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Clare Bradley

Publications and source records attributed to Clare Bradley.

18 recordsLinked to original sources
PubMed2006

Quality of life in age-related macular degeneration: a review of the literature.

BACKGROUND: The Age-related Macular Degeneration Alliance International commissioned a review of the literature on quality of life (QoL) in macular degeneration (MD) with a view to increasing awareness of MD, reducing its impact and improving services for people with MD worldwide. METHOD: A systematic review was conducted using electronic databases, conference proceedings and key journal hand search checks. The resulting 'White Paper' was posted on the AMD Alliance website and is reproduced here. REVIEW: MD is a chronic, largely untreatable eye condition which leads to loss of central vision needed for tasks such as reading, watching TV, driving, recognising faces. It is the most common cause of blindness in the Western world. Shock of diagnosis, coupled with lack of information and support are a common experience. Incidence of depression is twice that found in the community-dwelling elderly, fuelled by functional decline and loss of leisure activities. Some people feel suicidal. MD threatens independence, especially when comorbidity exacerbates functional limitations. Rehabilitation, including low vision aid (LVA) provision and training, peer support and education, can improve functional and psychological outcomes but many people do not receive services likely to benefit them. Medical treatments, suitable for only a small minority of people with MD, can improve vision but most limit progress of MD, at least for a time, rather than cure. The White Paper considers difficulties associated with inappropriate use of health status measures and misinterpretation of utility values as QoL measures: evidence suggests they have poor validity in MD. CONCLUSION: There is considerable evidence for the major damage done to QoL by MD which is underestimated by health status and utility measures. Medical treatments are limited to a small proportion of people. However, much can be done to improve QoL by early diagnosis of MD with good communication of prognosis and continuing support. Support could include provision of LVAs, peer support, education and effective help in adjusting to MD. It is vital that appropriate measures of visual function and QoL be used in building a sound evidence base for the effectiveness of rehabilitation and treatment.

Health Knowledge, Attitudes, Practice↗
PubMed2006

Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.

I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalize their guidelines.

Attitude to Health↗
PubMed2006

Development of the Well-being questionnaire short-form in Japanese: the W-BQ12.

BACKGROUND: The Well-being Questionnaire (W-BQ) was designed to measure psychological well-being in people with diabetes. This study aimed to develop a Japanese version and a short form of the W-BQ. METHODS: A linguistic validation process produced a preliminary Japanese version of the 22-item W-BQ, which was distributed to 550 patients. Factor structure, reliability (Cronbach's alpha) and aspects of validity (hypothesised group differences and correlations with other measures) were evaluated. RESULTS: Questionnaires were returned by 464 patients (84.4%). Preliminary factor analysis revealed that the Depression and Anxiety items were dispersed according to the positive or negative direction of the wording. A 12-item W-BQ (Japanese W-BQ12), consisting of three 4-item subscales (Negative Well-being, Energy and Positive Well-being), was constructed that balanced positively and negatively worded items. Cronbach's alpha was high (>0.85) for the 12-item questionnaire and consistently high (>0.82) across sex and treatment subgroups. Cronbach's alpha for subscale scores in the total sample ranged from 0.69 (Energy) to 0.80 (Positive Well-being). Expected subgroup differences indicated significantly poorer well-being in women compared with men and in insulin-treated patients compared with tablet/diet treated patients. Discriminant and convergent validity was supported by minimal correlations between W-BQ12 scores and HbA1c and low-to-moderate correlations with Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores. CONCLUSION: The W-BQ12 (Japanese) is a short, reliable and valid measure of psychological well-being that is suitable for use with people with diabetes. The items selected to produce the W-BQ12 (Japanese) have since produced psychometrically sound 12-item short-form measures in other translations for use in diabetes and in other chronic illnesses.

Adult↗
PubMed2006

Psychometric properties of two measures of psychological well-being in adult growth hormone deficiency.

