- Email: [email protected]
Outcomes research
a lobectomy or a pneumonectomy and develops a bronchopleural fistula, which acts as a conduit from the pharynx to the pleural space with repeated inoculation of organisms into the pleural space through the open bronchus. Finally, any procedure or injury that violates the pleural space such as a thoracentesis or insertion of a chest tube or a catheter can be the source of an empyema. The outcome of developing an empyema as a result of one of the above causes is serious and can have long-term consequences. It consists of infected fluid in the pleural space with an inflammatory reaction that produces pus in the pleural space. This empyema causes an outpouring of fibrin and fibroblasts that produce septa and multiple loculations. Finally, the inflammatory peel and scar entraps the lung and prevents its expansion and causes restrictive pulmonary function and reduces gas exchange. After understanding the serious consequences of allowing this process to continue undrained and untreated, surgeons have developed a number of methods to interrupt this process in its early stages to prevent the long-term destruction of the lung itself. The initial treatment of a patient who has an empyema is antibiotics and drainage. Although thoracentesis can provide fluid for culture to identify the organisms to confirm the diagnosis and guide the choice of the antibiotics, repeated thoracenteses for drainage are seldom (⬍10%) effective in eliminating the empyema. The evaluation of the progress of the empyema has been stressed in the abstract reviews. The primary evaluation tool is the routine chest x-ray with PA and lateral views that will reveal undrained fluid in the chest, air fluid levels, and multiple sites of fluid collection. As documented in the abstract by Velmahos et al, a CT scan is required to determine accurately the location of the fluid as either in the lung or in the pleural space. Surgeons and radiologists were incorrect approximately 50% of the time in deciding the location of the fluid from a chest x-ray. In addition, the abstract by Cassina et al documented that ultrasound was twice (80%) as accurate as CT (40%) in staging the empyema and measuring the peel thickness on the lung. Ultrasound provides a way of measuring the depth and width of the lung peel. If the peel encases the lung and prevents its
expansion, the patient should have a thoracotomy and decortication rather than some lesser procedure. The 2 main principles are to treat the infection and to drain the pleural space and expand the lung to obliterate the intrapleural cavities between the lung and the pleura and thereby eliminate the empyema. If the chest tube drainage with or without other catheter drainage of the empyema cavities is placed on a closed suction drainage for 7 to 14 days, the empyema should be markedly improved. If there is not significant improvement (⬎60%), the patient would be a candidate for a video-assisted thoracoscopy (VATS). This minimally invasive procedure is done in the operating room with trocar holes through the chest wall for the scope and instruments, collapse of the lung, and direct visualization of the pleural cavity to identify pus, fibrin, and fibrous tissue. The fibropurulent material is then irrigated and aspirated and manually removed from the pleural cavity to clear the multiple loculi of pus and expand the lung to the parietal pleura to obliterate all of the cavities between the lung and the pleura. The success rate with VATS is approximately 80% or more. The remaining patients who do not respond to this minimally invasive technique for treating the empyema will require a thoracotomy and direct removal of the peel around the lung and the cavities that are trapping the lung. This decortication is the gold standard treatment for empyema that does not respond to more conservative treatments. The main goal in managing an empyema is to treat the empyema aggressively in its early stages, to prevent the development of a thick peel around the lung that contains fibrin and scar. Although most of the empyemas can be treated with more conservative measures, using VATS is especially helpful because it provides a method of treatment that is more effective than chest tube drainage, suction, and antibiotics, but it is not as invasive as a thoracotomy for decortication. L. BEATY PEMBERTON, MD Department of Surgery Truman Medical Center University of Missouri Kansas City Kansas City, Missouri
General
Outcomes Research Guest Reviewer: James F. FitzGerald, MD FOLLOW-UP OF ELDERLY PATIENTS AFTER CARDIAC SURGERY AND INTENSIVE CARE UNIT ADMISSION, 1991 TO 1995.
