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Biomedical subjects

Stephen P McKenna

Publications and source records attributed to Stephen P McKenna.

At least 19 recordsLinked to original sources

Measuring the psychosocial consequences of screening.

The last three decades have seen a dramatic rise in the implementation of screening programmes for cancer in industrialised countries. However, in contrast to screening for infectious diseases, most cancer screening programmes only have the potential to reduce mortality; they cannot lower the incidence of cancer in a population. In fact, most cancer screening programmes have been shown to increase the incidence of the disease as a consequence of over-diagnosis. A further dilemma of cancer screening programmes is that they do not distinguish between healthy people and those with disease. Rather, they identify a continuum of disease severity. Consequently, many healthy people who have abnormal screening tests are wrongly diagnosed. Indeed, studies have demonstrated that for each screening-prevented death from cancer, at least 200 false-positive results are given. Therefore, screening has the potential to be harmful as well as beneficial. The psychosocial consequences of false-positive screening results cannot be determined by diagnostic tests or by other technical means. Instead, patient reported outcome measures must be employed. To measure the outcomes of screening accurately and comprehensively patient reported outcome measures have to capture; the nature and extent of the psychosocial consequences and how these change over time. The outcome measures used must have high content validity and their psychometric properties should be determined prior to their use in the specific population. In particular it is important to establish unidimensionality, additivity and item ordering through the application of Item Response Theory.

Diagnostic Errors↗

Synchrony of change in depressive symptoms, health status, and quality of life in persons with clinical depression.

BACKGROUND: Little is known about longitudinal associations among measures of depression, mental and physical health, and quality of life (QOL). We followed 982 clinically depressed persons to determine which measures changed and whether the change was synchronous with change in depressive symptoms. METHODS: Data were from the Longitudinal Investigation of Depression Outcomes (LIDO). Depressive symptoms, physical and mental health, and quality of life were measured at baseline, 6 weeks, 3 months, and 9 months. Change in the measures was examined over time and for persons with different levels of change in depressive symptoms. RESULTS: On average, all of the measures improved significantly over time, and most were synchronous with change in depressive symptoms. Measures of mental health changed the most, and physical health the least. The measures of change in QOL were intermediate. The 6-week change in QOL could be explained completely by change in depressive symptoms. The instruments varied in sensitivity to changes in depressive symptoms. CONCLUSION: In clinically depressed persons, measures of physical health, mental health, and quality of life showed consistent longitudinal associations with measures of depressive symptoms.

Adolescent↗

Adaptation of the rheumatoid arthritis quality of life scale for Estonia.

The aim of the study was to adapt the rheumatoid arthritis quality of life scale (RAQoL) for Estonia and assess its psychometric properties. The RAQoL was translated into Estonian using the dual panel method. The translation was assessed for face and content validity by means of interviews with 15 rheumatoid arthritis (RA) patients. Reproducibility and construct validity were estimated using a further sample of 50 patients. Unidimensionality of the final scale was assessed by Rasch analysis. No major problems occurred in translating the instrument, it was well accepted by interviewees. The Estonian RAQoL had good test-retest reliability, internal consistency and ability to discriminate between groups defined by patient-perceived severity. Predicted convergent and divergent validity was demonstrated. Unidimensionality of the instrument was confirmed by excellent fit to the Rasch model. The RAQoL is appropriate for use in clinical studies and trials involving RA patients.

Arthritis, Rheumatoid↗

International development of the Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD).

OBJECTIVE: The international development of the Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. METHOD: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. RESULTS: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test-retest reliability (above 0.85), internal consistency and promising validity. CONCLUSIONS: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.

Child↗

The psychometric properties of the psoriasis disability index in United States patients.

Although it has had only limited psychometric assessment in one country (the UK), the Psoriasis Disability Index (PDI) is a commonly used measure of the impact of psoriasis on patients. This study's objective was to analyze the psychometric properties of the PDI in 1196 US patients. High Cronbach's alpha coefficients suggested that the PDI's internal consistency is good. The validity of the PDI was tested using a global question on disease burden and self-assessed extent of disease and both appeared to be good predictors of the PDI. Large floor effects and the suboptimal response distribution of most items, however, suggested that the PDI is insensitive to mild functional limitation. Factor analyses indicated that the current PDI subscales are suboptimal. In the Rasch analysis, the PDI and its subscales appeared to measure multiple constructs, making the validity of deriving a single overall score questionable. The frequent presence of differential item functioning related to several patient characteristics confirmed the instrument's multidimensionality. These findings suggest that the PDI is not an optimal measure for use in US study populations. The psychometric properties of instruments designed to measure the impact of psoriasis should be tested in populations in which the instrument is to be applied.

Clinical Trials as Topic↗

Development of the US PSORIQoL: a psoriasis-specific measure of quality of life.

