Nontuberculous Mycobacterial Musculoskeletal Infection Research Study Analysis

Research Designs and Participants’ Protection

Before examining different types of research designs, it is essential to describe what research design purpose is.  A research design is the set of strategies and methods utilized in obtaining, collecting, and analyzing measures of the variables defined in the problem research (Tappen, 2016).  “


Nontuberculous Mycobacterial Musculoskeletal Infection Cases from a Tertiary Referral Center, Colorado, USA” (Goldstein, St. Clair, Kasperbauer, & Daley, 2019) research and its design, analysis, and flaws will be summarized and discussed in this assignment.

The descriptive epidemiology research study completed by Zahnd, Jenkins, and Muller-Luckey (2017) and the analytic research study was done by Rouzine and Rozhnova (2018) will be summarized, and their research designs will also be discussed in this assignment.  The U.S. government reinforces clinical research with human subjects follows a system of federal laws and guidelines that were created to defend human participants and safeguard that clinical research is conducted ethically (Lapid, Clarke, & Wright, 2019).  The same guidelines and practices apply to research whether it entails earlier collected blood samples, evaluations of actions, or first-in-human evaluation of medications or biologics.  Recommendations on Protecting Research Participants discussed on www.onlineethics.org/about/permissions.aspx will be summarized.

Discussion

Summarizing


Nontuberculous Mycobacterial Musculoskeletal Infection Research

In 2019,


Goldstein et al. did a research study on patients who were exposed toNontuberculous Mycobacterial Musculoskeletal Infection.  This research was done to highlight the significance of attentiveness for nontuberculous mycobacterial musculoskeletal infection, especially in immunosuppressed patients and those who had the musculoskeletal disease.  The soil and water contain nontuberculous mycobacteria (NTM) are opportunistic pathogens.  Many infections are caused by these pathogens.  These infections mainly occur in immunocompetent people, usually via traumatic skin puncture.  Goldstein et al. (2019) reported that in the previous case reports from South Korea, all 29 cases were treated with surgical and antibacterial drug interventions.  Three patients didn’t respond to the treatments, and four patients left the study and were not found. Twenty of these cases were treated with NTM-specific antimicrobial therapy, and the other five patients got empirical antimicrobial therapy.   93% of the patients had fingers or hands infections, and 87% were related to the aquatic submission.  75% of the patients recovered after aggressive antibacterial and surgical treatments.  The remaining 25% didn’t follow up.  Goldstein et al. (2019) also reported that in another study, eight patients with prosthetic joint infection (PJI) got mycobacteria infection of the prosthetic joint and were treated by resection of infected prostheses or aggressive antimicrobial therapy. Goldstein et al. (2019) reviewed all cases of non-spinal Nontuberculous Mycobacterial Musculoskeletal Infection at the University of Colorado Hospital (UCH; Aurora, CO, USA) over six years by a multidisciplinary group of physicians at UCH and National Jewish Health (NJH; Denver, CO, USA).  The retrospective chart review (RCR), also recognized as a medical history review research design, was used in the study of 14 patients with non-spinal NTM musculoskeletal infections treated at UCH during 2009–2015 in this research.  The spinal cases were omitted in this study because they were treated by a different department at the University of Colorado Hospital (UCH).  Medical records of patients who had non-spinal NTM musculoskeletal infections cured by orthopedic surgeons at UCH were reviewed after approval from the Institutional Review Board.

All data were collected using a retrospective chart review design.  Seven patients were on immunosuppressive medications, and five patients had an autoimmune disease.  These twelve patients were referred from National Jewish Health.  All patients had surgical treatments and received antimicrobial chemotherapy based on their culture results.  The secondary analysis was used in this research. Goldstein et al. (2019) re-examined, compared, and analyzed the two previous study cases with the research that they did on fourteen patients over six years to get a better and alternative perspective to the original research question.  The finding of this research and analysis of the two previous cases reveals the requirement for initial detection and assertive management of NTM infection.  This research played a very important role in identifying how critical it is to provide early and assertive treatment for this infection to decrease and limit the severe complications and physical injuries that would occur with delays in treatments.  There were a couple of flaws in this study. It was regrettable that the documents did not find more extensive diagnostic measures based upon inflammatory markers. Whereas the ESR in the patients was normally risen, the C-reactive protein and leukocyte calculations were typically healthy. “The patient who failed treatment had one of the highest ESRs in our patient group, nearly double the median value of 38 at intake, perhaps because of her chronic autoimmune condition” (Goldberg et al., 2019, p. 7).

