Related Quality Of Life Outcomes Research Articles

The effects of individual music therapy in nursing home residents with dementia to improve general well-being: study protocol of a randomized controlled trial

BackgroundDementia is often associated with Neuropsychiatric Symptoms (NPS) such as agitation, depression, hallucinations, anxiety, that can cause distress for the resident with dementia in long-term care settings and can impose emotional burden on the environment. NPS are often treated with psychotropic drugs, which, however, frequently cause side effects. Alternatively, non-pharmacological interventions can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Other QoL related outcomes, such as pain, discomfort and sleep disruption are relevant outcomes in music trials as well. Music therapy is a non-pharmacological intervention that can reduce NPS and improve well-being, and its associated symptoms in dementia.MethodsThe research will be conducted at eight nursing home facilities of a health care organization in the Netherlands. A sample size of 30 in each group (experimental and control group) is required, totalling 60 residents increased to 80 when considering expected drop out to follow up. The participants in the intervention group receive 30 min of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group will receive 30 min of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, will assess directly observed well-being (primary outcome) and pain (secondary outcome) before and after the sessions. Nurses will assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS, both assessed with validated scales. The sleep duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use will be derived from electronic medical chart review.DiscussionThe main purpose of this study is to assess the effects of individual music therapy on directly observed well-being controlled for individual attention in nursing home residents with dementia with NPS. The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as not blinded designs and music facilitators that were not only music therapists but also occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia such as music therapy.Trial registrationThe trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.

Minimally Invasive Surgery vs Nonoperative Treatment for Displaced Intraarticular Calcaneal Fracture: A Prospective Propensity Score Matched Cohort Study With 2-Year Follow-up.

Optimal management of displaced intraarticular calcaneal fractures remains controversial. The aim of this prospective cohort study was to compare the clinical and radiologic outcomes of minimally invasive surgery vs nonoperative treatment in displaced intraarticular calcaneal fracture up to 2 years. All displaced intraarticular calcaneal fractures between August 2014 and January 2019 that presented to a level 1 trauma center were considered for inclusion. The decision to treat was made by a multidisciplinary team consisting of fellowship-trained orthopaedic surgeons. Operative treatment protocol involved sinus tarsi approach or percutaneous reduction and internal fixation. Nonoperative protocol involved symptomatic management with no attempt at closed reduction. The Manchester-Oxford Foot Questionnaire (MOXFQ) and EuroQol-5 Dimensions-5 Level (EQ-5D-5L) patient-reported outcome measures were used to assess foot and ankle and general health related quality of life outcomes, respectively, at 2-year follow-up. Radiographic assessment was performed based on preinjury and 12-week postinjury radiographs. A total of 101 patients were included for analysis between August 2014 and January 2019. We propensity score matched 46 patients in the surgical cohort to 46 patients in the nonsurgical cohort. At 24 months, there was no significant difference in the MOXFQ Index score (P > .05); however, the surgical cohort had a significantly higher EQ-5D-5L Index score (P < .05) and return to work (91% vs 72%, P < .05) and physical activity rate (46 vs 35%, P < .05) despite a higher proportion of more complex fractures in the surgical cohort. The wound complication rate following surgery was 16%. In addition, 14% of patients in the nonoperative cohort subsequently underwent arthrodesis compared with none of the patients in the surgical cohort. In this study, we found that operative treatments were associated with low rates of surgical complication at 2 years and long-term pain improvement, facilitating earlier and better functional outcomes for complex injury patterns compared with nonoperative treatment for less severe fractures. Level III, retrospective cohort.

Surgical and health related quality of life outcomes following treatment with zygomatic implant perforated (ZIP) flaps.

The zygomatic implant perforated (ZIP) flap is a novel approach to the challenge of reconstructing the maxilla. We report on our experience using the ZIP flap technique for patients undergoing infrastructure maxillectomy at Chris O'Brien Lifehouse, Sydney, Australia. Thirteen patients who underwent a ZIP flap reconstruction between August 2019 and August 2021 were identified. Demographic, surgical, and histopathological information was collected. Health Related Quality of Life (HRQOL) was assessed using the FACE-Q Head and Neck Cancer module, the M.D. Anderson Dysphagia Inventory, and the Speech Handicap Index. A total of 44 zygomatic implants were placed, of which 42 (95%) survived. The median time from surgery to dental rehabilitation was 35 days. HRQOL data was available for nine patients over 24 months, demonstrating improved speech and swallowing outcomes over the follow up period. The ZIP flap is a reproducible surgical technique that facilitates rapid dental rehabilitation post infrastructure maxillectomy.

