The evolving value assessment of cancer therapies: Results from a modified Delphi study.

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society).

International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials.

INTRODUCTION: To evaluate the effects of the global coronavirus disease 2019 (COVID-19) pandemic on lung cancer trials, we surveyed investigators and collected aggregate enrollment data for lung cancer trials across the world before and during the pandemic. METHODS: A Data Collection Survey collected aggregate monthly enrollment numbers from 294 global lung cancer trials for 2019 to 2020. A 64-question Action Survey evaluated the impact of COVID-19 on clinical trials and identified mitigation strategies implemented. RESULTS: Clinical trial enrollment declined from 2019 to 2020 by 14% globally. Most reductions in enrollment occurred in April to June where we found significant decreases in individual site enrollment (p = 0.0309). Enrollment was not significantly different in October 2019 to December of 2019 versus 2020 (p = 0.25). The most frequent challenges identified by the Action Survey (N = 172) were fewer eligible patients (63%), decrease in protocol compliance (56%), and suspension of trials (54%). Patient-specific challenges included access to trial site (49%), ability to travel (54%), and willingness to visit the site (59%). The most frequent mitigation strategies included modified monitoring requirements (47%), telehealth visits (45%), modified required visits (25%), mail-order medications (25%), and laboratory (27%) and radiology (21%) tests at nonstudy facilities. Sites that felt the most effective mitigation strategies were telehealth visits (85%), remote patient-reported symptom collection (85%), off-site procedures (85%), and remote consenting (89%). CONCLUSIONS: The COVID-19 pandemic created many challenges for lung cancer clinical trials conduct and enrollment. Mitigation strategies were used and, although the pandemic worsened, trial enrollment improved. A more flexible approach may improve enrollment and access to clinical trials, even beyond the pandemic.

Systematic review and meta-analysis identifies potential host therapeutic targets in COVID-19.

The increasing body of literature describing the role of host factors in COVID-19 pathogenesis demonstrates the need to combine diverse, multi-omic data to evaluate and substantiate the most robust evidence and inform development of therapies. Here we present a dynamic ranking of host genes implicated in human betacoronavirus infection (SARS-CoV-2, SARS-CoV, MERS-CoV, seasonal coronaviruses). Researchers can search and review the ranked genes and the contribution of different experimental methods to gene rank at https://baillielab.net/maic/covid19. We conducted an extensive systematic review of experiments identifying potential host factors. Gene lists from diverse sources were integrated using Meta-Analysis by Information Content (MAIC). This previously described algorithm uses data-driven gene list weightings to produce a comprehensive ranked list of implicated host genes. From 32 datasets, the top ranked gene was PPIA, encoding cyclophilin A, a drug-gable target using cyclosporine.Other highly-ranked genes included proposed prognostic factors (CXCL10, CD4, CD3E) and investigational therapeutic targets (IL1A) for COVID-19. Gene rankings also inform the interpretation of COVID-19 GWAS results, implicating FYCO1 over other nearby genes in a disease-associated locus on chromosome 3. As new data are published we will regularly update list of genes as a resource to inform and prioritise future studies.

Parity of match play: an LPGA replication.

This study investigated whether the slight advantage of higher seeded players to win in match play on the men's Professional Golfers' Association Tour generalizes to the Ladies Professional Golf Association Tour. Analysis showed no significant advantage for the higher seeded player in match play. The highly restricted range of skill of tour players makes it mainly a matter of chance who will win any match-play event or who will have the better or worse scores on any given day.

On the unreliability of golf scores for professional golfers: a case for restriction of range.

This study investigated whether the unreliability of golf scores for professional golfers can be accounted for by restriction of range. Reliability estimates for hole-to-hole scores were calculated from data from 2679 players on the PGA Tour, 32 senior club professionals, and 62 men and 49 women amateurs who had won either their club or course championship. Reliability estimates were small and negative for the PGA Tour (Cronbach alphas ranging from -.31 to -.15) but mostly positive and substantially higher for senior club professionals and amateurs (Cronbach alphas ranging from -.46 to .76). It was concluded that the greater reliability of performance for senior club pros and amateurs than for PGA Tour players was due to the greater variability in skills and performance of the club professionals and amateurs.

