https://research.vu.nl/ws/files/2901670/267479.pdf

Quality criteria were proposed for measurement properties of health status questionnaires

Clinicians and policymakers are recognizing the importance of measuring health-related quality of life (HRQL) to inform patient management and policy decisions. Self- or interviewer-administered qu...

Measuring health-related quality of life.

OBJECTIVES: To consider methods and related evidence for evaluating bias in non-randomised intervention studies. DATA SOURCES: Systematic reviews and methodological papers were identified from a search of electronic databases; handsearches of key medical journals and contact with experts working in the field. New empirical studies were conducted using data from two large randomised clinical trials. METHODS: Three systematic reviews and new empirical investigations were conducted. The reviews considered, in regard to non-randomised studies, (1) the existing evidence of bias, (2) the content of quality assessment tools, (3) the ways that study quality has been assessed and addressed. (4) The empirical investigations were conducted generating non-randomised studies from two large, multicentre randomised controlled trials (RCTs) and selectively resampling trial participants according to allocated treatment, centre and period. RESULTS: In the systematic reviews, eight studies compared results of randomised and non-randomised studies across multiple interventions using meta-epidemiological techniques. A total of 194 tools were identified that could be or had been used to assess non-randomised studies. Sixty tools covered at least five of six pre-specified internal validity domains. Fourteen tools covered three of four core items of particular importance for non-randomised studies. Six tools were thought suitable for use in systematic reviews. Of 511 systematic reviews that included non-randomised studies, only 169 (33%) assessed study quality. Sixty-nine reviews investigated the impact of quality on study results in a quantitative manner. The new empirical studies estimated the bias associated with non-random allocation and found that the bias could lead to consistent over- or underestimations of treatment effects, also the bias increased variation in results for both historical and concurrent controls, owing to haphazard differences in case-mix between groups. The biases were large enough to lead studies falsely to conclude significant findings of benefit or harm. Four strategies for case-mix adjustment were evaluated: none adequately adjusted for bias in historically and concurrently controlled studies. Logistic regression on average increased bias. Propensity score methods performed better, but were not satisfactory in most situations. Detailed investigation revealed that adequate adjustment can only be achieved in the unrealistic situation when selection depends on a single factor. CONCLUSIONS: Results of non-randomised studies sometimes, but not always, differ from results of randomised studies of the same intervention. Non-randomised studies may still give seriously misleading results when treated and control groups appear similar in key prognostic factors. Standard methods of case-mix adjustment do not guarantee removal of bias. Residual confounding may be high even when good prognostic data are available, and in some situations adjusted results may appear more biased than unadjusted results. Although many quality assessment tools exist and have been used for appraising non-randomised studies, most omit key quality domains. Healthcare policies based upon non-randomised studies or systematic reviews of non-randomised studies may need re-evaluation if the uncertainty in the true evidence base was not fully appreciated when policies were made. The inability of case-mix adjustment methods to compensate for selection bias and our inability to identify non-randomised studies that are free of selection bias indicate that non-randomised studies should only be undertaken when RCTs are infeasible or unethical. Recommendations for further research include: applying the resampling methodology in other clinical areas to ascertain whether the biases described are typical; developing or refining existing quality assessment tools for non-randomised studies; investigating how quality assessments of non-randomised studies can be incorporated into reviews and the implications of individual quality features for interpretation of a review's results; examination of the reasons for the apparent failure of case-mix adjustment methods; and further evaluation of the role of the propensity score.

/pdf/evaluating-non-randomised-intervention-studies-2k25cz7x6r.pdf

Evaluating non-randomised intervention studies.

