On a daily basis, practitioners in orthotics and prosthetics collect hundreds of pieces of data that can be integrated into clinical research studies. A well-written research proposal guides investigators through the research process. It describes questions or hypotheses to be studied, the purpose of the study, a review of the literature, how the study will be conducted and how data will be analyzed. The proposal also may include estimates of equipment, supplies, and human and financial resources. The process of research is relevant to the orthotic and prosthetic practitioner's roles as clinician, manager and educator. It should not disrupt the daily routine but should facilitate practice and improve models for service delivery.
While the process of research is complex, it need not be complicated. Every day practitioners collect hundreds of pieces of data that can be effectively integrated into clinical research studies. The process of research should not disrupt the practitioner's daily routine but should facilitate his or her ability to practice. Data collected during this process can go far in developing a body of knowledge from which to study principles and theories to support the profession.
Orthotics and prosthetics (O&P) practitioners must conduct research to validate clinical outcomes and provide a basis for the efficacy of orthotic and prosthetic intervention. Research findings often lead to an improvement in service delivery and quality of care. The process of research helps the practitioner/researcher develop skills in organization, time management, negotiation, critical thinking, problem solving and written communication. This process also is relevant to the O&P practitioner's roles as clinician, manager and educator.
Those who believe research is not a part of clinical practice and should be conducted by someone else are mistaken. No one else understands the intricacies of orthotics or prosthetics as well as practitioners in the clinic. While an advanced degree might be helpful in learning the research process, it is not imperative.
Writing a research proposal aids the researcher in his or her thought process and ensures research questions or hypotheses are relevant, the literature review is representative of existing studies, and the research design is appropriate for addressing questions or hypotheses. A well-written research proposal guides investigators through the process. A good proposal also leads to an easier final report after the research has been completed.
The research proposal might be part of a grant application or request for proposal when a researcher applies for funding outside of his or her institution. A review board at the researcher's institution or at the funding source examines the research proposal before approving the project to help ensure the research will be conducted in an ethical, morally responsible manner.
The first step in developing a research project is writing a research proposal: a written description of a project that has yet to be done. The research proposal describes questions or hypotheses to be studied, the purpose of the study, a review of existing literature and plans for how the study will be conducted. The proposal also may include a budget-an estimate of necessary equipment, supplies, and human and financial resources.
Before beginning the research proposal, the researcher must obtain appropriate forms. If the research is to be conducted within the practitioner's own institution, an institutional review board or office of human investigations may have to review and approve any research proposal.
Before writing the proposal, researchers must find out how often the review committee meets and its submission deadlines as well as the date the final decision will be announced. The researcher should collect any necessary forms from the institutional review board or investigations committee and check to see how many copies of the proposal must be submitted.
If funding is being sought outside of the researcher's institution, that source must be contacted for its particular forms. Research proposals must conform to a particular manual of style; so researchers must investigate which style is preferred and obtain a copy of the prescribed guidelines.
Regardless of the source, it is important to determine the history of research that has been conducted as well as funding preferences of the sponsoring institution. Organizations may review proposals at set times. When must proposals be submitted? How long does the review process take? How many proposals generally are received in any one funding cycle? How many projects are funded? What types of projects have been funded recently? What are the current research priorities? Are funds available for developing programs, or does the organization prefer funding studies related to clinical outcomes, efficacy of treatment or student research? What is the average amount of funding given? How are funds distributed? When must the study be completed? What common mistakes are made in completing the proposal forms? Armed with this information, the researcher can personalize the research proposal to fit the requirements of any institution.
