Evaluation of the Psychometric Properties of the Functional Assessment of Cancer Therapy-Cervix Questionnaire in Brazil

Background

Although cervical cancer is ​​the second most common tumor among Brazilian women, studies that evaluate the quality of life of these women are still scarce. This situation is explained by the lack of specific and validated tools for this purpose in Portuguese (Brazil). The aim of this study was to evaluate the psychometric properties of the Portuguese version of the FACT-CX (Functional Assessment of Cancer Therapy-Cervix) questionnaire in a population of Brazilian women with cervical cancer.

Methods

The psychometric properties of the FACT-CX questionnaire were tested in a sample of 100 women diagnosed with cervical cancer who were previously treated in the Barretos Cancer Hospital. We analyzed the internal consistency (Cronbach''s alpha), reproducibility (intraclass correlation coefficient - ICC), confirmatory factor analysis, convergent validity (correlation with the SF-36 questionnaire), and discriminant validity by disease stage and two questions related to self-perception of health was also performed.

Results

The scales had Cronbach´s alpha coefficients ranging from 0.61 to 0.80. However, three scales did not have a statistically significant coefficient greater than 0.70. The ICC ranged from 0.68 to 0.82 and all considered satisfactory. Factor analysis did not generate consistent components. The FACT-G and FACT-CX total scores had good internal consistency and reproducibility, and also correlated well with the General Health and Vitality scales of the SF-36. However, only two FACT-CX scales had a significant correlation with SF-36. Discriminant analysis showed that FACT-CX failed to discriminate groups according to clinical stage but was able to divide the women according to the self-perception of health.

Conclusion

FATC-CX total score had good internal consistency, reproducibility and discriminant validity. In addition, it correlated well with General Health and Vitality scales of SF-36. However, three scales had questionable internal consistency and only two had significant correlation with SF-36.     

Is the Concept of Quality of Life Relevant for Multiple Sclerosis Patients with Cognitive Impairment? Preliminary Results of a Cross-Sectional Study

Background

Cognitive impairment occurs in about 50% of multiple sclerosis (MS) patients, and the use of self-reported outcomes for evaluating treatment and managing care among subjects with cognitive dysfunction has been questioned. The aim of this study was to provide new evidence about the suitability of self-reported outcomes for use in this specific population by exploring the internal structure, reliability and external validity of a specific quality of life (QoL) instrument, the Multiple Sclerosis International Quality of Life questionnaire (MusiQoL).

Methods

Design: cross-sectional study. Inclusion criteria: MS patients of any disease subtype. Data collection: sociodemographic (age, gender, marital status, education level, and occupational activity) and clinical data (MS subtype, Expanded Disability Status Scale, disease duration); QoL (MusiQoL and SF36); and neuropsychological performance (Stroop color-word test). Statistical analysis: confirmatory factor analysis, item-dimension correlations, Cronbach''s alpha coefficients, Rasch statistics, relationships between MusiQoL dimensions and other parameters.

Principal Findings

One hundred and twenty-four consecutive patients were enrolled. QoL scores did not differ between the 69 cognitively non-impaired patients and the 55 cognitively impaired patients, except for the symptoms dimension. The confirmatory factor analysis performed among the impaired subjects showed that the structure of the questionnaire matched with the initial structure of the MusiQoL. The unidimensionality of the MusiQoL dimensions was preserved, and the internal validity indices were satisfactory and close to those of the reference population.

Conclusions/Significance

Our study suggests that executive dysfunction did not compromise the reliability and the validity of the self-reported QoL questionnaires.     

Relevance of Quality of Life Assessment for Multiple Sclerosis Patients with Memory Impairment

Background

Memory disturbances, in particular episodic verbal memory dysfunction, are the most frequent cognitive impairment observed in multiple sclerosis (MS) patients. The use of self-reported outcomes for evaluating treatment and managing care of these subjects has been questioned. The aim of this study was to provide new evidence about the suitability of self-reported outcomes for use in this impaired population by exploring the internal structure, reliability and external validity of a specific quality of life (QoL) instrument, the Multiple Sclerosis International Quality of Life questionnaire (MusiQoL).

