Importance Of Patient-reported Outcome Measures Research Articles

Auswahl von Fragebögen für klinische Studien in der Orthopädie und Unfallchirurgie

AbstractIn orthopedics the importance of patient-reported outcome measures (PROMs) has increased enormously, not only clinically and academically but also with respect to health policy. Many such measurement instruments are available for several areas and joints, so that a uniform application of suitable PROMs is recommended for comparisons under scientific and clinical aspects. A PROM must fulfil certain scientific criteria (e.g., reliability, validity, and responsiveness), should be validated for the pathology of interest, and a validated translated version should be available for the respective language. Furthermore, data should be available to interpret results not only with respect to the statistical significance but also regarding their clinical relevance, e.g., the minimal clinically important difference (MCID).

Reliability, validity, and responsiveness of the Arabic version of HIT-6 questionnaire in patients with migraine indicated for preventive therapy: A multi-center study.

The Headache Impact Test (HIT-6) is an important patient-reported outcome measure (PROM) in migraine prevention trials. This study aimed to (i) assess the reliability and validity of the Arabic version of HIT-6 in Arabic-speaking patients experiencing migraine, and (ii) evaluate the responsiveness of HIT-6 following migraine preventive therapy. In this prospective study, patients with migraine (n = 145) were requested to fill out a headache diary, the Arabic version of HIT-6, and Migraine Disability Assessment Scale (MIDAS) at two time points (baseline and 3 months after initiation of prophylactic treatment). Some respondents (n = 73) were requested to fill out HIT-6 again 1 week from the baseline for test-retest reliability. The intensity of migraine headache attacks was evaluated using the Visual Analogue Scale (VAS). An anchor-based method was used to establish the minimal important change (MIC) value and responsiveness of HIT-6. The total scores of HIT-6 were significantly correlated to a fair degree with MIDAS (r = 0.41), as well as VAS (r = 0.53), and monthly migraine days (r = 0.38) at the baseline while at the follow-up (after 3 months), the correlations were of moderate degree with MIDAS scores (r = 0.62) and monthly migraine days (r = 0.60; convergent validity). Reliability estimates of the Arabic HIT-6 were excellent (Cronbach's α = 0.91 at baseline and 0.89 at follow-up). The average measure interclass correlation coefficient (ICC) value for the test-retest reliability was 0.96 (95% confidence interval = 0.94-0.98, p < 0.001). The HIT-6 total score is sensitive to change, being significantly reduced after prophylactic treatment compared to before (effect size = 1.5, standardized response mean = 1.3). A reduction from baseline of 4.5 on HIT-6 showed the highest responsiveness to predict improvement with an area under the curve equal to 0.66, sensitivity of 80%, specificity of 45%, and significance at 0.021. Changes in the HIT-6 total score were positively correlated with changes in monthly migraine days (r = 0.40) and VAS scores (r = 0.69) but not with changes in the score of MIDAS (r = 0.07). The Arabic version of HIT-6 is valid, reliable, and sensitive to detect clinical changes following migraine prophylactic treatment with a MIC of 4.5 points.

Assessing Appearance, Speech, and Hearing (dis)Satisfaction in Individuals with Cleft Lip and/or Palate: A Contribution to General Population Norms.

Individuals with cleft lip and/or palate (CL/P) may grow up with a visible facial difference, alongside speech and/or hearing challenges. Self-perceptions are stronger predictors of psychosocial adjustment than objective assessments, highlighting the importance of patient-reported outcome measures. Previously titled the Satisfaction with Appearance (SwA) questionnaire, the Cleft Hearing, Appearance and Speech Questionnaire (CHASQ) has been used in several countries to assess patient satisfaction, guide clinical decision-making, and conduct craniofacial research, but has lacked general population norms from which to draw comparisons. The aim of this study was to contribute to the development of norms by utilising existing data collected in the United Kingdom (UK) in 2004 using the original SwA. SwA data collected from school pupils (n = 761) aged 10-16 years were analysed across age and gender. Hair, Eyes and Ears received the highest ratings, while Teeth received the lowest ratings. Those who were younger, and those who were male, generally rated their appearance more favourably. Thresholds are proposed to identify young people in need of clinical monitoring (10%) and intervention (5%). This study supports the potential of the CHASQ as a clinically useful outcome measure and research tool with the ability to identify appearance concerns in relation to specific facial features, as well as overall appearance satisfaction in young people with and without CL/P. Further validation of its use in the CL/P population and other patient groups, as well as countries outside the UK would add additional weight to the CHASQ's utility.

