The Schedule for the Evaluation of Individual Quality of Life (SEIQoL). Administration Manual.

Advances in the clinical sciences this century have resulted in an impressive range of diagnostic procedures, therapies, drugs and surgical techniques which have revolutionised the management of heretofore fatal conditions. In addition to being concerned about life expectancy, people are also concerned about the quality of their lives. Partly in response to the views of patients, assessment of patient Quality of Life (QoL) is becoming increasingly important in medicine, nursing and in the behavioural sciences. It has already become an important outcome variable in assessing the impact of disease, illness and treatment (Spilker, 1990; Walker and Rosser, 1993; Bowling 1991; O\u27Boyle, 1992). QoL is a multi-dimensional construct and there are various approaches to its evaluation. The approach varies depending on the aims of the exercise. Health economists, for example, use techniques such as the QALY (Quality Adjusted Life Year), standard gamble and time-trade-off techniques in order to incorporate QoL measures into economic analysis and clinical trials. Clinical research has utilised standardised and disease specific measures, usually in the form of questionnaires, in order to determine the impact of disease and treatment on patients\u27 QoL. One of the problems of conducting research in this area is that there is no single agreed definition of QoL nor is there a single \u27gold standard\u27 measurement technique. However, there is broad agreement that studies of health related QoL should include assessments of physical functioning, including somatic sensations such as physical symptoms and pain; psychological function including concentration and mood; social and sexual functioning and occupational status. Many researchers also assess patients\u27 global satisfaction and the economic impact of the condition. While QoL scales and questionnaires, as well as the methods of rating and analysing them, have been developed by assessing the QoL of individuals, the specific items and the response categories do not represent the free choice of individuals who are subsequently investigated using the scale. Furthermore, the measures will often have been standardised in samples other than those currently being assessed. Results are generally presented as group statistics and provide little or no data on the QoL of individual patients

Interim analyses of data as they accumulate in laboratory experimentation

BACKGROUND: Techniques for interim analysis, the statistical analysis of results while they are still accumulating, are highly-developed in the setting of clinical trials. But in the setting of laboratory experiments such analyses are usually conducted secretly and with no provisions for the necessary adjustments of the Type I error-rate. DISCUSSION: Laboratory researchers, from ignorance or by design, often analyse their results before the final number of experimental units (humans, animals, tissues or cells) has been reached. If this is done in an uncontrolled fashion, the pejorative term 'peeking' has been applied. A statistical penalty must be exacted. This is because if enough interim analyses are conducted, and if the outcome of the trial is on the borderline between 'significant' and 'not significant', ultimately one of the analyses will result in the magical P = 0.05. I suggest that Armitage's technique of matched-pairs sequential analysis should be considered. The conditions for using this technique are ideal: almost unlimited opportunity for matched pairing, and a short time between commencement of a study and its completion. Both the Type I and Type II error-rates are controlled. And the maximum number of pairs necessary to achieve an outcome, whether P = 0.05 or P > 0.05, can be estimated in advance. SUMMARY: Laboratory investigators, if they are to be honest, must adjust the critical value of P if they analyse their data repeatedly. I suggest they should consider employing matched-pairs sequential analysis in designing their experiments

Meaning in life in the Federal Republic of Germany: results of a representative survey with the Schedule for Meaning in Life Evaluation (SMiLE)

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Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]

BACKGROUND: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). METHODS/DESIGN: Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. DISCUSSION: Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery