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PubMed1997

Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis.

The objective of this study is to present and validate a clinical scale for the diagnosis of drug-induced liver injury (DILI). Five components were selected to be included in the scale: temporal relationship between drug intake and the onset of clinical picture, exclusion of alternative causes, extrahepatic manifestations, rechallenge or accidental re-exposure, and previous report in medical literature. The relative importance of each component was weighed, and arbitrary scores were attributed. The probability of the diagnosis of DILI was expressed as a final score, which could vary from -6 to 20. Content validity, criterion validity, construct validity, and inter-rater reliability were studied. To analyze validity and reliability, a random sample of 50 cases of suspected DILI was drawn from a series of 120 cases reported to our unit. The classification of the 50 cases by three experts in DILI was used as the external standard in the study of criterion validity. Agreement between the scale and the standard, and agreement between two independent raters (inter-rater reliability) was analyzed by weighted kappa coefficient. There was agreement between the scale and the standard in 42 cases (84%) with a weighted kappa coefficient of 0.90. A good discriminatory capacity of the scale was found when construct validity was studied. Agreement between raters was observed in 86% of the cases, corresponding to the weighted kappa of 0.93. In conclusion, the clinical scale was shown to have a high-level of validity and inter-rater reliability as well as a good discriminatory capacity between different levels of probability. These data suggest that the scale is suitable for use in clinical practice and may contribute to overcome the difficulties in the process of causality assessment in DILI.

Bias↗

PubMed2004

Prescribing indicators. Development and validation of guideline-based prescribing indicators as an instrument to measure the variation in the prescribing behaviour of general practitioners.

BACKGROUND: Differences in prescribing behaviour among general practitioners (GPs). AIM: To formulate and validate clinical prescribing indicators based on general practice guidelines. DESIGN: Validatory study. SETTING: Pharmacies and general practices in the Netherlands in 2003. PARTICIPANTS: A total of 379 pharmacies, 947 general practices and 3.8 million patients. METHODS: A total of 51 potential indicators were formulated, based on medicinal recommendations from the evidence-based guidelines of the Dutch College of General Practitioners and the corresponding recommendations from the Commission Pharmaceutical Help of the Health Care Insurance Board. These indicators were submitted to an expert panel to assess content validity. The panel assessment was analysed using the RAND-UCLA appropriateness method (RAM). Then, for the remaining indicators, it was assessed to what extent these could be used to determine the prescribing behaviour of GPs and the level to which this behaviour varies among GPs. This was done using a prescribing analyses and cost (PACT) database that was compiled from prescription databases from 379 pharmacies, with all prescriptions from 1,434 GPs over an entire year to 3.8 million patients. RESULTS: The panel considered 34 of the 51 potential indicators to be valid with respect to providing an adequate reflection of the central recommendations in the guideline and in terms of relevance with respect to health gain and/or efficiency. Of these 34 indicators, 20 revealed considerable differences in the prescribing behaviour of GPs. CONCLUSION: On the basis of existing general practice guidelines, 20 prescribing indicators could be formulated that were assessed by an expert panel to be sufficiently valid and which could also discriminate the prescribing behaviour of GPs as reflected in the prescription databases of pharmacies.

Databases, Factual↗

PubMed1992

The Canadian Cardiovascular Society grading scale for angina pectoris: is it time for refinements?