McHugh GJ, Havill JH, Armistead SH, Ullal RR, Fayers TM. N Z Med J 1997;110:432– 435. Objective
Design
202
To examine the outcome of cardiac surgery and intensive care admission in elderly cardiac surgery patients. Chart review and postal questionnaire. CURRENT SURGERY
•
Volume 56 / Numbers 4/5 • May/June 1999
Waikato Hospital, Hamilton, New Zealand.
Setting
Clinical records of all cardiac patients 75 years old or older admitted to the intensive care unit between 1991 and 1995 were reviewed. Eighty of the 97 patients identified were alive. These patients were sent a postal questionnaire evaluating quality of life and cardiac-related symptom control. Specifically, information was collected concerning functional class and symptom control, domicile type and dependency, quality of life, and desire for repeat surgery if indicated.
Participants
Functional status improved postoperatively and cardioactive medications fell by 0.7 drug per patient. Of the survivors, 27% became more dependent, as defined by domicile type. However, responses to the perceived quality of life scale (0 ⫽ complete dissatisfaction, 100 ⫽ complete satisfaction) had a mean of 77 for the limited group who gave numerical responses to all 11 items on the scale. Values ranged from lows of 44 in response to contribution to the community and 53 to leisure activities outside work, to highs of 87 for happiness, 89 for respect from others, 87 for meaning and purpose of the patient’s life, and 86 for work or retirement status.
Results
Surviving elderly patients experienced a favorable outcome in terms of symptom control and quality of life, and mortality rates were acceptably low.
Conclusions
REVIEWER COMMENTS. Although there were intergroup comparisons (old, 75 to 79 years; and very old, 80 years and older), there were no comparisons with the rest of the cardiac surgery population. However, this information does provide true outcomes research in a sensitive area (ie, utilizing expensive surgery and intensive care unit resources in an elderly population). As patients seem highly satisfied, data from other groups likely to be under high scrutiny should certainly be amassed to help defend our belief that even mortality rate data have never supported excluding elderly patients from access to high-cost care. IMPROVEMENT IN QUALITY OF LIFE MEASURES AFTER LAPAROSCOPIC ANTIREFLUX SURGERY.
Trus TL, Laycock WS, Waring JP, Branum GD, Hunter JG. Ann Surg 1999;229:331–336. To compare the quality of life in patients with gastroesophageal reflux “well controlled medically” with those who have residual symptoms and to determine whether laparoscopic antireflux surgery significantly altered quality of life.
Objective
Prospective, nonrandomized study.
Design
Department of Surgery, Division of Gastrointestinal Surgery, and Department of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia.
Setting
A total of 345 patients referred to the Emory Swallowing Center who underwent laparoscopic antireflux surgery completed at least 1 questionnaire. After confirmation of gastroesophageal reflux disease, patients were considered for surgery if their symptoms persisted despite medical therapy or if their symptoms were eliminated by medical therapy but the patient wished to discontinue medical therapy. Two hundred ninety patients completed preoperative questionnaires, 223 completed a questionnaire 6 weeks postoperatively, and 50 completed the same questionnaire 1 year later. A subgroup of 70 patients was divided into 2 groups before surgery on the basis of their response to standard medical therapy.
Participants
All 8 SF-36 scores improved significantly 6 weeks after surgery compared with preoperative levels, and this difference remained significantly improved 1 year later. The postoperative levels improved to those established for a healthy population. In the subgroup of 70 patients, 76% underwent surgery for symptoms refractory to medical treatment, and 24% were well controlled on medical therapy but requested surgery in order to discontinue medical treatment. Other than role physical scores, there were no significant differences between the preoperative evaluations of the 2 groups. Postoperatively, there were no differences between the 2 groups.
Results
Laparoscopic antireflux surgery is an effective therapy for patients with gastroesophageal reflux and may be more effective than medical therapy at improving quality of life.
