Outcome Measure In Clinical Settings Research Articles

Patient-reported health-related quality of life outcomes following mastectomy for breast cancer, with immediate, delayed or no breast reconstruction: Four-year follow-up from a prospective cohort study.

Breast reconstruction (BR) improves women's health-related quality of life (HRQOL) following mastectomy for breast cancer, yet factors contributing to improved HRQOL remain unclear. This study aimed to explore the overall impact of mastectomy with or without BR on participants' perceptions of HRQOL over time in a cohort of women with high-risk breast cancer; to examine differences in mean HRQOL scores between immediate BR, delayed BR and no BR groups; to assess the influence of patient characteristics potentially associated with HRQOL scores; and to determine the feasibility of long-term collection of patient-reported outcome measures in clinical settings. A prospective, longitudinal study of 100 women with high-risk breast cancer who underwent mastectomy with or without breast reconstruction and were likely to require post-mastectomy radiotherapy. Four validated patient-reported questionnaires, comprising 21 outcome measures relating to HRQOL, administered at baseline and up to 4 years post-mastectomy. Demographic, clinical and surgical data extracted from patient medical records. Consistently significant declines in perceptions of future health and arm symptoms, consistently significant improvements in treatment side effects, breast symptoms and fatigue, as well as significant improvements, compared to baseline, in social functioning and financial difficulties at 48 months. No significant differences in mean HRQOL scores between women given a choice of reconstructive options. Similar trajectories of HRQOL scores were found in women with high-risk breast cancer who were offered a choice of BR. Informed choice may be an independent contributing factor in long-term maintenance of most HRQOL indicators at their pre-mastectomy levels.

Employing cognitive interviewing to evaluate, improve and validate items for measuring the health-related quality of life of women diagnosed with ovarian cancer.

BackgroundUse of patient-reported outcome measures in clinical settings facilitate the delivery of better health care to improve patient health outcomes. Previously collected qualitative data indicated themes that could inform items for a health-related quality of life measure. This study investigated the content validity of items for inclusion in a new health-related quality of life measure suitable for patients with ovarian cancer.MethodsCognitive interviewing techniques were used with fourteen women diagnosed with ovarian cancer and at different times since diagnosis, to evaluate items derived from the previously collected qualitative dataset. A set of draft items was administered via telephone, Zoom and WhatsApp app together with questions on item meaning and wording. Interviews were transcribed and thematically analysed.ResultsFour broad themes emerged in relation to the questionnaire construction and comprehension of items: intent and clarity, wording, relevance and context, and overall questionnaire construct. All draft items were adjusted based on the interview findings. A final set of 38 health-related quality of life items comprised 7 items describing physical health and functioning, 21 describing emotional wellbeing and 10 items describing social wellbeing; each rated on a five-point frequency response scale. ConclusionThe items reflected a range of personal experiences associated with the patient clinical journey, creating a health-related quality of life tool specific to women diagnosed with ovarian cancer. The cognitive interviewing process established content validity for the tool, thereby, preparing it for field testing and evaluation of its psychometric properties. This study highlighted the fundamental role of cognitive interviewing during health-related quality of life questionnaire development to ensure that item content is grounded in patient feelings, functioning and meaning.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12905-022-01966-w.

Using Machine Learning to Develop a Short-Form Measure Assessing 5 Functions in Patients With Stroke

ObjectiveThis study aimed to develop and validate a machine learning-based short measure to assess 5 functions (the ML-5F) (activities of daily living [ADL], balance, upper extremity [UE] and lower extremity [LE] motor function, and mobility) in patients with stroke. DesignSecondary data from a previous study. A follow-up study assessed patients with stroke using the Barthel Index (BI), Postural Assessment Scale for Stroke (PASS), and Stroke Rehabilitation Assessment of Movement (STREAM) at hospital admission and discharge. SettingA rehabilitation unit in a medical center. ParticipantsPatients (N=307) with stroke. InterventionsNot applicable. Main Outcome MeasuresThe BI, PASS, and STREAM. ResultsA machine learning algorithm, Extreme Gradient Boosting, was used to select 15 items from the BI, PASS, and STREAM, and transformed the raw scores of the selected items into the scores of the ML-5F. The ML-5F demonstrated good concurrent validity (Pearson's r, 0.88-0.98) and responsiveness (standardized response mean, 0.28-1.01). ConclusionsThe ML-5F comprises only 15 items but demonstrates sufficient concurrent validity and responsiveness to assess ADL, balance, UE and LE functions, and mobility in patients with stroke. The ML-5F shows great potential as an efficient outcome measure in clinical settings.