5 year follow up of a hydroxyapatite coated short stem femoral component for hip arthroplasty: a prospective multicentre study

Short stem, uncemented femoral implants for hip arthroplasty are bone conserving achieving stability through initial metaphyseal press-fit and biological fixation. This study aimed to evaluate the survivorship, mid-term function and health related quality of life outcomes in patients who have undergone total hip arthroplasty (THA) with a fully hydroxyapatite coated straight short stem femoral component with up to 5 years follow-up. 668 patients were recruited to a multicentre study investigating the performance of the cementless Furlong Evolution® stem for THA. 137 patients withdrew at various time points. The mean follow-up was 49 months. Clinical (Harris Hip Score (HHS), radiographic and patient-reported outcome measures—Oxford Hip Score (OHS) and EuroQol 5D (EQ-5D), were recorded pre-operatively and at 6 weeks, 6 months, 1 year, 3 year and 5 year follow ups. At 5-year follow-up, 12 patients underwent revision surgery, representing a cumulative revision rate of 1.8%. Median OHS, HHS and EQ5D scores improved significantly: OHS improved from a pre-operative median of 21 (IQR 14–26) to 47 (IQR 44–48) (p < 0.001). HHS improved from 52 (IQR 40–63) to 98 (IQR 92–100) (p < 0.001) and EQ5D improved from 70 (IQR 50–80) to 85 (IQR 75–95) (p < 0.001). This fully HA-coated straight short femoral stem implant demonstrated acceptable mid-term survivorship and delivered substantial improvements in function and quality of life after THA.

Health Related Quality of Life of Oral Cancer Patients Who Receive Radiotherapy With or Without Chemotherapy in Sri Lanka

Patient reported health related quality of life outcomes have considered as valid information when deciding the treatments and making protocols in cancer management. The aim of the study was to assess the health-related quality of life of oral cancer patients who receive radiotherapy (RT) with or without chemotherapy and the changes in health-related quality of life. A prospective study was conducted among 90 oral cancer patients who receive RT with or without chemotherapy. Two European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires: EORTC QLQ-C30 and EORTC QLQ-H&amp;N35, were used to assess health-related quality of life before RT, during the last week of RT and three months after RT. The majority were males (88%) and 68% were aged 50-69. The median scores of all the domains and items in EORTC QLQ-H&amp;N35 and symptom domains and items in EORTC QLQ-C30 were higher during the last week of RT compared to the baseline (most scores were zero). Except for ‘Appetite loss’ item, all the symptom domains and items scores were lower at three months after RT than the median scores during last week of RT. Statistically significant differences were observed in almost all the changes in health-related quality of life between three time frames (p&lt;0.05). Health-related quality of life of oral cancer patients declined due to RT from baseline to the last week of RT and improved three months after RT from last week of RT but had not returned to the baseline level. Keywords: Oral cancer, Health related quality of life, Radiotherapy, EORTC QLQ-H&amp;N35, EORTC QLQ-C30

Individual and population level costs and health-related quality of life outcomes of third-generation cephalosporin resistant bloodstream infection in Blantyre, Malawi.

