Search PubMed⌕ Search

Biomedical subjects

S P McKenna

Publications and source records attributed to S P McKenna.

At least 19 recordsLinked to original sources

Adaptation of the RAQoL for use in Australia.

Quality of life is an important patient-reported outcome of rheumatoid arthritis (RA) in addition to structural and functional outcomes. The RAQoL (Rheumatoid Arthritis Quality of Life questionnaire) was developed in the UK and the Netherlands as a disease-specific tool. It was adapted for use in the Australian social context and the reliability and validity was tested. A lay panel assessed the UK version and adapted the wording for use within Australia. Reliability and validity were assessed by a postal survey of the RAQoL and comparator questionnaires to 100 patients with RA. The RAQoL was easily adapted into Australian-English. Test-retest reliability was high with a Spearman rank correlation coefficient of 0.93. RAQoL scores correlated well with patient-perceived disease activity and severity--indicating good validity. The Australian version of the RAQoL is a valid and reliable tool for the assessment of quality of life. It is practical, easy to administer and has good potential for use in clinical settings and trials in Australia.

Adult↗

The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension.

OBJECTIVE: No outcome measures specific to pulmonary hypertension (PH) currently exist. The aim of the study was to develop health-related quality of life (symptoms and functioning) scales and a quality of life scale that would allow comprehensive, accurate and valid patient-reported outcome assessment in clinical studies. METHODS: The content of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was derived from qualitative interviews conducted with 35 patients. Item reduction was based on the analysis of responses to a postal survey (n=75) and patient interviews (n=15) designed to determine face and content validity. A final postal validation study (n=91) was performed to determine reproducibility and construct validity. RESULTS: The questionnaire was well received by participants who found it to be relevant, comprehensible and quick and easy to complete. Rasch and factor analyses were conducted to ensure unidimensionality of the final CAMPHOR scales; Overall symptoms (made up of Energy, Breathlessness and Mood subscales), Functioning and Quality of life. The CAMPHOR scales had good internal consistency (alpha=0.90-0.92) and reproducibility (test-retest correlations=0.86-0.92). They also exhibited convergent, divergent and known groups validity. CONCLUSIONS: The CAMPHOR is a valuable new instrument for assessing patient-reported outcome in PH clinical trials and routine practice.

Activities of Daily Living↗

Treatment of paediatric atopic dermatitis with pimecrolimus (Elidel, SDZ ASM 981): impact on quality of life and health-related quality of life.

AIM: To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZ ASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis. METHODS: QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months. RESULTS: Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points. CONCLUSIONS: The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.

Administration, Cutaneous↗

Double-blind placebo-controlled study of testosterone patch therapy on bone turnover in men with borderline hypogonadism.

Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit. We evaluated the response to testosterone in men with borderline hypogonadism. A randomized double-blind placebo-controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level (total testosterone <10 nmol/L or free androgen index <30%). Patients were randomized to Testoderm TTS body patch (5 mg/day, n = 20) or a placebo patch (n = 19) for 6 months, followed by open-label testosterone replacement for a further 6 months in all patients. During the placebo-controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment (p = 0.004); this was associated with a decrease in total body fat mass (p = 0.019) and increase in haemoglobin level (p = 0.036). There were no significant changes in lean body mass, markers of bone turnover, and measures of bone mineral density (BMD). There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life questionnaire (MEDQoL score, p = 0.017), mainly accounted for by deterioration in the placebo arm. When the active treatment period was combined for placebo and testosterone groups, the within-patient analysis showed a significant effect of testosterone to decrease markers of bone resorption (uNTX/Cr, p = 0.007; iFDPD/Cr, p = 0.0006) and to increase lean body mass (p = 0.001). There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction. However, there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD.

Adipose Tissue↗

The quality of life of parents of children with atopic dermatitis: interpretation of PIQoL-AD scores.

