What Are the Minimum Clinically Important Differences in SF-36 Scores in Patients with Orthopaedic Oncologic Conditions?

BACKGROUND: The SF-36 is widely used to evaluate the health-related quality of life of patients with musculoskeletal tumors. The minimum clinically important difference (MCID) is useful for interpreting changes in functional scores because it defines the smallest change each patient may perceive. Since the MCID is influenced by the population characteristics, MCIDs of the SF-36 should be defined to reflect the specific conditions of orthopaedic oncology patients. QUESTIONS/PURPOSES: (1) What is the MCID of SF-36 physical component summary (PCS) and mental component summary (MCS) scores in patients with orthopaedic oncologic conditions when calculated with distribution-based methods? (2) What is the MCID of SF-36 PCS and MCS scores in patients with orthopaedic oncologic conditions when calculated by anchor-based methods? METHODS: Of all 960 patients who underwent surgery from 1999 to 2005, 32% (310) of patients who underwent musculoskeletal oncologic surgery and completed two surveys during postoperative follow-up were reviewed. We evaluated a dataset that ended in 2005, completing follow-up of data accrued as part of the cooperative effort between the American Academy of Orthopaedic Surgeons and the Council of Musculoskeletal Specialty Societies to create patient reported quality of life instruments for lower extremity conditions. This effort, started in 1994 was validated and widely accepted by its publication in 2004. We believe the findings from this period are still relevant today because (1) this critical information has never been available for clinicians and researchers to distinguish real differences in outcome among orthopaedic oncology patients, (2) the SF-36 continues to be the best validated and widely used instrument to assess health-related quality of life, and unfortunately (3) there has been no significant change in outcome for oncology patients over the intervening years. SF-36 PCS and MCS are aggregates of the eight scale scores specific to physical and mental dimension (scores range from 0 to 100, with higher scores representing better health). Their responsiveness has been shown postoperatively for several surgical procedures (such as, colorectal surgery). Two different methods were used to calculate the MCID: the distribution-based method, which was based on half the SD of the change in score and standard error of the measurement at baseline, and anchor-based, in which a receiver operating characteristic (ROC) curve analysis was performed. The anchor-based method uses a plain-language question to ask patients how their individual conditions changed when compared with the previous survey. Answer choices were "much better," "somewhat better," "about the same," "somewhat worse," or "much worse." The ROC curve-derived MCIDs were defined as the change in scores from baseline, with sensitivity and specificity to detect differences in patients who stated their outcome was, about the same and those who stated their status was somewhat better or somewhat worse. This approach is based on each patient's perception. It considers that the definition of MCID is the minimal difference each patient can perceive as meaningful. RESULTS: Using the distribution-based method, we found that the MCIDs of the PCS and MCS were 5 and 5 by half the SD, and 6 and 5 by standard error of the measurement. In the anchor-based method, the MCIDs of the PCS and MCS for improvement/deterioration were 4 (area under the curve, 0.82)/-2 (area under the curve, 0.79) and 4 (area under the curve, 0.72)/ (area under the curve, 0.68), respectively. CONCLUSIONS: Since both anchor-based and distribution-based MCID estimates of the SF-36 in patients with musculoskeletal tumors were so similar, we have confidence in the estimates we made, which were about 5 points for both the PCS and the MCS subscales of the SF-36. This suggests that interventions improving SF-36 by less than that amount are unlikely to be perceived by patients as clinically important. Therefore, those interventions may not justify exposing patients to risk, cost, or inconvenience. When applying new interventions to orthopaedic oncology patients going forward, it will be important to consider these MCIDs for evaluation purposes. LEVEL OF EVIDENCE: Level III, diagnostic study.

Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Long-term women-reported quality of life after radical cystectomy and orthotopic ileal neobladder reconstruction.