BACKGROUND: Psychometric properties of two measures of psychological well-being were evaluated for adults with growth hormone deficiency (GHD): the General Well-being Index, (GWBI)--British version of the Psychological General Well-being Index, and the 12-item Well-being Questionnaire (W-BQ12). METHODS: Reliability, structure and other aspects of validity were investigated in a cross-sectional study of 157 adults with treated or untreated GHD, and sensitivity to change in a randomised placebo-controlled study of three months' growth hormone (GH) withdrawal from 12 of 21 GH-treated adults. RESULTS: Very high completion rates were evidence that both questionnaires were acceptable to respondents. Factor analyses did not indicate the existence of useful GWBI subscales, but confirmed the validity of calculating a GWBI Total score. However, very high internal consistency reliability (Cronbach's alpha = 0.96, N = 152), probably indicated some item redundancy in the 22-item GWBI. On the other hand, factor analyses confirmed the validity of the three W-BQ12 subscales of Negative Well-being, Energy, and Positive Well-being, each having excellent internal reliability (alphas of 0.86, 0.86 and 0.88, respectively, N from 152 to 154). There was no sign of item redundancy in the highly acceptable Cronbach's alpha of 0.93 (N = 148) for the whole W-BQ12 scale. Whilst neither questionnaire found significant differences between GH-treated and non-GH-treated patients, there were correlations (for GH-treated patients) with duration of GH treatment for GWBI Total (r = -0.36, p = 0.001, N = 85), W-BQ12 Total (r = 0.35, p = 0.001, N = 88) and for all W-BQ12 subscales: thus the longer the duration of GH treatment (ranging from 0.5 to 10 years), the better the well-being. Both questionnaires found that men had significantly better overall well-being than women. The W-BQ12 was more sensitive to change than the GWBI in the GH-Withdrawal study. A significant between-group difference in change in W-BQ12 Energy scores was found [t(18) = 3.25, p = 0.004, 2-tailed]: patients withdrawn from GH had reduced energy at end-point. The GWBI found no significant change. CONCLUSION: The W-BQ12 is recommended in preference to the GWBI to measure well-being in adult GHD: it is considerably shorter, has three useful subscales, and has greater sensitivity to change.

Adult↗
PubMed2006

Validation of the genital herpes treatment satisfaction questionnaire (GHerpTSQ) in status and change versions.

A new measure of treatment satisfaction (GHerpTSQ) for recurrent genital herpes simplex virus (HSV) was validated and used to evaluate two therapeutic strategies widely used for the management of HSV: episodic treatment, where individual herpes outbreaks are treated as they arise; suppressive therapy, where treatment is taken daily to prevent HSV outbreaks. Satisfaction with treatment is important since daily dosing with suppressive therapy is necessary in the absence of symptoms. A 12-item questionnaire was designed using a modified form of the Diabetes treatment satisfaction questionnaire (DTSQ). The psychometric properties of the GHerpTSQ were evaluated within a sample of 125 Canadians with a history of HSV (type 1, 2) infection participating in a 48 week randomised cross-over trial. Factor analysis suggested that the items can be analysed as two separate subscales corresponding to Control/effectiveness, and Convenience/lifestyle; the single item concerning side effects was retained for separate analysis. Forced one-factor analysis showed that the two subscales can be combined to obtain a total score relating to overall treatment satisfaction. The GHerpTSQ has good internal reliability, clear structure with little overlap of subscales and evidence of good sensitivity to changes in treatment.

Acyclovir↗
PubMed2006

Preliminary development of the new individualized HDQoL questionnaire measuring quality of life in adult hypopituitarism.