Methods

Design: cross-sectional study. Inclusion criteria: MS patients of any disease subtype. Data collection: sociodemographic (age, gender, marital status, education level, and occupational activity) and clinical data (MS subtype, Expanded Disability Status Scale, disease duration); QoL (MusiQoL and SF36); and memory performance (Grober and Buschke test). In accordance with the French norms of the memory test, non-impaired and impaired populations were defined for short- and long-delay free composites and for short- and long-delay total composites. For the 8 populations, psychometric properties were compared to those reported from the reference population assessed in the validation study.

Principal Findings

One hundred and twenty-four consecutive patients were enrolled. The analysis performed in the impaired populations showed that the questionnaire structure adequately matched the initial structure of the MusiQoL. The unidimensionality of the dimensions was preserved, and the internal/external validity indices were close to those of the reference population.

Conclusions/Significance

Our study suggests that memory dysfunction did not compromise the reliability or validity of the self-reported QoL questionnaires.     

The reliability and validity for Japanese type 2 diabetes patients of the Japanese version of the acceptance and action diabetes questionnaire

Background

The purpose of this study was to determing which psychological traits of Japanese type 2 diabetes patients would provide reliability and validity to the Japanese version of the Acceptance and Action Diabetes Questionnaire (AADQ-J).

Methods

Various questionnaires were administered to type 2 diabetes patients who were registered on the database of the research service provider; data from a total of 600 patients (mean?±?SD age was 57.50?±?9.87 years, female 21.83%) were analyzed.

Results

Three items were excluded because of psychometric concerns related to the original 11-item AADQ. Confirmation factor analyses revealed that the eight-item version demonstrated the best indicators of a goodness of fit. The questionnaire showed adequate internal consistency. The questionnaire demonstrated high measurement accuracy in broad trait values by the test information function of Item Response Theory. The questionnaire showed stronger positive correlations with self-care activities and HbA1c than with diabetes distress and depressive mood.

Conclusions

The eight-item Japanese version of AADQ has reliability and validity for type 2 diabetes patients.

     

The Quality of Life of Men Who Have Sex with Men in China: Reliability and Validity Testing of the SF-36 Questionnaire

Objective

The aim of the study was to assess the psychometric properties of the 36-Item Short Form Health Survey (SF-36) in the men who have sex with men (MSM) population in China.

Methods

A cross-sectional survey was conducted among 373 MSM from September to December, 2012, in Zhengzhou and Huludao City, China. Internal reliability of the questionnaire was calculated by Cronbach’s α coefficient. Validity was analyzed through construct validity, divisional validity, and collective validity testing.

Results

The overall Cronbach’s α coefficient of the SF-36 questionnaire was 0.943, while the Cronbach’s α coefficients for each of the dimensions were all > 0.70. Results showed that the SF-36 questionnaire was reliable and valid.

Conclusions

This study provided evidence that the SF-36 is an acceptable, valid and reliable instrument in evaluating the quality of life of MSM in Mainland China.     

Trunk rotational strength asymmetry in adolescents with idiopathic scoliosis: an observational study

Background

Body image and HRQL are significant issues for patients with scoliosis due to cosmetic deformity, physical and psychological symptoms, and treatment factors. A selective review of scoliosis literature revealed that self report measures of body image and HRQL share unreliable correlations with radiographic measures and clinician recommendations for surgery. However, current body image and HRQL measures do not indicate which aspects of scoliosis deformity are the most distressing for patients. The WRVAS is an instrument designed to evaluate patient self assessment of deformity, and may show some promise in identifying aspects of deformity most troubling to patients. Previous research on adolescents with scoliosis supports the use of the WRVAS as a clinical tool, as the instrument shares strong correlations with radiographic measures and quality of life instruments. There has been limited use of this instrument on adult populations.

