Condition-specific Outcome Measures Research Articles

Shoulder Outcomes Measures

General health as well as disease- or condition-specific outcome measures have long been used to assess patients with shoulder conditions. Currently, a variety of validated measures is available. Shoulder outcomes measures may be general (eg, American Shoulder and Elbow Surgeons; Constant; Disabilities of the Arm, Shoulder, and Hand), disease-specific (eg, Rotator Cuff Quality of Life, Western Ontario Rotator Cuff Index), or condition-specific (eg, Oxford Shoulder Instability Questionnaire). The results of shoulder arthroplasty and arthritis treatment can be assessed with the Hospital for Special Surgery score and the validated Western Ontario Osteoarthritis of the Shoulder Index. Combining a general health outcome measure, a general shoulder measure, a disease- or condition-specific shoulder measure, and an activity measure allows for broad patient assessment.

Factors associated with satisfaction in patients undergoing elbow surgery: A prospective study

Evidence on factors associated with patient satisfaction with elbow surgery is sparse; outcomes of surgery are not necessarily related to patient satisfaction. This study explored the hypothesis that condition-specific outcome measures would more closely reflect patient satisfaction than generic measures. The prospective cohort comprised 104 consecutive patients/elbows undergoing elbow surgery. Preoperative and 6 month postoperative outcome questionnaires included the Oxford Elbow Score (OES), Disabilities of the Arm, Shoulder and Hand (DASH), and Short Form (SF)-36 general health survey. Clinical assessments used the standard Mayo Elbow Performance Score (MEPS). Patients who were "very pleased" with surgery were compared with others regarding which factors were associated with being "very pleased" at 6 months after surgery. By 6 months, 54% of patients were very pleased with their surgery. Preoperative scores were generally not associated with subsequent patient satisfaction. Postoperative scores and change scores for the OES Pain and Social-Psychological scales and the DASH were moderately to highly correlated with patient satisfaction (r(s), -0.43 to -0.72; all P < .001), whereas SF-36 and MEPS change scores were only correlated to a small extent (r < or = 0.34; all P < .05). A multivariable analysis revealed that patients' age, postoperative elbow pain, and change in elbow function each independently influenced the odds of patients being very pleased with surgery. Associations between outcome measures and patient satisfaction revealed likely differences between patients' and clinicians' perceptions of which aspects of outcome rated as important. Patient-reported results are more likely than clinically assessed outcome measures, and condition-specific are more likely than generic measures, to reflect patient-rated satisfaction with elbow surgery.

Outcome Measures in Facial Plastic Surgery

To survey the existing literature to identify, summarize, and evaluate procedure- and condition-specific outcome measures for use in facial plastic and reconstructive surgery. A review of the English-language literature was performed to identify outcomes instruments specific for targeted facial plastic surgery interventions and conditions. A search was performed using MEDLINE (1950 to September 2007), CINAHL (Cumulative Index to Nursing & Allied Health) (1982 to September 2007), and PsychINFO (1806 to September 2007). Outcomes instruments were categorized as patient-reported or clinical efficacy measures (observer-reported or objective measures). Instruments were then categorized to include relevant details on the intervention, degree of validation, and subsequent use. Sixty-eight distinct instruments were identified (23 patient-reported, 35 observer-reported, and 10 objective measures), with some overlap among categories. Most patient-reported measures (76%) and half observer-reported instruments (51%) were developed in the past 10 years. The rigor of validation varied widely among measures, with formal validation being most common among the patient-reported outcome measures. Validated outcomes measures are present for many common facial plastic surgery conditions and have become more prevalent during the past decade, especially for patient-reported outcomes. Challenges remain in harmonizing patient-reported, observer-based, and other objective measures to produce standardized clinically meaningful outcome measures.

EuroQol EQ-5D and condition-specific measures of health outcome in women with urinary incontinence: reliability, validity and responsiveness

To evaluate the measurement properties of the EuroQoL EQ-5D and two condition-specific patient-reported outcome measures--the Symptom Severity Index (SSI) and the Urinary Incontinence-Specific Quality of Life instrument (I-QoL)--in women with urinary incontinence. A questionnaire comprising all instruments was completed by women taking part in a clinical trial of physiotherapy for urinary incontinence. Follow-up questionnaires were at 6 weeks and 5 months. Data quality, internal consistency reliability, validity and responsiveness were assessed. One hundred and seventy-four patients taking part in the clinical trial completed the questionnaire. Instruments had low levels of missing data. The EQ-5D had a large ceiling effect and poor responsiveness. The SSI had poor validity and responsiveness. The I-QoL had levels of reliability that supported application in group assessment, and in some cases, individual assessment, and good evidence of validity. The I-QoL was the most responsive instrument at both 6 weeks and 5 months. The I-QoL was the best performing instrument and is recommended as a continence-specific measure of quality of life in a clinical trial setting. The SSI and EQ-5D are not recommended. Alternative generic instruments, which support economic evaluation, require further evaluation in trials of female urinary incontinence.