BACKGROUND: The purpose of this study was to determine health-related quality of life (HRQoL) among long-term disease-free survivors in women who underwent radical cystectomy (RC) for urothelial carcinoma and orthotopic ileal neobladder (ONB) reconstruction, using validated patient-reported outcome instruments. METHODS: From 2000 to 2011, a total of 46 women with urothelial bladder carcinoma had RC and ONB at our institution; 31 (67 %) eligible women completed 3 validated questionnaires: the medical outcome study short form 12 (SF-12), the urinary symptom profile, and the Contilife, respectively evaluating general HRQoL, voiding function, and urinary incontinence specific HRQoL. Unadjusted analyses were performed to analyze standardized measures of HRQoL and voiding symptoms; p < 0.05 was considered significant. RESULTS: The mean follow-up was 5.7 years; 24 women (77 %) considered their health as good, very good, or excellent. The SF-12 physical and mental scores were not significantly different between the population study and the general population (p > 0.05). A total of 20 women (65 %) declared to be fully continent. Daytime incontinence, nighttime incontinence, and hypercontinence were reported by 26, 29, and 31 % of women, respectively. On unadjusted analysis, incontinence was associated with age > 65 years at the time of surgery (p < 0.001). Hypercontinence was not associated with any variable. CONCLUSIONS: This study suggests that in the setting of radical cystectomy in women, ileal neobladder reconstruction provides long-term satisfaction with maintained HRQoL. For properly selected women, orthotopic neobladder can be considered an appropriate diversion choice.

Living with a malignant musculoskeletal tumor: experiences of family caregivers.

PURPOSE: To describe the experiences of the family caregivers of patients with malignant musculoskeletal tumors. DESIGN AND METHODS: Descriptive qualitative approach using a semi-structured interview guide. SETTING: Orthopaedics Department of the Gulhane Military Medical Academy in Ankara, Turkey. A total of 11 family caregivers aged 25-62 years were recruited. RESULTS: The analysis revealed 5 themes: religious attributions in terms of the cause and treatment of the tumor, the effect of malignant tumor on daily life, the tendency to think positively and constructively and find meaning through caregiving, the anxiety about the prognosis of the malignant tumor, and the support received from significant others. CONCLUSION: It is important to develop effective nursing care to family caregivers of patients with malignant musculoskeletal tumor to understand the physical, emotional, and spiritual experiences in their lives.

Direct integration of government funding and family support for musculoskeletal tumor care in a resource-constrained country.

BACKGROUND: Malignant musculoskeletal tumor (MMST) outcome reflects the level of supportive care provided. In Nigeria, the supportive care available to patients with MMST is limited by a lack of funding. Patients often present late, and receive only orthodox care as psychosocial care is not available. We evaluated the effect of direct incorporation of government funding and family support on MMST patient acceptance and completion of treatment. METHODS: A 3-year prospective multicenter intention-to-treat study was undertaken in a tertiary care setting. The first step was a nonselective randomization of MMST patients into 2 groups, Wesley Guilds Hospital Firm A (WGHFA) and Wesley Guilds Hospital Firm B (WGHFB) using the computer software Excel. The control group was WGHFA, which consisted of patients who self-financed their oncology care. The WGHFB patients' governments (local or state) provided funds according to medical reports and the patients had relatives who offered psychosocial support. The second step entailed treatment (surgery, chemotherapy and radiotherapy) and follow-up. Outcome measures were the interval between presentation at hospital and surgical intervention, acceptability of limb amputation, completeness of treatment courses, duration of hospital stay and mortality. The reproducibility of the methodology was reappraised at the Federal Medical Center. Kruskal-Wallis analysis was used, and an alpha error of <0.05 at a CI of 95% was taken to be significant. RESULTS: A total of 112 cases of MMST were managed during the study period. Seventy-one (63.4%; 37 WGHFA; 34 WGHFB) met the inclusion criteria. Age, sex, tribe, religion, comorbid factors and mean weekly income were not significant factors influencing improved MMST care among the WGHFB patients. 32 WGHFB versus 7 WGHFA patients accepted the treatment plan. The mean duration of hospital stay before surgery (p < 0.001), discharge against medical advice (p < 0.000), limb salvage (21 vs. 2, p < 0.001), limb amputation (3 vs. 12, p < 0.05, 95% CI 8.3-37.9), completeness of treatment (33 vs. 7, p < 0.05), mean duration of hospital stay, in days (23 vs. 39, p < 0.05) and mortality at 1-year follow-up (13 vs. 28, p < 0.02) were significant. CONCLUSION: The cost of cancer care is a challenge for patients with MMST in a resource-constrained country such as Nigeria. Direct integration of the government and family into MMST care will serve as a link between the cancer patient and the source of funds. It raises the possibility of an effective psychosocial approach to improve patient outcome through enhanced treatment acceptability and completion, and so reduce morbidity and short-term mortality.