An Example of a Journal Article That Uses Descriptive Epidemiology and its Design

Zahnd, Jenkins, and Mueller-Luckey (2017) performed research on Cancer Mortality in the Mississippi Delta Region to describe the region’s mortality load from the most available interval of data between 2008 and 2012.  Zahnd et al. (2017) reported that Delta Region covers 252 counties in eight states (Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri).  Delta Region is federally designated, poor, mostly rural, and has a high population of black residents.  Zahnd et al. (2017) used National Center for Health Statistics (NCHS) information received through the National Cancer Institute’s Surveillance Epidemiology and End Findings (SEER) design to get evidence on patients who had breast(female), cervical, prostate, lung, and colorectal cancers. The result of this research showed that the mortality rate in the Delta Region was remarkably higher than the whole United States.  Cancer rates among blacks were higher than their whites.  Cancer mortality rates in the Delta Region was higher than the whole United States.  Cancer levels were higher in a rural area of Delta Region contrasted to the urban Delta Region.  These findings suggest that the Delta residents may benefit from public health and health promotion attempts such as cancer screening access and health behavior alteration.  There were two limitations to this study.  First, the study was being solely descriptive and didn’t control other risk factors such as health behaviors or socioeconomic status.  Second, the population of the Delta Region was primarily white and black.  Other racial groups were not calculated to provide a more accurate distinguished racial disparity.  “these findings suggest that further research is needed to elucidate the causes of greater cancer burden in this region” (Zahnd et al., 2017, p. 5).

An Example of a Journal Article That Uses Analytic Epidemiology and its Design

Rouzine and Rozhnova (2018) completed the Antigenic development of viruses in host research.  The purpose of this study was to ascertain broad and straightforward connections for the velocity of virus advancement, genetic variety, and yearly frequency in terms of people parameters, and to prepare them on the existing data for influenza virus.  They implemented a strain-based design of epidemiological models, in which all people are diseased or improved. Recovered people are categorized corresponding to their existing power to reply to various viral strains that signify genetic deviations of an antibody-binding state of the virus.  Once the infected person recovered from the virus infection, they calculated time in the units of the infectious cycle.  Infected people with compactness i(x, t) recuperate. Then, people infected with a strain x may generate a modified strain x’ with a little possibility.  “The model described in the previous section establishes a general analytic relationship between immunological, epidemiological, and evolutionary properties of a virus causing non-chronic infection” (Rouzine & Rozhnova, 2018, p. 4).  They started their analytic origin by noting that, in the maximum of low mutation rates, the main role of mutation is to develop new strains with antigenic synchronize x larger than for previously occurring strains.  “Their analysis predicts that substitution rate of antigenic mutation c, Eq 13, is inversely proportional to the cross-immunity distance a and increases logarithmically with host population size and mutation rate” (Rouzine & Rozhnova, 2018, p. 6).  To check and test the model


, Rouzine and Rozhnova (2018) linked its estimates with presented data on influenza A H3N2 and H1N1.  Combining the standard epidemiological method and the modern traveling wave theory, they established a broad analytic approach that links epidemiological and immunological factors to the detected factors of influenza growth.

Compare and Contrast of Both Study Designs

Zahnd et al. (2017) study used the data assessed through the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) program.  The simple descriptive design was used to describe the thorough cancer mortality problem in the Delta Region for the first time. This study was the first to assess cancer rates in the Delta Region.  “A simple descriptive design focuses on a single group or population” (Tappen, 2016, p. 78).  This study was on Delta Region residents, which is a single group or population.  However, Rouzine and Rozhnova (2018) used a combined comparative and correlational design.  “In studies using this type of design, a number of observations are made on the same group, and the relationships (correlations) between them are calculated” (Tappen, 2016, p. 83).  The study evaluated those who were affected by the influenza virus for the first time.  Then the study evaluated those who were exposed to the virus the second time after being recovered from the first infection.  “Analytic solution, Eps and 4, was based on the assumption that the infected wave i(u) is much more than the recovered wave r(u)” (Rouzine & Rozhnova, 2018, p.4).  The analytic outcomes for wave velocity c by Monte-Carlo simulation in a wide array of N and Ub were verified.

