[ Diabetes Type 1 ]

Health and Quality of Life Outcomes

Although guidelines for the management of children with type 1 diabetes include recommendations to screen for diabetic peripheral neuropathies (DPN), the research into the diagnostic utility of screening methods has not been systematically reviewed. This recent article was published in the Current Clinical Pharmacology Journal in November 2011 and was reviewed and published by the National Institute of Health in its NIH Public Access: Author Manuscript: Metabolic Correction in the Management of Diabetic Peripheral Neuropathy: Improving Clinical Results beyond Symptom Control. The reasons for any differences should be assessed and addressed where appropriate. Diabetic peripheral neuropathic pain affects the functionality, mood, and sleep patterns of approximately 10 to 20 percent of patients with diabetes mellitus. Many people who claim to have extremely debilitating sicknesses and conditions could take years to get accredited, and some in no way get accredited. As patients are left with a difficult compromise between pain relief on the one hand and adverse effects and daily treatment regimens on the other, a clear unmet need remains in the management of neuropathic pain. caused by diabetic nerve damage, says Kimberly Sackheim, DO, a clinical assistant professor of rehabilitation .

This initiates a positive feedback with more active approach to the treatment of diabetes, better glycaemic control, and less serious complications. The annual foot examination should include a visual check, palpation of pulses and assessment of foot sensory nerve function. The Neuropathy Action Foundation (NAF) is dedicated to ensuring neuropathy patients obtain the necessary resources and information to access individualized treatment to improve their quality of life. Several factors have been implicated, including genetics, insulin resistance, oxidative stress, accumulation of sorbitol, abnormal glucose metabolism, advanced glycation end products, and protein kinase C activation. The timed vibration test takes longer, and the interpretation is more complicated. Click here to see the Library]. Fluoxetine had the lowest risk of adverse events (0.94; [0.62, 1.23]); oxycodone had the highest (1.55; [1.45, 1.64]).

Special clinical challenge for a neurologist is the presence of radiculopathy in a high percentage of subjects in the painful group, which is also unexpected; i.e. it was considered that diabetic patients had reduced walking distance exclusively due to claudications [28],[29] caused by stenotic changes of the lower extremity arteries. Prevalence of diabetic peripheral neuropathy and its relation to glycaemic control and potential risk factors: the EURODIAB IDDM Complications Study. Symptoms may occur at any time during the course of chemotherapy (seen with paclitaxel), or even after termination (commonly known as “coasting”) [3], which refers to neuropathic symptoms that present after discontinuation of anticancer treatment, and which may continue or worsen over weeks or months. Tanaka S, Tanaka S, Iimuro S, Yamashita H, Katayama S, et al. Additionally, both groups show values significantly different from the general population. The quality of life is expectedly lower in the painful group than in the group of subjects with DPN without pain.

We believe that there is a number of reasons for that. The American Diabetic Association recommends that treatment should be directed at underlying causes, even when effective symptomatic treatments are available to prevent further manifestations of diabetic peripheral neuropathy and autonomic neuropathy. These conditions require an additional effort in terms of time and energy needed for treatment, and lay a burden on subject’s financial resources in terms of medications and additional medical treatment. Of all the treatments used for diabetic neuropathy and rated by the AAN, the seizure medication pregabalin was the only one found to have “strong evidence” supporting its effectiveness. The other important factor is mental health. It reflects on the quality of life of subjects with painful polyneuropathy as lower value of cumulative parameter MCS, as well as higher level of depression according to BDI scale. This is expected, both in terms of the higher incidence of depression in diabetics in general [30] and in higher intensity of depressive symptoms in group with painful neuropathy [31].

In our opinion, and in line with some previously published results [32],[18], depression is a major contributor impairing quality of life in diabetics. Sleeping disorders are drastically more common in the painful group. With its particular influence they additionally deteriorate the condition of these subjects. This vicious circle is intensified by the fact that painful diabetic polyneuropathy is very difficult to treat, and 30-40% of patients do not respond to any kind of therapy [33], thus increasing the overall cost of treatment [33]. In this context, some recent studies [34] show patients more often neglect the treatment of the primary disease, like diabetes or hypertension, and rather take medications for pain treatment, e.g. However, in our experience and to our knowledge, the type of diabetes is not a discriminating factor in the occurrence of pain symptoms in patients with neuropathy. This is confirmed in our study as well, with significantly higher proportion of subjects taking multiple medications in the painful group, especially analgesics (Table 6).