Reliability and Validity of the Vulvar Functional Status Questionnaire (VQ)

Objective: This study describes the development of a functional outcome measure addressing the physical dimension of chronic vulvar pain, and explores the psychometric properties of the instrument. Study Design: Descriptive, correlational. Background: As many as 16% of women experience noninfectious vulvar pain. Existing studies of treatment effectiveness primarily measure impairment, and there are no published condition-specific functional outcome measures for vulvar pain. Methods and Measures: Sixty women with vulvar pain completed the questionnaire, the McGill Pain Questionnaire, and the Rand 36 scales before intake physical therapy examination, and again within 24 hours. Twenty-nine subjects repeated all of the measurement instruments again after 4 to 6 weeks of physical therapy treatment. Test-retest reliability, internal consistency, correlations among the instruments, and construct validity were all evaluated. Results: The VQ demonstrated desirable internal consistency with a Cronbach's alpha of 0.75, and 87% agreement on test-retest. Fair correlations existed between the VQ and the general health, physical function, role limits physical, and bodily pain subscales of the Rand 36 (r = -0.32, r= -0.27, r = -0.49, r = -0.48, respectively) and between the VQ and the McGill Pain Questionnaire (r= 0.26). Patients who self-rated their improvement higher after 4 to 6 weeks of physical therapy had better scores on the VQ. Conclusions: The VQ has sufficient internal consistency, test-retest reliability, and validity to be useful for women's health physical therapists. Further validation is necessary to investigate its relative psychometric properties among women with different subtypes of vulvar pain.

Measuring health-related quality of life in bipolar disorder: Relationship of the EuroQol (EQ-5D) to condition-specific measures

Generic utility measures of health-related quality of life provide an independent net valuation of health states. They are increasingly used with condition-specific outcome measures in assessing treatments. In Bipolar Disorder, a few studies indicate poorer quality of life for depressed vs. euthymic patients. A single study suggests mania is less negative than depression. This analysis examines the relationship of one such scale, the EuroQol (EQ-5D), to objective and subjective measures of depression and mania in 221 Bipolar subjects, recently or still in an episode of illness. Depressed patients showed a very poor quality of life (median EQ-5D Index score 0.41). Index and Visual Analogue scores improved significantly as level of depression decreased (Jonckheere-Terpstra test p<0.001). Both scores were significantly negatively related to all depression measures. Patients reported problems across all areas of life covered by the EQ-5D. No such relationships were observed between EQ-5D scores and mania measures, though all mania measures were inter-related. However, the range of mania shown was quite restricted. The EQ-5D is a useful measure of quality of life for Bipolar patients suffering from depression. Conclusions about the role of the EQ-5D in mania are restricted by the limited range of mania observed.

Vision and Quality of Life: The Development of a Utility Measure

To identify the content for a vision and quality of life-related utility measure (Vision Quality of Life Index [VisQoL]) for the economic evaluation of eye care and rehabilitation programs. Focus groups of the visually impaired elicited key concepts. Based on these and previous research, 33 items were generated. These were administered to visually impaired adults (n = 70) and a representative sample of unimpaired adults (n = 86). The item bank was reduced through examination of item properties, exploratory factor (EFA), item response theory (IRT), and structural equation modeling (SEM) analyses. The resultant model was confirmed through administration to a second sample of participants. Focus group themes included physical well-being, social well-being, independence, self-actualization, emotional well-being, and planning and organization. Poorly performing items were eliminated on basic psychometric properties, including failure to discriminate. Next, EFA loadings were used to select items. Twelve items survived. To minimize redundancy, IRT analysis and SEM reduced the VisQoL item pool to six items (Cronbach alpha = 0.88). To confirm this model, these items were then administered to an additional 218 participants; 35% with a vision impairment. A pooled SEM analysis showed the model to have very good fit properties (root mean square error of approximation [RMSEA] = 0.000). A preliminary test of the model against visual acuity showed a significant monotonic relationship. The short 6-item VisQoL has excellent psychometric properties as a simple summative instrument. It can be used in its present state as a condition-specific outcome measure for the evaluation of healthcare interventions for the visually impaired. The descriptive model is also suitable for generating utility values for the economic evaluation of vision-related programs and services.

