Checklist items are worded so that 1 of 5 responses is possible:

Indicates that for that particular aspect of study design, the study has been designed or conducted in such a way as to minimize the risk of bias.

Indicates that either the answer to the checklist question is not clear from the way the study is reported, or that the study may not have addressed all potential sources of bias for that particular aspect of study design.

−

Should be reserved for those aspects of the study design in which significant sources of bias may persist.

Not reported (NR)

Should be reserved for those aspects in which the study under review fails to report how they have (or might have) been considered.

Not applicable (NA)

Should be reserved for those study design aspects that are not applicable given the study design under review (for example, allocation concealment would not be applicable for case-control studies).

In addition, the reviewer is requested to complete in detail the comments section of the quality appraisal form so that the grade awarded for each study aspect is as transparent as possible.

Each study is then awarded an overall study quality grading for internal validity (IV) and a separate one for external validity (EV):

++ All or most of the checklist criteria have been fulfilled, where they have not been fulfilled the conclusions are very unlikely to alter.

+ Some of the checklist criteria have been fulfilled, where they have not been fulfilled, or not adequately described, the conclusions are unlikely to alter.

− Few or no checklist criteria have been fulfilled and the conclusions are likely or very likely to alter.

Checklist

Study identification: (Include full citation details)

Study design:

Refer to the glossary of study designs (appendix D) and the algorithm for classifying experimental and observational study designs (appendix E) to best describe the paper’s underpinning study design

Guidance topic:

Assessed by:

Section 1: Population

1.1 Is the source population or source area well described?

Was the country (e.g. developed or non-developed, type of healthcare system), setting (primary schools, community centers, etc.), location (urban, rural), population demographics, etc. adequately described?

−

Comments: the study is based on the use of the participants or the students enrolled in Bushehr nursing and midwifery school. These are the students in their third semester of nursing and midwifery program and have access to computer or midwifery program.

1.2 Is the eligible population or area representative of the source population or area?

Was the recruitment of individuals, clusters, or areas well defined (e.g. advertisement, birth register)?

Was the eligible population representative of the source? Were important groups under-represented?

−

Comments: The population selected is well described, however, the study utilized a small sample size. Therefore, it is impossible to generalize the outcomes to teach other courses since it is not guaranteed that the integration of the FC and the NPE will be the most effective strategy.

1.3 Do the selected participants or areas represent the eligible population or area?

Was the method of selection of participants from the eligible population well described?

What % of selected individuals or clusters agreed to participate? Were there any sources of bias?

Were the inclusion or exclusion criteria explicit and appropriate?

−

Comments: the selected participants represented the population within the specified area of Bushehr nursing and midwifery school. The article shows that 82 nursing and midwifery students were enrolled and fails to give the true data on those who were selected and those who dropped out of the study. The inclusion and the exclusion criteria were explicit and in this case, the inclusion criteria were based on the students in their third semester of nursing and midwifery program, having access to a computer or smartphone. The exclusion included absenteeism for any reason, not viewing educational content, and the unpreparedness to continue with the study.

Section 2: Method of allocation to intervention (or comparison)

2.1 Allocation to intervention (or comparison). How was selection bias minimized?

Was allocation to exposure and comparison randomized? Was it truly random ++ or pseudo-randomized + (e.g. consecutive admissions)?

If not randomized, was significant confounding likely (−) or not (+)?

If a cross-over, was the order of intervention randomized?

−

Comments: the subject were allocated to the four groups through block randomization.

2.2 Were interventions (and comparisons) well described and appropriate?

Were interventions and comparisons described in sufficient detail (i.e. enough for the study to be replicated)?

Were comparisons appropriate (e.g. usual practice rather than no intervention)?

-−

Comments: detailed description of both comparison and the interventions is provided. The intervention of the flipped classroom through near-peer education (FC through NPE) on the patient safety awareness retention in nursing and midwifery learners as compared to the conventional intervention (Comparison).

