Factors associated with negative self-perception of oral health among elderly people in a Brazilian community

Objective: Self‐perception of oral health is an important measurement for assessing the health and quality of life of elderly people. The aim of this study was to analyse associations between negative self‐perception of oral health and poor oral state, socio‐demographic variables, depression and use of medications. Method: In this cross‐sectional study, elderly people aged 60 to 74 years living in the urban zone of a city in southern Brazil were interviewed and examined. Functionally dependent individuals were excluded. Self‐perception was measured using the General Oral Health Assessment Index, and scores of 30 points or less were considered to represent negative perception. The physical, social and worry dimensions of this indicator were also analysed. Results: Two hundred and sixty‐seven elderly people (mean age 66.5 years, 59.9% female) were included in the study. Most of them had had little schooling. Negative self‐perception was identified in 18.7%, although none of the poor oral state was associated with this variable. In multivariate analysis, negative self‐perception was associated with female gender and depression. The women presented significantly lower means in the three dimensions analysed and individuals with depression, in the physical and social dimensions. Poor oral health (edentulism and absence of posterior occlusion) were associated with the physical dimension. Conclusion: Negative self‐perception of oral health was associated with gender and depression, but not with poor oral health. Therefore, gender and the presence of depression are factors to be taken into account in assessments involving this age group.     

The health status and health care use of elderly living in sheltered residences. A comparison with independently living elderly

A sheltered residence for older persons is a living arrangement in between independent living and a residential institution. There is little knowledge about the health of elderly living in these residences. We studied the physical, functional and psychosocial health of 401 persons living in a sheltered residence for elderly in Zwolle through a standardised interview. We compared the health of these elderly to the health of independently living elderly in the same region studied in the Longitudinal Aging Study Amsterdam and adjusted for sex, age and married state. We found an impaired functional health and more chronic illnesses among elderly living in a sheltered residence. In addition, more medication was used (OR = 2.4). The studied elderly felt more often depressed (OR = 1.9) or lonely (OR = 1.7). Their mental state was more frequently impaired (OR = 1.7), they visited health professionals more often and received more help for personal care (OR = 2.0) and housekeeping (OR = 1.6). We conclude that people living in sheltered residences form a distinct group of elderly, characterised by impaired physical, functional and psychosocial health. Planners of future care must be aware of this vulnerable group.     

A cross-sectional analysis of the prevalence of dental anxiety and its relation to the oral health-related quality of life in patients with dental treatment needs at a university clinic in Switzerland

doi: 10.1111/j.1741‐2358.2011.00465.x A cross‐sectional analysis of the prevalence of dental anxiety and its relation to the oral health‐related quality of life in patients with dental treatment needs at a university clinic in Switzerland Objectives: The aim of this observational, cross‐sectional study was to analyse the relationship between dental anxiety (DA) and health‐related quality of life aspects associated with oral conditions of a population with dental treatment needs in Switzerland. Methods: The measurements of DA were collected by means of two questionnaires, the Dental Anxiety Scale (DAS) and a Visual Analogue Scale (VAS). Oral health‐related quality of life (OHRQoL) was assessed with the Oral Health Impact Profile (OHIP). The sample included 223 patients enrolled at a university clinic which specialises in oral prosthetic rehabilitation and temporomandibular disorders. Of them, 78.9% were at or above the age of 50. Results: No gender or age dependencies were observed. A comparison of answers regarding OHRQoL and DA revealed a significant interdependence (p = 0.0118); highly anxious patients were 3.55 times more likely to suffer from poor quality of life compared with less anxious ones. Conclusion: This cross‐sectional study of mostly elderly patients seeking dental treatment in Switzerland found that increased DA was associated with an impaired OHRQoL. The average DA was slightly higher than the results of other industrialised countries and the average OHRQoL was reduced.     

