A comparison of implant-retained mandibular overdentures and conventional dentures on quality of life in edentulous patients: a randomized, prospective, within-subject controlled clinical trial.

OBJECTIVES: To determine any difference in patient response to implant overdentures compared with conventional complete dentures alone. MATERIALS AND METHODS: In a randomized, prospective, controlled study, 122 edentulous patients (Mean age 64; 39 men, 83 women) underwent baseline assessment of denture satisfaction and quality of life using the Oral Health Impact Profile-49 (OHIP-49) and a Denture Satisfaction Questionnaire. All patients were provided with new conventional complete dentures (CCDs) that they wore for 3 months, at which point they were reassessed using the same measures. Patients were randomly assigned either to continue with CCDs (CC group) or to have implant-retained overdentures (IODs) made (CI group). The CC group was assessed after a further 3 months (6 months after receiving CCDs). The CI group was assessed 3 months after receiving IODs. RESULTS: Significant improvements in satisfaction and quality of life were found in the patients 3 months after receiving CCDs (P < 0.05). No further improvements were found in the CC group at 6 months on any of the measures. The CI group showed significant additional improvements at 3 months following IODs on the functional limitation, physical pain, psychological discomfort, physical disability, social disability, psychological disability and handicap scales of the OHIP and on 10 of the 11 scales of the Denture Satisfaction Questionnaire (P < 0.05, ANOVA). CONCLUSIONS: The findings show that, controlling for expectancy bias and variability in baseline levels, IODs significantly increase patient satisfaction, dental function and quality of life over and above those achieved with good quality CCDs.

Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients.

BACKGROUND: Quality of life (QoL) is now established as an important outcome for evaluating the impact of disease, and for assessing the efficacy of treatments. However, individuals change with time and the basis on which they make a QoL judgement may also change, a phenomenon increasingly referred to as response shift. Here, the individual may change his or her internal standards, values, and/or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status. This has important implications for assessing the effects of treatments as a change in QoL may reflect a response shift, a treatment effect, or a complex combination of both. In this study, we used an individualised quality of life (IQoL) measure, the SEIQoL, together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients. METHODS: Data are reported here for the first phase of a randomised controlled clinical trial designed to assess the impact, on IQoL, of implant supported dentures compared with high quality conventional dentures. IQoL was measured using the SEIQoL-DW in 117 patients (mean age 64.8; 32% male) at baseline (T1) and 3 months (T2) after receiving high quality conventional dentures. The work was carried out in dental teaching hospitals in Dublin and Belfast. RESULTS: Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months (baseline: 75.0; 3 months: 73.2, p = .33, n.s.). However, the then-test at 3 months revealed that patients retrospectively rated their baseline IQoL as significantly lower (P < .001) than they had rated it at the time (then-test baseline: 69.2). Comparison of the 3 month scores with this readjusted baseline indicated a significant treatment effect (then-test baseline: 69.2; 3 months: 73.2, p = 0.016). 81% of patients nominated at least one different IQoL domain at 3 months. CONCLUSION: The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration. The nature of the response shifts was highly complex but the data indicated a degree of re-conceptualization and reprioritisation. Assessment of the impact of treatments using patient-generated reports must take account of the adaptive nature of patients.

The SHEL model: a useful tool for analyzing and teaching the contribution of Human Factors to medical error.

Recent reports on the problem of medical error pointed to a discipline that has been until recently, largely disregarded by the medical profession. The interdisciplinary science of Human Factors, the reports argue, provides a pragmatic framework for analyzing and assessing risk and reducing error in health care. The argument for applying Human Factors analysis to health care is increasingly accepted, and the application of Human Factors systems models for understanding medical error in particular have proved to be especially illuminating. The authors present a conceptual model of Human Factors--the SHEL model (named after the initial letters of its components' names, Software, Hardware, Environment, and Liveware)--that has been used in investigations of error in aviation. The authors use this simple model to examine and elucidate the Human Factors issues in a specific real-life example of medical error. The SHEL model is particularly useful in examining Human Factors issues in microsystems in health care such as the emergency room or the operating theatre; it argues that mismatches at the interface between the components in these health care microsystems are often conducive to medical errors. The authors propose that the SHEL model may have some unexploited potential in analyzing error and in training medical professionals about the science of Human Factors and its application to medical error. Empirical studies are needed, however, to ascertain the optimal amount of training needed to make clinically significant reductions in the occurrence of medical error.

Individual quality of life factors distinguishing low-burden and high-burden caregivers of dementia patients.

Dementia patient (n = 72) and caregiver characteristics and individual quality of life (IQoL) factors distinguishing low- and high-burden caregivers were evaluated. Measures included patient cognitive, functional and behavioural status, and caregiver burden, well-being, social support appraisal and IQoL. The caregivers were divided by median split into low- and high-burden groups. In the high-burden group daughters were over-represented, psychological morbidity was higher, QoL was lower, the patients were more behaviourally disturbed, and there was a trend towards more negative appraisal of informal social support. Of the many QoL factors elicited from caregivers, only 'time for self' and 'finances' differed significantly between the groups. A need for more time away from the patient is a major QoL concern for highly burdened caregivers, and a perceived lack of adequate informal support and/or financial constraints are contributory factors.