Project Management in Healthcare Research - Myassignmenthelp.Com

Question: Explanation of healthcare research in project Management? Answer: Introduction A large percentage of the world's TB burden occurs among the Asian populations with approximately 22 % and 37% of reported cases occurring in Western Pacific and South East Asia respectively (1). While there are large numbers of cases reported of TB in Asia's lowest income countries such as Bangladesh, Indonesia, and India, there have also been notifications reported in high income areas such as Japan, Singapore, and Hong Kong and often in larger amounts than those witnessed in Western populations over the last half century. In the late 50s, Hong Kong reported annual rates of notifications that surpassed 500 for every 100,000 in comparison to the UK that reported 70 to 120 for every 100,000. Since the 70s, the rates of notification from Hong Kong have reduced slowly reaching levels that are tenfold greater than the UK, that is, 100 for every 100,000 in comparison to 10 for every 100, 000. The rates of TB induced by HIV in Hong Kong have been relatively low to the current day (1). The occurrence of TB pleural effusions was until recently, assumed to be caused by a delayed reaction to hypersensitivity(2). With improvement of culture media, culturingM. tuberculosisis now possible for pleural tissue and pleural fluid in approximately 70% of patients and based on Koch's infection postulate, this is suggestive of a causal relationship (2). The likelihood of the pleural effusion as a paucibacillary mycobacterial infection manifestation inside the pleural space is high, and this is acquired from initial lesions in the parenchyma resulting in an immunological response which causes an increase in formation of pleural fluid and a decrease in the removal of pleura fluid (3) . Pleural takes second place after lymphatic involvement with reference to it being an extra pulmonary TB site, and occurs either in the reactivation or primary phases of the disease (4). The TB diagnosis gold standard in pleura detection ofM. tuberculosisin the pleural fluid, sputum, or pleural biopsy samples is done either by culture or microscopy or the demonstration of histological caseating granulomas present in the pleura in addition to presence of acid fast bacilli (AFB) (4,5). However, in settings of high burden of the disease, the diagnosis of TB is most times inferred in persons who have high level of ADA and exudates that are lymphocytic predominant (6). In this study conducted at a regional hospital in Hong Kong, the researchers aimed at evaluating the Lights criteria usefulness in differentiating exudates and transudates; and evaluating the Lights criteria usefulness in working together with other biochemical parameters. The prospective cohort study was conducted between August 2002and March 2003 at eh princess Margaret Hospital, Department of Medicine and Geriatrics. Role of candidate Diagnosis of pleural effusion TB is done through laboratory, histological, radiological, and clinical findings(7,8). There are other useful and modern techniques that are also used in diagnosing TB and these include: polymerase chain reaction(9), nucleic acid probes, gas chromatography, rapid culture (Bactec) (10), and adenosine deaminase (ADA) (11). Pleural effusion ranks second after TB lymphadeitis in the extra pulmonary tuberculosis that are most common. After history and informed consent was taken from all participating patients, they were taken through a series of clinical examinations that were detailed including lab examinations such as haemoglobin tests, WBC count, WBC differential counts, Random Blood Sugar, Erythrocyte Sedimentation Rate, RFTs, Urine Examination, S. Proteins, Tuberculin Test, and Sputum Examination were done. In addition, the patients were subjected to PA view plain chest X-ray before and after thorecocentesis to eliminate any possible complications that may be present. Further, ultrasound and films, as well as CT scans, were also done where it was deemed necessary. Analysis of pleural fluid was also done for total cell count, sugar, protein, differential cell count, ZN stain, Gram stain, ADA, and culture sensitivity. Clinical examination was the basis of diagnosis, and so too were the laboratory results and radiological examination data that was collected. The role played by the researcher included: The researcher was tasked with guiding participants on the requirements of the research and explaining to them their right to accede or deny participation. Those that accepted to participate were given consent forms to fill-in their demographic and other details prior to signing it. The researcher explained to the participants that no information collected during the duration of the research and related to the participant's personal interests would be shared. The researcher assured participants of the confidentiality and privacy of all details that the participants shared with the research team. The researcher was also involved in carrying out physical examination of the participants including measuring of weight, height and BMI; collection of blood samples and sending the same to the laboratory for examination; recording of clinical symptoms and any other relevant information garnered form the participants. Leadership role of the researcher Turner and Miller (12)assert that a leadership that is project-focused is necessary for the success of the project where managers need to focus on competent teams' maintenance. Coleman and MacNicol (13) suggest that managers can lead a successful project by ensuring that efficiency and effectiveness are maintained by the team members. Hence, the focus of project managers should be the utilization of innovative and flexible leadership styles that allow for ideas to be shared which is critical for the success of the project to be achieved (14). Further, the focus of project managers should also be on building teams effectively as well as motivating them through different strategies that will ensure that the different members of the team work in harmony to achieve the goals of the project(15). Chiocchio, Kelloway, and Hobbs (16) have defined team building as activities utilized by organizations or project managers to enhance social relations among team members or employee and which include tasks that are collaborative. In addition to these tasks, team building also involves diverse roles played by the team members and more, so roles that include tasks that are collaborative in nature. Team building plays a significant role in improvement of efficiency during the implementation phase of the project which is critical in ensuring the achievement of the set goals and objectives of the overall project. The researcher was tasked with planning for and executing team building activities. These involved short exercises that the team members were engaged in at the end of every week. The researcher ensured that all team members attended the weekly update meeting and it was during these meetings that team building that aimed at building cohesiveness was undertaken. These included 1)legoman (see Appendix 1): the goal of this game was to teach the participants how to communicate in an effective manner, strategize, as well as solve problems within the group. 