The PIQoL-AD has been used in several trials assessing quality of life (QoL) in parents of children with atopic dermatitis (AD), treated with pimecrolimus cream 1%. Secondary analysis of data from four trials (n = 621) was undertaken to help interpret the meaningfulness (significance) of the QoL results. A combination of anchor-based and distribution-based methods of interpreting instrument scores were employed. For each level on four AD severity indicators, mean PIQoL-AD scores and 95% confidence intervals were calculated. Low levels of association (r(s) range = 0.12-0.45) were observed between QoL and clinical indicators; confirming previous findings. When data from the different trials and time-points were combined clear patterns emerged indicating the clinical meaning of PIQoL-AD scores. Distribution-based statistics such as effect sizes, the standard error of measurement (SEM) and the standard error of difference (S(diff)) were also calculated. Despite a lack of consensus on how best to determine the meaningfulness of QoL scores, a large database of trial data was successfully used to link QoL scores to disease severity, aiding clinical interpretation of the former. Effect size, SEM and S(diff) values were consistent across the trials indicating that a change of 2 to 3 PIQoL-AD points over time could be considered meaningful. It is argued that it would be useful for clinicians to gain an understanding of the meaning of QoL scores through routine use of such measures in clinical practice.

Adolescent↗

The development of a preference-based measure of health in children with atopic dermatitis.

BACKGROUND: Outcomes of health care interventions can be measured in many different ways, but there has been growing interest in the role that quality-adjusted life-years (QALYs) can play in informing priorities in health care. While existing generic preference-based measures can be used to obtain QALYs, these measures may often be inappropriate for some conditions such as atopic dermatitis (AD). These measures are also usually developed for adults and may not capture the domains pertinent to children. OBJECTIVES: To develop a preference-based quality-of-life measure for use in children with AD. METHODS: Items generated from interviews conducted with parents of children with AD were used to form a health state classification system that gives 16 unique health states. One hundred and fifty members of the general population were interviewed to derive preference weights for these states, following the methods used in the valuation of the Health Utilities Index 2 (HUI 2). Each person valued 10 health states using the standard gamble technique. The primary analysis was the estimation of mean health state values for each of the 16 states. RESULTS: Mean values across the 16 health states range from 0.36 (SD = 0.36) for the worst state to 0.84 (SD = 0.19) on a scale from zero to one, where zero is for health states thought to be as bad as being dead and one is for perfect health. There was some support for the validity of the values from the fact that the values were logically consistent with the ordering of the health state classification system. CONCLUSIONS: These results show the perceived importance of the defined health states of childhood AD to the general population. The resultant health state classification and values can be used to calculate QALYs for use in assessing the cost-effectiveness of interventions for children with AD.

Adolescent↗

Quality of Life in Depression Scale (QLDS): adaptation and evaluation of the psychometric properties of the Norwegian version.

Despite the prevalence of depression, few studies on the quality of life of depressed patients have been conducted. The Quality of Life in Depression Scale (QLDS) is the first depression-specific measure. Since its publication in 1992, the measure has been adapted and re-validated for use in several countries. This paper describes the adaptation and psychometric evaluation of the Norwegian version of the QLDS. The QLDS was translated into Norwegian by means of bilingual and lay translation panels. Face and content validity was assessed, and a validation study was conducted with 72 depressed patients in order to establish the new adaptation's internal consistency, reproducibility, construct validity and responsiveness. No major problems were experienced during the translation of the QLDS into Norwegian and patient interviews indicated that the questionnaire was both acceptable to and relevant for depressed patients. The validation/adaptation of the QLDS into Norwegian had been successful. High test-retest correlations indicated excellent reproducibility with no evidence of excessive random measurement error. The internal consistency of the measure was confirmed, with items adequately inter-related. Evidence of construct validity and responsiveness is also encouraging. The Norwegian QLDS is a reliable and valid measure of quality of life.

Adolescent↗

A new instrument for assessing quality of life in atopic dermatitis: international development of the Quality of Life Index for Atopic Dermatitis (QoLIAD).

