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RESEARCH FORUM-- Protocol and Procedures

C. Michael Schuch, CPO, FISPO

ABSTRACT

A research protocol is a detailed plan that guides the conduct and execution of a research study or investigation. The protocol provides a list of steps or procedures for a specific experimental construct or design. The protocol and its related procedures are a vital requirement for any research project. This article will address the essentials, goals and objectives of the research protocol.

Introduction

Most definitions of research include reference to the adjective "systematic." Webster's dictionary defines systematic as: "methodical in procedure or plan, (investigation) (scholar)," and "marked by thoroughness" (1). This adjective and its definitions are most appropriate to formulating a research protocol and related procedures. The research protocol, or proposal, is the written plan of a formal study or investigation. It is the design of a research study that outlines the problem, proposed procedures of data collection and analyses, and presentation of the investigation's resources (2). An organized plan of the proposed research, the research protocol serves the same function as a blueprint (3). In addition to being an invaluable tool for finding research funding, the protocol provides structure and organization to the study, detailing the numerous procedures required to meet a given study's objectives and goals.

Protocol: The Research Proposal

In a review of literature on research protocol, the number of issues addressed in the protocol ranged from six to 21 (2,4-8). Many of these issues are interrelated, allowing the author to easily categorize them in order of occurrence.

Title, Subject and Objectives

Variously referred to as title (2,4), the research question (6,7,8), the problem statement (4), purposes (4) or objectives (2,5), the author proposes the importance of a title followed by a brief statement of clarification. The words in the title should be concise but sufficiently precise to provide subject information and, more specifically, the question or problem to be addressed-for example, "The Use of Wiliner's Instrument of Spinal Stabilization as a Good Predictor of the Outcome of Orthotic Treatment for Chronic Low Back Pain." Willner's instrument is the device, chronic low back pain is the pathology and the outcome predictor is to be investigated (9,10). The study also may be titled to align it more closely to the funding source (4).

Regarding objectives, Currier states in his book, Elements of Research in Physical Therapy (2) :

If a single objective is to be achieved by the research, a succinct statement of the aim or purpose of the study should be stated. If more than one objective is to be achieved, the objectives should be listed in outline form to reduce wording and to catch the reviewer's attention. The objectives must be specific and listing them in order is helpful to the researcher and reviewer for establishing priorities of effort and emphasis.

The problem and objective must be delineated so that the plan of the study will enable data to be collected and analyzed in such fashion that answers to questions or tested hypotheses are possible.

A stated hypothesis or question in this section would take the place of a problem statement. The remainder of the proposal is built from the foundation provided by the stated problem and the objective of the study.

Significance

In this section, the researcher must justify the research and related objectives. The discussion must address such questions as: What is known about the question or problem presented in the title and objectives? Why is the question or problem important? What kinds of answers will be provided by the study? What is the study expected to contribute? Will the contributions be problem solving or additions to a body of knowledge? What is the ultimate goal and significance of the research, and who might benefit from the results?

Currier addresses the issue of significance succinctly (2):

The investigator should provide supporting statements for the practical or theoretical importance of the research and state whether the proposed study is a replication of former research, a step in advancing knowledge (area of little or much research), or whether the problem will open up new areas of research.

Background

Other research in the area of interest is presented and discussed here. If the investigator has undertaken any related pilot studies, these must be presented in light of the current proposal. An extensive literature search should be pursued with related research identified. Previous research identified should be critically analyzed with its flaws pointed out in the discussion. The investigator should use the literature and existing related research to demonstrate that either his or her proposal is indeed original, or how it will complement and add to similar research.

Investigators and Facilities

The investigators' names, titles, credentials, positions and institutional/company affiliations should be provided, beginning with the principal investigator and proceeding in order of importance and contribution to the study. The principal facility should be identified as well as any cooperating facilities. A curriculum vitae for each investigator should be provided in the proposal's appendix.

Methods and Procedures

In the reviewed literature, this section either included or was referred to as design (5,6,8), type of study (7), statistical issues (6), data analysis (8), population (5,7), subjects (6), variables (6,7), and case and control definition and selection (8). Essentially, all of these concepts should be addressed in the "methods and procedures" section, which is the principal and most detailed part of the proposal.

The study population should be identified, including source and description of subjects (age, sex, physical or mental status), sample size, methods of assigning subjects to groups, and the welfare of the subjects (safeguards, consent forms).

Procedures should be discussed in detail with literature justification of procedural choices. A description of how the study will be conducted should include the variables (dependent, independent, confounding), controls, measurement, tools, equipment, techniques and conditions. The type of measuring instrument used should be described, including rationale for its selection, validity and reliability data (2).

The study type and design should be described. Procedures as described above depend somewhat on study type and design. If the study is descriptive, determine whether the design is cross-sectional (measured on a single occasion) or longitudinal (measured over a period of time). Is the descriptive research retrospective or prospective? Are data gathered by observation, interview, questionnaire or survey? Campbell and Stanley discuss 16 experimental designs; Lunsford describes six experimental designs and includes prosthetic and orthotic examples (11). The specifics of experimental design should be provided. Discussion should include internal and external validity based on the research design.

