Prospective Cohort Feasibility Study Research Articles

Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study

IntroductionSome specific pregnancy disorders are known to be associated with increased incidence of long-term maternal ill health (eg, gestational diabetes with late onset type 2 diabetes; pre-eclampsia with arterial disease)....

Patient-Powered Reporting of Modified Rankin Scale Outcomes Via the Internet.

The modified Rankin Scale (mRS) is a common and resource-intensive measure of functional outcome in stroke-related conditions. In this observational prospective cohort feasibility study, mRS scores are generated using a patient-powered online survey and compared to scores obtained by structured telephonic interview. Fifty-one patients with subarachnoid hemorrhage (SAH) or their surrogates responded to an online survey following discharge from the hospital. These responses were used to generate an mRS score and then compared to blinded telephonic assessments by trained personnel. A weighted kappa (Kw) with confidence intervals (CIs) was calculated. The Kw between the patient/surrogate and the trained personnel scores was 0.85 (95% CI, 0.74-0.95, P < .001). This study provides first evidence that patient/surrogate survey responses may be an efficient and reliable alternative to generate mRS scores compared to trained personnel after SAH.

Binge Eating Predicts Excess Gestational Weight Gain: A Pilot Prospective Cohort Study.

One half of women's gestational weight gain (GWG) exceeds the recommended amount. In attempting to prevent this, randomized trials targeting diet and/or exercise have been generally unsuccessful. In response, study of psychological factors has been called for. We aimed to determine the feasibility of a full-scale prospective cohort study examining psychological and other factors affecting GWG and to obtain prospective pilot data. We conducted a prospective cohort feasibility study in seven clinics in southwestern Ontario. Women with a singleton pregnancy were recruited between May and September 2013 and subsequently completed a questionnaire. GWG was abstracted from medical records and was categorized as below, within, or above guideline-recommended limits. All clinics and 89.7% of women approached (n = 525) agreed to participate, and 514 were eligible for analysis. For the prospective analysis, we included participants enrolled during their first or second trimester (27%), because only 11% were less than 21 weeks' gestation. Planning GWG predicted excess GWG (adjusted RR [aRR] 9.44; 95% CI 2.64 to 33.80), as did binge eating (aRR 6.51; 95% CI 1.03 to 41.18). Dietary restraint was not significantly associated with excess GWG (aRR 2.74; 95% CI 0.67 to 11.22) or inadequate GWG (aRR 3.86; 95% CI 0.82 to 18.11). This prospective pilot study demonstrated the feasibility of a full-scale study and identified a need for additional strategies to permit recruitment before 21 weeks, such as a longer recruitment period and involvement of more clinics. Previously identified knowledge factors, particularly planned weight gain, were predictive of excess GWG. However, psychological factors identified in this study, especially binge eating (which was found to be independently predictive for the first time) and dietary restraint, are areas requiring further study.

Development and Application of Medication Appropriateness Indicators for Persons with Advanced Dementia: A Feasibility Study

No studies have been conducted in the UK context to date that categorise medications in terms of appropriateness for patients with advanced dementia, or that examine medication use in these vulnerable patients. The objectives of this study were to categorise the appropriateness of a comprehensive list of medications and medication classes for use in patients with advanced dementia; examine the feasibility of conducting a longitudinal prospective cohort study to collect clinical and medication use data; and determine the appropriateness of prescribing for nursing home residents with advanced dementia in Northern Ireland (NI), using the categories developed. A three-round Delphi consensus panel survey of expert clinicians was used to categorise the appropriateness of medications for patients with advanced dementia [defined as having Functional Assessment Staging (FAST) scores ranging from 6E to 7F]. This was followed by a longitudinal prospective cohort feasibility study that was conducted in three nursing homes in NI. Clinical and medication use for participating residents with advanced dementia (FAST scores ranging from 6E to 7F) were collected and a short test of dementia severity administered. These data were collected at baseline and every 3 months for up to 9 months or until death. For those residents who died during the study period, data were also collected within 14 days of death. The appropriateness ratings from the consensus panel survey were retrospectively applied to residents' medication data at each data collection timepoint to determine the appropriateness of medications prescribed for these residents. Consensus was achieved for 87 (90 %) of the 97 medications and medication classes included in the survey. Fifteen residents were recruited to participate in the longitudinal prospective cohort feasibility study, four of whom died during the data collection period. Mean numbers of medications prescribed per resident were 16.2 at baseline, 19.6 at 3 months, 17.4 at 6 months and 16.1 at 9 months. Fourteen residents at baseline were taking at least one medication considered by the consensus panel to be never appropriate, and approximately 25 % of medications prescribed were considered to be never appropriate. Post-death data collection indicated a decrease in the proportion of never appropriate medications and an increase in the proportion of always appropriate medications for those residents who died. This study is the first to develop and apply medication appropriateness indicators for patients with advanced dementia in the UK setting. The Delphi consensus panel survey of expert clinicians was a suitable method of developing such indicators. It is feasible to collect information on quality of life, functional performance, physical comfort, neuropsychiatric symptoms and cognitive function for this subpopulation of nursing home residents with advanced dementia.