OBJECTIVES: The objectives were (1) to report the preliminary development of the Hormone Deficiency-dependent Quality of Life (HDQoL) questionnaire, a new individualized questionnaire in which respondents rate personally applicable domains for importance and impact of hormonal deficiency and its treatment; (2) to evaluate the HDQoL's psychometric properties for adults with hypopituitarism including growth hormone deficiency (GHD). METHODS: Internal consistency reliability, aspects of validity, and sensitivity to change of the HDQoL were investigated in: (1) a cross-sectional survey of 157 adults with treated or untreated GHD; (2) a randomized, placebo-controlled study of 3 months' growth hormone (GH) withdrawal from 12 of 21 GH-treated adults. RESULTS: Thirteen of the original 18 HDQoL domains were relevant and important for GH-deficient adults. The shorter 13-item HDQoL had excellent internal reliability (Cronbach's alpha coefficient = 0.914, n = 109), and was sensitive to sex differences (cross-sectional study): women perceived worse present QoL than men [t(149.8) = 2.33, P = 0.021]. The HDQoL was sensitive to change (GH-withdrawal study) with a significant between-group difference in change in domain scores for things I can do physically[t(16) = 2.47, P = 0.025, 2-tailed], patients withdrawn from GH reporting greater negative impact of hormone deficiency on this domain at end-point. Qualitative work resulted in the addition of seven new HDQoL domains, including energy and bodily pain. CONCLUSION: The HDQoL, although at an early stage of development, proved useful in identifying expected changes following GH withdrawal. The extended 20-item version is recommended for further evaluation in assessing the impact of hypopituitarism on QoL.

Adult↗
PubMed2005

The effects of growth hormone and/or testosterone in healthy elderly men: a randomized controlled trial.

CONTEXT: Declines in GH and testosterone (Te) secretion may contribute to the detrimental aging changes of elderly men. OBJECTIVE: To assess the effects of near-physiological GH with/without Te administration on lean body mass, total body fat, midthigh muscle cross-section area, muscle strength, aerobic capacity, condition-specific quality of life (Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire), and generic health status (36-Item Short-Form Health Survey) of older men. DESIGN, SETTINGS, AND PARTICIPANTS: A 6-month, randomized, double-blind, placebo-controlled trial was performed on 80 healthy, community-dwelling, older men (age, 65-80 yr). INTERVENTIONS: Participants were randomized to receive 1) placebo GH or placebo Te, 2) recombinant human GH (rhGH) and placebo Te (GH), 3) Te and placebo rhGH (Te), or 4) rhGH and Te (GHTe). GH doses were titrated over 8 wk to produce IGF-I levels in the upper half of the age-specific reference range. A fixed dose of Te (5 mg) was given by transdermal patches. RESULTS: Lean body mass increased with GHTe (P = 0.008) and GH (P = 0.004), compared with placebo. Total body fat decreased with GHTe only (P = 0.02). Midthigh muscle (P = 0.006) and aerobic capacity (P < 0.001) increased only after GHTe. Muscle strength changes were variable; one of six measures significantly increased with GHTe. Significant treatment group by time interactions indicated an improved Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire score (P = 0.007) in the GH and GHTe groups. Bodily pain increased with GH alone, as determined by the Short-Form Health Survey (P = 0.003). There were no major adverse effects. CONCLUSION: Coadministration of low dose GH with Te resulted in beneficial changes being observed more often than with either GH or Te alone.

Aged↗
PubMed2005

+Psychometric evaluation of the MacDQoL individualised measure of the impact of macular degeneration on quality of life.

BACKGROUND: The MacDQoL is an individualised measure of the impact of macular degeneration (MD) on quality of life (QoL). There is preliminary evidence of its psychometric properties and sensitivity to severity of MD. The aim of this study was to carry out further psychometric evaluation with a larger sample and investigate the measure's sensitivity to MD severity. METHODS: Patients with MD (n = 156: 99 women, 57 men, mean age 79 +/- 13 years), recruited from eye clinics (one NHS, one private) completed the MacDQoL by telephone interview and later underwent a clinic vision assessment including near and distance visual acuity (VA), comfortable near VA, contrast sensitivity, colour recognition, recovery from glare and presence or absence of distortion or scotoma in the central 10 degrees of the visual field. RESULTS: The completion rate for the MacDQoL items was 99.8%. Of the 26 items, three were dropped from the measure due to redundancy. A fourth was retained in the questionnaire but excluded when computing the scale score. Principal components analysis and Cronbach's alpha (0.944) supported combining the remaining 22 items in a single scale. Lower MacDQoL scores, indicating more negative impact of MD on QoL, were associated with poorer distance VA (better eye r = -0.431 p < 0.001; worse eye r = -0.350 p < 0.001; binocular vision r = -0.419 p < 0.001) and near VA (better eye r = -0.326 p < 0.001; worse eye r = -0.226 p < 0.001; binocular vision r = -0.326 p < 0.001). Poorer MacDQoL scores were associated with poorer contrast sensitivity (better eye r = 0.392 p < 0.001; binocular vision r = 0.423 p < 0.001), poorer colour recognition (r = 0.417 p < 0.001) and poorer comfortable near VA (r = -0.283, p < 0.001). The MacDQoL differentiated between those with and without binocular scotoma (U = 1244 p < 0.001). CONCLUSION: The MacDQoL 22-item scale has excellent internal consistency reliability and a single-factor structure. The measure is acceptable to respondents and the generic QoL item, MD-specific QoL item and average weighted impact score are related to several measures of vision. The MacDQoL demonstrates that MD has considerable negative impact on many aspects of QoL, particularly independence, leisure activities, dealing with personal affairs and mobility. The measure may be valuable for use in clinical trials and routine clinical care.