OBJECTIVE: To appraise the measurement properties of the Canadian Cardiovascular Society (CCS) classification of stable angina pectoris. DATA SOURCES: Relevant articles were identified through a MEDLINE search (1976 to November 1991). Bibliographies of retrieved articles were also reviewed. STUDY SELECTION: Studies chosen directly addressed the validity and reliability of the CCS scale. Recent studies and reviews of related topics (for example, silent ischemia) are selectively cited. DATA SYNTHESIS: No data address the scale's applicability, that is, how clinicians typically assign angina grades in practice. Comprehensiveness would be improved by coverage of the patient's perceptions of symptom burden; mixed exertional and rest symptoms; episodic or changing symptoms; and modifying factors. Reliability was assessed in one study with two clinicians; the interobserver, chance-corrected agreement on patient grading was 60%. Content validity (the ability of the scale to measure what it claims) is threatened by the unproven assumption of symptomatic or physiologic equivalence among diverse levels of different activities within any given grade of angina. Construct validity is uncertain, given weak relations between angina grade and noninvasive markers of ischemia, anatomical disease, or prognosis. The scale's responsiveness (the ability to detect the smallest clinically important changes) is limited by the reliance on four coarse gradations based on only ambulation or stair-climbing. CONCLUSIONS: The CCS scale for stable angina might be made more useful by developing measurements for patients' self-rated symptom burden and the changes they deem important; by adding items on clinical instability (that is, progressive symptoms or pain at rest); and by empirically testing the current scale to eliminate redundant or inconsistent elements.

Angina Pectoris↗

PubMed1998

The Norwegian version of the Quality of Life Scale (QOLS-N). A validation and reliability study in patients suffering from psoriasis.

The aim of this study was to adapt, validate, and test for reliability the Quality of Life Scale in Norwegian (QOLS-N) for patients suffering from psoriasis. Two hundred and eighty-two patients with psoriasis were included in the study. Self-reported health was measured using the SF-36. Disease severity was also measured in 95 patients using the Psoriasis Area and Severity Index (PASI). The reliability of the QOLS-N was computed using the internal consistency reliability (Cronbach's alpha) and the test-retest reliability test. Face and content validity and construct discriminant ability of the QOLS-N were assessed. The results indicated that the QOLS-N has highly satisfactory rates of test-retest reliability (r = 0.83) and internal consistency reliability (alpha 0.86). As expected, the QOLS-N had a lower correlation with physical health (r = 0.24, p < 0.000) and self-reported symptoms (r = -0.20, p < 0.001), and a higher correlation with mental health (r = 0.52, p < 0.000). The correlation with disease severity was not significant (-0.06). The results reported in the present paper are in accordance with those derived in other validation studies. The QOLS-N seems to be a reliable and valid measure of global quality of life in patients suffering from psoriasis.

Activities of Daily Living↗

PubMed2005

Assessing reliability and validity of the Chinese version of the stroke scale: scale development.

BACKGROUND: The National Institutes of Health Stroke Scale (NIHSS) is a systematic, 15-point evaluation tool, designed to assess neurological deficit in acute stroke patients and written in English. It is used to support important medical and nursing decisions. OBJECTIVES: To translate the NIHSS into Chinese and establish its psychometric properties using Chinese evaluators. DESIGN: Methodological research design. SETTING: One medical centre. PARTICIPANTS: Using convenience sampling, 48 subjects admitted with acute ischemic stroke were selected. METHODS: In this study, six clinicians from the Department of Neurology (3 nurses, 3 doctors) assessed the 48 patients using the C-NIHSS, the Glasgow Coma Scale and the Barthel index. RESULTS: The C-NIHSS content validity index reached 1.00, and the Cronbach's alpha coefficient for internal consistency was 0.92. Of the 15 scale items, two (facial palsy and limb ataxia) had low inter-rater values (k values below 0.39). Kappa (kappa) values were substantial (over 0.60) for all other items. The C-NIHSS has a significantly negative correlation with both Glasgow Coma Scale (r = -0.824, p < 0.01), and Barthel index (r = -0.683, p < 0.01) scores. CONCLUSIONS: The C-NIHSS is a reliable and valid scale for the clinical assessment of neurological deficit in acute stroke patients.

Activities of Daily Living↗

PubMedDate not supplied

Development and testing of a clinical tool measuring self-management of heart failure.