A cross-sectional study of oral health and oral health-related quality of life among frail elderly persons on admission to a special oral health care programme in Copenhagen City, Denmark

doi: 10.1111/j.1741‐2358.2011.00486.x
A cross‐sectional study of oral health and oral health‐related quality of life among frail elderly persons on admission to a special oral health care programme in Copenhagen City, Denmark Aim: To describe the oral health and the oral‐health‐related quality of life (OHRQoL) of citizens in Copenhagen City on admission to a specific oral health‐care programme for disabled elderly persons. Further, to analyse how various factors influence the oral health and the OHRQoL among these patients. Methods: A cross‐sectional study of 189 persons (average 85 years) consecutively admitted to a special oral health‐care programme. Clinical data and data from interviews comprising social factors, life‐style, dental visit habits, oral hygiene practices and self‐perceived oral health were collected. A modified index on perceived dysfunction, discomfort and disability due to oral disorders was used. Results: Sixty‐eight per cent had natural teeth, among those 57% had decayed teeth and two out of three wore dentures. Smoking habits influence the number of teeth present and the OHRQoL (p < 0.05) of the patients. Edentulousness, decayed teeth, and presence of dentures did not seem to cause OHRQoL problems, while higher OHRQoL scores (more problems) were reported by those with 1–9 teeth and tooth mobility. Conclusion: OHRQoL of these patients can be increased by removal of loose teeth and provision of dentures to those with very few teeth rather than focus on traditional caries treatment.     

A preliminary investigation into tooth care, dental attendance and oral health related quality of life in adult stroke survivors in Tayside, Scotland

Objective: The aim of this study was to investigate patterns of oral care, dental attendance and oral health‐related quality of life among adults who had suffered a stroke. Background: Stroke is the most common cause of adult disability in the UK. Seventy per cent of strokes occur in adults over 65 years of age. A mild stroke may leave little residual disability but in cases of moderate or severe stroke the disability may be significant and may impact on oral health and function. Materials and methods: A cross‐sectional survey was conducted among adults surviving 1 year after stroke, between January and July 2001. A medical screening was carried out which included an assessment of disability and handicap using the modified Rankin scale. A structured interview was conducted to identify normal patterns of oral care and dental attendance and to elicit if since suffering a stroke any changes had occurred or were likely to occur. The Short Form Oral Health Impact Profile (OHIP‐14) was administered prior to an oral examination. Analysis used SPSS 11.0 for Windows. Parametric and nonparametric tests were undertaken (t‐tests and chi‐squared tests with Yates correction where appropriate). Results: Forty‐one adults were recruited into the study comprising 21 female and 20 male. They ranged in age from 50 to 87 years and the mean age was 69 years (SD = 9.8). Forty per cent of participants experienced moderate disability or greater following their stroke. Thirty‐seven per cent had difficulty with tooth cleaning. The most frequently reported problem was being unable to use one hand properly as a result of the stroke. There was a significant association between the degree of disability following stroke and difficulty with tooth cleaning (P = 0.015). Disability as a result of the stroke was cited as the main reason for reported or projected attendance pattern change. The most frequently experienced OHIP‐14 dimension was functional limitation (39%). Conclusion: Individuals who have been left disabled after a stroke may require help with or advice on oral care and information on how to access dental services in a setting appropriate to their disability. Further research is needed to identify the dental needs of adults with stroke and to identify appropriate interventions to meet these needs.     

Implant‐supported overdenture in an elderly patient with Huntington’s disease

doi:10.1111/j.1741‐2358.2009.00343.x
Implant‐supported overdenture in an elderly patient with Huntington’s disease Huntington’s disease is a hereditary, progressive, neuro‐degenerative disorder characterised by increasingly severe motor impairment, cognitive decline and behavioural manifestations leading to functional disability. Dyskinesia and hyperkinesia of the tongue and the peri‐oral musculature make it impossible for the patient to wear a conventional complete denture, despite an adequate alveolar ridge. The present paper reports on a patient with Huntington’s disease who was rehabilitated with a mandibular overdenture supported by two endosteal implants. One year follow‐up examination showed that the prosthesis was stable and there was considerable improvement in the patient’s masticatory function.     