The title of the research proposal must be concise yet long enough to give the reader an idea of the sample and variables involved in the study. The title might be written once the research proposal is completed, after reviewing the purpose of the study and methodology sections. The power of a title cannot be underestimated (1). It entices and engages someone to read the abstract and, subsequently, the study. The title should give information without being convoluted or wordy. The title "Upper-Limb Orthotics" is too general, but even the longer title "Using Cable-Driven Tenodeses Versus Wrist-Driven Tenodeses" gives no idea who the sample is or the real purpose of the study. A more specific title could be "Efficacy of Cable-Driven Tenodeses Versus Wrist-Driven Tenodeses with C5 Quadriplegics." This title tells the reader the sample is comprised of C5 quadriplegics, and the study will compare the efficacy of using a wrist-driven to a cable-driven tenodesis.
An abstract summarizes a study, enabling the reader to grasp its essence (2). It usually has a predetermined number of words as defined by the prescribed manual of style. An average abstract might contain no more than 150 words. Therefore, it must be concise while stressing the important aspects of the study.
Found at the beginning of the research proposal, the abstract generally includes a brief description of the study's statement of purpose, statement of the problem, number or types of subjects in the sample, method of study, method of data analysis, and significant results or interesting conclusions.
The next section of the research proposal is the introduction, which sets the stage for the problem to be researched. The introduction must express the rationale for the study in an unbiased, objective manner. It is not a lengthy section and may contain only three or four paragraphs.
The introduction should first discuss the general issues and then outline a more specific problem. Imagine the beginning of the introduction is the widest opening of a funnel. The researcher describes the topic to be studied in broad terms. Where are these issues or problems experienced? Who is affected? What are national or international implications and statistics? Enough information should be provided so the reader gets a sense of the scope and prevalence of the problem.
The end of the introduction represents the smallest opening of the funnel. By this time the researcher has focused on a specific aspect of the topic. What is the relevance of this study to a specific group of individuals? What is the relevance of identified issues to O&P practitioners? How will this study affect the O&P practitioner as manager, educator, clinician and researcher?
The problem statement, which reflects problems emanating from the broad picture described in the introduction, should be written in the past tense. It may be only two or three paragraphs in length.
This section must be focused and concise and should describe what precipitated the need for the study or why the problem is of concern. Have others studied it? If so, their findings must be mentioned briefly prior to discussing the differences between the proposed study and previous efforts. Making the proposed study unique and distinct will capture a reader's attention. Including opinions and facts can be an effective way of substantiating the problem.
The problem statement provides a reason for conducting the study. Once the reader has read the problem statement, he or she should agree with the researcher that this problem is significant and worthy of investigation (2).
The purpose of the study is a succinct statement describing exactly what the study will accomplish. It must follow logically from the rationale presented in the introduction and problem statement.
For example, a prosthetist might be interested in what influences a client's choice of upper-limb terminal devices. Is it occupation, age, gender, use or cosmesis? The statement of purpose might be written as follows: "This study attempts to determine what single factor most influences the choice of the primary terminal device used by clients between the ages of 30 and 50 years having a unilateral transhumeral amputation on their dominant side."
Funding agencies often require specific objectives or aims for a research study. Such objectives might highlight that the study adds to the body of knowledge in a certain content area; tests or applies a particular theory; establishes reliability or validity of an instrument; or identifies a relationship between variables that will form the basis for making treatment planning decisions (1).
A research proposal will have either one or more hypotheses or one or more research questions. In general, a study should contain no more than three or four research hypotheses or questions since more than that can become unwieldy. Everything written in the research proposal must relate directly to one of the hypotheses (or research questions) so the study remains clearly focused on its purpose. Any research question or hypothesis generated must allow researchers to conduct inquiries in a moral and ethical manner.
A hypothesis is a statement of the expected relationship between the variables under study. A hypothesis generally is used if the research study is more experimental or explanatory than descriptive in nature. If the content under study can be either proven or disproved, then use of a hypothesis is more appropriate than use of research questions. A hypothesis should contain the variables under study and associate them in a way supported by the literature (2).
The hypothesis states the expected result and how changing one variable will affect the other. This may result in a cause-effect relationship (i.e., A causes B to happen) or in a correlation (i.e., if A happens, then B is more [or less] likely to happen) (2). The null hypothesis does not belong in the text unless the research study is designed specifically to show that no relationship exists between variables (1).