A longitudinal study of "choking" in professional golfers.

This study followed the performance of 35 professional golfers who played from 1997 to 2004 on the Professional Golfers Association Tour (PGA Tour) and investigated whether any players were prone to "choke" when placed in high-pressure situations. Choking was defined as a player having significantly higher than expected final round scores and being less likely than other professional golfers to win when in contention to win tournaments. Analysis yielded no support for a choking under pressure hypothesis. None of the players when in contention to win were both more likely to have higher than expected scores in the final round and less likely to win than other professional golfers in the sample. Limitations of the study were mentioned.

Is the independence of golf scores for professional golfers a statistical artifact?

This study investigated whether the lack of day-to-day consistency in performance for professional golfers would occur if round ranks were employed instead of round scores. When players' round scores from the 2004 Clark study were converted to round ranks, the results were very similar to those found in that study. It was concluded that the range of abilities for professional golfers is so restricted that the fluctuation in players' scores or rankings will show little consistency from day to day.

The beauty of match play.

This study investigated whether higher seeded players have an advanage in the only match play event on the PGA Tour. Analysis showed that the higher seeded won 54% of the time (p=.06); the correlation was .17 (p<.01) between higher seeded players winning and the difference in World Rankings between players. Given professional golfers are at the highest end of the distribution of golf ability, these players are so nearly equal in ability, it is mainly a matter of chance who will win a match play event or who will have the best round on any given day.

An analysis of players' consistency among professional golfers: a longitudinal study.

This study followed the performance of individual professional golfers who played from 1997 to 2000 on the Professional Golfers Association Tour (PGA Tour, N=35), Ladies Professional Golfers Association Tour (LPGA Tour, N = 25), and Senior Professional Golfers Association Tour (SPGA Tour, N = 31) and investigated individual players' consistency in round-to-round performance within tournaments. Although the number of players showing consistency for most years exceeded chance expectations, evidence for round-to-round consistency from one year to the next for any player was small. Such evidence suggests that variability in player performance is more the rule than the exception for players on the three American professional tours.

Examination of hole-to-hole streakiness on the PGA Tour.

A study investigated streakiness among professional golfers. Hole-to-hole scores within 747 tournaments from a randomly chosen group of 35 players on the 1997 PGA Tour were analyzed. Contingency analyses gave no evidence for streakiness. Players were just as likely to score par or better following an above par hole as to make a par or better following a par or better hole. These results are consistent with those found for individual players in baseball and basketball.

An examination of the "hot hand" in professional golfers.

A study investigated the "hot hand" among professional golfers. Hole-to-hole scores within 747 tournaments from a randomly chosen group of 35 players on the 1997 PGA Tour were analyzed. Contingency analyses gave no evidence for the "hot hand". Players were just as likely to score a birdie or better following a par or worse hole as make a birdie or better following a birdie or better hole. These results are consistent with those found for individual players in baseball and basketball.

On the independence of golf scores for professional golfers.

This study involved professional golfers who played in 1999 on the Professional Golfers' Association Tour (PGA Tour, N=2,967), Senior Professional Golfers' Association (SPGA Tour, N=2,751), and the Ladies Professional Golfers' Association (LPGA Tour, N=2,638) and investigated whether there is independence between golfers' scores on consecutive rounds within tournaments. The mean correlations between scores on consecutive rounds for players on the PGA Tour (r=-.08, p<.01) and LPGA Tour (r=-.03, p=.05) were negative although negligible and of little practical importance. There was a small, positive correlation (r=.27, p<.01) between scores on consecutive rounds for players on the SPGA Tour. Such evidence suggests the greater dependence of golf scores on the SPGA Tour may be due to the greater range of players' skill on that tour.

An analysis of streaky performance on the LPGA Tour.