Data which accurately enumerate the economic costs of antimicrobial resistance (AMR) in low- and middle- income countries are essential. This study aimed to quantify the impact of third-generation cephalosporin resistant (3GC-R) bloodstream infection (BSI) on economic and health related quality of life outcomes for adult patients in Blantyre, Malawi. Participants were recruited from a prospective, longitudinal cohort study of hospitalised patients with bloodstream infection caused by Enterobacterales at Queen Elizabeth Central Hospital (QECH). Primary costing studies were used to estimate the direct medical costs associated with the inpatient stay. Recruited participants were asked about direct non-medical and indirect costs associated with their admission and their health-related quality of life was measured using the EuroQol EQ-5D questionnaire. Multiple imputation was undertaken to account for missing data. Costs were adjusted to 2019 US Dollars. Cost and microbiology surveillance data from QECH, Blantyre was used to model the annual cost of, and quality-adjusted life years lost to, 3GC-R and 3GC-Susceptible BSI from 1998 to 2030 in Malawi. The mean health provider cost per participant with 3GC-R BSI was US$110.27 (95%CR; 22.60-197.95), higher than for those with 3GC-S infection. Patients with resistant BSI incurred an additional indirect cost of US$155.48 (95%CR; -67.80, 378.78) and an additional direct non-medical cost of US$20.98 (95%CR; -36.47, 78.42). Health related quality of life outcomes were poor for all participants, but participants with resistant infections had an EQ-5D utility score that was 0.167 (95% CR: -0.035, 0.300) lower than those with sensitive infections. Population level burden estimates suggest that in 2016, 3GC-R accounted for 84% of annual societal costs from admission with bloodstream infection and 82% of QALYs lost. 3GC-R bloodstream infection was associated with higher health provider and patient level costs than 3GC-S infection, as well as poorer HRQoL outcomes. We demonstrate a substantial current and future economic burden to society as a result of 3GC-R E. coli and Klebsiella spp. BSI, data urgently needed by policy makers to provide impetus for implementing strategies to reduce AMR.

1361 THE EFFECTIVENESS OF PREVENTIVE HOME VISIT ON RESILIENCY,HEALTH STATUS AND QUALITY OF LIFE OF OLDER ADULTS: A SYSTEMATIC REVIEW

Abstract Introduction Resilient ageing is conceptualised as strive towards achieving satisfactory quality of life (QoL) at old age by embracing adaptive and coping mechanisms against adversities regardless of health conditions. Preventive Home Visit (PHV) including various types of home-care interventions were introduced to delay health deterioration and improved QoL. However, research related to resilience as indicator for QoL is scarce. Therefore, this systematic review aims to evaluate the effectiveness of PHV in improving resilience among community dwelling older adults and the association with health and other QoL related outcomes. Method Database search was conducted by using five databases (PubMed, PsycINFO, CINAHL, Web of Science and Scopus) up to 31 March 2022 involving community dwelling older adults who received PHV. Three authors reviewed the articles for inclusion and performed methodological quality assessment. Results Out of 1,580 records, 13 articles involving 7,254 participants met the inclusion criteria with age range between 79 to 85 years old. Quality assessment by using Joanna Briggs Institute (JBI) Critical Appraisal Tools indicated that all Randomised Controlled Trials (RCTs) and non-RCTs articles were having low risks of bias, suggesting high-quality studies were selected for this review. One remaining study was a cross-sectional study. More than two third of the studies focused on health or combination of health and QoL and only three studies yield positive impact of PHV. The rest were either yielded mixed results or no impact of PHV intervention. There was only one study measuring resilience with results showed no significant impact of PHV or home care intervention on resiliency of the older adults. Conclusion Research on the effectiveness of PHV has been introduced since for decades ago, however study focusing on resilience related outcomes is still lacking. Based on current evidence, it is essential to further evaluate the impact of multi-domain health and psychological intervention in PHV design considering the ability of older adults to face adversity in late life.

Recording of patients’ mental health and quality of life-related outcomes in primary care: a cross-sectional study in the UK

ObjectiveTo compare patient-reported anxiety, depression and quality-of-life (QoL) outcomes, with data registered in patients’ primary care electronic health record (EHR).DesignCross-sectional study.SettingPrimary care in the UK.ParticipantsA convenience sample of 608 women...

