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People with sickle cell disease (SCD) or sickle cell trait (SCT) may not have information about genetic inheritance needed for making informed reproductive health decisions. CHOICES is a Web-based, multimedia educational intervention that provides information about reproductive options and consequences to help those with SCD or SCT identify and implement an informed parenting plan. Efficacy of CHOICES compared with usual care must be evaluated.The purpose was to compare immediate posttest effects of CHOICES versus an attention-control usual care intervention (e-Book) on SCD-/SCT-related reproductive health knowledge, intention, and behavior.


In a randomized controlled study, we recruited subjects with SCD/SCT from clinics, community settings, and online networks with data collected at sites convenient to the 234 subjects with SCD (n = 136) or SCT (n = 98). Their ages ranged from 18 to 35 years; 65% were women, and 94% were African American. Subjects completed a measure of sickle cell reproductive knowledge, intention, and behavior before and immediately after the intervention.
b Results: Compared with the e-Book group, the CHOICES group had significantly higher average knowledge scores and probability of reporting a parenting plan to avoid SCD or SCD and SCT when pretest scores were controlled. Effects on intention and planned behavior were not significant.

The CHOICES group showed significant change in their intention and planned behavior, whereas the e-Book group did not show significant change in their intention, but their planned behavior differed significantly. Initial efficacy findings are encouraging but warrant planned booster sessions and outcome follow-ups to determine sustained intervention efficacy on reproductive health knowledge, intention, and actual behavior of persons with SCD/SCT.behavior & sickle cell disease & sickle cell trait & young adult Despite longstanding scientific knowledge about genetic inheritance of sickle cell disease (SCD) or sickle cell trait (SCT), translation of that knowledge to the affected community has been insufficient.

Pregnancies in the at-risk population may occur with little forethought or opportunity for well-informed reproductive health decisions and may be based on insufficient or erroneous knowledge about genetic inheritance (Gallo, Knafl, & Angst, 2009; Long, Thomas, Grubs, Gettig, & Krishnamurti, 2011).

Article Appraisal Questions

Student Answers

Sample. (For help with these questions, refer to chapters 3, 15, & 18)

a) What sampling method was used

 by the authors in this study?

The study used stratified sampling technique by stratifying by SCT or SCD conditions and obtained a simple random sample from each stratum. This was done by randomly assigning participants in permuted blocks.  

b)   What are the potential biases of this sampling method?

The stratified sampling technique has the highest potential of minimizing the selection bias of the sample and making sure that some segments of population are never underrepresented or overrepresented but is cannot be used where authors cant classify with confidence each population member into a subgroup.

c)   What was the final sample size and what was the acceptance

     rate?

The final sample size was 234 out of the 242 eligible participants and the acceptance rate was about 97%.

d)   Was a power analysis conducted?

     If so, describe it here.

The power analysis was done in the study using the sample size, effect size and P-level. The 234 participants showed either SCD (n=136) or the SCT (n=98). Sixty-five percent were women while 94% were African Americans. The CHOIECS stratum’s mean ages stood at 25.3 years with SD being 4.90 while that of the e-Book stratum was 26.4 years with SD being 4.90 years. There was no significant statistical difference between two strata with a p-value of 0.09.

e)  Describe the inclusion and

    Exclusion sample criteria.

The inclusion criteria: The participants were only included if they fall under age bracket of 18 to 35 years and must have reported SCT or SCD. They must have been able to understand spoken English as well as read English. They must had the ability as well as desire to have kids in the future. Exclusion Criteria: People who were legally blind, unable physically to have kids, or unable to complete study stood excluded. People who had reported knowing or even being a friend/relative to an already enrolled subject in study were also excluded to decrease the potential for contamination.

f)  Calculate the refusal rate.

Recruited eligible subjects were 242 and those who completed the questionnaire were 234; thus the difference was 8; hence the refusal rate is (8/242) multiplied by 100%= 3.30%  

g)  Calculate the attrition rate.

The number of participants who left during the study were 8 while the number of the participants who recruited once the sample had been chosen was zero, thus; attrition rate is got by dividing 8 by 0 and multiplying by 100% to get (8/0)100. This indicates that there was no attrition rate.

h)  Is the sampling method going to produce a sample that is representative of the study population?  Explain your answer.