Aged↗
PubMed2005

The Renal Treatment Satisfaction Questionnaire (RTSQ): a measure of satisfaction with treatment for chronic kidney failure.

BACKGROUND: Quality and effectiveness of care can be enhanced through the use of condition-specific measures of satisfaction with treatment. The aim of the present study was to design and develop a measure of satisfaction with treatment for patients with chronic kidney failure (CKF) for use in routine clinical care and clinical trials. The Renal Treatment Satisfaction Questionnaire (RTSQ) was designed to be suitable for people using any of the various treatment modalities for CKF. Items measure satisfaction with aspects of treatment, including convenience, flexibility, freedom, and satisfaction to continue with present form of treatment. METHODS: A 12-item RTSQ was investigated at a UK hospital-based renal unit, using data from 140 outpatients undergoing renal replacement therapy (hemodialysis, n = 35; continuous ambulatory peritoneal dialysis, n = 57; transplantation, n = 46). RESULTS: An 11-item scale was developed from the original 12-item version, with a single factor accounting for 59% of the variance and item loadings greater than 0.58. Scale reliability was excellent (alpha = 0.93) in the full sample and proved robust to analysis in separate treatment subgroups. As expected, RTSQ scores differed significantly ( P < 0.0001) between the transplantation and other treatment groups. Those who had received a transplant expressed greater overall satisfaction, with specific advantages of transplantation shown by all individual items, including convenience, time, lifestyle, freedom, and satisfaction to continue current treatment. CONCLUSION: The RTSQ provides a brief reliable measure of satisfaction with treatment for patients with CKF that is suitable for use in routine clinical care and clinical trials.

Adult↗
PubMed2004

The development of a new measure of quality of life for young people with diabetes mellitus: the ADDQoL-Teen.

BACKGROUND: This study evaluated the psychometric properties of the ADDQoL-Teen, an innovative individualised, patient-centred questionnaire measuring perceived impact of diabetes mellitus on quality of life (QoL) of teenagers. Respondents rate all 30 life domains for frequency, and personally applicable domains for 'bother'. Two overview items measure present QoL and diabetes-dependent QoL. ADDQoL-Teen design was based on the ADDQoL (for adults with diabetes). METHODS: Interviews and discussion groups were conducted with 23 teenagers aged 13-16 years, during work to design the ADDQoL-Teen. The new questionnaire was then completed by 152 young people, (mean age 16.4 +/- 2.4 years), attending diabetes clinics at six UK centres. RESULTS: Five domains detracted from the measure's reliability and factor structure, four of which were analysed separately and one deleted. The 25-domain ADDQoL-Teen had high internal consistency reliability [Cronbach's alpha = 0.91, (N = 133)] and could be summed into an overall Average Weighted Impact score. There were two subscales: a 10-item Impact-Self subscale (measuring impact of diabetes and its treatment on the individual) and a 15-item Impact-Other subscale (measuring impact on interactions with others and the external world). Both subscales had good internal consistency reliability, [Cronbach's alpha coefficients of 0.82 (N = 142) and 0.88 (N = 138) respectively]. Domains reported as most severely (and negatively) impacted by diabetes were (mean weighted impact +/- SD): lie in bed (-3.68 +/- 3.41), interrupting activities (-3.5 +/- 3.23), worry about the future (-3.45 +/- 3.28), career (-3.43 +/- 3.15) and sweets (-3.24 +/- 3.24), (maximum range -9 to +3). Analysis of the overview items showed that although 72.5% considered that their present QoL was good or brilliant, 61.8% felt that having diabetes had a negative impact on QoL, but 35.6% reported no impact and 2.6% reported a positive impact on QoL. CONCLUSIONS: The ADDQoL-Teen is a new measure of perceived impact of diabetes and its treatment on QoL of teenagers. It will help healthcare professionals and parents consider QoL issues as well as medical outcomes when caring for young people with diabetes. It may be used in clinical trials and for routine clinical monitoring in a context of continuing evaluation.