BACKGROUND: Self-management is a primary goal of treatment for heart failure. Yet no measure of self-management in this patient group currently exists. OBJECTIVES: To develop a clinically useful measure of the abilities of patients with heart failure to manage their disease. Self-management in this context was defined as a cognitive decision-making process undertaken in response to signs and symptoms of heart failure. A panel of experts agreed that the process involved 4 distinct stages: recognizing a change, evaluating the change, implementing a treatment strategy, and evaluating the treatment. The tool was developed to reflect this process. METHODS: Face validity of the process model was assessed in a sample of 25 patients with heart failure and used to develop a 65-item tool with 6 subscales. The subscales measure the 4 stages as well as the patients' ease in evaluating the signs and symptoms and their self-efficacy. The tool was pilot tested with 2 samples of patients with heart failure (N = 17; N = 129). Psychometrics of the final tool were then tested in a sample of 127 patients with heart failure. RESULTS: Face and content validity of the tool were demonstrated adequately through this study. Internal consistency scores of the 6 subscales of the Self-Management of Heart Failure instrument ranged from 0.79 (ease of evaluating treatment) to 0.92 (evaluating the change). Reliability could not be calculated for 1 subscale (evaluating the treatment) because of missing data that resulted from patients skipping sections because they had not experienced a symptom. CONCLUSION: Clinicians interested in evaluating the self-management abilities of their patients with heart failure are encouraged to use this tool and to contribute to additional testing.

Aged↗

PubMed2004

A pilot study to validate modification of the Duke University Severity of Illness scale to measure a family's burden of illness.

BACKGROUND: Measurement of burden of illness is rarely undertaken in general practice, although a specific tool [Duke University Severity of Illness DUSOI scale] has been incorporated in the International Classification in Primary Care. This measures the burden of illness in an individual at a point in time. There has not been any measure of the burden of illness in families. Such an instrument would allow measurement of the impact of events on the health of families. OBJECTIVE: This pilot study aimed to modify the DUSOI to measure a family's burden of illness and to validate any changes. METHODS: The DUSOI was modified to measure the mean burden of illness in a family over a 1 year period. The changes were then subject to a validation process using convenient samples of patients from the author's multidoctor practice in Australia. Reliability was examined by the test-re-test method. Inter-rater reliability could not be assessed. Responsiveness was measured by measuring changes in score in the years before and after four events: counselling for a minor mental health problem; referral to a psychiatrist; diagnosis and treatment of breast cancer; and the occurrence of an acute myocardial infarction. RESULTS: The modifications made to the DUSOI have not altered the face or content validity of the original instrument. Construct validity and test-re-test reliability were satisfactory. Inter-rater reliability was not tested, but the original single patient score showed levels lower than are desirable. Responsiveness varied significantly. Families where a member was referred to a psychiatrist showed a decrease in burden after referral, while families where a member suffered an infarct showed a large increase. The other family groups did not show any change. CONCLUSION: A Family DUSOI will be of value in research when validated for individual conditions.

Australia↗

PubMed1997

[Using "Care Note" to measure the level of satisfaction patients feel with their care, in palliative cancer care, as a measure of their quality of life].

In this study, a new Questionnaire, "Care Note", was developed for palliative cancer care and it was validated in relation to the level of satisfaction in their daily lives felt by patients during supportive care. Care Note and EORTC QLQ-C 30 were administered to 97 patients with various forms of malignant disease (mean age 61, M/F 73/24). They filled in a Care Note questionnaire twice a week, on average they completed 6.77 questionnaires (a total of 657 questionnaires). The average time to answer was 5.49 minutes, and patients compliance was good. Evaluation indices in the first examination (n = 97) were shown as: content validity, test-retest reliability, item-scale correlation revealed discriminant validity and convergent validity with internal consistency, using Cronbach in the range alpha = 0.695-0.814, were proved. Concurrent validity with EORTC QLQ-C 30 was satisfied. A multiple regression analysis showed that social well-being (p < 0.0001) and global quality of life (p = 0.0001) were explanatory valuables for expressing satisfaction in relation to daily life.