BACKGROUND: Several instruments are available for assessing impairment and disability associated with psoriasis. The first true psoriasis-specific quality of life (QoL) questionnaire suitable for use in clinical trials, the Psoriasis Index of Quality of Life (PSORIQoL), has recently been developed in the UK. The aim of the current study was to produce and validate a conceptually equivalent US version of the PSORIQoL with equally good psychometric properties. METHODS: A lay translation panel was employed to ensure that the wording of the questionnaire was appropriate for a US population. Semi-structured interviews conducted with 37 patients tested the instrument's ease of completion, relevance and comprehensiveness. Finally, a test-retest validation mail survey was conducted with 72 patients to determine reliability, internal consistency and construct validity. RESULTS: Few changes were necessary to the wording of the questionnaire. Interviewees found the questionnaire easy to complete (requiring an average of 4 min) and the content relevant and comprehensive. The adapted measure had comparable psychometric properties to the original, with a test-retest reliability coefficient of 0.90, indicating excellent reproducibility. Internal consistency and initial indications of construct validity were also good, with scores on the measure related as expected to perceived general health and severity of psoriasis and the presence of visible lesions. CONCLUSIONS: The US PSORIQoL is a practical, reliable and valid instrument for measuring the impact of psoriasis and its treatment on QoL in clinical trials and in routine practice. It remains necessary to establish the instrument's responsiveness to changes in QoL associated with effective interventions.

Adult↗

Development and psychometric analysis of the Japanese version of the Nottingham Health Profile: cross-cultural adaptation.

OBJECTIVE: To adapt the Nottingham Health Profile (NHP) for Japanese and to describe the results of the assessment of its psychometric properties. METHODS: Assessments included test-retest reliability over approximately a 2-week interval, internal consistency and construct validity in 133 patients with COPD. RESULTS: The distribution of scores indicated that most of the NHP sections exhibited a floor effect, although this is greatly reduced with the NHP-Distress scale. The test-retest reliability was above 0.8 for all sections when patients reporting any change in their health status rating were excluded. Cronbach's alpha coefficients reflected the number of items contained in each section. The internal consistency of the emotional reactions section at one timepoint and the physical mobility section at both timepoints were lower than expected to be higher. All sections except the pain section could be used to distinguish patients who reported their health status to be good or fair from those who rated it to be poor or very poor. CONCLUSION: The adaptation of the NHP for Japanese was successful. Most sections showed reasonable test-retest reliability, indicating that they produced acceptable levels of random measurement error. The internal consistency of the sections was confirmed, although the alpha values of the emotional reactions and physical mobility sections were lower than might be expected for scales of their length. Different sections of the Japanese NHP were shown to have known group validity.

Adaptation, Psychological↗

Health status measurement in Parkinson's disease: validity of the PDQ-39 and Nottingham Health Profile.

We assessed the feasibility and psychometric properties of two commonly used health status questionnaires in Parkinson's disease (PD): the generic Nottingham Health Profile (NHP) and the disease-specific 39-item Parkinson's disease Questionnaire (PDQ-39), from a cross-sectional postal survey of PD patients (N = 81), using traditional and Rasch measurement methodologies. Overall response rate was 88%. Both questionnaires were found feasible, although the NHP performed less well. The PDQ-39 had fewer floor effects and was better able to separate respondents into distinct groups than the NHP, whereas the latter exhibited less ambiguous dimensionality and better targeting of respondents with non-extreme scores. Reliability and validity indices were similar, and potential differential item functioning by age and gender groups was found for both questionnaires. PDQ-39 response alternatives indicated ambiguity. With few exceptions, questionnaire scales were unable to meet recommended standards fully. While preliminary, this study illustrates the need for thorough evaluation of outcome measures and has implications beyond the questionnaires used here. Although promising, both questionnaires warrant further developmental work and stronger support of measurement validity before they could be considered fully suitable for valid use in PD, in particular in earlier stages of the disease.

Activities of Daily Living↗

Establishing a standard for patient-completed instrument adaptations in Eastern Europe: experience with the Nottingham Health Profile in Hungary.

The widely used generic patient-completed measures of health status were developed in the USA or the UK. Few Eastern European versions of these measures have been produced and these have used questionable translation methodologies. Clinical trials now commonly include patients from Eastern Europe and require the use of patient-completed instruments. The absence of such instruments led to the development of a Hungarian version of the Nottingham Health Profile (NHP). The adaptation process employed (translation, field-testing and psychometric assessment) also served as a test of whether the standardised rigorous methodology used for adapting the NHP could be applied in Eastern Europe. Few problems were found in producing a conceptually equivalent Hungarian NHP that was acceptable to interviewees. Reliability and internal consistency of the Hungarian NHP were comparable to other language versions. The measure also correlated as expected with perceived physical disability, general health, disease severity and rating of day. This successful adaptation confirms the value of the methodology applied. The Hungarian NHP will be invaluable as an outcome measure in both clinical and health economic trials and (in the absence of a generic quality of life instrument) as a comparator instrument for the validation of future Hungarian adaptations of disease-specific quality of life instruments.

Adult↗

International use of health status questionnaires in Parkinson's disease: translation is not enough.