Conclusions
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REVIEWER COMMENTS. This study used a non– disease-specific questionnaire (Short Form 36, or SF-36) to assess patients’ quality of life after antireflux surgery. A disease-specific questionnaire was administered preoperatively and used to divide the subgroup of 70 patients into a responsive and a nonresponsive group. The authors did not describe the validity of this instrument, and it was not administered postoperatively. Also, 2 surgical procedures were employed, and it would have been interesting to see a comparison between the 2 of them. Because all the patients in the study requested surgery, no valid comparison can be made between surgical and medical therapy. In addition, the use of United States norms for comparison with postoperative values may be biased if these 2 populations are not matched demographically. The authors acknowledged these last 2 limitations and plan to have follow-up studies. RANDOMISED CONTROLLED TRIAL OF LAPAROSCOPIC VERSUS OPEN MESH REPAIR FOR INGUINAL HERNIA: OUTCOME AND COST.
Wellwood J, Sculpher MJ, Stoker D, et al. BMJ 1998;317:103–110. Objective
To compare the outcome and cost of tension-free open mesh hernioplasty with transabdominal preperitoneal laparoscopic hernia repair.
Design
Randomized, controlled trial.
Setting
Whipps Cross Hospital and North Middlesex Hospital, London, England.
Participants
Four hundred patients with a diagnosis of groin hernias seen at 1 of the 2 acute general hospitals between May 1995 and December 1996.
Results
The open group had a higher percentage of same-day discharges and lower pain scores while the local anesthetic was still effective. The laparoscopic group had significantly lower pain scores for the remainder of the first 2 weeks. In addition, the laparoscopic group showed a significantly greater improvement in 5 of the 8 Short Form 36 (SF-36) scores when compared with the open group. The laparoscopic group also showed a significantly shorter return to normal for all the activities considered. The cost of the laparoscopic repair was significantly greater than that of the open repair.
Conclusions
Laparoscopic hernia repair has considerable short-term clinical advantages after discharge compared with open mesh hernioplasty, although it was more expensive. REVIEWER COMMENTS. This study represents the true “power” of outcomes research. If you consider only the typical “outcomes” (percent same-day discharge, cost, immediate postoperative pain), you would conclude that the open repair is superior to the laparoscopic technique. However, as these data show, these end points do not accurately reflect the overall impact on the patients’ quality of life. Given this information, patients may reach an entirely different conclusion. In addition, although the hospital costs may be higher for laparoscopic repair, the overall cost to society in terms of lost work days, etc, may be less.
SUMMARY In the late 1980’s, 3 forces converged on medicine to fuel the outcomes research movement: rising costs, increasing competition, and significant regional variation in health care practices. The medical establishment was fearful that efforts to contain costs would have a negative effect on the quality of health care. In addition, with a renewed sense of competition among third-party payers, there was an increasing demand to compare outcomes and quality. Finally, several studies showed significant regional variation in the use of medical procedures and resources. These differences could not be accounted for by differences in patient populations, and they raised questions concerning cost and quality of care.1 There was a lack of information in the medical literature to answer any of these concerns. In response to the growing need for outcomes information, the federal government passed the Patient Outcome Re-
204
search Act in 1989. This act requires the Secretary of Health and Human Services to establish a broad-based, patientcentered outcomes research program. By congressional mandate, the effectiveness of a specific treatment will be determined by an assessment of the patient’s functional status, general well-being, and satisfaction with the medical care provided.2 Outcomes research represents a fundamental change in the way we measure the success or failure of the care given to patients. Traditionally, medicine has defined health as the lack of injury or disease. Outcomes research challenges us to go beyond this simple definition and accept health as defined by the World Health Organization: a state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity. This definition translates into a health-related quality of life and an evaluation of all aspects of our lives, including where we live, how we live, and how we play.2
CURRENT SURGERY
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Volume 56 / Numbers 4/5 • May/June 1999
For the purposes of analysis, health-related quality of life is typically broken down into several areas or domains: physical, psychological, and social. Each of these domains has 2 important dimensions: the objective assessment of functioning and the subjective perception of health. Obviously, it is possible for 2 individuals to have the same objective assessment of health while having vastly different subjective perceptions.3 In order to measure this “subjective” or “soft” data in a scientific manner, researchers have developed tools or questionnaires that allow them to collect and compare valid and reliable information concerning quality of life issues. Valid refers to the concept that the results pertain directly to the desired attribute or characteristic being measured. Reliable indicates that the results are consistent and reproducible.3 The SF-36 and SF-12 are examples of these tools. Just as in any other scientific publication, outcomes research papers should explicitly describe the rationale, objectives, methods, results, and conclusions of a study. A study that evaluates quality of life must begin with a clear definition of health and quality of life and state which domains of health-related quality of life will be addressed. It must support the selection of particular domains and the omission of others. In the Methods section, at least 5 areas of background information should be documented or referenced: 1. Summary of the original instrument.
