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PubMed2002

Healthy sleepers are rare: problems and success rates in establishing a control group for sleep studies.

A large and representative control group is paramount for establishing normative values for sleep in middle-aged persons. However, it is very difficult to recruit normal sleepers. From 286 volunteers who responded to an advertisement for healthy sleepers, only 47 finished the study. We excluded 221 after evaluation of their medical sleep history, general health data, and results of physical examination. We further excluded 18 volunteers after nighttime polysomnography. We finally eliminated from the study 37.5% of the volunteers who entered the screening procedure, on grounds of their sleep disturbances. Our study reveals that investigators face major difficulties when trying to establish a control group of healthy sleepers from the middle-aged population. Sufficient interest on the part of potential test persons does in fact exist, but their general health-and, especially, previously undiscovered sleep disorders-frequently prohibit their inclusion. International and interdisciplinary cooperation is necessary to establish a sufficiently large control group for both clinical and research purposes.

Adult↗
PubMed2004

Consumer and service determinants of completion of a consumer self-rating outcome measure.

OBJECTIVE: To study the relative contribution of consumer, clinician and service factors to whether or not consumers completed a self-rating measure in the context of routine outcome measurement. METHODS: Four Victorian mental health services commenced routine outcome measurement in their adult services in mid-2000. Clinician-completed measures (Health of the Nation Outcome Scales (HoNOS) and Life Skills Profile (LSP)) and a consumer self-rated measure (Behaviour and Symptom Identification Scale (BASIS)) were entered into specialized software. Analyses were restricted to assessments conducted at review in the community. RESULTS: Wide differences were observed between the four agencies in the rates of completion of the self-rating measure. Overall, consumer characteristics associated with greater likelihood of completion were lower age, non-organic diagnosis, lesser severity as measured by the HoNOS, and lesser disability as measured by the LSP. A more focused analysis showed that agency, lower age, and higher compliance were most reliably associated with completion. Significant proportions of clinicians had no recorded instances of consumer self-rating associated with their assessments. CONCLUSIONS: Service and clinician factors appear to be equally important as consumer factors in whether or not a self-rating measure was completed. Information systems designed for outcomes measurement should include indications of whether or not a self-rating was invited, and, if not, why not. The results suggest that consumer self-rating is not yet firmly established in the outcomes measurement culture.

Age Factors↗
PubMed2003

The effectiveness of personalized smoking cessation strategies for callers to a Quitline service.

AIM: To assess the effectiveness of a program of computer-generated tailored advice for callers to a telephone helpline, and to assess whether it enhanced a series of callback telephone counselling sessions in aiding smoking cessation. DESIGN: Randomized controlled trial comparing: (1) untailored self-help materials; (2) computer-generated tailored advice only, and (3) computer-generated tailored advice plus callback telephone counselling. Assessment surveys were conducted at baseline, 3, 6 and 12 months. SETTING: Victoria, Australia. PARTICIPANTS: A total of 1578 smokers who called the Quitline service and agreed to participate. MEASUREMENTS: Smoking status at follow-up; duration of cessation, if quit; use of nicotine replacement therapy; and extent of participation in the callback service. FINDINGS: At the 3-month follow-up, significantly more (chi2(2) = 16.9; P < 0.001) participants in the computer-generated tailored advice plus telephone counselling condition were not smoking (21%) than in either the computer-generated advice only (12%) or the control condition (12%). Proportions reporting not smoking at the 12-month follow-up were 26%, 23% and 22%, respectively (NS) for point prevalence, and for 9 months sustained abstinence; 8.2, 6.0, and 5.0 (NS). In the telephone counselling group, those receiving callbacks were more likely than those who did not to have sustained abstinence at 12 months (10.2 compared with 4.0, P < 0.05). Logistic regression on 3-month data showed significant independent effects on cessation of telephone counselling and use of NRT, but not of computer-generated tailored advice. CONCLUSION: Computer-generated tailored advice did not enhance telephone counselling, nor have any independent effect on cessation. This may be due to poor timing of the computer-generated tailored advice and poor integration of the two modes of advice.

Adolescent↗
PubMed1997

Subject retention in a controlled clinical trial.