Adult↗

PubMed2000

The alcohol use disorders identification test (AUDIT): validation of an instrument for enhancing nursing practice in Hong Kong.

This paper describes the psychometric analysis of the alcohol use disorders identification test (AUDIT) after it was modified for use in Hong Kong and administered to examine the patterns of hazardous and harmful drinking. The modified version of AUDIT was an 18-item instrument in which 10 items were completely adopted from the original version and 8 items were added to improve its cultural sensitivity. It was translated into Chinese and back translation was undertaken to confirm the equivalence of the Chinese and English versions. Following a pilot study the instrument was administered to 450 subjects who were recruited from two acute general hospitals, a University Health Clinic and three community health centres. The content validity was judged as adequate by a panel of five international and local experts and the instrument achieved a high reliability coefficient of 0.99 during a test-retest procedure conducted with 20 subjects. Factor analysis was performed on the responses obtained from 450 subjects which supported the construct validity of the 18-item instrument. The modified instrument had a consistently high internal consistency reliability (Cronbach's alpha=0.96-0.97) when tested in the different settings. It was found that a higher percentage of respondents from the hospitals (14.5%) drank at a hazardous or harmful levels compared to those from the community (6.2%) or the University (5.3%). The AUDIT proved a reliable and valid measure with potential applications in Chinese cultures. Early intervention and identification of 'at risk' drinking by the AUDIT is supported as a strategy to be implemented by nurses in primary and secondary health care settings in Hong Kong, where there are indications of increasing alcohol overuse.

Adolescent↗

PubMed2003

[Standardisation and validation of the German version 2.0 of the Disability of Arm, Shoulder,Hand (DASH) questionnaire].

The Disability of Arm, Shoulder, Hand (DASH) Version 2.0 questionnaire captures the subjective experience of patients regarding their own health. This 78-item instrument was developed by the American Academy of Orthopedic Surgeons (AAOS), the Council of Musculoskeletal Specialty Societies and the Institute for Work and Health,Toronto and measures components of health-status relevant to upper-extremity conditions. We translated and validated DASH with the aim of producing a tool which could also be used in German-speaking countries. The paper reports the method of translation and cross-cultural adaptation which was carried out according to the AAOS guidelines. The result was a standardised German version of DASH. Psychometric testing of the translated questionnaire was carried out with 6 samples (n=342) who had undergone hand surgery for a variety of conditions. The study yielded good results across all groups with regard to the construct, criterion and content validity. We confirm that the German version is suitable for use in future studies.

Adult↗

PubMed2002

Validity of the French-language version of the Quebec back pain disability scale in low back pain patients in France.

OBJECTIVES: The primary objectives were to evaluate the acceptability in France of the Quebec Back Pain Disability Scale (QBPDS) in its original French-language version and to study its correlational validity against indicators of impairment, pain, disability, psychological status, and perceived health status. MATERIAL AND METHODS: Thirty-two patients with chronic low back pain were recruited at the rheumatology outpatient clinic of a French hospital. A physical examination was performed for determination of an impairment score, and scales were completed for pain (visual analog scale and Saint-Antoine Questionnaire), disability (QBPDS and Dallas Scale [DS]), perceived health status (Nottingham Health Profile, NHP), and psychological status (Hospital Anxiety and Depression Scale, HADS). RESULTS: Acceptability, internal consistency, and content validity of the QBPDS were satisfactory. Investigation of correlational validity showed good agreement with the DPQ (r = 0.755) and NHP (r = 0.739) and fair agreement with the impairment score (r = 0.449), the VAS pain score (r = 0.448), and the HADS score (r = 0.473). The QBPDS showed good discriminating power. Validity of the QBPDS was confirmed. DISCUSSION: Our results confirm the good measurement properties of the original French-language version of the QBPDS in French hospital-clinic patients with chronic low back pain. Comparison of the QBPDS and DPQ in this study shows that the QBPDS is better for evaluating disability, whereas the DPQ evaluates the overall, functional, psychological, and social impact of low back pain.