Methods

The WRVAS and the SF-36v2, a HRQL measure, were administered to 71 adults with scoliosis, along with a form to report age and gender. Preliminary validation analyses were performed on the WRVAS (floor and ceiling effects, internal consistency and collinearity, correlations with the SF-36v2, and multiple regression with the WRVAS total score as the predictor, and SF-36v2 scores as outcomes).

Results

The psychometric properties of the WRVAS were acceptable. Older participants perceived their deformities as more severe than younger participants. More severe deformities were associated with lower scores on the Physical Component Summary Score of the SF-36v2. Total WRVAS score also predicted Physical Component Summary scores.

Conclusion

The results of the current study indicate that the WRVAS is a reliable tool to use with adult patients, and that patient self assessment of deformity shared a relationship with physical rather than psychological aspects of HRQL. The current and previous studies concur that revision of the WRVAS is necessary to more accurately represent the diversity of scoliosis deformities. Ability to identify disturbing aspects of deformity could potentially be improved by evaluating each WRVAS items against indicators of pain, physical/psychosocial function, and self image from previous measures such as the SRS, SF-36 or BSSQ-deformity.     

Development of a novel,short, self-completed questionnaire on empowerment for patients with type 2 diabetes mellitus and an analysis of factors affecting patient empowerment

Background

Patient empowerment has recently been proposed as an important concept in self-management for effective glycemic control. A concise self-completed questionnaire for patients with type 2 diabetes mellitus was created to comprehensively evaluate their empowerment on the basis of self-managed dietary/exercise behaviors, psychological impact, and family support. The reliability and validity of this short questionnaire were tested and factors relating to patient empowerment were analyzed.

Methods

The self-completed empowerment questionnaire was based on questionnaires for self-managed dietary and exercise behaviors, the Appraisal of Diabetes Scale, and the Diabetes Family Behavior Checklist. The questionnaire was trialed on 338 male and female patients with type 2 diabetes mellitus who lived with family. The validity and reliability of the questionnaire were investigated and stepwise multiple linear regression analysis was used to identify factors that affect patient empowerment.

Results

The self-completed patient empowerment questionnaire included 13 questions on background data (e.g., age, gender, and HbA1c) and 18 questions within five scales to assess self-managed dietary behaviors, self-managed exercise behaviors, and psychological impact of diabetes, as well as positive and negative feedback in patient-family communication. The questionnaire showed sufficient internal consistency, construct validity, reproducibility, factorial construct validity, and concurrent validity. The results were generally satisfactory, and the questionnaire reflected the particular characteristics of treatment methods. Multiple linear regression analysis showed that patient empowerment was strongly affected by the number of disease-related symptoms, age, and gender.

Conclusions

The results suggest that the concise self-completed empowerment questionnaire developed here is useful for measuring the empowerment of individual patients and evaluating the impact of symptoms and therapies on empowerment.

     

Hospital staff education on severe sepsis/septic shock and hospital mortality: an original hypothesis

Background

The Functional Comorbidity Index (FCI) was recently developed to predict physical function in acute lung injury patients using comorbidity data. Our objectives were to determine: (1) the inter-rater reliability of the FCI collected using in-patient discharge summaries (primary objective); and (2) the accuracy and predictive validity of the FCI collected using hospital discharge summaries and admission records versus complete chart review (secondary objectives).

Methods

For reliability, we evaluated the FCI’s intraclass correlation coefficient (ICC) among trained research staff performing data collection for 421 acute lung injury patients enrolled in a prospective cohort study. For validity and accuracy, we compared the detection of FCI comorbidities across three types of inpatient medical records, and the association of the respective FCI scores obtained with patients’ SF-36 physical function subscale (PFS) scores at 1-year follow-up.