[Psychological evaluation of patients with benign musculoskeletal system tumors]. / Benign kas-iskelet sistemi tümörü olan hastalarda psikolojik durum degerlendirmesi.

OBJECTIVES: This study was designed to determine to what extent psychological status was affected by sociodemographic characteristics and by being informed about the diagnosis in patients with benign musculoskeletal tumors. METHODS: The study included 112 male patients (mean age 23.8 years; range 20 to 35 years) who were hospitalized for benign tumors of the musculoskeletal system. A questionnaire was administered to all the patients concerning their sociodemographic characteristics and the status of their knowledge about the diagnosis. Psychological status was assessed by the Hamilton Depression Evaluation Scale. RESULTS: The depression level was not correlated with the localization (upper or lower extremity) of the musculoskeletal system tumor, the marital status of the patient, and the presence or absence of knowledge of the patient about the diagnosis (p>0.05). Educational status was the only factor that was found to be in correlation with the depression level (p<0.05). CONCLUSION: Lack of correlation between sociodemographic characteristics and the psychological status suggests that informing the patients with special attention to their physical and psychological integrity may contribute positively to the patients' psychiatric status.

Effects of musculoskeletal neoplasms on patient self assessment of health status.

Eighty-five consecutive patients referred to the Musculoskeletal Tumor Service completed a standardized short form questionnaire to evaluate their health status and function. Each patient completing the Short Form-36 questionnaire had a diagnosis of musculoskeletal neoplasm, including benign soft tissue and bone tumors, malignant soft tissue and bone tumors, and metastatic tumors. The results of this preliminary study show that the authors' patient population experienced health status and functional deficits in each of the eight Short Form-36 assessed domains. Data show that the most severe deficits were experienced by patients who had diagnoses of bone tumors and malignant tumors. This study shows that the Short Form-36 is a practical and effective method for documenting perceived deficits in health status in patients with musculoskeletal tumors. These data allow the physician to understand the presenting condition from the patient's perspective. This is an important and often neglected aspect of the overall assessment of the health of patient on presentation. An understanding of these deficits is critical for effective planning of treatment and evaluation of treatment effectiveness.

Quality of life as defined by orthopedic oncology patients.

BACKGROUND: Quality of life (QOL), not just survival, is central to outcomes analysis in musculoskeletal oncology. However, little information exists about the patients' definition of what constitutes QOL. METHODS: Self-administered outcomes questionnaires were given to 201 surgically treated patients with lower extremity tumors. Of these patients, 192 (137 with malignant tumors, 55 with benign tumors) provided a written definition of QOL. Their responses were independently collated and matched with clinical information. RESULTS: For most patients (153, or 80%) the definition of QOL encompassed several attributes. A consistent combination of four major attributes was used in the QOL definition by 44 (32%) of the malignant cases and 19 (35%) of the benign cases. Differences in responses between men and women were idiosyncratic and more common in the benign group. Good family relations and good health were equally important to men and women. Responses varied by patient age. Older patients valued self-sufficiency and freedom from pain, whereas younger patients emphasized happiness, trust in God or church, achieving goals and being successful, and love. Those whose surgery was less extensive cited good family relations, the ability to function physically and emotionally, and having a good job or work. CONCLUSION: The variation in patients' perspectives and definitions of quality of life must be taken into account when assessing QOL in musculoskeletal oncology patients. Patients often emphasize concerns that are not adequately addressed by current outcomes-measures in orthopedics and general oncology.