BACKGROUND: Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin condition that can have a considerable impact on those affected. There are a number of instruments available to measure outcome in dermatological conditions but none have been developed specifically for AD. In addition, most measure symptoms and/or daily functioning, which are potential influences on quality of life (QoL) rather than assessments of the construct itself. OBJECTIVES: The aim of the current study was to develop a new instrument specifically designed to measure QoL in adults with AD-the Quality of Life Index for Atopic Dermatitis (QoLIAD). METHODS: The instrument was developed based on the needs-based model of QoL and was produced in several different countries simultaneously. Its content was derived from 65 in-depth interviews with relevant patients in the U.K., Italy and the Netherlands. The initial version of the measure was produced in U.K. English and translations were produced for the Netherlands, Italy, Germany, France and the U.S.A. using a dual translation panel methodology. A Spanish version was developed using the same adaptation process after the instrument was finalized. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. The instrument [in addition to the Dermatology Life Quality Index (DLQI) and the Psychological General Well-Being Schedule (PGWB)] was then administered to up to 300 AD patients in each country at two time points to finalize the instrument and test its psychometric properties. RESULTS: The initial version of the QoLIAD had 56 items that reflected the areas of need fulfillment identified in the qualitative interviews as having been affected by AD: mental and emotional stimulation, physical and emotional stability, security, sharing and belonging, self-esteem, personal development and fulfillment. Comments from patients in field-test interviews resulted in the removal of 14 items, to leave a 42-item instrument that was considered relevant and acceptable. The number of patients participating in the survey were 286 in the U.K., 46 in the Netherlands, 213 in France, 187 in Germany, 178 in the U.S.A. and 83 in Spain. Application of the Rasch model to these data identified the final 25-item QoLIAD. Unidimensionality was confirmed, with deviation of the total scale from the Rasch model evident at a single time point in one country only (the U.K.). All language versions, with the exception of the Dutch measure, had test-retest reliability coefficients in excess of 0.85. The test-retest in the Netherlands was 0.80. However, this country had the smallest sample size and the corresponding reliability for the DLQI was only 0.40. The QoLIAD had adequate internal consistency and the initial indications of construct validity were good. The levels of association with the DLQI indicated that the two instruments measure related but distinct constructs. CONCLUSIONS: The QoLIAD is a practical, reliable, valid and culturally applicable instrument for measuring the impact of AD and its treatment on QoL in clinical trials or in routine clinical practice.

Adolescent↗

Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis.

BACKGROUND: Patient reported outcome measures used in studies of psoriatic arthritis (PsA) have been found to be inadequate for determining the impact of the disease from the patient's perspective. OBJECTIVE: To produce the PsAQoL, a PsA-specific quality of life (QoL) instrument, employing the needs based model of QoL that would be relevant and acceptable to respondents, valid, and reliable. METHODS: Content was derived from qualitative interviews conducted with patients with PsA. Face and content validity were assessed by field test interviews with a new sample of patients with PsA. A postal survey was conducted to improve the scaling properties of the new measure. Finally, a test-retest postal survey was used to identify the final measure and to test its scaling properties, reliability, internal consistency, and validity. RESULTS: Analysis of the qualitative interview transcripts identified a 51 item questionnaire. Field test interviews confirmed the acceptability and relevance of the measure. Analysis of data from the first postal survey (n = 94) reduced the questionnaire to 35 items. Rasch analysis of data from the test-retest survey (n = 286) identified a 20 item version of the PsAQoL with good item fit. This version had excellent internal consistency (alpha = 0.91), test-retest reliability (0.89), and validity. CONCLUSIONS: The PsAQoL is a valuable tool for assessing the impact of interventions for PsA in clinical studies and trials. It is well accepted by patients, taking about three minutes to complete, is easy to administer, and has excellent scaling and psychometric properties.

Adult↗

Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials.