Results

Inter-rater reliability was near-perfect (ICC 0.91; 95% CI 0.89-0.94). Hospital admission records and discharge summaries (vs. complete chart review) significantly underestimated the total FCI score. However, using multivariable linear regression, FCI scores collected using each of the three types of inpatient medical records had similar associations with PFS, suggesting similar predictive value.

Conclusions

Data collection using in-patient discharge summaries represents a reliable and valid method for collecting FCI comorbidity information.     

Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study

Introduction

To assess the effect of canakinumab, a fully human anti-interleukin-1β antibody, on symptoms and health-related quality of life (HRQoL) in patients with cryopyrin-associated periodic syndrome (CAPS).

Methods

In this 48-week, phase 3 study, patients with CAPS received canakinumab 150 mg subcutaneously at 8-week intervals. All patients (n = 35) received canakinumab during weeks 1 through 8; weeks 9 through 24 constituted a double-blind placebo-controlled withdrawal phase, and weeks 24 through 48 constituted an open-label phase in which all patients received canakinumab. Patient and physician assessments of symptoms, levels of inflammatory markers, and HRQoL were performed.

Results

Rapid symptom remission was achieved, with 89% of patients having no or minimal disease activity on day 8. Responses were sustained in patients receiving 8-weekly canakinumab. Responses were lost during the placebo-controlled phase in the placebo group and were regained on resuming canakinumab therapy in the open-label phase. Clinical responses were accompanied by decreases in serum levels of C-reactive protein, serum amyloid A protein, and interleukin-6. HRQoL scores at baseline were considerably below those of the general population. Improvements in all 36-item Short-Form Health Survey (SF-36) domain scores were evident by day 8. Scores approached or exceeded those of the general U.S. population by week 8 and remained stable during canakinumab therapy. Improvements in bodily pain and role-physical were particularly marked, increasing by more than 25 points from baseline to week 8. Therapy was generally well tolerated.

Conclusions

Canakinumab, 150 mg, 8-weekly, induced rapid and sustained remission of symptoms in patients with CAPS, accompanied by substantial improvements in HRQoL.

Trial registration

Clintrials.gov NCT00465985     

Cone rod dystrophies

Background

To examine the subjective health status of adults with short stature (ShSt) and compare with the general population (GP) and one well-known chronic disease, rheumatoid artritis (RA). In addition, to explore the association between age, gender, height, educational level and different aspects of health status of adults with short stature.

Methods

A questionnaire was mailed to 72 subjects with short stature registered in the database of a Norwegian resource centre for rare disorders, response rate 61% (n = 44, age 16–61). Health status was assessed with SF-36 version 2. Comparison was done with age and gender matched samples from the general population in Norway (n = 264) and from subjects with RA (n = 88).

Results

The ShSt sample reported statistically significant impaired health status in all SF-36 subscales compared with the GP sample, most in the physical functioning, Mean Difference (MD) 34 (95% Confidence Interval (CI) 25–44). The ShSt reported poorer health status in mental health, MD 11 (95% CI 4–18) and social functioning, MD 11 (95% CI 2–20) but better in role physical MD 13 (95% CI 1–25) than the RA sample. On the other subscales there were minor difference between the ShSt and the RA sample. Within the short stature group there was a significant association between age and all SF-36 physical subcales, height was significantly associated with physical functioning while level of education was significantly associated with mental health.

Conclusion

People with short stature reported impaired health status in all SF-36 subscales indicating that they have health problems that influence their daily living. Health status seems to decline with increasing age, and earlier than in the general population.     

Multi-Dimensional Health Assessment Questionnaire in China: Reliability,Validity and Clinical Value in Patients with Rheumatoid Arthritis

Objective

To evaluate the psychometric properties and clinical utility of Chinese Multidimensional Health Assessment Questionnaire (MDHAQ-C) in patients with rheumatoid arthritis (RA) in China.