Oral health of the elderly living in residential homes in Slovenia

doi: 10.1111/j.1741‐2358.2011.00497.x
Oral health of the elderly living in residential homes in Slovenia Objectives:  To evaluate oral health status of the elderly, living in eight randomly selected residential homes for senior citizens across the country. Background: The percentage of the elderly is growing worldwide. With ageing, risks of various oral diseases, including dental caries and periodontal disease, are growing. Methods: Altogether 296 elderly people (88 men, 208 women) of average age 79.89 ± 7.4 years were questioned about their medical condition and oral health practice and examined orally. Evaluation of clinical examination was carried out by DMFT, plaque index ( 10 ) and Community Periodontal Index of Treatment Need (CPITN). Results: Of 296 participants, 106 (35.8%) were edentulous, 95 (32.1%) had one to nine teeth and 95 persons (32.1%) had 10 or more teeth. The average number of teeth in an individual was small: 6.76 ± 7.47. The average number of teeth with caries lesions was 3.59 ± 4.70, filled teeth 1.94 ± 3.63 and teeth without caries or fillings 1.19 ± 2.41. The average DMFT value was 30.75. In 69.5% of participants, dental plaque was visible with the naked eye. Of 171 subjects, in whom CPITN index was appraised, 81.9% would need oral hygiene education, 56.7% would need scaling and root planning and 21.6% would need periodontal surgical treatment. Conclusions: The results of this study indicate poor oral health of the elderly living in residential homes situated in different towns in Slovenia. It is of utmost importance to highlight the necessity of improving oral health care of this population.     

Analysis of socio-demographic and systemic health factors and the normative conditions of oral health care in a population of the Brazilian elderly

doi: 10.1111/j.1741‐2358.2010.00446.x
Analysis of socio‐demographic and systemic health factors and the normative conditions of oral health care in a population of the Brazilian elderly Objective: To investigate the association of socio‐demographic and systemic health factors according to the normative conditions of oral health care (dental caries, edentulism, periodontal disease and oral mucosal lesion) in elderly individuals. Material and methods: A cross‐sectional study was carried out in a group of elderly with access to community health care (n = 200). The normative conditions of oral health were then investigated according to the WHO and the SB Brazil criteria. Bivariate analyses were evaluated by the chi‐square test and Fisher’s exact test. An estimation of prevalence for the covariates was performed using Poisson’s regression models. Results: The prevalence of edentulism and oral mucosal lesions was detected in 58% and 21.5% of elderly patients, respectively. In the dentate subjects, the prevalence of dental caries and periodontal disease was 51.2% and 20.8%, respectively. Older men and individuals from lower‐income groups exhibited a higher prevalence of dental caries. Elderly women, illiterate individuals, and individuals over the age of 65 years exhibited a higher prevalence of edentulism. Elderly 60–64 years old and those who are employed had a significant association with periodontal disease. Conclusion: Socio‐demographic factors were associated with some notable oral diseases in the elderly.     

General health, dental status and perceived dental treatment needs of an elderly population in Istanbul

doi: 10.1111/j.1741‐2358.2010.00363.x
General health, dental status and perceived dental treatment needs of an elderly population in Istanbul Background: Comprehensive data on the oral health status and dental treatment needs of the elderly population in Turkey are deficient. Objectives: This pilot study determined the general and dental health status, perceived medical and dental treatment needs of an elderly population dwelling in residential homes in Istanbul. Method: Subjects at three different residential homes, namely one belonging to the state and two supported by foundations in Istanbul (N=121, female: 63 and male: 58) were involved in this study. A detailed questionnaire was prepared and dental examinations were conducted. Information was collected related to age, education levels, financial status, current physical functional status, general health, mental health, previous dental history, current dental status, oral hygiene practices and denture hygiene of these elderly people. The prevalence of edentulism, the presence and type of dental prostheses, dental and denture status and denture cleanliness were further evaluated. Results: The three most prevalent reported general health problems were associated with genito‐urinary problems (24%) followed by cardiovascular (18%) and respiratory problems (14%) varying significantly between genders, with males suffering more from cardiovascular problems than females (p < 0.05). Females showed significantly higher gastrointestinal and orthopaedic problems than males (p < 0.05). Females were more frequently edentulous than males but denture hygiene was significantly better in females than in males (p < 0.05). Brushing frequency did not significantly increase denture hygiene (p = 0.6). More than one‐third of the subjects had not been to the dentist within the previous 5–10 years, mainly due to lack of demand, followed by the cost of the dental care and fear. More than two‐thirds of denture‐wearing subjects wore their dentures only during eating. Conclusions: There was significant perceived dental treatment and care need for the sample population of elderly studied.     