Alternatively, it is possible that increased medication results in lower alcohol consumption in the same group (Table 2). As we have shown with the analysis of the effects of comorbidities on the quality of life (Table 7), low values of all SF-36 scale parameters in group P can be (in part, at least) explained by higher prevalence of comorbidities in the P group. Mayo Clin Proc 2010;85:S3-S14. The IL-6 level was increased in the sciatic nerve and DRG of CIPN mice, and administration of IL-6 antibodies to the sciatic nerve reduced tactile hyperalgesia significantly. A systematic review and meta-analysis. Subjects in group D have higher mean values in all SF-36 parameters compared to group P, but also show somewhat higher quality of life compared to general population in Croatia in 4 of 8 dimensions, namely vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH), which was an unexpected result. Our hypothesis is that this outcome was a result of a significantly bigger portion of male subjects, as well as those with high education in group D versus group P, but also versus general population from year 2000 [15].

The proportion of the highly educated in Croatia in year 2001 was 12.0%, and in 2011 the proportion increased to 16.4%. In the year 2011 the proportion of the highly educated of the age 60–64, which is the age of our subjects, was 20% for men and 16.2% for women. The said proportions were in a distinct opposition with subjects in group P, where proportion of the highly educated was 25.1%, as well as in group D where the same proportion was 32.6% [3]. Plan ahead and buy only what’s on your list to avoid impulse buying Click here to download a printable copy of a shopping list. Neuropathic pain, besides its direct incapacitating effect on patient, shows additional negative effect by significantly lowering the quality of life. Treatment of neuropathic pain can therefore have multiple positive effects on such patients.

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[ Herbal Remedies ]

Health and Quality of Life Outcomes

Description: Quality of Life Research is an international, multidisciplinary journal devoted to the rapid communication of original research, theoretical articles and methodological reports related to the field of quality of life in all the health sciences. Considerable and unrelenting personal and family stress arise from the regular administration of subcutaneous insulin, frequent blood glucose testing, monitoring, dietary alterations and management of hypo- and hyperglycaemia. Patients scoring 63 or greater on the global severity index of the SCL-90-R and 30% below this cutoff were then evaluated using the Structured Clinical Interview for the DSM-III-R (SCID). In 67 participants, satisfaction with treatment was also assessed, and an open interview was performed, assessing the impact of diabetes, long-term worries, flexibility, restrictions, and self-perception of QoL. Sabbir Liakat, the paper’s lead author, said the team was pleasantly surprised at the accuracy of the method. Sleep complaints and sleep disorders, such as restless legs syndrome and sleep-related breathing disorders, are very common among adult diabetics. Diabetes was also associated with impaired mental health (OR 2.8).

Of the original 30 items, one item, concerning sleeping away from home, was deleted from the scale as it detracted from scale reliability and factor structure, and was not applicable to the great majority of respondents. Validity was measured by comparison with three established instruments: the Symptom Checklist-90-R (SCL), the Bradburn Affect Balance Scale (ABS), and the Psychosocial Adjustment of Illness Scale (PAIS). In week 2 to week 9, the researcher was with the intervention group and had 1 meeting with them once in a week. The scale has demonstrated acceptability and excellent psychometric properties. Most measures were brief and contained less than 30 items but many lacked age appropriate versions or parallel versions for child and proxy raters. That is, a good “signal-to-noise” ratio. Those instruments based on direct valuation of health states (i.e.