2)Mine field: the activity was set to improve the trust and relationships between team members as well as enhance their communication skills to become more effective. 3)Win, Lose, or Draw: this activity aimed at enhancing cohesion in the team as well as reflection based on observed information. These were among the many other activities that the researcher organized for the team to enable them work together cohesively while building on s kills such as observation and logical thinking. Stakeholders involved in the study Individual patients: These were patients presenting with TB at the regional hospital in Hong Kong. The total number of participants were STATE HERE. The patients were recruited through the AE department of Medicine and Geriatrics, Princess Margaret Hospital. Inclusion criteria: Newly diagnosed pleural effusion evident on Chest X ray without previous known diagnosis of pleural effusion; and diagnostic tapping decision that was initiated by the in charge medical officer. Research Ethics Committee at the department of Medicine and Geriatrics, Princess Margaret Hospital: The ethics committee was tasked with revising, reviewing, and appraising the clinical investigations as the research involved patients. The goal was to protect the participants in the research and to ensure that they were accorded the right ethical treatment as participants. The committee paid keen attention to the process of patient consent (17, 18). In addition, the researchers followed the Guideline for Good Clinical Practice (GCP) International Conference on Harmonization's (ICH's) (ICH E6), which is a guideline that is closest in similarity to the U.S. regulations and consent on Food and Drug Administration's (FDA's (19). The ICH provides regulation that informed consent forms include statements on the extent to which individual identification records confidentiality is maintained. Data Monitoring Committees (DMCs): these had wide data quality assessment and monitoring responsibilities which focused on the benefit/risk ratio during the course of participant recruitment and subsequent follow up. Initially, the reviews were made by the DMC on the protocol used for the trial so as to gain details' familiarity without necessarily approving it. The DMC also carefully reviewed the draft DMC charter so as to effectively execute it as per the request of the researchers and sponsors and make any modification suggestions where necessary before they finally approved it. During the trial conduct, the DMC reviewed the interim data detailed report which was made by the intervention arm and which was unblinded to the assignment of the intervention. The review encompassed the progress of recruitment, base line data that gave a description of the characteristics of the participants, baseline data comparison, interventions or medications concomitance, data on adverse events, ser ious adverse events, data on the primary outcome, data on the secondary outcome, and a description on the subgroups that were pre-specified. Additionally, the DMC requested further analyses that were interim data motivated. The DMC maintained strict confidentiality of the interim data up to the point when the trial was completed. Throughout the entire trial conduct, the DMC were keen and looking out for signals that highlighted any inadequacies with regard to data quality and data integrity and often asked for follow up reports that would clarify any suspected inadequacies. The work of the DMC was completed with the researchers' last visit and asked the researchers and sponsors to share their views and results interpretations once the data files were completed. Although it was not the DMCs role to approve or review the research, the researchers solicited their input on the same. Disease advocacy organization: The Hong Kong Tuberculosis Chest and Heart Diseases Association was another stakeholder in the research study. The association was involved primarily to facilitate and promote participation in the study and also to raise money for the research funding. In addition, the association collaborated with the researchers on the design of the study and protocol review of the clinical research. The association was also involved in the development and management of the clinical research networks. This was in addition to incorporating the data collected with regard to the outcomes of the research (20). Furthermore, through online networks, the advocacy group acted as a conduit where in the event the participants wanted to express any frustrations with regard to miscommunication after the research was concluded, such participants would receive redress on the issues they raised (21). Funders and sponsors : the research was funded by (STATE HERE) with the grant sent to the sponsor (Princess Margaret Hospital). The recipient organization took up the role of sponsor. According to the ICH GCP, the sponsor is tasked with specific responsibilities such as ensuring the scientific robustness of the research, compliance of the research procedure with ethical and safety standards, and that the participants were adequately compensated in case they encountered any harm resulting as a direct consequence of their participation. The sponsor was also responsible for listing the research in a recognized register of researches The researchers: there were two types of researchers involved: the key figure in the research design as well as those participating in the interface; and the data analysis researchers who examined the processes and projects