Adult↗

PubMed2001

A preliminary study to investigate the empowerment factors of survivors who have experienced brain damage in rehabilitation.

BACKGROUND: This study was an extension of previous studies on the empowering of families caring for a relative who had experienced brain damage. The demand to adopt a similar empowerment concept in the direct rehabilitation of people with brain damage was proposed. OBJECTIVE: The development of a theory-driven instrument, in the form of a person-administered empowerment questionnaire, so as to establish the empowerment factors of people with brain damage during their rehabilitation process. RESEARCH DESIGN: A kind of methodological study was used to develop, validate and evaluate research tools. This study concentrated on the development of a questionnaire that accurately measures empowerment in people with brain damage. METHODS AND PROCEDURE: This questionnaire derived items from both the existing literature on brain damage rehabilitation and related studies on people coping with brain damage. Open-ended questions were also included to investigate how patients may be encouraged to achieve successful rehabilitation (such as degree of acceptance, learning of adaptive skills and community re-entry). A structural empowerment model has been constructed by both content validity analysis and construct validity through an explorative factor analysis of 112 people with brain damage. MAIN OUTCOME AND RESULTS: A 42-item questionnaire has been developed, constructing four interpretable factors: Support (13 items), Skill (14 items), Aspiration (nine items), and Knowledge (six items), which accounted for 49.99% of the total variance. Analyses of open-ended questions showed that they generally lack external resources and support in the coping process. They did not have sufficient information to face their problems in a variety of areas, although they were quite aware of their importance. They could rely only on personal assets and families, and less on friends, work-mates, and external social resources. CONCLUSION: It is suggested that the results of this initial empowerment framework can either guide ways to improve the case management of patients with brain damage (in terms of structure, methods, and evaluation mechanisms) or assist in the research and design (R&D) of rehabilitation programmes with better efficacy and effectiveness. Further research using Rasch Analysis is suggested to establish item difficulties, and using the findings as an outcome measure in rehabilitation is recommended.

Adaptation, Psychological↗

PubMed2026

Validation of a Turkish Translation of the Stress in Emergency Healthcare Professionals: The Stress Factors and Manifestations Scale.

AIM: The primary duties of emergency healthcare professionals (EHPs) are to provide emergency patient care to acutely ill and injured individuals. Due to the nature of their work, EHPs operate under constant stress, often requiring rapid decision-making, swift action, and the delivery of necessary medical care in life-or-death situations, sometimes under inadequately safe conditions. Therefore, the aim of this study is to determine the validity and reliability of the Emergency Healthcare Professional Stress Factors and Symptoms (SEHP:SFMS) Scale in Turkish for identifying stress factors and symptoms in emergency medical care professionals providing emergency patient care services. DESIGN: A methodological study design was used in this study. METHODS: The study was conducted with the participation of 211 EHPs from employees working in emergency care institutions affiliated with the Muğla Provincial Health Directorate between November 2023 and June 2024. Data were collected via a face-to-face survey. Data were analysed using Lawshe content validity ratio, Kaiser-Meyer-Olkin coefficient, Bartlett test, exploratory factor analysis, principal component analysis, Varimax factor rotation method, confirmatory factor analysis, Cronbach's α internal consistency coefficient, convergent validity, discriminant validity, test-retest, and Spearman correlation coefficient tests. RESULTS: The linguistic translation and cultural adaptation of the SEHP:SFMS showed strong performance. The scope validity index of the scale is 0.83. The item-total correlation values of the scale were found to be between 0.486 and 0.794, and the factor loadings were between 0.474 and 0.816. Confirmatory factor analysis fit indices: χ2 = 248.727; df = 101; n = 211; p = 0.000; χ2/df = 2.463; RMSEA = 0.083; CFI = 0.914, SRMR = 0.052, which was found to be compatible and acceptable with the proposed 3-factor model. The Cronbach's α reliability coefficient of the scale was 0.931, and the total variance was 61.97%. CONCLUSIONS: SEHP:SFMS is a valid and reliable tool to assess stress factors and symptoms of Turkish emergency healthcare professionals. Its use improves the quality of emergency care. PATIENT OR PUBLIC CONTRIBUTION: These study findings have been used to create a tool with Turkish validity and reliability that allows for the examination of stress factors among healthcare professionals working in emergency and critical services. Identifying and reducing stress factors among healthcare professionals is crucial for the delivery of quality healthcare services. It can also be used to develop targeted interventions and ongoing strategies to facilitate improved clinical supervision and mentoring. IMPLICATION FOR NURSING PRACTICE: Nurses in emergency departments, which are among the most stressful, dynamic, intense, life-saving, and critical environments in healthcare institutions, and where life-saving treatment is administered, are at high risk of experiencing psychological trauma. Trauma experienced in the work environment is a significant problem for nursing. The consequences of trauma negatively affect nurses and institutions. Studies show that post-traumatic stress, anxiety, depression, and burnout are commonly observed in emergency department nurses. In this sense, understanding the stress and stress factors experienced by nurses can guide future interventions. The results of this study are considered important in making visible the stress and stress factors experienced by nurses in the emergency department, and also in guiding managers and nurses working in this field in terms of preventive and protective measures.