EQ-5D and SF-36) tend to have lower signal to noise ratios (indicating greater variation in the utility measures) than those using some form of mapping, however this is due to differences in methods of derivation. In particular, the latter is generally based on predictions of mean utilities derived from regression equations that tend to reduce the degree of variation across health states. In regard to the instruments based on direct valuation, the EQ-5D generally seemed to perform as well as the SF-36 based methods. Some sex differences were found. A third criterion for choosing a utility instrument is the generation of an appropriate range for the utility values. In this regard, the Brazier algorithm, which is now the standard summary score for the SF-36, has a much narrower range as it cannot achieve scores lower than 0.296. The 30-item C-DQOLY-SF was administered to these participants for psychometric testing.

The CHQ-PF50 is a global health-related quality-of-life instrument for parents of children aged 5 to 18 years [14, 15]. The individual counselling programme, conducted at the diabetes outpatient clinic at Bispebjerg University Hospital, was based on the same clinical guidelines and the empowerment approach as in the primary health care centre [15, 18]. This has also been observed in other disease areas such as patients with liver transplantation [19] in which patients 12 months after transplant had a significant improvement in utilities derived from the EQ-5D, but not from the SF-6D. A similar pattern has been found for patients visiting a rheumatology clinic [20]. A final criterion is the simplicity or ease of administration of the instrument. The collection of health-related quality of life information is often subject to cost or time constraints, as the contact time with a patient in trials is limited. Liver transplantation has recently become a life-saving intervention for the majority of patients with cirrhosis and other life threatening end-stage CLDs [13].

The SF-36 is usually administered as a self-completed questionnaire which contains 36 items covering different aspects of health-related quality of life, and administered when patients attend clinics. Furthermore, it is likely that proxy-reports reflect parental anxiety about their child; in this study parents of children with chronic health problems consistently underestimated their child’s HRQL. The EQ-5D is a shorter five item questionnaire which has three response levels to each item and hence its administration time is likely to be well below five minutes. Besides the cost of administration, the use of the EQ-5D may have other advantages as it has been shown to have a higher response rate than those based on the SF-36 and, given the small number of items, there is a greater chance of full-completion which minimizes the problem of missing data [23]. Unless the researcher is interested in deriving domain scores for the SF-36, another option would be to ask a sub-set of questions that match the existing instruments. In this regard, the SF-12 would appear to be a good choice, as five of the seven algorithms were based on SF-12. Since researchers must choose a utility algorithm in addition to choosing a quality of life instrument, the differences in the utilities for the EQ-5D derived using the algorithms developed by Shaw for a US population and original tariffs that were derived in the United Kingdom are of note.

For example, the Dolan algorithm indicated patients with no complications had a utility around 0.8 (similar to previous studies that used this algorithm [3, 24]), while the Shaw algorithm utility gave values 0.05 higher for the same group of patients. While this may reflect differences in health related quality of life between these populations, it is not obvious which should be used, especially in countries where valuation exercises to derive tariff values for EQ-5D states have not been undertaken. Given the increasing internationalization of clinical trials it is important to address this issue in future work. Finally it is important to consider the limitations of the study. First, patients were restricted to Australian patients with diabetes who were eligible and willing to participate in a clinical trial, and hence it may not be a representative sample. However, we were not trying to estimate population values but rather to analyze the relationship between health states and utility, and there appeared to be sufficient diversity of the sample for this. While the maximum value of H′ for the 5L is 2.32, our H′ values ranged from 0.21 to 1.40 which was lower than the findings from Pickard et al.

For example, though we have treated stroke as a single state, its effects are diverse ranging from full recovery to severe disability. They were recruited in the endocrinology offices. Fourth, while we had patients complete the full SF-36, some of the utility scorings only used a subset of questions. Finally, our estimate of test-retest stability is based on patients with no event re-measured after 2 years, and it is likely that the variability represents measurement error plus some real, though minor, changes. However, this is common across all the utility measures and hence should not greatly influence the relative signal-to-noise ratio.