Digital Goniometer for Measuring 3-Dimensional Neck Movement: Reliability and Validity Test

Background In clinical setting, the cervical range of motion (ROM) is commonly used to identify movement impairment and assess function of neck. For assessing and improving the cervical ROM and proprioception, we developed the device using the digital goniometer with inertial measurement unit. Purpose The purpose of this study was to determine the intra-rater reliability and validity of cervical ROM measurement using the digital goniometer and Cervcial Range-of-Motion (CROM) device. Study design Cross-sectional study. Methods Fifteen healthy subjects without neck pain were participated in this study. The measure-ments of flexion, extension, side-bending (right/left), and rotation (right/left) were made with CROM device and digital goniometer in sitting. Two trials of cervical ROM measurement (6 movements) were performed for each subject. Validity and intra-rater reliability were determined using Spearman correlation coefficient and intra-class correlation coefficient (ICC_3,1) for digital goniometer and CROM, respectively. Results The digital goniometer demonstrated good (Spearman ρ=0.88–0.98, <italic>p</italic>&lt;0.01) validity for CROM. The intra-rater reliability was demonstrated for cervical flexion (ICC_3,1=0.99), extension (ICC_3,1=0.99), right (ICC_3,1=0.99) and left (ICC_3,1=0.99) lateral flexion, right (ICC_3,1=0.99) and left (ICC_3,1=0.99) rotation. Conclusions The digital goniometer was found to be reliable and valid for measuring cervical ROM in three planes for normal subjects. However, before using the digital goniometer as an outcome measure in clinical settings, studies should be performed on subjects with neck pain.

Development of a Patient-Reported Outcome Measure for Geriatric Care: The Older Persons and Informal Caregivers Survey Short Form

BackgroundThe Older Persons and Informal Caregivers Minimum Data Set (TOPICS-MDS) is a standardized data set that was developed to evaluate the quality of multidimensional geriatric care. There is an inherent need to reduce the number of TOPICS-MDS survey items to core outcomes to allow it to be more easily applied as a patient-reported outcome measure in clinical settings. ObjectivesTo create a TOPICS-short form (TOPICS-SF) and examine its validity. MethodsData in the TOPICS-MDS from persons aged 65 years and older in the Netherlands were used for the following analyses. Multiple linear regression analyses were performed to select the items and to derive domain weights of TOPICS-SF. A priori hypotheses were made on the basis of psychometric properties of the full-length TOPICS-MDS preference-weighted score (TOPICS-CEP). The validity of TOPICS-SF was evaluated by 1) examining the meta-correlation of the TOPICS-SF score with TOPICS-CEP and two quality-of-life measures, that is, the Cantril Ladder score and the EuroQol five-dimensional questionnaire utility index, and 2) performing mixed multiple regression of TOPICS-SF scores across key sociodemographic characteristics. ResultsTOPICS-SF scores were strongly correlated with the TOPICS-CEP (r = 0.96) and had stronger correlation with the EuroQol five-dimensional questionnaire utility index compared with the Cantril Ladder (r = 0.61 and 0.38, respectively). TOPICS-SF scores were higher among older persons who were married, living independently, and having higher levels of education. ConclusionsWe have developed the 22-item TOPICS-SF and demonstrated its validity, supporting its use as a patient-reported outcome measure in geriatric care.

Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients

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 in clinical settings.

Reliability and criterion validity of two applications of the iPhone™ to measure cervical range of motion in healthy participants

