Pilot observational prospective cohort study on the use of a novel home-based urinary pregnanediol 3-glucuronide (PDG) test to confirm ovulation when used as adjunct to fertility awareness methods (FAMs) stage 1.

RATIONALE: Ovulation confirmation is a fundamental component of the evaluation of infertility. PURPOSE: To inform the design of a larger clinical trial to determine the effectiveness of a new home-based pregnanediol glucuronide (PDG) urine test to confirm ovulation when compared with the standard of serum progesterone. METHODS: In this observational prospective cohort study (single group assignment) in an urban setting (stage 1), a convenience sample of 25 women (aged 18-42 years) collected daily first morning urine for luteinisinghormone (LH), PDG and kept a daily record of their cervical mucus for one menstrual cycle. Serum progesterone levels were measured to confirm ovulation. Sensitivity and specificity were used as the main outcome measures. Estimation of number of ultrasound (US)-monitored cycles needed for a future study was done using an exact binomial CI approach. RESULTS: Recruitment over 3 months was achieved (n=28) primarily via natural fertility regulation social groups. With an attrition rate of 22%, specificity of the test was 100% for confirming ovulation. Sensitivity varied depending on whether a peak-fertility mucus day or a positive LH test was observed during the cycle (85%-88%). Fifty per cent of participants found the test results easy to determine. A total of 73 US-monitored cycles would be needed to offer a narrow CI between 95% and 100%. CONCLUSION: This is first study to clinically evaluate this test when used as adjunct to the fertility awareness methods. While this pilot study was not powered to validate or test efficacy, it helped to provide information on power, recruitment and retention, acceptability of the procedures and ease of its use by the participants. Given this test had a preliminary result of 100% specificity, further research with a larger clinical trial (stage 2) is recommended to both improve this technology and incorporate additional approaches to confirm ovulation. TRIAL REGISTRATION NUMBER: NCT03230084.

Pilot study compares scores of the Resident Assessment Instrument Minimum Data Set Version 2.0 (MDS 2.0) Pressure Ulcer Risk Scale with the Braden Pressure Ulcer Risk assessment for patients in complex continuing care.

OBJECTIVE: To determine if the Braden Scale for Predicting Pressure Sore Risk (Braden Scale) and the Resident Assessment Instrument Minimum Data Set Version 2.0 (MDS 2.0) Pressure Ulcer Risk Scale (PURS) provide a comparable assessment of the level of risk of developing a pressure ulcer at admission in complex continuing care. SETTING: Saint-Vincent Hospital, Bruyère Continuing Care, a 336-bed complex continuing care facility that provides restorative, complex, specialized, and supportive care to adults in Ottawa, Ontario, Canada. METHODS: A retrospective chart review was conducted from February 2012 to April 2012 on 51 patient charts that were chosen based on the completion of an admission Braden Scale assessment within a maximum of 4 weeks from admission and completed admission MDS 2.0. RESULTS: The Braden Scale categorized 63% of patients at risk when using scores between 15 and 23, compared with 33% for the MDS 2.0 PURS scores of 0-2 (low and very low risk). Both scales were comparable in identifying patients in the lower risk categories when data was reviewed using a cutoff point of 18 for the Braden. At the high risk end of the spectrum, the MDS 2.0 PURS categorized more patients, 45%, as high or very high risk, compared with 21% for using the Braden Scale. CONCLUSION: This preliminary study may provide some evidence that the MDS 2.0 PURS may be an alternative risk assessment tool option that utilizes mandatory collected data, reduces workload duplication, and would generate a Resident Assessment Protocol, when indicated, in complex continuing care.

A prospective, descriptive study to assess the reliability and usability of a rapid foot screen for patients with diabetes mellitus in a complex continuing care setting.

Inlow's 60-second Diabetic Foot Screen is a paper-pencil tool developed to guide professionals in the completion of a quick foot assessment of persons with diabetes mellitus to determine recommended frequency of assessments. The tool has been used in various healthcare settings and its reliability and validity previously tested in acute and long-term care settings. The purpose of this study was to assess content, time to complete assessment, ease of use, and reliability of the tool in a complex continuing care setting. The tool includes questions about 10 variables; skin, nails, deformities, footwear, temperature, range of motion, sensation, pulses, dependent rubor, and erythema. Answers convert to a score ranging from 0 (low risk, yearly screenings) to 23 (high risk, weekly screenings). Using the tool, the study questionnaire, and a watch, three nurse assessors experienced in assessing the feet of persons with diabetes completed 70 assessments on 35 patients during a period of 30 days. Content areas assessed included significance of comorbidities and interval screening times. Mean time to complete the assessment was 7 minutes (range 2 to 21 minutes); 39% of assessments took 6 to 7 minutes. Times to perform assessment varied widely due to the functional and cognitive well-being of the patient. Inter-rater reliability was low (ICC 0.608 [95% confidence interval 0.349-0.781]), perhaps due to varying interpretations of assessment parameters related to the complexity of the study patient population. Comments suggest that some tool revisions may increase ease of use as well as tool validity and reliability, especially for complex care patients with multiple comorbidities.

Comparison of visual estimation methods for regular and modified textures: real-time vs digital imaging.

A variety of methods are available for assessing diet; however, many are impractical for large research studies in an institutional environment. Technology, specifically digital imaging, can make diet estimations more feasible for research. Our goal was to compare a digital imaging method of estimating regular and modified-texture main plate food waste with traditional on-site visual estimations, in a continuing and long-term care setting using a meal-tray delivery service. Food waste was estimated for participants on regular (n=36) and modified-texture (n=42) diets. A tracking system to ensure collection and digital imaging of all main meal plates was developed. Four observers used a modified Comstock method to assess food waste for vegetables, starches, and main courses on 551 main meal plates. Intermodal, inter-rater, and intra-rater reliability were calculated using intraclass correlation for absolute agreement. Intermodal reliability was based on one rater's assessments. The digital imaging method results were in high agreement with the real-time visual method for both regular and modified-texture food (intraclass correlation=0.90 and 0.88, respectively). Agreements between observers for regular diets were higher than those for modified-texture food (range=0.91 to 0.94; 0.82 to 0.91, respectively). Intra-rater agreements were very high for both regular and modified-texture food (range=0.93 to 0.99; 0.91 to 0.98). The digital imaging method is a reliable alternative to estimating regular and modified-texture food waste for main meal plates when compared with real-time visual estimation. Color, shape, reheating, mixing, and use of sauces made modified-texture food waste slightly more difficult to estimate, regardless of estimation method.

A mix of bulk and ready-to-use modified-texture food: impact on older adults requiring dysphagic food.

Ready-to-use modified-texture food (rMTF) products are commercially available and may have greater appeal than conventional in-house or commercial bulk modified-texture food (cMTF) products. A nine-month pilot study using a prospective interrupted time-series design where participants (n = 42) served as their own controls investigated the impact of cMTF + rMTF on weight goals, weight, food intake, and co-morbidity. Seventy-four per cent of participants achieved their weight goals at the end of six months on rMTF and, although insignificant, participants did have a trend towards weight gain while on rMTF (OR 3.5 p = .16). Main-plate food intake (grams) was not significantly different over time, but a downwards trajectory suggests decreased consumption that was compensated for by a significantly higher fat intake during the intervention period (p = .01). Increased co-morbidity and a decreasing volume of food consumed are common in older adults with dysphagia, and enhanced food products are needed to meet nutrient needs. Methodological issues encountered in this study can provide guidance for future work.