changes. When interpreting the data in the Discussion section, the authors must recognize that 3 major factors can influence the interpretation of health status scoring: timing, patient characteristics, and measurement properties. Patient characteristics can be further subdivided into 4 major components: sociodemographics, past or baseline functional status and well-being, disease-specific severity, and comorbidity.2 Each of these components should be addressed by the study. Until recently, the medical literature has ignored a patient’s assessment of various treatment options and measured the success of an intervention based on purely clinical criteria, such as patency rates and mortality. Whereas most physicians recognize the ethical importance of allowing individual patients to choose which treatment is best for them, they did not have any scientifically obtained information about the overall impact of a given treatment on their patients’ lives. Instead, they had to rely on anecdotal cases and their own biases when recommending one care plan over another. Outcomes research enables physicians to see diseases and treatments through the eyes of their patients. It allows them to provide their patients with accurate information regarding medical decisions and therefore to truly inform them before they consent to a given course of action. As medical costs increase and technology races forward, outcomes research restores a human face to medicine and refocuses it where it should have been all along— on the patient. JAMES F. FITZGERALD, MD UConn Integrated Residency in General Surgery University of Connecticut Health Center Farmington, Connecticut
2. The original reliability and validity of the instrument. 3. Use of the instrument in a similar population. 4. Support for any changes and proof that revisions achieve the same standard of reliability and validity. 5. Choice of recall period and interval administration. If the Methods section describes changes in the instrument, the Results section should include the impact of these
References 1. Epstein AM. The outcomes movement: will it get us where we want to go? N Engl J Med 1990;323:266 –270. 2. Bungay KM, Ware JE Jr. Measuring and monitoring health-related quality of life. Curr Concepts 1993 April 3–39. 3. Testa MA, Simonson DC. Current concepts: assessment of qualityof-life outcomes. N Engl J Med 1996;334:835– 840.
General
Minimally Invasive Surgery in Infants Guest Reviewer: David R. Farley, MD ANESTHETIC CONSIDERATIONS FOR LAPAROSCOPY IN CHILDREN.
Tobias JD. Semin Laparosc Surg 1998;5:60 – 66. To clarify the specific anesthetic implications for laparoscopic procedures in neonates, infants, and children.
Objective
Review article covering anesthetic considerations for laparoscopic and minimally invasive surgery (MIS) in children.
Design
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expansion, the patient should have a thoracotomy and decortication rather than some lesser procedure. The 2 main principles are to treat the infection and to drain the pleural space and expand the lung to obliterate the intrapleural cavities between the lung and the pleura and thereby eliminate the empyema. If the chest tube drainage with or without other catheter drainage of the empyema cavities is placed on a closed suction drainage for 7 to 14 days, the empyema should be markedly improved. If there is not significant improvement (⬎60%), the patient would be a candidate for a video-assisted thoracoscopy (VATS). This minimally invasive procedure is done in the operating room with trocar holes through the chest wall for the scope and instruments, collapse of the lung, and direct visualization of the pleural cavity to identify pus, fibrin, and fibrous tissue. The fibropurulent material is then irrigated and aspirated and manually removed from the pleural cavity to clear the multiple loculi of pus and expand the lung to the parietal pleura to obliterate all of the cavities between the lung and the pleura. The success rate with VATS is approximately 80% or more. The remaining patients who do not respond to this minimally invasive technique for treating the empyema will require a thoracotomy and direct removal of the peel around the lung and the cavities that are trapping the lung. This decortication is the gold standard treatment for empyema that does not respond to more conservative treatments. The main goal in managing an empyema is to treat the empyema aggressively in its early stages, to prevent the development of a thick peel around the lung that contains fibrin and scar. Although most of the empyemas can be treated with more conservative measures, using VATS is especially helpful because it provides a method of treatment that is more effective than chest tube drainage, suction, and antibiotics, but it is not as invasive as a thoracotomy for decortication. L. BEATY PEMBERTON, MD Department of Surgery Truman Medical Center University of Missouri Kansas City Kansas City, Missouri
General
Outcomes Research Guest Reviewer: James F. FitzGerald, MD FOLLOW-UP OF ELDERLY PATIENTS AFTER CARDIAC SURGERY AND INTENSIVE CARE UNIT ADMISSION, 1991 TO 1995.