DENTAL PATIENT-REPORTED OUTCOMES IN GERIATRIC DENTISTRY : A call for clinical translation

As the proportion of older adults in the world population increases, there is an increasing need to provide adequate dental care for this very heterogeneous group of individuals. The relationship between oral and systemic health, the impact of medication on oral health, and the influence of accessibility to dental care and other social and environmental factors shape the provision of dental care for older adults more than in children, younger, and middle-aged adults.However, while dental care for older adults is shaped by these factors and is often different from the care for other adults, what matters to older dental patients does not differ from what matters to dental patients in general. The four dimensions of oral health-related quality of life (OHRQoL)–Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact–capture dental patients’ suffering from oral disorders. OHRQoL questionnaires can be used to assess this impact and to achieve results that are compatible with adults in general. More than in other age groups, cognitive impairments or dementia limit the usefulness of questionnaires or interviews for oral health impact assessment. In these situations, family members or caregivers can assess the patient's oral health impact, and oral health care providers need to rely more on physical oral health characteristics for clinical decision-making than in other dental patients. While the tools to measure oral health impact change, the targets for dental care stay the same. Prevention and reduction of functional, painful, aesthetical, and broader psychosocial impact related to oral disorders are the central tasks for geriatric dentistry as they are for dentistry in general.The aim of the manuscript is to highlight the importance of patient-reported outcome measures in geriatric dentistry, addressing challenges and opportunities for their application.

A Qualitative Study Exploring the Regional Feasibility of Patient-Reported Outcome Measures (PROMs) Data Collection for Orthopedic Trauma Patients.

Behavioral health has been shown to impact both short- and long-term health outcomes in trauma patients. Recommendations for screening for behavioral health concerns in the acute setting exist, but longitudinal data collection is infrequently performed. The Trauma Quality Improvement Program describes the importance of patient-reported outcome measures (PROMs), including behavioral health data. In thisqualitative feasibility study, a multidisciplinary team participated inone-hour virtual focus groups; a semi-structured interview guide was used to ascertain feedback on a proposed PROMs study design. This study utilized a qualitative methodology to reveal thematic results from the staff feedback to determine the feasibility of the proposed study design. Three virtual one-hour focus groups consisting of a combination of seven trauma program managers and orthopedic practice managers were asked questions related to the feasibility of a PROMs study design before thematic saturation was reached.Through the analysis, four themes emerged: barriers, possible improvements, representation and research design. Themes included subthemes as well. Noteworthy results included the impact of an integrated orthopedic practice and the technological options available for use. This study revealed the barriers that would exist in the implementation of PROMs for orthopedic trauma patients, which may be useful when designing data collection procedures for PROMs. The results related to barriers may assist other trauma centers or regional trauma systems in designing an optimal methodology for PROMs data. Furthermore, the American College of Surgeons might consider these results prior to any mandated implementation of PROMs for trauma centers to avoid any possible burden on staff and systems.

Second opinion and time to knee arthroplasty: a prospective cohort study of 142 patients

ObjectiveThe objective of this study was to determine the impact of obtaining a second opinion consultation on time to knee arthroplasty (KA). We further examined the frequency of KA and...

Functional outcome measures for distal radius fractures: A systematic review.

