Peripheral Nerve Regeneration A Follow-Up Study of 3,656 World War II Injuries (1957) / Chapter Skim
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Organization and Conduct of Study
Organization and Conduct of Study
Pages 1-30
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(56) in 1946, prominent reference was made to the desirability of a study of peripheral nerve injuries based on the Army Registry, and, when the NRC accepted from the Armed Forces and the Veterans Administration (VA)
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The chairman, at the same time Peripheral Nerve Consultant to the VA, assumed responsibility for the sampling plan, the allocation of patients for study, the development of procedures for facilitating access to patients, the provision of medical records covering the original injury and its treatment, assisting the centers in establishing a standard protocol for the follow-up examination, and for the final collection, analysis, and publication of the basic data obtained. 7 Under the Committee there was established the Follow-up Agency as a records and statistical organization to provide operating assistance to investigators participating in the entire VA-NRC follow-up program.
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At the Chicago center, for instance, where most patients were hospitalized for 4 or 5 days while their studies were being made, primary responsibility for different elements of the examination was assigned in terms of sensory examination, motor examination, electrical studies, sympathetic function studies, photography, and a final surgical evaluation and interpretation of regeneration by the responsible investigator. In other centers patients were examined on an
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Allocations of patients for study were made by the chairman through the NRC Follow-up Agency, and at the same time photostatic copies of all relevant medical records were provided to all but the Chicago center, where necessary data were abstracted from original records in VA claims folders. Allocations were made on standard NRC forms bearing the latest address obtainable by the Follow-up Agency, usually through the local VA office.
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The secondary purpose of this study, and one of considerable immediate value, is that of discovering nerve injuries among veterans of all services that still require remedial measures." The specific objectives which dictated the sampling plan, however, may be listed as follows: 1. To describe the final level of regeneration in representative cases of complete suture, neurolysis, and nerve graft.
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Rosters of bona fide peripheral nerve injuries were acquired on the basis of the above interests and these merit careful description. Rosters of Complete Lesions Primarily Roster #39, contributed by James C
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D., of Philadelphia, Pa., and consisting of 1,220 men with peripheral nerve injuries seen by him at Cushing General Hospital. The roster was used primarily as a source of incomplete lesions.
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Radial Cook County. Sciatic Cook County.
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Men from other rosters were allocated solely on the basis of propinquity to the nearest center and do not contribute sutures to the representative sample; they do, however, contribute neurolyses to the representative sample. Figure 1 provides a rough diagram of these various interrelations.
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Men were allocated on the basis of a single nerve injury, and if a man had more than a single injured nerve the interest in him depended upon the roster to which he belonged. When a man was examined, of course, all his injured nerves were taken into account.
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There were in all 42 roster 68 men with such sutures or grafts, of which 18 were found on the Registry. The 24 cases excluded from the Registry were then compared with the 18 overlapping cases, the points of comparison being rank, month of injury, place of injury, place of final treatment, evacuation home, coding of first, second, and third diagnoses, location of first diagnosis, operations performed, final result of injury, disposition from hospital, and total time spent in hospital.
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7, 179 Final allocation to all five centers 2, 714 Later dropped from study 52 Ineligible 50 Follow-up data received too late 2 Used in final study 2* 662 Brachial plexus or C, or C, 108 Other injuries 2, 554 Examined 1, 920 Record follow-up 207 No follow-up 427 The 2,554 men had, in all, 3,656 peripheral nerve injuries, and table 3 provides a summary of their distribution by nerve, definitive reparative procedure, and role in the analysis.
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In this study, where so many of the observations are objective in nature, the interference of compensation considerations would have been minimal. The British follow-up studies on peripheral nerves have been accomplished 13
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As a final step, a few VA regional offices were asked to write to a fraction of the men who refused even under urging by Red Cross workers, and their response was rather favorable. The aggregate yield of all these efforts was 75 percent of the allocation.
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Letter From Columbia University College of Physicians and Surgeons^ Peripheral Nerve Study Center €01 u mfc ifl Qbtfbtrfrtp Columbia University is making a medical survey of peripheral nerve injuries* such as you received during the war.