The sample is representative of the population. This is because of the 242 who were recruited, 234 completed the study. This indicates about 97% completion rate. Thus, the final sample size is representative of the population and can help the authors generalize the finding as this a big enough sample. Moreover, the stratified sampling technique used here highly reduced the potential of selection bias thereby giving a representative sample.

Further, the setting were effective in that the author used a range of settings for the identification of the subjects, including sickle cell clinic at 2 healthcare institutions, public settings like university students centres/grocery/drug stores, and community organizations as well as online networks. The data was also gathered at convenient sites to subjects which included clinical settings, subject homes and coffee shops.  

i)   Briefly discuss the

     institutional review board

     approval and informed consent

     obtained for this study.  

The protocol was approved by the institutional review board (IRB) at the University of Illinois, Chicago alongside the Ann and Robert H. Lurie Children’s Hospital, Chicago. The well-trained Research Specialists (RSs) obtained the signed informed consents alongside pretests measures utilizing a pen tablet computer. The subjects were given $25 in cash by the research specialists for the travel and time.  

j)   Briefly describe the setting and

     indicate whether it was

     appropriate for conducting this

     study.

The setting were effective in that the author used a range of settings for the identification of the subjects, including sickle cell clinic at 2 healthcare institutions, public settings like university students centres/grocery/drug stores, and community organizations as well as online networks. The data was also gathered at convenient sites to subjects which included clinical settings, subject homes and coffee shops.  

Measurement Methods: (For help with these questions, refer to chapters 16, 17, 18)

a)  List and briefly describe the measures / instruments / tools used in the study.

The SCKnowIQ instrument (based on Cronbach’s alpha and test-retest reliability) was developed and used under the guidance of TRA. Other existing tools like Kaslow et al., 2000, helped select or modify items or even created for measuring 4 outcomes (parenting plan, knowledge, reproductive health intention, and demographics (age, gender, education, ethnicity, genetic status, marital status, income and race as well as experience with a family member with SCD).  

b)   Who administers each measurement / instrument / tool?

These were administered by the well-trained research specialist, RSs.

c)   How do the subjects complete

      each measurement / instrument

      tool?

The subjects responded to each instrument/measurement by choosing the responses options that indicated different scores.

d)  How is each measurement / instrument / tool scored?

Parenting Plan: Derived from 2 items directed to importance of having a kid without SCT or SCD. The response options are scored by 0 to mean not all important; 1 to mean not very important; 2 to mean somewhat important; 3 to mean very important and 4 to mean extremely important.

Knowledge: 18 knowledge items for outcomes stressed on SCT or SCD genetic transmission. Responses are scored by multiple options for individual with SCT or SCD with 1 correct response scored by 0 to mean not correct and 1 to mean correct.

Reproductive Health Intention: Has 8 items stressed on intention of avoiding having kids to bar having SCD or SCT to give birth to a kid unaffected (without SCD) or affected by SCD, to do abortion due to health concern/ to bar SCD/SCT, to utilize a range of advanced reproductive technologies as well as to pursue other non-childbearing alternatives; adopt/foster. It is scored by five responses ranging from 0 that means not at all likely to 4 which means extremely likely.

Reproductive Health Behavior: Has ten items directed towards behavior of implementing parenting plan involved in each and in the course of previous six months (pre-test)/planned in next six months (posttest). It is scored by coded response options on the basis of consistency with plan for parenting. The scores were 0 for inconsistent with plan and 1 consistent with plan and 5 somewhat consistent.  

Demographics: Scored by items focusing on marital status, experience with the family member with SCD, ethnicity, gender, genetic status or partner and subject, race, income, education, age  

e)  How do the authors describe the PAST reliability of each measurement / instrument / tool?

The past reliability have been described based on test-retest reliability in e-Book and the Cronbach’s alpha.

f)  How do the authors describe the reliability of each measurement / instrument / tool for THIS STUDY?

The reliability have been described by both Cronbach’s alpha and test-retest reliability

g) How do the authors describe the PAST validity of each measurement / instrument / tool?

The authors describe the past validity of SCKnowIQ scales based on the published or those in press as described by Gallo et al., 2010.

h) How do the authors describe the validity of each measurement / instrument / tool for THIS STUDY?

