through computerized adaptive testing. This paper describes the translation of 563 items from 17 PROMIS item banks (domains) for adults from the English source into Dutch-Flemish. The translation was performed by FACITtrans using standardized methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three to five independent reviews (at least two Dutch, one Flemish) and pre-testing in 70 adults (age range 20-77) from the Netherlands and Flanders. A small number of items required separate translations for Dutch and Flemish: physical function (five items), pain behaviour (two items), pain interference (one item), social isolation (one item) and global health (one item). Challenges faced in the translation process included: scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. The methodology used and experience gained in this study can be used as an example for researchers in other countries interested in translating PROMIS. The Dutch-Flemish PROMIS items are linguistically equivalent. Short forms will soon be available for use and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.
Horn, Katyana Kowalchuk; Jennings, Sophie; Richardson, Gillian; Vliet, Ditte Van; Hefford, Cheryl; Abbott, J Haxby
2012-01-01
Systematic review of the literature. To summarize peer-reviewed literature on the reliability, validity, and responsiveness of the Patient-Specific Functional Scale (PSFS), and to identify its use as an outcome measure. Searches were performed of several electronic databases from 1995 to May 2010. Studies included were published articles containing (1) primary research investigating the psychometric and clinimetrics of the PSFS or (2) the implementation of the PSFS as an outcome measure. We assessed the methodological quality of studies included in the first category. Two hundred forty-two articles published from 1994 to May 2010 were identified. Of these, 66 met the inclusion criteria for this review, with 13 reporting the measurement properties of the PSFS, 55 implementing the PSFS as an outcome measure, and 2 doing both of the above. The PSFS was reported to be valid, reliable, and responsive in populations with knee dysfunction, cervical radiculopathy, acute low back pain, mechanical low back pain, and neck dysfunction. The PSFS was found to be reliable and responsive in populations with chronic low back pain. The PSFS was also reported to be valid, reliable, or responsive in individuals with a limited number of acute, subacute, and chronic conditions. This review found that the PSFS is also being used as an outcome measure in many other conditions, despite a lack of published evidence supporting its validity in these conditions. Although the use of the PSFS as an outcome measure is increasing in physiotherapy practice, there are gaps in the research literature regarding its validity, reliability, and responsiveness in many health conditions.
Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.
2018-01-01
Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650
Burr, Sean K; Fowler, James C; Allen, Jon G; Wiltgen, Anika; Madan, Alok
2017-09-01
The use of patient-reported outcomes (PROs) has become increasingly common. They have been used to assess quality of care and to support policy decisions, but the evidence concerning their utility to improve patient outcomes is inconsistent. A better understanding of clinicians' experience with PROs has the potential to improve their effectiveness. This exploratory, quantitative, and qualitative study investigated the perspectives of clinicians (N=70) from multiple disciplines (psychiatrists, psychologists, social workers, and psychiatric nurses) on the utility of PROs in an inpatient psychiatric setting. During scheduled, monthly, discipline-specific administrative meetings, clinicians in attendance completed a 1-time, 5-item survey. The highest rated item related to the frequency of reviewing outcomes reports; this item was rated higher than all other items (mean±SD, 4.5±1.5), which 37.5% of the participants in the overall sample stated they "always" did. The lowest rated item related to the frequency of conveying the results of the outcomes reports to patients (3.3±1.9), which 20% of participants reported "always" doing; this item was rated lower than all other items (P<0.03). Qualitative analyses were based on 30 comments from 22 clinicians, which resulted in the emergence of 6 themes. The 2 themes that received the highest number of comments related to: (1) the sensitivity and specificity of measures across the PROs platform and (2) the value of the reports in directly influencing treatment decisions. Clinicians' relatively favorable perspective of PROs in practice in this study may be related to the assessment-oriented culture at the study institution. Nonetheless, many barriers to the routine use of PROs exist. Addressing clinician concerns has the potential to improve utilization of this facet of good clinical care.
Outcomes assessment in rotator cuff pathology: what are we measuring?
Makhni, Eric C; Steinhaus, Michael E; Morrow, Zachary S; Jobin, Charles M; Verma, Nikhil N; Cole, Brian J; Bach, Bernard R
2015-12-01
Assessments used to measure outcomes associated with rotator cuff pathology and after repair are varied. This lack of standardization leads to difficulty drawing comparisons across studies. We hypothesize that this variability in patient-reported outcome measures and objective metrics used in rotator cuff studies persists even in high-impact, peer reviewed journals. All studies assessing rotator cuff tear and repair outcomes in 6 orthopedic journals with a high impact factor from January 2010 to December 2014 were reviewed. Cadaveric and animal studies and those without outcomes were excluded. Outcome measures included range of motion (forward elevation, abduction, external rotation, and internal rotation), strength (in the same 4 planes), tendon integrity imaging, patient satisfaction, and functional assessment scores. Of the 156 included studies, 63% documented range of motion measurements, with 18% reporting range of motion in all 4 planes. Only 38% of studies reported quantitative strength measurements. In 65% of studies, tendon integrity was documented with imaging (38% magnetic resonance imaging/magnetic resonance anrhrogram, 31% ultrasound, and 8% computed tomography arthrogram). Finally, functional score reporting varied significantly, with the 5 most frequently reported scores ranging from 16% to 61% in studies, and 15 of the least reported outcomes were each reported in ≤6% of studies. Significant variability exists in outcomes reporting after rotator cuff tear and repair, making comparisons between clinical studies difficult. Creating a uniformly accepted, validated outcomes tool that assesses pain, function, patient satisfaction, and anatomic integrity would enable consistent outcomes assessment after operative and nonoperative management and allow comparisons across the literature. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
Using an evidence-based approach to measure outcomes in clinical practice.
MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J
2009-02-01
Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.
Hoch, Johanna M; Sinnott, Cori W; Robinson, Kendall P; Perkins, William O; Hartman, Jonathan W
2018-03-01
There is a lack of literature to support the diagnostic accuracy and cut-off scores of commonly used patient-reported outcome measures (PROMs) and clinician-oriented outcomes such as postural-control assessments (PCAs) when treating post-ACL reconstruction (ACLR) patients. These scores could help tailor treatments, enhance patient-centered care and may identify individuals in need of additional rehabilitation. To determine if differences in 4-PROMs and 3-PCAs exist between post-ACLR and healthy participants, and to determine the diagnostic accuracy and cut-off scores of these outcomes. Case control. Laboratory. A total of 20 post-ACLR and 40 healthy control participants. The participants completed 4-PROMs (the Disablement in the Physically Active Scale [DPA], The Fear-Avoidance Belief Questionnaire [FABQ], the Knee Osteoarthritis Outcomes Score [KOOS] subscales, and the Tampa Scale of Kinesiophobia [TSK-11]) and 3-PCAs (the Balance Error Scoring System [BESS], the modified Star Excursion Balance Test [SEBT], and static balance on an instrumented force plate). Mann-Whitney U tests examined differences between groups. Receiver operating characteristic (ROC) curves were employed to determine sensitivity and specificity. The Area Under the Curve (AUC) was calculated to determine the diagnostic accuracy of each instrument. The Youdin Index was used to determine cut-off scores. Alpha was set a priori at P < 0.05. There were significant differences between groups for all PROMs (P < 0.05). There were no differences in PCAs between groups. The cut-off scores should be interpreted with caution for some instruments, as the scores may not be clinically applicable. Post-ACLR participants have decreased self-reported function and health-related quality of life. The PROMs are capable of discriminating between groups. Clinicians should consider using the cut-off scores in clinical practice. Further use of the instruments to examine detriments after completion of standard
Terada, Masafumi; Harkey, Matthew S; Wells, Ashley M; Pietrosimone, Brian G; Gribble, Phillip A
2014-01-01
We investigated the influence of ankle dorsiflexion range of motion (DF-ROM) and self-reported patient outcomes on dynamic postural control assessed with the Star Excursion Balance Test (SEBT) in individuals with chronic ankle instability (CAI). Twenty-nine participants with self-reported CAI volunteered. The primary outcome measurements were categorized into clinician-and patient-generated. Clinician-generated outcome measurements included anterior (SEBT-A), posteriormedial (SEBT-PM) and posteriorlateral (SEBT-PL) reach distances (cm) normalized by leg length (cm) of the SEBT, maximum weight-bearing dorsiflexion (WB-DF) (cm), and open-chain DF-ROM (°). Self-reported patient-generated outcome measures included the foot and ankle ability measure and the level of perceived pain, stiffness, stability, and function of their involved ankle on a 10-cm visual analog scale (VAS). Pearson product moment correlations were used to examine the relationship of the SEBT performances with DF-ROM and self-reported patient outcome measures. A multiple linear regression was performed to determine the influence of patient- and clinician-generated measures on the SEBT. SEBT-A performance was significantly and fairly correlated with WB-DF (r=0.410, p=0.014), perceived ankle stiffness (r=0.477, p=0.014), and open-chain DF-ROM (r=0.404, p=0.015). The strongest predictor of the variance in SEBT-A was the combination of the variance in WB-DF and VAS-stiffness (R2=0.348, p=0.004). There were no significant correlations with the SEBT-PM and SEBT-PL. WB-DF and VAS-stiffness may represent targets for intervention that need to be addressed to produce the best outcome in participants with CAI when altered dynamic postural control is detected on the SEBT-A. Copyright © 2014 Elsevier B.V. All rights reserved.
de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David
2017-02-01
Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; P<.001), psychosocial distress (r = -0.26; P<.001), and HRQOL, as measured by the FACT-G (r = 0.42; P<.001) and by the EORTC QOL instruments (r = 0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P = .04), employment status (P<.001), income (P = .003), number of inpatient admissions (P = .01), and psychological distress (P = .003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and
Long-term patient-reported outcome after fractures of the clavicle in patients aged 10 to 18 years.
Randsborg, Per-Henrik; Fuglesang, Hendrik F S; Røtterud, Jan H; Hammer, Ola-Lars; Sivertsen, Einar A
2014-06-01
Fractures of the clavicle are common among adolescents and have traditionally been treated nonoperatively. Recent literature has demonstrated less satisfactory results than expected after conservative management of displaced fractures in adults. The purpose of this study was to evaluate the long-term patient-reported outcome after clavicle fractures in older children and adolescents. Children aged 10 to 18 years who sustained a fracture of the clavicle between 2006 and 2008 were identified in our institution's computerized files. The radiographs were examined and the fracture patterns, degree of dislocation, and shortening were measured. Medical records were reviewed and the patient-reported outcome was assessed using the Oxford Shoulder score and the Quick version of the Disability of Arm, Shoulder, and Hand questionnaire, and specific and general satisfaction scores. A total of 185 patients (median age, 14.4 y) with 172 midshaft and 13 lateral fractures were included in the study. Sixty-five (37.8%) of the midshaft fractures were displaced, and 9 of these were operated. There was one case of nonunion and one delayed union. One hundred twenty-two (70.9%) of the patients with a midshaft fracture responded to the questionnaires on an average 4.7 years after injury. Overall results were good to excellent for the majority of nonoperatively treated patients; however, shortening of the fracture had a negative effect on the Oxford Shoulder score (P=0.02), the cosmetic satisfaction score (P=0.02), and the overall satisfaction score (P=0.01). The long-term patient-reported outcome after nonoperatively treated fractures of the clavicle in adolescents is good to excellent for the majority of the patients, and nonunion is rare. However, shortening of the fracture had a small negative effect on the outcome. Conservative management should remain the mainstay of management for fractures of the clavicle in this age group. Level IV-retrospective case series.
McKenna, Stephen P; Wilburn, Jeanette
2018-05-01
The assessment of "patient value" is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value-they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.
Hung, Man; Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D
2015-01-01
Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties.
A quantitative assessment of patient and nurse outcomes of bedside nursing report implementation.
Sand-Jecklin, Kari; Sherman, Jay
2014-10-01
To quantify quantitative outcomes of a practice change to a blended form of bedside nursing report. The literature identifies several benefits of bedside nursing shift report. However, published studies have not adequately quantified outcomes related to this process change, having either small or unreported sample sizes or not testing for statistical significance. Quasi-experimental pre- and postimplementation design. Seven medical-surgical units in a large university hospital implemented a blend of recorded and bedside nursing report. Outcomes monitored included patient and nursing satisfaction, patient falls, nursing overtime and medication errors. We found statistically significant improvements postimplementation in four patient survey items specifically impacted by the change to bedside report. Nursing perceptions of report were significantly improved in the areas of patient safety and involvement in care and nurse accountability postimplementation. However, there was a decline in nurse perception that report took a reasonable amount of time after bedside report implementation; contrary to these perceptions, there was no significant increase in nurse overtime. Patient falls at shift change decreased substantially after the implementation of bedside report. An intervening variable during the study period invalidated the comparison of medication errors pre- and postintervention. There was some indication from both patients and nurses that bedside report was not always consistently implemented. Several positive outcomes were documented in relation to the implementation of a blended bedside shift report, with few drawbacks. Nurse attitudes about report at the final data collection were more positive than at the initial postimplementation data collection. If properly implemented, nursing bedside report can result in improved patient and nursing satisfaction and patient safety outcomes. However, managers should involve staff nurses in the implementation process and
Dewitt, Barry; Feeny, David; Fischhoff, Baruch; Cella, David; Hays, Ron D; Hess, Rachel; Pilkonis, Paul A; Revicki, Dennis A; Roberts, Mark S; Tsevat, Joel; Yu, Lan; Hanmer, Janel
2018-06-01
Health-related quality of life (HRQL) preference-based scores are used to assess the health of populations and patients and for cost-effectiveness analyses. The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS ® ) consists of patient-reported outcome measures developed using item response theory. PROMIS is in need of a direct preference-based scoring system for assigning values to health states. To produce societal preference-based scores for 7 PROMIS domains: Cognitive Function-Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Online survey of a US nationally representative sample ( n = 983). Preferences for PROMIS health states were elicited with the standard gamble to obtain both single-attribute scoring functions for each of the 7 PROMIS domains and a multiplicative multiattribute utility (scoring) function. The 7 single-attribute scoring functions were fit using isotonic regression with linear interpolation. The multiplicative multiattribute summary function estimates utilities for PROMIS multiattribute health states on a scale where 0 is the utility of being dead and 1 the utility of "full health." The lowest possible score is -0.022 (for a state viewed as worse than dead), and the highest possible score is 1. The online survey systematically excludes some subgroups, such as the visually impaired and illiterate. A generic societal preference-based scoring system is now available for all studies using these 7 PROMIS health domains.
Haverman, Lotte; Grootenhuis, Martha A; Raat, Hein; van Rossum, Marion A J; van Dulmen-den Broeder, Eline; Hoppenbrouwers, Karel; Correia, Helena; Cella, David; Roorda, Leo D; Terwee, Caroline B
2016-03-01
The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish. The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders. For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.
Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials.
Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Tonsgard, James H; Solomon, Sondra E; Baldwin, Andrea; Bergner, Amanda L; Walsh, Karin; Thompson, Heather L; Gardner, Kathy L; Hingtgen, Cynthia M; Schorry, Elizabeth; Dudley, William N; Franklin, Barbara
2016-08-16
Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials. The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials. The REiNS PRO group chose the Numeric Rating Scale-11 (≥8 years) to assess pain intensity, the Pain Interference Index (6-24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (≥18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (≥5 years) for NF clinical trials. The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research. © 2016 American Academy of Neurology.
Clinical and patient reported outcomes of bleaching effectiveness.
Klaric Sever, Eva; Budimir, Zrinka; Cerovac, Matea; Stambuk, Mario; Par, Matej; Negovetic Vranic, Dubravka; Tarle, Zrinka
2018-01-01
The objective of this study is to evaluate clinical and patient reported outcomes of different bleaching products. Thirty participants were randomly divided into three bleaching groups (n = 10). Bleaching was performed with high concentrations of hydrogen peroxide (HP) - Boost (40%) and Dash (30%), and with prefabricated splints Bite&White (6% HP). Tooth colour was measured before, immediately after, and 1 and 6 months after the bleaching by using classical shade guide and spectrophotometer. Tooth hypersensitivity was self-rated by patients on the Wong-Baker's face scale. Patient satisfaction was evaluated on a 7-point Likert-type scales that measured perceived performance and importance of different characteristics of bleaching treatment. All products were effective in teeth colour change (ΔE > 3.3), which was significantly higher for Boost (p = .016) and Dash (p = .024) than Bite&White treatment. Perception of hypersensitivity was the highest in Boost group, followed by Dash and Bite&White treatment. Most of the patients were satisfied with final tooth colour, length and comfort during treatment, but were dissatisfied with the stability of bleached tooth colour. Materials with the higher concentrations of bleaching agent demonstrated greater bleaching effectiveness than at-home bleaching product, but also a greater hypersensitivity. Lengthening the treatment process, but achieving a more stable tooth colour may improve the perceived value of a bleaching service.
Gater, Adam; Kitchen, Helen; Heron, Louise; Pollard, Catherine; Håkan-Bloch, Jonas; Højbjerre, Lise; Hansen, Brian Bekker; Strandberg-Larsen, Martin
2015-01-01
The primary objective of this review is to develop a conceptual model for Crohn's disease (CD) outlining the disease burden for patients, healthcare systems and wider society, as reported in the scientific literature. A search was conducted using MEDLINE, PsycINFO, EconLit, Health Economic Evaluation Database and Centre for Reviews and Dissemination databases. Patient-reported outcome (PRO) measures widely used in CD were reviewed according to the US FDA PRO Guidance for Industry. The resulting conceptual model highlights the characterization of CD by gastrointestinal disturbances, extra-intestinal and systemic symptoms. These symptoms impact physical functioning, ability to complete daily activities, emotional wellbeing, social functioning, sexual functioning and ability to work. Gaps in conceptual coverage and evidence of reliability and validity for some PRO measures were noted. Review findings also highlight the substantial direct and indirect costs associated with CD. Evidence from the literature confirms the substantial burden of CD to patients and wider society; however, future research is still needed to further understand burden from the perspective of patients and to accurately understand the economic burden of disease. Challenges with existing PRO measures also suggest the need for future research to refine or develop new measures.
Mercieca-Bebber, Rebecca; Williams, Douglas; Tait, Margaret-Ann; Roydhouse, Jessica; Busija, Lucy; Sundaram, Chindhu Shunmuga; Wilson, Michelle; Langford, Ailsa; Rutherford, Claudia; Roberts, Natasha; King, Madeleine; Vodicka, Elisabeth; Devine, Beth
2018-06-18
It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.
Walker, E M K; Bell, M; Cook, T M; Grocott, M P W; Moonesinghe, S R
2016-06-12
Understanding the patient perspective on healthcare is central to the evaluation of quality. This study measured selected patient-reported outcomes after anaesthesia in order to identify targets for research and quality improvement. This cross-sectional observational study in UK National Health Service hospitals, recruited adults undergoing non-obstetric surgery requiring anaesthesia care over a 48 h period. Within 24 h of surgery, patients completed the Bauer questionnaire (measuring postoperative discomfort and satisfaction with anaesthesia care), and a modified Brice questionnaire to elicit symptoms suggestive of accidental awareness during general anaesthesia (AAGA). Patient, procedural and pharmacological data were recorded to enable exploration of risk factors for these poor outcomes. 257 hospitals in 171 NHS Trusts participated (97% of eligible organisations). Baseline characteristics were collected on 16,222 patients; 15,040 (93%) completed postoperative questionnaires. Anxiety was most frequently cited as the worst aspect of the perioperative experience. Thirty-five per cent of patients reported severe discomfort in at least one domain: thirst (18.5%; 95% CI 17.8-19.1), surgical pain (11.0%; 10.5-11.5) and drowsiness (10.1%; 9.6-10.5) were most common. Despite this, only 5% reported dissatisfaction with any aspect of anaesthesia-related care. Regional anaesthesia was associated with a reduced burden of side-effects. The incidence of reported AAGA was one in 800 general anaesthetics (0.12%) Anxiety and discomfort after surgery are common; despite this, satisfaction with anaesthesia care in the UK is high. The inconsistent relationship between patient-reported outcome, patient experience and patient satisfaction supports using all three of these domains to provide a comprehensive assessment of the quality of anaesthesia care. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For
Razdan, Shantanu N; Patel, Vishal; Jewell, Sarah; McCarthy, Colleen M
2016-06-01
Bilateral prophylactic mastectomy (BPM) is effective in reducing the risk of breast cancer in women with a well-defined family history of breast cancer or in women with BRCA 1 or 2 mutations. Evaluating patient-reported outcomes following BPM are thus essential for evaluating success of BPM from patient's perspective. Our systematic review aimed to: (1) identify studies describing health-related quality of life (HRQOL) in patients following BPM with or without reconstruction; (2) assess the effect of BPM with or without reconstruction on HRQOL; and (3) identify predictors of HRQOL post-BPM. We performed a systematic review of literature using the PRISMA guidelines. PubMed, Embase, PsycINFO, Web of Science, Scopus and Cochrane databases were searched. The initial search resulted in 1082 studies; 22 of these studies fulfilled our inclusion criteria. Post-BPM, patients are satisfied with the outcomes and report high psychosocial well-being and positive body image. Sexual well-being and somatosensory function are most negatively affected. Vulnerability, psychological distress and preoperative cancer distress are significant negative predictors of quality of life and body image post-BPM. There is a paucity of high-quality data on outcomes of different HRQOL domains post-BPM. Future studies should strive to use validated and breast-specific PRO instruments for measuring HRQOL. This will facilitate shared decision-making by enabling surgeons to provide evidence-based answers to women contemplating BPM.
How patient outcomes are reported in drug advertisements.
Lexchin, J
1999-05-01
To examine how changes in outcomes are reported in drug advertisements in medical journals. Advertisements from a convenience sample of 38 issues of Canadian Family Physician, Canadian Journal of Anaesthesia, Canadian Journal of Psychiatry, Canadian Medical Association Journal, and the New England Journal of Medicine. Method of reporting changes in clinical outcomes (relative risk reduction [RRR], absolute risk reduction [ARR], number needed to treat [NNT]), name of product, and company marketing product were sought. In the 22 advertisements included in the analysis, 11 reported results as RRRs; two reported results as RRRs, but readers could calculate ARRs or NNTs from figures given in the advertisement; and nine gave no measure of results, but readers could calculate RRRs, ARRs, or NNTs from figures given. Most companies report changes in outcomes as RRRs, and this bias could influence the way physicians prescribe. Changes to the rules governing journal advertising and increased emphasis on critical appraisal skills would help mitigate this bias.
Liu, Yanyan; Hinds, Pamela S; Wang, Jichuan; Correia, Helena; Du, Shizheng; Ding, Jian; Gao, Wen Jun; Yuan, Changrong
2013-01-01
The Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) measures were developed using modern measurement theory and tested in a variety of settings to assess the quality of life, function, and symptoms of children and adolescents experiencing a chronic illness and its treatment. Developed in English, this set of measures had not been translated into Chinese. The objective of this study was to develop the Chinese version of the Pediatric PROMIS measures (C-Ped-PROMIS), specifically 8 short forms, and to pretest the translated measures in children and adolescents through cognitive interviewing methodology. The C-Ped-PROMIS was developed following the standard Functional Assessment of Chronic Illness Therapy Translation Methodology. Bilingual teams from the United States and China reviewed the translation to develop a provisional version, which was then pretested with cognitive interview by probing 10 native Chinese-speaking children aged 8 to 17 years in China. The translation was finalized by the bilingual teams. Most items, response options, and instructions were well understood by the children, and some revisions were made to address patient's comments during the cognitive interview. The results indicated that the C-Ped-PROMIS items were semantically and conceptually equivalent to the original. Children aged 8 to 17 years in China were able to comprehend these measures and express their experience and feelings about illness or their life. The C-Ped-PROMIS is available for psychometric validation. Future work will be directed at translating the rest of the item banks, calibrating them and creating a Chinese final version of the short forms.
Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D
2015-01-01
Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131
Fenton, Bradford W.; Grey, Scott F.; Tossone, Krystel; McCarroll, Michele; Von Gruenigen, Vivian E.
2015-01-01
Chronic pelvic pain affects multiple aspects of a patient's physical, social, and emotional functioning. Latent class analysis (LCA) of Patient Reported Outcome Measures Information System (PROMIS) domains has the potential to improve clinical insight into these patients' pain. Based on the 11 PROMIS domains applied to n=613 patients referred for evaluation in a chronic pelvic pain specialty center, exploratory factor analysis (EFA) was used to identify unidimensional superdomains. Latent profile analysis (LPA) was performed to identify the number of homogeneous classes present and to further define the pain classification system. The EFA combined the 11 PROMIS domains into four unidimensional superdomains of biopsychosocial dysfunction: Pain, Negative Affect, Fatigue, and Social Function. Based on multiple fit criteria, a latent class model revealed four distinct classes of CPP: No dysfunction (3.2%); Low Dysfunction (17.8%); Moderate Dysfunction (53.2%); and High Dysfunction (25.8%). This study is the first description of a novel approach to the complex disease process such as chronic pelvic pain and was validated by demographic, medical, and psychosocial variables. In addition to an essentially normal class, three classes of increasing biopsychosocial dysfunction were identified. The LCA approach has the potential for application to other complex multifactorial disease processes. PMID:26355825
Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E; Johnston, Kelly L; Lawrence, Suzanne M; Daley, Dennis C
2016-04-01
The Patient-Reported Outcomes Measurement Information System (PROMIS) includes five item banks for alcohol use. There are limited data, however, regarding their validity (e.g., convergent validity, responsiveness to change). To provide such data, we conducted a prospective study with 225 outpatients being treated for substance abuse. Assessments were completed shortly after intake and at 1-month and 3-month follow-ups. The alcohol item banks were administered as computerized adaptive tests (CATs). Fourteen CATs and one six-item short form were also administered from eight other PROMIS domains to generate a comprehensive health status profile. After modeling treatment outcome for the sample as a whole, correlates of outcome from the PROMIS health status profile were examined. For convergent validity, the largest correlation emerged between the PROMIS alcohol use score and the Alcohol Use Disorders Identification Test (r=.79 at intake). Regarding treatment outcome, there were modest changes across the target problem of alcohol use and other domains of the PROMIS health status profile. However, significant heterogeneity was found in initial severity of drinking and in rates of change for both abstinence and severity of drinking during follow-up. This heterogeneity was associated with demographic (e.g., gender) and health-profile (e.g., emotional support, social participation) variables. The results demonstrated the validity of PROMIS CATs, which require only 4-6 items in each domain. This efficiency makes it feasible to use a comprehensive health status profile within the substance use treatment setting, providing important prognostic information regarding abstinence and severity of drinking. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J
2016-12-01
Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.
Wolfensberger, Adrian; Vuistiner, Philippe; Konzelmann, Michel; Plomb-Holmes, Chantal; Léger, Bertrand; Luthi, François
2016-09-01
Validated clinician outcome scores are considered less associated with psychosocial factors than patient-reported outcome measurements (PROMs). This belief may lead to misconceptions if both instruments are related to similar factors. We asked: In patients with chronic shoulder pain, what biopsychosocial factors are associated (1) with PROMs, and (2) with clinician-rated outcome measurements? All new patients between the ages of 18 and 65 with chronic shoulder pain from a unilateral shoulder injury admitted to a Swiss rehabilitation teaching hospital between May 2012 and January 2015 were screened for potential contributing biopsychosocial factors. During the study period, 314 patients were screened, and after applying prespecified criteria, 158 patients were evaluated. The median symptom duration was 9 months (interquartile range, 5.5-15 months), and 72% of the patients (114 patients) had rotator cuff tears, most of which were work injuries (59%, 93 patients) and were followed for a mean of 31.6 days (SD, 7.5 days). Exclusion criteria were concomitant injuries in another location, major or minor upper limb neuropathy, and inability to understand the validated available versions of PROMs. The PROMs were the DASH, the Brief Pain Inventory, and the Patient Global Impression of Change, before and after treatment (physiotherapy, cognitive therapy and vocational training). The Constant-Murley score was used as a clinician-rated outcome measurement. Statistical models were used to estimate associations between biopsychosocial factors and outcomes. Greater disability on the DASH was associated with psychological factors (Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale combined coefficient, 0.64; 95% CI, 0.25-1.03; p = 0.002) and social factors (language, professional qualification combined coefficient, -6.15; 95% CI, -11.09 to -1.22; p = 0.015). Greater pain on the Brief Pain Inventory was associated with psychological factors (Hospital Anxiety and
Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable
Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.
2017-01-01
Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of
Browne, John P; Jeevan, Ranjeet; Pusic, Andrea L; Klassen, Anne F; Gulliver-Clarke, Carmel; Pereira, Jerome; Caddy, Christopher M; Cano, Stefan J
2018-03-01
There is little evidence about the long-term donor site outcome of latissimus dorsi breast reconstruction and no patient-reported outcome measures designed specifically for the procedure. A prospective cohort of breast cancer patients having latissimus dorsi reconstruction after a mastectomy was recruited from 270 hospitals in the United Kingdom. An 18-month follow up questionnaire containing two novel scales was sent to consenting patients. The prevalence of aesthetic and functional morbidity at the donor site was described. The two new scales were refined using the Rasch measurement model and subsequently validated. 1,096 women completed the new scales. 78% of patients reported that no back appearance issues had bothered them "most of the time" or "all of the time" in the past two weeks. The equivalent figure for functional morbidity was 60%. Four items were eliminated following initial psychometric testing. This produced an 8-item Back Appearance scale and an 11-item Back and Shoulder Function scale. Both scales showed adequate fit to the Rasch measurement model. Higher levels of aesthetic and functional bother were observed for completely autologous procedures versus those where latissimus dorsi reconstruction was used to cover an implant (p <0.05). Higher levels of aesthetic bother were observed in women who had suffered a perioperative complication at the donor site (p = 0.003). These results can inform patients of the morbidity associated with latissimus dorsi reconstruction. The new scales can be used to compare groups undergoing different variations of the procedure and to monitor individual patients. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M; Yazici, Hasan; Merkel, Peter A
2015-12-01
There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients' perspectives, concerns, and ideas into outcome measure development was emphasized. The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS.