Humans↗

PubMedDate not supplied

Client satisfaction: traditional care versus cluster care.

The purposes of this study were to describe and compare the level of satisfaction of clients receiving traditional care and those receiving cluster care. None of the studies reviewed described client satisfaction in the traditional and cluster care service delivery models using a reliable and valid instrument. The study sample consisted of 77 Medicaid-eligible elderly clients from three different home care agencies in an urban city. Of the 77 subjects, 37 (48 per cent) received cluster care, and 40 (52 percent) received traditional care. After receiving approval from the home health care agencies, subjects who agreed to participate in the study were asked to sign a consent form and to complete a demographic data sheet and the Gray's Home Care Satisfaction Scale (GHCSS). Internal consistency reliability for the GHCSS is 0.78, with content validity present. An independent student's t test showed a statistically significant difference in the level of satisfaction of clients receiving traditional care and cluster care (t = -5.27, P = .0005). Clients receiving traditional care had higher levels of satisfaction than clients receiving cluster care. Additional findings showed that men in both the traditional and cluster care groups were more satisfied than women (t = -3.19, P = .003 and t = -2.96, P = .007, respectively). Analysis of variance showed that blacks in both the traditional and cluster care groups had lower levels of satisfaction than either whites or Hispanics. Implications of study findings are discussed.

Aged↗

PubMed1996

Functional status in children with limb deficiency: development and initial validation of an outcome measure.

OBJECTIVE: To develop a new outcome measure in response to the increasing demands for cost effectiveness analyses and empirically derived outcome instruments in the treatment of pediatric limb deficiency. This article describes the development, refinement, and initial psychometric properties of the Child Amputee Prosthetics Project-Functional Status Inventory (CAPP-FSI). DESIGN: Parents of children with limb deficiency were surveyed during routine clinic visits. SETTING: Two outpatient pediatric clinics. PARTICIPANTS: Seventy-five parents and their children with limb deficiency (ages 8 to 17 years) participated in the study as part of annual physical evaluations or routine follow-up care. MAIN OUTCOME MEASURE: The newly developed CAPP-FSI. RESULTS: Internal consistency reliability (Cronbach's alpha) = .96 for the CAPP-FSI. Content validity is described and initial construct validity is empirically confirmed. CONCLUSION: The CAPP-FSI is a promising assessment instrument for measuring important health outcomes in children with upper or lower limb deficiency.