The current study’s reliabilities for SCKnowIQ scales have been described in the table format (table 2) based on both Cronbach’s alpha and Test-retest reliability:

i)  Did the authors develop a measurement / instrument / tool for this study?  If so, describe the development process.

The authors developed the SCKnowIQ instrument under the guidance of the TRA. They then selected or even modified the items from the prevailing tools.

j)  Did the authors use any physiological measurements in this study?  If so, how did they describe the methods for collecting and recording the data?

The authors did not use any physiological measurements.

 Collection and Managing Data.  (For help with these questions, refer to chapters 18 & 20.)

a)  Briefly describe the data collection process used in this study.

The primary data collection method was used to gather data from the subjects using the developed SCKnowIQ instruments. The authors selected the items or modified them and then gave them to the subjects to responses based on the different scores on the scales. The authors specifically focused on four outcomes and demographics which then were responded to by the subjects to get the required data for the study.

b)  Is there more than one data collector for the study?  If so, describe what the authors did to train the data collectors.  Do you think there was adequate training to ensure inter-rater reliability (IRR)?

There were more than data collectors. The authors hired well-trained research specialists (RSs.) to help in the collection of data. I think there was adequate training to guarantee IRR (inter-rater reliability) because the authors hired already well-trained research specialists.

Data Analysis. (For help with these questions, refer to chapters 18, 21, 22, 23, 24, 25)

a)  What descriptive statistics are used in this study?

The authors used the measures of central tendency and variability. These include the mean, standard deviation and the range in this study.

b)  What inferential statistics are used to examine the data obtained from the subjects?  **Hint: for help recognizing names of statistical tests, look at Figure 21-7.

The authors used Student’s t test for continuous variables alongside chi-square/Fisher’s exact test for the categorical ones to compare the demographic features of CHOICEs and e-Book strata. Cumulative logit link model for 3-level ordinal parenting plan outcome was utilized to control the pre-test p-values alongside status of sickle cell while knowledge, behavior and intention were analyzed with linear regression to examine the effects of intervention on the posttest values.

c)  What is the level of significance set at for this study?

The authors set the statistical significance level at a 2-sided alpha level of 0.05.  

d)  Are tables or figures used to

     present the results of the data

     analysis?  List and briefly explain

     the content of each table or

     figure.

The authors have used only tables to present the results:

Table 3: showed descriptive outcomes for parenting plan. Here, a great percentage of subjects expressed their preference for evading having kids with SCT or SCD.

Table 4: This showed descriptive results for intention, knowledge, and behavior at the current both posttest and pretests by CHOICES and e-Book.

The average scores (pretest) stood identical in both strata.

Table 5: Showed the inferential analysis for all the four outcomes.

Researchers Interpretation of the Findings. (For help with these questions, refer to chapters 18 & 26)

a)  What are the key findings from this study (as stated by the authors)?  In parentheses next to each finding, indicate whether the finding is significant, non-significant, or unpredicted / serendipity.

The authors discovered that odds of CHOICES stratum participant parenting plan to evade having a kid with SCD or a kid with either SCT or SCD stood at 2.30 times the e-Book stratum subjects. This was significant 

The authors also discovered that as opposed to e-Book stratum, the CHOICES stratum showed a significantly significant enhancement in knowledge instantly following a one-hour Web-oriented, multimedia educational scheme/program. This was significant 

The authors also discovered that intervention stratum differences in behavior and intention outcomes remained insignificant statistically, however, trends stayed in direction hypothesized. This was significant 

b)  Which of the key findings that you listed in 13a were consistent with what the authors were expecting? 

The authors also discovered that as opposed to e-Book stratum, the CHOICES stratum showed a significantly significant enhancement in knowledge instantly following a one-hour Web-oriented, multimedia educational scheme/program.

c)   Which of the key findings from this study were identified by the authors as being clinically significant / clinically important?

All the findings by the authors were identified as being significant/important clinically. This is because they gave insights for the authors to optimize reproductive behavior change based on the instant posttest findings as this supported their pans of delivering intervention boosters as well as conducting recurrent posttest over two years ( Wilkie et al., 2013). Moreover, CHOICES presents opportunity for young individuals with SCD or SCT to taken into account their reproductive alternatives, to converse with partners regarding status of sickle cell, and hence plan for coming pregnancies. Thus, this study has a potential for positive influence linked to Healthy People 2020 goals. This study remains relevance since Healthy People 2020 entails a developmental aim of increasing the share of hemoglobinopathy carrier that know their individual carrier status

d)  List the study’s limitations as described by the authors. Did you find any other limitations not mentioned by the authors?