Objective: This systematic review aimed to identify and describe the utility of functional outcome measures reported in intervention trials between 2010 and 2020, and to map these measures to the International Classification of Functioning, Disability and Health (ICF) model. Method: The search was carried out on MEDLINE, CINAHL and Cochrane Register of Clinical Trials. Peer-reviewed intervention studies detailing the functional outcome measures used for any treatment for distal radius fracture were selected. Participant characteristics, outcome measures reported and the trends in their use over time and geographical locations were extracted. Results: This review analysed 119 studies. Thirty-one functional outcome measures were used across 36 countries. Ninety-two percent of studies measured both the Body Function/Structure and Activity/Participation domains of the ICF. The most frequently used measures were the Disabilities of the Arm, Shoulder and Hand Questionnaire, Range of Motion and Grip Strength. There is a lack of measures on successful return to meaningful occupation. Conclusion: The outcome measures identified were equally spread across the ICF domains. There is a growing importance of Patient-Reported Outcome Measures to supplement performance-based measures, but a lack of measure on successful return to meaningful occupation.

Multiarm study comparing patient-reported and clinical outcome measures in patients undergoing antipsoriatic therapy with non-biological systemic agents in a real-world setting

ABSTRACT Background Although the inclusion of patients’ preferences and needs is essential for therapy adherence, the assessment of patient-reported outcome measures in clinical trials is often neglected. Therefore, the aim of this study was to quantify several patient-reported outcome measures in psoriasis patients undergoing systemic therapy in a real-life clinical setting. Methods This clinical trial has been designed as a prospective, multiarm study to investigate the treatment satisfaction, adherence to therapy, quality of life, and clinical response in a real-life clinical setting during the initial six months of treatment with apremilast, methotrexate and fumaric acids in 80 patients suffering from plaque psoriasis. Results The treatment satisfaction for the three systemic therapies was rated “sufficient” with a mean (±SD) Treatment Satisfaction Questionnaire for Medication (TSQM) score of 275.0 (±62.7). Most potential for improvement was seen in the “effectiveness” domain (54.3 ± 21.5). The highest treatment satisfaction level in all four domains (convenience, effectiveness, global satisfaction, side-effects) was seen in the methotrexate group with a mean TSQM score of 306.3 ± 50.9, followed by apremilast (267.1 ± 61.6) and fumaric acids (254.9 ± 65.0; p = 0.005). Analysis of the TSQM revealed a considerable discrepancy between patient-reported clinical response and the actual Psoriasis Area and Severity Index (PASI) reduction. This applies equally to the patient- versus physician-reported side-effects. Conclusions This real-life study demonstrates that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underlines the importance of patient-reported outcome measures not only in clinical trials, but also for improved patient care.

How are patients’ preferences for anti-TNF influenced by quality of life? A discrete choice experiment in Crohn’s disease patients

Background and objective Anti-TNFs have been shown to significantly improve the health-related quality of life (HRQoL) in Crohn’s disease (CD) patients. The purpose of this study was to investigate to what extend the patients’ preferences for these intravenous (IV) and subcutaneous (SC) treatments differ based on respondents’ quality of life. An online discrete choice experiment (DCE) was conducted to understand patient trade-offs in treatment choice. Methods Fifty-seven Crohn's disease anti-TNF naïve patients were asked to choose between two different scenarios, considering the following attributes: mode of administration (MODE), total availability for injection (TIME), speed of onset (DELAY), risk of anti-TNF administration despite a contraindication (RISK) and total monthly out-of-pocket expenses (COST). At the same time, patients completed the IBDQ-32 questionnaire. Conditional logit models without and with interaction terms were estimated to evaluate attribute weights. Results Patients preferred to self-administer SC anti-TNF rather than have a primary care nurse do it, whereas the preference for IV route was negative. After adding interaction terms however, the IV route became preferred for patients with impaired HRQoL, this preference having decreased as HRQoL increased. Surprisingly, patients with impaired HRQoL were less willing to spend more time on treatment, and this effect diminished as HRQoL (overall and in each dimension) became higher. Conclusions HRQoL level changed patients’ preferences for the anti-TNF treatment. The results suggest the need to optimise the management of IV infusions in the hospital and reinforce the importance of patient-reported outcome measures (PROMS) as a common practice to improve shared medical decision making.

Not an awkward high school dance! Highlighting the growing importance of patient-reported outcome measures (PROMs) in chronic limb-threatening ischemia

Not an awkward high school dance! Highlighting the growing importance of patient-reported outcome measures (PROMs) in chronic limb-threatening ischemia

The Implementation of PROMs/PREMs in the Assessment of Orthodontic Treatment Outcomes: A Questionnaire Survey.