The present study assessed the linguistic and content validity of the Swedish version of the 39-item Parkinson's disease questionnaire (PDQ-39). The frame question, response alternatives and two of the 39 items yielded substantial linguistic and stylistic problems. Such shortcomings would be expected to influence responses to, and the quality of, the whole questionnaire. Data support content validity of the PDQ-39 as a functional health status questionnaire, although some shortcomings were identified. This preliminary study illustrates the need for documented linguistic validity before new language adaptations of patient-reported outcome measures can be considered suitable for use in clinical trials, research, and practice.

Aged↗

Change in generic and disease-specific health-related quality of life during a one-year period in patients with newly detected chronic obstructive pulmonary disease.

BACKGROUND: Although the health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD) has been assessed by generic or disease-specific HRQoL measures, the responsiveness of the generic HRQoL measures is generally weak. OBJECTIVES: To investigate the responses generated by generic and disease-specific HRQoL questionnaires, we prospectively followed the clinical course of patients with newly detected COPD after the initiation of treatment. METHODS: A prospective, longitudinal study with a 1-year follow-up was designed. The forced expiratory volume in 1 s (FEV(1)), forced vital capacity (FVC), the Nottingham Health Profile (NHP) as a generic HRQoL measure, and the Chronic Respiratory Disease Questionnaire (CRQ) as a disease-specific HRQoL measure were measured at baseline and at 3, 6, and 12 months after the initiation of standard treatment. RESULTS: Eighty-two patients completed the study. The FEV(1), FVC, and NHP and CRQ scores improved significantly during the first 3 months (p < 0.05). During the last 6 months, although the FEV(1) declined (p < 0.05), the HRQoL assessed by the NHP and CRQ remained elevated. Except for the score on the social isolation section of the NHP at 12 months, all HRQoL scores at 6 and 12 months were significantly improved compared to baseline (p < 0.05). CONCLUSION: In new patients with COPD, the NHP as well as the CRQ was able to detect changes in the HRQoL associated with effective medical interventions. The influence of the changes in airflow limitation on the HRQoL was weak.

Aged↗

The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents' quality of life in the treatment of pediatric atopic dermatitis.

OBJECTIVE: Two 26-week US clinical trials of identical design were conducted to evaluate the efficacy and safety of pimecrolimus (Elidel, SDZ ASM 981) cream 1% in pediatric atopic dermatitis (AD). A secondary aim of both trials, and the focus of this article, was to evaluate the quality-of-life (QoL) impact of pimecrolimus compared with its vehicle. METHODS: A 6-week randomized, double-blind treatment phase was followed by a 20-week open-label phase during which all patients received pimecrolimus (403 patients 2 to 17 years old with mild to moderate AD; 267 randomized to pimecrolimus and 136 to vehicle). QoL analyses were conducted on the intention-to-treat data and included patients 8 years old or younger. QoL was evaluated with the Parent's Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) at baseline, 6 weeks, and 6 months. The PIQoL-AD is a 28-item measure completed by the parents of children with AD (0 to 8 years old). RESULTS: PIQoL-AD scores were available for 241 cases at baseline (158 pimecrolimus, 83 vehicle), 193 at 6 weeks (132 pimecrolimus, 61 vehicle), and 161 at 6 months (113 pimecrolimus, 48 vehicle). Improvement in parents' QoL was seen for both groups between baseline and 6 weeks and 6 months. Analysis of covariance on PIQoL-AD scores at 6 weeks showed statistically significant superiority of pimecrolimus compared with vehicle. After all patients were switched to receive pimecrolimus at week 6, mean PIQoL-AD scores were the same across both groups at 6 months. Positive but low levels of association were observed between changes in PIQoL-AD scores and changes in severity of AD (Investigator's Global Assessment and parent-perceived severity of pruritus). CONCLUSION: The results showed that pimecrolimus had a beneficial effect on parents' QoL in pediatric AD.

Adult↗

Defining patient-reported outcomes.

This paper considers and defines the different types of patient-reported outcomes that can be collected in clinical studies. In particular, it argues that quality of life (QoL) is a distinctly different type of outcome from Health-Related Quality of Life (HRQL). QoL is seen as providing an overall assessment of the effect of both illness and its treatment on the patient. In contrast, HRQL assesses issues that are of clinical or societal importance that may or may not cause concern to the patient. Needs-based QoL is defined and it is argued that this approach (the extent to which an individual is able to meet his or her needs) provides a good working indicator of QoL.

Health Services Needs and Demand↗

Integrating patient-reported outcomes.

This paper discusses the relations between different types of patient-reported outcomes that may be collected in clinical studies. Two models are presented that argue that there is a linear relation between the different outcomes. When needs-based quality of life (QoL) is incorporated into the model it is proposed that a two-dimensional relation is more appropriate. The new model is illustrated by data collected using different types of outcome measures. Finally, the different outcomes are related to their purpose in clinical studies.

Clinical Trials as Topic↗