McHugh GJ, Havill JH, Armistead SH, Ullal RR, Fayers TM. N Z Med J 1997;110:432– 435. Objective
Design
202
To examine the outcome of cardiac surgery and intensive care admission in elderly cardiac surgery patients. Chart review and postal questionnaire. CURRENT SURGERY
•
Volume 56 / Numbers 4/5 • May/June 1999
Waikato Hospital, Hamilton, New Zealand.
Setting
Clinical records of all cardiac patients 75 years old or older admitted to the intensive care unit between 1991 and 1995 were reviewed. Eighty of the 97 patients identified were alive. These patients were sent a postal questionnaire evaluating quality of life and cardiac-related symptom control. Specifically, information was collected concerning functional class and symptom control, domicile type and dependency, quality of life, and desire for repeat surgery if indicated.
Participants
Functional status improved postoperatively and cardioactive medications fell by 0.7 drug per patient. Of the survivors, 27% became more dependent, as defined by domicile type. However, responses to the perceived quality of life scale (0 ⫽ complete dissatisfaction, 100 ⫽ complete satisfaction) had a mean of 77 for the limited group who gave numerical responses to all 11 items on the scale. Values ranged from lows of 44 in response to contribution to the community and 53 to leisure activities outside work, to highs of 87 for happiness, 89 for respect from others, 87 for meaning and purpose of the patient’s life, and 86 for work or retirement status.
Results
Surviving elderly patients experienced a favorable outcome in terms of symptom control and quality of life, and mortality rates were acceptably low.
Conclusions
REVIEWER COMMENTS. Although there were intergroup comparisons (old, 75 to 79 years; and very old, 80 years and older), there were no comparisons with the rest of the cardiac surgery population. However, this information does provide true outcomes research in a sensitive area (ie, utilizing expensive surgery and intensive care unit resources in an elderly population). As patients seem highly satisfied, data from other groups likely to be under high scrutiny should certainly be amassed to help defend our belief that even mortality rate data have never supported excluding elderly patients from access to high-cost care. IMPROVEMENT IN QUALITY OF LIFE MEASURES AFTER LAPAROSCOPIC ANTIREFLUX SURGERY.
Trus TL, Laycock WS, Waring JP, Branum GD, Hunter JG. Ann Surg 1999;229:331–336. To compare the quality of life in patients with gastroesophageal reflux “well controlled medically” with those who have residual symptoms and to determine whether laparoscopic antireflux surgery significantly altered quality of life.
Objective
Prospective, nonrandomized study.
Design
Department of Surgery, Division of Gastrointestinal Surgery, and Department of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia.
Setting
A total of 345 patients referred to the Emory Swallowing Center who underwent laparoscopic antireflux surgery completed at least 1 questionnaire. After confirmation of gastroesophageal reflux disease, patients were considered for surgery if their symptoms persisted despite medical therapy or if their symptoms were eliminated by medical therapy but the patient wished to discontinue medical therapy. Two hundred ninety patients completed preoperative questionnaires, 223 completed a questionnaire 6 weeks postoperatively, and 50 completed the same questionnaire 1 year later. A subgroup of 70 patients was divided into 2 groups before surgery on the basis of their response to standard medical therapy.