Abstract 15610: Long Term Health Related Quality of Life Outcomes Across the Therapeutic Spectrum in Patients With Congenitally Corrected Transposition of Great Arteries

Introduction: Congenitally corrected transposition of the great arteries (ccTGA) encompasses a diverse morphologic cohort with multiple treatment pathways. We characterized long term health related quality of life (HR-QoL) outcomes in adult patients with ccTGA across the therapeutic spectrum. Hypothesis: Methods: Between 1995-2020, 240 ccTGA patients were treated at the Cleveland Clinic. Of these, 59 adults were prospectively assessed with a hybrid PROMIS-10 and MacNew HR-QoL questionnaire at median follow-up of 10 years. Mental and physical scores were captured utilizing PROMIS 10 questionnaire, and social score from MacNew instrument. One-sample non-parametric sign tests evaluated deviations from referenced normative values. Differences among anatomic (AR) and physiologic repairs (PR) were assessed with Wilcoxon rank-sum test. Confidence intervals (95%) around measured means were generated from 1000 bootstrap samples. Results: Thirty one (18%) patients were female with median presentation age 26.3 years. Sixteen (27%) patients had PR, 12 (20%) had AR, 12 (20%) were medically managed, 5 (8.5%) had heart transplant and 3 (5.1%) underwent Fontan. Social scores were higher than the population norms (median= 6, P =.0002) for the overall cohort, but physical scores were lower than normative values (median = 44, P =.0183).Mental functioning was equivalent to normative values (median = 50, P =.9). AR and PR scores across domains were similar (Table 1). Conclusions: Adult patients living with ccTGA across the treatment spectrum have lower physical functioning than population norms. Despite these perceived physical impediments, social and mental functioning are unaffected. PR and AR had equivalent HR-QoL, providing important data to inform patient selection and triage.

Health related quality of life outcomes following stereotactic body radiotherapy in patients with oligo-metastatic disease: A systematic review and individual patient data meta-analysis

IntroductionPublished health-related quality of life (HRQOL) outcomes are lacking in patients treated for oligo-metastatic disease (OMD). The aim of this systematic review and individual patient data meta-analysis is to determine the effect of stereotactic body radiotherapy (SBRT) on HRQOL outcomes of patients with OMD. MethodsStudies screened included adults with extra-cranial OMD, defined as ≤ 5 metastases, SBRT intended as definitive treatment, and HRQOL as primary or secondary outcome. Primary outcome was change in HRQOL at 12-months from baseline in patients with OMD who received SBRT (versus not), reported as standardized mean difference (SMD). ResultsA total of 7556 publications were identified, four studies met inclusion criteria (2 single arm interventional studies and 2 randomised controlled trials [RCTs]), and individual patient data was available from 3 studies (175 patients). In the two RCTs, there was no SS difference in the SMD between patients who received SBRT and those that did not (0.09 [95 % CI −0.32, 0.5], P = 0.66). On meta-analysis of patients (N = 107) who received SBRT the SMDwas −0.23 (95 % CI [−0.42, −0.04], versus −0.25 (95 % CI [−0.57, 0.07]) in those who did not (N = 37) receive SBRT, demonstrating a small deterioration from baseline. ConclusionIn patients with OMD, there is no difference in HRQOL at 12-months from baseline between patients who received SBRT and those that did not. However, a small HRQOL deterioration was found in both groups of patients. More in-depth analysis of relevant HRQOL domains, in the setting of OMD, is required to better understand the potential impact of SBRT.

Evaluating the effects of dance on motor outcomes, non-motor outcomes, and quality of life in people living with Parkinson\u2019s: a feasibility study

BackgroundCommunity-based dance programs for people living with Parkinson’s have grown in popularity over the past two decades. Studies investigating these programs have demonstrated multidimensional benefits in motor, non-motor, and quality of life related outcomes, yet there is a need to focus on the feasibility of larger trials. The primary objective of this study was to assess the feasibility and acceptability of conducting a trial investigating dance and Parkinson’s in Northern Ireland. The secondary objectives were to conduct preliminary analyses of the classes’ effects and to assess the appropriateness of outcome measures for a randomized controlled trial.MethodsParticipants were recruited through the community, Parkinson’s UK, and university contacts to participate in a 12-week dance intervention inspired by the Dance for PD® model. Pre- and post-intervention, participants completed the following outcomes: MDS-UPDRS III, TUG, DT-TUG, Sensory Organization Test, MoCA, Trail Making Tests A&B, Digit Symbol Substitution Test, Digit Span, PDQ-39, FOG-Q, PHQ-9, FES-I, and an exit questionnaire (post-test only). Data were analyzed using paired samples t tests or Wilcoxon signed ranked test.ResultsTen people living with Parkinson’s participated. Running a larger trial was deemed infeasible in this setting due to recruitment issues; conversely, the dance intervention was accepted by participants with all but one completing the study. Functional mobility (TUG), symptoms of depression (PHQ-9), and bodily discomfort showed improvement. All other outcomes did not. The exit questionnaire revealed that the social aspect of classes was important, and improvements in mood or mental state were cited most frequently as perceived benefits. Outcome measures were feasible, with some changes suggested for future trials.ConclusionsThis study highlighted the infeasibility of running a larger trial using this design in this setting despite demonstrating the acceptability of implementing a dance program in Northern Ireland for people living with Parkinson’s. The results support existing evidence demonstrating that dance may improve functional mobility and symptoms of depression in people living with Parkinson’s, though the study design and small sample size prevent the generalizability of results. The findings also support the idea that dancing has the potential to support several aspects of physical, emotional, mental, and social health.