Souter-Strathclyde total elbow arthroplasty in rheumatoid arthritis

We present the outcome of 47 Souter-Strathclyde replacements of the elbow with a mean follow-up of 82 months (12 to 129). The clinical results were assessed using a condition-specific outcome measure. The mean total score (maximum 100) before the operation was 47.21 and improved to 79.92 (p < 0.001). The mean pain score (maximum 50) improved from 21.41 to 46.70 (p < 0.001) and the mean functional component of the score (maximum 30) from 11.19 to 18.65 (p < 0.001). There was negligible change in the score for the range of movement although a significant improvement in mean flexion from 124 degrees to 136 degrees was noted (p < 0.001). Revision surgery was required in four patients, for dislocation, wound dehiscence and early infection in one, late infection in two and aseptic loosening in one. The cumulative survival was 75% at nine years for all causes of failure and 97% at ten years for aseptic loosening alone. Our study demonstrates the value of the Souter-Strathclyde total elbow arthroplasty in providing relief from pain and functional improvement in rheumatoid patients.

Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee.

The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The purpose of this study was to determine the psychometric properties of the Lysholm knee scale for various chondral disorders of the knee. Test-retest reliability, internal consistency, content validity, criterion validity, construct validity, and responsiveness to change were determined for the Lysholm knee scale within subsets of an overall study population of 1657 patients with chondral disorders of the knee. The study population was a heterogeneous group of patients with various types of traumatic and degenerative chondral lesions, including isolated lesions and those associated with meniscal and ligament injuries. The overall Lysholm knee scale and six of the eight domains had acceptable test-retest reliability (intraclass correlation coefficient = 0.91) and internal consistency (Cronbach alpha = 0.65). The overall Lysholm knee scale demonstrated acceptable floor (0%) and ceiling (0.7%) effects; however, the floor effects for the domain of squatting and the ceiling effects for the domains of limp, instability, support, and locking were unacceptable (>30%). There was acceptable criterion validity with significant (p < 0.05) correlations between the overall Lysholm knee scale and the physical functioning, role-physical, and bodily pain domains of the Short Form-12 scale; the pain, stiffness, and function domains of the Western Ontario and McMaster Universities Osteoarthritis Index; and the Tegner activity scale. The overall Lysholm knee scale had acceptable construct validity, with all nine hypotheses demonstrating significance (p < 0.05), and it had acceptable responsiveness to change (effect size, 1.16; standardized response mean, 1.10), with large effects (> or = 0.80) for the domains of pain, limping, swelling, and squatting and a small effect (> or = 0.20) for the domain of instability. The Lysholm knee scale demonstrated overall acceptable psychometric performance for outcomes assessment of various chondral disorders of the knee, although some domains demonstrated suboptimal performance. Psychometric testing of other condition-specific knee instruments in patients with chondral disorders of the knee would be helpful to allow for comparison of psychometric properties.

Condition-specific outcome measures for low back pain. Part II: scale construction.

A literature review of the most widely used, condition-specific, self-administered assessment questionnaires for low back pain has been undertaken. In part I, technical issues such as validity, reliability, availability and comparability were analyzed for the nine most widely used outcome tools. This second part focuses on the content and wording of questions and answers in each of the nine questionnaires, and an analysis of the different score results is performed. The issue of score bias is discussed and suggestions are given in order to increase the construct validity in the practical use of the individual questionnaires.

Condition-specific outcome measures for low back pain. Part I: validation.

A literature review of the nine most widely used, condition-specific, self-administered assessment questionnaires for low back pain has been undertaken. General and historic aspects, reliability, responsiveness and minimum clinically important difference, external validity, floor and ceiling effects and available languages were analysed for the nine most-used outcome tools. When considering which condition-specific measure to employ, the present overview on assessment tools should provide the necessary information to define the technical aspects of the nine questionnaires. These criteria, however, are only part of the consideration. In part II the construction of these scales in relationship to the measurement domains will be evaluated.

Validity and feasibility of the use of condition-specific outcome measures in economic evaluation.

Usually, generic questionnaires such as the EQ-5D or Health Utility Index (HUI) are used to obtain utility scores for computing QALYs. Sometimes, however, application of these instruments is not possible, or the responsiveness is doubted. An alternative strategy is to attribute utility scores to health states of a condition-specific outcomes measure (CSOM). We explored the validity and feasibility of this strategy. Our samples determined utility scores for the health states of the International Index of Erectile Function (IIEF) using time tradeoff (TTO). To reduce costs and time, the general population (n = 169) was interviewed in groups. We tested the validity of the group sessions in students. To test the extent of agreement between values obtained using the group and those obtained through individual administration, 63 students were interviewed individually and 54 in groups. The utility scores for the disease-specific health states showed good construct validity. Also, the criterion validity of the adapted TTO was confirmed. Disease-specific utility scores can be used in QALY analysis by converting them to a generic scale. Efforts should be undertaken to prevent response spreading. Administrating TTO in groups could reduce the time and costs of TTO administration and render the strategy of determining utilities for condition-specific health states more feasible.