Methods

162 RA patients were recruited in the evaluation process. The reliability of the questionnaire was tested by internal consistency and item analysis. Convergent validity was assessed by correlations of MDHAQ-C with Health Assessment Questionnaire (HAQ), the 36-item Short-Form Health Survey (SF-36) and the Hospital anxiety and depression scales (HAD). Discriminant validity was tested in groups of patients with varied disease activities and functional classes. To evaluate the clinical values, correlations were calculated between MDHAQ-C and indices of clinical relevance and disease activity. Agreement with the Disease Activity Score (DAS28) and Clinical Disease Activity Index (CDAI) was estimated.

Results

The Cronbach''s alpha was 0.944 in the Function scale (FN) and 0.768 in the scale of psychological status (PS). The item analysis indicated all the items of FN and PS are correlated at an acceptable level. MDHAQ-C correlated with the questionnaires significantly in most scales and scores of scales differed significantly in groups of different disease activity and functional status. MDHAQ-C has moderate to high correlation with most clinical indices and high correlation with a spearman coefficient of 0.701 for DAS 28 and 0.843 for CDAI. The overall agreement of categories was satisfying.

Conclusion

MDHAQ-C is a reliable, valid instrument for functional measurement and a feasible, informative quantitative index for busy clinical settings in Chinese RA patients.     

The pressure/volume relationship during dobutamine stress echocardiography in transplanted heart: comparison with quality of life and coronary anatomy

Background

Cardiac allograft vasculopathy (CAV) is a major late complication in cardiac transplant recipients and has a relevant impact on outcome of these patients. Aims of this study: to compare, in cardiac transplant recipients patients, the diagnostic value of pressure/volume relationship (ESPVR) during dobutamine stress echocardiography (DSE) for coronary artery disease, assessed by Multislice Computed Tomography (MSCT), and by coronary angiography (CA). We also analyzed any possible relationship between ESPVR and the Health Related Quality of Life of the patients (HRQoL), evaluated by SF–36 questionnaire.

Methods

25 consecutive patients underwent DSE within 24 hours after MSCT coronary angiogram and then they underwent CA. The HRQoL questionnaire was administered to the patients in the settings of DSE. They were followed-up for 6 months.

Results

DSE has a sensitivity in detecting CAV of 67%, specificity of 95%, positive predictive value of 67% and negative predictive value of 95%; DSE with ESPVR has a sensitivity of 100%, specificity of 95%, positive predictive value of 75%, negative predictive value of 100%; MSCT has a sensitivity of 100%; specificity of 82%; positive predictive value of 43%; negative predictive value of 100%. Htx recipients with a flat-biphasic ESPVR, although asymptomatic, perceived a worst HRQoL compared with the up-sloping ESPVR population, and this is statistically significant for the general health (p 0.0004), the vitality (p 0.0013) and the mental health (p 0.021) SF-36 subscale.

Conclusions

Evaluation with DSE and ESPVR is accurate in the clinical control of heart transplant recipients reserving invasive evaluation only for patients with abnormal contractility indexes.     

A Community-Based Validation Study of the Short-Form 36 Version 2 Philippines (Tagalog) in Two Cities in the Philippines

Objective

To evaluate the validity and reliability of the Philippines (Tagalog) Short Form 36 Health Survey version 2 (SF-36v2^®) standard questionnaire among Filipinos residing in two cities.

Study Design and Setting

The official Philippines (Tagalog) SF-36v2 standard (4-week recall) version was pretested on 30 participants followed by formal and informal cognitive debriefing. To obtain the feedback on translation by bilingual respondents, each SF-36v2 question was stated first in English followed by Tagalog. No revisions to the original questionnaire were needed except that participants thought it was appropriate to incorporate "po" in the instructions to make it more polite. Face-to-face interviews of 562 participants aged 20-50 years living in two barangays (villages) in the highly urbanized city of Makati City (Metro Manila) and in urban and rural barangays in Tanauan City (province of Batangas) were subsequently conducted. Content validity, item level validity, reliability and factor structure of the SF-36v2 (Tagalog) were examined.