Examining health related quality of life outcomes in multiple myeloma: Past and future perspectives

Multiple myeloma (MM) is a complex hematological malignancy. Advances in therapy over the last decade have resulted in significant improvement in overall survival for patients with a diagnosis of MM, leading to a substantial number of older people living with the disease. However, patients continue to suffer from a multitude of debilitating symptoms that can significantly affect their quality of life, a problem that especially can impact patients with MM considered in the geriatric age group. In the first part of our review, we reflect on traditional measurement tools that are used to assess health related quality of life in patients living with MM, as they undergo different types of treatment regimens. In the second part, we discuss the potential role of the Internet of Medical Things in tracking and actively enhancing health related quality of life in patients with a diagnosis of MM. We conceptualize models of passive and active digital health technology platforms that are posed to transform the patient-physician relationship in the new era of advanced care.

Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation

ObjectiveTo evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after...

How Shared Is Shared Decision Making? Reaching the Full Potential of Patient-Clinician Collaboration in Mental Health.

Shared decision making in mental health is a priority for stakeholders, but faces significant implementation barriers, particularly in settings intended to serve people with serious mental illnesses (SMI). As a result, current levels of shared decision making are low. We highlight these barriers and propose that a novel paradigm, collaborative decision making, will offer conceptual and practical solutions at the systemic and patient/clinician level. Collaborative decision making is tailored for populations like people with SMI and other groups who experience chronic and complex symptoms, along with power imbalances within health systems. Advancing from shared decision making to collaborative decision making clarifies the mission of the model: to facilitate an empowering and recovery-oriented decision-making process that assigns equal power and responsibility to patients and clinicians; to improve alignment of treatment decisions with patient values and priorities; to increase patient trust and confidence in clinicians and the treatment process; and, in the end, to improve treatment engagement, satisfaction, and outcomes. The primary purpose of collaborative decision making is to increase values-aligned care, therefore prioritizing inclusion of patient values, including cultural values and quality of life-related outcomes. Given the broad and constantly changing context of treatment and care for many people with SMI (and also other groups), this model is dynamic and continuously evolving, ready for use across diverse contexts. Implementation of collaborative decision making includes increasing patient knowledge but also patient power, comfort, and confidence. It is one tool to reshape patient-clinician and patient-system relationships and to increase access to value-aligned care for people with SMI and other groups.

Introducing trifecta for percutaneous nephrolithotomies: a proposal for standard reporting outcomes after treatment for renal stones