For example, a study to examine energy expended by 30year-old paraplegics using the reciprocal gait orthosis might test the following null hypothesis:
There will be no significant difference between subjects after walking 100 feet on each of the following dependent variables: 1) pulse-rate increase from baseline to cessation of walking; 2) time taken to complete the walk; and 3) lesion level.
The purpose of another study might be to explore the efficacy of two different seating orthoses in preventing decubitus ulcers. Some sample hypotheses might include the following:
When researchers want to either prove or disprove something, hypotheses often are used.
Research questions often are used in descriptive studies. Data are generated, offering depth and breadth from which to consider answering the research questions. Research questions must be relevant and of interest to both the researcher and a reasonable number of subjects. In answering research questions researchers must make contributions beyond existing literature to practice or health policy. As researchers explore one set of research questions, new questions surface, providing a direction for future research.
In a study identifying benchmarks by which to describe quality care provided at an O&P facility, the following research questions might be asked:
Research questions are used when the researcher sets out to gather information to describe a phenomenon. Research questions can build on themselves and relate to one another. They seek to inform the reader about an issue, clarify what already has been studied or add to the body of existing literature by seeking new information.
A thorough review of the literature is essential in justifying and supporting the design of an effective research study. By reviewing existing literature, researchers learn what others already have done and how and why studies were conducted.
Reviewing the literature might even reveal a proposed study already has been completed! If so, the literature may provide a basis for revising the proposed study by extending parts of previous studies. Perhaps someone tried to pursue the proposed study topic but ran into many problems. Reading about such problems in the literature can help subsequent researchers refine or redefine research questions, the sample or instrumentation to avoid those same problems. Studying results of previous studies, however significant or insignificant, can be quite helpful in coming up with research ideas in the first place.
A literature review also provides a rationale for the proposed study by placing it next to previous studies. Providing a context for the proposed study will help readers determine how to perceive it (2). Finally, the literature review should give the study a theoretical and historical frame of reference to help readers determine its potential significance and contribution (2).
The literature review is not an exercise in creative writing; it is a methodical interweaving of existing resources that supports the purpose of the study. It must be organized in a logical, sequential, methodical manner. Since it summarizes current writings it generally is written in the present tense. Subheadings should define content, and transitional sentences should facilitate flow from section to section.
Subheadings in a literature review for a study about orthoses used postoperatively in clients with hip replacements might include the following:
When searching for studies to fit into each section, it is important to use current references (from the past five years). If landmark studies were published prior to the past five years, they may be included to provide a historical or theoretical perspective to the proposed study. Care must be taken not to use resources that simply advertise a product, vendor or business. References and studies cited should be taken from scholarly work. Several appropriate articles or cases may be reported in the popular literature; these should be used sparingly.
One common mistake in citing references within the literature review is to report them as distinct entries, beginning each paragraph or sentence with the author followed by a summary of the study. For example, "Nolinske identified the three most and least important functions of a mentoring relationship for the mentor. Horatio found that mentors help socialize proteges into an organization. Gertrude's study showed mentors gave proteges a network of resources." Written this way, the literature review becomes a boring list of separate resources. By beginning each sentence with proper nouns, the reader's focus shifts from concepts, which should be primary information, to names of researchers, which should be secondary information.
How much more interesting and appropriate it is to focus on the concepts presented in each resource while the reference is discretely placed in parentheses or designated in a footnote, depending on the style being followed. In this way, concepts and issues can be clustered or compared to strengthen or refute a position taken by the researcher for the purpose of the study. For example, "Three important functions of a mentoring relationship are to socialize proteges into an organization, provide them with resources and explain department politics (Horatio...; Gertrude...; Nolinske...)."
Phrasing the literature review in this way facilitates flow among concepts that enables the reader to easily grasp key similarities or differences represented by many sources. This means researchers must have an intimate knowledge of their subject and its component parts. Researchers must be able to present their resources, dissect them, reorganize them and integrate the information to support the need for their proposed study. It also means a thorough review of the literature has been done.