Threats to subject retention in a controlled clinical trial require strategies that encourage continued participation of subjects, with consideration of the effect of the strategies on the dependent variable. Methods to encourage retention must be based on sensitivity to the patient's changing condition and perspective. Primary considerations in the design and implementation of an intervention study are the acceptability of the intervention to particular patients and the compatibility of the intervention with other care activities. In addition, qualities of the research personnel and changes in patient conditions are important factors in retention of subjects. Vignettes illustrate the threats to retention and solutions used in a clinical trial. Threats to retention include the research nurse's approach and patient factors such as worries, control issues, visitors, symptoms of confusion and pain, and lack of cooperation. Retention strategies include supporting and educating research nurses, providing empathy and respect, including patients in decisions, negotiating with visitors, alleviating symptoms, and supporting a plan of care consistent with both the research protocol and the patient's recovery. While providing a similar approach to all groups, experimental researchers in a variable clinical environment must also provide some individualization and communication to retain valuable subjects who are ill.

Adult↗
PubMed1999

Absconding: why patients leave.

Absconding by patients from acute psychiatric care poses a significant problem to professional staff, and can involve significant risks for patients and others. This paper describes the methodology of a major prospective study of absconding recently completed in the East End of London, and reports the findings on why patients abscond from hospital. Interviews with 52 patients who returned to their wards showed that they abscond because they are bored, frightened of other patients, feel trapped and confined, have household responsibilities they feel they must fulfil, feel cut off from relatives and friends, or are worried about the security of their home and property. Psychiatric symptoms also contribute to the decision to leave, but in nearly every case patients can give additional and rational reasons for their abscond. Some patients leave impulsively and in anger following unwelcome news about delayed permission for leave or discharge. Others leave specifically in order to carry out some activity outside the hospital. In order to reduce absconding and rejection of care, nurses may need to carefully consider the meaning admission has for patients, and the impact it can have upon their everyday lives.

Escape Reaction↗
PubMed1999

Absconding: how and when patients leave the ward.

Information about how and when patients abscond from acute psychiatric wards may provide important clues to effective prevention strategies. This paper reports relevant findings from a large scale study of absconding conducted in the East End of London. In contrast to the findings in previous studies, the vast majority of absconders left from the ward directly, mostly via the front door. Some were known to be at risk of absconding, and although more than half had declared their intention to leave, they still succeeded in getting away. On some occasions they circumvented locked or guarded doors, or special nursing observation. Shift handovers were a peak time for absconds, possibly due to decreased nursing surveillance of the ward. Most absconds occur during the first few weeks of admission, and most absconders simply went home and engaged in normal, everyday activities. The findings indicate that physical security measures alone are not a sufficient answer to the problem of absconding, and nurses need to work harder to develop supportive alliances with patients.

Escape Reaction↗
PubMed1999

Absconding: outcome and risk.

Absconding by patients from acute psychiatric wards is known to be linked to self harm and harm to others. Previous research has focused only on officially reported absconds, thus missing out many patients who although they abscond and pose a risk, are never officially processed. This paper reports the findings of a large prospective study of absconding in the East End of London using an objective definition of absconding not linked to official bureaucratic processes. Absconders are considered by staff to be high risk patients, and many have histories of violence and/or suicide attempts. Nevertheless nurses only request the aid of the police in returning patients on 47% of occasions. The actions of the police are very variable, and range from two policemen calling at the patient's house, to an entire team in riot gear appearing at the patient's door in the early hours of the morning. Most absconds result in no harm to anyone, and most absconders return by themselves. Relatives and carers also play a significant role in persuading the patient to return or bringing them back. Nurses should develop more sophisticated ways of working with the police and with relatives to maintain absconding patients' safety.

Escape Reaction↗
PubMed2000

Bath psoralen-ultraviolet A therapy in atopic eczema.

AIMS: To evaluate the efficacy of bath psoralen-ultraviolet A (PUVA) therapy in severe cases of atopic dermatitis (AD) in adults using the extended Six Area, Six Sign Atopic Dermatitis (SASSAD) score. METHODS: Thirty-five adult subjects with severe AD underwent bath PUVA therapy for a maximum of 30 sessions ranging from one to three times a week. The only other treatment allowed during the study was topical application of hydrocortisone. RESULTS: There were a total of six drop-outs, three due to aggravation of symptoms. After the maximum 30 sessions the remaining 29 subjects showed 82.1% improvement in the severity of lesions, 75.2% reduction in extension of lesions, 74% improvement in itching and 79% improvement in night-time rest. Patient evaluations gave an overall score of 8.8 on a scale of 0-10.