Activities of Daily Living↗
PubMed2004

Daily stress and glycaemic control in Type 1 diabetes: individual differences in magnitude, direction, and timing of stress-reactivity.

The aim of this study was to investigate the relationships between daily stress and glycaemic control in 54 people with Type 1 diabetes over 21 days. Measures included daily reports of stress (hassles), four-times-daily blood glucose measurements, and HbA1c levels. Time-series analyses revealed considerable variation between individuals in the nature and extent of blood glucose response to stress (stress-reactivity). In approximately one-third of the sample, stress was significantly associated with either same- or next-day blood glucose levels (r-range: -0.79 to 0.58). The majority of stress-reactive individuals (20.4% of the sample) demonstrated a positive association between hassles and same-day blood glucose levels. A much less common effect was found in two individuals (3.7%), where hassles were related to decreased same-day blood glucose. 'Stress-reactive' individuals tended to have high HbA1c values at baseline (t(52) = 2.2; P < 0.05), and significant relationships between emotion-focused coping and blood glucose levels (r = 0.93; P < 0.01). In conclusion, although a significant majority of this sample was resistant to the effects of stress, marked individual differences were found in the nature and extent of stress-reactivity. Our study goes beyond other published results as it is longitudinal, uses time-series analyses and includes a relatively larger sample. Clinicians need to be aware of these individual differences in order to advise patients about anticipating and preventing stress-related disruptions of glycaemic control.

Adaptation, Psychological↗
PubMed2004

The influence of diabetic retinopathy on quality of life: interviews to guide the design of a condition-specific, individualised questionnaire: the RetDQoL.

An individualised measure of the impact of diabetic retinopathy on quality of life (QoL) was developed, using a four-phase iterative approach, incorporating qualitative and quantitative methods. In semi-structured interviews, eleven people with diabetic retinopathy in each of two UK and two German hospitals described how QoL would be different without diabetic retinopathy. They completed and commented on the latest Retinopathy Dependent QoL (RetDQoL) draft. Interviews were content analysed before questionnaire revision and translation for the next centre. Twenty-six men and 18 women were interviewed: median age 60.5 (28-82) years; severity ranged from untreated background diabetic retinopathy to proliferative diabetic retinopathy requiring photocoagulation in both eyes, and vitrectomy. The resulting 26-domain RetDQoL asks about the impact of 'diabetic eye problems'. Iterative methodology ensured good understanding, face and content validity. It can be self- or interviewer-completed. Visual impairment, worries and movement restrictions impaired many aspects of QoL, with impacts before vision loss. Practice implications relate to using the RetDQoL and improving practitioner-patient communication.

Activities of Daily Living↗
PubMed2004

Design of an individualised measure of the impact of macular disease on quality of life (the MacDQoL).