A thorough literature review does not mean a lengthy literature review. The number of references depends entirely on the topic under study and how much has been written about it. The literature review is complete when it has presented a representative sampling of information, tightly written and well-organized, about the topic that documents findings of previous studies, implications for orthotics and prosthetics, and indications for subsequent study. If writing a case study, where an expanded or lengthy literature review might be inappropriate, the researcher must include a representative sampling of all facts and opinions about the topic under study as compiled from an exhaustive literature search. A general rule is a literature review is relatively complete when the researcher starts seeing the same references over and over again, even in secondary sources.
Many beginning researchers review only literature with an obvious connection to the proposed study. It is important to broaden the scope by looking at the subject from many points of view. Reviewing studies from the medical, anthropological, educational, social, psychological and engineering sciences vantage points may add perspective and depth to the study (2).
Imagine key study hypotheses or questions are at the hub of a bicycle wheel. The spokes, each angled in different directions, represent multiple resources with obvious and less obvious connection to the proposed study. Each spoke carries a different point of view yet is just as necessary to support the structure, connecting concepts from one body of literature to another through the central hub of the proposed study.
References should be sought through reference librarians, online networks, card catalogs, reference books, government documents, journal indices/abstracts, computer searches, and recognized experts in the field. As sources are compiled, researchers must constantly check to see whether each source relates directly to any one research hypothesis or question. If not, that source should be eliminated. This will result in a focused, purposeful representation of the literature.
The section describing the methods used to conduct the study is the most important part of the research proposal. Since it describes a proposed study, it is presented in the future tense in the research proposal and rewritten in the past tense once the study is completed and submitted for publication.
The methodology section must supply enough detail so a reader could replicate the study. It is not a creative process but must be well-organized and clear in meaning. This section generally consists of four subheadings that describe subjects, instruments, data collection or procedures, and methods of data analysis.
The subjects participating in the study must be thoroughly described. Who are they? Were they a sample of convenience, or was randomization involved in their selection? Researchers must be sure the sample describes the population at large. Where are they from? Researchers must explicitly define criteria used for inclusion and exclusion of subjects in the study. Subjects might be included in or excluded from the study based on such variables as age, gender, diagnosis or medical condition, height, weight, hand dominance, race, cognition, occupation, or functional ability.
Once subjects have been selected, how much have they been told about the purpose and content of the study? Have subjects, or their parents, signed a consent form? A description of procedures for how the researcher plans to maintain confidentiality or anonymity of the subjects must be included.
The instrumentation or materials section can include a description of equipment, questionnaires, evaluation forms or measurement instruments used to collect data in the study. Instruments must be described in detail (including manufacturers, brand or trade names, and model numbers as appropriate). The researcher must describe methods used to determine the validity of the instrument. How is the researcher certain the instrument measures what it was intended to measure?
Depending on how many researchers collect data, the process of establishing intra-rater or inter-rater reliability must be described. This helps assure the reader that data are collected consistently over time. If a pilot study was conducted, researchers should describe any changes made to the instrument(s) as a result. Copies of any instruments usually are included in the appendix to the research proposal.
When writing the procedures or data collection section of the research proposal, researchers must ask themselves who, what, where, when, why and how. This section describes in detail what will be done in the study from start to finish. The data collection section is an essential part of the research proposal since procedures used to conduct the study must be appropriate for the hypotheses or research questions and clearly reflect the purpose of the study. If a pilot study is to be conducted, it should be described in this section.
Other questions that must be answered in the data collection section include the following: Who will be conducting the study? How many people will be involved in data collection? What are their backgrounds or credentials? Those collecting the data must be described, just as those participating in the study have been described. Procedures undertaken to establish reliability and validity of instruments and researchers must be delineated. Where is the study being implemented, and why? What is the proposed timeline of the study?
