Qualitative studies conducted alongside randomized controlled trials in oncology: A scoping review of use and rigour of reporting.

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard for generating evidence to inform clinical oncology practice. Knowledge gained through qualitative research methodologies can be complementary to that gained through RCTs. How qualitative research has been combined with RCTs in oncology has not been previously characterized. OBJECTIVE: This scoping review was conducted to summarize how qualitative research associated with RCTs in the oncology setting has been conducted and examine the quality of reporting. ELIGIBILITY CRITERIA: Manuscripts reporting on qualitative research linked with RCTs in the cancer context that involved patients (both adult and pediatric) and/or informal caregiver (friends/family) were included. SOURCES OF EVIDENCE: Peer-reviewed manuscripts indexed in MEDLINE (OVID) and CINAHL, published in English between 2008 and January 2019. CHARTING METHODS: Formal scoping review methods were followed. A data extraction tool informed by the research questions as well as the COnsolidated criteria for REporting Qualitative research (COREQ) was utilized. Extraction was conducted independently by two authors, with disagreements resolved by a third. RESULTS: Fifty-four articles were included. Assessing information sharing, diet/exercise, and psychotherapeutic interventions were the most common focuses of the RCTs. The most common focus of the qualitative component was on gaining insight into the experience of receiving the intervention or participating in RCT procedures. How the intervention impacted the cancer experience was not a common focus of the qualitative components. Some reports provided insufficient information to understand how the qualitative components aligned with the RCT components. The results of the qualitative and RCT components were not integrated to draw meaningful conclusions about the efficacy of the intervention under study in most cases. Reports focusing on only qualitative methods had higher median (Mdn) reporting of COREQ items compared to reports that included both the qualitative and RCT components (Mdn = 18 vs. Mdn = 14, respectively; p <0.001). CONCLUSIONS: This review identified that qualitative research has been combined with RCTs in the cancer context in a number of ways, most commonly to understand the experience of receiving study interventions or participating in trial procedures. Exploring how interventions impact other aspects of the cancer experience is an approach that should be considered in future work. Formalized guidelines for the design and reporting of investigations that combine qualitative and RCT approaches in the cancer context are expected to be of value. TWEETABLE ABSTRACT: Combining qualitative research with randomized controlled trials in oncology: an impornt opportunity for discovery.

Blood protein fraction comparisons of normal and schizophrenic patients.

Whole blood, plasma, or serum levels of various components were measured in fasting, drug-free control subjects and drug-free schizophrenic patients. Compared to normal controls, chronic schizophrenic patients showed increased alpha2-globulins and decreased plasma cholinesterase activity and ceruloplasmin activity, and acute schizophrenic patients showed decreased alpha2-globulins. Compared to chronic patients, acute schizophrenics showed decreased alpha2-globulins and IgA. Compared to normal controls of similar age, chronic schizophrenic patients weighed less, were shorter, and had smaller body surface area. The acute schizophrenic patients were significantly younger than the normal subjects or chronic schizophrenics but there was no difference in the other physical measurements. The present study indicates no gross disturbances in the blood variables studied. That some differences are statistically significant from controls is of scientific interest, but of no clinical value in the diagnosis of schizophrenia.

Indirect methods of assessing thyroid function. Protein-bound iodine and thyroxine by column chromatography, a 1976 CAP survey.

An assessment of the infrequently performed protein-bound iodine determinations (PBI) and thyroxine (T4) determinations by column chromatography is presented after analysis of data contributed by participants in the 1976 College of American Pathologists Chemistry Survey Programs. The two technics yield comparable mean concentrations, but there is considerable interlaboratory variance within method groups, especially among laboratories performing column chromatographic T4 iodine assays.

Paradoxical effect of high and low dose aspirin in experimental arterial thrombosis.

The effect of different dosage regimens of aspirin was investigated in an experimental model of arterial thrombosis. A paradoxical effect with an increase of the arterial thrombus growth could be seen after a first single dose of 100 mg aspirin/kg body weight. When the high dose of aspirin was given repeatedly, a thrombus size minor than under low dose aspirin therapy with 10 mg/kg body weight has been observed. Our experimental thrombosis experiments do not provide sufficient evidence to support antithrombotic therapy with low doses of aspirin.

Basic rest activity cycle and stereotyped behavior of a mentally defective child.

Stereotyped acts of a mentally defective girl, 6 1/2 years old, were observed from 6 a.m. til 8 p.m. during 16 days. Alternating phases of more or less frequent hand waving showed intervals of about 1 1/2 hours. Sleep stages were also determined by polygraphic recordings during 10 nights. As statistically proved the mean peak-to-peak interval of stereotyped activity at days corresponded with the mean REM-to-REM period of consecutive nights. This suggests, that the stereotyped hand waving of this child was driven by the BASIC REST ACTIVITY CYCLE (BRAC) already described by Kleitman. The mean periodicity of sleep cycles was represented by model rhythms adapted to the scored sleep stages. If the model rhythms of all 10 nights were extended backward to the preceding days, they paralleled the stereotyped activity. Thereby half periods found in phase with REM-stages approximatly corresponded to maxima of stereotyped activity. It will be discussed that the BRAC triggers motor and sensory mechanisms characterizing both the phases of enhanced stereotyped activity at day and REM stages at night.