In literature, the reports of outcomes after percutaneous nephrolithotomies are rather heterogeneous. This may influence studies comparison, it may also render difficult to evaluate surgical adequacy, perioperative morbidity, and patient's Quality of Life between studies. For this reason, we propose to introduce PNL-Trifecta as composite measure to standardize data reporting outcomes after percutaneous nephrolithotomies. We performed a prospective multicentric study on consecutive patients undergone PNL to treat renal stones between 2018 and 2020. Successful PNL-trifecta was considered achieved when procedures obtained the three following results: no residual fragments >2 mm at unenhanced CT scan at 3 months postop, no complications (defined as Clavien-Dindo Score 0) and operation carried out without placing a nephrostomy tube (tubeless or totally tubeless). We compared results of standard versus mini-PNL and between stones of different complexity (evaluated with Guy's Stone Score and S.T.O.N.E. Nephrolithometry Score). Univariate analysis was utilized to identify other factors influencing achievement of PNL-Trifecta. Two hundred forty-five patients fulfilled inclusion/exclusion criteria and have been enrolled in the study (median age: 56, IQR 48-57). The overall PNL-Trifecta achievement rate was 22.85% (28.66% in the mini-PNL group and 13.68% in the standard-PNL group, P=0.010). The stone free rate, CD 0 rate and tubeless/totally tubeless rate in the mini-PNL group were 60.66%, 89.33% and 51.33% respectively. In the standard-PNL group they were 44.21%, 40.00% and 15.78% respectively. At the univariate analysis, differences between Guy's Stone Score groups in achieving PNL-Trifecta were significant (P=0.001). Also, the level of upper puncture (P=0.010) and utilization of device with active suction (P=0.002) showed statistically significant differences. Furthermore, the length of stay in the patient's group achieving Trifecta was 2.28 versus a mean length of stay of 4.64 days in the group of patients not achieving Trifecta (P=0.046). We present Trifecta for PNLs as a potential tool to evaluate quality of percutaneous nephrolithotomies and to provide an instrument for an adequate standard data reporting. It can represent a valid way to assess and monitor surgeon's learning curves. It will require further external validation and studies to evaluate its correlation with mid- and long-term results and patient's health related Quality of Life outcomes.

Endoscopic ear surgery in middle ear cholesteatoma

ObjectiveEndoscope has been used as diagnostic tool for recidivism and as an adjunct to microscopic technique in the management of cholesteatoma. At present transcanal endoscopic ear surgery (TEES) is being used as a minimally invasive alternative for microscopic approach. We aim to evaluate the feasibility, structural, functional and quality of life outcomes of endoscopic technique in middle ear cholesteatoma. MethodThis prospective study was conducted at a tertiary care hospital from January 2017 to January 2018 including 32 adult patients who were treated by TEES for middle ear cholesteatoma. Feasibility of endoscopic technique was assessed by the conversion rates, visualization of middle ear structures and complications. Structural outcomes were evaluated in terms of graft uptake at the third month follow-up and presence of residual or recurrent disease. Functional outcomes were evaluated in terms of post-operative air-bone gap closure at third month follow-up. Patient outcomes in terms of post-operative pain, cosmetic score, day of return to daily activities and patient comfort scores were evaluated. The quality of life outcomes were evaluated using chronic ear survey (CES) and short form questionnaire −12 version 2 (SF-12V2) which are disease specific and general quality of life assessment tools respectively. ResultOut of 32 patients, endoscopic intact canal wall mastoidectomy was done for 28 and endoscopic canal wall down mastoidectomy in 4 patients. One (3.1%) patient had to be converted to microscopic technique. Median follow-up period was 32.8 months (9–46 months). There were no post-operative complications in any of our patients. The mean middle ear structural visibility index score was 8.4 ± 1.4 with the use of zero-degree endoscope. Graft uptake rate at third month follow-up was 100%. Two (6.3%) patients had recurrent disease at 6 months follow-up and were treated by revision endoscopic surgery. The air conduction (51.3 ± 20.2 dB vs. 34.5 ± 20.4 dB, p < 0.001), and air-bone gap (33.5 ± 11.1 dB vs. 16.9 ± 11.8 dB, p < 0.001) has been significantly improved. The mean pain score at 0 hours, 6 hours and 24 hours after surgery were 2.5/10, 1.6/10 and 0.75/10 respectively. At the discharge, the mean patient comfort score was 9.3 ± 0.6 out of 10. Mean cosmetic score was 9.3 ± 0.5 at the third month follow-up. There was significant post-operative improvement in the sub-scale and total scores of CES and SF-12V2. ConclusionEndoscopic approach to middle ear cholesteatoma is feasible and confers excellent structural, functional as well as patient related quality of life outcomes.