Waheeb, Androu; Zywiel, Michael G; Palaganas, Marvilyn; Venkataramanan, Viji; Davis, Aileen M
2015-02-01
Recent evidence suggests that patient factors can influence response to medical and surgical treatment and may play an under-recognized role in predicting treatment outcomes. However, the current state of knowledge concerning potential associations following orthopedic surgery in particular is unclear. The purpose of the present study was to systematically review current literature to investigate the currently known associations between pre-operative patient factors and patient-reported outcomes following orthopedic surgery. A systematic review was performed of the PubMed database to identify original studies that investigated the relationships between one or more patient factors and patient-reported outcomes of primary orthopedic surgical procedures involving implantation of a medical device. A total of 10,174 records were identified, with 83 studies included in the final review. The most commonly assessed patient factors included age, sex, and body mass index (BMI), reported in 63%, 55%, and 48% of studies, respectively. The only other patient factors identified were socioeconomic status and race, both of which were assessed in a single study. Considerable heterogeneity was observed in the methods used to stratify subjects by patient factors, patient-reported outcome constructs assessed, and follow-up intervals. Only 10% of studies performed appropriate sample size or power calculations, only 51% used methodologies to control for potentially confounding factors, and 6% assessed responder status. Overall, variable and conflicting findings were seen. While female sex and increasing BMI did appear to be associated with worse absolute outcomes, these differences did not appear to be maintained when differences in baseline status were considered. No clear associations between age and outcomes were identified. The present understanding of these relationships between patient factors and patient-reported outcomes following orthopedic surgery is limited. There is a need
Hill, Bridget; Pallant, Julie; Williams, Gavin; Olver, John; Ferris, Scott; Bialocerkowski, Andrea
2016-12-01
To evaluate the internal construct validity and dimensionality of a new patient-reported outcome measure for people with traumatic brachial plexus injury (BPI) based on the International Classification of Functioning, Disability and Health definition of activity. Cross-sectional study. Outpatient clinics. Adults (age range, 18-82y) with a traumatic BPI (N=106). There were 106 people with BPI who completed a 51-item 5-response questionnaire. Responses were analyzed in 4 phases (missing responses, item correlations, exploratory factor analysis, and Rasch analysis) to evaluate the properties of fit to the Rasch model, threshold response, local dependency, dimensionality, differential item functioning, and targeting. Not applicable, as this study addresses the development of an outcome measure. Six items were deleted for missing responses, and 10 were deleted for high interitem correlations >.81. The remaining 35 items, while demonstrating fit to the Rasch model, showed evidence of local dependency and multidimensionality. Items were divided into 3 subscales: dressing and grooming (8 items), arm and hand (17 items), and no hand (6 items). All 3 subscales demonstrated fit to the model with no local dependency, minimal disordered thresholds, no unidimensionality or differential item functioning for age, time postinjury, or self-selected dominance. Subscales were combined into 3 subtests and demonstrated fit to the model, no misfit, and unidimensionality, allowing calculation of a summary score. This preliminary analysis supports the internal construct validity of the Brachial Assessment Tool, a unidimensional targeted 4-response patient-reported outcome measure designed to solely assess activity after traumatic BPI regardless of level of injury, age at recruitment, premorbid limb dominance, and time postinjury. Further examination is required to determine test-retest reliability and responsiveness. Copyright © 2016 American Congress of Rehabilitation Medicine
van Geel, Nanja; Lommerts, Janny E; Bekkenk, Marcel W; Prinsen, Cecilia A C; Eleftheriadou, Viktoria; Taieb, Alain; Picardo, Mauro; Ezzedine, Khaled; Wolkerstorfer, Albert; Speeckaert, Reinhart
2017-03-01
The Vitiligo Extent Score (VES) has recently been introduced as a physicians' score for the clinical assessment of the extent of vitiligo, but a good patient self-assessment score is lacking. The objective is to develop and validate a simplified version of the VES as a patient-reported outcome measure (PROM). After extensive pilot testing, patients were asked to score their vitiligo extent twice with an interval of 2 weeks using the Self Assessment Vitiligo Extent Score (SA-VES). The scores were compared with the physicians' evaluation (VES). The SA-VES demonstrated very good test-retest reliability (intraclass correlation = 0.948, 95% confidence interval [CI]: 0.911-0.970) that was not affected by age, skin type, or vitiligo distribution pattern. According to patients, this evaluation method was easy to use (22% very easy; 49% easy; 29% normal) and required <5 minutes in the majority of patients (73%, <5 minutes; 24%, 5-10 minutes; 2%, 10-15 minutes). Comparison of the SA-VES and the VES demonstrated excellent correlation (r = 0.986, P <.001). Few patients had a dark skin type. The results demonstrate excellent reliability of the SA-VES and excellent correlation with its investigator-reported counterpart (VES). This patient-oriented evaluation method provides a useful tool for the assessment of vitiligo extent. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Zheng, Hua; Li, Wenjun; Harrold, Leslie; Ayers, David C; Franklin, Patricia D
2014-01-01
Patient-reported outcomes (PROs) are rarely included in quality monitoring systems, surgeon comparative feedback reports, or registries. We present the design and implementation of a secure website in a federally funded research program-Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)-to return comparative PRO reports to participating surgeons, in addition to including traditional quality measures, in order to monitor and improve quality and health outcomes. The surgeon-specific comparative PRO reports were designed and structured based on user input for content, data elements, integration, and display. Three questions are addressed regarding the knee and hip joint symptom profiles of patients before TJR, as well as outcomes of surgery. The website is organized with a hierarchical structure to display data at national, practice, and individual surgeon levels, and provides a comprehensive site-level executive summary and surgeon-level data reports that can be downloaded. As of September 2014, over 22,000 patients were enrolled from more than 130 surgeons in 22 states. The reporting website was launched in September 2012 and has been updated quarterly for all surgeons to review their site- and individual-specific outcomes data compared to national benchmarks. In this novel system, quarterly comparative surgeon feedback extends beyond traditional measures of complication rates to include PROs of pain relief and functional gain. We anticipate that this enhanced data will facilitate patient-centered quality improvement (QI) and outcomes research from the registry. As the Centers for Medicare & Medicaid Services (CMS) and other insurers consider future implementation of PROs, surgeons will increasingly need comparative data by which to self-monitor their practice outcomes.
Liu, Yanyan; Yuan, Changrong; Wang, Jichuan; Brown, Jeanne Geiger; Zhou, Fen; Zhao, Xiufang; Shen, Min; Hinds, Pamela S
2016-10-01
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric forms measure symptoms and function of pediatric patients experiencing chronic disease by using the same measures. Comparability is one of the most important purposes of the PROMIS initiative. This study aimed to test the factorial structures of four symptom measures (i.e., Anxiety, Depression, Fatigue, and Pain Interference) in the original English and the Chinese versions and examine the measurement invariance of the measures across two cultures. Four PROMIS Pediatric measures were used to assess symptoms, respectively, in Chinese (n = 232) and American (n = 200) children and adolescents (8-17 years old) in treatment for cancer or in survivorship. The categorical confirmatory factor analysis (CCFA) model was used to examine factorial structures, and multigroup CCFA was applied to test measurement invariance of these measures between the Chinese and American samples. The CCFA models of the four PROMIS Pediatric symptom measures fit the data well for both the Chinese and American children and adolescents. Minor partial measurement invariance was identified. Factor means and factor variances of the four PROMIS measures were not significantly different between the two populations. Our results provide evidence that the four PROMIS Pediatric symptom measures have valid factorial structures and a statistical property of measurement invariance across American and Chinese children and adolescents with cancer. This means that the items of these measures were interpreted in a conceptually similar manner by two groups. They could be readily used for meaningful cross-cultural comparisons involving pediatric oncology patients in these two countries.
Physical performance measures for predicting outcome in cancer patients: a systematic review.
Verweij, Norbert M; Schiphorst, Anandi H W; Pronk, Apollo; van den Bos, Frederiek; Hamaker, Marije E
2016-12-01
Decision making regarding cancer treatment is challenging and there is a need for clinical parameters that can guide these decisions. As physical performance appears to be a reflection of health status, the aim of this systematic review is to assess whether physical performance tests (PPTs) are predictive of the clinical outcome and treatment tolerance in cancer patients. A literature search was conducted on 2 April 2015 in the electronic databases Medline and Embase to identify studies focusing on the association between objectively measured PPTs and outcome. No limitations in language or publication dates were applied. The search retrieved 9680 articles, 16 publications were included involving 4187 patients with various cancer types and different treatments. Reported median or mean age varied from 58 to 78 years. Nine studies used the Timed Up & Go (TUG) test, five the Short Physical Performance Battery (SPPB) and five studies focused on gait speed. Poorer TUG, SPPB and gait speed outcome were associated with decreased survival. TUG, SPPB and gait speed were also associated with treatment-related complications. Furthermore, two studies reported an association between poorer TUG and SPPB outcome with higher rates of functional decline. PPTs appear to show a significant correlation with survival and these tests could be used as a prognostic tool, particular for older adult patients. A less explicit correlation for treatment-related complications and functional decline was also found. To optimize decision making, future research should focus on developing and validating individualized treatment algorithms that incorporate PPTs in addition to cancer- and treatment-related variables.
Spencer, Jeffrey; Blakely, Stephen; Daugherty, Michael; Angulo, Javier C; Martins, Francisco; Venkatesan, Krishnan; Nikolavsky, Dmitriy
2018-01-01
To evaluate clinical and patient-reported urinary and sexual outcomes after a long-segment stricture repair using the 1-sided urethral dissection, penile invagination, and dorsal buccal mucosa graft onlay technique described by Kulkarni et al. Patients from 4 institutions after single-stage repairs for long-segment urethral strictures (>8 cm) from January 2002 to April 2016 were reviewed. Technique described by Kulkarni et al was used in all cases. Clinical outcomes included uroflowmetry (Qmax) and post-void residuals. Patient-reported outcome measures included International Prostate Symptom Score survey, Sexual Health Inventory for Men, Male Sexual Health Questionnaire, and Global Response Assessment questionnaire to measure voiding, sexual, ejaculatory symptoms, and overall improvement, respectively. Seventy-three patients with a minimum of 12 months' follow-up were included. The mean age and stricture length were 56 (21-80) years and 13.6 (8-21) cm, respectively. At a mean follow-up of 44 (12-162) months, 9 of 73 (12%) strictures recurred. The mean baseline International Prostate Symptom Score of 23 (7-24) decreased to 10 (1-17) on follow-up (P <.001). Eight of 42 patients (21.4%) reported an increase, and 6 of 42 patients (14.3%) decreased in Sexual Health Inventory for Men following urethroplasty. Ejaculatory function on Male Sexual Health Questionnaire improved after urethroplasty from 8 preoperatively to 11 postoperatively (P <.004). All patients reported improvement after urethroplasty on Global Response Assessment questionnaire. Post-void dribbling and chordee occurred in 45% and 25% of patients, respectively. Durable patency in most patients is demonstrated in this study. PROMs indicate an improvement in urinary function and moderate effect on sexual function. Transient penile chordee was evident in 25% of patients. Copyright © 2017 Elsevier Inc. All rights reserved.
Browne, John; Jamieson, Liz; Lewsey, Jim; van der Meulen, Jan; Copley, Lynn; Black, Nick
2008-04-09
There has been considerable concern expressed about the outcomes achieved in Independent Sector Treatment Centres (ISTCs) introduced in England since 2003. Our aim was to compare the case-mix and patients' reported outcomes of surgery in ISTCs and in NHS providers. Prospective cohort study of 769 patients treated in six ISTCs and 1895 treated in 20 NHS providers (acute hospitals and treatment centres) in England during 2006-07. Participants underwent one of three day surgery procedures (inguinal hernia repair, varicose vein surgery, cataract extraction) or hip or knee replacement. Change in patient-reported health status and health related quality of life (measured using a disease-specific and a generic (EQ-5D) instrument) was assessed either 3-months (day surgery) or 6-months (hip/knee) after surgery. In addition patient-reported post-operative complications and an overall assessment of success of surgery were collected. Outcome measures were adjusted (using multivariable regression) for patient characteristics (disease severity, duration of symptoms, age, sex, socioeconomic status, general health, previous similar surgery, comorbidity). Post-operative response rates varied by procedure (73%-88%) and were similar for those treated in ISTCs and NHS facilities. Patients treated in ISTCs were healthier, were less likely to have any comorbidity and, for those undergoing cataract surgery or joint replacement, their primary condition was less severe. Those undergoing hernia repair or joint replacement were less likely to have had similar surgery before. When adjustment was made for pre-operative characteristics, patients undergoing cataract surgery or hip replacement in ISTCs achieved a slightly greater improvement in functional status and quality of life than those treated in NHS facilities, while the opposite was true of patients undergoing hernia repair. No significant differences were found for the two other procedures. Patients treated in ISTCs were less likely to
Systematic Review of Treatment Outcome Measures for Vulvodynia.
Sadownik, Leslie A; Yong, Paul J; Smith, Kelly B
2018-07-01
To systematically evaluate the literature regarding vulvodynia treatment outcome measures. A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.
Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.
2017-01-01
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation
Coons, Stephen Joel; Gwaltney, Chad J; Hays, Ron D; Lundy, J Jason; Sloan, Jeff A; Revicki, Dennis A; Lenderking, William R; Cella, David; Basch, Ethan
2009-06-01
Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted. The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting
Predictors of Patient-Reported Outcomes of Total Joint Arthroplasty in a Developing Country.
Bido, Jennifer; Yang, Ying H; Collins, Jamie E; Dong, Yan; Driscoll, Daniel A; Alcantara, Luis A; Thornhill, Thomas S; Katz, Jeffrey N
2017-06-01
In response to the growing burden of joint disease, developing countries are starting to create their own total joint arthroplasty (TJA) programs. To date, there has been limited research on predictors of TJA outcomes in a developing country. This investigation uses patient-reported outcome measures collected by a medical mission to assess predictors of TJA outcomes in the Dominican Republic. Baseline and postoperative information from 156 of the mission's recipients of hip and knee TJA was used. Demographics were abstracted from clinical notes, and self-reported pain and functional status were assessed using Western Ontario and McMaster University Osteoarthritis Index and Short-Form 36 measures. Bivariate analysis identified variables to include in multivariable regression models of factors associated with function and pain outcomes and improvement in these domains 1 or 2 years postoperatively. The cohort had a mean age of 61.3 years, 82% were female, 79% had total knee arthroplasty, and 42% of the procedures were bilateral. In multivariate analyses, at P < .05, male sex, better preoperative function, and use of bilateral procedure were associated with better functional outcome. Male sex and worse preoperative pain were associated with better pain outcome. Worse preoperative pain and function, as well as bilateral surgery were associated with greater improvement in function. Additionally, a greater number of bothersome joints was associated with greater pain reduction. Our findings of better follow-up pain scores among patients with worse pain preoperatively and better functional improvement among those undergoing bilateral replacements contrast with study results from developed countries. The explanations for these observations merit further study. Copyright © 2017 Elsevier Inc. All rights reserved.
Pratt-Chapman, Mandi; Simon, Melissa A.; Patterson, Angela; Risendal, Betsy C.; Patierno, Steven
2013-01-01
Survivorship navigation is a relatively new concept in the field of patient navigation, but an important one. This paper highlights the essential functions of the survivorship navigator and defines core outcomes and measures for navigation in the survivorship period. Barriers to access to care experienced by patients during active cancer treatment can continue into the post-treatment period, affecting quality follow-up care for survivors. These barriers to care can be particularly acute for non-English speakers, immigrants, the uninsured, the underinsured and other vulnerable populations. The survivorship navigator can help reduce barriers and facilitate access to survivorship care and services through communication and information exchange for patients. Survivorship navigation may improve appropriate health care utilization through education and care coordination, potentially improving health outcomes and quality of life of survivors while reducing cost to the health care system. Survivorship navigators can also educate survivors on how to improve their overall wellness, thereby directly impacting the health of a growing population of cancer survivors. PMID:21780092
Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria
2016-07-01
To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.
Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review.
Viecelli, Andrea K; O'Lone, Emma; Sautenet, Benedicte; Craig, Jonathan C; Tong, Allison; Chemla, Eric; Hooi, Lai-Seong; Lee, Timmy; Lok, Charmaine; Polkinghorne, Kevan R; Quinn, Robert R; Vachharajani, Tushar; Vanholder, Raymond; Zuo, Li; Irish, Ashley B; Mori, Trevor A; Pascoe, Elaine M; Johnson, David W; Hawley, Carmel M
2018-03-01
Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials. Systematic review. Adults requiring maintenance hemodialysis. All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. Any hemodialysis-related intervention. The frequency and characteristics of vascular access outcome measures were analyzed and classified. From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions. Restricted sampling frame for feasibility and focus on contemporary trials. The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular
Alam, Roshni; Figueiredo, Sabrina M; Balvardi, Saba; Nauche, Bénédicte; Landry, Tara; Lee, Lawrence; Mayo, Nancy E; Feldman, Liane S; Fiore, Julio F
2018-05-17
We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery. Participants were experts in perioperative care identified through two major surgical societies (35 invited). The systematic review identified 19 PROMs covering 66 ICF domains. 23 experts (66%) participated in the Delphi process. After Round 2, experts agreed that 22 health domains (8 body functions, 14 activities and participation) are potentially relevant to the process of recovery after abdominal surgery. These domains were organized into a diagram, representing our hypothesized conceptual framework. This hypothesized conceptual framework is an important first step in our research program and will be further refined based on in-depth qualitative interviews with patients. The sound methodological approach used to derive this framework may be valuable for studies aimed to develop PROMs according to FDA standards.
Poulsen, Lotte; Klassen, Anne; Rose, Michael; Roessler, Kirsten K; Juhl, Claus Bogh; Støving, René Klinkby; Sørensen, Jens Ahm
2017-09-01
Health-related quality of life and satisfaction with appearance are important outcomes in bariatric and body contouring surgery. To investigate these outcomes, scientifically sound and clinically meaningful patient-reported outcome instruments are needed. The authors measured health-related quality of life and appearance in a cohort of Danish patients at different phases in the weight loss journey: before bariatric surgery, after bariatric surgery, before body contouring surgery, and after body contouring surgery. From June of 2015 to June of 2016, a cross-sectional sample of 493 bariatric and body contouring patients were recruited from four different hospital departments. Patients were asked to fill out the BODY-Q, a new patient-reported outcomes instrument designed specifically to measure health-related quality of life and appearance over the entire patient journey, from obesity to the post-body contouring surgery period. Data were collected using REDCap, and analyzed using SPSS software. For all appearance and health-related quality-of-life scales, the mean score was significantly lower in the pre-bariatric surgery group compared with the post-body contouring group. Furthermore, the correlation between body mass index and mean scores was significant for all appearance and health-related quality-of-life scales, with higher scores associated with lower body mass index. The mean score for the group reporting no excess skin compared with the group reporting a lot of excess skin was significantly higher for five of seven appearance scales and four of five health-related quality-of-life scales. This study provides evidence to suggest that body contouring plays an important role in the weight loss patient's journey and that patients need access to treatments.
Lang, Niklaus P; Zitzmann, Nicola U
2012-02-01
The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.
2011-01-01
Background Hip arthroscopies are often used in the treatment of intra-articular hip injuries. Patient-reported outcomes (PRO) are an important parameter in evaluating treatment. It is unclear which PRO questionnaires are specifically available for hip arthroscopy patients. The aim of this systematic review was to investigate which PRO questionnaires are valid and reliable in the evaluation of patients undergoing hip arthroscopy. Methods A search was conducted in Pubmed, Medline, CINAHL, the Cochrane Library, Pedro, EMBASE and Web of Science from 1931 to October 2010. Studies assessing the quality of PRO questionnaires in the evaluation of patients undergoing hip arthroscopy were included. The quality of the questionnaires was evaluated by the psychometric properties of the outcome measures. The quality of the articles investigating the questionnaires was assessed by the COSMIN list. Results Five articles identified three questionnaires; the Modified Harris Hip Score (MHHS), the Nonarthritic Hip Score (NAHS) and the Hip Outcome Score (HOS). The NAHS scored best on the content validity, whereas the HOS scored best on agreement, internal consistency, reliability and responsiveness. The quality of the articles describing the HOS scored highest. The NAHS is the best quality questionnaire. The articles describing the HOS are the best quality articles. Conclusions This systematic review shows that there is no conclusive evidence for the use of a single patient-reported outcome questionnaire in the evaluation of patients undergoing hip arthroscopy. Based on available psychometric evidence we recommend using a combination of the NAHS and the HOS for patients undergoing hip arthroscopy. PMID:21619610
Patterson, Joanne M; McColl, Elaine; Carding, Paul N; Hildreth, Anthony J; Kelly, Charles; Wilson, Janet A
2014-03-01
This prospective study evaluated swallowing outcomes prechemoradiotherapy (pre-CRT) up to 1 year post-CRT, in a substantial cohort of patients with head and neck cancer and explored factors predicting outcome. One hundred twelve patients were assessed pretreatment and at 3, 6, and 12 months posttreatment using a questionnaire, endoscopic assessment, water swallow test, and diet score. Seventy-one patients were retained, the majority had oropharyngeal (53%) or hypopharyngeal cancer (20%). A marked deterioration occurred between pretreatment and 3 months posttreatment (p ≤ .01). Significant improvement between 3 and 12 months was found on 2 swallowing measures, but not self reported. Three of the 4 pretreatment assessments predicted outcomes at 1 year. CRT results in a marked deterioration on different paradigms of swallowing measurements. Improvement occurs on some clinical measures, but limited change is observed in patients' perceptions. Pretreatment measures are important indicators of long-term dysphagia. Swallowing recovery is complex, taking different courses between clinical tests and perspectives. Copyright © 2013 Wiley Periodicals, Inc., A Wiley Company.
Arbuckle, Rob; Abetz-Webb, Linda
2013-01-01
The US FDA and the European Medicines Agency (EMA) have issued incentives and laws mandating clinical research in pediatrics. While guidances for the development and validation of patient-reported outcomes (PROs) or health-related quality of life (HRQL) measures have been issued by these agencies, little attention has focused on pediatric PRO development methods. With reference to the literature, this article provides an overview of specific considerations that should be made with regard to the development of pediatric PRO measures, with a focus on performing qualitative research to ensure content validity. Throughout the questionnaire development process it is critical to use developmentally appropriate language and techniques to ensure outcomes have content validity, and will be reliable and valid within narrow age bands (0-2, 3-5, 6-8, 9-11, 12-14, 15-17 years). For qualitative research, sample sizes within those age bands must be adequate to demonstrate saturation while taking into account children's rapid growth and development. Interview methods, interview guides, and length of interview must all take developmental stage into account. Drawings, play-doh, or props can be used to engage the child. Care needs to be taken during cognitive debriefing, where repeated questioning can lead a child to change their answers, due to thinking their answer is incorrect. For the PROs themselves, the greatest challenge is in measuring outcomes in children aged 5-8 years. In this age range, while self-report is generally more valid, parent reports of observable behaviors are generally more reliable. As such, 'team completion' or a parent-administered child report is often the best option for children aged 5-8 years. For infants and very young children (aged 0-4 years), patient rating of observable behaviors is necessary, and, for adolescents and children aged 9 years and older, self-reported outcomes are generally valid and reliable. In conclusion, the development of PRO
Patient Compliance With Electronic Patient Reported Outcomes Following Shoulder Arthroscopy.
Makhni, Eric C; Higgins, John D; Hamamoto, Jason T; Cole, Brian J; Romeo, Anthony A; Verma, Nikhil N
2017-11-01
To determine the patient compliance in completing electronically administered patient-reported outcome (PRO) scores following shoulder arthroscopy, and to determine if dedicated research assistants improve patient compliance. Patients undergoing arthroscopic shoulder surgery from January 1, 2014, to December 31, 2014, were prospectively enrolled into an electronic data collection system with retrospective review of compliance data. A total of 143 patients were included in this study; 406 patients were excluded (for any or all of the following reasons, such as incomplete follow-up, inaccessibility to the order sets, and inability to complete the order sets). All patients were assigned an order set of PROs through an electronic reporting system, with order sets to be completed prior to surgery, as well as 6 and 12 months postoperatively. Compliance rates of form completion were documented. Patients who underwent arthroscopic anterior and/or posterior stabilization were excluded. The average age of the patients was 53.1 years, ranging from 20 to 83. Compliance of form completion was highest preoperatively (76%), and then dropped subsequently at 6 months postoperatively (57%) and 12 months postoperatively (45%). Use of research assistants improved compliance by approximately 20% at each time point. No differences were found according to patient gender and age group. Of those completing forms, a majority completed forms at home or elsewhere prior to returning to the office for the clinic visit. Electronic administration of PRO may decrease the amount of time required in the office setting for PRO completion by patients. This may be mutually beneficial to providers and patients. It is unclear if an electronic system improves patient compliance in voluntary completion PRO. Compliance rates at final follow-up remain a concern if data are to be used for establishing quality or outcome metrics. Level IV, case series. Copyright © 2017 Arthroscopy Association of North
Jensen, Roxanne E; Rothrock, Nan E; DeWitt, Esi M; Spiegel, Brennan; Tucker, Carole A; Crane, Heidi M; Forrest, Christopher B; Patrick, Donald L; Fredericksen, Rob; Shulman, Lisa M; Cella, David; Crane, Paul K
2015-02-01
Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.
Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.
2016-01-01
Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135
2017-01-01
Background Information to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician’s personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measurements are rarely available. Objective The aim was to describe a generic method for individual long-term prognosis of symptom burden and functioning that implied few statistical presumptions, to evaluate an implementation for prognosis of depressive symptoms in stroke patients and to provide open access to a Web-based prototype of this implementation for individual use. Methods The method used to describe individual prognosis of a PRO outcome was based on the selection of a specific subcohort of patients who have the same score as the patient in question at the same time (eg, after diagnosis or treatment start), plus or minus one unit of minimal clinically important difference. This subcohort’s experienced courses were then used to provide quantitative measures of prognosis over time. A cohort of 1404 stroke patients provided data for a simulation study and a prototype for individual use. Members of the cohort answered questionnaires every 6 months for 3.5 years. Depressive symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS) and a single item from the SF-12 (MH4) health survey. Four approaches were compared in a simulation study in which the prognosis for each member of the cohort was individually assessed. Results The mean standard deviations were 40% to 70% higher in simulated scores. Mean errors were close to zero, and mean absolute errors were between 0.46 and 0.66 SD in the four approaches. An approach in which missing HADS scores were estimated from the single-item SF-12 MH4 performed marginally better than methods restricted to questionnaires with a genuine HADS score, which indicates that data collected with shorter questionnaires (eg, in
Paty, Jean; Elash, Celeste A; Turner-Bowker, Diane M
2017-02-01
Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials. The development of the VVSymQ ® instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ ® instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument. Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI™]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ ® instrument queries patients on the HASTI™ symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from "None of the time" to "All of the time," and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ ® instrument. Content validity was established for the VVSymQ ® instrument, which assesses the five HASTI™ symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.
Barone, M; Cogliandro, A; Salzillo, R; Tambone, V; Persichetti, P
2018-06-19
The objectives of the current study were: (1) to perform a systematic review of the existing scientific literature on appearance and any subsequently related disorders and (2) to research in the literature the correlation between the role of appearance and patient's disease. A systematic review protocol was developed a priori in accordance with the Preferred Reporting for Items for Systematic Reviews and Meta-Analyses-Protocols (PRISMA-P) guidance. A multistep search of the PubMed, MEDLINE, PreMEDLINE, Embase, Ebase, CINAHL, PsychINFO and Cochrane databases was performed to identify studies on patient satisfaction, quality of life, and body image. Our search generated a total of 347 articles. We performed a systematic review of the 18 studies, which had sufficient data and met all inclusion criteria. All studies identified from the literature review were assessed to determine the utilization of validated patient satisfaction questionnaires. The questionnaires were analyzed by reviewers to assess adherence to the rules of the US Food and Drug Administration and the Scientific Advisory Committee of the Medical Outcomes Trust. We identified 27 individual questionnaires. We summarized development and validation characteristics and content of the 27 validated measures used in the studies. This is the first systematic review to identify and critically appraise patient-reported outcome measures for appearance and body image using internationally accepted criteria. DAS59 was deemed to have adequate levels of methodological and psychometric evidence. We also introduced the concept of Appearance-Pain which consists of the recomposed systematic view of the experimental indicators of suffering, linked to one of the dimensions of appearance. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www
Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z.; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M.; Yazici, Hasan; Merkel, Peter A.
2016-01-01
Objective There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). Methods During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Results Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients’ perspectives, concerns, and ideas into outcome measure development was emphasized. Conclusion The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS. PMID:26373563
Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M
2010-01-01
The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.
Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M
2015-02-01
There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.
Levis, Alexander W; Harel, Daphna; Kwakkenbos, Linda; Carrier, Marie-Eve; Mouthon, Luc; Poiraudeau, Serge; Bartlett, Susan J; Khanna, Dinesh; Malcarne, Vanessa L; Sauve, Maureen; van den Ende, Cornelia H M; Poole, Janet L; Schouffoer, Anne A; Welling, Joep; Thombs, Brett D
2016-11-01
To develop and validate a short form of the Cochin Hand Function Scale (CHFS), which measures hand disability, for use in systemic sclerosis, using objective criteria and reproducible techniques. Responses on the 18-item CHFS were obtained from English-speaking patients enrolled in the Scleroderma Patient-Centered Intervention Network Cohort. CHFS unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit to CHFS items. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible form length between 1 and 17 items. The final short form selected was the form with the least number of items that maintained statistically equivalent convergent validity, compared to the full-length CHFS, with the Health Assessment Questionnaire (HAQ) disability index (DI) and the physical function domain of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29). There were 601 patients included. A 6-item short form of the CHFS (CHFS-6) was selected. The CHFS-6 had a Cronbach's alpha of 0.93. Correlations of the CHFS-6 summed score with HAQ DI (r = 0.79) and PROMIS-29 physical function (r = -0.54) were statistically equivalent to the CHFS (r = 0.81 and r = -0.56). The correlation with the full CHFS was high (r = 0.98). The OTA procedure generated a valid short form of the CHFS with minimal loss of information compared to the full-length form. The OTA method used was based on objective, prespecified criteria, but should be further studied for viability as a general procedure for shortening patient-reported outcome measures in health research. © 2016, American College of Rheumatology.
Sadiqi, Said; Verlaan, Jorrit-Jan; Lehr, A Mechteld; Dvorak, Marcel F; Kandziora, Frank; Rajasekaran, S; Schnake, Klaus J; Vaccaro, Alexander R; Oner, F Cumhur
2016-12-15
International web-based survey. To identify clinical and radiological parameters that spine surgeons consider most relevant when evaluating clinical and functional outcomes of subaxial cervical spine trauma patients. Although an outcome instrument that reflects the patients' perspective is imperative, there is also a need for a surgeon reported outcome measure to reflect the clinicians' perspective adequately. A cross-sectional online survey was conducted among a selected number of spine surgeons from all five AOSpine International world regions. They were asked to indicate the relevance of a compilation of 21 parameters, both for the short term (3 mo-2 yr) and long term (≥2 yr), on a five-point scale. The responses were analyzed using descriptive statistics, frequency analysis, and Kruskal-Wallis test. Of the 279 AOSpine International and International Spinal Cord Society members who received the survey, 108 (38.7%) participated in the study. Ten parameters were identified as relevant both for short term and long term by at least 70% of the participants. Neurological status, implant failure within 3 months, and patient satisfaction were most relevant. Bony fusion was the only parameter for the long term, whereas five parameters were identified for the short term. The remaining six parameters were not deemed relevant. Minor differences were observed when analyzing the responses according to each world region, or spine surgeons' degree of experience. The perspective of an international sample of highly experienced spine surgeons was explored on the most relevant parameters to evaluate and predict outcomes of subaxial cervical spine trauma patients. These results form the basis for the development of a disease-specific surgeon reported outcome measure, which will be a helpful tool in research and clinical practice. 4.