2.3 Was the allocation concealed?

Could the person(s) determine the allocation of participants or clusters to intervention or comparison groups have influenced the allocation?

Adequate allocation concealment (++) would include centralized allocation or computerized allocation systems.

−

Comments: the subjects were allocated to four groups through the use of block randomization.

2.4 Were participants or investigators blind to exposure and comparison?

Were participants and investigators – those delivering or assessing the intervention kept blind to intervention allocation? (Triple or double-blinding score ++)

If lack of blinding is likely to cause important bias, score −.

−

Comments: the investigators never considered some key elements that might impact the overall outcomes of the research. For example, there was a failure to find out whether the integration of the conventional and the comparison method was effective compared to the FC and the NPE. Other factors such as motivation, experience, and attitudes that are important in the comparison groups were not considered the confounding variables.

2.5 Was the exposure to the intervention and comparison adequate?

Is reduced exposure to intervention or control related to the intervention (e.g. adverse effects leading to reduced compliance) or fidelity of implementation (e.g. reduced adherence to protocol)?

Was lack of exposure sufficient to cause important bias?

−

Comments: the exposure to intervention and comparison was not adequate. The integration of the conventional method failed to determine if the integrated method was more effective compared to the new techniques like FC and NPE.

2.6 Was contamination acceptably low?

Did any in the comparison group receive the intervention or vice versa?

If so, was it sufficient to cause important bias?

If a cross-over trial, was there a sufficient wash-out period between interventions?

−

Comments: the intervention group received educational content online for 14 days and later attended the FC through NPE. On the other hand, the control groups were merely provided with an education that is based on the conventional technique. The use of this method together with the new method failed to find out whether the integrated method would be effective compared to FC and NPE alone.

2.7 Were other interventions similar in both groups?

Did either group receive additional interventions or have services been provided differently?

Were the groups treated equally by researchers or other professionals?

Was this sufficient to cause important bias?

−

Comments: the groups receive different interventions for example the groups were divided into four. The subject in the intervention groups received the educational content online for 14 days and subsequently attended the FC through NPE. The control groups were merely provided with an education based on the conventional technique. Both groups received a post-test after the completion of the program and once again four weeks after it.

2.8 Were all participants accounted for at the study conclusion?

Were those lost-to-follow-up (i.e. dropped or lost pre-, during or post-intervention) acceptably low (i.e. typically <20%)?

Did the proportion drop differ by group? For example, were drop-outs related to the adverse effects of the intervention?

−

Comments: There was no mention anywhere about the participants who dropped out of the study.

2.9 Did the setting reflect usual UK practice?

Did the setting in which the intervention or comparison was delivered differ significantly from usual practice in the UK? For example, did participants receive intervention (or comparison) conditions in a hospital rather than a community-based setting?

−

Comments: even though the researchers enrolled 82 nursing and midwifery learners enrolled from Bushehr nursing and midwifery school (community-based setting)

2.10 Did the intervention or control comparison reflect usual UK practice?

Did the intervention or comparison differ significantly from usual practice in the UK? For example, did participants receive the intervention (or comparison) delivered by specialists rather than GPs? Were participants monitored more closely?

−

Comments: The participants received the interventions i.e. the subjects on the Flipped Classroom through the Near Peer Education on the knowledge retention in nursing on the safety of the patient. The targeted groups were the nurses and the midwifery learners.

Section 3: Outcomes

3.1 Were outcome measures reliable?

Were outcome measures subjective or objective (e.g. biochemically validated nicotine levels ++ vs self-reported smoking −)?

How reliable were outcome measures (e.g. inter- or intra-rater reliability scores)?

Was there any indication that measures had been validated (e.g. validated against a gold standard measure or assessed for content validity)?

−

Comments: the measures of the outcome were reliable. The measures such as the Kruskal-Wallis test and the Chi-Square among others help in comparing the variable between the four groups. They also revealed the means score of the dependent groups for example the t-test assisted in revealing this. One ANOVA and the t-test were used for the independent samples to compare between-group comparisons.

