Prospective Study Designs in Outcomes Research

@article{Rothermich2012ProspectiveSD,
  title={Prospective Study Designs in Outcomes Research},
  author={Elizabeth A. Rothermich and Meryl Brod and Warren H. Schonfeld and Clayton R. Rowland and Baltazar Gomez-Mancilla},
  journal={PharmacoEconomics},
  year={2012},
  volume={20},
  pages={715-725},
  url={https://api.semanticscholar.org/CorpusID:46986832}
}
Patient-reported outcomes (PROs), including resource utilisation, productivity and quality of life, are important outcomes in the field of migraine. Clinical trials have begun to incorporate PROs; however, not all research questions can be answered fully within the framework of a clinical trial design. Other prospective designs, including effectiveness trials, observational studies, and study hybrids may be used to answer many of the different research questions related to PROs. This paper… 
View on Springer
1 Citation

One Citation

Validation of the Italian version of the Cluster Headache Impact Questionnaire (CHIQ)

The data show the validity of the Italian version of the CHIQ, which represents a suitable tool for evaluating the social and psychological impact of CH in clinical practice and research.

29 References

Randomized trials or observational tribulations?

If claims that observational studies give results similar to those of randomized, controlled trials lead to more observational studies of therapeutic interventions and fewer randomized,controlled trials, there are considerable dangers to clinical research and even to the well-being of patients.

Randomized, controlled trials, observational studies, and the hierarchy of research designs.

The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Experimental versus Observational Data in the Economic Evaluation of Pharmaceuticals

It is argued that research to substantiate pharmacoeconomic claims, including cost-effectiveness and quality-of-life claims, must meet traditional standards for adequate and wellcontrolled studies.

Changes in resource use and outcomes for patients with migraine treated with sumatriptan: a managed care perspective.

In the 6 months after sumatriptan therapy was initiated, health care resource use and time lost from workplace productivity and nonworkplace activity were reduced, while health-related quality of life and patient satisfaction scores improved for the managed care migraineurs enrolled in this study.

A comparison of observational studies and randomized, controlled trials

Little evidence is found that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials.

Health-Related Quality of Life Under Six Months' Treatment of Migraine-An Open Clinic-Based Longitudinal Study

Short-term treatment comprising conventional therapy or subcutaneous sumatriptan reduced number of days per month with migraine and absenteeism from work, migraine-associated symptoms, but did not significantly improve general well-being between attacks.

Sumatriptan treatment for migraine in a health maintenance organization: economic, humanistic, and clinical outcomes.

Improvements in health-related quality of life with sumatriptan treatment for migraine.

Patients using sumatriptan to treat migraines for up to 24 months experienced improvements in disability and productivity as well as in health-related quality of life as measured either by a general health status instrument or a disease-specific instrument.

Healthcare Resource and Lost Labour Costs of Migraine Headache in the US

Migraine headache is responsible for significantly more healthcare resource and lost labour costs than previously reported and the extrapolated costs to employers ranged from $US5.6 billion to $US17.2 billion dollars annually due to decreased productivity and missed work days.

Health Care Technology: Effectiveness, Efficiency and Public Policy@@@Methods for the Economic Evaluation of Health Care Programmes