Summary of Recommendations on Protecting Research Participants



Safeguarding the human rights of those who volunteer to partake in the research is described on

www.onlineethics.org/about/permissions.aspx

. These rights are summarized in this section.    The investigation must recognize the freedom of contestants, must be reasonable in both conception and execution, and must expand possible advantages while minimizing potential injuries.  An independent review of research is necessary because it enhances the likelihood that choices are made free of inappropriate impacts that could interfere with the central purpose of evaluating dangers and possible advantages.  No one should partake in research without granting voluntary informed consent (except in the case of a suitable authorized spokesperson or a waiver).  Vulnerable people, such as children or disabled individuals, need supplementary protection in research.

Investigators should design investigations that lower the risk of abuse, whether by using a separate method of enrollment, by utilizing a recruiter who shares the applicants’ qualities, or by some other technique. Participants who are injured as a direct result of the research should be cared for and reimbursed.  A thorough and efficient oversight structure is essential to consistently protect the rights and welfare of participants while permitting ethically and scientifically responsible research to proceed, not including unnecessary gaps.  Education is the basis of the oversight system and is crucial to protecting research participants.  Some research does need control to prevent placing individuals at danger of individuality release or discrimination without their information. Federal guidelines should clearly distinguish the categories of research that are subject to review and the types of research members to whom protections should apply.  Research review and observing should be strengthened as the risk and complication of the research expand and always should emphasize defending participants rather than following harsh guidelines.

Conclusion

The research design implies the overall strategy that is selected to combine the different elements of the study in a rational and logical way, thereby confirming that the research problem is efficiently addressed. Several articles summarize, and their designs that are discussed confirms how different types of research can use different types of designs. Federal laws and regulations strictly enforce human participants protection.  The summary of the research human participants’ rights is mentioned.  These regulations will assist both researchers and human participants. The researchers can find more volunteers to participate since the participants are aware that their rights are protected. Those who participate in the research also feel safe and more willing to help society by participating in the research.

References

• 
  
  Goldstein, N., St. Clair, J., Kasperbauer, S. H.,
  
  
  Daley, C. L., & Lindeque, B. (2019). Nontuberculous Mycobacterial Musculoskeletal Infection Cases from a Tertiary Referral Center, Colorado, USA.
  
  Emerging Infectious Diseases, 25
  
  (6), 1075-1083.
  
  http://dx.doi.org/10.3201/eid2506.181041
  
  .
• Lapid, M. I., M.D.,
  
  
  Clarke, B. L., M.D., & Wright, R. S. (2019). Institutional review boards: What clinician researchers need to know.
  
  Mayo Clinic Proceedings, 94
  
  (3), 515-525. doi:
  
  http://dx.doi.org/10.1016/j.mayocp.2019.01.020
  
• Rouzine, I. M., & Rozhnova, G. (2018). Antigenic evolution of viruses in host populations.
  
  PLoS Pathogens, 14
  
  (9) doi: http://dx.doi.org/10.1371/journal.ppat.1007291
• Tappen, R. (2016). Advanced nursing research: From theory to practice (2nd ed.). Burlington, MA: Jones & Barlett Learning.
• “Use of Materials on the OEC” Online Ethics Center for Engineering 12/6/2007 OEC Accessed: Sunday, October 6, 2019 <www.onlineethics.org/about/permissions.aspx>
• Vasser, M, & Holzmann, M. (2013). The retrospective chart review: important methodological considerations.
  
  Journal of educational evaluation for health professions, 10
  
  , 12. Doi: 10.3352/jeehp.2013.10.12
• Zahnd, W. E., M.S., Jenkins, Wiley D, PhD., M.P.H., & Mueller-Luckey, G. (2017). Cancer mortality in the Mississippi delta region: Descriptive epidemiology and needed future research and interventions.
  