Results

Content validity of the SF-36v2 was assessed to be adequate for assessing health status among Filipinos. Item means of Philippines (Tagalog) SF-36v2 were similar with comparable scales in the US English, Singapore (English and Chinese) and Thai SF-36 version 1. Item-scale correlation exceeded 0.4 for all items except the bathing item in PF (correlation: 0.31). In exploratory factor analysis, the US two-component model was supported. However, in confirmatory factor analysis, the Japanese three-component model fit the Tagalog data better than the US two-component model.

Conclusions

The Philippines (Tagalog) SF-36v2 is a valid and reliable instrument for measuring health status among residents of Makati City (Metro Manila) and Tanauan City (Province of Batangas).     

Sleep problems in Parkinson’s disease: a community-based study in Norway

Background

Neurogenic claudication (NC) is a common symptom in patients with lumbar spinal stenosis (LSS). The Neurogenic Claudication Outcome Score (NCOS) is a very short instrument for measuring functional status in these patients. This study aimed to translate and validate the NCOS in Iran.

Methods

This was a prospective clinical validation study. The 'forward-backward' procedure was applied to translate the NCOS from English into Persian (Iranian language). A total of 84 patients with NC were asked to respond to the questionnaire at two points in time: at preoperative and at postoperative (6 months follow-up) assessments. The Oswestry Disabiltiy Index (ODI) also was completed for patients. To test reliability, the internal consistency was assessed by Cronbach's alpha coefficient. Validity was evaluated using known groups comparison and criterion validity (convergent validity). Internal responsiveness of the NCOS to the clinical intervention (surgery) also was assessed comparing patients?? pre- and postoperative scores.

Results

The Cronbach??s alpha coefficients for the NCOS at preoperative and postoperative assessments were 0.77 and 0.91, respectively. Known groups analysis showed satisfactory results. The instrument discriminated well between sub-groups of patients who differed in claudication distance as measured by the Self-Paced Walking Test (SPWT). The change in the ODI after surgery was strongly correlated with change in the NCOS, lending support to its good convergent validity (r?=?0.81; P?<?0.001). Further analysis also indicated that the questionnaire was responsive to the clinical intervention (surgery) as expected (P?<?0.0001).

Conclusion

In general, the Iranian version of the NCOS performed well and the findings suggest that it is a reliable and valid measure of functionality in patients with lumbar spinal stenosis who are suffering from neurogenic claudication.     

Toward Meeting the Needs of Homeless People with Schizophrenia: The Validity of Quality of Life Measurement

Objective

To provide new evidence regarding the suitability of using quality of life (QoL) measurements in homeless people with schizophrenia, we assess the acceptability and psychometric properties of a specific QoL instrument (S-QoL 18) in a population of homeless people with schizophrenia, and we compare their QoL levels with those observed in non-homeless people with schizophrenia.

Methods

This multi-centre prospective study was conducted in the following 4 French cities: Lille, Marseille, Paris and Toulouse. Two hundred and thirty-six homeless patients with schizophrenia were recruited over a 12 month-period. The S-QoL 18 was tested for construct validity, reliability, external validity and sensitivity to change. The QoL of the 236 homeless patients was compared with 236 French age- and sex-matched non-homeless patients with schizophrenia.

Results

The eight-factor structure of the S-QoL 18 was confirmed by confirmatory factor analysis (RMSEA = 0.035, CFI = 0.95, GFI = 0.99 and SRMR = 0.015). Internal consistency, reliability and sensitivity to change were satisfactory. External validity was confirmed via correlations between S-QoL 18 dimension scores and SF-36, symptomatology and recovery scores. The percentage of missing data did not exceed 5%. Finally, homeless patients had significantly lower QoL levels than non-homeless patients with schizophrenia.