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[ Diabetes Type 1 ]

Health and Quality of Life Outcomes

Diabetes is an illness where a person has high blood glucose (blood sugar) levels because your body does not produce enough insulin or does not respond to insulin. DHP Research and Consultancy Ltd is an independent consulting business specialising in health-related qualitative and quantitative research for industry, academia, public and private health care sector with a specific focus on the measurement of patient reported outcomes (PRO) and patient reported experience (PRE). With Type 1 diabetes, the beta cells of the pancreas no longer make insulin because the body’s immune system has attacked and destroyed them. Furthermore, in a separate study, when consultations were videoed to provide a permanent record of what actually happened, approxi- mately one-third of the issues discussed in most consultations could not be recalled by the patient or professional ((4); Fig. We also provide customised training either delivered at our Banbury office or on-site at your offices at a time convenient to you, Our training workshops are fully customised to your requirements. These support services include translation and linguistic validation, ePROs and expert advice in support of the deployment, scoring and analysis of data from the use of PRO measures. Eleven items were excluded with item factor cross loadings > 0.30 or item factor loadings < 0.30. Associated with long-term complications including blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage, diabetes is widely recognized as one of the leading causes of death and disability and in 2006 was the seventh leading cause of death in the USA. It is important to know what patient reported outcome measure (PROM) scores relate to a meaningful change in health status across time. This is because the measures have some level of sensitivity to diabetes specific health concerns, and the results suggest some overlap in terms of the constructs measured which are of relevance to people with diabetes. However there is also clear divergence observed at the dimension level, where a range of areas of HRQL are assessed. Therefore the use of the measures alongside each other may increase the accuracy of outcomes assessment in Type 2 diabetes by enabling the measurement of generic health concerns alongside diabetes specific indicators. The MID values may guide researchers who are using the measures as part of their assessment of both Type 1 and Type 2 patients with diabetes mellitus. With regard to responsiveness, both the EQ-5D and SF-6D perform better in the groups who self-report health change, although all three measures had low SRMs indicating a generally low level of responsiveness.
This low level of sensitivity could be problematic in the assessment of change in QALYs before and after interventions. However, this finding could be due to the study design and sample used, which was not testing a specific intervention, but was a population survey testing a change in service structure, where health may not be expected to change for all respondents between baseline and follow up. Secondly, the measure of change used was a self-report generic question which may not have a strong relationship with changes on generic or diabetes specific PROMs. All design, text, graphics, program code and the selection or arrangement of them are the copyright of DHP Research & Consultancy Limited or our licensors. Recently, a five level version of EQ-5D (EQ-5D-5L) [23] has been developed, and this may increase the sensitivity of the instrument to change over time. Diabetes prevalence has continued to rise, although this may be as a result of improved casefinding (QOF 2010, QMAS Analysis 2004-10). Another key finding of this work is the strong relationship between the EQ-5D and SF-6D which has been found for diabetes [11] but is not consistently found across other health conditions [24].

The utility values derived from the measures were similar, but due to differences in the range of the utility scale (where SF-6D has a much smaller range) the spread of values differed. Handbook of Psychology and Diabetes. The utility scales were well correlated and at the dimension level, the correlations across similar dimensions indicates overlap in the constructs being measured. Being overweight/obese causes the body to release chemicals that can destabilize the body’s cardiovascular and metabolic systems. This means that both measures have a level of validity for use in Type 2 diabetes, and the values from both instruments could be used in the estimation of QALYs with some confidence. The overlap between the measures means that there is not the requirement to include both in surveys, and there are advantages and disadvantages to both. EQ-5D is short and easy to complete, and is accepted by NICE for use in the economic evaluation of interventions.

The SF-6D is derived from the SF-36 or SF-12, and therefore requires this to be included, but these measures also provide detailed information about the HRQL of patient samples. There are a number of limitations to this study which should be considered when interpreting the findings. Firstly, psychometric validity is difficult to prove as there is no gold standard for the measurement of outcomes against which to compare the measures. Therefore validity can only be inferred against other indicators and across the instruments. Secondly, the findings are limited to the sample used which has specific characteristics which may impact on findings, particularly in relation to the level of responsiveness that should be expected in a population survey. Further work should be done to test the validity and responsiveness of EQ-5D, SF-6D and DHP-18 in relation to other diabetes specific PROMS and clinical indicators using a range of patient samples (including clinical trials to assess responsiveness in more detail). There is no cure for type 1 diabetes.