Deodhar, Atul A; Dougados, Maxime; Baeten, Dominique L; Cheng-Chung Wei, James; Geusens, Piet; Readie, Aimee; Richards, Hanno B; Martin, Ruvie; Porter, Brian
2016-12-01
To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS. © 2016 The
Volders, J H; Haloua, M H; Krekel, N M A; Negenborn, V L; Kolk, R H E; Lopes Cardozo, A M F; Bosch, A M; de Widt-Levert, L M; van der Veen, H; Rijna, H; Taets van Amerongen, A H M; Jóźwiak, K; Meijer, S; van den Tol, M P
2017-04-01
The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy. Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.
Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna
2018-05-01
To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier
Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E
2018-05-10
Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Roborel de Climens, Aude; Tunceli, Kaan; Arnould, Benoit; Germain, Nicola; Iglay, Kristy; Norquist, Josephine; Brodovicz, Kimberly G
2015-04-01
Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find
Patient satisfaction and self-reported outcomes after complete brachial plexus avulsion injury.
Franzblau, Lauren E; Shauver, Melissa J; Chung, Kevin C
2014-05-01
Reconstructive surgery for complete brachial plexus avulsion injuries only partially restores function, and many patients are dissatisfied with results that surgeons consider good. Preoperative expectations have been shown to influence postoperative satisfaction but are poorly understood in patients with complete brachial plexus avulsion injuries. Qualitative methodology can elucidate patient beliefs and attitudes, which are difficult to quantify. The purpose of this study was to examine patient-reported outcomes, including satisfaction, and to understand the patient perspective. We used qualitative interviews and questionnaires to assess patient-reported outcomes. Two members of the research team analyzed interview data using Grounded Theory methodology. Data from participants who had and did not have reconstructive surgery were compared. Twelve patients participated in this study. Of the 7 participants who had reconstructive surgery, 4 felt their expectations had been met and 5 were satisfied with their outcomes. Reconstruction did not produce statistically significant improvements in upper extremity function, pain, or work ability. All patients reported dissatisfaction with upper extremity ability, and 9 expressed hope for innovative treatments (e.g., stem cell therapy, nerve reinsertion) that could potentially provide better outcomes than existing procedures and enable return to work. Satisfaction with surgical outcomes after complete avulsion brachial plexus injury depends heavily on whether preoperative expectations are met, but patients are unfamiliar with nerve avulsion and do not always know what to expect. Low satisfaction with upper extremity ability and the lack of statistically significant differences produced by reconstruction suggest that current treatments may not be meeting patients' needs. Physicians must provide robust preoperative education to encourage realistic expectations and direct patients toward resources for pain management to facilitate
Berliner, Jonathan L; Brodke, Dane J; Chan, Vanessa; SooHoo, Nelson F; Bozic, Kevin J
2017-01-01
Despite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery. The purpose of this study was to determine if an association exists between preoperative PROM scores and patients' likelihood of experiencing a clinically meaningful change in function 1 year after TKA. A retrospective study design was used to evaluate preoperative and 1-year postoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) scores from 562 patients who underwent primary unilateral TKA. This cohort represented 75% of the 750 patients who underwent surgery during that time period; a total of 188 others (25%) either did not complete PROM scores at the designated times or were lost to follow-up. Minimum clinically important differences (MCIDs) were calculated for each PROM using a distribution-based method and were used to define meaningful clinical improvement. MCID values for KOOS and SF12v2 physical component summary (PCS) scores were calculated to be 10 and 5, respectively. A receiver operating characteristic analysis was used to determine threshold values for preoperative KOOS and SF12v2 PCS scores and their respective predictive abilities. Threshold values defined the point after which the likelihood of clinically meaningful improvement began to diminish. Multivariate regression was used to control for the effect of preoperative mental and emotional health, patient attributes quantified by SF12v2 mental component summary (MCS) scores, on patients' likelihood of experiencing meaningful improvement in function after surgery. Threshold values for preoperative KOOS and SF
Katz, Patricia P; Barton, Jennifer; Trupin, Laura; Schmajuk, Gabriela; Yazdany, Jinoos; Ruiz, Pedro J; Yelin, Edward
2016-05-01
Despite advances in therapies, disparities in outcomes have been documented for rheumatoid arthritis (RA) patients for both ethnicity and English language proficiency. The goals of these analyses were to compare differences in RA patient-reported outcomes, by both self-identification of ethnicity and English language proficiency, and to identify factors that might explain differences among groups. Data were collected through structured telephone interviews of a longitudinal cohort with physician-diagnosed RA (n = 438); only women were included (n = 335). Three groups were defined based on self-reported ethnicity and English proficiency: white/English (n = 219), Hispanic/English (n = 39), and Hispanic/Spanish (n = 77). Outcomes examined were patient-reported physical functioning, pain, and presence of moderate or severe fatigue. Multivariate regression analyses compared outcomes among groups, adjusting for sociodemographic characteristics, health and disease factors, and depression. Hispanic/Spanish women had worse function, pain, and fatigue than either English-proficient group. Depression was associated with all outcomes (P < 0.0001), and accounted for greater differentials in scores than ethnicity/language proficiency. In interaction analyses, differences between women who were and were not depressed were greater for Hispanic/English than for Hispanic/Spanish. Nondepressed Hispanic/Spanish scores were significantly worse than nondepressed Hispanic/English, i.e., the impact of depression was less for Hispanic/Spanish women because both depressed and nondepressed women in this group reported worse outcomes. After adjustment for sociodemographic factors and depression, language remained significantly associated with outcomes. Disparities in patient-reported outcomes may be driven less by ethnicity than by sociodemographic or psychological factors. Measurement instruments that are not culturally appropriate and equivalent may also hamper
Petrillo, Jennifer; Cano, Stefan J; McLeod, Lori D; Coon, Cheryl D
2015-01-01
To provide comparisons and a worked example of item- and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory (CTT), item response theory (IRT), and Rasch measurement theory (RMT)-in an analysis of the National Eye Institute Visual Functioning Questionnaire (VFQ-25). Baseline VFQ-25 data from 240 participants with diabetic macular edema from a randomized, double-masked, multicenter clinical trial were used to evaluate the VFQ at the total score level. CTT, RMT, and IRT evaluations were conducted, and results were assessed in a head-to-head comparison. Results were similar across the three methods, with IRT and RMT providing more detailed diagnostic information on how to improve the scale. CTT led to the identification of two problematic items that threaten the validity of the overall scale score, sets of redundant items, and skewed response categories. IRT and RMT additionally identified poor fit for one item, many locally dependent items, poor targeting, and disordering of over half the response categories. Selection of a psychometric approach depends on many factors. Researchers should justify their evaluation method and consider the intended audience. If the instrument is being developed for descriptive purposes and on a restricted budget, a cursory examination of the CTT-based psychometric properties may be all that is possible. In a high-stakes situation, such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling, however, a thorough psychometric evaluation including IRT or RMT should be considered, with final item-level decisions made on the basis of both quantitative and qualitative results. Copyright © 2015. Published by Elsevier Inc.
Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat
2017-01-01
Background The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes. Methods We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63–1.1, I2 = 21%). Conclusion A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study. PMID:28234219
Patient-Reported Outcome Measures in Individuals With Chronic Ankle Instability: A Systematic Review
Houston, Megan N.; Hoch, Johanna M.; Hoch, Matthew C.
2015-01-01
Context A comprehensive systematic literature review of the health-related quality-of-life (HRQOL) differences among individuals with chronic ankle instability (CAI), ankle-sprain copers, and healthy control participants has not been conducted. It could provide a better indication of the self-reported deficits that may be present in individuals with CAI. Objective To systematically summarize the extent to which HRQOL deficits are present in individuals with CAI. Data Sources We searched for articles in the electronic databases of EBSCO Host and PubMed Central using key words chronic, functional, mechanical, coper, instability, sprains, and patient-assessed. We also performed a hand search of reference lists, authors, and patient-reported outcomes (PROs) of the articles screened for inclusion. Study Selection Studies were included if they (1) incorporated a PRO as a participant descriptor or as a study outcome to compare adults with CAI to ankle-sprain copers or healthy controls, (2) were written in English, and (3) were published in peer-reviewed journals. Data Extraction Two authors independently assessed methodologic quality using the modified Downs and Black Index. Articles were filtered into 3 categories based on between-groups comparisons: CAI and copers, CAI and healthy control participants, copers and healthy participants. We calculated Hedges g effect sizes and 95% confidence intervals to examine PRO group differences. Data Synthesis Of the 124 studies assessed for eligibility, 27 were included. A total of 24 articles compared PROs in individuals with CAI and healthy controls, 7 compared individuals with CAI and copers, and 4 compared copers and healthy controls. Quality scores on the modified Downs and Black Index ranged from 52.9% to 88.2%, with 8 high-, 16 moderate-, and 3 low-quality studies. Overall, we observed moderate to strong evidence that individuals with CAI displayed deficits on generic and region-specific PROs compared with
Outcome measures in coeliac disease trials: the Tampere recommendations.
Ludvigsson, Jonas F; Ciacci, Carolina; Green, Peter Hr; Kaukinen, Katri; Korponay-Szabo, Ilma R; Kurppa, Kalle; Murray, Joseph A; Lundin, Knut Erik Aslaksen; Maki, Markku J; Popp, Alina; Reilly, Norelle R; Rodriguez-Herrera, Alfonso; Sanders, David S; Schuppan, Detlef; Sleet, Sarah; Taavela, Juha; Voorhees, Kristin; Walker, Marjorie M; Leffler, Daniel A
2018-02-13
A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Price, Matthew; Maples, Jessica L; Jovanovic, Tanja; Norrholm, Seth D; Heekin, Mary; Rothbaum, Barbara O
2015-06-01
Outcome expectancy, or the degree to which a client believes that therapy will result in improvement, is related to improved treatment outcomes for multiple disorders. There is a paucity of research investigating this relation in regards to posttraumatic stress disorder (PTSD). Additionally, the bulk of the research on outcome expectancy and treatment outcomes has relied mostly on self-report outcome measures. The relation between outcome expectancy on self-report measures, clinician-rated measures, and two biological indices (fear-potentiated startle and cortisol reactivity) of PTSD symptoms was explored. The sample included combat veterans (N = 116) treated with virtual reality exposure therapy for PTSD. Results supported a negative association between outcome expectancy and both self-report and clinician-rated symptoms at the conclusion of treatment, but outcome expectancy was related to the magnitude of change during treatment for self-report measures only. Outcome expectancy was unrelated to biological measures of treatment response. These findings suggest that outcome expectancy may be related to patient and clinician perceptions of outcomes, but not biological indices of outcome for PTSD. © 2015 Wiley Periodicals, Inc.
El Miedany, Yasser; El Gaafary, Maha; Youssef, Sally; Ahmed, Ihab
2016-01-01
Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p < 0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p < 0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management. PMID:27190648
Measurement properties of outcome measures for vitiligo. A systematic review.
Vrijman, Charlotte; Linthorst Homan, May W; Limpens, Jacqueline; van der Veen, Wietze; Wolkerstorfer, Albert; Terwee, Caroline B; Spuls, Phyllis I
2012-11-01
OBJECTIVE To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. DATA SOURCES Electronic databases including PubMed (1948 to July 2011), OVID EMBASE (1980 to July 2011), and CINAHL (EBSCOhost) (1982 to July 2011) were searched. STUDY SELECTION Two authors independently screened all records for eligibility. For inclusion, the study population had to include patients with vitiligo, for which outcome measures were developed or evaluated on their measurement properties. The initial search retrieved 1249 records, of which 14 articles met the inclusion criteria. DATA EXTRACTION Characteristics of the included instruments, study population, and results of the measurement properties were extracted. The Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) 4-point checklist, combined with quality criteria for measurement properties, was used to calculate the overall level of evidence per measurement property of each instrument. Independent extraction and assessment was performed by 2 authors. DATA SYNTHESIS Eleven different measurement instruments were identified. Strong evidence was found for a positive internal consistency of the Dermatology Life Quality Index. For other instruments, the evidence of measurement properties was limited or unknown. CONCLUSIONS Recommendations on the use of specific outcome measures for vitiligo should be formulated with caution because current evidence is insufficient owing to a low number of studies with poor methodological quality and unclear clinical relevance. To recommend outcome measures for vitiligo, further research on measurement properties of clinical relevant outcome measures for vitiligo according to COSMIN quality criteria is needed.
Measuring voice outcomes: state of the science review.
Carding, Pau N; Wilson, J A; MacKenzie, K; Deary, I J
2009-08-01
Researchers evaluating voice disorder interventions currently have a plethora of voice outcome measurement tools from which to choose. Faced with such a wide choice, it would be beneficial to establish a clear rationale to guide selection. This article reviews the published literature on the three main areas of voice outcome assessment: (1) perceptual rating of voice quality, (2) acoustic measurement of the speech signal and (3) patient self-reporting of voice problems. We analysed the published reliability, validity, sensitivity to change and utility of the common outcome measurement tools in each area. From the data, we suggest that routine voice outcome measurement should include (1) an expert rating of voice quality (using the Grade-Roughness-Breathiness-Asthenia-Strain rating scale) and (2) a short self-reporting tool (either the Vocal Performance Questionnaire or the Vocal Handicap Index 10). These measures have high validity, the best reported reliability to date, good sensitivity to change data and excellent utility ratings. However, their application and administration require attention to detail. Acoustic measurement has arguable validity and poor reliability data at the present time. Other areas of voice outcome measurement (e.g. stroboscopy and aerodynamic phonatory measurements) require similarly detailed research and analysis.
mHealth and big data will bring meaning and value to patient-reported outcomes.
Weiler, Anne
2016-01-01
The intersection of widespread mobile adoption, cloud computing and healthcare will enable patient-reported outcomes to be used to personalize care, draw insights and shorten the cycle from research to clinical implementation. Today, patient-reported outcomes are largely collected as part of a regulatory shift to value-based or bundled care. When patients are able to record their experiences in real-time and combine them with passive data collection from sensors and mobile devices, this information can inform better care for each patient and contribute to the growing body of health data that can be used to draw insights for all patients. This paper explores the current limitations of patient reported outcomes and how mobile health and big data analysis unlocks their potential as a valuable tool to deliver care.
Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob
2015-09-01
Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.
Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials
Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins
2014-01-01
Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191
Razdan, Shantanu N.; Patel, Vishal; Jewell, Sarah; McCarthy, Colleen M.
2016-01-01
Purpose Bilateral prophylactic mastectomy (BPM) is effective in reducing the risk of breast cancer in women with a well-defined family history of breast cancer or in women with BRCA 1 or 2 mutations. Evaluating patient-reported outcomes following BPM are thus essential for evaluating success of BPM from patient’s perspective. Our systematic review aimed to: (1) identify studies describing health-related quality of life (HRQOL) in patients following BPM with or without reconstruction; (2) assess the effect of BPM with or without reconstruction on HRQOL; and, (3) identify predictors of HRQOL post BPM. Methods We performed a systematic review of literature using the PRISMA guidelines. PubMed, Embase, PsycINFO, Web of Science, Scopus and Cochrane databases were searched. Results The initial search resulted in 1082 studies; 22 of these studies fulfilled our inclusion criteria. Post BPM, patients are satisfied with the outcomes and report high psychosocial well-being and positive body image. Sexual well-being and somatosensory function are most negatively affected. Vulnerability, psychological distress and preoperative cancer distress are significant negative predictors of quality of life and body image post BPM. Conclusion There is a paucity of high quality data on outcomes of different HRQOL domains post BPM. Future studies should strive to use validated and breast-specific PRO instruments for measuring HRQOL. This will facilitate shared decision-making by enabling surgeons to provide evidence-based answers to women contemplating BPM. PMID:26577764
Alexanderson, Helene; Del Grande, Maria; Bingham, Clifton O; Orbai, Ana-Maria; Sarver, Catherine; Clegg-Smith, Katherine; Lundberg, Ingrid E; Song, Yeong Wook; Christopher-Stine, Lisa
2014-03-01
The newly formed Outcome Measures in Rheumatology (OMERACT) Myositis Special Interest Group (SIG) was established to examine patient-reported outcome measures (PROM) in myositis. At OMERACT 11, a literature review of PROM used in the idiopathic inflammatory myopathies (IIM) and other neuromuscular conditions was presented. The group examined in more detail 2 PROM more extensively evaluated in patients with IIM, the Myositis Activities Profile, and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, through the OMERACT filter of truth, discrimination, and feasibility. Preliminary results from a qualitative study of patients with myositis regarding their symptoms were discussed that emphasized the range of symptoms experienced: pain, physical tightness/stiffness, fatigue, disease effect on emotional life and relationships, and treatment-related side effects. Following discussion of these results and following additional discussions since OMERACT 11, a research agenda was developed. The next step in evaluating PROM in IIM will require additional focus groups with a spectrum of patients with different myositis disease phenotypes and manifestations across a range of disease activity, and from multiple international settings. The group will initially focus on dermatomyositis and polymyositis in adults. Qualitative analysis will facilitate the identification of commonalities and divergent patient-relevant aspects of disease, insights that are critical given the heterogeneous manifestations of these diseases. Based on these qualitative studies, existing myositis PROM can be examined to more thoroughly assess content validity, and will be important to identify gaps in domain measurement that will be required to develop a preliminary core set of patient-relevant domains for IIM.
Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.
Johansson, M L; Tysome, J R; Hill-Feltham, P; Hodgetts, W E; Ostevik, A; McKinnon, B J; Monksfield, P; Sockalingam, R; Wright, T
2018-05-07
The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcomes measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1,434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised in 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcomes measures are most suitable for inclusion in the core set This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn
2014-01-01
Background The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. Patients 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1–3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Results Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2–5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Interpretation Patients operated with the lateral approach reported worse outcomes 1–3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach. PMID:24954494
Mundy, Lily R; Miller, H Catherine; Klassen, Anne F; Cano, Stefan J; Pusic, Andrea L
2016-10-01
Patient-reported outcomes (PROs) are of growing importance in research and clinical care and may be used as primary outcomes or as compliments to traditional surgical outcomes. In assessing the impact of surgical and traumatic scars, PROs are often the most meaningful. To assess outcomes from the patient perspective, rigorously developed and validated PRO instruments are essential. The authors conducted a systematic literature review to identify PRO instruments developed and/or validated for patients with surgical and/or non-burn traumatic scars. Identified instruments were assessed for content, development process, and validation under recommended guidelines for PRO instrument development. The systematic review identified 6534 articles. After review, we identified four PRO instruments meeting inclusion criteria: patient and observer scar assessment scale (POSAS), bock quality of life questionnaire for patients with keloid and hypertrophic scarring (Bock), patient scar assessment questionnaire (PSAQ), and patient-reported impact of scars measure (PRISM). Common concepts measured were symptoms and psychosocial well-being. Only PSAQ had a dedicated appearance domain. Qualitative data were used to inform content for the PSAQ and PRISM, and a modern psychometric approach (Rasch Measurement Theory) was used to develop PRISM and to test POSAS. Overall, PRISM demonstrated the most rigorous design and validation process, however, was limited by the lack of a dedicated appearance domain. PRO instruments to evaluate outcomes in scars exist but vary in terms of concepts measured and psychometric soundness. This review discusses the strengths and weaknesses of existing instruments, highlighting the need for future scar-focused PRO instrument development. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www
2014-01-01
Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. Results The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and
Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker
2014-07-22
Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI
Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Dutton, Mary; Slade, Anita; Marklew, Neil; Price, Gary; Verdi, Rav; Waters, Judi; Sharpe, Keeley; Calvert, Melanie
2017-06-30
Advanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for 'Using Patient-Reported Outcome measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney Disease' (PRO-trACK) project, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD. The project will use a mixed-methods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system-this will involve qualitative face-to-face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM. This project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017.The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients' Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peer-reviewed journals. © Article author(s) (or their employer
Designing of Intelligent Multilingual Patient Reported Outcome System (IMPROS)
Pourasghar, Faramarz; Partovi, Yeganeh
2015-01-01
Background: By self-reporting outcome procedure the patients themselves record disease symptoms outside medical centers and then report them to medical staff in specific periods of time. One of the self-reporting methods is the application of interactive voice response (IVR), in which some pre-designed questions in the form of voice tracks would be played and then the caller responses the questions by pressing phone’s keypad bottoms. Aim: The present research explains the main framework of such system designing according to IVR technology that is for the first time designed and administered in Iran. Methods: Interactive Voice Response system was composed by two main parts of hardware and software. Hardware section includes one or several digital phone lines, a modem card with voice playing capability and a PC. IVR software on the other hand, acts as an intelligent control center, records call information and controls incoming data. Results: One of the main features of the system is its capability to be administered in common PCs, utilizing simple and cheap modems, high speed to take responses and it’s appropriateness to low literate patients. The system is applicable for monitoring chronic diseases, cancer and also in psychological diseases and can be suitable for taking care of elders and Children who require long term cares. Other features include user-friendly, decrease in direct and indirect costs of disease treatment and enjoying from high level of security to access patients’ profiles. Conclusions: Intelligent multilingual patient reported outcome system (IMPROS) by controlling diseases gives the opportunity to patients to have more participation during treatment and it improves mutual interaction between patient and medical staff. Moreover it increases the quality of medical services, Additional to empowering patients and their followers. PMID:26635441
Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard
2017-01-01
Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791
Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel
2016-11-01
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.
Duman-Lubberding, S; van Uden-Kraan, C F; Jansen, F; Witte, B I; Eerenstein, S E J; van Weert, S; de Bree, R; Leemans, C R; Verdonck-de Leeuw, I M
2017-12-01
To investigate the long-term follow-up (5 years) of implementing patient-reported outcome measures (PROMs) in clinical practice to monitor health-related quality of life (HRQOL) in head and neck cancer (HNC) patients. A mixed method design was used. The usage rate of OncoQuest (a touch screen computer system to monitor HRQOL) and the subsequent nurse consultation was calculated among HNC patients who visited the outpatient clinic for regular follow-up, as well as differences between ever users and never users (sociodemographic and clinical characteristics). The content of the nurse consultation was investigated. Reasons for not using (barriers) or using (facilitators) OncoQuest and the nurse consultation were explored from the perspective of HNC patients, and of head and neck surgeons. Usage rate of OncoQuest was 67% and of the nurse consultation 79%. Usage of OncoQuest was significantly related to tumor subsite and tumor stage. Topics most frequently (>40%) discussed during the nurse consultation were global quality of life (97%), head and neck cancer related symptoms (82%), other physical symptoms such as pain (61%), and psychological problems such as anxiety (44%). Several barriers and facilitators to implement PROMs in clinical practice were reported by both patients and head and neck surgeons. Usage of PROMs in clinical practice and a nurse consultation is durable, even 5 years after the introduction. This study contributes to better insight into long-term follow-up of implementation, thereby guiding future research and projects that aim to implement PROMs in clinical practice to monitor HRQOL among (head and neck) cancer patients.
Jones, Jordan T; Carle, Adam C; Wootton, Janet; Liberio, Brianna; Lee, Jiha; Schanberg, Laura E; Ying, Jun; Morgan DeWitt, Esi; Brunner, Hermine I
2017-01-01
To validate the pediatric Patient-Reported Outcomes Measurement Information System short forms (PROMIS-SFs) in childhood-onset systemic lupus erythematosus (SLE) in a clinical setting. At 3 study visits, childhood-onset SLE patients completed the PROMIS-SFs (anger, anxiety, depressive symptoms, fatigue, physical function-mobility, physical function-upper extremity, pain interference, and peer relationships) using the PROMIS assessment center, and health-related quality of life (HRQoL) legacy measures (Pediatric Quality of Life Inventory, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters [SMILEY], and visual analog scales [VAS] of pain and well-being). Physicians rated childhood-onset SLE activity on a VAS and completed the Systemic Lupus Erythematosus Disease Activity Index 2000. Using a global rating scale of change (GRC) between study visits, physicians rated change of childhood-onset SLE activity (GRC-MD1: better/same/worse) and change of patient overall health (GRC-MD2: better/same/worse). Questionnaire scores were compared in support of validity and responsiveness to change (external standards: GRC-MD1, GRC-MD2). In this population-based cohort (n = 100) with a mean age of 15.8 years (range 10-20 years), the PROMIS-SFs were completed in less than 5 minutes in a clinical setting. The PROMIS-SF scores correlated at least moderately (Pearson's r ≥ 0.5) with those of legacy HRQoL measures, except for the SMILEY. Measures of childhood-onset SLE activity did not correlate with the PROMIS-SFs. Responsiveness to change of the PROMIS-SFs was supported by path, mixed-model, and correlation analyses. To assess HRQoL in childhood-onset SLE, the PROMIS-SFs demonstrated feasibility, internal consistency, construct validity, and responsiveness to change in a clinical setting. © 2016, American College of Rheumatology.
Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J
2017-04-01
The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.
Jahagirdar, Deepa; Kroll, Thilo; Ritchie, Karen; Wyke, Sally
2012-11-26
Patient reported outcome measures (PROMs) are self-report measures of health status increasingly promoted for use in healthcare quality improvement. However people with low literacy skills or learning disabilities may find PROMs hard to complete. Our study investigated stakeholder views on the accessibility and use of PROMs to develop suggestions for more inclusive practice. Taking PROMs recommended for chronic obstructive pulmonary disease (COPD) as an example, we conducted 8 interviews with people with low literacy skills and/or learning disabilities, and 4 focus groups with 20 health professionals and people with COPD. Discussions covered the format and delivery of PROMs using the EQ-5D and St George Respiratory Questionnaire as prompts. Thematic framework analysis focused on three main themes: Accessibility, Ease of Use, and Contextual factors. Accessibility included issues concerning the questionnaire format, and suggestions for improvement included larger font sizes and more white space. Ease of Use included discussion about PROMs' administration. While health professionals suggested PROMs could be completed in waiting rooms, patients preferred settings with more privacy and where they could access help from people they know. Contextual Factors included other challenges and wider issues associated with completing PROMs. While health professionals highlighted difficulties created by the system in managing patients with low literacy/learning disabilities, patient participants stressed that understanding the purpose of PROMs was important to reduce intimidation. Adjusting PROMs' format, giving an explicit choice of where patients can complete them, and clearly conveying PROMs' purpose and benefit to patients may help to prevent inequality when using PROMs in health services.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Conijn, Anne P., E-mail: a.p.conijn@amc.nl; Jonkers, Wilma, E-mail: wilma.jonkers@achmea.nl; Rouwet, Ellen V., E-mail: e.rouwet@erasmusmc.nl
PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. Inmore » addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.« less
Park, Kt; Harris, Merissa; Khavari, Nasim; Khosla, Chaitan
2014-02-01
Patients with celiac disease (CD) are increasingly interconnected through social media, exchanging patient experiences and health-tracking information between individuals through various web-based platforms. Social media represents potentially unique communication interface between gastroenterologists and active social media users - especially young adults and adolescents with celiac disease-regarding adherence to the strict gluten-free diet, gastrointestinal symptoms, and meaningful discussion about disease management. Yet, various social media platforms may be underutilized for research purposes to collect patient-reported outcomes data. In this commentary, we summarize the scientific rationale and potential for future growth of social media in patient-reported outcomes research, focusing on college freshmen with celiac disease as a case study and provide overview of the methodological approach. Finally, we discuss how social media may impact patient care in the future through increasing mobile technology use.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk; Ziegler, Lucy; Martland, Maisie
The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses ofmore » Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between
Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari
2011-01-01
Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.
Günay, S M; Tuna, Z; Oskay, D
2016-12-31
Rheumatoid arthritis (RA) often results in impairments in upper extremities, especially in the small joints of hand. Involvement of hand brings limitations in activities of daily living. However, it is commonly observed that patient-reported functional status of hand does not always corresponds to their actual physical performance in the clinical setting. The aim of this pilot study is to investigate the relationship between patient self-reported and objectively measured hand functions in patients with RA. Twenty-six patients (51±13 years) with RA diagnosis participated in the study. Hand grip and pinch (lateral, bipod, tripod) strengths were measured and Jebsen Hand Function Test (JHFT) was performed for objective functional performance. Duruöz Hand Index and Beck Depression Inventory - Turkish version were completed by patients. Grip and all three-pinch strength results significantly correlated with Duruöz Hand Index scores (p<0.05). JHFT results except the sentence writing also correlated with the Duruöz scores (p<0.05). Our results showed that self-reported outcome scales might be used for determining functional level of hand in patients with RA in rheumatology practice. Objective quantitative functional tests are the best methods in evaluating functional level of hand, but require valid and reliable equipment with accurate calibration. Therefore, in case of unavailability of objective assessment tools, patient-reported scales may also reflect the real status of hand functions.
Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne
2018-04-30
To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.
Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C
2008-01-01
Background The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data ≤ 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha ≥ 0.92, test-retest intraclass correlations ≥ 0.83); and 5) validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis. PMID:18684327
Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C
2008-08-06
The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data < or = 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha > or = 0.92, test-retest intraclass correlations > or = 0.83); and 5) validity was supported. This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.
Wan, Eric Yuk Fai; Fung, Colman Siu Cheung; Wong, Carlos King Ho; Choi, Edmond Pui Hang; Jiao, Fang Fang; Chan, Anca Ka Chun; Chan, Karina Hiu Yen; Lam, Cindy Lo Kuen
2017-02-01
Little is known about how the patient-reported outcomes is influenced by multidisciplinary-risk-assessment-and-management-programme for patients with diabetes mellitus (RAMP-DM). This paper aims to evaluate the effectiveness of RAMP-DM on patient-reported outcomes. This was a prospective longitudinal study on 1039 diabetes mellitus patients (714/325 RAMP-DM/non-RAMP-DM) managed in primary care setting. 536 and 402 RAMP-DM participants, and 237 and 187 non-RAMP-DM participants were followed up at 12 and 24 months with completed survey, respectively. Patient-reported outcomes included health-related quality of life, change in global health condition and patient enablement measured by Short Form-12 Health Survey version-2 (SF-12v2), Global Rating Scale, Patient Enablement Instrument respectively. The effects of RAMP-DM on patient-reported outcomes were evaluated by mixed effect models. Subgroup analysis was performed by stratifying haemoglobin A1c (HbA1c) (optimal HbA1c < 7 % and suboptimal HbA1c ≥ 7 %). RAMP-DM with suboptimal HbA1c was associated with greater improvement in SF-12v2 physical component summary score at 12-month (coefficient:3.80; P-value < 0.05) and 24-month (coefficient:3.82;P-value < 0.05), more likely to feel more enabled at 12-month (odds ratio: 2.57; P-value < 0.05), and have improved in GRS at 24-month (odds ratio:4.05; P-value < 0.05) compared to non-RAMP-DM participants. However, there was no significant difference in patient-reported outcomes between RAMP-DM and non-RAMP-DM participants with optimal HbA1c. Participation in RAMP-DM is effective in improving physical component of HRQOL, Global Rating Scale and patient enablement among diabetes mellitus patients with suboptimal HbA1c, but not in those with optimal HbA1c. Patients with sub-optimal diabetes mellitus control should be the priority target population for RAMP-DM. This observational study design may have potential bias in the characteristics between
Determining the non-inferiority margin for patient reported outcomes.