3.2 Were all outcome measurements complete?

Where all or most study participants who met the defined study outcome definitions likely to have been identified?

−

Comments: the study outcomes show that the post-test means scores of the knowledge retention in both interventions were similar but high in the control groups. There were no significant differences between the four study groups.

3.3 Were all important outcomes assessed?

Were all important benefits and harms assessed?

Was it possible to determine the overall balance of benefits and harms of the intervention versus comparison?

−

Comments: the overall outcomes were effectively assessed. The use of FC through NPE leads to an increase in the mean score of the PSKRE hence boosting the learning, nevertheless, it did not affect the retention of the knowledge linked to the patient safety in nursing and the midwifery learners. The authors also warned about the use of the outcome for the generalization of teaching other courses since it does not implies that the integration of the FC and the NPE is an effective strategy.

3.4 Were outcomes relevant?

Where surrogate outcome measures were used, did they measure what they set out to measure? (e.g. a study to assess the impact on physical activity assesses gym membership – a potentially objective outcome measure – but is it a reliable predictor of physical activity?)

Comments: the outcome of the study is important to the students while practicing as nurses and midwifery. It shows that the integration of the FC and the NPE compared to the conventional technique broadens the levels of knowledge in the learners in the field of patient safety. The FC through the NPE and the conventional techniques helps in boosting the learner’s knowledge and this was evident in the within-group. there is also an increase in the learning process after receiving FC through NPE. The outcome of the study is also important since it supports the use of the process of integrating the pedagogical techniques that need to be used for the creation of active learning thinking in learners.

3.5 Were there similar follow-up times in exposure and comparison groups?

If groups are followed for different lengths of time, then more events are likely to occur in the group followed up for longer distorting the comparison.

Analyses can be adjusted to allow for differences in length of follow-up (e.g. using person-years).

Comments: There were follow-up groups in the study, however, the authors failed to report on whether there was a follow-up program. There is also no mention of the number of days that were taken for the follow-up program.

3.6 Was follow-up time meaningful?

Was follow-up long enough to assess long-term benefits or harms?

Was it too long, e.g. participants lost to follow-up?

−

Comments: The authors failed to report on the number of days that were allocated for the follow-up even though there were groups in the four mentioned groups of study.

Section 4: Analyses

4.1 Were exposure and comparison groups similar at baseline? If not, were these adjusted?

Were there any differences between groups in important confounders at baseline?

If so, were these adjusted for in the analyses (e.g. multivariate analyses or stratification).

Were there likely to be any residual differences of relevance?

−

Comments: even though the authors failed to provide the baseline information related to what is tested, the subjects were allocated to four groups through the block randomization approach. The authors managed to ensure that the subjects in the intervention groups were provided with the educational content online for 14 days and later attended the Flipped Classroom through the NPE. On the other hand, the control groups merely received an education based on the conventional technique.

4.2 Was the intention to treat (ITT) analysis conducted?

Were all participants (including those that dropped out or did not fully complete the intervention course) analyzed in the groups (i.e. intervention or comparison) to which they were originally allocated?

−

Comments: yes, the intention to treat was performed as the authors focused on finding out the effect of the flipped classroom through the near-peer education (FC through NPE) on the patient safety knowledge retention in nursing and midwifery learners. This is important in addressing the safety of the patients since it allows the nurses and the midwifery to acquire the knowledge for the performance of the required services targeted at improving the safety of the patients.

4.3 Was the study sufficiently powered to detect an intervention effect (if one exists)?

A power of 0.8 (that is, it is likely to see an effect of a given size if one exists, 80% of the time) is the conventionally accepted standard.

Is a power calculation presented? If not, what is the expected effect size? Is the sample size adequate?

−

Comments: according to the information provided in the article, the authors failed to provide the power to help in the detection of the intervention effect. It, therefore, implies that it becomes hard to determine the expected effect. The sample size used by the authors is also inadequate and this resulted in the occurrence of a wide interval range. Therefore, this somehow interfered with the accuracy of the study outcomes.