Psychometric evidence is one method of assessing validity, and should be considered alongside other evidence to build up a picture of the measures performance. This study complements an earlier systematic review that found support for the construct validity of EQ-5D [10]. Qualitative work could also be used to assess whether all of the HRQL issues of importance to people with diabetes are assessed by the PROMS that are used for the condition (see, for example Brazier et al. [27] who used this approach in mental health. Finally, the results are limited to Type 2 diabetes, and further assessment of the GPBMs and Type 1 diabetes specific PROMs is warranted.

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[ Diabetes Type 2 ]

Health and Quality of Life Outcomes

A number of studies have examined the influence of self-efficacy, social support and patient-provider communication (PPC) on self-care and glycemic control. The self-efficacy goal achievement intervention comprises patient goal-setting consultations with practice nurses using the Diabetes Management Self-Efficacy Scale. Addressing this problem requires enhancing self-efficacy towards self-management. This article presents the secondary data analyses of a multicenter, cross-sectional study. Results of this study revealed that outpatients with schizophrenia and T2DM had significantly lower total self-efficacy and self-care scores than outpatients with only T2DM. The target HbA1c was < 7.0% in accordance with the general standard of the American Diabetes Association for patients with type 1 DM. The mean time spent on the educational component of the program was under 30 minutes. As there were no existing instruments available to measure the concept of self-efficacy, the DSEL (the Diabetes Self-Efficacy Scale for Latinos) was developed and standardized in a sample of 200 adult Latinos. (Current Controlled Trials ISRCTN84568563). Fifty-four percent (n=76) were females; 97.1% were married (n=136), and 53.6% had education lower than diploma (n=75). A1C was not measured. Therefore, strategies to enhance and promote self-efficacy and self-management behaviors for patients are essential components of diabetes education programs. A limitation is that we clearly focused on methodological aspects and not primarily on the content of the instruments. We therefore hypothesize that the intervention will significantly increase exercise self-efficacy, compared to the control group. Conclusions. Int J Nurs Stud 2006; 43(5): 611-21. First, one should use rigorous and established methods for the development and validation of patient-reported outcomes. Second, one should consider the implications of Bandura's theoretical concept which includes that self-efficacy instruments should measure a judgment of perceived capability ("I can do") for carrying out specific activities. Future research utilizing the MUSE in the context of longitudinal data and medication adherence measures will be of great benefit in to this line of research. A limitation of this study is the lack of a responsiveness test to detect changes when patients improve or deteriorate [45]. The methodological limitations of the development processes, which we discovered, implies that researchers often seem to be unclear about what they want to measure with the self-efficacy scales. High scores of PPC characterize a person who is confident in their ability to communicate with healthcare professionals and has good understanding of ways to access healthcare in order to get their needs met. Scores ranged from 36 to 180. For example, if the aim is evaluative, this is to detect change over time, items should be selected that are modifiable and the answer options should allow patients to express small but important changes over time. Latter requires that the answer scales offer a sufficient number of options so that patients can express small but important changes [39]. The validation process must consider the measurement properties that are important for evaluative instruments; this is test-retest reliability, longitudinal validity, and responsiveness. The Cronbach’s alpha of 0.78 for the PMCSMS in this study shows that it is nearly as reliable (i.e., internally consistent) when used as a measure of self-management efficacy for persons with HIV as had previously been found when the same item stems had been administered to rheumatology patients or those with diabetes. In this systematic review, however, we observed that a substantial number of self-efficacy scales were developed without a clear definition of their aim. Only self-care behavior was predicted to relate to lipid ratios in Chinese adults with T2DM (Figure 1). First, the aim of the instrument should be defined and described. Those characteristics are then built upon as the athlete continues to play basketball. Second, a priori considerations should be specified to base the development process upon (step B). A priori considerations include methodological and practical issues of the questionnaire, which may include the number and type of domains to be covered, the administration formats, time to complete the questionnaire, and others. Patients participating in the risk factors and complications of diabetes session were questioned regarding what kind of complication screenings they had before. Common sources for item identification in the reviewed instruments were existing scales, unsystematic literature searches, and input from experts and patients. We recommend beginning the identification process with a systematic literature search of existing instruments. Subsequent input from patients is crucial in order to make sure that the most relevant areas of potentially low self-efficacy are included. The standard approach is to conduct focus groups with patients and to use cognitive debriefing techniques. Journal of the Academy of Nutrition and Dietetics. Study participants will weekly fill in the diary starting from 2nd session until the 19th session for a total of 18 weeks. We found that the item selection process was often not clearly described. The most commonly used methods, if reported, were patient-data driven selection of items (using of statistical methods like factor analysis) or a selection based on the opinion of experts. We recommend, as for the item identification process, that the patient perspective should be considered during the item selection process.