Gerlinger, Christoph; Schmelter, Thomas
2011-01-01
One of the cornerstones of any non-inferiority trial is the choice of the non-inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often "negotiated" between the sponsor of the trial and the regulatory agencies. However, for patient reported, or more precisely patient observed outcomes, the patients' minimal clinically important difference (MCID) can be determined empirically by relating the treatment effect, for example, a change on a 100-mm visual analogue scale, to the patient's satisfaction with the change. This MCID can then be used to define delta. We used an anchor-based approach with non-parametric discriminant analysis and ROC analysis and a distribution-based approach with Norman's half standard deviation rule to determine delta in three examples endometriosis-related pelvic pain measured on a 100-mm visual analogue scale, facial acne measured by lesion counts, and hot flush counts. For each of these examples, all three methods yielded quite similar results. In two of the cases, the empirically derived MCIDs were smaller or similar of deltas used before in non-inferiority trials, and in the third case, the empirically derived MCID was used to derive a responder definition that was accepted by the FDA. In conclusion, for patient-observed endpoints, the delta can be derived empirically. In our view, this is a better approach than that of asking the clinician for a "nice round number" for delta, such as 10, 50%, π, e, or i. Copyright © 2011 John Wiley & Sons, Ltd.
Ivey, Susan L; Shortell, Stephen M; Rodriguez, Hector P; Wang, Yue Emily
2018-05-12
Accountable care organizations (ACOs) have increased their use of patient activation and engagement strategies, but it is unknown whether they achieve better outcomes for patients with comorbid chronic physical and mental health conditions. To assess the extent to which practices with patient-centered cultures, greater shared decision-making strategies, and better coordination among team members have better patient-reported outcomes (PROs) for patients with diabetes and/or cardiovascular and comorbid mental health diagnoses. Sixteen practices randomly selected from top and bottom quartiles of a 39-item patient activation/engagement implementation survey of primary care team members (n=411) to assess patient-centered culture, shared decision-making, and relational coordination among team members. These data were linked to survey data on patient engagement and on emotional, physical, and social patient-reported health outcomes. Adult patients (n=606) with diabetes, cardiovascular, and comorbid mental health conditions who had at least 1 visit at participating primary care practices of 2 ACOs. Depression/anxiety, physical functioning, social functioning; patient-centered culture, patient activation/engagement implementation, relational coordination. Patients receiving care from practices with high patient-centered cultures reported better physical functioning (0.025) and borderline better emotional functioning (0.059) compared with less patient-centered practices. More activated patients reported better PROs, with higher activation levels partially mediating the relationship of patient-centered culture and better PROs. ACO patients with comorbid physical and mental health diagnoses report better physical functioning when practices have patient-centered cultures. More activated/engaged patients report better patient emotional, physical, and social health outcomes.
Pietrosimone, Brian; Blackburn, J Troy; Padua, Darin A; Pfeiffer, Steven J; Davis, Hope C; Luc-Harkey, Brittney A; Harkey, Matthew S; Stanley, Laura E; Frank, Barnett S; Creighton, R Alexander; Kamath, Ganesh M; Spang, Jeffery T
2018-05-21
The study sought to determine the association between gait biomechanics (vertical ground reaction force [vGRF], vGRF loading rate [vGRF-LR]) collected six months following anterior cruciate ligament reconstruction (ACLR) with patient-reported outcomes at twelve months following ACLR. Walking gait mechanics and all subsections of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) were collected at six and twelve months following ACLR, respectively, in 25 individuals with a unilateral ACLR. Peak vGRF and peak instantaneous vGRF-LR were extracted from the first 50% of the stance phase. Limb symmetry indices (LSI) were used to normalize outcomes in the ACLR limb to that of the uninjured limb (ACLR /uninjured). Linear regression analyses were used to determine associations between biomechanical outcomes and KOOS while accounting for walking speed. Receiver operator characteristic curves were used to determine the accuracy of 6-month biomechanical outcomes for identifying individuals with acceptable patient-reported outcomes, using previously defined KOOS cut-off scores,12 months post-ACLR. Individuals with lower peak vGRF LSI 6 months post-ACLR demonstrated worse patient-reported outcomes (KOOS Pain, Activities of Daily life, Sport and Recreation, Quality of Life) at the 12-month exam. A peak vGRF LSI ≥0.99 6 months following ACLR associated with 13.33x higher odds of reporting acceptable patient-reported outcomes 12 months post-ACLR. Lesser peak vGRF LSI during walking at 6-months post-ACLR may be a critical indicator of worse future patient-reported outcomes. Achieving early symmetrical lower extremity loading and minimizing under-loading of the ACLR limb during walking may be a potential therapeutic target for improving patient-reported outcomes post-ACLR. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Patient-reported outcomes and health status associated with chronic graft-versus-host disease.
Lee, Stephanie J; Onstad, Lynn; Chow, Eric J; Shaw, Bronwen E; Jim, Heather S L; Syrjala, Karen L; Baker, K Scott; Buckley, Sarah; Flowers, Mary E
2018-06-01
Chronic graft-versus-host disease occurs in 20-50% of allogeneic hematopoietic cell transplantation survivors. We surveyed patients about their quality of life, symptoms, health status, comorbid conditions and medication. Instruments included the Short-Form-36 (SF-36), the Patient-Reported Outcomes Measurement Information System (PROMIS) Global and PROMIS-29 scales and the Lee Chronic Graft-versus-Host Disease Symptom Scale. Functional status was measured by self-reported Karnofsky and work status. Of 3027 surveys sent to recipients surviving one or more years after transplantation, 1377 (45%) were returned. Among these, patients reported their chronic graft-versus-host disease was mild (n=257, 18.7%), moderate (n=110, 8.0%) or severe (n=25, 1.8%). Another 377 (27.4%) never had chronic graft-versus-host disease and 280 (20.3%) had chronic graft-versus-host disease but it resolved. We excluded 328 (23.8%) who did not answer the questions about chronic graft-versus-host disease. Patients who reported moderate or severe chronic graft-versus-host disease reported worse quality of life, lower performance status, a higher symptom burden and were more likely to be taking prescription medications for pain, anxiety and depression compared to those with resolved chronic graft-versus-host disease. Self-reported measures were similar between patients with resolved chronic graft-versus-host disease and those who never had it. Our data suggest that the PROMIS measures may be able to replace the SF-36 in chronic graft-versus-host disease assessment. Between 26.7-39.4% of people with active chronic graft-versus-host disease were unable to work due to health reasons, compared with 12.1% whose chronic graft-versus-host disease had resolved and 15.4% who never had chronic graft-versus-host disease. Mouth, eye and nutrition symptoms persisted after resolution of chronic graft-versus-host disease. These results show that better prevention of and treatment for chronic graft
Nübling, R; Kaluscha, R; Krischak, G; Kriz, D; Martin, H; Müller, G; Renzland, J; Reuss-Borst, M; Schmidt, J; Kaiser, U; Toepler, E
2017-02-01
Aim of the Study The outcome quality of medical rehabilitation is evaluated often by "Patient Reported Outcomes" (PROs). It is examined to what extent these PROs are corresponding with "hard" or "objective" outcomes such as payments of contributions to social insurance. Methods The "rehabilitation QM outcome study" includes self-reports of patients as well as data from the Rehabilitation Statistics Database (RSD) of the German pension insurance Baden-Wurttemberg. The sample for the question posed includes N=2 947 insured who were treated in 2011 in 21 clinics of the "health quality network" and who were either employed or unemployed at the time of the rehabilitation application (e. g. the workforce or labour force group, response rate: 55%). The sample turned out widely representative for the population of the insured persons. Results PROs and payment of contributions to pension insurance clearly correspond. In the year after the rehabilitation improved vs. not improved rehabilitees differed clearly with regard to their payments of contributions. Conclusions The results support the validity of PROs. For a comprehensive depiction of the outcome quality of rehabilitation PROs and payments of contributions should be considered supplementary. © Georg Thieme Verlag KG Stuttgart · New York.
Al-Sabbagh, Mohanad; Jenkins, Diane W; de Leeuw, Reny; Nihill, Patricia; Robinson, Fonda G; Thomas, Mark V
2014-11-01
The University of Kentucky College of Dentistry (UKCD) established an implant training program that provides training in the use of a single implant system, evidence-based diagnostic and treatment protocols (standardized work practices), and a total quality management system (Implant Quality Assurance Program). The aim of this study was to assess the programmatic effectiveness of the UKCD implant training program by reporting the success and survival of implants placed, using patient-reported outcomes and comparing them to previously established benchmarks. A total of 415 patients (963 implants) were interviewed, approximately 50 percent of all qualified patients. The implant survival rate was 97 percent, and 88 percent of the implants were considered successful (as determined by patient-centric criteria). These outcomes were consistent with the program's previously established benchmarks of 90 percent. These results suggest that work standardization (in the form of specific treatment protocols) and the use of a formal, incremental learning system can result in positive patient outcomes. Clinical outcomes should be monitored in academic dental settings as part of clinical process improvement, and these outcomes can provide a means of assessing the effectiveness of the training program.
Golightly, Yvonne M; Allen, Kelli D; Nyrop, Kirsten A; Nelson, Amanda E; Callahan, Leigh F; Jordan, Joanne M
2015-10-01
Although many treatment guidelines exist for hip and knee osteoarthritis (OA), uptake in clinical practice is typically low. Valid patient-reported outcome measures (PROs) that can be easily used in the clinic could aid implementation and evaluation of treatment recommendations, and the tracking of symptoms and function over time. This project responded to a 2012 Call to Action of the Chronic Osteoarthritis Management Initiative of the United States Bone and Joint Initiative; we aimed to develop a tiered list of recommended PROs that could be feasibly applied in common clinical settings, across four domains of pain, function, fatigue, and sleep. PROs were identified through a focused literature review. Clinicians and researchers with OA expertise evaluated each measure' feasibility for use in routine clinical practice, followed by meaningfulness in assessing OA outcomes. Eligible PROs were categorized by domain and ranked into Tiers One (very brief measures for initial use in clinical settings), Two (brief measures with more in-depth assessment), and Three (most detailed assessment). Total PROs identified were 172 for pain, 160 for function, 55 for fatigue, and 60 for sleep. Of these, 9 pain, 7 function, 7 fatigue, and 8 sleep PROs were ranked into one of three tiers. This three-tiered list of recommended PROs provides a basis for tools to systematically track outcomes, facilitate provider-patient dialog, and guide treatment for hip or knee OA. Research is needed to test the utility and feasibility of systematic implementation of these measures in primary care and specialty clinical settings. Copyright © 2015 Elsevier Inc. All rights reserved.
White, Michelle C; Randall, Kirsten; Alcorn, Dennis; Greenland, Rachel; Glasgo, Christine; Shrime, Mark G
2018-04-27
Patient reported outcomes (PRO) measure the quality of care from the patient's perspective. PROs are an important measure of surgical outcome and can be used to calculate health gains after surgical treatment. The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a PRO used to evaluate pre and post-operative disability across a range of surgical specialities. In this study, Mercy Ships, a non-governmental organisation (NGO), used WHODAS 2.0 to evaluate patient reported disability in 401 consecutive patients in Madagascar. We hypothesised that surgical interventions would decrease pre-operative patient reported disability across a range of specialties (maxillofacial, plastic, orthopaedic, general and obstetric fistula surgery). WHODAS 2.0 was administered preoperatively by face-to-face interview, and at 3 months post-operatively by telephone. Demographic data, American Society of Anesthesiologists (ASA) physical classification score, duration of surgery, length of hospital stay, and in-hospital post-operative complications were collected from a separately maintained patient database. The primary outcome measure was difference in pre- and post-operative WHODAS 2.0 scores. No differences were seen between the two groups in preoperative disability (p = 0.25), ASA score (p = 0.46), or duration of surgery (p = 0.85). At 3 months 44% (176/401) of patients were available for telephone for postoperative evaluation. All had a significant reduction in their disability score from 8.4% to 1.0% (p < 0.001), 17 experienced a post-operative complication, but none had residual disability and there were no deaths. The group lost to follow-up were more likely to be female (65% versus 50%, p < 0.05), were younger (mean age 31 versus 35, p < 0.05), had longer hospital stays (10 versus 4 days, p < 0.001), and were more likely to have experienced post-operative complications (p < 0.05). This study demonstrates that surgical
Reiman, Michael P; Peters, Scott; Sylvain, Jonathan; Hagymasi, Seth; Ayeni, Olufemi R
2018-04-01
The purposes of this review were (1) to collate and synthesize research studies reporting any outcome measure on both open and arthroscopic surgical treatment of femoroacetabular impingement (FAI) syndrome and (2) to report the prevalence and consistency of outcomes across the included studies. A computer-assisted literature search of the MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases was conducted using keywords related to FAI syndrome and both open and arthroscopic surgical outcomes, resulting in 2,614 studies, with 163 studies involving 14,824 subjects meeting the inclusion criteria. Two authors independently reviewed study inclusion and data extraction with independent verification. The prevalence of reported outcomes was calculated and verified by separate authors. Between 2004 and 2016, there has been a 2,600% increase in the publication of surgical outcome studies. Patients had a mean duration of symptoms of 27.7 ± 21.5 months before surgery. Arthroscopy was the surgical treatment used in 71% of studies. The mean final follow-up period after surgery was 32.2 ± 17.3 months. Follow-up time frames were reported in 78% of studies. Ten different patient-reported outcome measures were reported. The alpha angle was reported to be measured 42% less frequently as a surgical outcome than as a surgical indication. Surgical complications were addressed in only 53% of studies and failures in 69%. Labral pathology (91% of studies reporting) and chondral pathology (61%) were the primary coexisting pathologies reported. Clinical signs, as defined by the Warwick Agreement on FAI syndrome, were reported in fewer than 25% of studies. Most FAI syndrome patients have longstanding pain and potential coexisting pathology. Patient-reported outcome measures and diagnostic imaging are the most frequently reported outcomes. Measures of hip strength and range of motion are under-reported. It is unclear whether the inconsistency in
Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel
2016-01-01
Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Khavanin, Nima; Clemens, Mark W; Pusic, Andrea L; Fine, Neil A; Hamill, Jennifer B; Kim, H Myra; Qi, Ji; Wilkins, Edwin G; Kim, John Y S
2017-05-01
Since the 2012 approval of shaped implants, their use in breast reconstruction has increased in the United States. However, large-scale comparisons of complications and patient-reported outcomes are lacking. The authors endeavored to compare surgical and patient-reported outcomes across implant types. The Mastectomy Reconstruction Outcomes Consortium database was queried for expander/implant reconstructions with at least 1-year postexchange follow-up (mean, 18.5 months). Outcomes of interest included postoperative complications, 1-year revisions, and patient-reported outcomes. Bivariate and mixed-effects regression analyses evaluated the effect of implant type on patient outcomes. Overall, 822 patients (73.5 percent) received round and 297 patients (26.5 percent) received shaped implants. Patients undergoing unilateral reconstructions with round implants underwent more contralateral symmetry procedures, including augmentations (round, 18.7 percent; shaped, 6.8 percent; p = 0.003) and reductions (round, 32.2 percent; shaped, 20.5 percent; p = 0.019). Shaped implants were associated with higher rates of infection (shaped, 6.1 percent; round, 2.3 percent; p = 0.002), that remained significant after multivariable adjustment. Other complication rates did not differ significantly between cohorts. Round and shaped implants experienced similar 2-year patient-reported outcome scores. This prospective, multicenter study is the largest evaluating outcomes of shaped versus round implants in breast reconstruction. Although recipients of round implants demonstrated lower infection rates compared with shaped implants, these patients were more likely to undergo contralateral symmetry procedures. Both implant types yielded comparable patient-reported outcome scores. With appropriate patient selection, both shaped and round implants can provide acceptable outcomes in breast reconstruction. Therapeutic, III.
Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard
2017-03-20
We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. NCT01794715; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Olson, Robert A; Howard, Fuchsia; Lapointe, Vincent; Schellenberg, Devin; Nichol, Alan; Bowering, Gale; Curtis, Susan; Walter, Allison; Brown, Steven; Thompson, Corinne; Bergin, Jackie; Lomas, Sheri; French, John; Halperin, Ross; Tyldesley, Scott; Beckham, Wayne
2018-01-01
The BC Cancer Agency Radiotherapy (RT) program started the Prospective Outcomes and Support Initiative (POSI) at all six centres to utilize patient-reported outcomes for immediate clinical care, quality improvement, and research. Patient-reported outcomes were collected at time of computed tomography simulation via tablet and 2 to 4 weeks post-RT via either tablet or over the phone by a registered nurse. From 2013 to 2016, patients were approached on 20,150 attempts by POSI for patients treated with RT for bone metastases (52%), brain metastases (11%), lung cancer (17%), gynecological cancer (16%), head and neck cancer (2%), and other pilots (2%). The accrual rate for all encounters was 85% (n = 17,101), with the accrual rate varying between the lowest and the highest accruing centre from 78% to 89% ( P < .001) and varying by tumour site ( P < .001). Using the POSI database, we have performed research and quality improvement initiatives that have changed practice.
Collecting Patient Reported Outcomes in the Wild: Opportunities and Challenges.
Cabitza, Federico; Dui, Linda Greta
2018-01-01
Collecting Patient Reported Outcomes (PROs) is generally seen as an effective way to assess the efficacy and appropriateness of medical interventions, from the patients' perspective. In 2016 the Galeazzi Orthopaedic Institute established a digitized program of PROs collection from spine, hip and knee surgery patients. In this work, we re-port the findings from the data analysis of the responses collected so far about the complementarity of PROs with respect to the data reported by the clinicians, and about the main biases that can undermine their validity and reliability. Although PROs collection is recognized as being far more complex than just asking the patients "how they feel" on a regular basis and it entails costs and devoted electronic platforms, we advocate their further diffusion for the assessment of health technology and clinical procedures.
Fredericksen, R J; Gibbons, L; Brown, S; Edwards, T C; Yang, F M; Fitzsimmons, E; Alperovitz-Bichell, K; Godfrey, M; Wang, A; Church, A; Gutierrez, C; Paez, E; Dant, L; Loo, S; Walcott, M; Mugavero, M J; Mayer, K; Mathews, W C; Patrick, D L; Crane, P K; Crane, H M
2018-06-01
Low health literacy is associated with poor medication adherence and poor health outcomes. Limited understanding of prescribed medications may decrease validity of patient-reported adherence measures. To assess knowledge of names and purposes of prescribed medications among patients with multiple chronic conditions. Individual interviews were conducted with a convenience sample of patients from six U.S. primary care clinics. Participants (n = 57) were English and/or Spanish-speaking patients prescribed 3+ medications for chronic conditions, for which non-adherence may lead to disability or death. In individual interviews, patients were asked to name their medications, explain the purpose of each, and to explain how they distinguish them from one another. Interviews were audio recorded, transcribed, and coded; coded content was quantified by 1) whether or not the patient could name medications; 2) method of categorizing medications; 3) whether or not the purpose of the medication was understood. Descriptive statistics were compiled using Fisher's exact test to determine the relationship between patient knowledge and medication characteristics. Thirty percent of patients could not name at least one of their medications; 19% did not know their purpose; 30% held misconceptions about the purpose of one or more medications. There was no significant difference in ability to name medications or state their medication's purpose between patients using medi-sets, pre-packaged rolls, or blister packs, and patients who stored pills in their original containers (p = 0.56 and p = 0.73, respectively), or across demographic groups (p = 0.085 to 0.767). Many patients demonstrated difficulty identifying the name and purpose of prescribed medications; this did not differ by demographic group or medication storage type. Patients may benefit from routine review of medications with their provider in order to improve health literacy, outcomes, and patient-reported adherence
Using Patient-Reported Information to Improve Clinical Practice.
Schlesinger, Mark; Grob, Rachel; Shaller, Dale
2015-12-01
To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the
SPIEGEL, B.; BOLUS, R.; HARRIS, L. A.; LUCAK, S.; NALIBOFF, B.; ESRAILIAN, E.; CHEY, W. D.; LEMBO, A.; KARSAN, H.; TILLISCH, K.; TALLEY, J.; MAYER, E.; CHANG, L.
2009-01-01
Background Controversy exists about how to effectively measure patient reported outcomes in IBS clinical trials. Pain numeric rating scales (NRS) are widely used in the non-IBS pain literature. The FDA has proposed using the NRS in IBS. Aim To test the psychometrics of an abdominal pain NRS in IBS. Methods We analyzed data from a longitudinal cohort of Rome III IBS subjects. At entry, subjects completed a 10-point NRS, bowel symptoms, IBS severity measurements (IBSSS, FBDSI), health related quality of life indices (IBS-QOL, EQ5D), and the worker productivity activity index (WPAI). We repeated assessments at 3 months along with a response scale to calculate the minimal clinically important difference (MCID). Results There were 277 subjects (82% women; age=42±15) at baseline and 90 at 3 months. The NRS correlated cross-sectionally with IBSSS (r=0.60; p<0.0011), FBDSI (r=0.49; p<0.0001), IBS-QOL (r=0.43; p<0.0001), EQ5D (r=0.48; p<0.0001), presenteeism (r=0.39; p<0.0001), absenteeism (r=0.17; p=0.04), and distension (r=0.46; p<0.0001), but not stool frequency or form. The MCID was 2.2 points, correlating with a 29.5% reduction over time. Conclusions An abdominal pain NRS exhibits excellent validity and can be readily interpreted with an MCID in patients with IBS. These data support the use of the NRS in IBS clinical trials. PMID:19751360
Patient-Reported Outcomes and Fatigue in Patients with Chronic Hepatitis C Infection.
Golabi, Pegah; Sayiner, Mehmet; Bush, Haley; Gerber, Lynn H; Younossi, Zobair M
2017-08-01
Fatigue is a common symptom. Diagnosis is difficult. Fatigue is often a complex symptom. In the recent years, fatigue has gained considerable amount of attention. It has 2 major types, central and peripheral, which may occur together or alone. Although fatigue has many strong relations with depression and sleep disorders, it is a separate entity. For the diagnosis of fatigue, self-reports and patient-reported outcomes are highly valuable tools because these methods can reflect patients' perceptions. Treating the underlying disease with newly developed direct-acting antivirals often improves the perceived fatigue. Healthy lifestyle changes are the cornerstone of the treatment. Copyright © 2017 Elsevier Inc. All rights reserved.
Juckett, David A; Davis, Fred N; Gostine, Mark; Reed, Philip; Risko, Rebecca
2015-05-28
An academic, community medicine partnership was established to build a phenotype-to-outcome model targeting chronic pain. This model will be used to drive clinical decision support for pain medicine in the community setting. The first step in this effort is an examination of the electronic health records (EHR) from clinics that treat chronic pain. The biopsychosocial components provided by both patients and care providers must be of sufficient scope to populate the spectrum of patient types, treatment modalities, and possible outcomes. The patient health records from a large Midwest pain medicine practice (Michigan Pain Consultants, PC) contains physician notes, administrative codes, and patient-reported outcomes (PRO) on over 30,000 patients during the study period spanning 2010 to mid-2014. The PRO consists of a regularly administered Pain Health Assessment (PHA), a biopsychosocial, demographic, and symptomology questionnaire containing 163 items, which is completed approximately every six months with a compliance rate of over 95%. The biopsychosocial items (74 items with Likert scales of 0-10) were examined by exploratory factor analysis and descriptive statistics to determine the number of independent constructs available for phenotypes and outcomes. Pain outcomes were examined both in the aggregate and the mean of longitudinal changes in each patient. Exploratory factor analysis of the intake PHA revealed 15 orthogonal factors representing pain levels; physical, social, and emotional functions; the effects of pain on these functions; vitality and health; and measures of outcomes and satisfaction. Seven items were independent of the factors, offering unique information. As an exemplar of outcomes from the follow-up PHAs, patients reported approximately 60% relief in their pain. When examined in the aggregate, patients showed both a decrease in pain levels and an increase in coping skills with an increased number of visits. When examined individually, 80-85% of
Anthony, Samantha J; Selkirk, Enid; Sung, Lillian; Klaassen, Robert J; Dix, David; Klassen, Anne F
2017-02-01
The assessment of quality of life (QOL) is key within pediatric oncology and requires a clearly defined construct of QOL. The purpose of our study was: (1) to conduct a qualitative study to inform the theoretical underpinnings of QOL and (2) to determine the appropriateness of patient-reported outcome (PRO) instruments to assess and evaluate QOL in pediatric cancer patients and survivors. The study used an interpretative description approach. Children diagnosed with childhood cancer, aged 8-18 years, were recruited from four Canadian hospitals. Semi-structured interviews were completed, transcribed verbatim and coded through methods of constant comparison. In-depth analysis facilitated a comparison between emerging themes and the content of commonly used PRO instruments. Thirty-seven children (19 females; 51 %) participated. The mean age was 13 years, and 19 (51 %) participants were post-treatment. Participant experiences reflected notions of positive and negative duality, including: maintaining physical functioning but longing for the ability to participate in activities; experiencing a new level of intimacy with family and friends amidst isolation; and developing positivity amidst anger, sadness and lingering worry. Analysis showed that existing PRO instruments are missing concerns specific to this population and contain content not reflective of the QOL experiences of childhood cancer patients and survivors. Our research highlights important problems with content validity of existing PRO scales, indicating that the tools we have to date have limited utility in research and clinical practice. The development of a new PRO instrument should be considered to ensure that content validity is achieved.
Nazarenko, Andrea Lamont; Ohm, Jeanne; Alcantara, Junjoe
2018-01-01
Abstract Objective: To quantify the quality of life (QoL) and visit-specific satisfaction of pregnant women. Design: A prospective cohort within a practice-based research network (PBRN). Setting/Locations: Individual chiropractic offices. Subjects: Pregnant women (age ≥18 years) attending chiropractic care. Intervention(s): Chiropractic care (i.e., The Webster Technique, spinal adjustments, and adjunctive therapies). Main outcome measures: The RAND VSQ9 to measure visit-specific satisfaction and the Patient Reported Outcomes Measurement Information System (PROMIS®)-29 to measure QoL. Results: A convenience sample of 343 pregnant patients (average age = 30.96 years) comprised their study population. They were highly educated with 75% attaining a 2-year associate's degree or higher. The pregnant patients presented for chiropractic care with a mean week of gestation of 25.67 weeks (median = 28 weeks; range = 0–42 weeks) and parity (i.e., the number of live births) of 0.92 live births (median = 1; range = 0–6). From baseline (i.e., at study entrance with minimum first visit) and comparative (i.e., following a course of chiropractic care), the VSQ9 measurements revealed increasingly high satisfaction on the part of the subjects (i.e., the mean difference of baseline minus comparative measures = −0.7322; p < 0.005). The median number of visits (i.e., visits attended) at baseline and comparative measures was 1.00 (standard deviation [SD] = 22.69) and 3.30 (SD = 22.71), respectively. Across outcomes, QoL improved from baseline to comparative measurement after holding constant for visit number and time lapse, trimester of pregnancy, and care provider type. There was a reduction in mean T scores associated with fatigue (p < 0.05), pain interference (p < 0.05), sleep disturbance (p < 0.05), and an improvement in satisfaction with social roles (p < 0.05). A significant decrease was also found with pain interference
Hewlett, Sarah; Nicklin, Joanna; Bode, Chistina; Carmona, Loreto; Dures, Emma; Engelbrecht, Matthias; Hagel, Sofia; Kirwan, John; Molto, Anna; Redondo, Marta; Gossec, Laure
2016-06-01
Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes. A full protocol used for the Bristol RA Fatigue Multi-dimensional Questionnaire and Numerical Rating Scale (BRAF-MDQ, BRAF-NRS) was compared with a simplified protocol used for the RA Impact of Disease scale (RAID). RA patients in the UK, France, the Netherlands, Germany, Spain and Sweden completed the PROMs during cognitive interviewing (BRAFs in the UK were omitted as these were performed during development). Transcripts were deductively analysed for understanding, information retrieval, judgement and response options. Usefulness of cognitive interviewing was assessed by the nature of problems identified, and translation processes by percentage of consistently problematic items (⩾40% patients per country with similar concerns). Sixty patients participated (72% women). For the BRAFs (full protocol) one problematic item was identified (of 23 items × 5 languages, 1/115 = 0.9%). For the RAID (simplified protocol) two problematic items were identified (of 7 items × 6 languages, 2/42 = 4.8%), of which one was revised (Dutch). Coping questions were problematic in both PROMs. Conceptual and cultural challenges though rare were important, as identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. Proportionately fewer problematic items were found for the full than for the simplified translation procedure, suggesting that while both are acceptable, professional PROM translation might be preferable. Coping may be a particularly challenging notion cross-culturally. © The Author 2016. Published by Oxford University Press on behalf of the British Society
Naili, Josefine E; Wretenberg, Per; Lindgren, Viktor; Iversen, Maura D; Hedström, Margareta; Broström, Eva W
2017-03-21
It is not well understood why one in five patients report poor outcomes following knee arthroplasty. This study evaluated changes in knee biomechanics, and perceived pain among patients reporting either a good or a poor outcome in knee-related quality of life after total knee arthroplasty. Twenty-eight patients (mean age 66 (SD 7) years) were included in this prospective study. Within one month of knee arthroplasty and one year after surgery, patients underwent three-dimensional (3D) gait analysis, completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), and rated perceived pain using a visual analogue scale. A "good outcome" was defined as a change greater than the minimally detectable change in the KOOS knee-related quality of life, and a "poor outcome" was defined as change below the minimally detectable change. Nineteen patients (68%) were classified as having a good outcome. Groups were analyzed separately and knee biomechanics were compared using a two-way repeated measures ANOVA. Differences in pain between groups were evaluated using Mann Whitney U test. Patients classified as having a good outcome improved significantly in most knee gait biomechanical outcomes including increased knee flexion-extension range, reduced peak varus angle, increased peak flexion moment, and reduced peak valgus moment. The good outcome group also displayed a significant increase in walking speed, a reduction (normalization) of stance phase duration (% of gait cycle) and increased passive knee extension. Whereas, the only change in knee biomechanics, one year after surgery, for patients classified as having a poor outcome was a significant reduction in peak varus angle. No differences in pain postoperatively were found between groups. Patients reporting a good outcome in knee-related quality of life improved in knee biomechanics during gait, while patients reporting a poor outcome, despite similar reduction in pain, remained unchanged in knee biomechanics one year after
Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis
Gossec, Laure; Dougados, Maxime; Dixon, William
2015-01-01
There is a growing interest in patient-reported outcomes (PROs) in rheumatology, which goes with a global trend for more ‘patient-centred care’. This review considers the use of PROs in trials, including their strengths and limitations. In rheumatoid arthritis (RA) trials, the most frequently used PROs to assess treatments include pain, patient global assessment, assessment of functional status, but also health-related quality of life and less commonly fatigue. Other aspects of importance for patients, such as sleep, psychological well-being or ability to cope, are rarely assessed. PROs as outcome measures in RA trials have strengths as well as limitations. PROs have face validity, they are reproducible and sensitive to change and they bring additional information beyond joint counts or acute phase reactants. However, their predictive validity for later outcomes has been little explored, some PROs show redundancy (they bring similar information) and, due to the apparently moderate link between some PROs such as fatigue and the disease process, the use of some PROs to inform treatment choices has been questioned. We suggest the choice of PROs for trials depends on the study objective and on the viewpoint of the stakeholder. There needs to be agreed prioritisation across all stakeholders about what is most important to collect in a trial, which is why a prioritisation and selection process is necessary. Trials in RA will continue to include PROs and their interpretation will become easier as our knowledge progresses. PMID:26509052
Living with a pacemaker: patient-reported outcome of a pacemaker system.
Magnusson, Peter; Liv, Per
2018-06-04
The aim of this study was to assess among pacemaker patients their overall satisfaction with the pacemaker system, pain, soreness/discomfort, cosmetic results, restrictions due to impaired movement of the shoulder/arm/chest, related sleep disturbances, and concern about possible device malfunction. The seven-item questionnaire was mailed to patients from a single center who had a pacemaker implant or replacement between 2006 and 2016. A higher score indicated worse outcome on a visual analog scale (VAS) of 0-100 mm. The response rate was 75.5% and 342 questionniares were analyzed. Median age of respondents was 77.6 years and 57.0% were males. In total, 65 complications requiring surgery (10 pocket corrections (2.9%), 5 in females) occurred during a median follow-up of 5.6 years.The distribution of the primary outcome had a median score of 5 while the 75th percentile was 13. Cosmetic appearance was significantly associated with reoperation (but not other variables). Overall scores for men and women were 5 vs. 6, respectively, which achieved significance (p = 0.042). Median ratings of pain, soreness/discomfort, cosmetic appearance, range of motion, sleep, and concern about device malfunction were all ≤5. Females reported worse outcomes for all questions, except for cosmetic results and concern about malfunction. The vast majority of patients report excellent overall satisfaction with the pacemaker system, and are not affected by pain, soreness/discomfort, or concern about device malfunction. They also reported favourable outcomes with respect to cosmetic results, shoulder movement, and sleep. However, some patients underwent a surgical correction of the pacemaker pocket.
Chen, Michael; Mangubat, Erwin; Ouyang, Bichun
2016-01-01
With greater survival rates, patient-reported outcome measures (PROMs) among survivors of ruptured cerebral aneurysm should be an increasing concern among neurointerventionalists. Prior studies were limited in scale and generalizability. Our study aims were to (1) evaluate the validity of cerebral aneurysm PROMs obtained from social media; (2) determine the persistence of PROMs over time; and (3) determine what PROMs still exist in those with no physical impairments. By engaging national brain aneurysm support groups and using an online questionnaire modeled after the generic EQ-5D instrument, we asked respondents to classify their health in five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-point Likert scale. In 2 months we received 604 responses from 46 states in the USA. Our cohort of ruptured aneurysm respondents reported PROMs similar to previously published series. Over time, headache and anxiety improved while depression, level of exercise, and return to work remained unchanged. We found that memory worsened after 2 years. Among those without any physical impairment, rates of 20.6%, 14.9%, 12.6%, and 23% were seen for significant headaches, significant memory loss, significant depression, and sense of life being negatively affected, respectively. Despite this novel study design, we obtained results comparable to prior studies. These results suggest that many patients with ruptured cerebral aneurysms, regardless of whether they are >2 years after the event and/or free of physical impairment, struggle with a poor quality of life. The latency, scale, and low cost of this study design may accelerate future cerebral aneurysm PROM research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich
2013-10-01
Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The
Arshad, Zeeshaan; Karmen, Lindsey; Choudhary, Rajan; Smith, James A; Branford, Olivier A; Brindley, David A; Pettitt, David; Davies, Benjamin M
2016-12-01
Cell assisted lipotransfer serves as a novel technique for both breast reconstruction and breast augmentation. This systematic review assesses the efficacy, safety and use of patient reported outcome measures in studies involving cell assisted lipotransfer. We also carry out an objective assessment of study quality focussing on recruitment, follow-up and provide an up-to-date clinical trial landscaping analysis. Key electronic databases were searched according to PRISMA guidelines and pre-defined inclusion and exclusion criteria. Two independent reviewers examined the retrieved publications and performed data extraction. 3980 publications were identified. Following screening, 11 studies were included for full review, representing a total of 336 patients with a follow-up time ranging from six to 42 months. A degree of variation was noted in graft retention and reported satisfaction levels, although there were only three comparative studies with conflicting results. Complications occurred at a rate of 37%. Additionally, there was a paucity of objective outcomes assessments (e.g. 3D assessment modalities or validated patient reported outcome measures) in the selected studies. Cell assisted lipotransfer is a surgical technique that is currently employed sparingly within the plastic & reconstructive surgery community. Presently, further technical and outcome standardization is required, in addition to rigorous randomized controlled trials and supporting long-term follow-up data to better determine procedural safety and efficacy. Routine use of more objective outcome measures, particularly 3D assessments and validated patient reported outcome measures, will also help facilitate wider clinical adoption and establish procedural utility.
Moore, P; Jackson, C; Mutch, K; Methley, A; Pollard, C; Hamid, S; Jacob, A
2016-09-30
This study outlines the development of a patient-reported outcome measure (PROM), an instrument to obtain self-reported health status for neuromyeltis optica (NMO), a disabling neurological condition. Development was conducted in accordance with international guidance for PROMs including systematic review of existing literature, item generation guided by qualitative interviews, health-related quality of life conceptual framework and clinical expert panel and cognitive interviews with NMO patients. Participants were identified through a national NMO clinic in a tertiary NHS neurosciences service. 15 individuals with NMO participated in cognitive interviews requiring review and ranking of proposed PROM items and qualitative feedback on content, layout and response options. Participants endorsed the draft instrument as reflecting their experience of the condition and as being easy to understand. Rating and ranking of item relevance and importance reduced the draft instrument from 106 to 48 items. Participant feedback on overlapping items eliminated a further 2 items and resulted in a preliminary instrument of 46 items. As a direct result of participant feedback ordering of the 10 domains was revised, a 4 option Likert scale was employed and a 4-week recall period for impact of symptoms was selected. A 46-item instrument developed in accordance with international PROM development guidelines through literature review, developed by subject matter experts and refined through pretesting examining content validity provides a preliminary measure for assessing patient-report of health status in NMO. Further evaluation is proposed including sensitivity to clinical change, and international contributions to evaluating the measure are encouraged. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Cheville, Andrea L; Wang, Chun; Ni, Pengsheng; Jette, Alan M; Basford, Jeffrey R
2014-11-01
Item response theory-based patient-reported outcomes such as the Activity Measure for Post Acute Care Computerized Adaptive Test are gaining use because of their flexibility and ease of administration. Their psychometric properties are being explored, but little is known about how respondent characteristics may impact precision. The goal of this study was, therefore, to assess the effects of age, sex, and symptom intensity on respondents' test taking behaviors and scores. Three hundred eleven adults with late-stage lung cancer were consecutively enrolled between April 2008 and April 2009. Demographics and comorbidities were abstracted from their electronic medical records. The participants were followed on a 3- to 4-wk basis by telephonic interviews that involved administration of the Activity Measure for Post Acute Care Computerized Adaptive Test, followed by numerical rating scales scoring of their pain, fatigue, and dyspnea. In more than 2538 computerized adaptive test (CAT) sessions, three findings were prominent. First, the women and the older patients took longer to complete CAT sessions, were more likely to skip items, and produced scores with larger standard errors. Second, the respondents with higher levels of dyspnea and fatigue, but not pain, completed their CAT sessions more rapidly and were less likely to skip items. Third, fatigue and dyspnea interact with age but not sex to influence CAT duration and skip count. The findings of this study suggest that certain common clinical populations, for example, women, geriatric patients, and patients with intense symptoms, differ systematically in the time they are willing to devote to testing and the precision of their responses. The latter finding, unstable precision, is unlikely to be CAT specific and has implications for the interpretation of the scores of the Activity Measure for Post Acute Care Computerized Adaptive Test and other patient-reported outcomes.
Blakeley, Jaishri O; Coons, Stephen Joel; Corboy, John R; Kline Leidy, Nancy; Mendoza, Tito R; Wefel, Jeffrey S
2016-03-01
The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed. Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Tonetti, Maurizio; Palmer, Richard
2012-02-01
The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome
Carlozzi, Noelle E; Tulsky, David S; Kisala, Pamela A
2011-10-01
This 2-part qualitative study explored health-related quality of life (HRQOL) in individuals with traumatic brain injury (TBI). A community-based participatory action research design was used, which emphasizes collaboration between researchers and individuals with disabilities to ensure that results are relevant for individuals with TBI. In study 1, community members (N=20) with TBI served as "experts" during 1-on-1 semistructured interviews, reviewing current HRQOL items and identifying HRQOL issues commonly experienced by individuals with TBI. Each participant identified at least 31 issues, with most generating more than 90 responses, highlighting the multifaceted nature of HRQOL in TBI. Study 2 consisted of 7 patient/consumer groups (33 individuals with TBI), 4 caregiver groups (17 caregivers), and 2 provider groups (15 providers). Qualitative analysis of patient focus groups indicated that 48% of focus group comments were related to emotional issues; 23%, to social functioning; 14%, to physical functioning; 11%, to cognition; and 7%, to personality changes (caregiver and provider focus group analysis indicated identical patterns of findings). In addition, both studies evaluated the applicability in TBI of generic items developed by the Patient-Reported Outcomes Measurement Information System and the Neurology Quality of Life Measurement initiative. Findings suggest that although there is some overlap between current generic measures of HRQOL and concepts reported by individuals with TBI, these generic measures do not capture the full complexity of HRQOL in TBI. TBI-targeted item banks are needed to ensure sensitive assessment of HRQOL in TBI. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Yu, H H; Bi, X; Liu, Y Y
2017-08-10
Objective: To evaluate the reliability and validity of the Chinese version on comprehensive scores for financial toxicity (COST), based on the patient-reported outcome measures. Methods: A total of 118 cancer patients were face-to-face interviewed by well-trained investigators. Cronbach's α and Pearson correlation coefficient were used to evaluate reliability. Content validity index (CVI) and exploratory factor analysis (EFA) were used to evaluate the content validity and construct validity, respectively. Results: The Cronbach's α coefficient appeared as 0.889 for the whole questionnaire, with the results of test-retest were between 0.77 and 0.98. Scale-content validity index (S-CVI) appeared as 0.82, with item-content validity index (I-CVI) between 0.83 and 1.00. Two components were extracted from the Exploratory factor analysis, with cumulative rate as 68.04% and loading>0.60 on every item. Conclusion: The Chinese version of COST scale showed high reliability and good validity, thus can be applied to assess the financial situation in cancer patients.
Rose, M; Bjorner, J B; Becker, J; Fries, J F; Ware, J E
2008-01-01
The Patient-Reported Outcomes Measurement Information System (PROMIS) was initiated to improve precision, reduce respondent burden, and enhance the comparability of health outcomes measures. We used item response theory (IRT) to construct and evaluate a preliminary item bank for physical function assuming four subdomains. Data from seven samples (N=17,726) using 136 items from nine questionnaires were evaluated. A generalized partial credit model was used to estimate item parameters, which were normed to a mean of 50 (SD=10) in the US population. Item bank properties were evaluated through Computerized Adaptive Test (CAT) simulations. IRT requirements were fulfilled by 70 items covering activities of daily living, lower extremity, and central body functions. The original item context partly affected parameter stability. Items on upper body function, and need for aid or devices did not fit the IRT model. In simulations, a 10-item CAT eliminated floor and decreased ceiling effects, achieving a small standard error (< 2.2) across scores from 20 to 50 (reliability >0.95 for a representative US sample). This precision was not achieved over a similar range by any comparable fixed length item sets. The methods of the PROMIS project are likely to substantially improve measures of physical function and to increase the efficiency of their administration using CAT.
Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane
2015-09-15
The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001). Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. © 2015 American Cancer Society.
Dalal, Anand A; Nelson, Lauren; Gilligan, Theresa; McLeod, Lori; Lewis, Sandy; DeMuro-Mercon, Carla
2011-01-01
The goal of this study was to provide recommended steps to assess measurement comparability using a crossover study design and to demonstrate these steps using a short patient-reported outcome (PRO) instrument as an example. The example PRO instrument was administered via paper, Web, interactive voice response system, and interview; a randomized crossover design was used to gather data across the multiple administration types. Participants completed the PRO instrument, demographic and health questions, and a short preference questionnaire. Evaluation included comparisons of the item-level responses and agreement, comparison of mean scale scores, score classifications, and questions designed to collect usability and administration preference. Here the authors provide a four-step evaluation guide to evaluate measurement comparability and illustrate these steps using a case-finding tool. In the example, item-level kappa statistics between the paper and the alternate versions ranged from good to excellent, intraclass correlation coefficient for mean scores were above 0.70, and the rate of disagreement ranged from 2% to 14%. In addition, although participants had an administration preference, they reported few difficulties with the versions they were assigned. The steps described in this article provide a guide for evaluating whether to combine scores across administration versions to simplify analyses and interpretation under a crossover design. The guide recommends the investigation of item-level responses, summary scores, and participant usability/preference when comparing versions, with each step providing unique information to support comprehensive evaluation and informed decisions regarding whether to combine data. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Gerson, C D; Gerson, M-J
2014-02-01
Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self-evaluation, usually in the form of questionnaires. This report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS). Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time-line graph for review at the time of the next office visit. Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6-month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients. The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies. © 2013 John Wiley & Sons Ltd.
2014-01-01
Background Vitiligo is a chronic depigmenting skin disorder which affects around 0.5-1% of the world’s population. The outcome measures used most commonly in trials to judge treatment success focus on repigmentation. Patient-reported outcome measures of treatment success are rarely used, although recommendations have been made for their inclusion in vitiligo trials. This study aimed to evaluate the face validity of a new patient-reported outcome measure of treatment response, for use in future trials and clinical practice. Method An online survey to gather initial views on what constitutes treatment success for people with vitiligo or their parents/carers, followed by online discussion groups with patients to reach consensus on what constitutes treatment success for individuals with vitiligo, and how this can be assessed in the context of trials. Participants were recruited from an existing database of vitiligo patients and through posts on the social network sites Facebook and Twitter. Results A total of 202 survey responses were received, of which 37 were excluded and 165 analysed. Three main themes emerged as important in assessing treatment response: a) the match between vitiligo and normal skin (how well it blends in); b) how noticeable the vitiligo is and c) a reduction in the size of the white patches. The majority of respondents said they would consider 80% or more repigmentation to be a worthwhile treatment response after 9 months of treatment. Three online discussion groups involving 12 participants led to consensus that treatment success is best measured by asking patients how noticeable their vitiligo is after treatment. This was judged to be best answered using a 5-point Likert scale, on which a score of 4 or 5 represents treatment success. Conclusions This study represents the first step in developing a patient reported measure of treatment success in vitiligo trials. Further work is now needed to assess its construct validity and responsiveness to
Tucker, Carole A; Escorpizo, Reuben; Cieza, Alarcos; Lai, Jin Shei; Stucki, Gerold; Ustun, T. Bedirhan; Kostanjsek, Nenad; Cella, David; Forrest, Christopher B.
2014-01-01
Background The Patient Reported Outcomes Measurement Information System (PROMIS®) is a U.S. National Institutes of Health initiative that has produced self-reported item banks for physical, mental, and social health. Objective To describe the content of PROMIS at the item level using the World Health Organization’s International Classification of Functioning, Disability and Health (ICF). Methods All PROMIS adult items (publicly available as of 2012) were assigned to relevant ICF concepts. The content of the PROMIS adult item banks were then described using the mapped ICF code descriptors. Results The 1006 items in the PROMIS instruments could all be mapped to ICF concepts at the second level of classification, with the exception of 3 items of global or general health that mapped across the first-level classification of ICF activity and participation component (d categories). Individual PROMIS item banks mapped from 1 to 5 separate ICF codes indicating one-to-one, one-to-many and many-to-one mappings between PROMIS item banks and ICF second level classification codes. PROMIS supports measurement of the majority of major concepts in the ICF Body Functions (b) and Activity & Participation (d) components using PROMIS item banks or subsets of PROMIS items that could, with care, be used to develop customized instruments. Given the focus of PROMIS is on measurement of person health outcomes, concepts in body structures (s) and some body functions (b), as well as many ICF environmental factor have minimal coverage in PROMIS. Discussion The PROMIS-ICF mapped items provide a basis for users to evaluate the ICF related content of specific PROMIS instruments, and to select PROMIS instruments in ICF based measurement applications. PMID:24760532
Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.
Matsumoto, Mikio; Baba, Tomonori; Homma, Yasuhiro; Kobayashi, Hideo; Ochi, Hironori; Yuasa, Takahito; Behrend, Henrik; Kaneko, Kazuo
2015-10-01
The Forgotten Joint Score-12 (FJS-12) is for patients to forget their artificial joint and is reportedly a useful patient-reported outcome tool for artificial joints. The purpose of this study was to determine whether the FJS-12 is as useful as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) in Japan. All patients who visited our hospital's hip joint specialists following unilateral THA from August 2013 to July 2014 were evaluated. Medical staff members other than physicians administered three questionnaires. Items evaluated were (1) the reliability of the FJS-12 and (2) correlations between the FJS-12 and the total and subscale scores of the WOMAC or JHEQ. Of 130 patients, 22 were excluded. Cronbach's α coefficient was 0.97 for the FJS-12. The FJS-12 showed a significantly lower score than the WOMAC or JHEQ (p < 0.01). The FJS-12 was moderately correlated with the total WOMAC score (r = 0.522) and its subscale scores for "stiffness" (r = 0.401) and "function" (r = 0.539) and was weakly correlated with the score for "pain" (r = 0.289). The FJS-12 was favorably correlated with the total JHEQ score (r = 0.686) and its subscale scores (r = 0.530-0.643). The FJS-12 was correlated with and showed reliability similar to that of the JHEQ and WOMAC. The FJS-12, which is not affected by culture or lifestyle, may be useful in Japan.
Patient characteristics and outcome measurement in a low secure forensic hospital.
Longdon, Laura; Edworthy, Rachel; Resnick, Jeremy; Byrne, Adrian; Clarke, Martin; Cheung, Natalie; Khalifa, Najat
2018-06-01
Health services are increasingly required to measure outcomes after treatment, which can be reported to the funding body and may be scrutinised by the public. Extensive high-quality measurements are time consuming. Routinely collected clinical data might, if anonymised, provide good enough evidence of useful change consequent on service received. Do the Health of the Nation Scale and the 20-item Historical, Clinical, Risk structured professional judgement tool scores provide evidence of clinical and risk change among low security hospital patients at 6 and 12 months after admission? One hundred and eight men were either resident on the unit on 1 January 2011 or new admissions to the census date of 31 May 2013. Their routinely collected data were added to an outcome register following each patient's Care Programme Approach clinical review meeting and analysed using repeated measures t-tests with Bonferroni corrections. Most of the men, mean age 34.3 years, were single (93%), White British (71%) and with a primary diagnosis of schizophrenia (62%). There were significant reductions in the 11-item Health of the Nation Scale (excluding the community living condition scale) scores between baseline and 6 months and between 6 and 12 months, but no change on its additional 7-item secure subscale. Individual effect sizes indicated that 39% of the men had better social function, although 18% had deteriorated at 6 months. There was little overall change in the 20-item Historical, Clinical, Risk; individual effect sizes indicated that 11 men (15%) were rated as being at lower risk level and 10 (14%) at higher after 6 months in the study. Standard clinical measures are promising as indicators of change in low security hospital patients. Risk ratings may be conservative, but at this stage of a secure hospital admission, higher scores may be as likely to indicate progress in identifying and quantifying risks as apparent increase in risk. Copyright © 2017 John Wiley & Sons
Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials
Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea
2013-01-01
Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806
Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.
Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea
2013-11-19
Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.
Tuken, Murat; Kiremit, Murat Can; Serefoglu, Ege Can
2016-08-01
To evaluate the effects of modafinil on the intravaginal ejaculatory latency time (IELT) and patient-reported outcomes in patients with lifelong premature ejaculation (PE). Treatment-naïve lifelong PE patients were included in this proof-of-concept study. Self-estimated IELTs of the patients were recorded and the Premature Ejaculation Profile (PEP) questionnaire was administered before the initiation of on-demand modafinil 100 mg treatment. At the end of 1 month of treatment, self-estimated IELTs were recorded again, along with posttreatment PEP outcomes. Overall, 55 lifelong PE patients with a mean age of 35.07 ± 7.80 (range: 22-58) years were enrolled. Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001). Moreover, at the end of 1 month, patients reported in the PEP questionnaire better control over ejaculation (0.75 ± 0.67 vs 1.35 ± 0.91, P = .0001), improved satisfaction with sexual intercourse (0.98 ± 0.78 vs 1.40 ± 0.85, P = .0001), lesser personal distress (0.42 ± 0.69 vs 0.89 ± 1.01, P = .0001), and reduced interpersonal difficulty (1.69 ± 1.48 vs 1.95 ± 1.47, P = .0001). In an uncontrolled proof-of-concept study of men with treatment-naïve lifelong PE where IELT was self-reported without a stopwatch, modest improvements of both IELT and patient-reported outcome measures were observed. Future controlled clinical trials are necessary to confirm these findings. Copyright © 2016 Elsevier Inc. All rights reserved.
Hareendran, Asha; Palsgrove, Andrew C; Mocarski, Michelle; Schaefer, Michael L; Setyawan, Juliana; Carson, Robyn; Make, Barry
2013-06-25
The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. Literature review and clinician interviews were conducted to inform discussion guides to explore patients' nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients. The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients' experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients' terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended. A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical
IsHak, Waguih W; Pan, Dana; Steiner, Alexander J; Feldman, Edward; Mann, Amy; Mirocha, James; Danovitch, Itai; Melmed, Gil Y
2017-05-01
Patients with inflammatory bowel disease (IBD) are at risk for psychiatric disorders that impact symptom experience and health-related quality of life (HRQOL). Therefore, comprehensive biopsychosocial assessments should be considered in ambulatory care settings. Patient-Reported Outcomes Measurement Information System (PROMIS) measures created by the National Institutes of Health have shown construct validity in a large IBD internet-based cohort, but their validity in ambulatory settings has not been examined. We sought to validate PROMIS patient-reported measures of HRQOL, functioning, and psychiatric symptom severity at a tertiary IBD clinic. Adult patients (n = 110) completed the PROMIS Global Health scale, PROMIS-29, SF-12, and WHODAS 2.0. Pearson's correlation coefficients (r) determined the relationships between scores to validate the PROMIS Global Health Physical and Mental metrics, compared with the SF-12 and WHODAS 2.0. We compared these measures by disease subtype of Crohn's disease or ulcerative colitis. PROMIS measures were highly correlated (r range = 0.64-0.82) with standard measures of HRQOL and functioning. On the PROMIS Global Health measures, 20.9% had impaired physical health, and 13.7% had impaired mental health. Impairments were reported in pain interference (20% of patients), anxiety (18.2%), satisfaction with social role (15.5%), physical functioning (10.9%), fatigue (10%), depression (7.3%), and sleep disturbance (5.5%). Patients with Crohn's disease had worse scores than those with ulcerative colitis on measures of the global physical health (P = 0.027), physical functioning (P = 0.047), and pain interference (P = 0.0009). PROMIS instruments provide valid assessment of HRQOL and functioning in ambulatory adults with IBD. Of note, patients with Crohn's disease demonstrated significantly worse impairments than those with ulcerative colitis.
Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B
2014-06-26
Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or
Neuburger, J; Hutchings, A; Black, N; van der Meulen, J H
2013-03-01
We investigated socioeconomic differences in patient-reported outcomes after a hip or knee replacement and the contribution of health differences beforehand. Our sample included 121 983 patients in England who had an operation in 2009-2011. Socioeconomic status was measured with quintiles of the ranking of areas by the English Index of Multiple Deprivation. Outcomes at 6 months were the Oxford hip or knee score (OHS or OKS) that measure pain and disability on a scale from 0 (worst) to 48 (best), and the percentage reporting no improvement in problems. Adjustment was made for age, sex, ethnicity, comorbidity, general health, revision surgery, primary diagnosis, preoperative OHS or OKS and having longstanding problems. Comparing the most- with the least-deprived group, the mean OHS was 5.0 points lower and the OKS 5.4 lower. Adjusted differences, reflecting the differences in improvement in the condition, were 2.8 [95% confidence interval (CI): 2.5-3.0] on OHS and 2.4 (95% CI: 2.2-2.7) on OKS. Adjusted odds ratios for reporting no improvement were 1.4 (1.2-1.6) for the hip and 1.4 (1.3-1.5) for the knee. On average, patients living in socioeconomically deprived areas had worse outcomes after surgery, partly related to preoperative differences in health and disease severity and partly to less postoperative improvement.
Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich
2013-01-01
Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically
Rasulnia, Mazi; Burton, Billy Stephen; Ginter, Robert P; Wang, Tracy Y; Pleasants, Roy Alton; Green, Cynthia L; Lugogo, Njira
2017-08-11
Low adherence and poor outcomes provide opportunity for digital coaching to engage patients with uncontrolled asthma in their care to improve outcomes. To examine the impact of a remote digital coaching program on asthma control and patient experience. We recruited 51 adults with uncontrolled asthma, denoted by albuterol use of >2 times per week and/or exacerbations requiring corticosteroids, and applied a 12-week patient-centered remote digital coaching program using a combination of educational pamphlets, symptom trackers, best peak flow establishment, physical activity, and dietary counseling, as well as coaches who implemented emotional enforcement to motivate disease self-management through telephone, text, and email. Baseline and post-intervention measures were quality of life (QOL), spirometry, Asthma Control Test (ACT), Asthma Symptom Utility Index (ASUI), rescue albuterol use, and exacerbation history. Among 51 patients recruited, 40 completed the study. Eight subjects required assistance reading medical materials. Significant improvements from baseline were observed for Patient-Reported Outcomes Measurement Information System mental status (p = 0.010), body weight, and outpatient exacerbation frequency (p = 0.028). The changes from baseline in ACT (p = 0.005) were statistically significant but did not achieve the pre-specified minimum clinically important difference (MCID), whereas for ASUI, the MCID and statistical significance were achieved. Spirometry and rescue albuterol use were no different. A patient-oriented, remote digital coaching program that utilized trained health coaches and digital materials led to statistically significant improvement in mental status, outpatient exacerbations, body weight, and ASUI. Digital coaching programs may improve some outcomes in adults with uncontrolled asthma.
Girgis, Afaf; Durcinoska, Ivana; Levesque, Janelle V; Gerges, Martha; Sandell, Tiffany; Arnold, Anthony; Delaney, Geoff P
2017-10-02
Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean
High Variability in Outcome Reporting Patterns in High-Impact ACL Literature.
Makhni, Eric C; Padaki, Ajay S; Petridis, Petros D; Steinhaus, Michael E; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R
2015-09-16
ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.
Ledingham, JM; Snowden, N; Rivett, A; Galloway, J; Firth, J; Ide, Z; MacPhie, E; Kandala, N; Dennison, EM; Rowe, I
2017-01-01
Objectives Our aim was to conduct a national audit assessing the impact and experience of early management of inflammatory arthritis by English and Welsh rheumatology units. The audit enables rheumatology services to measure for the first time their performance, patient outcomes and experience, benchmarked to regional and national comparators. Methods All individuals >16 years of age presenting to English and Welsh rheumatology services with suspected new-onset inflammatory arthritis were included in the audit. Clinician- and patient-derived outcome and patient-reported experience measures were collected. Results Data are presented for the 6354 patients recruited from 1 February 2014 to 31 January 2015. Ninety-seven per cent of English and Welsh trusts participated. At the first specialist assessment, the 28-joint DAS (DAS28) was calculated for 2659 (91%) RA patients [mean DAS28 was 5.0 and mean Rheumatoid Arthritis Impact of Disease (RAID) score was 5.6]. After 3 months of specialist care, the mean DAS28 was 3.5 and slightly >60% achieved a meaningful DAS28 reduction. The average RAID score and reduction in RAID score were 3.6 and 2.4, respectively. Of the working patients ages 16–65 years providing data, 7, 5, 16 and 37% reported that they were unable to work, needed frequent time off work, occasionally and rarely needed time off work due to their arthritis, respectively; only 42% reported being asked about their work. Seventy-eight per cent of RA patients providing data agreed with the statement ‘Overall in the last 3 months I have had a good experience of care for my arthritis’; <2% disagreed. Conclusion This audit demonstrates that most RA patients have severe disease at the time of presentation to rheumatology services and that a significant number continue to have high disease activity after 3 months of specialist care. There is a clear need for the National Health Service to develop better systems for capturing, coding and integrating information from
Morris, Scott; Bass, Mike; Lee, Mirinae; Neapolitan, Richard E
2017-09-01
The Patient Reported Outcomes Measurement Information System (PROMIS) initiative developed an array of patient reported outcome (PRO) measures. To reduce the number of questions administered, PROMIS utilizes unidimensional item response theory and unidimensional computer adaptive testing (UCAT), which means a separate set of questions is administered for each measured trait. Multidimensional item response theory (MIRT) and multidimensional computer adaptive testing (MCAT) simultaneously assess correlated traits. The objective was to investigate the extent to which MCAT reduces patient burden relative to UCAT in the case of PROs. One MIRT and 3 unidimensional item response theory models were developed using the related traits anxiety, depression, and anger. Using these models, MCAT and UCAT performance was compared with simulated individuals. Surprisingly, the root mean squared error for both methods increased with the number of items. These results were driven by large errors for individuals with low trait levels. A second analysis focused on individuals aligned with item content. For these individuals, both MCAT and UCAT accuracies improved with additional items. Furthermore, MCAT reduced the test length by 50%. For the PROMIS Emotional Distress banks, neither UCAT nor MCAT provided accurate estimates for individuals at low trait levels. Because the items in these banks were designed to detect clinical levels of distress, there is little information for individuals with low trait values. However, trait estimates for individuals targeted by the banks were accurate and MCAT asked substantially fewer questions. By reducing the number of items administered, MCAT can allow clinicians and researchers to assess a wider range of PROs with less patient burden. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
Ingegnoli, Francesca; Carmona, Loreto; Castrejon, Isabel
2017-04-01
The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML. A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist. From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements. Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.
Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.
Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B
2017-10-10
The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management
Manson, Neil A.; Green, Alana J.; Abraham, Edward P.