Symptom status and functional status outcomes: humanistic outcomes in obesity disease management.

Introduction Obesity is a complex, chronic health problem that is associated with increased mortality, morbidity, and health care costs, as well as decreased life quality (1–6). “The pathway to obesity is a complex journey,” involving biologic and genetic, emotional, social, and cultural factors (7). Changes in the U.S. health care delivery system, including managed care or disease management approaches, necessitate the development of systems that can be used to assess quality of care and demonstrate accountability in the health care of obese populations. Inherent in this is the identification of outcome, intermediate, and process measures (8,9). Disease management outcome measures must meet identified standards for scientific validity, relevance, and feasibility as outlined in the charge to the Team on Developing Obesity Outcomes and Learning Standards (TOOLS) Task Force of the North American Association for the Study of Obesity (NAASO) (10). The purpose of this paper is to recommend obesity disease management outcome measures to assess symptom status and functional status of populations in outcomes research evaluating the effectiveness of the management of obesity (grades I to III).

Regarding: "The Intermittent Claudication Questionnaire: A patient-assessed conditionspecific health outcome measure"

The work reported by Dr Chong and his colleagues in this issue ofthe Journal of Vas cuI a r Surgery represents an important step fonvard for our patients with intermittent claudication. Whereas in the recent past we have mea­ sured success in their care largely with physician-cen­ tered metrics, we will now, with confidence in the valid­ ity of the measures, be able to refine our assessment of their overall well being as it pertains to their arterial disease. Intermittent claudication is not a life-threatening dis­ ease in and of itself. For patients who are relatively asymp­ tomatic from their burden of atherosclerosis in other arte­ rial beds and from other comorbid conditions, however, intermittent claudication does threaten the quality of life. Without serial assessment of the perception of quality oflife of a patient with claudication, physicians purporting to treat or follow the progress of the disease will have an incomplete picture of its course and effect on the patient. It is for this reason that the Trans-Atlantic Consensus Con­ ference on Clinical Trials in Peripheral Artery Disease} recommended that disease-specific functional health mea­ surement should be an integral part of primary outcome measurement in intermittent claudication. Functional health and health-related quality oflife as­ sessment have been topics of general interest tor many years. One might argue that there was no need for addi­ tional time, effort, and journal pages to be devoted to the development and reporting of an additional instrument for assessing these dimensions 111 patients with intermittent claudication. There are several reasons why this is not the case. First, existing instruments are frequently insensitive

Extending the Aberdeen Back Pain Scale to include the whole spine: a set of outcome measures for the neck, upper and lower back

Many therapists treat the spine as a ‘functional unit’, but suitable condition-specific outcome measures for the whole spine are not available. One of the most rigorously tested measures for back pain related health status is the Aberdeen Back Pain Scale, but it is only suitable for the lower back. The Aberdeen Back Pain Scale was extended to create a set of interlocking outcome measures for the neck, upper and lower back. Questions in these extended outcome measures had to fulfil a series of psychometric criteria before being accepted into the final questionnaires. This involved response frequency, item-total correlation and principal component analysis. The final questionnaires were tested for reliability, criterion and construct validity, responsiveness and acceptability, on patients attending a primary care musculoskeletal clinic. One question was discarded from all three sets of questionnaires and a further question was removed from the neck questionnaire. Baseline scores approximated to normal distributions. Although not completely reproducible, they were internally consistent, so showed evidence of reliability. They were highly correlated with the SF-12 and their mean scores changed according to whether their health status, measured by a transition question, improved, stayed the same or worsened. Modified standardised response means showed large changes when health status improved and moderate-sized changes when health status worsened. Patients made few adverse comments about the questionnaires and found them acceptable. The Extended Aberdeen Spine Pain Scales for neck, upper and lower back pain, showed evidence of reliability, validity, responsiveness and acceptability. They can be used for single regions of the spine or combined as clinically necessary. They are particularly recommended for primary care patients.

Generic and condition-specific outcome measures for people with osteoarthritis of the knee.