Adolescent↗
PubMed2000

Use of an orientation clinic to reduce failed new patient appointments in primary care.

Patients who fail to attend initial appointments reduce clinic efficiency. To maximize attendance by newly referred outpatients, we introduced a mandatory group orientation clinic for all new patients and determined its effects on no-show rates. Orientation clinic also provided health care screening and opportunities for patient feedback. The new patient no-show rate for initial provider visits decreased significantly from 45% before institution of orientation clinic to 18% afterwards (P<.0001). The total no-show (patients who failed to attend orientation clinic or an initial provider visit) rate of the postintervention group was 51% (P = .28, compared with before the intervention). This intervention improved the efficiency and minimized the wasted time of our clinicians.

Appointments and Schedules↗
PubMed1999

Clinical audit of 5 years provision of the Odstock dropped foot stimulator.

The Odstock dropped foot stimulator (ODFS) is a foot switch controlled single channel neuromuscular stimulator for correction of dropped foot. Following a randomized controlled trial, the ODFS was recommended for use in the United Kingdom's National Health Service and a clinical service established. The patient performance was assessed by measurement of walking speed over 10 m, physiological cost index (PCI), and by questionnaire. After 4.5 months stroke patients (n = 111) showed a mean increase in walking speed of 27% and reduction in PCI of 31% with stimulation and changes of 14% and 19%, respectively, unassisted. Multiple sclerosis patients (n = 21) gained similar orthotic benefit but no carry over. The principal reason cited for using the equipment was that it reduced the effort of walking. The principal reasons identified for discontinuing were an improvement in mobility, electrode positioning difficulties, and deteriorating mobility. A comprehensive clinical follow-up service is essential to achieve the maximum continuing benefit from FES based orthosis.

Cerebrovascular Disorders↗
PubMed2003

The multicenter study of epilepsy surgery: recruitment and selection for surgery.

PURPOSE: Multiple studies have examined predictors of seizure outcomes after epilepsy surgery. Most are single-center series with limited sample size. Little information is available about the selection process for surgery and, in particular, the proportion of patients who ultimately have surgery and the characteristics that identify those who do versus those who do not. Such information is necessary for providing the epidemiologic and clinical context in which epilepsy surgery is currently performed in the United States and in other developed countries. METHODS: An observational cohort of 565 surgical candidates was prospectively recruited from June 1996 through January 2001 at six Northeastern and one Midwestern surgical centers. Standardized eligibility criteria and protocol for presurgical evaluations were used at all seven sites. RESULTS: Three hundred ninety-six (70%) study subjects had resective surgery. Clinical factors such as a well-localized magnetic resonance imaging (MRI) abnormality and consistently localized EEG findings were most strongly associated with having surgery. Of those who underwent intracranial monitoring (189, 34%), 85% went on to have surgery. Race/ethnicity and marital status were marginally associated with having surgery. Age, education, and employment status were not. Demographic factors had little influence over the surgical decision. More than half of the patients had intractable epilepsy for >/=10 years and five or more drugs had failed by the time they initiated their surgical evaluation. During the recruitment period, eight new antiepileptic drugs were approved by the Food and Drug Administration for use in the United States and came into increasing use in this study's surgical candidates. Despite the increased availability of new therapeutic options, the proportion that had surgery each year did not fluctuate significantly from year to year. This suggests that, in this group of patients, the new drugs did not provide a substantial therapeutic benefit. CONCLUSIONS: Up to 30% of patients who undergo presurgical evaluations for resective epilepsy surgery ultimately do not have this form of surgery. This is a group whose needs are not currently met by available therapies and procedures. Lack of clear localizing evidence appears to be the main reason for not having surgery. To the extent that these data can address the question, they suggest that repeated attempts to control intractable epilepsy with new drugs will not result in sustained seizure control, and eligible patients will proceed to surgery eventually. This is consistent with recent arguments to consider surgery earlier rather than later in the course of epilepsy. Postsurgical follow-up of this group will permit a detailed analysis of presurgical factors that predict the best and worst seizure outcomes.

Adolescent↗
PubMed1993

Strategies to recruit plateletpheresis donors from a registry of HLA-typed, unrelated, bone marrow donors.

