Ankylosing spondylitis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs--results of a consensus development (Delphi) exercise.

Defining the minimum clinically important difference or delta to be detected in a clinical trial depends on a number of factors including the research hypothesis, patient characteristics, the nature of the intervention and the trial design. In 2 previous studies, we have developed standardized procedures for conducting outcome measurement based on current Food and Drug Administration and European League Against Rheumatism guidelines for clinical trials in ankylosing spondylitis, and thereafter, determined the standard deviation for these outcome measures. In the final component of this series of studies, we have employed a Delphi technique to establish estimates for delta, and calculated the sample size requirements under 2 different conditions of Type I and Type II error probabilities.     

Public health medicine and drinking water in Scotland

The prevention of the spread of disease by drinking water relies on a tripartate arrangement among the supplier, the regulator and their medical advisers. This paper describes the role of Public Health Medicine in Scotland in preventing a ‘significant risk to health’ from potable water. The legislative framework is highlighted. The rationale of water monitoring is examined and the role of Consultant in Public Health Medicine. The concept of Significant Medical Risk Values is introduced and their derivation, uses, and levels presented.     

Evaluation of the Usefulness of Open Lung Biopsies

The role of open lung biopsy (OLB) in the diagnosis of the etiology of lung infiltrates in children was analyzed for a 10-year period 1979-1989 in a tertiary referral center. A total of 18 children had 19 lung biopsies to ascertain the cause of lung infiltrates. Thirteen of these children (72 %) were immunocompromised due to treatment of hematological/solid malignancies and bone marrow transplantation. The clinical diagnosis was bilateral lung infiltrates of unknown etiology in 17 of 18 children. Eight of these children were ventilated for respiratory failure. The biopsy was useful in achieving a histological diagnosis in 18 of 19 samples (diagnostic yield 95%) and an etiological diagnosis in 14 of 19 samples (etiological yield 74 %). Therapeutic strategy was altered in 14 of 18 patients based on the biopsy results. Five of 14 patients responded favorably to a change in specific treatment. The lime interval from onset of respiratory illness to biopsy was 2-60 days (mean 16 days). Despite the critical state of these children there were few complications associated with the biopsy and no mortality directly related to the procedure. We recommend that OLE be undertaken sooner rather than later in immunocompromised children with bilateral pulmonary infiltrates of unknown etiology.     

Quality indicators for primary care mental health services

Objectives: To identify a generic set of face valid quality indicators for primary care mental health services which reflect a multi-stakeholder perspective and can be used for facilitating quality improvement.

Design: Modified two-round postal Delphi questionnaire.

Setting: Geographical spread across Great Britain.

Participants: One hundred and fifteen panellists representing 11 different stakeholder groups within primary care mental health services (clinical psychologist, health and social care commissioner, community psychiatric nurse, counsellor, general practitioner, practice nurse/district nurse/health visitor, psychiatrist, social worker, carer, patient and voluntary organisations).

Main outcome measures: Face validity (median rating of 8 or 9 on a nine point scale with agreement by all panels) for assessing quality of care.

Results: A maximum of 334 indicators were rated by panels in the second round; 26% were rated valid by all panels. These indicators were categorised into 21 aspects of care, 11 relating to general practices and 10 relating to health authorities or primary care groups/trusts. There was variation in the total number of indicators rated valid across the different panels. Overall, GPs rated the lowest number of indicators as valid (41%, n=138) and carers rated the highest number valid (91%, n=304).

Conclusions: The quality indicators represent consensus among key stakeholder groups in defining quality of care within primary care mental health services. These indicators could provide a guide for primary care organisations embarking on quality improvement initiatives in mental health care when addressing national targets and standards relating to primary care set out in the National Service Framework for Mental Health for England. Although many of the indicators relate to parochial issues in UK service delivery, the methodology used in the development of the indicators could be applied in other settings to produce locally relevant indicators.

     

Salivary disease in childhood

Salivary disease in childhood is uncommon. Clinical features are much the same as in adult disease, however, congenital, inflammation, and functional disease is more common. Management is governed by the same general principles in all age groups. Congenital abnormalities are rare. Inflammation, either bacterial or viral, is the most common disease. Chronic sialadenitis usually resolves at puberty. Neoplasia is rare, and the majority of tumors are benign and occur in the parotid gland. Malignancy is suggested by rapid growth, pain, skin fixation, and lymphadenopathy. Surgical treatment of sialorrhea should only be considered after careful assessment. Relocation of the submandibular ducts is the treatment of choice.     

Haemophilus parainfluenzae complicating total hip arthroplasty: a rapid failure.

We present a case of rapid failure of a total hip arthroplasty caused by infection with Haemophilus parainfluenzae. The septic loosening occurred over a period of 3 months and followed a dental extraction that had not been covered by prophylactic antibiotics. This failure occurred in a previously well-functioning and asymptomatic prosthetic joint.     

Public knowledge about AIDS increasing

In response to concern over the perceived limited effectiveness of Department of Health and Social Security (UK) advertising campaigns to inform the public of the basic facts of Acquired Immunodeficiency Syndrome (AIDS), a prospective questionnaire study was undertaken in Southampton, England to test the effectiveness of government education prior to a January, 1987 government television/leaflet advertising campaign. 300 questionnaires about AIDS were mailed in December of 1986 to a sample drawn from electoral rolls. The response rate was 61%. Most of the questions were drawn from material covered in the campaign. The results seemed to indicate a small overall increase in knowledge about AIDS. Some changes from a June survey were noted, e.g.: more people were aware that AIDS is a virus for which there is no cure and that it is not readily transmitted by sharing washing, eating or drinking utensils; more people believed that the statement that women are at greater risk for catching AIDS is false. Respondents were generally favorable to the government's continued use of television, even with explicit language, and to its use of the schools, for AIDS education. Many were not aware of the dangers to intravenous drug users or of the symptoms of AIDS. Other surveys have shown an increasing knowledge of AIDS dangers. It is possible that television coverage of the problem will continue to be necessary, in order that less literate populations be reached. Further AIDS health education in general is needed.