ABSTRACTObjectives:The aim of this study was to explore the impact of self-perceived treatment outcomes and experiences on psychological aspects, reflecting the importance of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in orthodontic practice.Materials and Methods:A questionnaire was constructed using the PROMs/PREMs concepts. It contained five parts: “Demographic data”, “Self-perceived esthetics”, “Self-perceived functional concern”, “Satisfaction of treatment procedures”, and “Psychological aspect”. The questionnaire was piloted in five experts and 50 orthodontic patients to ensure its quality, using content validity, test-retest reliability, and Cronbach’s alpha. The validated version was provided to patients who had a complete fixed appliance orthodontic treatment. These data were analyzed using descriptive statistics, Mann-Whitney U test, and Spearman correlation. In addition, a multiple linear regression was used to analyze whether there were any influential factors on a psychological aspect. Statistical significance was taken at P < 0.05.Results:A total of 271 respondents completed the questionnaire. They tended to have positive perceptions toward the outcomes of orthodontic treatment. There was a significant difference in self-perceived esthetics between the male and female groups. Self-perceived esthetic and functional concerns as well as satisfaction of treatment procedures were found to have significant correlations with the psychological aspect. Sex and self-perceived esthetics were also found to be significant predictors of the psychological aspect.Conclusion:PROMs/PREMs should be considered as an important tool to assess treatment outcomes in orthodontic practice. There appeared to be significant impact of self-perceived esthetics on psychological aspects. Consequently, PROMs and PREMs should be introduced in orthodontic postgraduate programs to enhance the concept of patient-centered care in orthodontic practice.

Prioritising pain in patients with systemic sclerosis.

Pain is the most prominent symptom interfering with quality of life in patients with rheumatic diseases. Therefore, pain reduction is rated as the most important outcome criteria in studies asking patients with rheumatoid arthritis for their preferences.1,2 However, since the introduction of biologics and the declaring of remission as the main target for those with rheumatic diseases by international societies (as is the case for treating rheumatoid arthritis), pain was somewhat out of focus. Only in recent years has pain been considered to be an integral part of studies of patients with rheumatic diseases and is investigated more frequently in clinical practice as an important patient-reported outcome measure.

Use and detailed metric properties of patient-reported outcome measures for rheumatoid arthritis: a systematic review covering two decades

IntroductionThe importance of patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA) clinical studies has been recognised for many years. The current study aims to describe the RA PROMs used over...

Outcome Measurement for Distal Radius Fractures.

Distal radius fractures (DRFs) are among the most common upper extremity injuries. Multiple medical conditions now are evaluated by standardized outcome sets that enable comparability. Recent international working groups have provided consensus statements for outcomes measurement after DRFs. These statements emphasized the growing importance of patient-reported outcome measures as well as traditional measures, including pain assessment, radiographic alignment, performance, and assessment of complications. A standardized instrument and timeline for measuring outcomes following DRFs offers clinicians, researchers, and health care economists a powerful tool. This article reviews the current evidence and provides recommendations for a DRF standardized outcome set.

Danish translation of the Neck Dissection Impairment Index

Background Shoulder pain and impairment are known complications to neck dissections (NDs) as part of the surgical management of head and neck cancer (HNC). The Neck Dissection Impairment Index (NDII) is a validated shoulder function-related quality-of-life instrument and an important patient reported outcome measure after head-neck surgery. The correct translation of questionnaires into other languages is important for both individual assessment of patients and future research. Aims Translation of the NDII into Danish. Methods The NDII was translated from English into Danish using forward and backward translational procedures. Pilot-testing was performed on the pre-final version of the translated questionnaire. Results Pilot-testing found the translation easily comprehensible, but a few changes were made to improve language flow. Conclusions NDII was successfully translated into Danish using forward and backward translations. Further validation on a larger scale is warranted. Significance NDII is an important aid to identifying patients with impairments and optimize the aftercare following ND for HNC. Translation of validated questionnaires into other languages is important for future research and international comparison of surgery outcome.

More Than Numbers: Discourses of Health Care Quality in Finland

Finnish institute for health and welfare is developing national health care quality registers for the ongoing project in 2018–2020, which covers seven disease pilot registers. This article describes professionals’ and patient associations’ cultural health care quality conceptions at developing process, reflecting to Weick’s sensemaking theory and patient-centered care. Research data ( N = 13) were collected by individual thematic semi-structured interviews from pilot registers’ professionals and patient associations. Data were analyzed using the discursive approach. Six main discourses on the shared sociocultural meanings of health care quality were constructed: confidence and reliability, information and understanding, safety and medical effectiveness, support, benchmarking and utility, and requirement and justice. Health care quality is built-in culture and action to achieve patient-centered care and is complex to define. Patient–clinician interaction, understanding, and support are constructive elements to make sense of quality registers’ necessity and data collection. The importance of Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) measures is recognized to strengthen the patient-centeredness, which reflects to all health care decision-making, processes, and care. The data publication should be designed clearly and visually versatile. The study can offer new aspects for selecting valid quality indicators to produce comprehensive information for health care quality registers.

EQ-5D-3L for Assessing Quality of Life in Older Nursing Home Residents with Cognitive Impairment.

Background: Quality of life (QoL) is recognized as an important patient-reported outcome measure. Assessing QoL in older people with cognitive impairment is a challenge due to discrepancies in the collection of data via proxies versus self-report. This study aimed to assess the psychometric properties of the self-reported EQ-5D (including the EQ index and EQ visual analog scale (VAS)) in nursing homes residents with cognitive impairment and to analyze its validity based on scales included in the comprehensive geriatric assessment. Methods: Cross-sectional, multicenter study analyzing the feasibility, acceptability, reliability, and validity of the EQ-5D based on 251 self-administered questionnaires in a sample of nursing home residents with cognitive impairment. Reference scales were those from the comprehensive geriatric assessment, equivalent to the five dimensions of the EuroQol. Results: The EQ index was 0.31 (0.37) and the EQ VAS was 35.96 (29.86), showing adequate acceptability and feasibility. Cronbach’s alpha was 0.723. The EQ index and EQ VAS, as outcome variables for multiple linear regression models including CGA titration scales, showed better validity for the EQ index than the EQ VAS. Conclusions: As a self-administered generic scale, the EQ-5D-3L could be a good tool for QoL assessment in nursing home residents with cognitive impairment.

No date for the PROM: the association between patient-reported health events and clinical coding in primary care

ObjectiveIt is unclear whether data from patient-reported outcome measures (PROMs) are captured and used by clinicians despite policy initiatives. We examined the extent to which fall risk and urinary incontinence (UI) reported on PROMS and provided to clinicians prior to a patient visit are subsequently captured in the electronic medical record (EMR). Additionally, we aimed to determine whether the use of PROMs and EMR documentation is higher for visits where PROM data was provided to clinicians.DesignWe conducted a cross-sectional patient-reported risk assessment survey and semi-structured interviews with clinicians to identify themes related to the use of PROMs.SettingFourteen primary care clinics in the US (eight intervention and six control clinics), between October 2013 and May 2015.ParticipantsPrimary care clinicians and older adult (≥66 years) patients completing a 46-item health risk assessment, including PROMs for fall risk and UI.InterventionRisk assessment results provided to the clinician or nurse practitioners prior to the clinic visit in intervention clinics; data was not provided in control clinics.Main outcome1) Agreement between ICD-9 codes of fall risk or UI in the EMR and patient-reports, and 2) clinician experience of PROMs use and impact on coding.ResultsA total of 505 older adult patients were included in the study, 176 at control clinics and 329 at intervention clinics. While patient reports of fall risk and UI were readily captured by PROMs, this information was only coded in the EMR between 3% – 14% of the time (poor Kappa agreement). Intervention clinics performed slightly better than control clinics. Clinician interviews (n = 16) revealed low use of PROMs data with multiple barriers cited including poor access to data, high quantity of data, interruption to workflow, and a lack of training on PROMs.ConclusionsCurrent strategies of providing PROMs data prior to clinic visits may not be an effective way of communicating important health information to busy clinicians; ultimately resulting in underuse. Better systems of presenting PROMs data, and clinician training on the importance of PROMs and their use, is needed.

