International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients.

PURPOSE: For patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue. METHODS: An international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n = 17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n = 141: patients/patient advocates (n = 45), health care professionals/researchers (n = 64), pharmaceutical industry representatives (n = 28), and health authority representatives (n = 4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting. RESULTS: The final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n = 26) and adverse events (n = 24); (2) baseline patient characteristics (n = 9); and (3) clinical variables (n = 42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team. CONCLUSION: The COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).

Effect of cognitive rehabilitation on outcomes for persons with traumatic brain injury: A systematic review.

We evaluated evidence for the effectiveness of cognitive rehabilitation methods to improve outcomes for persons with traumatic brain injury (TBI). A search of MEDLINE, HealthSTAR, CINAHL, PsycINFO, and the Cochrane Library produced 600 potential references. Thirty-two studies met predetermined inclusion criteria and were abstracted; data from 24 were placed into evidence tables. Two randomized controlled trials and one observational study provided evidence that specific forms of cognitive rehabilitation reduce memory failures and anxiety, and improve self-concept and interpersonal relationships for persons with TBI. The durability and clinical relevance of these findings is not established. Future research utilizing control groups and multivariate analysis must incorporate subject variability and must include standard definitions of the intervention and relevant outcome measures that reflect health and function.

Summary report: evidence for the effectiveness of rehabilitation for persons with traumatic brain injury.

We evaluated the evidence for effectiveness of rehabilitation methods throughout the phases of recovery from traumatic brain injury (TBI) in adults. MEDLINE, HealthSTAR, CINAHL, PsycINFO, and the Cochrane Library were searched, and a total of 3,098 abstracts were reviewed. The strongest studies were critically appraised and their data placed in evidence tables. Results showed that to determine the effectiveness of rehabilitation interventions for persons with TBI, a commitment must be made to population-based studies, strong controlled research design, standardization of measures, adequate statistical analysis, and specification of health outcomes of importance to persons with TBI and their families.

Evidence of case management effect on traumatic-brain-injured adults in rehabilitation.

The purpose of this study was to evaluate the evidence for effectiveness of case management during recovery from traumatic brain injury (TBI) in adults. After an overview of TBI incidence, prevalence, and problems, and a brief explanation of case management, the study methods are described, the findings are discussed and recommendations are made for future research. Medline, HealthSTAR, CINAHL, PsychINFO, and the Cochrane Library databases were searched and 83 articles met the criteria for review. The strongest studies (n = 3) were critically appraised and their design features and data were placed in two evidence tables. Due to methodological limitations, there was neither clear evidence of effectiveness nor of ineffectiveness. For future research, we recommend controlled research designs, standardization of measures, adequate statistical analysis and specification of health outcomes of importance to persons with TBI and their families.

Ovulation and embryo recovery rates following immunization of mares against an inhibin alpha-subunit fragment.

Six normally cycling mares were immunized 5 times at 3-week intervals with a synthetic porcine inhibin alpha-subunit fragment which had been conjugated to bovine serum albumin and emulsified in Freund's incomplete adjuvant. Immunized mares ovulated a significantly larger (P < 0.01) number of follicles per estrous cycle (2.8 +/- 1.1; range 1 to 8 ovulations) than 14 nonimmunized control mares (1.1 +/- 0.1; range 1 to 2 ovulations). Day-7 embryo recovery rates tended to be higher (P < 0.1) in immunized mares (1.6 +/- 0.5 embryos per flush) than in control mares (0.7 +/- 0.2 embryos per flush). No differences in interovulatory intervals were found between the 2 groups. These results indicate that immunization against inhibin may be useful in inducing development and ovulation of multiple follicles for embryo transfer in the mare.

Comparison of pregnancy rates from transfer of fresh versus cooled, transported equine embryos.

Donor mares of mixed, light-horse breeds, maintained at Colorado State University, provided 104 embryos for immediate transfer (fresh embryos). One hundred and thirty-six additional embryos were collected on various breeding farms in the United States and were shipped to Colorado State University via commercial airlines (cooled embryos). Embryos were harvested 7 d after ovulation, graded, and either transferred into a mare immediately (<1 h) or placed in Ham's F-10 medium plus 10% fetal calf serum in an atmosphere of 5% CO2, 5% O2, 90% N2 and packaged in a passive cooling unit (Equitainer) for shipment to our laboratory. All embryos were measured and graded just prior to surgical transfer via flank incision into synchronized mares. Recipients had ovulated 1 or 2 d before (+1, +2), on the same day as (0), or 1, 2 or 3 d after (-1, -2, -3) the donor mare. Pregnancy of recipients was determined by ultrasonography on 12, 35, and 50 d after ovulation of the donor. Pregnancy rates at 12, 35, and 50 d were similar for fresh (74, 64, 61%) and cooled embryos (80, 67, 66%), respectively. Overall, embryo size affected (P<0.05) pregnancy rates at 12, 35 and 50 d. Embryos of Grade 1 (excellent) or 2 resulted in more pregnancies than those of Grade 3 or 4 (poor) embryos. Embryonic losses between 12 and 35 d or between 35 and 50 d were not altered (P>0.05) by treatment (fresh or cooled) nor by age of the donor mare (P>0.05), but embryonic losses between 12 and 35 d were greater (P<0.06) for embryos stored for >12 h (25%) versus those stored for <12 h (10%). The duration needed for shipment (<12 h or >12 h) of cooled embryos did not alter pregnancy rates at 12 d (P>0.05). Age of donor mare had no effect (P>0.05) upon pregnancy rates of cooled or fresh embryos transferred nor on embryo quality. In summary, equine embryos can be cooled to 5 degrees C and maintained in storage for up to 24 h without decreased fertility, compared with those of embryos transferred in <1 hour.