Rising demand for single-donor platelet components--from random donors, to maintain platelet inventories, or from HLA-compatible donors, to support alloimmune platelet-refractory patients--necessitated increasing the size of a community plateletpheresis donor registry. This study compares two strategies for recruiting whole-blood donors into a plateletpheresis program. The whole-blood donors who were asked to participate in this study had recently joined an unrelated bone marrow donor registry and had been HLA-typed as part of that process. An in-person recruitment strategy, which was time-intensive for the apheresis donor coordinator, served as the standard. A by-mail strategy involved the mailing of recruitment materials to marrow-donor registry participants. Marrow-donor registry participants were approached about apheresis participation after they had indicated an interest in the plateletpheresis program by returning a tear-off section of an informational brochure that was sent to them along with their marrow-donor registry materials. A total of 852 marrow-donor registry participants were randomly assigned to one of two recruitment strategies, and the recruitment rates were the same (46%) for both methods. In addition, levels of apheresis participation and attrition rates of donors recruited by either strategy were comparable. Thus, the simple strategy of mailing information about a plateletpheresis program is a very cost-effective method of recruiting donors.

Blood Donors↗
PubMed2001

Long-term economic evaluation of intensive patient education during the first treatment year in newly diagnosed adult asthma.

The cost-effectiveness of intensive patient education of guided asthma self-management given during the first treatment year was evaluated after 5 years of follow-up. Consecutive, newly-diagnosed asthmatics (n = 162, age 18-76 years) were randomized for intensive (80 patients) vs. conventional patient education. Effectiveness was evaluated in terms of lung functions, airway hyperresponsiveness (PD15), and quality of life as measured by the generic 15D and disease-specific St. George's Respiratory Questionnaire (SGRQ). Total treatment costs were also estimated. All patients had anti-inflammatory treatment from the beginning. Sixty-four intervention group (IG) patients and 70 control group (CG) patients were evaluated after 5 years. Forced expiratory volume in 1 sec (FEV1) improved only in the IG, and only during the first treatment year. However, PD15 improved throughout the follow-up. The unscheduled healthcare costs were significantly higher in the CG than in the IG (P = 0.04) and the relative risk for sickness days due to asthma was lower in the IG than in the CG, odds ratio 0.33 (95% CI 0.28; 0.40). However, because there was no significant difference between the groups in any outcome variable or in total costs at 5 years, the incremental cost-effectiveness ratio could not be calculated. The first year intervention had only a short-term beneficial treatment effect, which the CG could catch up during the two last follow-up years, except in FEV1. The peak expiratory flow (PEF)-based self-management had no advantage over the symptom-based self-management. However, the intervention had a consistent tendency of being less costly in the long-run. It is possible to conclude tentatively that regular effective medical treatment and control visits during the first treatment year is at least as important for the long-term treatment result as intensive patient education.

Adolescent↗
PubMed2000

[Whole-body cryotherapy in rehabilitation of patients with rheumatoid diseases--pilot study].

UNLABELLED: Cryotherapy as a whole-body cold therapy (with cold air cooled by addition of nitrogen blown on the patients in an open cabin) for treatment of inflammatory rheumatic diseases already started in Bad Säckingen in 1986. In 1996, a new cold chamber (this time a closed chamber without any addition of nitrogen) based on compressor technology was introduced. The aim of our study was to test whether significant pain relief could be achieved by means of this cold therapy. Furthermore, we were interested in the practicability and acceptance of this new technique. Wellbeing during the treatment application and pain level were assessed using verbal and numerical rating scales. The sample consisted of 120 consecutive patients (75% women, age: 30-67 yrs, M = 52.6 yrs). These patients were suffering from primary fibromyalgia (40.7%), rheumatoid arthritis (17.3%), chronic low back pain (16.4%), ankylosing spondylitis (10.9%), osteoarthritis (9.1%), secondary fibromyalgia (3.6%) and other autoimmune diseases (1.8%) (mean duration of symptoms: 4 yrs). The patients were treated 2.5 minutes on average in the main chamber (mean temperature: -105 degrees C). The patients' statements concerning their pain level were analyzed by means of analyses of variance with repeated measures and paired-sample t-tests. RESULTS: The pain level after application of the cold therapy decreases significantly. The pain reduction lasts about 90 minutes. The initial pain level decreases during the whole time of treatment, no significant improvement, though, can be shown from the middle to the end of the four-weeks treatment. According to the results of our study, there is evidence that the whole-body cold therapy generates important short-term effects and somewhat weaker effects over the treatment period as a whole. Short-term pain reduction facilitates intensive application of physiotherapy and Occupational Therapy. The treatment procedure is practicable, and all in all well tolerated. From the patients' point of view, whole-body cold therapy is an essential part of the rehabilitation programme.

