Sid Frankel

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

Rationale Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.

Reconciling healthcare professional and patient perspectives in the development of disease activity and response criteria in connective tissue disease-related interstitial lung diseases.

Interstitial lung diseases (ILD), including those related to connective tissue disease (CTD), and idiopathic pulmonary fibrosis (IPF) carry high morbidity and mortality. Great efforts are under way to develop and investigate meaningful treatments in the context of clinical trials. However, efforts have been challenged by a lack of validated outcome measures and by inconsistent use of measures in clinical trials. Lack of consensus has fragmented effective use of strategies in CTD-ILD and IPF, with a history of resultant difficulties in obtaining agency approval of treatment interventions. Until recently, the patient perspective to determine domains and outcome measures in CTD-ILD and IPF had never been applied. Efforts described here demonstrate unequivocally the value and influence of patient involvement on core set development. Regarding CTD-ILD, this is the first OMERACT working group to directly address a manifestation/comorbidity of a rheumatic disease (ILD) as well as a disease not considered rheumatic (IPF). The OMERACT 11 proceedings of the CTD-ILD Working Group describe the forward and lateral process to include both the medical and patient perspectives in the urgently needed identification of a core set of preliminary domains and outcome measures in CTD-ILD and IPF.

Family Therapy, Family Practice, and Child and Family Poverty: Historical Perspectives and Recent Developments.

ABSTRACT This paper assesses the engagement of family therapy and family practice with families with children, who are living in poverty. It analyzes four promising models from two perspectives. The first perspective relates to critiques, which have been made of the practice of family therapy with families living in poverty; and the second relates to the implications of the theoretical and empirical literature on the impact of poverty on children. To place this discussion in context, the history of family therapys involvement with families living in poverty is described and the relevance of the cause versus function debate is highlighted.

Book Reviews : Vass, Anthony A. (1990) Alternatives to Prison: Punishment, Custody and the Community. London: Sage 205 pp

The author has provided us with a cogent demonstration that in the UK the officially voiced de jure policy of community alternatives to prison masks an actual de facto policy of incarceration as the dominant state sanction for those convicted of contravening the criminal law. This gulf between rhetoric and reality is similar to that which has been demonstrated to exist in mental health care in the US (Kiesler and Sibulkin, 1987). In addition, Vass has made a major contribution in articulating a coherent framework for analysis of the case for community alternatives, in identifying the active elements in the process of implementing community service orders and probation day centres, and in suggesting what might practically be done to bring the reality closer to the rhetoric.