2015-01-01
Study Design Retrospective study. Objective Quantify the effect of obesity on elective thoracolumbar spine surgery patients. Methods Five hundred consecutive adult patients undergoing thoracolumbar spine surgery to treat degenerative pathologies with minimum follow-up of at least 1 year were included. Primary outcome measures included Numerical Rating Scales for back and leg pain, the Short Form 36 Physical Component Summary and Mental Component Summary, the modified Oswestry Disability Index, and patient satisfaction scores collected preoperatively and at 3, 6, 12, and 24 months postoperatively. Secondary outcome measures included perioperative and postoperative adverse events, postoperative emergency department presentation, hospital readmission, and revision surgeries. Patients were grouped according to World Health Organization body mass index (BMI) guidelines to isolate the effect of obesity on primary and secondary outcome measures. Results Mean BMI was 30 kg/m2, reflecting a significantly overweight population. Each BMI group reported statistically significant improvement on all self-reported outcome measures. Contrary to our hypothesis, however, there was no association between BMI group and primary outcome measures. Patients with BMI of 35 to 39.99 visited the emergency department with complaints of pain significantly more often than the other groups. Otherwise, we did not detect any differences in the secondary outcome measures between BMI groups. Conclusions Patients of all levels of obesity experienced significant improvement following elective thoracolumbar spine surgery. These outcomes were achieved without increased risk of postoperative complications such as infection and reoperation. A risk–benefit algorithm to assist with surgical decision making for obese patients would be valuable to surgeons and patients alike. PMID:26933611
SRTR center-specific reporting tools: Posttransplant outcomes.
Dickinson, D M; Shearon, T H; O'Keefe, J; Wong, H-H; Berg, C L; Rosendale, J D; Delmonico, F L; Webb, R L; Wolfe, R A
2006-01-01
Measuring and monitoring performance--be it waiting list and posttransplant outcomes by a transplant center, or organ donation success by an organ procurement organization and its partnering hospitals--is an important component of ensuring good care for people with end-stage organ failure. Many parties have an interest in examining these outcomes, from patients and their families to payers such as insurance companies or the Centers for Medicare and Medicaid Services; from primary caregivers providing patient counseling to government agencies charged with protecting patients. The Scientific Registry of Transplant Recipients produces regular, public reports on the performance of transplant centers and organ procurement organizations. This article explains the statistical tools used to prepare these reports, with a focus on graft survival and patient survival rates of transplant centers--especially the methods used to fairly and usefully compare outcomes of centers that serve different populations. The article concludes with a practical application of these statistics--their use in screening transplant center performance to identify centers that may need remedial action by the OPTN/UNOS Membership and Professional Standards Committee.
Pectus patient information website has improved access to care and patient reported outcomes.
Tikka, Theofano; Webb, Joanne; Agostini, Paula; Kerr, Amy; Mannion, Glenn; Steyn, Richard S; Bishay, Ehab; Kalkat, Maninder S; Rajesh, Pala B; Naidu, Babu
2016-04-26
Pectus is the most common congenital disorder. Awareness amongst primary care physicians and the general public is poor. NHS commissioning bodies plan to withdraw funding for this surgery because they deem a lack of sufficient evidence of benefit. The purpose of this study is to assess the effects of introducing a patient information website on referral and activity patterns and on patients reported outcomes. We produced an innovative information website, www.pectus.co.uk , accessible to the general public, providing information about pectus deformities; management options and advice about surgery. Referral patterns and number of cases where studied before and after the introduction of the website in 2010. Patients' satisfaction post-op was assessed using the Brompton's single step questionnaire (SSQ). The website had considerable traffic with 2179 hits in 2012, 4983 in 2013 and 7416 in 2014. This has led to 1421 contacts and 372 email enquiries. These emails have resulted in an increased number of patients who have been assessed and go on to have surgery. We asked 59 pectus excavatum patients who were operated from 2008 to 2014 to complete the SSQ. We received 32 replies. Eighty-four percent (16/19) of patients who visited the website and then underwent surgery, found the website useful. All patients scored satisfactorily in SSQ. Even though those who visited the website tended to be more satisfied with the surgical outcomes this did not reach statistical significance. This group of patients said that would have the operation again given the option compared to 76.9 % of the group who did not visit the website before surgery (p=0.031). Despite the fact that patients who visited the website experienced more post-operative complications were equally or more satisfied with post-operative outcomes. The overall SSQ obtainable score was not different for the two subgroups, being more widespread in the group that did not visit the website. The introduction of a pectus
Fonarow, Gregg C; Alberts, Mark J; Broderick, Joseph P; Jauch, Edward C; Kleindorfer, Dawn O; Saver, Jeffrey L; Solis, Penelope; Suter, Robert; Schwamm, Lee H
2014-05-01
Because stroke is among the leading causes of death, disability, hospitalizations, and healthcare expenditures in the United States, there is interest in reporting outcomes for patients hospitalized with acute ischemic stroke. The American Heart Association/American Stroke Association, as part of its commitment to promote high-quality, evidence-based care for cardiovascular and stroke patients, fully supports the development of properly risk-adjusted outcome measures for stroke. To accurately assess and report hospital-level outcomes, adequate risk adjustment for case mix is essential. During the development of the Centers for Medicare & Medicaid Services 30-day stroke mortality and 30-day stroke readmission measures, concerns were expressed that these measures were not adequately designed because they do not include a valid initial stroke severity measure, such as the National Institutes of Health Stroke Scale. These outcome measures, as currently constructed, may be prone to mischaracterizing the quality of stroke care being delivered by hospitals and may ultimately harm acute ischemic stroke patients. This article details (1) why the Centers for Medicare & Medicaid Services acute ischemic stroke outcome measures in their present form may not provide adequate risk adjustment, (2) why the measures as currently designed may lead to inaccurate representation of hospital performance and have the potential for serious unintended consequences, (3) what activities the American Heart Association/American Stroke Association has engaged in to highlight these concerns to the Centers for Medicare & Medicaid Services and other interested parties, and (4) alternative approaches and opportunities that should be considered for more accurately risk-adjusting 30-day outcomes measures in patients with ischemic stroke.
Mlakar, Miha; Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja
2018-01-01
This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.
Girgis, Afaf; Delaney, Geoff P; Arnold, Anthony; Miller, Alexis Andrew; Levesque, Janelle V; Kaadan, Nasreen; Carolan, Martin G; Cook, Nicole; Masters, Kenneth; Tran, Thomas T; Sandell, Tiffany; Durcinoska, Ivana; Gerges, Martha; Avery, Sandra; Ng, Weng; Della-Fiorentina, Stephen; Dhillon, Haryana M; Maher, Ashley
2016-11-24
Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales
Jensen, Roxanne E; Potosky, Arnold L; Moinpour, Carol M; Lobo, Tania; Cella, David; Hahn, Elizabeth A; Thissen, David; Smith, Ashley Wilder; Ahn, Jaeil; Luta, George; Reeve, Bryce B
2017-06-10
Purpose To estimate cancer population-based reference values in the United States for eight PROMIS (Patient-Reported Outcomes Measurement Information System) domains by age and stage of disease. Patients and Methods For the Measuring Your Health (MY-Health) study, persons newly diagnosed with cancer (prostate, colorectal, non-small-cell lung, non-Hodgkin lymphoma, breast, uterine, or cervical) from 2010 to 2012 (N = 5,284) were recruited through the National Cancer Institute's SEER Program. Participants were mailed surveys 6 to 13 months after diagnosis. Raking by race/ethnicity, age, and stage generated weighted average PROMIS scores for pain interference, fatigue, anxiety, depression, sleep disturbance, physical function, ability to participate in social roles, and cognitive function. PROMIS measures are standardized to a T-score metric, with a score of 50 representing the general US population mean. Clinically meaningful differences were defined as a 3-point difference in scores. Results Several reference values (means) for patients with cancer were worse than the general United States population norms of 50. These include pain interference (52.4), fatigue (52.2), and physical function (44.1). Reference values were highest (ie, showed greatest symptom burden) in lung cancer (pain interference, 55.5; fatigue, 57.3; depression, 51.4) and cervical cancer (anxiety, 53.2; sleep disturbance, 53.4). Reference values for patients age 65 to 84 years reported lower sleep disturbance, anxiety, and depression, and better cognitive function than younger patients. Cancer reference values were poorer among those with advanced disease compared with patients with limited or no evidence of disease, specifically physical function (41.1 v 46.6, respectively), fatigue (55.8 v 50.2, respectively), and pain interference (55.2 v 50.9, respectively). Conclusion In a large, population-based sample of patients with recently diagnosed cancer, we observed symptom severity and functional
Rinkel, Rico N; Verdonck-de Leeuw, Irma M; Doornaert, Patricia; Buter, Jan; de Bree, Remco; Langendijk, Johannes A; Aaronson, Neil K; Leemans, C René
2016-07-01
The objective of this study is to assess swallowing and speech outcome after chemoradiation therapy for head and neck cancer, based on the patient-reported outcome measures Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI), both provided with cut-off scores. This is a cross-sectional study. Department of Otolaryngology/Head and Neck Surgery of a University Medical Center. Sixty patients, 6 months to 5 years after chemoradiation for head and neck squamous cell carcinoma. Swallowing Quality of Life Questionnaire (SWAL-QOL) and SHI, both validated in Dutch and provided with cut-off scores. Associations were tested between the outcome measures and independent variables (age, gender, tumor stage and site, and radiotherapy technique, time since treatment, comorbidity and food intake). Fifty-two patients returned the SWAL-QOL and 47 the SHI (response rate 87 and 78 %, respectively). Swallowing and speech problems were present in 79 and 55 %, respectively. Normal food intake was noticed in 45, 35 % had a soft diet and 20 % tube feeding. Patients with soft diet and tube feeding reported more swallowing problems compared to patients with normal oral intake. Tumor subsite was significantly associated with swallowing outcome (less problems in larynx/hypopharynx compared to oral/oropharynx). Radiation technique was significantly associated with psychosocial speech problems (less problems in patients treated with IMRT). Swallowing and (to a lesser extent) speech problems in daily life are frequently present after chemoradiation therapy for head and neck cancer. Future prospective studies will give more insight into the course of speech and swallowing problems after chemoradiation and into efficacy of new radiation techniques and swallowing and speech rehabilitation programs.
Kamin, Hayley S; McCarthy, Alyssa E; Abel, Madelaine R; Jellinek, Michael S; Baer, Lee; Murphy, J Michael
2015-12-01
The Pediatric Symptom Checklist (PSC) is a widely-used, parent-completed measure of children's emotional and behavioral functioning. Previous research has shown that the PSC and its subscales are generally responsive to patient progress over the course of psychiatric treatment. In this naturalistic study, we examined the performance and utility of the five-item PSC Internalizing Subscale (PSC-IS) as an assessment of routine treatment in outpatient pediatric psychiatry. Parents and clinicians of 1,593 patients aged 17 or younger completed standardized measures at intake and three-month follow-up appointments. Comparisons between PSC-IS scores and clinician-reported diagnoses, internalizing symptoms, and overall functioning showed acceptable levels of agreement. Change scores on the PSC-IS were also larger among patients with internalizing diagnoses than those with non-internalizing diagnoses. As a brief measure of internalizing symptoms, the PSC may be particularly useful to mental health clinicians treating youth with depression and anxiety as a quality assurance or treatment outcome measure.
Schneider, Stefan; Choi, Seung W; Junghaenel, Doerte U; Schwartz, Joseph E; Stone, Arthur A
2013-09-01
The Patient-Reported Outcomes (PRO) Measurement Information System (PROMIS(®)) has developed assessment tools for numerous PROs, most using a 7-day recall format. We examined whether modifying the recall period for use in daily diary research would affect the psychometric characteristics of several PROMIS measures. Daily versions of short-forms for three PROMIS domains (pain interference, fatigue, depression) were administered to a general population sample (n = 100) for 28 days. Analyses used multilevel item response theory (IRT) models. We examined differential item functioning (DIF) across recall periods by comparing the IRT parameters from the daily data with the PROMIS 7-day recall IRT parameters. Additionally, we examined whether the IRT parameters for day-to-day within-person changes are invariant to those for between-person (cross-sectional) differences in PROs. Dimensionality analyses of the daily data suggested a single dimension for each PRO domain, consistent with PROMIS instruments. One-third of the daily items showed uniform DIF when compared with PROMIS 7-day recall, but the impact of DIF on the scale level was minor. IRT parameters for within-person changes differed from between-person parameters for 3 depression items, which were more sensitive for measuring change than between-person differences, but not for pain interference and fatigue items. Notably, mean scores from daily diaries were significantly lower than the PROMIS 7-day recall norms. The results provide initial evidence supporting the adaptation of PROMIS measures for daily diary research. However, scores from daily diaries cannot be directly interpreted on PROMIS norms established for 7-day recall.
How to Measure Outcomes of Peripheral Nerve Surgery
Wang, Yirong; Sunitha, Malay; Chung, Kevin C.
2013-01-01
Synopsis Evaluation of outcomes after peripheral nerve surgeries include a number of assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, neurophysiological and patient- reported outcomes. This review makes a list of measurements addressing these aspects as well as advantage and disadvantage of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers focus on measurements best relevant to specific conditions and research questions. PMID:23895715
Patrick, Donald L; Giuliano, François; Ho, Kai Fai; Gagnon, Dennis D; McNulty, Pauline; Rothman, Margaret
2009-02-01
To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE, 201; non-PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo-controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five-point response scales. Test-retest reliability, known-groups validity, and ability to detect a patient-reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non-PE groups (P < 0.001). Men who reported a reduction in PE with treatment in the phase III trial had significantly greater scores on each of the four measures. The PEP profiles of men with and without PE differed significantly (P < 0.001) in both observational studies; higher levels of PGI were associated with higher PEP profiles (P < 0.001). The PEP index score also showed acceptable reliability and was significantly different between the PE and non-PE groups (P < 0.001). Men who reported an improvement in PE with treatment in the phase III trial had significantly greater PEP index scores. In the phase III trial, nausea was the most common adverse event with dapoxetine. The PEP provides a reliable, valid, and interpretable measure for use in monitoring
How to Measure Quality-of-Life Concerns in Patients with Neurogenic Lower Urinary Tract Dysfunction.
Patel, Darshan P; Myers, Jeremy B; Lenherr, Sara M
2017-08-01
There is an evolving role for quality-of-life measures and patient-reported outcomes in the evaluation of neurogenic lower urinary tract dysfunction. We review available health-related quality-of-life instruments and patient-reported outcomes measures used in the assessment of patients with neurogenic bladder. We also discuss considerations for incorporation of these measures into clinical and patient-reported research. Emphasizing patient-reported outcomes in neurogenic bladder research will guide clinicians and other stakeholders to improve quality of life in this patient population. Copyright © 2017 Elsevier Inc. All rights reserved.
Gutacker, Nils; Street, Andrew; Gomes, Manuel; Bojke, Chris
2015-08-01
The best practice tariff for hip and knee replacement in the English National Health Service (NHS) rewards providers based on improvements in patient-reported outcome measures (PROMs) collected before and after surgery. Providers only receive a bonus if at least 50% of their patients complete the preoperative questionnaire. We determined how many providers failed to meet this threshold prior to the policy introduction and assessed longitudinal stability of participation rates. Retrospective observational study using data from Hospital Episode Statistics and the national PROM programme from April 2009 to March 2012. We calculated participation rates based on either (a) all PROM records or (b) only those that could be linked to inpatient records; constructed confidence intervals around rates to account for sampling variation; applied precision weighting to allow for volume; and applied risk adjustment. NHS hospitals and private providers in England. NHS patients undergoing elective unilateral hip and knee replacement surgery. Number of providers with participation rates statistically significantly below 50%. Crude rates identified many providers that failed to achieve the 50% threshold but there were substantially fewer after adjusting for uncertainty and precision. While important, risk adjustment required restricting the analysis to linked data. Year-on-year correlation between provider participation rates was moderate. Participation rates have improved over time and only a small number of providers now fall below the threshold, but administering preoperative questionnaires remains problematic in some providers. We recommend that participation rates are based on linked data and take into account sampling variation. © The Royal Society of Medicine.
Ahmed, Sara; Ware, Patrick; Gardner, William; Witter, James; Bingham, Clifton O; Kairy, Dahlia; Bartlett, Susan J
2017-09-01
Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.
Does CPAP Affect Patient-Reported Voice Outcomes?
Hartke, Vance; Gillespie, Amanda; Smith, Libby J; Soose, Ryan J
2018-04-01
Upper aerodigestive tract symptoms are common in patients with obstructive sleep apnea (OSA). It remains unclear whether continuous positive airway pressure (CPAP) improves or worsens these otolaryngology symptoms. As therapy-related side effects limit CPAP adherence, this study aimed to determine if CPAP negatively affects voice, sinonasal, and reflux symptoms of the upper airway. Case series with planned data collection was performed at an academic otolaryngology sleep center. Newly diagnosed patients with OSA were evaluated before and 6 months after initiating CPAP therapy. Data collected included CPAP data download, Reflux Symptom Index (RSI), Epworth Sleepiness Scale (ESS), Voice Handicap Index 10 (VHI-10), Sino-Nasal Questionnaire (SNQ), and oral dryness visual analog scale (VAS). For the 11 CPAP-adherent participants, the RSI significantly improved with CPAP (mean RSI, 22.0-9.5; P = .002); however, the VAS, VHI-10, and SNQ did not change after 6 months of CPAP therapy. In a small sample size, patient-reported voice outcomes (VHI-10) and other upper aerodigestive tract symptoms did not worsen with CPAP; rather, CPAP therapy was associated with a reduction in reflux symptoms.
2006-10-11
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably
2006-01-01
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably
How to measure outcomes of peripheral nerve surgery.
Wang, Yirong; Sunitha, Malay; Chung, Kevin C
2013-08-01
Evaluation of outcomes after peripheral nerve surgeries include several assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, and neurophysiologic and patient-reported outcomes. This review lists measurements addressing these aspects as well as the advantages and disadvantages of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers to focus on measurements best relevant to specific conditions and research questions. Copyright © 2013 Elsevier Inc. All rights reserved.
Chandrasekaran, Sivashankar; Vemula, S Pavan; Lindner, Dror; Lodhia, Parth; Suarez-Ahedo, Carlos; Domb, Benjamin G
2015-08-19
significant correlation between dGEMRIC indices and the patient-reported outcome measures. Patients with a dGEMRIC index of ≥323 msec (less than one SD below the cohort mean) demonstrated significantly greater improvement in patient-reported outcome scores and the VAS for pain after hip arthroscopy. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.
Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja
2018-01-01
This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials. PMID:29494601
Schubert, Maria; Clarke, Sean P; Glass, Tracy R; Schaffert-Witvliet, Bianca; De Geest, Sabina
2009-07-01
In the Rationing of Nursing Care in Switzerland Study, implicit rationing of care was the only factor consistently significantly associated with all six studied patient outcomes. These results highlight the importance of rationing as a new system factor regarding patient safety and quality of care. Since at least some rationing of care appears inevitable, it is important to identify the thresholds of its influences in order to minimize its negative effects on patient outcomes. To describe the levels of implicit rationing of nursing care in a sample of Swiss acute care hospitals and to identify clinically meaningful thresholds of rationing. Descriptive cross-sectional multi-center study. Five Swiss-German and three Swiss-French acute care hospitals. 1338 nurses and 779 patients. Implicit rationing of nursing care was measured using the newly developed Basel Extent of Rationing of Nursing Care (BERNCA) instrument. Other variables were measured using survey items from the International Hospital Outcomes Study battery. Data were summarized using appropriate descriptive measures, and logistic regression models were used to define a clinically meaningful rationing threshold level. For the studied patient outcomes, identified rationing threshold levels varied from 0.5 (i.e., between 0 ('never') and 1 ('rarely') to 2 ('sometimes')). Three of the identified patient outcomes (nosocomial infections, pressure ulcers, and patient satisfaction) were particularly sensitive to rationing, showing negative consequences anywhere it was consistently reported (i.e., average BERNCA scores of 0.5 or above). In other cases, increases in negative outcomes were first observed from the level of 1 (average ratings of rarely). Rationing scores generated using the BERNCA instrument provide a clinically meaningful method for tracking the correlates of low resources or difficulties in resource allocation on patient outcomes. Thresholds identified here provide parameters for administrators to
Larsson, Maria E H; Kreuter, Margareta; Nordholm, Lena
2010-07-01
Musculoskeletal disorders are prevalent and a major burden on individuals and society. Information on relationships of patient involvement and responsibility to outcome is limited. This study aimed to explore relationships between self-reported outcome of physiotherapy treatment and attitudes toward responsibility for musculoskeletal disorders. A cross-sectional postal survey design was used. Patients (n=615) from an outpatient physiotherapy clinic, who had finished their physiotherapy treatment within the last 6 months were sent a questionnaire that included the Attitudes regarding Responsibility for Musculoskeletal disorders instrument (ARM), self-reported outcome of treatment and sociodemographic data. A total of 279 (45%) completed forms were returned. Multiple logistic regression analysis was used. The patients' scores on the four dimensions of ARM ("responsibility self active," "responsibility out of my hands," "responsibility employer," and "responsibility medical professionals"), controlled for age, sex, education, and physical activity as well as for number of treatments, main treatment, and physiotherapist, were associated with the patients' self-reported treatment outcome. Patients who attributed responsibility more to themselves were more likely (OR 2.37 and over) to report considerable improvement as the outcome of physiotherapy treatment. Because this study was conducted at only one physiotherapy outpatient clinic and had a cross-sectional design, the results should be replicated in other settings. Because patients' attitudes regarding responsibility for musculoskeletal disorders can possibly affect the outcome of physiotherapy treatment, it might be useful to decide whether to systematically try to influence the person's attitude toward responsibility for the management of the disorder or to match treatment to attitude.
Vinney, Lisa A; Grade, John D; Connor, Nadine P
2012-01-01
The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus, we used a cross-over design to compare responses to a pediatric health quality of life instrument (PedsQL 4.0) delivered using a handheld electronic device to those from a traditional paper form. Respondents were children with (n=9) and without (n=10) a speech or voice disorder. For paper versus the electronic format, we examined time to completion, number of incomplete or inaccurate question responses, intra-rater reliability, ease of use, and child and parent preference. There were no significant differences between children's scores, time to complete the measure, or ratings related to ease of answering questions. The percentage of children who made answering errors or omissions with paper and pencil was significantly greater than the percentage of children who made such errors using the device. This preliminary study demonstrated that use of an electronic device to collect QOL or patient-reported outcomes (PRO) data from children is more efficient than and just as feasible, reliable, and acceptable as using paper forms. The development of hardware and software applications for the collection of QOL and/or PRO data in children with speech disorders is likely warranted. The reader will be able to understand: (1) The potential benefits of using electronic data capture via handheld devices for collecting pediatric patient reported outcomes; (2) The Pediatric Quality of Life Inventory 4.0 is a measure of the perception of general health quality that has distinguished between
Egger, Michael E; Ohlendorf, Joanna M; Scoggins, Charles R; McMasters, Kelly M; Martin, Robert C G
2015-01-01
Background The aim of this paper is to assess the current state of quality and outcomes measures being reported for hepatic resections in the recent literature. Methods Medline and PubMed databases were searched for English language articles published between 1 January 2002 and 30 April 2013. Two examiners reviewed each article and relevant citations for appropriateness of inclusion, which excluded papers of liver donor hepatic resections, repeat hepatectomies or meta-analyses. Data were extracted and summarized by two examiners for analysis. Results Fifty-five studies were identified with suitable reporting to assess peri-operative mortality in hepatic resections. In only 35% (19/55) of the studies was the follow-up time explicitly stated, and in 47% (26/55) of studies peri-operative mortality was limited to in-hospital or 30 days. The time period in which complications were captured was not explicitly stated in 19 out of 28 studies. The remaining studies only captured complications within 30 days of the index operation (8/28). There was a paucity of quality literature addressing truly patient-centred outcomes. Conclusion Quality outcomes after a hepatic resection are inconsistently reported in the literature. Quality outcome studies for a hepatectomy should report mortality and morbidity at a minimum of 90 days after surgery. PMID:26228262
Patient-Reported Measures of Narcolepsy: The Need for Better Assessment
Kallweit, Ulf; Schmidt, Markus; Bassetti, Claudio L.
2017-01-01
Study Objectives: Narcolepsy, a chronic disorder of the central nervous system, is clinically characterized by a symptom pentad that includes excessive daytime sleepiness, cataplexy, sleep paralysis, hypnopompic/hypnagogic hallucinations, and disrupted nighttime sleep. Ideally, screening and diagnosis instruments that assist physicians in evaluating a patient for type 1 or type 2 narcolepsy would be brief, easy for patients to understand and physicians to score, and would identify or rule out the need for electrophysiological testing. Methods: A search of the literature was conducted to review patient-reported measures used for the assessment of narcolepsy, mainly in clinical trials, with the goal of summarizing existing scales and identifying areas that may require additional screening questions and clinical practice scales. Results: Of the seven scales reviewed, the Epworth Sleepiness Scale continues to be an important outcome measure to screen adults for excessive daytime sleepiness, which may be associated with narcolepsy. Several narcolepsy-specific scales have demonstrated utility, such as the Ullanlinna Narcolepsy Scale, Swiss Narcolepsy Scale, and Narcolepsy Symptom Assessment Questionnaire, but further validation is required. Conclusions: Although the narcolepsy-specific scales currently in use may identify type 1 narcolepsy, there are no validated questionnaires to identify type 2 narcolepsy. Thus, there remains a need for short, easily understood, and well-validated instruments that can be readily used in clinical practice to distinguish narcolepsy subtypes, as well as other hypersomnias, and for assessing symptoms of these conditions during treatment. Citation: Kallweit U, Schmidt M, Bassetti CL. Patient-reported measures of narcolepsy: the need for better assessment. J Clin Sleep Med. 2017;13(5):737–744. PMID:28162143
Alexander, Angel M; Flynn, Kathryn E; Hahn, Elizabeth A; Jeffery, Diana D; Keefe, Francis J; Reeve, Bryce B; Schultz, Wesley; Reese, Jennifer Barsky; Shelby, Rebecca A; Weinfurt, Kevin P
2014-08-01
There is a significant gap in research regarding the readability and comprehension of existing sexual function measures. Patient-reported outcome measures may use terms not well understood by respondents with low literacy. This study aims to test comprehension of words and phrases typically used in sexual function measures to improve validity for all individuals, including those with low literacy. We recruited 20 men and 28 women for cognitive interviews on version 2.0 of the Patient-Reported Outcome Measurement Information System(®) (PROMIS(®) ) Sexual Function and Satisfaction measures. We assessed participants' reading level using the word reading subtest of the Wide Range Achievement Test. Sixteen participants were classified as having low literacy. In the first round of cognitive interviews, each survey item was reviewed by five or more people, at least two of whom had lower than a ninth-grade reading level (low literacy). Patient feedback was incorporated into a revised version of the items. In the second round of interviews, an additional three or more people (at least one with low literacy) reviewed each revised item. Participants with low literacy had difficulty comprehending terms such as aroused, orgasm, erection, ejaculation, incontinence, and vaginal penetration. Women across a range of literacy levels had difficulty with clinical terms like labia and clitoris. We modified unclear terms to include parenthetical descriptors or slang equivalents, which generally improved comprehension. Common words and phrases used across measures of self-reported sexual function are not universally understood. Researchers should appreciate these misunderstandings as a potential source of error in studies using self-reported measures of sexual function. This study also provides evidence for the importance of including individuals with low literacy in cognitive pretesting during the measure development. © 2014 International Society for Sexual Medicine.
Martin, T P C; Moualed, D; Paul, A; Ronan, N; Tysome, J R; Donnelly, N P; Cook, R; Axon, P R
2015-04-01
The Cambridge Otology Quality of Life Questionnaire (COQOL) is a patient-recorded outcome measurement (PROM) designed to quantify the quality of life of patients attending otology clinics. Item-reduction model. A systematically designed long-form version (74 items) was tested with patient focus groups before being presented to adult otology patients (n. 137). Preliminary item analysis tested reliability, reducing the COQOL to 24 questions. This was then presented in conjunction with the SF-36 (V1) questionnaire to a total of 203 patients. Subsequently, these were re-presented at T + 3 months, and patients recorded whether they felt their condition had improved, deteriorated or remained the same. Non-responders were contacted by post. A correlation between COQOL scores and patient perception of change was examined to analyse content validity. Teaching hospital and university psychology department. Adult patients attending otology clinics with a wide range of otological conditions. Item reliability measured by item–total correlation, internal consistency and test– retest reliability. Validity measured by correlation between COQOL scores and patient-reported symptom change. Reliability: the COQOL showed excellent internal consistency at both initial presentation (a = 0.90) and 3 months later (a = 0.93). Validity: One-way analysis of variance showed a significant difference between groups reporting change and those reporting no change in quality of life (F(2, 80) = 5.866, P < 0.01). The COQOL is the first otology-specific PROM. Initial studies demonstrate excellent reliability and encouraging preliminary criterion validity: further studies will allow a deeper validation of the instrument.
Initial constructs for patient-centered outcome measures to evaluate brain-computer interfaces.
Andresen, Elena M; Fried-Oken, Melanie; Peters, Betts; Patrick, Donald L
2016-10-01
The authors describe preliminary work toward the creation of patient-centered outcome (PCO) measures to evaluate brain-computer interface (BCI) as an assistive technology (AT) for individuals with severe speech and physical impairments (SSPI). In Phase 1, 591 items from 15 existing measures were mapped to the International Classification of Functioning, Disability and Health (ICF). In Phase 2, qualitative interviews were conducted with eight people with SSPI and seven caregivers. Resulting text data were coded in an iterative analysis. Most items (79%) were mapped to the ICF environmental domain; over half (53%) were mapped to more than one domain. The ICF framework was well suited for mapping items related to body functions and structures, but less so for items in other areas, including personal factors. Two constructs emerged from qualitative data: quality of life (QOL) and AT. Component domains and themes were identified for each. Preliminary constructs, domains and themes were generated for future PCO measures relevant to BCI. Existing instruments are sufficient for initial items but do not adequately match the values of people with SSPI and their caregivers. Field methods for interviewing people with SSPI were successful, and support the inclusion of these individuals in PCO research. Implications for Rehabilitation Adapted interview methods allow people with severe speech and physical impairments to participate in patient-centered outcomes research. Patient-centered outcome measures are needed to evaluate the clinical implementation of brain-computer interface as an assistive technology.