BACKGROUND: Patients with psoriasis have significant impairment in their quality of life (QoL). Several patient-completed instruments are available to measure outcome in dermatological conditions but these primarily focus on severity of disease rather than on QoL. OBJECTIVES: To develop a new instrument specifically designed to measure QoL in psoriasis-the Psoriasis Index of Quality of Life (PSORIQoL). METHODS: The content of the instrument was derived from qualitative interviews with 62 psoriasis patients in the U.K., Italy and the Netherlands. Content analysis of the interview transcripts from the three countries identified potential items for the questionnaire. All further stages of the project were conducted in the U.K. only. Face and content validity were determined by means of a focus group held with seven psoriasis patients and face-to-face interviews with a further 21 patients. A new draft version of the PSORIQoL, together with the Dermatology Life Quality Index (DLQI) and the General Well-Being Index (GWBI), were completed by a new sample of psoriasis patients contacted by mail, in order to determine construct validity. A subsample of the respondents completed a similar package 2 weeks later, to assess reproducibility (reliability). RESULTS: The first version of the PSORIQoL consisted of 61 items covering the needs identified in the interviews as having been affected by psoriasis or its treatment. These included fear of negative reactions from others, self-consciousness and poor self-confidence, problems with socialization, physical contact and intimacy, limitations on personal freedom and impaired relaxation, sleep and emotional stability. Following the focus group and field-test interviews, a new draft measure consisting of 45 items was completed by 148 patients, 88 of whom completed and returned a similar package 2 weeks later. Application of Rasch analysis identified a final 25-item version of the PSORIQoL. This version had a test-retest reliability coefficient of 0.89, indicating good reproducibility. The levels of association with the DLQI and PGWB indicated that the PSORIQoL measures a related but distinct construct. CONCLUSIONS: The PSORIQoL appears to be a practical, reliable and valid instrument for measuring the impact of psoriasis on QoL. It remains necessary to establish the instrument's responsiveness to changes in QoL associated with treatment.

Adult↗

Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis.

BACKGROUND: Although disease-specific health status measures are available for ankylosing spondylitis (AS), no instrument exists for assessing quality of life (QoL) in the condition. OBJECTIVE: To produce an AS-specific QoL measure that would be relevant and acceptable to respondents, valid, and reliable. METHODS: The ASQoL employs the needs-based model of QoL and was developed in parallel in the UK and the Netherlands (NL). Content was derived from interviews with patients in each country. Face and content validity were assessed through patient field test interviews (UK and NL). A postal survey in the UK produced a more efficient version of the ASQoL, which was tested for scaling properties, reliability, internal consistency, and validity in a further postal survey in each country. RESULTS: A 41 item questionnaire was derived from interview transcripts. Field testing interviews confirmed acceptability. Rasch analysis of data from the first survey (n=121) produced a 26 item questionnaire. Rasch analysis of data from the second survey (UK: n=164; NL: n=154) showed some item misfit, but showed that items formed a hierarchical order and were stable over time. Problematic items were removed giving an 18 item scale. Both language versions had excellent internal consistency (alpha=0.89-0.91), test-retest reliability (r(s)=0.92 UK and r(s)=0.91 NL), and validity. CONCLUSIONS: The ASQoL provides a valuable tool for assessing the impact of interventions for AS and for evaluating models of service delivery. It is well accepted by patients, taking about four minutes to complete, and has excellent scaling and psychometric properties.

Adult↗

International development of the Quality of Life in Depression Scale (QLDS).

BACKGROUND: The Quality of Life in Depression Scale (QLDS) employs the needs-based model of quality of life (QoL) and was developed in the UK and The Netherlands as an outcome measure for clinical trials. This paper describes the production and psychometric assessment of nine new language versions for Canada (French and English), Denmark, France, Germany, Italy, Morocco, Spain and the US. METHODS: Three adaptation stages were employed; production of conceptually equivalent translations, field-test interviews and assessment of reliability and construct validity by survey of patients with major depression. RESULTS: Few problems were experienced with producing conceptually equivalent translations, except in Morocco. Patients in the field-test interviews found the instrument to have appropriate content and to be easy to complete. Internal consistency and test-retest reliability were excellent for all language versions and scores were found to relate appropriately to measures of depression severity and health status. LIMITATIONS: Further investigation is required of the ability of the measure to assess individuals at the extremes of the QoL continuum. Data collected with the Arabic QLDS should not be combined with those from other countries. CONCLUSIONS: The QLDS is the first instrument designed to assess QoL in depression based on a coherent model of the construct. Each language version has been shown to be well accepted by respondents and to have excellent psychometric properties. As the instrument is now available in a large number of languages, the QLDS is the QoL instrument of choice for inclusion in clinical trials of interventions for depression.