Adult↗
PubMed2004

[Intention-to-treat].

What is meant by intention-to-treat? Why should data be analyzed in controlled trials in a way that all participants are included in the group to which they were randomly assigned, regardless of whether they completed the intervention given to the group? In this Tutorial, the logic of the intention-to-treat principle is outlined. It is shown that study results may be biased by excluding patients post hoc thus producing spurious effects that do not exist in the population under study. The intention-to-treat strategy avoids this bias.

Bias↗
PubMed1985

[Continuous ambulatory peritoneal dialysis. 5-year clinical experience].

Continuous ambulatory peritoneal dialysis (CAPD) is, next to conventional home dialysis, a world-wide method of treating chronic renal failure. This is the report of clinical experience of 34 CAPD patients who, from October 1978 to the end of 1983, had undergone 642 treatment months. The incidence of peritonitis after introduction of a new connector system in 1983 was reduced to 1 per 46 CAPD treatment months. In only 7 patients was it necessary to discontinue CAPD for reasons connected with the type of dialysis. No patient requested discontinuance of CAPD. Suitable bag and tube materials, adequate space, and well trained personnel are decisive for a successful CAPD programme, in addition to careful selection of patients. The latter aims at optimal patient motivation for the treatment method which, in principle, is more cost effective than home dialysis. In so far as patients fulfil the requirements for home dialysis they can be excellently rehabilitated.

Adolescent↗
PubMed2000

Cognitive decline affects subject attrition in longitudinal research.

We evaluated prospectively 210 patients with idiopathic Parkinson's disease (PD) to determine whether cognitive deterioration and disease disability affect subject drop out. Subjects who refused to return for follow-up testing had a greater degree of bradykinesia and overall disability, more advanced disease, fewer years of education and greater depressive symptomatology. However, discriminant analysis indicated that performance on the neuropsychological measures, rather than PD severity, significantly predicted whether patients return for follow-up testing. Our findings indicate that cognitive impairment uniquely contributes to subject attrition, which may distort dementia estimates in PD.

Aged↗
PubMed2004

Eight-year study on conventional glass ionomer and amalgam restorations in primary teeth.

The aim of this randomized clinical study was to compare the longevity and the cariostatic effects of conventional glass ionomer and amalgam restorations in primary teeth placed in everyday practice in the Danish Public Dental Health Service. All restorations inserted during a 7-month period by 14 clinicians in 2 municipalities were included in the study. The sample consisted of 515 conventional glass ionomer restorations and 543 amalgam restorations in 666 children aged between 2.8 and 13.5 years. The restorations were in contact with 592 unrestored surfaces in primary and permanent teeth. The study was terminated after 8 years, with 2% of the restorations in function and 7% patient dropouts. Fifty percent of the teeth restored with glass ionomer and 63% of those with amalgam were exfoliated with the restoration in situ, while 42% of the glass ionomer and 20% of the amalgam restorations had been repaired or replaced. Fracture of restoration, endodontic complication, and loss of retention were the major reasons for failure. The 50% survival time for glass ionomer restorations in all cavity types was 42 months, while the median survival time for amalgam restorations could not be estimated but exceeded 7.8 years (P < 0.001). Progression of caries lesions on tooth surfaces adjacent to amalgam restorations required operative treatment on 30% of the teeth, while only on 16% of teeth adjacent to glass ionomer restorations. The 75% survival time was 40 months for surfaces in contact with glass ionomer compared to 25 months for surfaces in contact with amalgam (P = 0.005). Multivariate analyses were performed in order to assess the influence of a number of factors on the longevity of restorations, occurrence of prevalent failures, and caries treatment of surfaces in contact with the restorations. Owing to the high frequency of failures of the conventional glass ionomer restorations, it was concluded that they are not an appropriate, universal alternative to amalgam for restorations in primary teeth, although they reduce caries progression and the need for operative treatment of adjacent surfaces.

Adolescent↗