Participants
All 8 SF-36 scores improved significantly 6 weeks after surgery compared with preoperative levels, and this difference remained significantly improved 1 year later. The postoperative levels improved to those established for a healthy population. In the subgroup of 70 patients, 76% underwent surgery for symptoms refractory to medical treatment, and 24% were well controlled on medical therapy but requested surgery in order to discontinue medical treatment. Other than role physical scores, there were no significant differences between the preoperative evaluations of the 2 groups. Postoperatively, there were no differences between the 2 groups.
Results
Laparoscopic antireflux surgery is an effective therapy for patients with gastroesophageal reflux and may be more effective than medical therapy at improving quality of life.
Conclusions
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Volume 56 / Numbers 4/5 • May/June 1999
203
REVIEWER COMMENTS. This study used a non– disease-specific questionnaire (Short Form 36, or SF-36) to assess patients’ quality of life after antireflux surgery. A disease-specific questionnaire was administered preoperatively and used to divide the subgroup of 70 patients into a responsive and a nonresponsive group. The authors did not describe the validity of this instrument, and it was not administered postoperatively. Also, 2 surgical procedures were employed, and it would have been interesting to see a comparison between the 2 of them. Because all the patients in the study requested surgery, no valid comparison can be made between surgical and medical therapy. In addition, the use of United States norms for comparison with postoperative values may be biased if these 2 populations are not matched demographically. The authors acknowledged these last 2 limitations and plan to have follow-up studies. RANDOMISED CONTROLLED TRIAL OF LAPAROSCOPIC VERSUS OPEN MESH REPAIR FOR INGUINAL HERNIA: OUTCOME AND COST.
Wellwood J, Sculpher MJ, Stoker D, et al. BMJ 1998;317:103–110. Objective
To compare the outcome and cost of tension-free open mesh hernioplasty with transabdominal preperitoneal laparoscopic hernia repair.
Design
Randomized, controlled trial.
Setting
Whipps Cross Hospital and North Middlesex Hospital, London, England.
Participants
Four hundred patients with a diagnosis of groin hernias seen at 1 of the 2 acute general hospitals between May 1995 and December 1996.
Results
The open group had a higher percentage of same-day discharges and lower pain scores while the local anesthetic was still effective. The laparoscopic group had significantly lower pain scores for the remainder of the first 2 weeks. In addition, the laparoscopic group showed a significantly greater improvement in 5 of the 8 Short Form 36 (SF-36) scores when compared with the open group. The laparoscopic group also showed a significantly shorter return to normal for all the activities considered. The cost of the laparoscopic repair was significantly greater than that of the open repair.
Conclusions
Laparoscopic hernia repair has considerable short-term clinical advantages after discharge compared with open mesh hernioplasty, although it was more expensive. REVIEWER COMMENTS. This study represents the true “power” of outcomes research. If you consider only the typical “outcomes” (percent same-day discharge, cost, immediate postoperative pain), you would conclude that the open repair is superior to the laparoscopic technique. However, as these data show, these end points do not accurately reflect the overall impact on the patients’ quality of life. Given this information, patients may reach an entirely different conclusion. In addition, although the hospital costs may be higher for laparoscopic repair, the overall cost to society in terms of lost work days, etc, may be less.