ObjectiveTo develop an objective scale to measure the severity of the multiple organ dysfunction syndrome as an outcome in critical illness.DesignSystematic literature review; prospective cohort study.SettingSurgical intensive care unit (ICU) of a tertiary-level teaching hospital.PatientsAll patient

Multiple organ dysfunction score : a reliable descriptor of a complex clinical outcome

Since 1948, when the World Health Organization defined health as being not only the absence of disease and infirmity but also the presence of physical, mental, and social well-being,1 quality-of-life issues have become steadily more important in health care practice and research. There has been a nearly exponential increase in the use of quality-of-life evaluation as a technique of clinical research since 1973, when only 5 articles listed “quality of life” as a reference key word in the MEDLINE data base; during the subsequent five-year periods, there were 195, 273, 490, and 1252 such articles. The growing fields of outcomes . . .

Assessment of quality-of-life outcomes.

https://www.gastrojournal.org/article/0016-5085(89)90905-0/pdf

A New Measure of Health Status for Clinical Trials in Inflammatory Bowel Disease

Responsiveness and validity in health status measurement: A clarification

To investigate the effect of inflammatory bowel disease (IBD) on the quality of life, we interviewed 43 patients with ulcerative colitis (UC) and 54 with Crohn's disease. Patients identified frequent and important problems in five areas. Primary bowel symptoms, systemic symptoms, and altered emotional function were common; functional and social impairment were less frequent. Systemic symptoms such as fatigue were more prevalent in patients with Crohn's disease. Apart from primary bowel complaints, patients seldom volunteered other facets of quality of life impairment; this was particularly true for impairment of emotional function. We conclude that despite troublesome intestinal and systemic symptoms, most patients with IBD avoid major disruption in work and personal lives. Physicians must inquire specifically about emotional problems relating to IBD; in particular, fear of surgery is important to address. Psychosocial interventions should be targeted to those patients with problems in this area.

Quality of life in patients with inflammatory bowel disease.

Recognizing the need to assess the caring aspects of childbirth care, we developed a Labor and Delivery Satisfaction Index (LADSI) for use in clinical trials of options for delivery. Thirty-eight items were constructed after extensive consultation with recent mothers and clinicians, and each was worded as a statement for ratings of agreement or disagreement on a six-point scale. Fifty-nine unselected women completed the index two days postpartum, and 35 of them completed it again at four to six weeks postpartum. Analysis of these data showed the LADSI to have stability over time with a correlation of 0.67 between test and retest, face validity to mothers and clinicians, construct validity by showing significantly different satisfaction scores among groups expected a priori to differ significantly, and enough internal consistency to use total scores (average item-total correlations of 0.5), but not enough to use subcomponent scores (Cronbach's alpha = 0.35). On the basis of this study, differences of as little as 10 percent in the scores of different groups of women on the LADSI represent clinically important differences in levels of satisfaction with labor and delivery.

The Labor and Delivery Satisfaction Index: The Development and Evaluation of a Soft Outcome Measure

The purpose of this systematic overview was to assess the evidence for the effectiveness of public health nursing interventions when carried out by the strategy of home visiting. A search of published and unpublished literature resulted in retrieval of 108 articles; 77 articles were judged to be relevant. Validity criteria included method of allocation to the study groups, level of agreement to participate in the study, control for confounders, method of data collection (pretesting of data collection tools, blinding of data collectors to group allocation of study participants), quantitative measure of effect and percentage of participants available at follow-up. Using these criteria, 9 articles were judged to be strong, 5 moderate and 63 weak. There were no reported negative effects of home visiting in the 9 strong articles. Positive outcomes included improvement in children's mental development, mental health and physical growth; reduction in mother's anxiety, depression, and tobacco use; improvement in maternal employment, nutrition and other health habits; government cost saving; and reduced level of care required for the elderly.

Alba Mitchell

Papers

A New Measure of Health Status for Clinical Trials in Inflammatory Bowel Disease

Responsiveness and validity in health status measurement: A clarification

Quality of life in patients with inflammatory bowel disease.

The Labor and Delivery Satisfaction Index: The Development and Evaluation of a Soft Outcome Measure

A systematic overview of the effectiveness of home visiting as a delivery strategy for public health nursing interventions