1. It was carried out in 1 geographical location in the United State yet it is feasible that intervention effects shall differ in other destinations with varying cultural norms.

2. The study also entailed primarily people of African origin, albeit other ethnic populace could have SCD and additional hemoglobinopathy straits.

3. Authors never included a cognitive ability’s measure alongside participants with SCD might have had cognitive impairment from previous silent strokes/low hemoglobin that could affect learning.

4. The authors were not able to conclude what long-run effects of CHOICES intervention shall be until they have finished 12, 18 and 24 months of data gathering and analysis ( Timonera et al., 2017).   

Another limitation: The single one-hour educational session used in this study could not have been adequate dose for studying complexities of genetic inheritance knowledge (Uy et al., 2017).

e)  Do the authors generalize the findings to other populations?  If so, who are they? Is this appropriate?

The authors don’t generalize the findings as the CHOICES stratum intervention offered info in manner solely acceptable to subjects.

f)  What implications do the findings have for nursing practice?

The study has an implication of showing efficacy for intervention to assist young adults with SCT or SCD to implement respective personal parenting plan in the informed manner.

g)  What suggestions have the authors made for future studies?

The authors have suggested to determine in the future if 1 or 2 extra sessions will be adequate for participants to retain knowledge essential for implementing behavior consistent with parenting plans (Gallo et al., 2016).  

Hint* use guidelines in Chapter 18 on page 438-442 in Step II

a) Identify one strength of the

    study related to the content in

    this assignment (find the

    strengths in the sample,

    measurement methods, data

    collection, or data analysis)

One strength was in the analysis of data whereby authors effectively performed all statistical analyses based on statistical software package R and effectively identified themes of qualitative data based on content analysis.

b) Identify one weakness of

    the study related to the content

    in this (find the weaknesses in

    the sample, measurement

    methods, data collection, or

    data analysis)

The one weakness in the finding is that actual behavior change was never determined in the study ( Rosenfeld, 2017).

 

Pick two of the guidelines and provide an answer (your choice).

In respect of the design guideline; the design remains effective and has helped the authors effectively answer the research questions ( Rochon et al., 1994)

With respect to validation of instruments and measures guideline, the authors used instruments as well as measures that were tested thereby guaranteeing accuracy and reliability (Girden & Kabacoff, 2010).

References

Chair: Danielle Jansen, Netherlands, & Organised by: MOCHA Project. (2017). 10. N. Workshop: Appraising Primary Care for children and adolescents in Europe–are we measuring the right things?. The European Journal of Public Health, 27(suppl_3), ckx187-799.

Gallo, A. M., Wilkie, D. J., Yao, Y., Molokie, R. E., Stahl, C., Hershberger, P. E., ... & Carrasco, J. (2016). Reproductive health CHOICES for young adults with sickle cell disease or trait: randomized controlled trial outcomes over two years. Journal of genetic counseling, 25(2), 325-336.

Girden, E. R., & Kabacoff, R. (Eds.). (2010). Evaluating research articles from start to finish. Sage.

Rochon, P. A., Gurwitz, J. H., Cheung, C. M., Hayes, J. A., & Chalmers, T. C. (1994). Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal. Jama, 272(2), 108-113.

Rosenfeld, P. (2017). How strong is the evidence? A primer on appraising the evidence and quality of research journal articles. World Council of Enterostomal Therapists Journal, 37(1), 12.

Timonera, M. R., Aw, M. M., Lim, S. G., Dans, A. L., & Dans, L. F. (2017). Evaluation of Articles on Therapy. Painless Evidence?Based Medicine, 12-37.

Uy, E. J. B., Ooi, S. B., Dans, A. L., Dans, L. F., & Silvestre, M. A. A. (2017). Evaluation of Articles on Diagnosis. Painless Evidence?Based Medicine, 38-57.

Wilkie, D. J., Gallo, A. M., Yao, Y., Molokie, R. E., Stahl, C., Hershberger, P. E., ... & Angulo, R. (2013). Reproductive health choices for young adults with sickle cell disease or trait: randomized controlled trial immediate posttest effects. Nursing research, 62(5),352.

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