How are data being collected? If a questionnaire is used, what response rate is acceptable, and what methods will be used to increase responses to that point? Will a reminder postcard be sent, or an entire packet of materials? A detailed account of the process must be made from start to finish.
Researchers also must describe efforts to obtain demographics or pertinent information about nonrespondents. This becomes important information to have when discussing the generalizability of results.
This section should contain a description of both qualitative and quantitative methods used to record, store, reduce, manipulate, analyze and interpret the data collected during the study. The level of statistical significance must be stated in this section. Were the methods used to analyze data appropriate for the study's hypothesis or research questions? Reviewers of the research proposal will determine whether said quantitative and qualitative methods are appropriate given the study design. Have the researchers given appropriate rationale for each method of analysis used in the study? Are methods of analysis and their rationale presented in clear, understandable terms appropriate to the level of the intended audience? Uncommon statistical tests should be described and referenced in this section. Statistical software also should be identified.
By translating technical, statistical jargon into conversational terms, the researcher helps promote a more
thorough understanding of the study's intentions and results.
Since few researchers also are statisticians, it is a good idea to engage a statistician at this point in the process. The statistician will review the method of analysis section and make sure it relates appropriately to each section of the research proposal.
The reference section should contain only references cited in the research proposal. It should not include every resource consulted in preparation for its writing. The reference list should follow the format defined in the prescribed manual of style.
Appendices are supporting documents found at the end of the research proposal but cited, when discussed, in the text. The material in the appendix should represent the entire data collection process and anything else someone might find helpful in replicating the study.
The appendix might include a copy of the cover letter requesting participation in the pilot study, the pilot study instrument, a cover letter for the study, a questionnaire, questions for a telephone interview and/or a sample consent form. The format for the appendices will vary according to the prescribed manual of style.
If the research proposal will be submitted as part of a grant application, additional information must be attached to the research proposal. Some examples of these attachments include a profile of investigators, a budget or a list of existing resources to be used in the study (1).
A biographical summary of each primary investigator or researcher may include information about an individual's education, professional experience, previous research projects and publications.
Each funding source has different requirements for primary investigators on the projects it funds. Associations supporting new researchers might require that a more experienced researcher supervise and work with the less experienced person. Other funding sources may be more or less stringent (1).
Analyzing the expense of a project in a financial plan always is a useful exercise because it can reveal how feasible the project is-in time, real dollars or hidden costs. While most researchers calculate a budget only if requested, it is something everyone should do. Researchers often pick up errors or inconsistencies in previous thinking while looking at the project from this more detached point of view.
Researchers seeking funding may find it necessary to describe existing resources to be used to support the project. Existing resources might include space, supplies, machinery, laboratories, fabrication area, clinical sites, equipment, books, overhead and information management support. It is important to document these resources and the percentage of time they will be dedicated to the project. This can show institutional support for the research project and may be viewed as goodwill by the granting agency.
An academic research proposal consists of an introduction, problem statement, statement of purpose, hypotheses or research questions, literature review, methodology (which contains sections describing the sample, instrumentation, data collection and methods of analysis), references and appendices. Once complete, the research proposal usually is submitted to an institutional review board or office of human investigations, where a committee will review the proposal to make sure all aspects of the research project have been seriously and thoroughly considered.
The research proposal is a document describing a project that has yet to be conducted. "The researcher's thinking begins with the present, acknowledges and draws from the past, but primarily leads to the future" (1).
The tone of the research proposal should be realistic, scholarly and compelling. It must engage readers and convince them of the serious need for this research by the qualified team proposing the project.
TERRIE NOLINSKE, PHD, OTR/L, CO, is president of TNI: Consultants in Professional Development, 930 North Blvd., Oak Park, IL 60301; (708) 386-1331. Nolinske also is associate professor in the department of occupational therapy and assistant professor of health systems management at Rush University, 1743 W Harrison St., Chicago, IL 60612; (312) 942-6988