Ledingham, Joanna M; Snowden, Neil; Rivett, Ali; Galloway, James; Ide, Zoe; Firth, Jill; MacPhie, Elizabeth; Kandala, Ngianga; Dennison, Elaine M; Rowe, Ian
2017-02-01
Our aim was to conduct a national audit assessing the impact and experience of early management of inflammatory arthritis by English and Welsh rheumatology units. The audit enables rheumatology services to measure for the first time their performance, patient outcomes and experience, benchmarked to regional and national comparators. All individuals >16 years of age presenting to English and Welsh rheumatology services with suspected new-onset inflammatory arthritis were included in the audit. Clinician- and patient-derived outcome and patient-reported experience measures were collected. Data are presented for the 6354 patients recruited from 1 February 2014 to 31 January 2015. Ninety-seven per cent of English and Welsh trusts participated. At the first specialist assessment, the 28-joint DAS (DAS28) was calculated for 2659 (91%) RA patients [mean DAS28 was 5.0 and mean Rheumatoid Arthritis Impact of Disease (RAID) score was 5.6]. After 3 months of specialist care, the mean DAS28 was 3.5 and slightly >60% achieved a meaningful DAS28 reduction. The average RAID score and reduction in RAID score were 3.6 and 2.4, respectively. Of the working patients ages 16-65 years providing data, 7, 5, 16 and 37% reported that they were unable to work, needed frequent time off work, occasionally and rarely needed time off work due to their arthritis, respectively; only 42% reported being asked about their work. Seventy-eight per cent of RA patients providing data agreed with the statement 'Overall in the last 3 months I have had a good experience of care for my arthritis'; <2% disagreed. This audit demonstrates that most RA patients have severe disease at the time of presentation to rheumatology services and that a significant number continue to have high disease activity after 3 months of specialist care. There is a clear need for the National Health Service to develop better systems for capturing, coding and integrating information from outpatient clinics, including measures of
Mattsson, M; Boström, C; Mihai, C; Stöcker, J; Geyh, S; Stummvoll, G; Gard, G; Möller, B; Hesselstrand, R; Sandqvist, G; Draghicescu, O; Gherghe, A M; Voicu, M; Distler, O; Smolen, J S; Stamm, T A
2015-08-01
Systemic sclerosis (SSc) is an autoimmune disease where thickening of the skin can lead to reduced body function and limitations in activities. Severe forms can also affect and seriously damage inner organs. Patient-centred rehabilitation emphasises considerations of patients' background, experience and behavior which highlights the need to know if patient-reported outcome measures (PROMs) include such personal factors. To identify and describe personal factors in the experiences of functioning and health of persons with SSc and to examine if and to what extent PROMs in SSc research cover these factors. Data from a qualitative study with focus group interviews were analysed. PROMs in SSc research were identified in a literature review between 2008-2013. Participants were recruited from outpatient clinics at rheumatology department. Sixty-three patients with SSc from four European countries participated. Data from interviews were analysed using a structure of personal factors developed by Geyh et al. Identified PROMs were analysed and linked to main concepts, related to the personal factors, found in the interview data. Nineteen main concepts were related to the area "patterns of experience and behaviour" in the personal factor structure, 16 to "thoughts and beliefs", nine to "feelings", one to "motives" and one to "personal history and biography", respectively. Among the 35 PROMs identified, 15 did not cover any of the identified concepts. Concepts within the area "feelings" were mostly covered by the PROMs. Five of the PROMs covered "patterns of experience and behaviour", while "motives" and "personal history and biography" were not covered at all. Four of the identified PROMs covered concepts within the areas "feelings", "thoughts and beliefs" and "patterns of experience and behaviour" in the same instrument. The Illness Cognition Questionnaire and Illness Behaviour Questionnaire were such PROMs. Patterns of experience and behaviour had the highest number of
Charles, Edmund R; Kumar, Vinod; Blacknall, James; Edwards, Kimberley; Geoghegan, John M; Manning, Paul A; Wallace, W Angus
2017-10-01
Patients with acromioclavicular joint (ACJ) and sternoclavicular joint (SCJ) injuries and with clavicle fractures are typically younger and more active than those with other shoulder pathologies. We developed the Nottingham Clavicle Score (NCS) specifically for this group of patients to improve sensitivity for assessing the outcomes of treatment of these conditions compared with the more commonly used Constant Score (CS) and Oxford Shoulder Score (OSS). This was a cohort study in which the preoperative and 6-month postoperative NCS evaluations of outcome in 90 patients were compared with the CS, OSS, Imatani Score (IS), and the EQ-5D scores. Reliability was assessed using the Cronbach α. Reproducibility of the NCS was assessed using the test/retest method. Effect sizes were calculated for each score to assess sensitivity to change. Validity was examined by correlations between the NCS and the CS, OSS, IS, and EQ-5D scores obtained preoperatively and postoperatively. Significant correlations were demonstrated preoperatively with the OSS (P = .025) and all subcategories of the EQ-5D (P < .05) and postoperatively with the OSS (P < .001), CS (P = .008), IS (P < .001), and all subcategories of EQ-5D (P < .02). The NCS had the largest effect size (1.92) of the compared scores. Internal consistency was excellent (Cronbach α = 0.87). The NCS has been proven to be a valid, reliable and sensitive outcome measure that accurately measures the level of function and disability in the ACJ, SCJ and clavicle after traumatic injury and in degenerative disease. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Jensen, Roxanne E; Snyder, Claire F; Basch, Ethan; Frank, Lori; Wu, Albert W
2016-01-01
In recent years, patient-reported outcomes have become increasingly collected and integrated into electronic health records. However, there are few cross-cutting recommendations and limited guidance available in this rapidly developing research area. Our goal is to report key findings from a 2013 Patient-Centered Outcomes Research Institute workshop on this topic and a summary of actions that followed from the workshop, and present resulting recommendations that address patient, clinical and research/quality improvement barriers to regular use. These findings provide actionable guidance across research and practice settings to promote and sustain widespread adoption of patient-reported outcomes across patient populations, healthcare settings and electronic health record systems. PMID:27586855
Jensen, Roxanne E; Snyder, Claire F; Basch, Ethan; Frank, Lori; Wu, Albert W
2016-11-01
In recent years, patient-reported outcomes have become increasingly collected and integrated into electronic health records. However, there are few cross-cutting recommendations and limited guidance available in this rapidly developing research area. Our goal is to report key findings from a 2013 Patient-Centered Outcomes Research Institute workshop on this topic and a summary of actions that followed from the workshop, and present resulting recommendations that address patient, clinical and research/quality improvement barriers to regular use. These findings provide actionable guidance across research and practice settings to promote and sustain widespread adoption of patient-reported outcomes across patient populations, healthcare settings and electronic health record systems.
Emerson, Lingamdenne Paul; Job, Anand; Abraham, Vinod
2013-01-01
Hearing loss is a major handicap in developing countries with paucity of trained audiologists and limited resources. In this pilot study trained community health workers were used to provide comprehensive hearing aid services in the community. One hundred and eleven patients were fitted with semi-digital hearing aid and were evaluated over a period of six months. They were assessed using self-report outcome measure APHAB. Results show that trained CHWs are effective in detecting disabling hearing loss and in providing HAs. APHAB can identify and pick up significant improvements in communication in daily activities and provides a realistic expectation of the benefits of a hearing aid. The model of using trained CHWs to provide rehabilitative services in audiology along with self-report outcome measures can be replicated in other developing countries. PMID:23724277
Hutchings, Andrew; Grosse Frie, Kirstin; Neuburger, Jenny; van der Meulen, Jan; Black, Nick
2013-02-01
Nonresponse to patient-reported outcome (PRO) questionnaires after surgery might bias the results. Our aim was to gauge the potential impact of nonresponse bias by comparing the outcomes of early and late responders. This study compares 59,565 early and 20,735 late responders who underwent a hip or knee replacement, hernia repair, or varicose vein (VV) surgery. The association between timeliness of response and three outcomes (the mean postoperative disease-specific PRO and generic PRO scores and the proportion reporting a fair or poor result) was examined by regression analysis. Late responders were slightly more likely to be young, nonwhite, deprived, and have a more severe preoperative condition with poorer quality of life. Late response was associated with a slightly poorer outcome in all four procedures although not statistically significant (P < 0.05) for VV surgery. Adjusting for preoperative characteristics reduced the strength of the associations, but they remained statistically significant. As nonresponse to PRO questionnaires introduces slight bias, differences in response rates between hospitals should be taken into account when making comparisons so as to avoid overestimating the performance of those with lower response rates and failing to detect poor performing hospitals. Copyright © 2013 Elsevier Inc. All rights reserved.
Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016.
Sreih, Antoine G; Alibaz-Oner, Fatma; Kermani, Tanaz A; Aydin, Sibel Z; Cronholm, Peter F; Davis, Trocon; Easley, Ebony; Gul, Ahmet; Mahr, Alfred; McAlear, Carol A; Milman, Nataliya; Robson, Joanna C; Tomasson, Gunnar; Direskeneli, Haner; Merkel, Peter A
2017-12-01
Among the challenges in conducting clinical trials in large-vessel vasculitis (LVV), including both giant cell arteritis (GCA) and Takayasu arteritis (TA), is the lack of standardized and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group initiated an international effort to develop and validate data-driven outcome tools for clinical investigation in LVV. An international Delphi exercise was completed to gather opinions from clinical experts on LVV-related domains considered important to measure in trials. Patient interviews and focus groups were completed to identify outcomes of importance to patients. The results of these activities were presented and discussed in a "Virtual Special Interest Group" using telephone- and Internet-based conferences, discussions through electronic mail, and an in-person session at the 2016 OMERACT meeting. A preliminary core set of domains common for all forms of LVV with disease-specific elements was proposed. The majority of experts agree with using common outcome measures for GCA and TA, with the option of supplementation with disease-specific items. Following interviews and focus groups, pain, fatigue, and emotional effect emerged as health-related quality of life domains important to patients. Current disease assessment tools, including the Birmingham Vasculitis Activity Score, were found to be inadequate to assess disease activity in GCA and standardized assessment of imaging tests were felt crucial to study LVV, especially TA. Initial data from a clinician Delphi exercise and structured patient interviews have provided themes toward an OMERACT-endorsed core set of domains and outcome measures.
Counting seizures: The primary outcome measure in epileptology from the patients' perspective.
Blachut, Barbara; Hoppe, Christian; Surges, Rainer; Stahl, Jutta; Elger, Christian E; Helmstaedter, Christoph
2015-07-01
Patient-reported seizure counts represent a key outcome measure for individual treatments and clinical studies in epileptology. Video-EEG based research, however, demonstrated lack of validity due to underreporting. Here we examined the practice of keeping seizure diaries and the patients' attitudes toward seizure counting. Anticipating a low return rate, a comprehensive survey was mailed to 1100 adult outpatients. Besides methods and reasons to document or not to document seizures, the questionnaire addressed clinical, personality and sociodemographic characteristics as well as the subjective experience of seizures. Questionnaires from 170 patients (15%) could be included in our analysis. Patients estimated to be aware of 5.3 out of 10 daytime seizures (nocturnal seizures: 2.6) while they supposed that relatives/colleagues noticed 7.1 (nocturnal: 4.6). Almost two-thirds of the patients reported to keep a seizure diary with a self-estimated documentation rate of 8.7 out of 10 noticed daytime seizures (nocturnal: 7.7). Documenters and non-documenters showed only marginal group differences with regard to clinical, personality and sociodemographic characteristics. Importantly, patients were more committed to keep a seizure diary when they judged it to be relevant for clinical treatment decisions. Patients appear to know that they underreport seizures. According to their view, seizure unawareness as induced by seizures themselves seems to be a more important factor than omitting documentation of noticed seizures. Thus, the potential to improve the validity of seizure diaries of electronic devices which facilitate documenting noticed seizures appears limited. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
ERIC Educational Resources Information Center
Hula, William D.; Doyle, Patrick J.; Stone, Clement A.; Hula, Shannon N. Austermann; Kellough, Stacey; Wambaugh, Julie L.; Ross, Katherine B.; Schumacher, James G.; St. Jacque, Ann
2015-01-01
Purpose: The purpose of this study is to investigate the structure and measurement properties of the Aphasia Communication Outcome Measure (ACOM), a patient-reported outcome measure of communicative functioning for persons with aphasia. Method: Three hundred twenty-nine participants with aphasia responded to 177 items asking about communicative…
Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C
2017-10-01
To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work
2013-01-01
Background Dupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment. Methods A literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren’s disease where outcomes had been monitored using functional measures. Results Ninety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years. Conclusions There is little consistency in the reporting of outcomes for interventions in patients with Dupuytren’s disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren’s disease tends to recur
Boyce, Maria B; Browne, John P; Greenhalgh, Joanne
2014-06-27
The use of patient-reported outcome measures (PROMs) to provide healthcare professionals with peer benchmarked feedback is growing. However, there is little evidence on the opinions of professionals on the value of this information in practice. The purpose of this research is to explore surgeon's experiences of receiving peer benchmarked PROMs feedback and to examine whether this information led to changes in their practice. This qualitative research employed a Framework approach. Semi-structured interviews were undertaken with surgeons who received peer benchmarked PROMs feedback. The participants included eleven consultant orthopaedic surgeons in the Republic of Ireland. Five themes were identified: conceptual, methodological, practical, attitudinal, and impact. A typology was developed based on the attitudinal and impact themes from which three distinct groups emerged. 'Advocates' had positive attitudes towards PROMs and confirmed that the information promoted a self-reflective process. 'Converts' were uncertain about the value of PROMs, which reduced their inclination to use the data. 'Sceptics' had negative attitudes towards PROMs and claimed that the information had no impact on their behaviour. The conceptual, methodological and practical factors were linked to the typology. Surgeons had mixed opinions on the value of peer benchmarked PROMs data. Many appreciated the feedback as it reassured them that their practice was similar to their peers. However, PROMs information alone was considered insufficient to help identify opportunities for quality improvements. The reasons for the observed reluctance of participants to embrace PROMs can be categorised into conceptual, methodological, and practical factors. Policy makers and researchers need to increase professionals' awareness of the numerous purposes and benefits of using PROMs, challenge the current methods to measure performance using PROMs, and reduce the burden of data collection and information
Abola, Ramon E; Bennett-Guerrero, Elliott; Kent, Michael L; Feldman, Liane S; Fiore, Julio F; Shaw, Andrew D; Thacker, Julie K M; Gan, Tong J; Miller, Timothy E; Hedrick, Traci L; McEvoy, Matthew D; Mythen, Michael G; Bergamaschi, Roberto; Gupta, Ruchir; Holubar, Stefan D; Senagore, Anthony J; Wischmeyer, Paul E; Carli, Franco; Evans, David C; Guilbert, Sarah; Kozar, Rosemary; Pryor, Aurora; Thiele, Robert H; Everett, Sotiria; Grocott, Mike
2018-06-01
Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using
Use of standardized outcome measures in physical therapist practice: perceptions and applications.
Jette, Diane U; Halbert, James; Iverson, Courtney; Miceli, Erin; Shah, Palak
2009-02-01
Standardized instruments for measuring patients' activity limitations and participation restrictions have been advocated for use by rehabilitation professionals for many years. The available literature provides few recent reports of the use of these measures by physical therapists in the United States. The primary purpose of this study was to determine: (1) the extent of the use of standardized outcome measures and (2) perceptions regarding their benefits and barriers to their use. A secondary purpose was to examine factors associated with their use among physical therapists in clinical practice. The study used an observational design. A survey questionnaire comprising items regarding the use and perceived benefits and barriers of standardized outcome measures was sent to 1,000 randomly selected members of the American Physical Therapy Association (APTA). Forty-eight percent of participants used standardized outcome measures. The majority of participants (>90%) who used such measures believed that they enhanced communication with patients and helped direct the plan of care. The most frequently reported reasons for not using such measures included length of time for patients to complete them, length of time for clinicians to analyze the data, and difficulty for patients in completing them independently. Use of standardized outcome measures was related to specialty certification status, practice setting, and the age of the majority of patients treated. The limitations included an unvalidated survey for data collection and a sample limited to APTA members. Despite more than a decade of development and testing of standardized outcome measures appropriate for various conditions and practice settings, physical therapists have some distance to go in implementing their use routinely in most clinical settings. Based on the perceived barriers, alterations in practice management strategies and the instruments themselves may be necessary to increase their use.
Measuring Quality and Outcomes in Sports Medicine.
Ruzbarsky, Joseph J; Marom, Niv; Marx, Robert G
2018-07-01
Patient-reported outcome measures (PROMs) are objective metrics critical to evaluating outcomes throughout orthopedic surgery. New instruments continue to emerge, increasing the breadth of information required for those intending to use these measures for research or clinical care. Although earlier metrics were developed using the principles of classic test theory, newer instruments constructed using item response theory are amenable to computer-adaptive testing and may change the way these instruments are administered. This article aims to define the psychometric properties that are important to understand when using all PROMs and to review the most widely used instruments in sports medicine. Copyright © 2018 Elsevier Inc. All rights reserved.
Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John
2013-01-01
Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
Schmitt, Jochen; Apfelbacher, Christian; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric L; Furue, Masutaka; Chalmers, Joanne; Williams, Hywel C
2015-01-01
Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.
Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A
2016-04-01
Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.
Alcantara, Joel; Nazarenko, Andrea Lamont; Ohm, Jeanne; Alcantara, Junjoe
2018-01-01
To quantify the quality of life (QoL) and visit-specific satisfaction of pregnant women. A prospective cohort within a practice-based research network (PBRN). Setting/Locations: Individual chiropractic offices. Pregnant women (age ≥18 years) attending chiropractic care. Chiropractic care (i.e., The Webster Technique, spinal adjustments, and adjunctive therapies). The RAND VSQ9 to measure visit-specific satisfaction and the Patient Reported Outcomes Measurement Information System (PROMIS ® )-29 to measure QoL. A convenience sample of 343 pregnant patients (average age = 30.96 years) comprised their study population. They were highly educated with 75% attaining a 2-year associate's degree or higher. The pregnant patients presented for chiropractic care with a mean week of gestation of 25.67 weeks (median = 28 weeks; range = 0-42 weeks) and parity (i.e., the number of live births) of 0.92 live births (median = 1; range = 0-6). From baseline (i.e., at study entrance with minimum first visit) and comparative (i.e., following a course of chiropractic care), the VSQ9 measurements revealed increasingly high satisfaction on the part of the subjects (i.e., the mean difference of baseline minus comparative measures = -0.7322; p < 0.005). The median number of visits (i.e., visits attended) at baseline and comparative measures was 1.00 (standard deviation [SD] = 22.69) and 3.30 (SD = 22.71), respectively. Across outcomes, QoL improved from baseline to comparative measurement after holding constant for visit number and time lapse, trimester of pregnancy, and care provider type. There was a reduction in mean T scores associated with fatigue (p < 0.05), pain interference (p < 0.05), sleep disturbance (p < 0.05), and an improvement in satisfaction with social roles (p < 0.05). A significant decrease was also found with pain interference (p < 0.05). No evidence was found that anxiety (p = 0.1404) or depression (p = 0
Hawkins, Melanie; Elsworth, Gerald R; Osborne, Richard H
2018-07-01
Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context. This paper proposes the application of contemporary validity theory and methodology to PROM validity testing. The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ). Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.
Palmer, Michael J; Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie; Richardson, Harriet; Brundage, Michael
2018-02-01
Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review. Two databases (MEDLINE and CINAHL) were searched from inception to March 2015 for English articles. Inclusion criteria were (a) relevant to patient-reported outcomes, (b) discussed missing data or compliance in prospective medical studies, and (c) examined predictors or causes of missing data, including reasons identified in actual trial datasets and reported on cover sheets. Two reviewers independently screened titles and abstracts. Discrepancies were discussed with the research team prior to finalizing the list of eligible papers. In completing the systematic review, four particular challenges to synthesizing the extracted information were identified. To address these challenges, operational principles were established by consensus to guide the development of the Classification Framework. A total of 6027 records were screened. In all, 100 papers were eligible and included in the review. Of these, 57% focused on cancer, 23% did not specify disease, and 20% reported for patients with a variety of non-cancer conditions. In total, 40% of the papers offered a descriptive analysis of possible factors associated with missing data, but some papers used other methods. In total, 663 excerpts of text (units), each describing a factor associated with missing patient-reported outcome data, were extracted verbatim. Redundant units were identified and sequestered. Similar units were grouped, and an iterative process of consensus among the investigators was used to reduce these units to a
Westin, Olof; Nilsson Helander, Katarina; Grävare Silbernagel, Karin; Samuelsson, Kristian; Brorsson, Annelie; Karlsson, Jón
2018-04-24
The aim of this study was to perform a long-term follow-up of patients treated for an Achilles tendon re-rupture, using established outcome measurements for tendon structure, lower extremity function and symptoms, and to compare the results with those for the uninjured side. A secondary aim was to compare the outcome with that of patients treated for primary ruptures. The hypotheses were that patients with a re-rupture recover well, and have similar long-term outcome as primary ruptures. Twenty patients (4 females) with a mean (SD) age of 44 (10.9) years, ranging from 24 to 64, were included. The patients were identified by reviewing the medical records of all Achilles tendon ruptures at Sahlgrenska University Hospital and Kungsbacka Hospital, Sweden, between 2006 and 2016. All patients received standardised surgical treatment and rehabilitation. The mean (SD) follow-up was 51 (38.1) months. A test battery of validated clinical and functional tests, patient-reported outcome measurements and measurements of tendon elongation were performed at the final follow-up. This cohort was then compared with the 2-year follow-up results from a previous randomised controlled trial of patients treated for primary Achilles tendon rupture. There were deficits on the injured side compared with the healthy side in terms of heel-rise height (11.9 versus 12.5 cm, p = 0.008), repetitions (28.5 versus 31.7, p = 0.004) and drop-jump height (13.2 versus 15.1 cm, p = 0.04). There was a significant difference in calf circumference (37.1 versus 38.4 cm, p =< 0.001) and ankle dorsiflexion on the injured side compared with the healthy side (35.3° versus 40.8°, p = 0.003). However, no significant differences were found in terms of tendon length 22.5 (2.5) cm on the injured side and 21.8 (2.8) cm on the healthy side. Compared with primary ruptures, the re-rupture cohort obtained significantly worse results for the Achilles tendon total rupture score, with a mean of
Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E; Johnston, Kelly L; Lawrence, Suzanne M; Hilton, Thomas F; Daley, Dennis C; Patkar, Ashwin A; McCarty, Dennis
2017-08-01
There is a need to monitor patients receiving prescription opioids to detect possible signs of abuse. To address this need, we developed and calibrated an item bank for severity of abuse of prescription pain medication as part of the Patient-Reported Outcomes Measurement Information System (PROMIS ® ). Comprehensive literature searches yielded an initial bank of 5,310 items relevant to substance use and abuse, including abuse of prescription pain medication, from over 80 unique instruments. After qualitative item analysis (i.e., focus groups, cognitive interviewing, expert review, and item revision), 25 items for abuse of prescribed pain medication were included in field testing. Items were written in a first-person, past-tense format, with a three-month time frame and five response options reflecting frequency or severity. The calibration sample included 448 respondents, 367 from the general population (ascertained through an internet panel) and 81 from community treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network. A final bank of 22 items was calibrated using the two-parameter graded response model from item response theory. A seven-item static short form was also developed. The test information curve showed that the PROMIS ® item bank for abuse of prescription pain medication provided substantial information in a broad range of severity. The initial psychometric characteristics of the item bank support its use as a computerized adaptive test or short form, with either version providing a brief, precise, and efficient measure relevant to both clinical and community samples. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
Ford, Catherine Elaine Longworth; Malley, Donna; Bateman, Andrew; Clare, Isabel C.H.; Wagner, Adam P.; Gracey, Fergus
2016-01-01
Background Outcome measurement challenges rehabilitation services to select tools that promote stakeholder engagement in measuring complex interventions. Objectives To examine the suitability of outcome measures for complex post-acute acquired brain injury (ABI) rehabilitation interventions, report outcomes of a holistic, neuropsychological ABI rehabilitation program and propose a simple way of visualizing complex outcomes. Methods Patient/carer reported outcome measures (PROMS), experience measures (PREMS) and staff-rated measures were collected for consecutive admissions over 1 year to an 18-week holistic, neuropsychological rehabilitation programme at baseline, 18 weeks and 3- and 6-month follow-up. Results Engagement with outcome measurement was poorest for carers and at follow-up for all stakeholders. Dependence, abilities, adjustment, unmet needs, symptomatology including executive dysfunction, and self-reassurance showed improvements at 18 weeks. Adjustment, social participation, perceived health, symptomatology including dysexecutive difficulties, and anxiety were worse at baseline for those who did not complete rehabilitation, than those who did. A radar plot facilitated outcome visualization. Conclusions Engagement with outcome measurement was best when time and support were provided. Supplementing patient- with staff-rated and attendance measures may explain missing data and help quantify healthcare needs. The MPAI4, EBIQ and DEX-R appeared suitable measures to evaluate outcomes and distinguish those completing and not completing neuropsychological rehabilitation. PMID:27341362
Comparison of clinician-predicted to measured low vision outcomes.
Chan, Tiffany L; Goldstein, Judith E; Massof, Robert W
2013-08-01
To compare low-vision rehabilitation (LVR) clinicians' predictions of the probability of success of LVR with patients' self-reported outcomes after provision of usual outpatient LVR services and to determine if patients' traits influence clinician ratings. The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre-and post-LVR to 316 low-vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression, and cognitive status. After patient evaluation, 38 LVR clinicians estimated the probability of outcome success (POS) using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients' baseline traits on predicted outcomes. A regression analysis with a hierarchical random-effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates that the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed-effects regression models show that POS ratings are associated with information about the patient's cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Clinicians' predictions of LVR outcomes seem to be influenced by knowledge of patients' cognitive functioning and the combination of visual acuity and functional ability-information clinicians acquire from the patient's history and examination. However, clinicians' predictions do not agree with observed
Gelfand, Joel M; Kimball, Alexa B; Mostow, Eliot N; Chiou, Chiun-Fang; Patel, Vaishali; Xia, H Amy; Freundlich, Bruce; Stevens, Seth R
2008-01-01
The 24-week Etanercept Assessment of Safety and Effectiveness (EASE) study evaluated the effectiveness and tolerability of continuous versus interrupted etanercept treatment in patients with moderate to severe plaque psoriasis. The objective of this analysis was to assess patient-reported outcomes (PROs) and health-care resource utilization (HRU) data from the EASE study. Patients received open-label etanercept 50 mg twice weekly for 12 weeks and then received either continued or interrupted (single round of discontinuation and re-treatment with etanercept) etanercept 50 mg once weekly for the second 12 weeks. PROs included the following: 1) the patient global assessments of psoriasis, joint pain, and itching scores; 2) the Dermatology Life Quality Index; 3) the Medical Outcomes Study Short Form 36 vitality domain; 4) the Beck Depression Inventory; 5) the European Quality-of-Life Group Feeling Thermometer; and 6) a patient satisfaction survey. HRU was evaluated using the Economic Implications of Psoriasis patient questionnaire. Continuous treatment with etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks produced sustained and clinically important improvements in PROs and reductions in HRU. Reductions in some outcome measures after treatment discontinuation at week 12 were observed in the interrupted group; however, most changes did not revert to baseline levels, consistent with some residual clinical effect, and re-treatment produced improvements similar to week 12 levels. Continuous etanercept treatment provided greater sustained improvements in PROs than interrupted therapy; however, interrupting etanercept therapy, if needed, has predictable and manageable effects.
Outcome-Reporting Bias in Education Research
ERIC Educational Resources Information Center
Pigott, Therese D.; Valentine, Jeffrey C.; Polanin, Joshua R.; Williams, Ryan T.; Canada, Dericka D.
2013-01-01
Outcome-reporting bias occurs when primary studies do not include information about all outcomes measured in a study. When studies omit findings on important measures, efforts to synthesize the research using systematic review techniques will be biased and interpretations of individual studies will be incomplete. Outcome-reporting bias has been…
Nuttall, David; Parkin, David; Devlin, Nancy
2015-01-01
This paper describes the development of a methodology for the case-mix adjustment of patient-reported outcome measures (PROMs) data permitting the comparison of outcomes between providers on a like-for-like basis. Statistical models that take account of provider-specific effects form the basis of the proposed case-mix adjustment methodology. Indirect standardisation provides a transparent means of case mix adjusting the PROMs data, which are updated on a monthly basis. Recently published PROMs data for patients undergoing unilateral knee replacement are used to estimate empirical models and to demonstrate the application of the proposed case-mix adjustment methodology in practice. The results are illustrative and are used to highlight a number of theoretical and empirical issues that warrant further exploration. For example, because of differences between PROMs instruments, case-mix adjustment methodologies may require instrument-specific approaches. A number of key assumptions are made in estimating the empirical models, which could be open to challenge. The covariates of post-operative health status could be expanded, and alternative econometric methods could be employed. © 2013 Crown copyright.
Chung, Hyewon; Kim, Jiseon; Cook, Karon F; Askew, Robert L; Revicki, Dennis A; Amtmann, Dagmar
2014-02-01
In order to test the difference between group means, the construct measured must have the same meaning for all groups under investigation. This study examined the measurement invariance of responses to the patient-reported outcomes measurement information system (PROMIS) pain behavior (PB) item bank in two samples: the PROMIS calibration sample (Wave 1, N = 426) and a sample recruited from the American Chronic Pain Association (ACPA, N = 750). The ACPA data were collected to increase the number of participants with higher levels of pain. Multi-group confirmatory factor analysis (MG-CFA) and two item response theory (IRT)-based differential item functioning (DIF) approaches were employed to evaluate the existence of measurement invariance. MG-CFA results supported metric invariance of the PROMIS-PB, indicating unstandardized factor loadings with equal across samples. DIF analyses revealed that impact of 6 DIF items was negligible. Based on the results of both MG-CFA and IRT-based DIF approaches, we recommend retaining the original parameter estimates obtained from the combined samples based on the results of MG-CFA.
Alternatives to Traditional EMS Dispatch and Transport: A Scoping Review of Reported Outcomes.
Jensen, Jan L; Carter, Alix J E; Rose, Jennifer; Visintini, Sarah; Bourdon, Emmanuelle; Brown, Ryan; McVey, Jennifer; Travers, Andrew H
2015-09-01
Emergency medical services (EMS) programs, which provide an alternative to traditional EMS dispatch or transport to the emergency department (ED), are becoming widely implemented. This scoping review identified and catalogued all outcomes used to measure such alternative EMS programs. Data Source Broad systematized bibliographic and grey literature searches were conducted. Study Selection Inclusion criteria were 911 callers/EMS patients, reported on alternatives to traditional EMS dispatch OR traditional EMS transport to the ED, and reported an outcome measure. Data Extraction The reports were categorized as either alternative to dispatch or to EMS transport, and outcome measures were categorized and described. Data Synthesis The bibliographic search retrieved 13,215 records, of which 34 articles met the inclusion criteria, with an additional 10 added from reference list hand-searching (n=44 included). In the grey literature search, 31 websites were identified, from which four met criteria and were retrieved (n=4 included). Fifteen reports (16 studies) described alternatives to EMS dispatch, and 33 reports described alternatives to EMS transport. The most common outcomes reported in the alternatives to EMS dispatch reports were service utilization and decision accuracy. Twenty-four different specific outcomes were reported. The most common outcomes reported in the alternatives to EMS transport reports were service utilization and safety, and 50 different specific outcomes were reported. Numerous outcome measures were identified in reports of alternative EMS programs, which were catalogued and described. Researchers and program leaders should achieve consensus on uniform outcome measures, to allow benchmarking and improve comparison across programs.
Patient-reported Outcomes in a French Nationwide Survey of Inflammatory Bowel Disease Patients.
