Diagnostic Validity of Patient-Reported History for Shoulder Pathology.
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ABSTRACT:
SUBMITTER: Somerville LE
PROVIDER: S-EPMC5553515 | biostudies-other | 2017 Apr
REPOSITORIES: biostudies-other
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Project description:BACKGROUND: Shoulder complaints are the third most common musculoskeletal problem in the general population. There are an abundance of physical examination maneuvers for diagnosing shoulder pathology. The validity of these maneuvers has not been adequately addressed. We propose a large Phase III study to investigate the accuracy of these tests in an orthopaedic setting. METHODS: We will recruit consecutive new shoulder patients who are referred to two tertiary orthopaedic clinics. We will select which physical examination tests to include using a modified Delphi process. The physician will take a thorough history from the patient and indicate their certainty about each possible diagnosis (certain the diagnosis is absent, present or requires further testing). The clinician will only perform the physical examination maneuvers for diagnoses where uncertainty remains. We will consider arthroscopy the reference standard for patients who undergo surgery within 8 months of physical examination and magnetic resonance imaging with arthrogram for patients who do not. We will calculate the sensitivity, specificity and positive and negative likelihood ratios and investigate whether combinations of the top tests provide stronger predictions of the presence or absence of disease. DISCUSSION: There are several considerations when performing a diagnostic study to ensure that the results are applicable in a clinical setting. These include, 1) including a representative sample, 2) selecting an appropriate reference standard, 3) avoiding verification bias, 4) blinding the interpreters of the physical examination tests to the interpretation of the gold standard and, 5) blinding the interpreters of the gold standard to the interpretation of the physical examination tests. The results of this study will inform clinicians of which tests, or combination of tests, successfully reduce diagnostic uncertainty, which tests are misleading and how physical examination may affect the magnitude of the confidence the clinician feels about their diagnosis. The results of this study may reduce the number of costly and invasive imaging studies (MRI, CT or arthrography) that are requisitioned when uncertainty about diagnosis remains following history and physical exam. We also hope to reduce the variability between specialists in which maneuvers are used during physical examination and how they are used, all of which will assist in improving consistency of care between centres.
| S-EPMC3579687 | biostudies-literature
Project description:BackgroundA number of prominent surgical trials and clinical guidelines regard length of hospital stay and rates of daycase surgery as being of upmost importance following cholecystectomy. However, it is unclear whether these outcomes also matter to patients. This study aimed to identify the factors patients regard as most important when admitted with acute gallstone pathology.MethodsA 41-item survey was produced by combining outcomes assessed in recent clinical trials with results from a preliminary patient questionnaire. This was then given out prospectively to patients presenting with acute gallstone pathology, prior to their cholecystectomy. Patients were asked to read an information sheet about laparoscopic cholecystectomy and then complete the survey, scoring each item out of 100 in terms of importance to them.ResultsFifty-six patients completed the survey (43 females; median age 51 years). Diagnoses were: cholecystitis (28 patients), biliary colic (13), pancreatitis (10), common bile duct stones (3) and cholangitis (2). The top-scoring survey item was "long-term quality of life after surgery", with a median value of 97 out of 100. Other high-scoring items included "cleanliness of the ward environment" and "pain control after surgery" (both 96). The lowest-scoring item was "being treated as a daycase" (54).ConclusionPatients with acute gallstone pathology view long-term quality of life after surgery as the most important factor and daycase surgery as the least important. These results should be considered when planning future surgical trials and clinical guidelines.
| S-EPMC5394152 | biostudies-literature
Project description:The purpose of this study was to compare patient reported functional outcomes following bilateral aTSA vs rTSA. A retrospective review was conducted on twenty-six pateints who underwent staged bilateral aTSA or rTSA, with a minimum of 2 years follow up. Thirteen patients were included in each group, and patient assessed functional outcomes were measured using the PENN Score, ASES, SST, and SF-12. No statistically significant differences were found between the two groups for all functional outcome scores, patient satisfaction, or SF-12. These findings suggest that patients undergoing bilateral rTSA can expect functional outcomes similar to those obtained after bilateral aTSA. None of the authors involved in the work nor any of the author's institutions at any time received payment or services from a third party for any aspect of the submitted work and have no conflicts of interest to disclose.