  Journal of Health Care for the Poor and Underserved, 28
  
  (1), 315-328. Doi://dx.doi.org/10.1353/hpu.2017.0025

Research Designs and Participants’ Protection

Before examining different types of research designs, it is essential to describe what research design purpose is.  A research design is the set of strategies and methods utilized in obtaining, collecting, and analyzing measures of the variables defined in the problem research (Tappen, 2016).  “


Nontuberculous Mycobacterial Musculoskeletal Infection Cases from a Tertiary Referral Center, Colorado, USA” (Goldstein, St. Clair, Kasperbauer, & Daley, 2019) research and its design, analysis, and flaws will be summarized and discussed in this assignment.

The descriptive epidemiology research study completed by Zahnd, Jenkins, and Muller-Luckey (2017) and the analytic research study was done by Rouzine and Rozhnova (2018) will be summarized, and their research designs will also be discussed in this assignment.  The U.S. government reinforces clinical research with human subjects follows a system of federal laws and guidelines that were created to defend human participants and safeguard that clinical research is conducted ethically (Lapid, Clarke, & Wright, 2019).  The same guidelines and practices apply to research whether it entails earlier collected blood samples, evaluations of actions, or first-in-human evaluation of medications or biologics.  Recommendations on Protecting Research Participants discussed on www.onlineethics.org/about/permissions.aspx will be summarized.

Discussion

Summarizing


Nontuberculous Mycobacterial Musculoskeletal Infection Research

In 2019,


Goldstein et al. did a research study on patients who were exposed toNontuberculous Mycobacterial Musculoskeletal Infection.  This research was done to highlight the significance of attentiveness for nontuberculous mycobacterial musculoskeletal infection, especially in immunosuppressed patients and those who had the musculoskeletal disease.  The soil and water contain nontuberculous mycobacteria (NTM) are opportunistic pathogens.  Many infections are caused by these pathogens.  These infections mainly occur in immunocompetent people, usually via traumatic skin puncture.  Goldstein et al. (2019) reported that in the previous case reports from South Korea, all 29 cases were treated with surgical and antibacterial drug interventions.  Three patients didn’t respond to the treatments, and four patients left the study and were not found. Twenty of these cases were treated with NTM-specific antimicrobial therapy, and the other five patients got empirical antimicrobial therapy.   93% of the patients had fingers or hands infections, and 87% were related to the aquatic submission.  75% of the patients recovered after aggressive antibacterial and surgical treatments.  The remaining 25% didn’t follow up.  Goldstein et al. (2019) also reported that in another study, eight patients with prosthetic joint infection (PJI) got mycobacteria infection of the prosthetic joint and were treated by resection of infected prostheses or aggressive antimicrobial therapy. Goldstein et al. (2019) reviewed all cases of non-spinal Nontuberculous Mycobacterial Musculoskeletal Infection at the University of Colorado Hospital (UCH; Aurora, CO, USA) over six years by a multidisciplinary group of physicians at UCH and National Jewish Health (NJH; Denver, CO, USA).  The retrospective chart review (RCR), also recognized as a medical history review research design, was used in the study of 14 patients with non-spinal NTM musculoskeletal infections treated at UCH during 2009–2015 in this research.  The spinal cases were omitted in this study because they were treated by a different department at the University of Colorado Hospital (UCH).  Medical records of patients who had non-spinal NTM musculoskeletal infections cured by orthopedic surgeons at UCH were reviewed after approval from the Institutional Review Board.

All data were collected using a retrospective chart review design.  Seven patients were on immunosuppressive medications, and five patients had an autoimmune disease.  These twelve patients were referred from National Jewish Health.  All patients had surgical treatments and received antimicrobial chemotherapy based on their culture results.  The secondary analysis was used in this research. Goldstein et al. (2019) re-examined, compared, and analyzed the two previous study cases with the research that they did on fourteen patients over six years to get a better and alternative perspective to the original research question.  The finding of this research and analysis of the two previous cases reveals the requirement for initial detection and assertive management of NTM infection.  This research played a very important role in identifying how critical it is to provide early and assertive treatment for this infection to decrease and limit the severe complications and physical injuries that would occur with delays in treatments.  There were a couple of flaws in this study. It was regrettable that the documents did not find more extensive diagnostic measures based upon inflammatory markers. Whereas the ESR in the patients was normally risen, the C-reactive protein and leukocyte calculations were typically healthy. “The patient who failed treatment had one of the highest ESRs in our patient group, nearly double the median value of 38 at intake, perhaps because of her chronic autoimmune condition” (Goldberg et al., 2019, p. 7).