A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review

doi:10.1111/j.1741‐2358.2009.00299.x
A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review Background: It has been stated that mandibular overdentures are more satisfactory than conventional dentures, but problems relating to the use of retrospective ratings, lack of control group and sequential provision of treatment may compromise the findings. Objective: To establish a comparison between treatment with conventional complete dentures and implant‐retained overdentures in elderly patients by conducting a literature review. Materials and methods: A search of English language peer‐review literature was completed using Medline up to 2008 focusing on evidence‐based research. Randomised clinical trials (RCTs) and longitudinal prospective studies were favoured in the review, using a general hierarchical classification. Articles that did not focus exclusively on the comparison of patient satisfaction between complete dentures and overdentures were excluded from further evaluation. The last search was conducted in February 2008. Key terms included quality of life, patient satisfaction, edentulism, complete denture and overdenture. Results: Among the 90 articles found in the initial search, 27 met the inclusion criteria. This included 18 RCTs and eight prospective and one cohort study. Most of the articles stated superiority of the mandibular implant‐retained overdenture therapy over the conventional complete denture regarding patient satisfaction and quality of life. Conclusion: Even with implant treatment presenting higher patient satisfaction and improvement of quality of life, it was not possible to establish a direct comparison between the studies due to differences in adopted methodologies.     

Factors associated with the oral health-related quality of life in elderly persons in dental clinic: validation of a Mandarin Chinese version of GOHAI

Gerodontology 2011; doi: 10.1111/j.1741‐2358.2009.00360.x
Factors associated with the oral health‐related quality of life in elderly persons in dental clinic: validation of a Mandarin Chinese version of GOHAI Objectives: To translate the original English version of Geriatric Oral Health Assessment Index (GOHAI) into Mandarin Chinese and assess its reliability and validity for use among the elderly in inland China and to explore the factors associated with oral health‐related quality of life (OHRQoL). Methods: The original English version of GOHAI was translated, back‐translated and cross‐culturally adapted. The psychometric properties of GOHAI‐M were assessed in a sample of 263 people aged 60 years and over and OHRQoL was examined in 221 subjects using GOHAI‐M. Multiple regression analysis was conducted. Results: Internal consistency of the GOHAI‐M was excellent (Cronbach’s α : 0.81). Split‐half reliability coefficient was 0.80, and item‐scale correlation coefficient ranged from 0.25 to 0.71. Self‐rated oral health was significantly associated with OHRQoL (r_s = 0.505, p < 0.01). The relation coefficient between GOHAI‐M and self‐perceived need for dental treatment and number of missing teeth were 0.231 and ?0.653, respectively (p < 0.05). Multiple regression analysis found that better OHRQoL was significantly associated with better self‐ratings of oral health (β = 0.497, p = 0.01), number of missing teeth (β = 0.187, p < 0.01) and life satisfaction (β = 0.132, p < 0.05). Conclusion: The Mandarin Chinese version of GOHAI demonstrates acceptable reliability and validity. OHRQoL is associated with self‐rated oral health, number of missing teeth and satisfaction with life.     

Dental anxiety among middle-aged and elderly women in Sweden. A study of oral state,utilisation of dental services and concomitant factors