| S-EPMC6919371 | biostudies-literature
Project description:BackgroundClinical laxity tests are commonly used together to identify individuals with multidirectional instability (MDI). However, their biomechanical validity in distinguishing distinct biomechanical characteristics consistent with MDI has not been demonstrated.ObjectiveTo determine if differences in glenohumeral (GH) joint laxity exist between individuals diagnosed with multidirectional instability (MDI) and asymptomatic matched controls without MDI.MethodsEighteen participants (9 swimmers with MDI, 9 non-swimming asymptomatic matched controls without MDI) participated in this observational study. Participants were classified as having MDI with a composite laxity score from three laxity tests (anterior/posterior drawer and sulcus tests). Single plane dynamic fluoroscopy captured joint motion with 2D-3D joint registration to derive 3D joint kinematics. Average GH translations occurring during the laxity tests were compared between groups using an independent sample's t-test. The relationship of composite laxity scores to overall translations was examined with a simple linear regression. Differences of each laxity test translation between groups were analyzed with a two-way repeated measures ANOVA.ResultsMean composite translations for swimmers were 1.7 mm greater (p = 0.04, 95% Confidence Interval (CI): 0.1, 3.3 mm) compared to controls. A moderate association occurred (r2 = 0.40, p = 0.005) between composite laxity scores and composite translation. Greater translations for the posterior drawer (-2.4 mm, p = 0.04, 95% CI: -0.1, -4.6) and sulcus tests (-2.7 mm, p = 0.03, 95% CI: -0.3, -5.0) existed in swimmers compared to controls.ConclusionSignificant differences in composite translation existed between symptomatic swimmers with MDI and asymptomatic control participants without MDI during GH joint laxity tests. The results provide initial biomechanically based construct validity for the clinical criteria used to identify individuals with MDI.
| S-EPMC8721088 | biostudies-literature
Project description:UnlabelledBackgroundOutcome measurement in shoulder surgery is essential to evaluate the patient safety and treatment efficiency. Currently this is jeopardized by the fact that most patient-reported self-assessment instruments are not comparable. Hence, the aim was to develop a reliable self-assessment questionnaire which allows an easy follow-up of patients. The questionnaire also allows the calculation of 3 well established scoring systems, i.e. the Shoulder Pain and Disability Index (SPADI), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) Score. The subjective and objective items of these three systems were condensed into a single 30-questions form and validated against the original questionnaires.MethodsA representative collective of patients of our shoulder clinic was asked to fill in the newly designed self-assessment Munich Shoulder Questionnaire (MSQ). At the same time, the established questionnaires for self-assessment of CONSTANT, SPADI and DASH scores were handed out. The obtained results were compared by linear regression analysis.ResultsFifty one patients completed all questionnaires. The correlation coefficients of the results were r?=?0.91 for the SPADI, r?=?-0.93 for the DASH and r?=?0.94 for the CMS scoring system, respectively.ConclusionsWe developed an instrument which allows a quantitative self-assessment of shoulder function. It provides compatible data sets for the three most popular shoulder function scoring systems by one single, short 30-item. This instrument can be used by shoulder surgeons to effectively monitor the outcome, safety and quality of their treatment and also compare the results to published data in the literature.
| S-EPMC3502470 | biostudies-literature
Project description:Background Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research. This study, provides the evidence for construct validity of the HM-PRO, specifically focusing on the convergent and divergent validity compared to the other established instruments used in hematology. Methods This validation study adopted a prospective cross-sectional design where a heterogeneous group of patients diagnosed with different HMs and different disease state were recruited. A total of 905 patients were recruited from seven secondary care hospitals in the UK and online through five patient organizations. Patients were asked to complete the HM-PRO and other cancer specific PRO’s, FACT-G and EORTC QLQ C-30. Data analysis was performed using IBM SPSS 23 statistical software. Results A total of 486 males (53.7%) and 419 females (46.3%), with a mean age of 64.3 (± 12.4) years and mean time since diagnosis of 4.6 ( ± 5.2) were recruited. The total score of Part A of the HM-PRO highly correlated with the five functional scales of the EORTC QLQ-C30 (Physical = ?0.71, Role = ?0.72, Emotional = ?0.64, Cognitive = ?0.58, Social = ?0.74—p < 0.001). With respect to correlation with FACT-G, the total score of Part A of the HM-PRO highly correlated with Physical (?0.74), Emotional (?0.57), Functional (?0.66) domains and overall score of FACT-G (?0.74). Similarly, the total score of Part B of the HM-PRO highly correlated with three symptoms scales of EORTC QLQ-C30 (Fatigue scale = ?0.74, Nausea and Vomiting = ?0.52, Pain = ?0.59—p < 0.001) and individual symptom items (Dyspnea = 0.51, Insomnia= 0.43, Appetite loss = 0.54—p < 0.001). Conclusion The construct validity evidence presented in this research is a testimony to the HM-PRO’s ability to measure HRQoL issues which it intends to measure. This is of utmost importance when a PRO is used in routine clinical practice so that the interpretation of the scores or response to an individual item is understood by the clinicians/nurses as intended by the patients.