Health-Related Quality of Life Among People Living with Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy in Ethiopia: PROQOL-HIV Based Survey.

BackgroundAs infection with the Human Immunodeficiency Virus (HIV) has evolved into a chronic disease, perceived health-related quality of life (HRQoL) is becoming a prominent and important patient-reported outcome measure in HIV care. This study aimed to assess HRQoL among people living with HIV on highly active antiretroviral therapy and factors associated with HRQoL in Ethiopia.MethodsAn institution-based cross-sectional study was conducted among 160 HIV–infected patients who were initiated highly active antiretroviral therapy at Jimma University Medical Center in 2016. HRQoL was assessed using the patient-reported outcome quality of life-HIV (PROQOL-HIV) measuring scale. Linear regressions were used to identify factors associated with outcome. Statistical significance was considered at p-value <0.05.ResultsOut of a total of 160 participants, 63.13% were females. The mean (±SD) age of study participants was 41.47±9.45 years. The median baseline CD4+ cell count was 182.00 cells/µL (IQR: 104.53–262.40 cells/µL). The mean (±SD) score of PROQOL-HIV scale domains was 77.58 ±15.11, 58.32 ±7.79, 61.75± 17.95, 85.07 ±15.67, 76.92 ± 20.52, 80.00 ±16.83, 74.37 ± 1.47, 81.45 ± 8.17 for physical health and symptoms, emotional distress, health concerns, body change, intimate relationships, social relationships, stigma, and treatment impact domains, respectively. Second line antiretroviral therapy showed a negative effect on the quality of life, especially on the treatment impact domain (β=−6.301). Cotrimoxazole preventive therapy had a significant positive effect on the physical health and symptoms of HIV patients (β= +8.381, p<0.05). Advanced disease (β=−2.709, p<0.05), and non-communicable disease comorbidity (β=−14.340, p<0.001) showed a significant negative effect on physical health and symptoms.ConclusionSeveral behavioral, clinical & immunological factors were negatively associated with health-related quality of life. The double burden of chronic non-communicable disease(s) and the impact of treatment were highly significant in all dimensions of HRQoL measures. Therefore, with HRQoL emerging as a key issue for HIV–infected patients, its routine assessment and appropriate interventions at each clinic visit would be very crucial.

Patient-Reported Outcomes and Perioperative Complications of Total Hip Arthroplasty Following Joint Preservation Surgery for Hip Dysplasia

BackgroundThere is growing recognition of the importance of patient-reported outcome measures and assessment of patient satisfaction in the evaluation of outcomes following surgical interventions. This study aimed to evaluate patient-reported outcomes and complication rates after total hip arthroplasty following joint preservation surgery for hip dysplasia. MethodsPatient-reported outcomes and complication rates of 85 hips with previous joint preservation surgery (salvage group) were compared with those of 1279 hips without joint preservation surgery (primary arthroplasty group). As a patient-reported outcome measure, the Japanese Orthopedic Association Hip Disease Evaluation Questionnaire was used to evaluate the hip condition both preoperatively and 12 months postoperatively. Operative data and postoperative (within 12 months) complications were investigated. ResultsThe salvage group had a longer operative time (56.8 vs 44.9 minutes, P < .001) and a higher total complication rate (5.9% vs 1.1%, P < .001). Additionally, the salvage group exhibited a lower degree of improvement in the visual analog scale value for satisfaction (75.1 vs 83.1 mm, P = .011), the pain and movement category scores, and the total score of the Japanese Orthopedic Association Hip Disease Evaluation Questionnaire (14.2 vs 16.2, P = .031; 13.7 vs 16.0, P = .005; and 42.3 vs 47.9, P = .007, respectively) compared with the primary arthroplasty group. ConclusionThis study demonstrated a lower rate of improvement in patient satisfaction and worse self-reported outcomes in the salvage group. Furthermore, these patients had a longer operative time and a higher risk of operative complications.