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[ Diabetes Type 1 ]

Health and Quality of Life Outcomes

The aim of this study was to compare two free tools, the specific Diabetes Quality of Life Measure (DQOL) and the generic Nottingham Health Profile (NHP), which measure the health-related quality of life (HRQL), in Brazilian patients with diabetes mellitus (DM). A total of 503 patients with type 2 diabetes were recruited from nine diabetes clinics across several Iranian cities. The study involved 130 diabetes outpatients and 127 diabetic foot ulcers patients. Exploratory factor analysis was conducted to evaluate construct validity of the two instruments. The Total Treatment Satisfaction (TTS) was highest in metformin treated patients (5.2) compared with insulin (4.7) or the combination (4.6). Both subscales have good internal consistency reliability. No significant associations between glycemic variability and DQOL total or subscale scores were demonstrated.

Conclusions  No single measure can suit every purpose or application but, when measures are selected inappropriately and data misinterpreted, any conclusions drawn are fundamentally flawed. For convenient clinical use, a 38-item short form of DQOLY (DQOLY-SF) (5) was adapted from DQOLY. Parents received compensation of $100, and children were given an age-appropriate gift valued at $50. The group-based rehabilitation programme, conducted at a primary health care centre, was founded on evidence-based clinical guidelines [18] and emphasized a multidisciplinary approach. Most measures were brief and contained less than 30 items but many lacked age appropriate versions or parallel versions for child and proxy raters. This instrument may be used in future studies to better understand the quality of life of the Chinese population with diabetes. The other instruments were not been formally assessed for responsiveness.

Hence it is important to ensure measures are used with clinical populations where psychometric data are available. In the United States, they are among the 15 most prevalent causes of death in the past decade with the estimated adjusted mortality rate being 10.3 per 100,000 inhabitants in 2010 [5]. In general, HRQL was improved following interventions for DR. What is apparent however, is that this issue merits further investigation. In cases of younger children proxy reports are necessary but there are questions about the relationship between child and parent report [4]. It is therefore positive that most (73.3%) studies obtained ratings from children with only four relying on parents alone to provide proxy ratings. CONSORT [44] guidelines recommend methods of reporting RCTs, but do not adequately deal with the issues concerning QOL assessment and psychometric validity.

Of the measured clinical abnormalities, 69% of the women and 40% of the men had BMI consistent with obesity classifications of moderate (BMI 30 to 35) or severe (BMI >35). Objections to inclusion of QOL measures in trials involve anticipated increased costs, extra time needed to gain patient and parent consent, and lack of sophistication of currently available measures [8]. A major restriction to inclusion of QOL assessment in clinical trials remains limitations in currently available measures, especially for less prevalent chronic conditions. However, it is only through including measures that we will learn more and be able to develop a second generation of measures that do show more sophisticated properties. A second problem is that disease specific measures may simply not be available for rare conditions. Attempts to develop such measures are promising and in this review instruments for ambylopia [25] and agranulocytosis [29] had been developed. In order to facilitate collection of QOL data from children with chronic illness, reliable and valid measures are increasingly required [46].

Other methodological limitations in current work include the lack of power calculations. However, it should be cautioned that the percentage agreement may give higher reproducibility figures than the kappa coefficient [35]. In cases where measurement of QOL is a secondary endpoint, sample size calculations are rare and difficult to establish. Curr Diabetes Rev.

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