The aim of this project was to investigate dental anxiety and its expression in utilisation of dental services, oral health and oral symptoms. In a cross-sectional study of women's health in Göteborg (population 432,000), Sweden, 1016 women aged 38 to 84 years participated. This randomly selected population took part in a series of investigative procedures including medical and dental clinical examinations, interviews and questionnaires. Levels of dental anxiety were measured on the Corah Dental Anxiety Scale (DAS). The average DAS score obtained was 7.2. The study showed that older women were significantly less anxious than younger ones. Severe dental anxiety (DAS 15) was experienced by 3.9% of the participants. This frequency corresponds well with findings by Hällström and Halling in their analysis of data from the first Göteborg study of women's health 24 years ago. High levels of dental anxiety were correlated with longer intervals between dental visits, poorer oral function and aesthetics and a higher frequency of oral symptoms. Headaches were more prevalent in the younger age groups and a correlation with dental anxiety was revealed. Our previous studies have shown that symptoms such as tension headaches are prevalent among dental phobic patients and that they are reported to be reduced by therapy for dental fear. The clinical and radiographical examinations revealed a generally poorer oral status, with a statistically significant higher number of decayed teeth among women with high dental anxiety.     

Knowledge and attitude of elderly persons towards dental implants

doi: 10.1111/j.1741‐2358.2011.00586.x Knowledge and attitude of elderly persons towards dental implants Background: Despite their unrivalled place in restorative treatment, dental implants are still scarcely used in elderly patients. Introduction: The aim of this survey was therefore to identify potential barriers for accepting an implant treatment. Materials and methods: Participants were recruited from a geriatric hospital, two long‐term‐care facilities and a private clinic. The final study sample comprised 92 persons, 61 women and 31 men with an average age of 81.2 ± 8.0 years. In a semi‐structured interview, the participants’ knowledge of implants and attitude towards a hypothetical treatment with dental implants were evaluated. Results: Twenty‐seven participants had never heard of dental implants, and another 13 participants could not describe them. The strongest apprehensions against implants were cost, lack of perceived necessity and old age. Univariate and multiple linear regression analysis identified being women, type and quality of denture, having little knowledge on implants and being hospitalised as the risk factors for refusing implants. However, old age as such was not associated with a negative attitude. Conclusion: The acceptance of dental implants in the elderly population might be increased by providing further information and promoting oral health in general. Regardless of the age, dental implants should be placed when patients are still in good health and live independently.     

First-time dental care and the most recent dental treatment in relation to utilisation of dental services among dentate elderly patients in Lithuania

Objectives: To describe the initial dental treatments of Lithuanian dentate elderly patients and the content of the most recent treatment in relation to their dentist‐visiting behaviour. Materials and methods: A cross‐sectional questionnaire study was carried out at two public dental offices in Kédainiai, Lithuania, among dentate patients aged 60+ years. A self‐administered questionnaire covered first‐time dental care, the most recent dental treatment, check‐up behaviour, interval since the most recent dental visit, and number of teeth. Age, gender and education served as background information. Statistical evaluation was by chi‐squared test, anova and logistic regression for odds ratio (OR). Results: In all, 174 dentate elderly responded, mean age being 69.2 (SD = 6.6) years. The mean age at the first visit was 16.3 years [95% confidence interval (CI) 14.9–17.6]. Regular dental check‐ups were reported by 30%, and 36% had visited a dentist within the past 12 months. As to the content of the most recent treatment, 78% of the elderly reported filling therapy, 50% endodontics, 48% tooth extraction, 21% radiography, 10% cleaning or scaling and 6% polishing of fillings. Those going for check‐ups were more likely to report diagnostic (OR 1.9; 95% CI 1.1–2.8; p = 0.01) and preventive (OR 4.8; 95% CI 2.5–9.0; p = 0.002) treatment when analysed by a logistic regression model, controlling for age, gender, education and number of teeth. Conclusions: Check‐up‐orientated utilisation of dental services should be encouraged among the Lithuanian elderly. Dentists and health officials should place greater emphasis on prevention.     