To gain meaningful results from a research effort, data must be collected and then analyzed correctly (12). Procedures for collecting and analyzing the data must be given. The statistical design used in analyzing the data should be stated by name. Currier provides the best advice concerning data and analysis (2):

Data should never be collected and then some statistical design found to fit the data;fit the data to the design. The full information contained in the data will not be obtained unless the researcher plans in advance the kinds of information he wishes to gather through selection of the types of tests, the test routines and the appropriate methods of analyses. Once data are collected the researcher is limited to the choice of appropriate analyses because statistical designs are only appropriate to specific data-gathering designs. The planning and selecting of techniques for analyses of data are procedural and ethical issues which must follow rules of scientific inquiry.

Finally, if statistical consultants are used for development of the proposal or analysis of data, this should be indicated in this section of the protocol.

Resources

Resources include investigators, collaborators, support personnel, subjects, time, space or facilities, and equipment and tools. The availability, or lack thereof, regarding any of these resources should be presented and described in this section. Generally, the more available resources, the stronger the proposal. Establish a schedule of the major phases of the study and their expected completion dates. (Time schedules are further discussed in the section on organization and work plan.)

Budget

Research projects always involve costs. Even internally funded studies have inherent costs although they may be hidden or absorbed. Every effort should be made to account for all costs regardless of how the cost is resolved. Externally funded projects require detailed budgets that account for both the direct and indirect costs of the research. Direct costs include equipment, supplies, salaries and benefits of the investigators compared to indirect costs, which include administrative costs, overhead and salaries and benefits of support personnel.

Organization and Work Plan

Organization of the study could be construed as two meanings, the organization of the personnel involved and the organization of the details of the actual study. For this reason, the author chose to use a work plan to relate to the study's details.

The organization of the personnel and even the department or company involved in the study is useful information, especially for study administration. Committees and subcommittees, if any, should be identified and discussed. Personnel organization might include an organizational chart designating responsibility and authority lines.

The work plan details when tasks will be accomplished and by whom, assisting the study's administration. All phases from planning through implementation and dissemination must be included in the work plan (4). Table 1 provides an example of a work plan.

Dissemination

How will the study findings be disseminated? Plans for conference presentations and, more importantly, journal articles should be presented in this section.

Human Subjects Protection

Perhaps one of the most important considerations in any study is the protection and concern for human subjects. To protect subjects from mental and physical harm, researchers must:

  • design sound studies in which dangers to subjects are minimized
  • secure the informed consent of participants
  • implement the research with care and consideration for participants' safety (4)

To ensure the protection, safety and informed consent of study subjects, review committees are established. Federal regulations since 1971 specify that research conducted with government funds be subject to review by a committee concerned with the participants' rights and welfare (4). A commonly used committee of this sort is the institutional review board (IRB). Domholdt states (4):

The purpose of the IRB is to review research conducted under the auspices of the institution to ensure that the rights of human subjects are protected. These rights are protected when research designs minimize risks to subjects, when subject selection and assignment are equitable, when researchers have made provisions for the confidentiality of information, and when subjects are provided with the information they need to make an informed decision about whether to participate in the research. The IRB accomplishes its purpose through regular meetings during which it reviews written proposals submitted in a format specified by the IRB.

Informed consent is a courtesy and required offering from the researcher to a potential study participant. It provides information that the potential participant needs to make an informed decision about whether to participate in the study. Signing the consent form indicates the subjects' agreement to participate and an understanding of the consequences of participation. The consent form's language should be understandable by the typical subject recruited for study participation. Table 2 illustrates elements required in the informed consent form (2).

Appendices

Items that serve as support documents to other aspects of the protocol belong in the appendices. Examples include, but are not limited to, curriculum vitae, signed informed consent forms, detailed diagrams of protocol procedures and organizational flow charts.

Conclusion

The research protocol and its accompanying procedures provide the road map by which the research project is guided and administered. It must contain adequate detail and cover the issues discussed within this article. The goal is to clearly communicate research intentions and procedures to all reviewers and participants.


C. MICHAEL SCHUCH, CPO, FISPO, is an assistant clinical professor and director, department of prosthetics and orthotics, Duke University Medical Center, Box 3885, Durham, NC 27710; (919) 684-6890. He is also the editor of the Journal of Prosthetics and Orthotics.

References:

  1. Webster's ninth new collegiate dictionary. Merriam-Webster Inc., Publishers. Springfield, Mass. 1986.
  2. Currier DP. Elements of research in physical therapy. 3rd ed. Baltimore: Williams & Wilkins, 1990:54-78.
  3. Treece EW, Treece JW Jr. Elements of research in nursing. 3rd ed. St. Louis: C.V. Mosby Co.: 1982.
  4. Domholdt E. Physical therapy research: principles and applications. Philadelphia: W.B. Saunders Co., Harcourt Brace Jovanovich Inc.: 1993:327-40.
  5. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 2nd ed. Littleton, Mass.: PSG Publishing Co. Inc.: 1985: 7-8.
  6. Hulley SB, Cummings, SR. Designing clinical research, an epidemiologic approach. Baltimore: Williams & Wilkins, 1992: 1-4.
  7. Payton OD. Research: the validation of clinical practice. Philadelphia: TA. Davis Co., 1973:149.
  8. Schlesselman JJ. Case-control studies: design, conduct, analysis. New York: Oxford University Press, 1982;101-4.
  9. Gavin TM, Patwardhan AG. Getting started in prostheticorthotic research. JPO 1993;5:4: 113.
  10. Gavin TM, et.al. Preliminary results of orthotic treatment for chronic low back pain. JPO 1993;5:1:25-9.
  11. Lunsford TR. Types of clinical studies. JPO 1993;5:4: 107.
  12. Lunsford BR. Statistics: screening and data summary. JPO 1993; 5:4:125.