| S-EPMC7506039 | biostudies-literature
Project description:ImportanceChemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings.ObjectiveTo compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory functional measures as the optimal method of CIPN assessment.Design, setting, and participantsThis cohort study evaluated participants treated with neurotoxic chemotherapy across 2 cohorts using a dual-study design. Participants commencing treatment were assessed prospectively at beginning of neurotoxic treatment, midtreatment, and at the end of treatment. Participants who completed treatment up to 5 years prior were assessed cross-sectionally and completed a single assessment time point. Participants were recruited from oncology centers in Australia from August 2015 to November 2022. Data analysis occurred from February to November 2023.ExposuresNeurotoxic cancer treatment including taxanes, platinums, vinca-alkaloids, proteasome inhibitors, and thalidomide.Main outcomes and measuresCIPN was assessed via PROMs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-CIPN20], Functional Assessment of Cancer Therapy/Gynecological Cancer Group Neurotoxicity Questionnaire (FACT/GOG-Ntx), and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]), neurological and neurophysiological assessment (Total Neuropathy Score and sural and tibial compound nerve amplitudes), and sensory measures (Grating orientation, Von Frey monofilament, and 2-point discrimination tasks). Core measurement properties of CIPN outcome measures were evaluated. Convergent and known-groups validity was assessed cross-sectionally following treatment completion, and responsiveness was evaluated prospectively during treatment. Neurological, neurophysiological, and sensory outcome measure scores were compared between those who reported high and low levels of CIPN symptoms using linear regressions.ResultsA total of 1033 participants (median [IQR] age, 61 [50-59] years; 676 female [65.4%]) were recruited to this study, incorporating 1623 assessments. PROMs demonstrated best ability to accurately assess CIPN (convergent validity), especially the PRO-CTCAE composite score (r = 0.85; P < .001) and EORTC-CIPN20 (r = 0.79; P < .001). PROMS also demonstrated the best ability to discriminate between CIPN severity (known-groups validity) and to detect changes at onset of CIPN development (responsiveness), especially for EORTC-CIPN20 (d = 0.67; 95% CI, 0.52-0.83), FACT/GOG-Ntx (d = 0.65; 95% CI, 0.49-0.81) and the PRO-CTCAE (d = 0.83; 95% CI, 0.64-1.02). Other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiological and sensory measures did not demonstrate acceptable responsiveness. In regression models, neurological, neurophysiological, and sensory outcome measures were significantly impaired in participants who reported high levels of CIPN symptoms compared with those who reported low levels of CIPN symptoms.Conclusions and relevanceIn this cohort study of 1033 cancer patients, PROMs were the only measures to satisfy all 3 core measurement property criteria (convergent validity, known-groups validity, and responsiveness). These findings suggest that adoption of PROMs in clinical practice can equip clinicians with valuable information in assessing CIPN morbidity.
| S-EPMC11316238 | biostudies-literature
Project description:BackgroundThe American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) is one of the most widely used shoulder outcome tools in clinical work and in scientific studies. However, it has not been validated in the Finnish language. The aims of this study were to cross-culturally adapt the ASES to the Finnish language and to study the psychometric properties of the self-report section of the ASES.MethodsA total of 105 patients with shoulder symptoms answered the questionnaires of the ASES, a single disability question, the Simple Shoulder Test (SST), and the Short-Form 36 Health Survey (SF-36). The reliability of the ASES questionnaire was studied using a test-retest procedure at 2-week intervals. Psychometric assessment was performed by testing the construct validity, internal consistency, the criterion validity, and the convergent validity of the ASES.ResultsThe reproducibility and internal consistency of the ASES were 0.83 (95% CI 0.70 to 0.90) and 0.88 (95% Cl 0.84 to 0.91). There were no significant differences between the diagnostic groups in the pain scores from the ASES, and the function score was significantly higher in the instability group compared to the other groups. The convergent validity of the ASES correlated with the SST, r = 0.73 (p < 0.001); the single disability question, r = -0.74 (p < 0.001); and the Physical Component Score of the SF-36, r = 0.57 (p < 0.001).ConclusionsThe Finnish version of the ASES proved to be a reliable and valid tool for assessing shoulder disabilities in patients with different shoulder diagnoses, including rotator cuff disease, instability, and osteoarthritis.