Health related quality of life outcomes following surgery and/or radiation for patients with potentially unstable spinal metastases

Currently there is no prospective pain and health related quality of life (HRQOL) data of patients with potentially unstable spinal metastases who were treated with surgery ± radiation or radiation alone. An international prospective cohort multicenter study of patients with potentially unstable spinal metastases, defined by a SINS score 7 to 12, treated with surgery ± radiation or radiotherapy alone was conducted. HRQOL was evaluated with the numeric rating scale (NRS) pain score, the SOSGOQ2.0, the SF-36, and the EQ-5D at baseline and 6, 12, 26, and 52 weeks after treatment. A total of 136 patients were treated with surgery ± radiotherapy and 84 with radiotherapy alone. At baseline, surgically treated patients were more likely to have mechanical pain, a lytic lesion, a greater median Spinal Instability Neoplastic score, vertebral compression fracture, lower performance status, HRQOL, and pain scores. From baseline to 12 weeks post-treatment, surgically treated patients experienced a 3.0-point decrease in NRS pain score (95% CI -4.1 to -1.9, p<.001), and a 12.7-point increase in SOSGOQ2.0 score (95% CI 6.3-19.1, p<.001). Patients treated with radiotherapy alone experienced a 1.4-point decrease in the NRS pain score (95% CI -2.9 to 0.0, p=.046) and a 6.2-point increase in SOSGOQ2.0 score (95% CI -2.0 to 14.5, p=.331). Beyond 12 weeks, significant improvements in pain and HRQOL metrics were maintained up to 52-weeks follow-up in the surgical cohort, as compared with no significant changes in the radiotherapy alone cohort. Patients treated with surgery demonstrated clinically and statistically significant improvements in pain and HRQOL up to 1-year postsurgery. Treatment with radiotherapy alone resulted in improved pain scores, but these were not sustained beyond 3 months and HRQOL outcomes demonstrated nonsignificant changes over time. Within the SINS potentially unstable group, distinct clinical profiles were observed in patients treated with surgery or radiotherapy alone.

Patterns in detection of recurrence among patients treated for breast cancer.

e14020 Background: Follow-up programs for breast cancer should according to ASCO and ESMO consist of regular visits including anamnestic screening for symptoms of recurrence and physical examination for ten years in addition to regular mammography. Recently, the Danish guideline for follow-up after early breast cancer was revised. Today most patients are offered open access to an outpatient clinic, but no scheduled visits following the first year after surgery. This strategy has been studied in regards to psychological and health related quality of life outcomes, but not in regards to detection of recurrence and survival. The aim of this study was to quantify the recurrences detected at scheduled outpatient visits in Denmark before the implementation of revised follow-up guidelines. Furthermore, we aimed to assess whether the duration of symptoms prior to recurrence detection differed depending on type of visit when recurrence was detected. Methods: We conducted a cross-sectional study among 310 patients with recurrent breast cancer. Through medical records, we retrieved information on type of visit when recurrence was detected, localization of recurrence, symptoms reported, and duration of symptoms. Tumor characteristics were obtained from the Danish Breast Cancer Group database. Results: Among the 310 breast cancer recurrences, more than half were distant (59%), 26% were loco-regional, and 15% loco-regional and distant. Among the 199 patients still in outpatient follow-up at time of recurrence, recurrence was detected at a scheduled outpatient visit (21%), at a patient-requested extra outpatient visit (15%), by the general practitioner or other specialist (47%), or on a scheduled mammography (11%). Among patients with recurrence detected at a scheduled outpatient visit, the majority (88%) reported symptoms related to the recurrence. Patients who waited for the scheduled outpatient visit despite symptoms had a markedly longer duration of symptoms (median 21 weeks) prior to detection of recurrence than patients who requested an extra visit (median 8 weeks). Conclusions: One-fifth of recurrences among patients attending outpatient follow-up were detected at scheduled outpatient visits. The majority was symptomatic, but the patients had not altered their scheduled appointment. Whether recurrences like these will be detected in follow-up without scheduled visits is unknown. Some recurrences may be detected earlier, if patients can be educated to react on relevant symptoms, but some recurrences may be detected with further delay. Thus, more research in this area is needed.