The aims of this study were to evaluate two condition-specific and two generic health status questionnaires for measuring health-related quality of life in patients with osteoarthritis (OA) of the knee, and to offer guidance to clinicians and researchers in choosing between them. Patients were recruited from two settings: 118 from knee surgery waiting lists and 112 from rheumatology clinics. Four self-completion questionnaires [Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36) and Euroqol] were sent to subjects on two occasions 6 months apart. Construct validity, convergent validity, internal consistency and responsiveness were examined using primarily non-parametric methods. All instruments proved satisfactory in terms of ease of use, acceptability to patients, internal consistency and reliability. In the surgical group, the OA-specific WOMAC performed better than the HAQ and the generic measures in terms of validity and responsiveness to change, whereas in the rheumatology group the SF-36 was more responsive. WOMAC is the instrument of choice for evaluating the outcome of knee replacement surgery in OA. The SF-36 provides a more general insight into patients' health and may be more responsive to change than the WOMAC in a heterogeneous rheumatology clinic population. Researchers wishing to undertake an economic evaluation might consider the EQ-5D for a surgical, but not a rheumatology clinic group.

Integrating Clinical Performance Improvement Across Physician Organizations: The PhyCor Experience

There is a paucity of literature describing the implementation of clinical performance improvement (CPI) efforts across geographically dispersed multispecialty group practices and independent practice associations. PhyCor, a physician management company based in Nashville, Tennessee, has integrated CPI initiatives into its operating infrastructure. PhyCor CPI INITIATIVES: The strategic framework guiding PhyCor's CPI initiatives is built around a physician-driven, patient-centered model. Physician/administrator leadership teams develop and implement a clinical and financial strategic plan for performance improvement; adopt local clinical and operational performance indicators; and agree on and gain consensus with local physician champions to engage in CPI initiatives. The area/regional leadership councils integrate and coordinate regional medical management and CPI initiatives among local groups and independent practice associations. In addition to these councils and a national leadership council, condition-specific care management councils have also been established. These councils develop condition-specific protocols and outcome measures and lead the implementation of CPI initiatives at their own clinics. Key resources supporting CPI initiatives include information/knowledge management, education and training, and patient education and consumer decision support. Localized efforts in both the asthma care and diabetes management initiatives have led to some preliminary improvements in quality of care indicators. Physician leadership and strategic vision, CPI-oriented organizational infrastructure, broad-based physician involvement in CPI, providing access to performance data, parallel incentives, and creating a sense of urgency for accelerated change are all critical success factors to the implementation of CPI strategies at the local, regional, and national levels.

Clinics in Musculoskeletal Medicine: What Outcomes Should Be Measured?

AbstractA primary care based musculoskeletal clinic has been set up in North Wales. Patient-based outcome measures are increasingly used for audit and research. What combination of outcome measures should be used in musculoskeletal clinics? Generic and condition-specific outcome measures were used before and after a course of treatment in the clinic. 57 patients completed SF-36 before and 35 after treatment. Only physical function, physical role and bodily pain scales improved significantly (standardised response means 0.47, 0.51 and 0.68). 79 completed SF-12 before and 29 after treatment. Both physical and mental health scores improved significantly (standardised response mean 0.47). 132 completed the Short-form McGill Pain Questionnaire before and 59 after treatment (standardised response mean for total verbal scale 0.6). 54 completed the Aberdeen Back Pain Scale before and 32 after treatment (standardised response mean 0.64). The SF-12, Short-form McGill Pain Questionnaire and the Aberdeen Back Pain Sc...

Pros and cons of condition-specific outcome measures

Pros and cons of condition-specific outcome measures

The use of condition specific outcome measures in economic appraisal.

Despite growing concern over the use of health utility measures in economic evaluations of health care programmes, economists have been reluctant to use the wealth of knowledge contained within studies using condition specific outcome measures (CSOMs). Problems with the measurement properties of many CSOMs means that the scope for their use in economic appraisal is extremely limited. This paper examines the potential uses of CSOMs in economics, namely: to provide valid descriptive material, to provide scales for comparing the effectiveness of interventions and to 'validate' the descriptive accuracy of economic measures of benefit. It is argued that valid descriptive information is essential for economic appraisal, no matter which method of evaluation is used. Generic measures have been criticised for being too narrow and insensitive to the consequences of specific conditions. CSOMs offer a rich source of information to produce quality adjusted life years (QALYs) but two potential methods, one of mapping health states from one scale to a QALY classification (such as Rosser), and the other, developing 'exchange rates' between scales are unsatisfactory. A more rigorous approach would necessitate a major research programme of revaluing existing CSOMs using preference based methods. Another interesting avenue of research would be to use the information from CSOMs to construct health scenarios for valuation. Given the current state of development of outcome measures, it seems advisable to use CSOMs alongside economic measures in trials. Such a strategy would help demonstrate the usefulness of economic measures to clinicians and to reconcile the two measures.