in which their involvement was not included. The first group of researcher played a significant role in the design of the trial, recruitment of participants, and accrual of data. University: the academic center provided the infrastructure to support the research .These infrastructure comprised of research coordinators, data managers, informatics and biostatistician support, and other relevant center expertise for research coordination. Goals of the Project As stated earlier, the study was conducted in 2002/2003. At that time, during the previous decade, the TB notification rate which was inclusive of bacteriologically unconfirmed clinically active cases and bacteriologically confirmed cases, reduced among populations aged 60 years and below, remained unchanged among populations aged between 60 and 69 years, and increased in populations aged 70 years and above. An increase in the bacteriologically confirmed cases rates (this included culture or smear that tested positive for Mycobacterium tuberculosis) was observed in the older age groups within the same time span. 31.9% of TB cases in 1989 were those recorded amongst populations aged 60 years and above and accounted for close to the total increase in TB prevalence in the previous decade. Patients from the populations with higher age groups presented with advanced disease forms during the time of diagnosis, in addition to higher comorbid illnesses proportions. These age groups also had higher rates of mortality in comparison to age groups that were younger. The key factors that contributed to the increased TB rates among the elderly were the equally increased longevity of population in Hong Kong (that is, people lived longer and those with TB that lived longer years tipped the scales on TB prevalence in Hong Kong) (22). The study in question that was conducted by the researchers, aimed at improving case detection and effective treatment of TB as these two were deemed to be key factors that were mandatory for better control of mycobacterial disease. The traditional methods using AFB smear and culture had the pitfalls of low sensitivity and long duration respectively. To overcome this shortcoming, the rapid detection method which utilizes adenosine deaminase was analyzed for efficiency and accuracy using pleural fluid in detection of TB. The study objectives were: To evaluate the usefulness of Lights criteria in differentiation of transudates and exudates. To evaluate the usefulness of Lights criteria in combinations with other biochemical parameters. Project plan for success A project can only be successful when a management plan is developed and executed in precision. The researchers embarked on developing a project plan which included arrangement details for the development and monitoring of every aspect of the research including steering committee servicing, as well as the committee tasked with independent data monitoring, but of more importance, how the day to day activities were to be run was planned in advanced and managed accordingly. A crucial element of the project plan was the inclusion of the statistical analysis robust plan; this was supported with considerable time and resources for the efficient conclusion of the research. The plan also gave a description of who was responsible for all activities that were essential such as recruitment of staff, management of staff, collaborative group communications, monitoring of recruitment, management of data, and promotion of the project through analysis, safety reporting, writing the reports, and trial results' dissemination. The project plan gave a brief but concise description of what the researchers wanted to achieve, resource utilization, and the time frame. It also included how monitoring of the project would be done and this ensured that the project was delivered as per the plan. The plan was reviewed and refined where it was deemed necessary, during the course of the research. The plan also included clear description of processes both within and without the office. The continuous reviewing of the plan was necessary to navigate unforeseeable incidences such as emerging evidence, natural disasters, accidents etc. Wise risk assessment, quality assurance tailored management systems, and monitoring that was done, were essential to the project as they optimized the project's potential in addition to providing evidence that was reliable (23). Difficulties Encountered Job descriptions: initially, there was overlapping of different posts' job descriptions. This created the potential for competition that was unhealthy or for individuals assuming that responsibility for a particular task belonged to another person; whereas there were those job descriptions that were too wide for completion to be feasible. The project management team revised the job descriptions and ensured that they were achievable, clear, and realistic Administrative work: this was very lengthy especially when getting ethical approval. The procedures, documentation, and necessary legislation took a lengthy period. This was mainly because of the bureaucracy that is involved in acquiring any permit from government run bodies. Monitor burnout was another challenge that was threatening to slow down the progress of the project. However, the weekly meetings that were characterized by one team building activity per week, as mentioned earlier, ensured that the project team were revitalized and rejuvenated in preparation for the work that awaited them. Resources deployed Desktop computers, laptops, and internet connection was provided for the project team members. The project heads were given an office to share while the rest of the team were given three offices to share. These offices were located at the Princess Margaret Hospital and the University respectively. In addition, the hospital availed three field personnel who were tasked with carrying out odd errands and also in assisting the patients during the trial with minor tasks such as walking them to and from the waiting area to the project offices, among other tasks. The grant money that was approved for the project was used in purchasing the experiment resources as well as paying research assistants. Laboratory personnel were also availed to the researchers and were responsible for analyzing all samples forwarded from the patients and giving back accurate and comprehensive results. Other resources included training material