SUMMARY In the late 1980’s, 3 forces converged on medicine to fuel the outcomes research movement: rising costs, increasing competition, and significant regional variation in health care practices. The medical establishment was fearful that efforts to contain costs would have a negative effect on the quality of health care. In addition, with a renewed sense of competition among third-party payers, there was an increasing demand to compare outcomes and quality. Finally, several studies showed significant regional variation in the use of medical procedures and resources. These differences could not be accounted for by differences in patient populations, and they raised questions concerning cost and quality of care.1 There was a lack of information in the medical literature to answer any of these concerns. In response to the growing need for outcomes information, the federal government passed the Patient Outcome Re-
204
search Act in 1989. This act requires the Secretary of Health and Human Services to establish a broad-based, patientcentered outcomes research program. By congressional mandate, the effectiveness of a specific treatment will be determined by an assessment of the patient’s functional status, general well-being, and satisfaction with the medical care provided.2 Outcomes research represents a fundamental change in the way we measure the success or failure of the care given to patients. Traditionally, medicine has defined health as the lack of injury or disease. Outcomes research challenges us to go beyond this simple definition and accept health as defined by the World Health Organization: a state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity. This definition translates into a health-related quality of life and an evaluation of all aspects of our lives, including where we live, how we live, and how we play.2
CURRENT SURGERY
•
Volume 56 / Numbers 4/5 • May/June 1999
For the purposes of analysis, health-related quality of life is typically broken down into several areas or domains: physical, psychological, and social. Each of these domains has 2 important dimensions: the objective assessment of functioning and the subjective perception of health. Obviously, it is possible for 2 individuals to have the same objective assessment of health while having vastly different subjective perceptions.3 In order to measure this “subjective” or “soft” data in a scientific manner, researchers have developed tools or questionnaires that allow them to collect and compare valid and reliable information concerning quality of life issues. Valid refers to the concept that the results pertain directly to the desired attribute or characteristic being measured. Reliable indicates that the results are consistent and reproducible.3 The SF-36 and SF-12 are examples of these tools. Just as in any other scientific publication, outcomes research papers should explicitly describe the rationale, objectives, methods, results, and conclusions of a study. A study that evaluates quality of life must begin with a clear definition of health and quality of life and state which domains of health-related quality of life will be addressed. It must support the selection of particular domains and the omission of others. In the Methods section, at least 5 areas of background information should be documented or referenced: 1. Summary of the original instrument.
changes. When interpreting the data in the Discussion section, the authors must recognize that 3 major factors can influence the interpretation of health status scoring: timing, patient characteristics, and measurement properties. Patient characteristics can be further subdivided into 4 major components: sociodemographics, past or baseline functional status and well-being, disease-specific severity, and comorbidity.2 Each of these components should be addressed by the study. Until recently, the medical literature has ignored a patient’s assessment of various treatment options and measured the success of an intervention based on purely clinical criteria, such as patency rates and mortality. Whereas most physicians recognize the ethical importance of allowing individual patients to choose which treatment is best for them, they did not have any scientifically obtained information about the overall impact of a given treatment on their patients’ lives. Instead, they had to rely on anecdotal cases and their own biases when recommending one care plan over another. Outcomes research enables physicians to see diseases and treatments through the eyes of their patients. It allows them to provide their patients with accurate information regarding medical decisions and therefore to truly inform them before they consent to a given course of action. As medical costs increase and technology races forward, outcomes research restores a human face to medicine and refocuses it where it should have been all along— on the patient. JAMES F. FITZGERALD, MD UConn Integrated Residency in General Surgery University of Connecticut Health Center Farmington, Connecticut
2. The original reliability and validity of the instrument. 3. Use of the instrument in a similar population. 4. Support for any changes and proof that revisions achieve the same standard of reliability and validity. 5. Choice of recall period and interval administration. If the Methods section describes changes in the instrument, the Results section should include the impact of these
References 1. Epstein AM. The outcomes movement: will it get us where we want to go? N Engl J Med 1990;323:266 –270. 2. Bungay KM, Ware JE Jr. Measuring and monitoring health-related quality of life. Curr Concepts 1993 April 3–39. 3. Testa MA, Simonson DC. Current concepts: assessment of qualityof-life outcomes. N Engl J Med 1996;334:835– 840.
General
Minimally Invasive Surgery in Infants Guest Reviewer: David R. Farley, MD ANESTHETIC CONSIDERATIONS FOR LAPAROSCOPY IN CHILDREN.
Tobias JD. Semin Laparosc Surg 1998;5:60 – 66. To clarify the specific anesthetic implications for laparoscopic procedures in neonates, infants, and children.
Objective
Review article covering anesthetic considerations for laparoscopic and minimally invasive surgery (MIS) in children.
Design
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