Emergency preparedness in the 21st century: Training and preparation modules in virtual environments

ObjectivesTo determine the feasibility of evidence-based design and use of low-cost virtual world environments for preparation and training in multi-agency, multi-site, major incident response. MethodsA prospective cohort feasibility study was carried out. One pre-hospital, and two in-hospital major incident scenarios, were created in an accessible virtual world environment. 23 pre-hospital and hospital-based clinicians each took part in one of three linked major incident scenarios: a pre-hospital bomb blast site, focusing on the roles of the team leader and triage person; a blast casualty in a resuscitation room, focusing on the role of the trauma team leader; a hospital command and control scenario focusing on the role of the clinical major incident co-ordinator/silver commander. Participants supplied both quantitative and qualitative feedback. ResultsUsing a systematic, evidence-based approach, three scenarios were successfully developed and tested using low-cost virtual worlds (Second Life and OpenSimulator). All scenarios were run to completion. 95% of participants expressed a desire to use virtual environments for future training and preparation. Pre-hospital responders felt that the immersive virtual environment enabled training in surroundings that would be inaccessible in real-life. ConclusionsThe feasibility and face/content validity of using low-cost virtual worlds for multi-agency major incident simulation has been established. Major incident planners and trainers should explore utilising this technology as an adjunct to existing methodologies. Future work will involve development of robust assessment metrics.

Concomitant intensity modulated boost during whole breast hypofractionated radiotherapy – A feasibility and toxicity study

BackgroundBreast cancer sensitivity to large fraction size may be enhanced using hypofractionated concomitant boost radiotherapy (CBRT), thereby shortening overall treatment time. This ethics approved, prospective single cohort feasibility study was designed to evaluate the dosimetry and toxicity of CBRT using an intensity-modulated radiotherapy (IMRT) technique, compared with a standard sequential boost technique (SBT). MethodsFifteen women (11 right-sided; 4 left-sided) received 42.4Gy to the whole breast and an additional 10.08Gy to the tumor bed in 16 daily fractions, using IMRT and standard dose constraints. Each patient was replanned with the SBT, using mixed photon–electrons. Clinical target volume (CTV), dose evaluation volume (DEV), and organs at risk (OAR) dose distributions were compared with the SBT. Toxicity and treatment times were prospectively recorded. ResultsAll 15 CBRT plans achieved the desired CTV (V49.9Gy⩾99%) and DEV (V49.9Gy⩾95%), coverage of the boost, compared with only 10 (66.7%, p=0.03), and 12 (80%, p=0.125) SBT plans, respectively. Ipsilateral lung (p<0.0001), and heart (right-sided, p=0.001; left-sided, p=0.13) doses were lower. Grade 3 acute toxicity occurred in 1 (6.7%) patient. At 1year, two (13.3%) additional patients had overall grade 2 late toxicity, compared with baseline. No grade 3–4 late toxicity was observed. ConclusionsCBRT using IMRT improved boost coverage and lowered OAR doses, compared with SBT. Toxicities were acceptable using a daily boost of 3.28Gy. While resource utilization was greater, overall treatment time was reduced.