The aim of this study was to design an individualised questionnaire to measure the impact of macular disease (MD) on quality of life (QoL). Principles underlying the Schedule for the Evaluation of Individual Quality of Life (SEIQoL) interview method and the Audit of Diabetes-Dependent Quality of Life (ADDQoL) diabetes-specific questionnaire influenced the Macular Disease-Dependent Quality of Life (MacDQoL) design. The MacDQoL specifies domains of QoL that were selected using focus group methodology and refined following a postal pilot study of members of the UK Macular Disease Society (MDS). Respondents rated the impact of MD on each domain and the importance of each domain to their QoL. Mean domain scores from 69 respondents indicated that MD had a negative impact on all the domains of QoL investigated in the measure. There was preliminary evidence of good internal consistency reliability (Cronbach's alpha = 0.93, n = 37). Respondents who were registered partially sighted (P/S) or blind reported poorer QoL than those who were not registered (Kruskal-Wallis: chi2 = 14.03, n = 62, p < 0.001). This evidence suggests that the measure will be sensitive to subgroup differences. The instrument has been further refined following the pilot study. The MacDQoL is being used in clinical trials and psychometric evaluation of the measure will be carried out using trial data. The measure is available for clinical use and has been linguistically validated in 15 other languages.

Focus Groups↗
PubMed2003

Preliminary development of a new individualised questionnaire measuring quality of life in older men with age-related hormonal decline: the A-RHDQoL.

BACKGROUND: There is increasing interest in hormone replacement therapy to improve health and quality of life (QoL) of older men with age-related decline in hormone levels. This paper reports the preliminary development and evaluation of the psychometric properties of a new individualised questionnaire, the A-RHDQoL, measuring perceived impact of age-related hormonal decline on QoL of older men. A-RHDQoL design was based on the HDQoL for people with growth hormone (GH) deficiency and the ADDQoL (for diabetes). METHODS: Internal consistency reliability and some aspects of validity of the A-RHDQoL were investigated in a cross-sectional survey of 128 older men (age range: 64 - 80 yrs), being screened for inclusion in a trial of GH and testosterone (T) replacement, and who completed the A-RHDQoL once. Respondents rated personally applicable life domains for importance and impact of their hormonal decline. A single overview item measured present QoL. Serum levels of Insulin-like Growth Factor-I and total T were measured. RESULTS: Of the 24 A-RHDQoL domains, 21 were rated as relevant and important for older men. All domains were perceived as negatively impacted by hormonal decline. The most negatively impacted domains were: memory (-4.54 +/- 3.02), energy (-4.44 +/- 2.49), sex life (-4.34 +/- 3.08) and physical stamina (-4.29 +/- 2.41), (maximum range -9 to +9). The shorter 21-domain A-RHDQoL had high internal consistency reliability (Cronbach's alpha coefficient = 0.935, N = 103) and applicable domains could be weighted and summed into an overall Average Weighted Impact score. The questionnaire was acceptable to the majority of respondents and content validity was good. The single overview item measuring present QoL correlated significantly with total T levels [r = 0.26, p <0.01, N = 114]. CONCLUSION: The new 21-item A-RHDQoL is an individualised questionnaire measuring perceived impact of age-related hormonal decline on the QoL of older men. The internal consistency reliability and content validity of the A-RHDQoL are established, but the measure is at an early stage of its development and its sensitivity to change and other psychometric properties need now to be evaluated in clinical trials of hormone replacement in older men.

Aged↗
PubMedDate not supplied

Patient perceptions of diabetes and diabetes therapy: assessing quality of life.

Efforts to prevent complications of diabetes often overlook the impact of the condition and its treatment on current quality of life (QoL). The Diabetes Treatment Satisfaction Questionnaire (DTSQ) has proved valuable for understanding and measuring patients' treatment satisfaction in assessments of new treatments and strategies. For example, the DTSQ has demonstrated improved patient satisfaction with fast-acting insulin lispro versus standard soluble insulin and with long-acting insulin glargine versus NPH insulin. However, improvements in treatment satisfaction are often inferred to be improvements in overall QoL without recognizing the limited scope of the satisfaction measure. It is necessary to evaluate not only satisfaction with treatment per se but also the impact of diabetes and its treatment on a broad range of life domains in order to assess the impact on QoL. The Audit of Diabetes-Dependent Quality of Life (ADDQoL) measure is a diabetes-specific instrument that assesses the impact of diabetes on 18 life domains. Use of the ADDQoL with people with type 1 or type 2 diabetes has shown, on average, almost universally negative impact of diabetes on all domains. Significant differences have also been shown in the magnitude of effect between insulin-treated and non-insulin-treated patients and patients with and without complications. The negative impact of diabetes on QoL has been observed despite high levels of treatment satisfaction (as measured by the DTSQ). The greatest negative impact was observed for the domain 'Freedom to eat as I wish', indicating the strong influence of dietary restrictions on QoL. Studies to assess the outcomes of treatment approaches designed to improve dietary flexibility are under way.

