NURS 8710 Week 3 Inclusion Criteria Memo Example

Memorandum

To: Doctoral Seminar I Faculty; second reviewer

From: DNP student

Date: Month Day, Year

Re: Five inclusion rules for the early mobilization review, each paired with the exclusion it implies, and two pilot records the readers sorted differently

Purpose

Before any study can be appraised, the review needs rules that decide what belongs in it. This memo sets out five rules for the review of early active mobilization in mechanically ventilated adults, each paired with the exclusion it implies so that nothing is left to inference. The aim is that two people applying the rules separately would end up holding the same studies. The structure follows the Cochrane guidance that eligibility criteria should be defined for the population, intervention, comparison, outcomes and study design before studies are selected (McKenzie et al., 2023). The last section reports a pilot on eight records, in which the two readers disagreed about two.

The Five Rules

Population. Include adults aged 18 and older who were invasively ventilated in intensive care when the intervention started. Exclude studies of patients receiving only noninvasive ventilation, of children and of patients whose rehabilitation began after ICU discharge. Where a study enrolls a mixed population, include it if at least 80% of participants were invasively ventilated at enrollment or if results for that group are reported separately. The 80% threshold is arbitrary, and the memo records it as a decision so that it can be changed openly if it proves too strict.

Intervention. Include active mobilization or exercise begun while the patient was in the ICU, meaning activity in which the patient participates, such as bed exercises, sitting, standing, walking or active cycling. Exclude interventions consisting only of passive range of motion or electrical muscle stimulation, because the review question concerns active participation. Interventions combining active and passive components are included if the active component is described.

Comparison. Left open: usual care, a lower dose of the same intervention or a different form of mobilization are all acceptable. The comparison is left open on purpose, because the earlier search showed that the trials differ mainly in what their control groups received, and that difference is part of what the review must explain. Excluding any comparison type would remove the evidence most needed.

Outcome. Include studies reporting at least one measure of physical function at ICU discharge, hospital discharge or later, such as a functional independence scale, a walking test, a performance battery or the physical function domain of a quality of life survey. Exclude studies reporting only process measures, such as the proportion of patients mobilized, or only physiological measures such as inflammatory markers. Adverse events will be extracted from every included study but are not by themselves enough for inclusion.

Design. Include randomized trials and controlled cohort studies with a concurrent or historical comparison group. Exclude case reports, case series without a comparison, protocols without results, and reviews, although reviews will be used to check reference lists. Consensus statements on safety are excluded from the evidence set but will inform the discussion of adverse events (Hodgson et al., 2014).

Pilot on Eight Records

Two readers, the author and a fellow student in the same seminar, applied the rules independently to eight records drawn from the search results: six known primary studies, one systematic review and one consensus statement. They agreed on six. The systematic review and the consensus statement were excluded by both on design. Four primary studies were included by both.

They disagreed on two. Record A was a randomized trial of a daily bedside cycle ergometer session in critically ill patients (Burtin et al., 2009). One reader included it as active exercise; the other excluded it because the intervention was described as passive or active cycling depending on the patient's ability. Under the intervention rule, a combined intervention is included if the active component is described. The abstract describes passive or active sessions without saying how many were active, so the readers agreed to include it provisionally and to extract the proportion of active sessions from the full text, excluding it if most sessions were passive.

Record B was a pilot trial of early physical rehabilitation in patients with sepsis syndromes in a general ICU (Kayambu et al., 2015). One reader included it as a critically ill population; the other excluded it because the abstract does not say whether participants were mechanically ventilated. Under the population rule, ventilation status must be established. The readers agreed to retrieve the full text and apply the 80% rule; if ventilation status is not reported, the study will be excluded and listed with its reason.

What the Pilot Changed

Both disagreements arose from abstracts that did not contain the information the rules needed, not from unclear rules. One change follows: any record whose abstract cannot settle population or intervention will move to full-text review rather than being decided at title and abstract stage. A second change is to the intervention rule's wording, which now says explicitly that the active component must be described in the methods, not just mentioned. Agreement on six of eight records is acceptable for a pilot, but the full screening will use both readers on a 20% sample and report the agreement.

Next Step

With the rules settled, title and abstract screening of the 488 unique records will begin. Records excluded at each stage will be counted with a reason, so that the flow from identification to inclusion can be reported as PRISMA 2020 recommends (Page et al., 2021).

References

Burtin, C., Clerckx, B., Robbeets, C., Ferdinande, P., Langer, D., Troosters, T., Hermans, G., Decramer, M., & Gosselink, R. (2009). Early exercise in critically ill patients enhances short-term functional recovery. Critical Care Medicine, 37(9), 2499-2505. https://doi.org/10.1097/CCM.0b013e3181a38937

Hodgson, C. L., Stiller, K., Needham, D. M., Tipping, C. J., Harrold, M., Baldwin, C. E., Bradley, S., Berney, S., Caruana, L. R., Elliott, D., Green, M., Haines, K., Higgins, A. M., Kaukonen, K.-M., Leditschke, I. A., Nickels, M. R., Paratz, J., Patman, S., Skinner, E. H., . . . Webb, S. A. (2014). Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Critical Care, 18(6), Article 658. https://doi.org/10.1186/s13054-014-0658-y

Kayambu, G., Boots, R., & Paratz, J. (2015). Early physical rehabilitation in intensive care patients with sepsis syndromes: A pilot randomised controlled trial. Intensive Care Medicine, 41(5), 865-874. https://doi.org/10.1007/s00134-015-3763-8

McKenzie, J. E., Brennan, S. E., Ryan, R. E., Thomson, H. J., Johnston, R. V., & Thomas, J. (2023). Defining the criteria for including studies and how they will be grouped for the synthesis. In J. P. T. Higgins, J. Thomas, J. Chandler, M. Cumpston, T. Li, M. J. Page, & V. A. Welch (Eds.), Cochrane handbook for systematic reviews of interventions (Version 6.4). Cochrane.

Page, M. J., McKenzie, J. E., Bossuyt, P. M., Boutron, I., Hoffmann, T. C., Mulrow, C. D., Shamseer, L., Tetzlaff, J. M., Akl, E. A., Brennan, S. E., Chou, R., Glanville, J., Grimshaw, J. M., Hróbjartsson, A., Lalu, M. M., Li, T., Loder, E. W., Mayo-Wilson, E., McDonald, S., . . . Moher, D. (2021). The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ, 372, Article n71. https://doi.org/10.1136/bmj.n71