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would urge further surgery, fear of pain associated with the examination, loss of time from work, belief that nothing beneficial could be done for oneself, feeling that any necessary information could be obtained from the VA regional office to which the man had returned periodically, concern about possibly adverse effect upon compensation status, and generalized aversion to "guinea-pig" role. Often such interviews suggested that a social worker might prove helpful to a man in further efforts to obtain compensation or treatment from the VA.
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The Injury. Including the identity of each injured nerve, the type of injury, evidence for injury, site of lesion, causative agent, degree of paralysis and sensory deficit at time of operation (for incomplete lesions only)
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Preparation of the interim report (88) , entailed by this request, which presented an integrated plan for the management of peripheral nerve injuries, served further to stimulate specific thinking about the content of any final report on the fruits of the study as a whole.
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Associated arterial injury. Presence of chronic infection delaying repair.
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Overall functional evaluation. Has occupation changed because of nerve injury?
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is discussed in connection with the presentation of appropriate data. There are, of course, two dangers associated with center variation.
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The complex nature of the sampling plan made it desirable to restrict the study of bias to the most homogeneous, representative cases. Accordingly, the tables on characteristics of injury and treatment were confined to lesions treated by complete suture, of men drawn from the Army Peripheral Nerve Registry, and of men resident within the sampling area defined for the representative sample.
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are associated with the chance of follow-up. To appreciate the import of these findings it is necessary to anticipate the results of the followup study by noting the relationship between the bias of follow-up and the apparent effect of each characteristic upon end result, as follows: Follow-up Performance percentage at follow-up Low lesions Low High.
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The New York allocation of complete lesions on the ulnar nerve, falling within the representative cross section and having no associated nerve lesions, was sampled at random to provide 31 nonexamined men and 26 examined. The VA claims folders contain all examinations made by VA examiners in connection with the adjudication of claims for compensation, and the chairman of the study group undertook to assess each case on the basis of two of the most summary scales employed in the follow-up study: (1)
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Table 6. -- Comparison of Examined and Unexamined Pure Ulnar Lesions as to British Classification of Motor Recovery Evaluated From VA Claims Folders, Representative Sutures From New York Allocation British motor classification Examined Not examined Total At most proximal muscles acting against gravity, no return of power in intrinsics Number of lesions Proximal muscles against gravity, and perceptible contraction in intrinsics 4 20 8 24 21 Return of function in both proximal and distal muscles such that all important muscles act against resistance, or better 13 9 3 12 Total 26 31 57 Table 7. -- Comparison of Examined and Unexamined Pure Ulnar Nerve Lesions as to Overall Functional Recovery Evaluated From VA Claims Folders, Representative Sutures From New York Allocation Overall functional recovery (percent) Examined Not examined Total Number of lesions 60 or less 8 17 10 4 25 17 15 70 7 11 80 or more ...
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.... 100.0 100.0 Number of men studied 26 57 Table 9. -- Comparison of Biased and Unbiased Estimates of Overall Functional Recovery Following Ulnar Nerve Suture, Based on Study of VA Claims Folders Biased (examined men)
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In seeking to determine whether a factor, e. g., presence of associated bone injury, has some influence upon, say, motor recovery, one may approach the analysis via seven separate nerves, asking the same question about each, and being content to learn, for example, that there seems to be evidence of an effect in certain nerves but not in others.
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Early pilot work on the content of the follow-up examination, with more recognition of the need for uniformity of concepts and examining procedures, would have permitted the drafting of the statistical code before the main series of examinations began and would have otherwise hastened and facilitated the successful conclusion of the study. More adequate advance planning would undoubtedly have enabled the investigators to approach their objectives on the basis of a smaller volume of observations per case, and to enter upon the final analysis in a leisurely and experimental fashion more in keeping with the complex interrelations among the variables under study.
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pilot study should then be subjected to a searching analysis by the intended author of each chapter of the final report, who, after consultation with the statistician, would prepare the examination procedure and coding system to be adopted. Another improvement would be the provision of a fulltime deputy, working closely with the chairman, who could make frequent visits of several days to each center, during which he would participate actively in the examination and coding of patients.
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