An Example of a Journal Article That Uses Descriptive Epidemiology and its Design

Zahnd, Jenkins, and Mueller-Luckey (2017) performed research on Cancer Mortality in the Mississippi Delta Region to describe the region’s mortality load from the most available interval of data between 2008 and 2012.  Zahnd et al. (2017) reported that Delta Region covers 252 counties in eight states (Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri).  Delta Region is federally designated, poor, mostly rural, and has a high population of black residents.  Zahnd et al. (2017) used National Center for Health Statistics (NCHS) information received through the National Cancer Institute’s Surveillance Epidemiology and End Findings (SEER) design to get evidence on patients who had breast(female), cervical, prostate, lung, and colorectal cancers. The result of this research showed that the mortality rate in the Delta Region was remarkably higher than the whole United States.  Cancer rates among blacks were higher than their whites.  Cancer mortality rates in the Delta Region was higher than the whole United States.  Cancer levels were higher in a rural area of Delta Region contrasted to the urban Delta Region.  These findings suggest that the Delta residents may benefit from public health and health promotion attempts such as cancer screening access and health behavior alteration.  There were two limitations to this study.  First, the study was being solely descriptive and didn’t control other risk factors such as health behaviors or socioeconomic status.  Second, the population of the Delta Region was primarily white and black.  Other racial groups were not calculated to provide a more accurate distinguished racial disparity.  “these findings suggest that further research is needed to elucidate the causes of greater cancer burden in this region” (Zahnd et al., 2017, p. 5).

An Example of a Journal Article That Uses Analytic Epidemiology and its Design

Rouzine and Rozhnova (2018) completed the Antigenic development of viruses in host research.  The purpose of this study was to ascertain broad and straightforward connections for the velocity of virus advancement, genetic variety, and yearly frequency in terms of people parameters, and to prepare them on the existing data for influenza virus.  They implemented a strain-based design of epidemiological models, in which all people are diseased or improved. Recovered people are categorized corresponding to their existing power to reply to various viral strains that signify genetic deviations of an antibody-binding state of the virus.  Once the infected person recovered from the virus infection, they calculated time in the units of the infectious cycle.  Infected people with compactness i(x, t) recuperate. Then, people infected with a strain x may generate a modified strain x’ with a little possibility.  “The model described in the previous section establishes a general analytic relationship between immunological, epidemiological, and evolutionary properties of a virus causing non-chronic infection” (Rouzine & Rozhnova, 2018, p. 4).  They started their analytic origin by noting that, in the maximum of low mutation rates, the main role of mutation is to develop new strains with antigenic synchronize x larger than for previously occurring strains.  “Their analysis predicts that substitution rate of antigenic mutation c, Eq 13, is inversely proportional to the cross-immunity distance a and increases logarithmically with host population size and mutation rate” (Rouzine & Rozhnova, 2018, p. 6).  To check and test the model


, Rouzine and Rozhnova (2018) linked its estimates with presented data on influenza A H3N2 and H1N1.  Combining the standard epidemiological method and the modern traveling wave theory, they established a broad analytic approach that links epidemiological and immunological factors to the detected factors of influenza growth.

Compare and Contrast of Both Study Designs

Zahnd et al. (2017) study used the data assessed through the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) program.  The simple descriptive design was used to describe the thorough cancer mortality problem in the Delta Region for the first time. This study was the first to assess cancer rates in the Delta Region.  “A simple descriptive design focuses on a single group or population” (Tappen, 2016, p. 78).  This study was on Delta Region residents, which is a single group or population.  However, Rouzine and Rozhnova (2018) used a combined comparative and correlational design.  “In studies using this type of design, a number of observations are made on the same group, and the relationships (correlations) between them are calculated” (Tappen, 2016, p. 83).  The study evaluated those who were affected by the influenza virus for the first time.  Then the study evaluated those who were exposed to the virus the second time after being recovered from the first infection.  “Analytic solution, Eps and 4, was based on the assumption that the infected wave i(u) is much more than the recovered wave r(u)” (Rouzine & Rozhnova, 2018, p.4).  The analytic outcomes for wave velocity c by Monte-Carlo simulation in a wide array of N and Ub were verified.