Conclusions

These results demonstrate the satisfactory acceptability and psychometric properties of the S-QoL 18, suggesting the validity of QoL measurement among homeless patients with schizophrenia. Our study also reported that QoL levels in homeless patients with schizophrenia were dramatically low, highlighting the need for new policies to eradicate homelessness and tackle poverty.     

The effect of aortic valve replacement on quality of life in symptomatic patients with severe aortic stenosis

Background

Although symptomatic patients with severe aortic stenosis have a high disease burden and guidelines recommend aortic valve replacement, many are treated conservatively. This study describes to what extent quality of life is changed by aortic valve replacement relative to conservative treatment.

Methods

This observational study followed 132 symptomatic patients with severe aortic stenosis who were subjected to an SF-36v2TM Health Survey.

Results

At baseline 84 patients were treated conservatively, 48 were referred for aortic valve replacement. In the conservatively treated group 15 patients died during a mean follow-up of 18 months (Kaplan-Meier survival was 85 % and 72 % at one and 2 years respectively) and 22 patients crossed over to the surgical group. Of the resulting 70 patients in the surgical group 3 patients died during a mean follow-up of 11 months (survival 95 % at 1 year). Physical functioning, vitality and general health improved significantly 1 year after aortic valve replacement. In conservatively treated patients physical quality of life deteriorated over time while general health, vitality and social functioning showed a declining trend. Mental health remained stable in both groups.

Conclusions

Aortic valve replacement improves physical quality of life, general health and vitality in patients with symptomatic severe aortic stenosis. Besides having a low life expectancy, conservatively treated patients experience deterioration of physical quality of life. Health surveys such as the SF-36v2TM can be valuable tools in monitoring the burden of disease for an individual patient and offer additional help in treatment decisions.     

A randomised controlled trial of a self-management education program for osteoarthritis of the knee delivered by health care professionals

Introduction

Our aim in the present study was to determine whether a disease-specific self-management program for primary care patients with osteoarthritis (OA) of the knee (the Osteoarthritis of the Knee Self-Management Program (OAK)) implemented by health care professionals would achieve and maintain clinically meaningful improvements in health-related outcomes compared with a control group.

Methods

Medical practitioners referred 146 primary care patients with OA of the knee. Volunteers with coexistent inflammatory joint disease or serious comorbidities were excluded. Randomisation was to either a control group or the OAK group. The OAK group completed a 6-week self-management program. The control group had a 6-month waiting period before entering the OAK program. Assessments were taken at baseline, 8 weeks and 6 months. The primary outcomes were the results measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Function subscales on the Short Form 36 version 1 questionnaire (SF-36) Secondary outcomes were Visual Analogue Scale (VAS) pain, Timed Up &; Go Test (TUG), knee range of motion and quadriceps and hamstring strength-isometric contraction. Responses to treatment (responders) and minimal clinically important improvements (MCIIs) were determined.

Results

In the OAK group, VAS pain improved from baseline to week 8 from mean (SEM) 5.21 (0.30) to 3.65 (0.29) (P ≤ 0.001). During this period, improvements in the OAK group compared with the control group and responses to treatment were demonstrated according to the following outcomes: WOMAC Pain, Physical Function and Total dimensions, as well as SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains. In addition, from baseline to week 8, the proportion of MCIIs was greater among the OAK group than the control group for all outcomes. For the period between baseline and month 6, WOMAC Pain, Physical Function and Total dimensions significantly improved in the OAK group compared to the control group, as did the SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains, as well as hamstring strength in both legs. During the same period, the TUG Test, range of motion extension and left-knee flexion improved compared with the control group, although these improvements had little clinical relevance.

Conclusions

We recorded statistically significant improvements compared with a control group with regard to pain, quality of life and function for participants in the OAK program on the basis of WOMAC and SF-36 measures taken 8 weeks and 6 months from baseline.