| S-EPMC4243510 | biostudies-literature
Project description:BACKGROUND:The lower-risk (low and intermediate-1 risk based on IPSS) myelodysplastic syndrome (MDS) has a negative impact on patients' health-related quality of life (HRQoL). Patient Reported Outcomes (PROs) instruments, which are used to collect patients' HRQoL data, should have established content validity in the target population to ensure that the instrument is comprehensive and comprehensible. The present study was conducted to evaluate the content validity of the Quality of Life in Myelodysplasia Scale (QUALMS) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An) PRO instruments in patients with lower-risk MDS. METHODS:In this cross-sectional, qualitative study, 16 patients aged ?18?years with lower-risk MDS, who were RBC transfusion dependent, literate and fluent in US-English were interviewed. Interviews were semi-structured comprising of two parts: concept elicitation (CE) explored symptoms and impacts important to patients, and cognitive debriefing (CD) assessed understanding and relevance of the QUALMS and FACT-An. A conceptual model was developed, which was used to map the concepts that emerged during CE onto the QUALMS and FACT-An to assess concept coverage and suitability of the instruments. RESULTS:The median age of participants was 67.5?years (range: 51-91), with half being female (n?=?8). Nine (56.2%) participants had intermediate-1-risk MDS and 10 (62.5%) were relapsed or refractory to erythropoiesis-stimulating agent treatment. Fatigue/tiredness (100.0%), shortness of breath (87.5%), weakness (81.2%), and low energy (75.0%) were reported most commonly and were the most bothersome symptoms as well. Of seven high-level HRQoL domains identified, activities of daily living (n?=?16, 100.0%), physical functioning (n?=?15, 93.8%), emotional wellbeing (n?=?13, 81.3%), social functioning (n?=?12, 75.0%), sleep disturbance (n?=?9, 56.3%), and impact on work (n?=?9, 56.3%) were the most commonly reported. For CD, the QUALMS and FACT-An were found to be mostly relevant and very well understood; response options were easy to use, and recall period was appropriate. CONCLUSION:Both QUALMS and FACT-An demonstrated a strong face and content validity in patients with lower-risk MDS, suggesting that these instruments are appropriate for assessing HRQoL in this population.
| S-EPMC7450032 | biostudies-literature
Project description:OBJECTIVES:To identify patient-reported experience measures (PREMs), assess their validity and reliability, and assess any bias in the study design of PREM validity and reliability testing. DATA SOURCES/STUDY SETTING:Articles reporting on PREM development and testing sourced from MEDLINE, CINAHL and Scopus databases up to March 13, 2018. STUDY DESIGN:Systematic review. DATA COLLECTION/EXTRACTION METHODS:Critical appraisal of PREM study design was undertaken using the Appraisal tool for Cross-Sectional Studies (AXIS). Critical appraisal of PREM validity and reliability was undertaken using a revised version of the COSMIN checklist. PRINCIPAL FINDINGS:Eighty-eight PREMs were identified, spanning across four main health care contexts. PREM validity and reliability was supported by appropriate study designs. Internal consistency (n = 58, 65.2 percent), structural validity (n = 49, 55.1 percent), and content validity (n = 34, 38.2 percent) were the most frequently reported validity and reliability tests. CONCLUSIONS:Careful consideration should be given when selecting PREMs, particularly as seven of the 10 validity and reliability criteria were not undertaken in ?50 percent of the PREMs. Testing PREM responsiveness should be prioritized for the application of PREMs where the end user is measuring change over time. Assessing measurement error/agreement of PREMs is important to understand the clinical relevancy of PREM scores used in a health care evaluation capacity.
| S-EPMC6736915 | biostudies-literature