that was used in training sessions and weekly meetings as teaching aids. Leadership and management principles There were several leadership principles that the researcher utilized during the duration of the project and these included: Distribution of responsibility. As a leader, gaining of skills required practice and called for a considerable amount of lending of autonomy (24). The researcher opted to push power down the level, and also across the team, in order to empower all the team members in every level in making decisions pertaining to their level of working. By distributing responsibility, the researcher as a leader got the opportunity to see firsthand, what would happen by taking risks. This strategy also increased collective intelligence, resilience, and adaptability of the team over time, by tapping on the wisdom of those who are traditionally not included in the hierarchy of decision making. Honesty and openness with information. Transparency allows and cements conversation on the meaning of any information as well as improving the daily practices (25). If for example, productivity declines, it calls for reason to implement change. By coming to a better understanding of the issue at hand, it will call for the participation of the team. In this case, the researcher ensured that team members were able to talk honestly and openly about any data. Concealment of information was discouraged as concealment increases the temptation for data manipulation to take place. In such a scenario, the opportunity of being a strategic leader is lost. Even worse is that team members are implicitly informed that expediency is of more value as opposed to leading the project to higher performance levels (26). As a leader, the researcher was able to know and communicate to the team that the actual power that is contained in information is not sourced from hoarding it but rather, from utilizing it to discover and create new growth opportunities (26). Creation of multiple ways of ideas to be raised and tested. The researcher was aware that ideas presentation is critical and of more importance, was being capable of connecting the ideas to the way the project would create value (27). The researcher set up different ways through which the team members would bring their innovative ideas to the table and assisted them in learning how they can utilize their creativity to the maximum. This approach that the researcher opted to take differs from the traditional culture where channels of new ideas are limited to a single individual manager. In the event that a manager fails to perceive and accept the value that the idea holds, he/she may hinder it from progressing to the next level and which would in turn de-moralize the innovator. However, indiscriminate provision for people to raise ideas at whatever and whenever stage of the project, is counterproductive especially if much attention has not been given to the development of the same. Too many ideas presented in several repetitive forms may eventually be impossible to sort them and the best opportunities may not get recognized and acted upon. To avoid such a situation, the researcher created a variety of channels that allowed for thinking that was innovative. To do this, the researchers created a cross functional forum where the team members presented their ideas to others and which were tested against the reasoning of others. Managerial Model For this project, the researchers utilized the Blake Mouton Managerial Grid which is founded on two dimensions of behaviour and these are: Concern for people; and concern for results (28). The concern for people refers to the degree to which the team members' interests, needs, and personal development areas, are considered by a leader when considering the best approach to completing a task. Concern for results refers to the degree to which concrete objectives, high productivity, and organizational efficiency, are emphasized by a leader when determining the best approach to completing a task (28). Five leadership styles were defined by Blake and Mouton that were based on these two dimensions as seen in the diagram below. The managerial quadrant of the Blake Mouton model that was adopted in the duration of the project was the Team Management High Production/High People. According to the model, the most effective leadership style is Team management as it is reflective of a leader that is passionate with what he does while at the same time doing what is best for the team members working with and under him. Team mangers commit to the objectives and goals of the organization , offer motivation for subordinates, and work relentlessly at getting people to go beyond their comfort zone in delivering high results. The team leader accomplishes this while at the same time inspiring figures who oversee their teams. The researchers opted for this managerial style as it allowed for team members to feel empowered and valued and also because it enabled for the team members to be committed to achieving any goals that had been set. The researchers also prioritized both the needs of the project at hand as well as those of the team members. This was done by ensuring that the members understood the purpose of the project as well as involving them in determining the needs of the project. When the team members got committed to the project and had a stake in its success (29), the project's needs and those of the individuals coincided. This created an environment based on respect and trust which resulted in high motivation, satisfaction, as well as good results. Result of the project management The results of the project showed that the greatest activity of ADA occurs in the lymphoid tissues. ADA is also responsible for lymphoid cells differentiation (30). There are two different isoenzymes and these are ADA1 and ADA2, where the ADA2 was located in macrophages and monocytes (31). The total ADA levels were high in TB pleural effusion was as a result of the high ADA2 activity (32). A biological plausible explanation exists for the negative correlation that was seen between age and ADA, and this is attributed to immunosenescence. Evidence shows that immune function in the elderly is lost with age (33). LDH and pleural protein both indicate for pleural inflammation degree and hence, would be a conceivable presence of ADA production and more lymphocytes that are activated in the event of pleura