Activities of Daily Living↗

PubMed2006

Validity and accuracy of electric response audiometry using the auditory steady-state response: evaluation in an empirical design.

The validity and accuracy of the application of the auditory steady-state response (ASSR) to electric response audiometry (ERA) was tested further in a study permitting subjects to be their own controls for hearing loss. Simulated sensorineural hearing loss (SSHL) of complex configuration and varying degrees was effected using filtered masking noise. Thresholds estimated via ASSR-ERA were compared to those measured via conventional pure-tone audiometry. Further, the slow vertex potential N1-P2 was recorded to permit a comparison with an evoked-response test of common content validity and known accuracy. Results in a homogeneous subject sample demonstrated strong interest correlation and agreement within 10 dB at 1000 to 4000 Hz (on average), but not at 500 Hz. The configurations determined by ASSR-ERA followed behavioral audiometric patterns well, except for the mildest degree of SSHL tested. Consequently, limitations of ERA remain, although ASSR-ERA appears to be quite valid overall and promises (justifiably) broad clinical applicability.

Adolescent↗

PubMed1977

Validating a measure of children's others-concept through population and behavior variables.

Data are presented to support the Paired Hands Test (PHT) as a valid measure of the others-concept in children. This construct is defined as a person's general expectancies or perceptions about other people along a positive-negative continuum. Behavioral data are reported which replicate findings from earlier, smaller studies that children who have relatively high others-concepts are likely to interact more positively in small, unsupervised groups than children having relatively low others-concepts. Population data are also given, based upon 1,235 PHT test scores broken down by such variables as sex and socioeconomic status. Additionally, content validity inherent in the nature of the test is discussed. The conclusion drawn is that the data can be best explained by employing the others-concept as a theoretical construct measured by the PHT.

Journal Article↗

PubMed2003

Shared decision making: developing the OPTION scale for measuring patient involvement.

BACKGROUND: A systematic review has shown that no measures of the extent to which healthcare professionals involve patients in decisions within clinical consultations exist, despite the increasing interest in the benefits or otherwise of patient participation in these decisions. AIMS: To describe the development of a new instrument designed to assess the extent to which practitioners involve patients in decision making processes. DESIGN: The OPTION (observing patient involvement) scale was developed and used by two independent raters to assess primary care consultations in order to evaluate its psychometric qualities, validity, and reliability. STUDY SAMPLE: 186 audiotaped consultations collected from the routine clinics of 21 general practitioners in the UK. METHOD: Item response rates, Cronbach's alpha, and summed and scaled OPTION scores were calculated. Inter-item and item-total correlations were calculated and inter-rater agreements were calculated using Cohen's kappa. Classical inter-rater intraclass correlation coefficients and generalisability theory statistics were used to calculate inter-rater reliability coefficients. Basing the tool development on literature reviews, qualitative studies and consultations with practitioner and patients ensured content validity. Construct validity hypothesis testing was conducted by assessing score variation with respect to patient age, clinical topic "equipoise", sex of practitioner, and success of practitioners at a professional examination. RESULTS: The OPTION scale provided reliable scores for detecting differences between groups of consultations in the extent to which patients are involved in decision making processes in consultations. The results justify the use of the scale in further empirical studies. The inter-rater intraclass correlation coefficient (0.62), kappa scores for inter-rater agreement (0.71), and Cronbach's alpha (0.79) were all above acceptable thresholds. Based on a balanced design of five consultations per clinician, the inter-rater reliability generalisability coefficient was 0.68 (two raters) and the intra-rater reliability generalisability coefficient was 0.66. On average, mean practitioner scores were very similar (and low on the overall scale of possible involvement); some practitioner scores had more variation around the mean, indicating that they varied their communication styles to a greater extent than others. CONCLUSIONS: Involvement in decision making is a key facet of patient participation in health care and the OPTION scale provides a validated outcome measure for future empirical studies.

Decision Making↗