The potential benefits of dental implants on the oral health quality of life of people with Parkinson’s disease

Objective: To investigate how dental implants impact on the oral health quality of life of people with Parkinson’s disease (PD). Background: PD is a progressive neurological disorder that can result in a number of oral health care challenges, including denture difficulties. Lack of evidence related to use of implants in PD prompted this study to investigate their use in this group of people. Materials and methods: Nine people with PD were provided with either fixed or removable prostheses using Astra‐Tech implants. Participants completed the socio‐dental questionnaire, ‘The Dental Impact on Daily Living Assessment’ (DIDL) prior to implant surgery, and at 3 and 12 months after provision of the final prosthesis. DIDL comprises two components – the Oral Health Quality of Life Inventory (OH‐QoL) and the Self‐Reported Assessment of Oral Health and Functional Status (SROH). Results: Nine people (with an age range of 54–77 years) had implants placed. The implant success rate was 85 and 81% in the maxilla and mandible, respectively. The OH‐QoL and SROH results (analysed using the one‐way analysis of variance and pairwise multiple comparisons) demonstrated a significant improvement in the domains of eating and satisfaction with the prosthesis after 3 months, which was maintained at the twelve month review. The OH‐QoL indicated a gradual improvement in oral well‐being over the 12‐month period. Conclusion: The oral health quality of life of people with PD was improved by the use of dental implants, indicating this as a viable treatment option.     

Isolation of clinically relevant fungal species from solid waste and environment of dental health services

Aims: This study was undertaken to detect, identify and determine antifungal susceptibility of yeast strains isolated from dental solid waste and to evaluate airborne fungi in the Brazilian dental health care environment and in the waste storage room. Methods and Results: A group of 17 yeast strains were identified by macroscopic and microscopic characteristics, API 20C Aux system and Multiplex PCR. All 104 airborne fungal colonies were identified by macroscopic and microscopic morphology. The CLSI broth microdilution method was utilized as the susceptibility test. Candida parapsilosis was the prevailing yeast species recovered from waste, followed by Rhodotorula glutinis. Three strains of Candida guilliermondii presented minimal inhibitory concentration values considered to be susceptible dose dependent (2 μg ml^?1) to voriconazole. Of all airborne fungal species, 69% were recovered from the waste storage room and 31% were recovered from the clinical/surgical environment. Most of them were identified as Cladosporium spp. Conclusions: These findings reinforce the potential risk of waste handling and point out the need for safe management to minimize the spread of these agents to the environment. Filamentous fungi isolation in almost all sampled environments indicates that a periodic monitoring of airborne microbiota in the dental health care service environment is required. Significance and Impact of the Study: The survival of yeast strains for 48 h suggests that dental waste should be carefully controlled and monitored.     

Screening for elder mistreatment in dental and medical clinics

doi: 10.1111/j.1741‐2358.2010.00405.x
Screening for elder mistreatment in dental and medical clinics Objective: Elder mistreatment (EM) is a potentially fatal and largely unrecognised problem in the United States. The purpose of this study was to determine the prevalence of EM in busy clinics and specifically, we report on the feasibility of screening for EM as well as the appropriate instrumentation for screening. Background: Prevalence estimates for elder mistreatment vary, but recent data from a national sample of community‐residing adults over 60 years of age indicate that 11.4% of older adults report some form of elder mistreatment. There is a paucity of research related to screening in dental and medical clinics to understand the prevalence in such practice settings. Methods: A cross‐sectional study was conducted from January 2008 to March 2009. We enrolled 241 patients at two clinics: a medical clinic (n = 102) and dental clinics (n = 139). A mini‐mental status exam was conducted with a minimum of 18 or better for inclusion. An elder mistreatment screen was next used [elder assessment instrument (EAI‐R) for medical and Hwalek–Sengstock elder abuse screening test (HS‐EAST) for dental]. Results: For the 241 patients, we were able to compare data from the EAI‐R with the HS‐EAST. This pilot work demonstrates the feasibility of screening for EM in busy clinics since we documented patient enrolment of 20% in the medical clinics and 66% in dental clinics. Patients are willing to answer extremely‐sensitive questions related to elder mistreatment and are also willing to use computer technology for interviewing. Conclusion: Dental and medical clinics are important practice venues to screen for elder mistreatment.     

Health status in the TORCH study of COPD: treatment efficacy and other determinants of change

Background

Little is known about factors that determine health status decline in clinical trials of COPD.

Objectives

To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.

Methods

St George''s Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.

Measurements and Main Results

Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV₁) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV₁ % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV₁. The relationship between deterioration in FEV₁ and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV₁ change.

Conclusions

In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT00268216","term_id":"NCT00268216"}}NCT00268216