4.4 Were the estimates of effect size given or calculable?

Were effect estimates (e.g. relative risks, absolute risks) given or possible to calculate?

−

Comments: Based on the information from the article, there is no evidence of the estimated effect of the size provided. This means that the authors failed to provide information on the relative or the absolute risks. This was evident despite the availability of the risks to the safety of the patients. According to the article, there is a need to ensure that there is an ongoing process of monitoring the risks, developing the strategies to help in the reduction of the risks, eliminating the risks, and preventing the transfer of the risks. dealing with the issue also requires an effective communication process. Nevertheless, the authors failed to provide the effect estimates associated with the relative risks, absolute risks.

4.5 Were the analytical methods appropriate?

Were important differences in follow-up time and likely confounders adjusted for?

If a cluster design, were analyses of sample size (and power), and effect size performed on clusters (and not individuals)?

Were subgroup analyses pre-specified?

−

Comments: the authors adopted descriptive statistics that included the frequency, the mean, and the SD. The analysis was performed on the individuals and was divided into subgroups. The authors utilized the Shapiro-Wilk test to help in the examination of the data distribution. The Kruskal-Wallis test, Chi-Square test, and Fisher’s exact test were utilized in comparing the demographic variables between the four groups. The authors utilized the t-test or the repeated measures analysis of the variance (ANOVA) to perform the comparison of the means scores of the dependent groupings. The authors adopted the independent t-test and the one-way ANOVA for between-group comparisons.

4.6 Was the precision of intervention effects given or calculable? Were they meaningful?

Were confidence intervals or p values for effect estimates given or possible to calculate?

Were CI’s wide or were they sufficiently precise to aid decision-making? If precision is lacking, is this because the study is underpowered?

−

Comments: the scores and the p-value of the patient safety knowledge before the intervention in the two groupings of the control and intervention are given to be 15.60 + or – 1.92 and 16.65 + or -2.10 respectively with the p-value of 0.098. The authors also provided the means score and the probability of the two groups that reveal no statistically significant differences in terms of the changes i.e. mean score of 1.89 ad the p-value of 0.071. In group two, the intervention group, and the total control groups in the follow-up, there is a significantly lower mean score for the Patient Safety Knowledge Retention Exam (PSKRE) compared to the posttest.

Section 5: Summary

5.1 Are the study results internally valid (i.e. unbiased)?

How well did the study minimize sources of bias (i.e. adjusting for potential confounders)?

Were there significant flaws in the study design?

−

Comments: The study was based on the method of the randomized controlled trial using a pretest-posttest and the follow-up as well as the intervention and the control groups. The authors utilized Solomon’s four-group design to ensure that there is a removal of the effects of the pretest in the sensitization of the learners and the prevention of the potential damages to the external validity of the study. The authors also ensured that the samples were randomly divided into four groups i.e. two in the intervention groups and the two in the control groups. The authors only administered the pretest to a single intervention group and a single control group. the four groups were provided with the post-test/follow-up knowledge retention. However, the authors failed to explain how the biases that might have occurred as a result of the limitations of the study were addressed.

5.2 Are the findings generalizable to the source population (i.e. externally valid)?

Are there sufficient details given about the study to determine if the findings are generalizable to the source population? Consider participants, interventions and comparisons, outcomes, resources, and policy implications.

−

Comments: Even though the study reveals that the use of the Flipped Classroom through the Near Peer Education (FC through PE) leads to an increase in the knowledge mean score, it failed to impact the retention of the knowledge in terms of patient safety in nursing and midwifery learners. There are also limited studies in the field and the present study utilized a small number of samples. The study also failed to consider the key variables such as satisfaction of the learners and the failure to consider the effectiveness of the integrated technique compared to the FC and NPE alone. the results of the study cannot be generalized to teaching other courses since it does not necessarily imply that the integration of the FC and the NPE is the most effective strategy.

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