Williet, Nicolas; Sarter, Hélène; Gower-Rousseau, Corinne; Adrianjafy, Charlotte; Olympie, Alain; Buisson, Anne; Beaugerie, Laurent; Peyrin-Biroulet, Laurent
2017-02-01
Patient reported-outcomes [PROs] are a major therapeutic goal in inflammatory bowel disease [IBD]. Between January and June 2014, patients affiliated with the French national IBD association filled out six self-questionnaires: quality of life 9QoL, according to the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] and the Short-Form-36 Questionnaire [SF-36] v2); fatigue (the Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]); work productivity (the Work Productivity and Activity Impairment [WPAI] questionnaire); disability [the I nflammatory Bowel Disease Disability Index]; and anxiety/depression (the Hospital Anxiety and Depression scale [HADS]). Associated factors were identified by univariate and multivariate logistic regression analyses. Datasets were obtained from 1185 IBD patients. Around half of patients reported poor QoL [SIBDQ <45: 53.3%], severe fatigue [FACIT-F <30: 47.4%] and/or depression [HAD-D >7: 49.4%]. One-third of the patients reported anxiety [HAD-A >7: 30.3%] and/or moderate [22.4%] or severe [11.9%] disability. About half of them reported presenteeism and moderate-to-severe loss of work productivity and loss of activity. Poor QoL, severe fatigue, severe disease-related disability, and/or high WPAI were all associated with female gender, unemployment, and disease activity. Poor QoL, severe fatigue, and high WPAI were also associated with the use of tumour necrosis factor antagonists. A history of surgery was associated with poor QoL, whereas age was associated with severe fatigue. Severe depression was associated with female gender and disease activity. The disease burden is very high in IBD, with poor QoL, fatigue, work impairment, and depression in half of patients. Marked disability and anxiety were reported by one-third of patients. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Changes in Patient and Nurse Outcomes Associated with Magnet Hospital Recognition
Kutney-Lee, Ann; Stimpfel, Amy Witkoski; Sloane, Douglas M.; Cimiotti, Jeannie P.; Quinn, Lisa W.; Aiken, Linda H.
2015-01-01
Background Research has documented an association between Magnet hospitals and better outcomes for nurses and patients. However, little longitudinal evidence exists to support a causal link between Magnet recognition and outcomes. Objective To compare changes over time in surgical patient outcomes, nurse-reported quality, and nurse outcomes in a sample of hospitals that attained Magnet recognition between 1999 and 2007 with hospitals that remained non-Magnet. Research Design Retrospective, two-stage panel design using four secondary data sources. Subjects 136 Pennsylvania hospitals (11 “emerging” Magnets and 125 non-Magnets) Measures American Nurses Credentialing Center Magnet recognition; risk-adjusted rates of surgical 30-day mortality and failure-to-rescue, nurse-reported quality measures, and nurse outcomes; the Practice Environment Scale of the Nursing Work Index Methods Fixed effects difference models were used to compare changes in outcomes between emerging Magnet hospitals and hospitals that remained non-Magnet. Results Emerging Magnet hospitals demonstrated markedly greater improvements in their work environments than other hospitals. On average, the changes in 30-day surgical mortality and failure-to-rescue rates over the study period were more pronounced in emerging Magnet hospitals than in non-Magnet hospitals, by 2.4 fewer deaths per 1000 patients (p<.01) and 6.1 fewer deaths per 1000 patients (p=0.02), respectively. Similar differences in the changes for emerging Magnet hospitals and non-Magnet hospitals were observed in nurse-reported quality of care and nurse outcomes. Conclusions In general, Magnet recognition is associated with significant improvements over time in the quality of the work environment, and in patient and nurse outcomes that exceed those of non-Magnet hospitals. PMID:25906016
McGirt, Matthew J; Parker, Scott L; Mummaneni, Praveen; Knightly, John; Pfortmiller, Deborah; Foley, Kevin; Asher, Anthony L
2017-07-01
Over the last decade, clinical investigators and biomedical industry groups have used significant resources to develop advanced technologies that enable less invasive spine fusions. These minimally invasive surgery (MIS) technologies often require increased expenditures by hospitals and payers. Although several small single center studies have suggested MIS technologies decrease surgical morbidity and reduce hospital stay, evidence documenting benefit from a patient perspective remains limited. Furthermore, MIS outcomes have yet to be evaluated from the perspective of multiple practice types representing the broad spectrum of US spine surgery. This study aimed to examine a population of patients who underwent one- or two-level interbody lumbar fusion diagnosed with lumbar stenosis or Grade 1 spondylolisthesis in an observational, prospective national registry for the purposes of determining how MIS and traditional open technologies affect postsurgical and patient-reported outcomes (PROs). This study used observational analysis of prospectively collected data. The sample consisted of cases from the National Neurosurgery Quality and Outcomes Database (N 2 QOD). Numeric rating scale for back and leg pain, Oswestry Disability Index, EuroQol-5D, return to work, and perioperative morbidity were the outcome measures. The N 2 QOD is a prospective PROs registry enrolling patients undergoing elective spine surgery from 60 hospitals in 27 US states via representative sampling. We analyzed the N 2 QOD aggregate dataset (2010-2014) to identify one- and two-level lumbar interbody fusion procedures performed for lumbar stenosis or Grade 1 spondylolisthesis with 12 months' follow-up where surgical instrumentation and implant types were clearly identified. Perioperative and 1-year outcomes were compared between cases performed with MIS enabling technologies versus traditional open technologies before and after propensity matching. There were 467 (24%) patients who underwent
Jo, Ayami; Kanazawa, Manabu; Sato, Yusuke; Iwaki, Maiko; Akiba, Norihisa; Minakuchi, Shunsuke
2015-08-01
To compare the effect of conventional complete dentures (CD) fabricated using two different impression methods on patient-reported outcomes in a randomized controlled trial (RCT). A cross-over RCT was performed with edentulous patients, required maxillomandibular CDs. Mandibular CDs were fabricated using two different methods. The conventional method used a custom tray border moulded with impression compound and a silicone. The simplified used a stock tray and an alginate. Participants were randomly divided into two groups. The C-S group had the conventional method used first, followed by the simplified. The S-C group was in the reverse order. Adjustment was performed four times. A wash out period was set for 1 month. The primary outcome was general patient satisfaction, measured using visual analogue scales, and the secondary outcome was oral health-related quality of life, measured using the Japanese version of the Oral Health Impact Profile for edentulous (OHIP-EDENT-J) questionnaire scores. Twenty-four participants completed the trial. With regard to general patient satisfaction, the conventional method was significantly more acceptable than the simplified. No significant differences were observed between the two methods in the OHIP-EDENT-J scores. This study showed CDs fabricated with a conventional method were significantly more highly rated for general patient satisfaction than a simplified. CDs, fabricated with the conventional method that included a preliminary impression made using alginate in a stock tray and subsequently a final impression made using silicone in a border moulded custom tray resulted in higher general patient satisfaction. UMIN000009875. Copyright © 2015 Elsevier Ltd. All rights reserved.
Outcome measurement in Australian rehabilitation environments.
Douglas, Heather; Swanson, Cheryl; Gee, Travis; Bellamy, Nicholas
2005-09-01
To determine the frequency and pattern of methods of outcome assessment used in Australian physical rehabilitation environments. Postal survey. A questionnaire on service type, staffing, numbers of adults treated and outcome measures used for 7 conditions related to injury and road trauma as well as stroke and neuromuscular disorders was sent to 973 services providing adult physical rehabilitation treatment. Questionnaires were completed by 440 service providers for a response rate of 45%, similar to that reported in a recent European survey reported in this journal. A small number of measures were reported as in use by most respondents, while a large number of measures were used by a few respondents. Measures of physical changes were used more frequently than those of generic well-being or quality of life. Ease of use and reporting to other professionals were cited as the most important reasons in selection of outcome measures. This Australian-wide survey detected considerable heterogeneity in outcome measurement procedures used in rehabilitation environments. While the goal of measurement may vary between providers and differ between conditions, the results highlight opportunities for harmonization, bench-marking and measurement of health-related quality of life.
Winters, Zoë Ellen; Benson, John R; Pusic, Andrea L
2010-12-01
) and II (n = 11) evidence. While these studies benefited from more robust design, the majority used generic instruments such as 36-item short form (SF-36), which may not be sufficiently sensitive to measure changes consequent to breast reconstruction (ie, effect on body image or psychosocial well-being). Furthermore, these studies were generally underpowered to detect meaningful clinical difference or to permit subgroup analyses. Further limitations included reliance on single center design that may negatively impact generalizability and deficiencies in reporting the number and types of surgical complications, which potentially has an effect on HRQoL outcomes. This systematic review reveals tendency for sound scientific methodology in HRQoL to be undermined by poorly designed and underpowered studies. In the current healthcare environment, patients and providers increasingly seek meaningful data to guide clinical decisions; policy makers are similarly in need of a rigorous patient-centered, comparative effectiveness data to inform national level decision-making. In light of this and the limitations of the existing published data, there is a pressing need for further Level I and II evidence in the form of randomized controlled trials as well as well-designed, multicenter prospective longitudinal studies in breast reconstruction. Such studies should incorporate sensitive and condition-specific patient-report outcome measures, provide adequate sample sizes, and respect established guidelines for rigorous HRQoL methodology.
2013-01-01
Background Involving patients in treatment is becoming increasingly popular in mental health [Sales & Alves: Personalized evaluation of psychological treatments: A review of tools and research designs, submitted]. However, in substance misuse treatment settings, the patient perspective about treatment tends to be overlooked. This has been cited as a key priority by Orford et al. [Addiction, 103: 875-885, 2008] who included patient feedback about treatment as one of ten areas requiring an urgent paradigm shift in addiction research and practice. This project will apply an innovative method to involve substance misuse patients in psychological therapies, by asking them to suggest topics to evaluate their treatment. These topics suggested by patients can be written as a list of personalised items, so-called as patient-generated outcome measures (PGOM). Despite its patient-friendly features, PGOM’s have never been used in this population, which is what this project aims to overcome. Methods/design This project is part of an International Exchange Platform on Personalising Addiction Treatment. Data will be collected in two phases (pre-post study and focus groups with patients) to explore the following: 1). How reliable and sensitive to change are PGOM’s and standardised measures in substance misuse treatment? 2). Do PGOM’s add relevant information to standardised measures? 3). What are the views of substance misuse patients about personalised outcome assessment? 4). Development of guidelines on using PGOM’s in this population Discussion This research will potentially demonstrate the diversity of personal problems among patients seeking substance misuse treatment, suggesting the relevance of PGOM as a method to personalise outcome measurement and, ultimately, guiding treatment provision. It is expected that, as in previous studies, PGOM’s will be perceived as helpful and patient-friendly tools, where patients may express their own concerns in a semi
Influence of interpersonal traits on patient outcomes in the treatment of chronic rhinosinusitis.
Levy, Joshua M; Mace, Jess C; Smith, Timothy L; Soler, Zachary M
2017-04-01
Patient-reported outcome measures (PROMs) measure health states in chronic rhinosinusitis (CRS) and have become the dominant metrics of treatment outcomes. Interpersonal traits (IPTs) are patient-specific factors that include personality type, perceived social support, and trust in physicians. The association of IPTs on treatment outcomes among patients with CRS has not been described previously, and IPTs may represent major clinical factors influencing treatment outcomes. Adult patients electing medical or surgical treatment for recalcitrant CRS were prospectively enrolled into a multi-institutional, observational outcomes study. Validated measures of IPTs, including the Big Five Inventory-10 Short Version (BFI-10), Multidimensional Scale of Perceived Social Support (MSPSS), and the Trust in Physician Scale (TPS), were completed and compared with PROMs, which included the 22-item SinoNasal Outcome Test (SNOT-22), the Medical Outcomes Study Short Form-6D (SF-6D), and the Patient Health Questionnaire-2 (PHQ-2). Three hundred fifty-four participants were included and followed for an average (± standard deviation) of 16.3 (±4.8) months. Significant within-subject improvement in mean PROM scores was reported (all p <0.001). No association was detected between PROM score improvement and baseline BFI-10 or MSPSS scores (p > 0.050). Significant, but weak, absolute correlations were reported between baseline TPS scores and improvement in SNOT-22, SF-6D, and PHQ-2 total scores (p < 0.050; r ≤ 0.138). Personality type and perceived social support do not associate with improvement after treatment for CRS. However, increased trust in physicians is weakly associated with greater posttreatment improvement. Further study is needed to examine the relationship between physician trust, patient satisfaction, and treatment outcomes among patients with CRS. © 2016 ARS-AAOA, LLC.
Slota, Christina; Bevans, Margaret; Yang, Li; Shrader, Joseph; Joe, Galen; Carrillo, Nuria
2018-05-01
The aim of this analysis was to evaluate the psychometric properties of three patient reported outcome (PRO) measures characterizing physical function in GNE myopathy: the Human Activity Profile, the Inclusion Body Myositis Functional Rating Scale, and the Activities-specific Balance Confidence scale. This analysis used data from 35 GNE myopathy subjects participating in a natural history study. For construct validity, correlational and known-group analyses were between the PROs and physical assessments. Reliability of the PROs between baseline and 6 months was evaluated using the intra-class correlation coefficient model; internal consistency was tested with Cronbach's alpha. The hypothesized moderate positive correlations for construct validity were supported; the strongest correlation was between the human activity profile adjusted activity score and the adult myopathy assessment endurance subscale score (r = 0.81; p < 0.0001). The PROs were able to discriminate between known high and low functioning groups for the adult myopathy assessment tool. Internal consistency of the PROs was high (α > 0.8) and there was strong reliability (ICC >0.62). The PROs are valid and reliable measures of physical function in GNE myopathy and should be incorporated in investigations to better understand the impact of progressive muscle weakness on physical function in this rare disease population. Implications for Rehabilitation GNE myopathy is a rare muscle disease that results in slow progressive muscle atrophy and weakness, ultimately leading to wheelchair use and dependence on a caregiver. There is limited knowledge on the impact of this disease on the health-related quality of life, specifically physical function, of this rare disease population. Three patient reported outcomes have been shown to be valid and reliable in GNE myopathy subjects and should be incorporated in future investigations to better understand how progressive muscle weakness impacts physical
Geisz, Matthew; Ha, Christina; Kappelman, Michael D; Martin, Christopher F; Chen, Wenli; Anton, Kristen; Sandler, Robert S; Long, Millie D
2016-06-01
Older individuals with inflammatory bowel disease (IBD) require ongoing medications. We aimed to describe (1) medication use in older and younger IBD patients and (2) medication associations with patient reported outcomes (PROs) in older patients. We conducted cross-sectional and longitudinal analyses within CCFA Partners internet-based cohort of patients with self-reported IBD. We assessed medication use by disease sub-type and age. We used bivariate analyses to (1) compare medication use in older and younger patients and (2) determine associations between continued steroid use and patient reported outcomes in older patients. We included 5382 participants with IBD; 1004 were older (≥age 60). Older patients with Crohn's disease (CD) had lower antitumor necrosis factor alpha (anti-TNF) use at baseline (29.1% versus 44.3%, P < 0.001), comparable steroid use (16.0% versus 16.5%, P = 0.77), and higher aminosalicylate use (40.3% versus 33.9%, P = 0.003) versus younger patients. Older ulcerative colitis (UC) patients had similar anti-TNF use (16.0% versus 19.2%, P = 0.16), lower steroid use (9.6% versus 15.4%, P = 0.004), and higher aminosalicylate use (73.8% versus 68.2%, P = 0.04) at baseline. In longitudinal analyses, older CD patients had higher continued steroid use (11.6% versus 7.8%, P = 0.002); which was associated with worsened anxiety (P = 0.02), sleep (P = 0.01), and fatigue (P = 0.001) versus nonuse. Older CD patients on steroids, versus anti-TNF or immunomodulators, had increased depression (P = 0.04) and anxiety (P = 0.03). Medication utilization differs in older patients with IBD. Older CD patients have higher continued steroid use associated with worsened patient reported outcomes. As in younger IBD populations, continued steroid use should be limited in older patients.
Donohue, James F; Jones, Paul W; Bartels, Christian; Marvel, Jessica; D'Andrea, Peter; Banerji, Donald; Morris, David G; Patalano, Francesco; Fogel, Robert
2018-04-01
In clinical trials of inhaled bronchodilators, chronic obstructive pulmonary disease (COPD) guidelines recommend that patient-reported outcomes (PROs) are assessed alongside lung function. How these endpoints are related is unclear. Pooled longitudinal data from 23 randomised controlled COPD studies were analyzed (N = 23,213). Treatments included long-acting β 2 agonists, long-acting muscarinic antagonists (LABAs or LAMAs) and the LABA/LAMA combination QVA149. Outcome measures were Transition Dyspnoea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) scores, COPD exacerbation frequency and rescue medication use. Relationships between changes in trough forced expiratory volume in one second (ΔFEV 1 ) and outcomes following treatment were assessed using correlations of data summaries and model-based analysis: generalized linear mixed-effect regression modelling to determine if ΔFEV 1 could predict patient outcomes with different treatments. Mean age was 64 years, 73% were male, and most had moderate (45%) or severe (52%) disease. Statistically significant correlations were observed between ΔFEV 1 and each outcome measure (exacerbations Rs = 0.05; rescue medication, SGRQ, TDI, r = 0.11-0.16; all p < .001). Patients with greater improvements in trough FEV 1 had on average better SGRQ and TDI scores, fewer exacerbations, and used less rescue medication. For SGRQ and TDI scores, minimal clinically important differences were observed over the range of pooled ΔFEV 1 values. Model-based predictions confirmed the treatment effect was partly explained by changes in FEV 1 from baseline with improvements in PROs observed across all treatments when trough FEV 1 improved. Across all endpoints active treatments were better than placebo (p < .0001), and LABA/LAMA treatment resulted in numerically better treatment outcomes than either monocomponent. These data suggest that FEV 1 improvements post-bronchodilation correlate with PRO improvements
Bhuskute, Aditi; Skirko, Jonathan R; Roth, Christina; Bayoumi, Ahmed; Durbin-Johnson, Blythe; Tollefson, Travis T
2017-09-01
Patients with cleft palate and other causes of velopharyngeal insufficiency (VPI) suffer adverse effects on social interactions and communication. Measurement of these patient-reported outcomes is needed to help guide surgical and nonsurgical care. To further validate the VPI Effects on Life Outcomes (VELO) instrument, measure the change in quality of life (QOL) after speech surgery, and test the association of change in speech with change in QOL. Prospective descriptive cohort including children and young adults undergoing speech surgery for VPI in a tertiary academic center. Participants completed the validated VELO instrument before and after surgical treatment. The main outcome measures were preoperative and postoperative VELO scores and the perceptual speech assessment of speech intelligibility. The VELO scores are divided into subscale domains. Changes in VELO after surgery were analyzed using linear regression models. VELO scores were analyzed as a function of speech intelligibility adjusting for age and cleft type. The correlation between speech intelligibility rating and VELO scores was estimated using the polyserial correlation. Twenty-nine patients (13 males and 16 females) were included. Mean (SD) age was 7.9 (4.1) years (range, 4-20 years). Pharyngeal flap was used in 14 (48%) cases, Furlow palatoplasty in 12 (41%), and sphincter pharyngoplasty in 1 (3%). The mean (SD) preoperative speech intelligibility rating was 1.71 (1.08), which decreased postoperatively to 0.79 (0.93) in 24 patients who completed protocol (P < .01). The VELO scores improved after surgery (P<.001) as did most subscale scores. Caregiver impact did not change after surgery (P = .36). Speech Intelligibility was correlated with preoperative and postoperative total VELO score (P < .01) and to preoperative subscale domains (situational difficulty [VELO-SiD, P = .005] and perception by others [VELO-PO, P = .05]) and postoperative subscale domains (VELO-SiD [P
El Miedany, Y; El Gaafary, M; El Aroussy, Nadia; Bahlas, S; Hegazi, M; Palmer, D; Youssef, S
2017-11-01
The study aimed to assess the value of evaluation of electronic patient reported outcome measures (e-PROMs) in the assessment and management of SLE disease activity flares, its association with adherence to therapy as well as organ damage. A randomized, controlled crossover study was carried out over a 24-month duration. One hundred forty-seven SLE patients meeting the revised American College of Rheumatology (ACR) criteria were enrolled. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) was used to assess disease activity, whereas organ damage was scored using the Systemic Lupus International Collaborating Clinics (SLICC)/ACR Damage Index. In the first 12 months, the patients were assessed every 3 months. At 12 months, the patients were randomized into a cohort of 73 patients who continued their care in the same style and 74 patients who completed an online e-PROMs questionnaire on monthly basis for another 12-month period. The data captured were then retrospectively analyzed at the end of the 24-month study period. At the end of the first year of the study, the mean SLEDAI and SDI scores were 8.72 (6.1) and 1.9 (2.2). At the end of the second year, the mean SLEDAI and SDI scores in the e-PROMs cohort were 3.1 (2.6) and 1.2 (1.3), whereas in the control group, the scores were 7.63 (6.7) and 1.8 (2.3), respectively (p < 0.01). Adjusting for possible confounding variables, the number of flares, regardless of their severity, was associated with damage accrual (OR 2.03, 95% CI 1.34 to 2.83, p < 0.001). Adherence to therapy was significantly (p < 0.1) higher in the e-PROMs group. e-PROMs was equivalent to PROMs paper format and has a potential disease-modifying effect as it facilitated close monitoring of disease activity with an option of management escalation whenever indicated.
Neumann, Melanie; Scheffer, Christian; Tauschel, Diethard; Lutz, Gabriele; Wirtz, Markus; Edelhäuser, Friedrich
2012-01-01
The present study gives a brief introduction into 1. the definition of physician empathy (PE) and 2. its influence on patients' health outcomes. Furthermore 3. we present assessment instruments to measure PE from the perspective of the patient and medical student. The latter topic will be explored in detail as we conducted a pilot study on the German versions of two self-assessment instruments of empathy, which are mostly used in medical education research, namely the "Jefferson Scale of Physician Empathy, Student Version" (JSPE-S) and the "Interpersonal Reactivity Index" (IRI). We first present an overview of the current empirical and theoretical literature on the definition and outcome-relevance of PE. Additionally, we conducted basic psychometric analyses of the German versions of the JSPE-S and the IRI. Data for this analyses is based on a cross-sectional pilot-survey in N=44 medical students and N=63 students of other disciplines from the University of Cologne. PE includes the understanding of the patient as well as verbal and non-verbal communication, which should result in a helpful therapeutic action of the physician. Patients' health outcomes in different healthcare settings can be improved considerably from a high quality empathic encounter with their clinician. Basic psychometric results of the German JSPE-S and IRI measures show first promising results. PE as an essential and outcome-relevant element in the patient-physician relationship requires more consideration in the education of medical students and, thus, in medical education research. The German versions of the JSPE-S and IRI measures seem to be promising means to evaluate these education aims and to conduct medical education research on empathy.
Langguth, B.; Goodey, R.; Azevedo, A.; Bjorne, A.; Cacace, A.; Crocetti, A.; Del Bo, L.; De Ridder, D.; Diges, I.; Elbert, T.; Flor, H.; Herraiz, C.; Sanchez, T. Ganz; Eichhammer, P.; Figueiredo, R.; Hajak, G.; Kleinjung, T.; Landgrebe, M.; Londero, A.; Lainez, M.J.A.; Mazzoli, M.; Meikle, M.B.; Melcher, J.; Rauschecker, J.P.; Sand, P.G.; Struve, M.; Van de Heyning, P.; Van Dijk, P.; Vergara, R.
2014-01-01
There is widespread recognition that consistency between research centres in the ways that patients with tinnitus are assessed and outcomes following interventions are measured would facilitate more effective co-operation and more meaningful evaluations and comparisons of outcomes. At the first Tinnitus Research Initiative meeting held in Regensburg in July 2006 an attempt was made through workshops to gain a consensus both for patient assessments and for outcome measurements. It is hoped that this will contribute towards better cooperation between research centres in finding and evaluating treatments for tinnitus by allowing better comparability between studies. PMID:17956816
Barger, Diana; Leleux, Olivier; Conte, Valérie; Sapparrart, Vincent; Gapillout, Marie; Crespel, Isabelle; Erramouspe, Marie; Delveaux, Sandrine; Dabis, Francois; Bonnet, Fabrice
2018-06-07
Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported
Abbott, J Haxby; Schmitt, John
2014-08-01
Multicenter, prospective, longitudinal cohort study. To investigate the minimum important difference (MID) of the Patient-Specific Functional Scale (PSFS), 4 region-specific outcome measures, and the numeric pain rating scale (NPRS) across 3 levels of patient-perceived global rating of change in a clinical setting. The MID varies depending on the external anchor defining patient-perceived "importance." The MID for the PSFS has not been established across all body regions. One thousand seven hundred eight consecutive patients with musculoskeletal disorders were recruited from 5 physical therapy clinics. The PSFS, NPRS, and 4 region-specific outcome measures-the Oswestry Disability Index, Neck Disability Index, Upper Extremity Functional Index, and Lower Extremity Functional Scale-were assessed at the initial and final physical therapy visits. Global rating of change was assessed at the final visit. MID was calculated for the PSFS and NPRS (overall and for each body region), and for each region-specific outcome measure, across 3 levels of change defined by the global rating of change (small, medium, large change) using receiver operating characteristic curve methodology. The MID for the PSFS (on a scale from 0 to 10) ranged from 1.3 (small change) to 2.3 (medium change) to 2.7 (large change), and was relatively stable across body regions. MIDs for the NPRS (-1.5 to -3.5), Oswestry Disability Index (-12), Neck Disability Index (-14), Upper Extremity Functional Index (6 to 11), and Lower Extremity Functional Scale (9 to 16) are also reported. We reported the MID for small, medium, and large patient-perceived change on the PSFS, NPRS, Oswestry Disability Index, Neck Disability Index, Upper Extremity Functional Index, and Lower Extremity Functional Scale for use in clinical practice and research.
Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study
Downing, Amy; Wright, Penny; Wagland, Richard; Watson, Eila; Kearney, Therese; Mottram, Rebecca; Allen, Majorie; Cairnduff, Victoria; McSorley, Oonagh; Butcher, Hugh; Hounsome, Luke; Donnelly, Conan; Selby, Peter; Kind, Paul; Cross, William; Catto, James W H; Huws, Dyfed; Brewster, David H; McNair, Emma; Matheson, Lauren; Rivas, Carol; Nayoan, Johana; Horton, Mike; Corner, Jessica; Verne, Julia; Gavin, Anna; Glaser, Adam W
2016-01-01
Background Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. Methods and analysis Postal surveys will be sent to prostate cancer survivors (18–42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). Ethics and dissemination The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers. PMID:27927667
Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S
2017-01-01
The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.
de Roos, Paul; Bloem, Bastiaan R.; Kelley, Thomas A.; Antonini, Angelo; Dodel, Richard; Hagell, Peter; Marras, Connie; Martinez-Martin, Pablo; Mehta, Shyamal H.; Odin, Per; Chaudhuri, Kallol Ray; Weintraub, Daniel; Wilson, Bil; Uitti, Ryan J.
2017-01-01
Background Parkinson’s disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential. Objective Propose a global consensus standard set of outcome measures for PD. Methods Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected. Results The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment. Conclusions The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of ‘best practices’, ultimately leading to better informed treatment decisions. PMID:28671140
Dunham, Annie L; Ramirez, Luis D; Vang, Choua A; Linebarger, Jared H; Landercasper, Jeffrey
2018-07-01
Patients want information to search for destination of care for breast-conserving surgery (BCS). To inform patients wanting a lumpectomy, we aimed to develop a pilot project that communicated composite quality measure (QM) results using a '4-star' rating system. Two patient-centered QMs were included in the model-reoperation rate (ROR) and cosmetic outcome (COSM). A prospective database was reviewed for stage 0-3 patients undergoing initial lumpectomy by three surgeons from 2010 to 2015. Self-reported COSM was assessed by survey. Multivariate analyses were used to test for interactions between surgeon and other variables known to influence RORs and COSMs. Models of surgeon profiling were developed that summed the ROR and COSM performance scores, then reported results using a Centers for Medicare and Medicaid Services (CMS) star-type system. Functionality for a patient to 'weight' the importance of the ratio of ROR:COSM before profiling was introduced. The unadjusted ROR for stage 1-3 patients for three surgeons was 9.5, 13.0, and 16.3%, respectively (p = 0.179) [overall rate 10.4% (38/366)]. After risk adjustment, differences between surgeons were observed for RORs, but not COSMs. Overall, patients reported excellent, good, fair, and poor COSMs of 55, 30, 11 and 4%, respectively. Composite star scores reflected differences in performance by surgeon, which could increase, or even disappear, dependent on the patient's weighting of the ROR:COSM ratio. Composite measures of performance can be developed that allow patients to input their weighted preferences and values into surgeon profiling before they consider a destination of care for BCS.
Effects of hospital care environment on patient mortality and nurse outcomes.
Aiken, Linda H; Clarke, Sean P; Sloane, Douglas M; Lake, Eileen T; Cheney, Timothy
2009-01-01
The objective of this study was to analyze the net effects of nurse practice environments on nurse and patient outcomes after accounting for nurse staffing and education. Staffing and education have well-documented associations with patient outcomes, but evidence on the effect of care environments on outcomes has been more limited. Data from 10,184 nurses and 232,342 surgical patients in 168 Pennsylvania hospitals were analyzed. Care environments were measured using the practice environment scales of the Nursing Work Index. Outcomes included nurse job satisfaction, burnout, intent to leave, and reports of quality of care, as well as mortality and failure to rescue in patients. Nurses reported more positive job experiences and fewer concerns with care quality, and patients had significantly lower risks of death and failure to rescue in hospitals with better care environments. Care environment elements must be optimized alongside nurse staffing and education to achieve high quality of care.
Effects of hospital care environment on patient mortality and nurse outcomes.
Aiken, Linda H; Clarke, Sean P; Sloane, Douglas M; Lake, Eileen T; Cheney, Timothy
2008-05-01
The objective of this study was to analyze the net effects of nurse practice environments on nurse and patient outcomes after accounting for nurse staffing and education. Staffing and education have well-documented associations with patient outcomes, but evidence on the effect of care environments on outcomes has been more limited. Data from 10,184 nurses and 232,342 surgical patients in 168 Pennsylvania hospitals were analyzed. Care environments were measured using the practice environment scales of the Nursing Work Index. Outcomes included nurse job satisfaction, burnout, intent to leave, and reports of quality of care, as well as mortality and failure to rescue in patients. Nurses reported more positive job experiences and fewer concerns with care quality, and patients had significantly lower risks of death and failure to rescue in hospitals with better care environments. Care environment elements must be optimized alongside nurse staffing and education to achieve high quality of care.
Roux, Hélène; Blanchet, Corinne; Stheneur, Chantal; Chapelon, Emeline; Godart, Nathalie
2013-06-01
(1) To describe the frequency of somatic pathologies and depression among former anorexia nervosa (AN) patients; (2) to study links with subjects' clinical history and global outcomes. 97 women hospitalised for AN during adolescence, 9.00 ± 1.92 years previously, were interviewed using structured questionnaires concerning somatic and psychiatric disorders that they had experienced. Iron deficiency, migraine, cystitis, upper digestive system disorders, fractures, osteoporosis, and dental problems were reported with a frequency >20 %. Depression was reported by 2/3 of the sample. Osteoporosis was 14 times more frequent in case of vitamin D deficiency. Fractures were three times more frequent in presence of osteoporosis and less frequent when the overall outcome was better. Among women who had AN in adolescence, somatic comorbidities are frequent in adulthood. They are linked to the severity and the duration of AN, and to the overall outcome of the subject.