Diabetes Mellitus↗
PubMedDate not supplied

Psychometric evaluation of a new questionnaire measuring treatment satisfaction in hypothyroidism: the ThyTSQ.

OBJECTIVES: There is a clinical impression of dissatisfaction with treatment for hypothyroidism among some patients. Psychometric properties of the new ThyTSQ questionnaire are evaluated. The questionnaire, measuring patients' satisfaction with their treatment for hypothyroidism, has two parts: the seven-item ThyTSQ-Present and four-item ThyTSQ-Past, measuring satisfaction with present and past treatment, respectively, on scales from 6 (very satisfied) to 0 (very dissatisfied). METHODS: The questionnaire was completed once by 103 adults with hypothyroidism, age (mean [SD]) 55.2 [14.4], range 23-84 years (all treated with thyroxine). RESULTS: Completion rates were very high. Internal consistency reliability was excellent for both ThyTSQ-Present and ThyTSQ-Past (Cronbach's alpha = 0.91 and 0.90, respectively [N = 102 and 103]). Principal components analyses indicated that the seven items of the ThyTSQ-Present and the four items of the ThyTSQ-Past could be summed into separate Present Satisfaction and Past Satisfaction total scores. Mean Present Satisfaction was 32.5 (7.8), maximum range 0-42, and mean Past Satisfaction was 17.5 (6.1), maximum range 0-24, indicating considerable room for improvement. Patients were least satisfied with their present understanding of their condition, mean 4.2 (1.7) (maximum range 0-6), and with information provided about hypothyroidism around the time of diagnosis, mean 3.9 (1.8) (maximum range 0-6). CONCLUSIONS: The ThyTSQ is highly acceptable to patients with hypothyroidism (excellent completion rates), and has established internal consistency reliability. It will assist health professionals in considering psychological outcomes when treating people with hypothyroidism, and is suitable for clinical trials and routine clinical monitoring.

Adult↗
PubMedDate not supplied

Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version.

OBJECTIVES: Previous validation of the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs) found that nine of the 10 items performed well, but the demands item needed revision. This study investigated the psychometric properties of the revised HIVTSQs and new change version (HIVTSQc). METHODS: English-speaking Americans completed the HIVTSQs at baseline and Week 48 of a clinical trial of HIV treatments, and the HIVTSQc at Week 48. Demographic and viral load information was collected. Psychometric validation used item frequency distributions, Confirmatory Factor Analysis (CFA), item-total correlations, Cronbach's alpha, Spearman's rank correlation, Kruskal-Wallis and Mann-Whitney tests. RESULTS: At baseline, 126 of the 152 patients completed the HIVTSQs fully (100 of 106 at Week 48). The negatively skewed distribution of the revised demands item resembled that of the other nine, with comparable missing data. CFA (baseline and Week 48) supported the general satisfaction/clinical subscale (alpha 0.83; 0.85), lifestyle/ease subscale including demands (alpha 0.82; 0.85), and 10-item treatment satisfaction scale (alpha 0.89; 0.91). Subscale and scale scores differed significantly between ethnic groups. Viral load was not significantly related to subscale or scale scores. At Week 48, 97 of 106 patients completed the HIVTSQc fully. All items had negatively skewed distributions. CFA supported two subscales (general satisfaction/clinical change alpha 0.85; lifestyle/ease change alpha 0.88) and 10-item treatment satisfaction change scale (alpha 0.92). Viral load change between baseline and Week 48 correlated significantly with patients' perceptions of change in HIV control (control(c) item), but not with scale or subscale scores. CONCLUSION: The excellent psychometric properties of the HIVTSQs and HIVTSQc support their use in clinical trials.

Adult↗