Adult↗

Evaluation of the Dutch version of the migraine quality of life instrument (MSQOL) and its application in headache coping.

The Dutch version of the MSQOL was evaluated psychometrically and applied in a convenience sample of 90 migraine patients from the Dutch Society of Headache Patients. Internal consistency and test-retest reliability of the Dutch MSQOL were good (> 0.90) and comparable with those of the original English version. The measure also had good validity, with its scores associated as expected with headache intensity, psychological well-being and level of patient functioning. Respondents who employ more passive methods of coping with their headaches, such as 'worrying', 'retreating' and 'resting', had worse quality of life. 'Worrying' was particularly associated with diminished quality of life, suggesting that cognitive interventions might be of benefit to migraineurs who use this method of coping.

Adaptation, Psychological↗

Adaptation into Danish of the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Scale (RAQoL).

OBJECTIVES: The study was designed to adapt the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) for use in Denmark. METHOD: The instruments were translated into Danish and then field-tested with 10 RA patients for relevance, and face and content validity. Reliability and validity were assessed by administering the new measures and a comparator instrument (the Danish Nottingham Health Profile) to 80 RA patients on two occasions. RESULTS: Patients found both measures acceptable and easy to complete. They had good test-retest reliability (>0.90) and internal consistency and were both able to discriminate between groups with different levels of functional status and self-perceived severity. When compared with the NHP sections, both measures showed expected convergence and divergence. CONCLUSION: Given the excellent psychometric properties of the Danish versions of the RAQoL and HAQ, both are recommended for inclusion in clinical trials and studies.

Adult↗

The development and psychometric assessment of the Turkish version of the Nottingham Health Profile.

The Nottingham Health Profile (NHP) is a widely used measure of perceived health status. The aim of the present study was to adapt the NHP for use in Turkey and to test its psychometric properties. Following translation and testing for its face and content validity, 50 patients with osteoarthritis were interviewed on two occasions. Each interview included administration of the NHP and the Stanford Health Assessment Questionnaire (HAQ), a measure of functional disability. Test-retest reliability of the new version was satisfactory and comparable with other available language versions. As predicted, high correlations were found between the HAQ and the physical mobility, pain and energy level sections of the NHP and low correlations between the HAQ and emotional reactions, social isolation and sleep, confirming the construct validity of the NHP. It is concluded that the adaptation of the NHP into Turkish was successful but that additional studies are required to assess its suitability for use with other patient populations and its equivalence to other language versions of the measure.

Adult↗

The development and validation of a Spanish version of the quality of life in depression scale (QLDS).

OBJECTIVE: The adaptation of the Quality of Life in Depression Scale, the QLDS, into Spanish. METHODS: The original UK version of the QLDS was considered by two translation panels, who produced a Spanish translation. Priority was given to conceptual rather than semantic equivalence. This version was then field-tested with 15 depressed patients. The final stage of the research involved a postal survey of 62 patients, who were asked to complete the measure on two occasions. RESULTS: The Spanish QLDS was found to be appropriate and acceptable by depressed patients. The questionnaire's test-retest reliability and internal consistency were both high, and QLDS scores correlated as predicted with scores on sections of the Nottingham Health Profile. The measure was sensitive to different levels of depression as assessed by the Hospital Anxiety and Depression Scale. CONCLUSION: The Spanish version of the QLDS is suitable for use in clinical trials and for monitoring individual patients in routine clinical practice.

Adaptation, Psychological↗