PIN90 COMPARATIVE QUALITY OF LIFE OUTCOMES OF DOLUTEGRAVIR-BASED OR EFAVIRENZ-BASED ANTIRETOVIRAL TREATMENT IN PREGNANCY FOR LATE PRESENTORS BETWEEN THE 3RD TRIAL-MESTER AND 48 WEEKS POSTPARTUM

Evidence on safety and health related quality of life outcomes is needed for rollout of new antiretroviral therapies. Dolutegravir-based treatment is being rolled out as the preferred first-line treatment for HIV in many low- and middle-income countries. We compared HRQoL between treatment-naïve pregnant women randomized to dolutegravir-based or efavirenz-base regimen in Uganda and South Africa. As part of the DoIPHIN-2 RCT, HRQoL data was gathered from 203 pregnant women mean age 28years, randomized to dolutegravir (101) and efavirenz (102). The medical outcomes study-HIV health survey was used at baseline, 24weeks and 48weeks between years 2017 and 2019. Physical health summary and mental health summary scores were primary-endpoints, while the 11 MOS-HIV subscales were secondary-endpoints. Pairwise t-tests were followed by ANCOVA analysis for within-group and between-group comparisons. Standardized multivariate regressions were included to associate selected-variables and MOS-HIV sub-scales with PHS and MHS scores. After 24weeks postpartum, significant improvements were seen in dolutegravir-treatment; PHS-scores (11.9±1.4, P<0.001); MHS-scores (10.7±1.7, P<0.001) and efavirenz-treatment; PHS-scores (9±1.1, P<0.001); MHS-scores (6.7, P<0.001) groups. Changes were not significantly different (PHS: P=0.106, MHS: P=0.087) between treatment-group comparison. Dolutegravir-treated women presented significantly higher improvements in physical function scores (8.18±3.2, P=0.012) than efavirenz treatment-group. Treatment-effects were not significant on PHS-scores (F(1,178)=0.00, P=0.967) and MHS-scores (F(1,177)=0.60, P=0.441) adjusting for viral-loads and CD4-count. After 48weeks postpartum, increase in PHS-scores and MHS-scores remained significant in both treatment-groups but were not significantly different between-groups (PHS: 1.1±1.0, P=0.269, MHS: -0.8±1.6, P=0.606). Dolutegravir-treated women presented higher scores in 8/11 MOS-HIV subscales relative to efavirenz group. Treatment effects remained insignificant on PHS-scores F(1,193)=1.32, P=0.252 and MHS-scores F(1,191)=0.04, P=0.841 adjusting for viral-loads and CD4-count. Increases in HRQoL-scores were generally higher in dolutegravir-treated women at 24weeks and 48weeks postpartum but not significantly different from those in efavirenz. Relationship between viral-load, CD4-count with PHS-scores and MHS-scores were similar in both treatments-groups.

Effects of Pulsed Electromagnetic Field Therapy on Pain, Stiffness, Physical Function, and Quality of Life in Patients With Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Pulsed electromagnetic field (PEMF) therapy is a potentially useful treatment for osteoarthritis (OA), but its effectiveness is still controversial. This study aimed to examine the effects of PEMF therapy and PEMF parameters on symptoms and quality of life (QOL) in patients with OA. Cochrane Central Register of Controlled Trials, PubMed, CINAHL, EMBASE, PEDro, clinical trial registers, and reference lists were searched until April 2019. This study examined randomized, placebo-controlled trials, patients with OA, symptom and/or QOL related outcomes, and articles published in English. Two authors extracted data and completed quality assessment. Sixteen studies were included in our systematic review, while 15 studies with complete data were included in the meta-analysis. Our primary outcome was the standardized mean difference, which was equal to the treatment effect in the PEMF group minus the treatment effect in the placebo group divided by the pooled standard deviation. For pain, the standardized mean difference was 1.06 (95% CI = 0.61 to 1.51), for stiffness 0.37 (95% CI = 0.07 to 0.67), for function 0.46 (95% CI = 0.14 to 0.78), and for QOL 1.49 (95% CI = -0.06 to 3.04). PEMF parameters did not influence symptoms. Compared with placebo, there was a beneficial effect of PEMF therapy on pain, stiffness, and physical function in patients with OA. Duration of treatment may not be a critical factor in pain management. Further studies are required to confirm the effects of PEMF therapy on QOL. Our study suggests that PEMF therapy has clinically significant effects on pain in patients with OA. The current evidence was limited to the short-term effects of PEMF therapy.