A study investigated the occurrence of streakiness among professional golfers on the LPGA Tour. For players, individually or as a group, the findings showed a significant tendency for players' par or better rounds to occur together and for players' above par rounds to occur together. However, the observed streakiness in players' scores was related to the difficulty of golf courses rather than to any inherent disposition of players' performances to be streaky. The results replicated those findings found on the PGA Tour and Senior PGA Tour.

Isolated traumatic rupture of the subscapularis tendon.

BACKGROUND: Although rotator cuff tears are well documented in the literature, there have been relatively few reported cases of isolated subscapularis tears. To our knowledge, no case has been reported that describes an isolated subscapularis tear in a woman without anterior shoulder dislocation or bony avulsion. METHODS: This report outlines the case of a healthy 46-year-old woman with no history of shoulder problems who sustained injury to her right shoulder while hanging a light fixture. We highlight several key points to early diagnosis and underscore operative management for a successful outcome. RESULTS AND CONCLUSIONS: Isolated subscapularis tendon ruptures are uncommon in women. Increased vigilance during the history and physical examination is necessary to detect these injuries. Subscapularis tendon ruptures are commonly mistaken for degenerative rotator cuff tears or subacromial impingement syndrome. The lift-off test can isolate a subscapularis injury. Pertinent radiographic and magnetic resonance imaging findings are described.

Do professional golfers "choke"?

A study involving results of the PGA Tour, Senior PGA Tour, and the LPGA Tour investigated whether "choking under pressure" occurs among professional golfers. Players were individuals who either were leading going into the final round or within five strokes of the lead. It was hypothesized that players who were one stroke from the lead and to a lesser extent players who were leading should have higher final round scores than those players who were two or more strokes from the lead ("choking"). However, the results did not support the choking hypothesis. Players who were leading going into the final round won the majority of the time.

Evaluating the phenomenon of choking in professional golfers.

A study involving 775 professional golfers investigated whether choking occurs in the PGA Tour's Qualifying Tournaments, known among golfers for its high pressure. It was hypothesized that players who were near or at the cutoff for earning a tour card would have higher final round scores than players whose scores entering the final round were either four or five strokes better or worse. However, the data did not support a choking hypothesis. There were no significant differences in final round scores for the conditions.

The Menstrual Cycle, Sex Hormones, and Anterior Cruciate Ligament Injury.

OBJECTIVE: To determine if anterior cruciate ligament (ACL) injuries in female athletes occur randomly or correlate with a specific phase of the menstrual cycle. DESIGN AND SETTING: Female athletes who sustained ACL injuries reported the days of their menstrual cycles and provided saliva samples for sex-hormone determination. Salivary sex-hormone profiles were assessed to confirm the self-reported menstrual histories. SUBJECTS: A total of 38 female athletes (20 college, 15 high school, 1 middle school, 2 recreational) with recent ACL injuries participated in the study over a 3-year period. MEASUREMENTS: Athletes with recent ACL injuries completed a questionnaire defining the injury, the last menstrual cycle, prior knee injury, school, and type of birth control used (if any). Each subject provided a 30-cc saliva sample within 72 hours of injury. Saliva samples were placed into sealed containers and frozen at -20 degrees C. We obtained 13 additional control samples from uninjured females to test the correlation between saliva and serum sex-hormone levels. Progesterone and estrogen were assayed by radioimmunoassay. Physical examination, magnetic resonance imaging, or surgery confirmed the injury in all subjects. RESULTS: The correlations between saliva and serum estrogen and progesterone were 0.73 (alpha =.01) and 0.72 (alpha =.01), respectively. Ten of 27 athletes who reported their cycle day at time of injury sustained an ACL injury immediately before or 1 to 2 days after the onset of menses. We rejected the null hypothesis that such high frequency was due to random chance. CONCLUSIONS: A significantly greater number of ACL injuries occurred on days 1 and 2 of the menstrual cycle. Salivary sex-hormone levels correlated with the reported cycle day.