Summary of background dataRecent smartphones, such as the iPhone, are often equipped with an accelerometer and magnetometer, which, through software applications, can perform various inclinometric functions. Although these applications are intended for recreational use, they have the potential to measure and quantify range of motion. The purpose of this study was to estimate the intra and inter-rater reliability as well as the criterion validity of the clinometer and compass applications of the iPhone in the assessment cervical range of motion in healthy participants.MethodsThe sample consisted of 28 healthy participants. Two examiners measured cervical range of motion of each participant twice using the iPhone (for the estimation of intra and inter-reliability) and once with the CROM (for the estimation of criterion validity). Estimates of reliability and validity were then established using the intraclass correlation coefficient (ICC).ResultsWe observed a moderate intra-rater reliability for each movement (ICC = 0.65-0.85) but a poor inter-rater reliability (ICC < 0.60). For the criterion validity, the ICCs are moderate (>0.50) to good (>0.65) for movements of flexion, extension, lateral flexions and right rotation, but poor (<0.50) for the movement left rotation.ConclusionWe found good intra-rater reliability and lower inter-rater reliability. When compared to the gold standard, these applications showed moderate to good validity. However, before using the iPhone as an outcome measure in clinical settings, studies should be done on patients presenting with cervical problems.

Implementing Standardized Assessments in Clinical Care: Now's the Time

In this Open Forum the Committee on Psychopathology within the Group for the Advancement of Psychiatry (GAP) strongly encourages clinicians and health systems to implement standardized assessments of patients' outcomes for mental disorders, particularly disorders such as depression. The GAP committee describes how calls for the regular use of standardized scales in clinical settings naturally follow from the development and dissemination of treatment guidelines. It discusses the challenges involved in implementing routine outcome measures in clinical settings and explains why the advantages of measurement-based care make addressing these challenges worthwhile. Finally, the committee makes practical suggestions for clinicians and systems attempting to implement routine outcome measures in their clinics.

Psychometric properties of the BASIS-24© (Behaviour and Symptom Identification Scale–Revised) Mental Health Outcome Measure

Objective. Outcome measurement in mental health services is an area of considerable clinical interest and policy priority. This study sought to assess the Behaviour and Symptom Identification Scale-24 (BASIS-24©), a brief, patient self-reported measure of psychopathology and functioning, in a UK sample, including establishing population norms for comparative purposes. Methods. Participants were 588 adults recruited from psychiatric inpatient, outpatient and primary care settings; and 630 adults randomly sampled from primary care lists who completed the BASIS-24©, and the Brief Symptom Inventory (BSI) at two time points. Results. BASIS-24© demonstrated adequate reliability (coefficient α values for combined clinical sample across subscales ranged from 0.75 to 0.91), validity and responsiveness to change (effect size for change of the BASIS-24© was 0.56 compared with 0.48 for BSI Global Severity Index). Population norms were established for the general population and adult in-patients (at in-take). The scale proved straightforward to complete across clinical settings. Variable rates of questionnaire distribution across clinical settings highlighted the ongoing challenge of incorporating outcome measures in clinical settings. Conclusion. BASIS-24© is a brief, easily administered, self-complete measure of mental well-being and functioning that adequately meets the requirements of reliability, validity and responsiveness to change required of an outcome measure.

Use of the Child and Adolescent Functional Assessment Scale (CAFAS) as an outcome measure in clinical settings.

This article discusses how the Child and Adolescent Functional Assessment Scale (CAFAS) can be used as an outcome measure in clinical settings. Outcome data from two clinical samples are provided: a small community mental health center located in Michigan and a large referred sample from the Fort Bragg Evaluation Project. Outcome indicators for assessing change over time included overall level of dysfunction, percentage of respondents with severe impairment, mean total score, mean scores for individual CAFAS subscales, and change in total score at the client level. Implications of the findings were discussed from several perspectives: improving services to individual clients, developing databases at the local level that can be used for the agency's continuing self-scrutiny, and pooling databases across sites that can be used to study broader issues within a managed care environment.

An inter‐rater reliability study of the Opiate Treatment Index

The development of standardized instruments to evaluate treatment outcome fo opioid dependence is necessary to determine individual patients' progress within a particular treatment programme and to compare treatment outcomes across programmes. This paper reports the results of an inter-rater reliability study utilizing the Opiate Treatment Index (OTI). The OTI questionnaire is a standardized opiate treatment evaluation tool developed within a research setting. The main aim of this study was to determine within the clinical setting of a Methadone Treatment Programme (MTP), whether information given by patients differed significantly according to whether the OTI questionnaire was administered by clinicians working within the service, or by an unknown research assistant. Results indicated that overall there were few differences between the information given to clinicians compared with that given to the research assistant and that in general, inter-rater reliability was good. A number of issues related to the development and use of treatment outcome measures in clinical settings are highlighted and it is proposed that for MTPs a shorter questionnaire, based on the OTI, be developed.