inflammation that was greater. Previous studies have shown why there lacks a relationship between pleural cell count and ADA standard measures using ADA for determining its activity which may depend on pathological stimulus such as presence of TB or rapid proliferation of T lymphocytes as opposed to the amount of present lymphocytes. The final results concluded that the routine use of ADA in hisotpthologic diagnosis of TB would have reduced the number of treated cases based on the clinical data only. Management Lesson Learned The first lesson that the researcher learned was that understanding stakeholders is key for the success of the project (34). At the onset of the project, the researcher did not consider the impact that the project would have on the stakeholders and this resulted in the researcher encountering a road block. The project had executive support which the researcher assumed was sufficient for moving forward to the next stage which was implementation. However, it soon became obvious that there was one group of stakeholders who had not bought into the vision of the project. At first, the researcher did not take the time to gain an understanding of the concerns that the said group raised; the more the researcher attempted to push work through, the more the group resisted. The researcher finally took some time to address the issue that the group was concerned with and was able to construct a way their concerns would be addressed. The lesson that the researcher learned was that even when execut ive support is guaranteed, it is critical that a leader takes time to understand all the stakeholders that are part of the project. The second lesson learned was that constant communication needs to be ingrained in the duration of any project (35). By having constant communication, poor awareness of any situations will be avoided. Team members all had one thing in common: they wanted to ensure that they did a good job and that their individual part of the work was in sync with the entire project's aspects. Where situational awareness is lacking, the good intentions remain just that. The lack of communication can lead to a wrong interpretation with regard to failure of the project to be in sync. Where communication is poor among team members, the probability of misunderstanding of root causes becomes very high and the entire project can fail. The third lesson was strengthening the weaknesses. Pinpointing any weaknesses that emerge during the project will ensure that the entire project does not fail (36). By not knowing what the weaknesses are, it becomes impossible to prevent the downfall of the project. The researcher and the team held meetings once a week where the project was carefully examined to figure out which parts flowed slowly or were difficult, and strategized how the leadership and team members would improve on the weak areas. Multitasking reduces productivity. This was another valuable lesson learned by the researcher. Contrary to popular belief that multitasking increases one's output, a research done at Stanford University (37) showed that when a person focuses on one task at a time, such a person is able to do the task faster, better, and have every memory levels that are higher in comparison to people who are flooded with information from multiple sources all at once. The researcher resolved to use the Promodor technique to increase focus. In addition, the researcher soon realized that multitasking increased levels of stress (38). When stress levels are high, there is diminished cognition, hormone fluctuations, and sleep problems, among other health complications. Constant switching from one task to another can result in panic even as the brain attempts to adjust to all information that it is subjected to process (39). Limitations of the report Inability for the project to be managed with an unspecified budget. This was one of the biggest limitations to the incarnation of the project. Project management imposes a deadline and budget which is potential recipe for major problems. Most projects that finish within the scheduled time (which occurs very rarely) are often compromise with regard to quality. The resources availed for the project in question was not allowed to offer the best and completion the project with the specified time and budget became a real struggle. Another issue was dependence of the project on a functional management. The non-agile traditional project is very specific on the authority that the management team of the project have over the resources and in this case, the sponsor and funder had a final say on the way the resources were deployed and utilized. It is this stakeholders that had the real ownership of the resources and who had to make reports on how they were utilized, their performance, and also their respect and gratitude. The research team was constantly subjected to the decision of the sponsor and funder which was very limiting to the optimal success of the project. Another limitation of the project with regard to its management is following a methodology that was exclusive which was very restrictive. In Project management, only one methodology is applicable at anyone given time which restricts any form of flexibility. Even when there is a better and more effective method that arises in the course of a project, the initial methodology cannot be altered. This restriction limited and undermined the potential of the project including those of the resources. Conclusion Project management in healthcare research is different from organizational based management. In researches involving human subjects, there are many unforeseeable situations which the traditional structured way of carrying out a project cannot accommodate. The need to have a flexible methodology hen carrying out such researches is critical for the successful completion of a project. In addition, having specified budget with minimal to no bureaucracy to resource access is critical for any research. There needs to be a new and all inclusive project management model that can encompass the issues that the researchers faced along with any other issues not mentioned herein. References 1)WHO, 2015. Global Tuberculosis Report. (Retrieved on 29th April, 2017). A large percentage of the world's TB burden occurs among the Asian populations 2) Vorster, M. J., Allwood, B. W., Diacon, A. 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