Summary of Recommendations on Protecting Research Participants



Safeguarding the human rights of those who volunteer to partake in the research is described on

www.onlineethics.org/about/permissions.aspx

. These rights are summarized in this section.    The investigation must recognize the freedom of contestants, must be reasonable in both conception and execution, and must expand possible advantages while minimizing potential injuries.  An independent review of research is necessary because it enhances the likelihood that choices are made free of inappropriate impacts that could interfere with the central purpose of evaluating dangers and possible advantages.  No one should partake in research without granting voluntary informed consent (except in the case of a suitable authorized spokesperson or a waiver).  Vulnerable people, such as children or disabled individuals, need supplementary protection in research.

Investigators should design investigations that lower the risk of abuse, whether by using a separate method of enrollment, by utilizing a recruiter who shares the applicants’ qualities, or by some other technique. Participants who are injured as a direct result of the research should be cared for and reimbursed.  A thorough and efficient oversight structure is essential to consistently protect the rights and welfare of participants while permitting ethically and scientifically responsible research to proceed, not including unnecessary gaps.  Education is the basis of the oversight system and is crucial to protecting research participants.  Some research does need control to prevent placing individuals at danger of individuality release or discrimination without their information. Federal guidelines should clearly distinguish the categories of research that are subject to review and the types of research members to whom protections should apply.  Research review and observing should be strengthened as the risk and complication of the research expand and always should emphasize defending participants rather than following harsh guidelines.

Conclusion

The research design implies the overall strategy that is selected to combine the different elements of the study in a rational and logical way, thereby confirming that the research problem is efficiently addressed. Several articles summarize, and their designs that are discussed confirms how different types of research can use different types of designs. Federal laws and regulations strictly enforce human participants protection.  The summary of the research human participants’ rights is mentioned.  These regulations will assist both researchers and human participants. The researchers can find more volunteers to participate since the participants are aware that their rights are protected. Those who participate in the research also feel safe and more willing to help society by participating in the research.

References

• 
  
  Goldstein, N., St. Clair, J., Kasperbauer, S. H.,
  
  
  Daley, C. L., & Lindeque, B. (2019). Nontuberculous Mycobacterial Musculoskeletal Infection Cases from a Tertiary Referral Center, Colorado, USA.
  
  Emerging Infectious Diseases, 25
  
  (6), 1075-1083.
  
  http://dx.doi.org/10.3201/eid2506.181041
  
  .
• Lapid, M. I., M.D.,
  
  
  Clarke, B. L., M.D., & Wright, R. S. (2019). Institutional review boards: What clinician researchers need to know.
  
  Mayo Clinic Proceedings, 94
  
  (3), 515-525. doi:
  
  http://dx.doi.org/10.1016/j.mayocp.2019.01.020
  
• Rouzine, I. M., & Rozhnova, G. (2018). Antigenic evolution of viruses in host populations.
  
  PLoS Pathogens, 14
  
  (9) doi: http://dx.doi.org/10.1371/journal.ppat.1007291
• Tappen, R. (2016). Advanced nursing research: From theory to practice (2nd ed.). Burlington, MA: Jones & Barlett Learning.
• “Use of Materials on the OEC” Online Ethics Center for Engineering 12/6/2007 OEC Accessed: Sunday, October 6, 2019 <www.onlineethics.org/about/permissions.aspx>
• Vasser, M, & Holzmann, M. (2013). The retrospective chart review: important methodological considerations.
  
  Journal of educational evaluation for health professions, 10
  
  , 12. Doi: 10.3352/jeehp.2013.10.12
• Zahnd, W. E., M.S., Jenkins, Wiley D, PhD., M.P.H., & Mueller-Luckey, G. (2017). Cancer mortality in the Mississippi delta region: Descriptive epidemiology and needed future research and interventions.
  
  Journal of Health Care for the Poor and Underserved, 28
  
  (1), 315-328. Doi://dx.doi.org/10.1353/hpu.2017.0025